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‘Goodie bag’ pill mill doctor sentenced to 2 decades in prison

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Thu, 05/12/2022 - 13:29

 

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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

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A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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

 

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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

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TV time related to poor eating in toddlers

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Mon, 05/02/2022 - 14:29

Toddlers who watched more TV were significantly more likely than those who watched less TV to consume sugar-sweetened drinks and junk foods, based on data from 529 children.

Previous research had shown an association between screen time and poor diet, but most have involved school-aged children; the relationship in toddlers has not been well studied, Melissa R. Lutz, MD, of Johns Hopkins University, Baltimore, said in a presentation at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics currently recommends no digital media for children younger than 18-24 months, and an hour or less daily for children aged 2-5 years.

To examine the association between TV time and dietary practices in 2-year-olds, the researchers conducted a secondary analysis of data from 529 children who presented for their 2-year-old well-child visit at a single center. The study population was 52% Latino/Hispanic and 30% non-Latino/Hispanic Black, and 69% had an annual household income less than $20,000. The median time spent watching TV daily was 42 minutes. The data were taken from participants in the Greenlight Intervention Study, a randomized trial of an obesity prevention program at four academic pediatric primary care clinics in the United States.

Daily screen time and dietary practices were based on parent reports, and included daily volume of juice, daily counts of fruits and vegetables, daily count of junk foods such as chips, ice cream, French fries, and fast food, and consumption of sugar-sweetened beverages. The cross-sectional analysis controlled for race/ethnicity, Women, Infants, and Children Program benefits, number of children at home, caregiver education level, and family income.

In adjusted analysis, more than an hour of TV time was significantly associated with junk food intake, with odds ratios of 1.12 for 90 minutes and 1.25 for 120 minutes (P < .05 for both). Similar associations were seen for TV times of 90 minutes and 120 minutes and intake of fast food and sugar-sweetened beverages.

Additionally, the researchers found that toddlers who watched TV during mealtimes were more than twice as likely to consume sugar-sweetened beverages (OR, 2.74), junk food (OR, 2.72), fast food (OR, 2.09), and only about half as likely to consume fruits and vegetables (OR, 0.62).

The study findings were limited by several factors including the cross-sectional design, the reliance on caregiver self-reports, potential for residual confounding, and the low average screen time, Dr. Lutz noted.

However, the results suggest that “increased screen TV time and mealtime TV were both associated with poor dietary practices in 2-year-old children,” she said.

Future research should include analysis of passive screen time, as well as the relationship between screen time and diet with other digital devices beyond TV, she added.
 

COVID drove screen time higher

The current study is especially important at this time because of the increased screen exposure for many young children in the wake of the ongoing pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. “Screen time use is up even more than before [the pandemic], and this study is a reminder to ask parents of young children about screen time and dietary history.”

Dr. Kinsella said she was not surprised by the study findings. In her practice, “I see families with more screen time use in general who also are more likely to have juice and junk food available. If kids had no access to screens, I believe they would still have access to unhealthy foods. I believe more research is needed into why screen time is so high in some families.”

The study received funding from NIH. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

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Toddlers who watched more TV were significantly more likely than those who watched less TV to consume sugar-sweetened drinks and junk foods, based on data from 529 children.

Previous research had shown an association between screen time and poor diet, but most have involved school-aged children; the relationship in toddlers has not been well studied, Melissa R. Lutz, MD, of Johns Hopkins University, Baltimore, said in a presentation at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics currently recommends no digital media for children younger than 18-24 months, and an hour or less daily for children aged 2-5 years.

To examine the association between TV time and dietary practices in 2-year-olds, the researchers conducted a secondary analysis of data from 529 children who presented for their 2-year-old well-child visit at a single center. The study population was 52% Latino/Hispanic and 30% non-Latino/Hispanic Black, and 69% had an annual household income less than $20,000. The median time spent watching TV daily was 42 minutes. The data were taken from participants in the Greenlight Intervention Study, a randomized trial of an obesity prevention program at four academic pediatric primary care clinics in the United States.

Daily screen time and dietary practices were based on parent reports, and included daily volume of juice, daily counts of fruits and vegetables, daily count of junk foods such as chips, ice cream, French fries, and fast food, and consumption of sugar-sweetened beverages. The cross-sectional analysis controlled for race/ethnicity, Women, Infants, and Children Program benefits, number of children at home, caregiver education level, and family income.

In adjusted analysis, more than an hour of TV time was significantly associated with junk food intake, with odds ratios of 1.12 for 90 minutes and 1.25 for 120 minutes (P < .05 for both). Similar associations were seen for TV times of 90 minutes and 120 minutes and intake of fast food and sugar-sweetened beverages.

Additionally, the researchers found that toddlers who watched TV during mealtimes were more than twice as likely to consume sugar-sweetened beverages (OR, 2.74), junk food (OR, 2.72), fast food (OR, 2.09), and only about half as likely to consume fruits and vegetables (OR, 0.62).

The study findings were limited by several factors including the cross-sectional design, the reliance on caregiver self-reports, potential for residual confounding, and the low average screen time, Dr. Lutz noted.

However, the results suggest that “increased screen TV time and mealtime TV were both associated with poor dietary practices in 2-year-old children,” she said.

Future research should include analysis of passive screen time, as well as the relationship between screen time and diet with other digital devices beyond TV, she added.
 

COVID drove screen time higher

The current study is especially important at this time because of the increased screen exposure for many young children in the wake of the ongoing pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. “Screen time use is up even more than before [the pandemic], and this study is a reminder to ask parents of young children about screen time and dietary history.”

Dr. Kinsella said she was not surprised by the study findings. In her practice, “I see families with more screen time use in general who also are more likely to have juice and junk food available. If kids had no access to screens, I believe they would still have access to unhealthy foods. I believe more research is needed into why screen time is so high in some families.”

The study received funding from NIH. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Toddlers who watched more TV were significantly more likely than those who watched less TV to consume sugar-sweetened drinks and junk foods, based on data from 529 children.

Previous research had shown an association between screen time and poor diet, but most have involved school-aged children; the relationship in toddlers has not been well studied, Melissa R. Lutz, MD, of Johns Hopkins University, Baltimore, said in a presentation at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics currently recommends no digital media for children younger than 18-24 months, and an hour or less daily for children aged 2-5 years.

To examine the association between TV time and dietary practices in 2-year-olds, the researchers conducted a secondary analysis of data from 529 children who presented for their 2-year-old well-child visit at a single center. The study population was 52% Latino/Hispanic and 30% non-Latino/Hispanic Black, and 69% had an annual household income less than $20,000. The median time spent watching TV daily was 42 minutes. The data were taken from participants in the Greenlight Intervention Study, a randomized trial of an obesity prevention program at four academic pediatric primary care clinics in the United States.

Daily screen time and dietary practices were based on parent reports, and included daily volume of juice, daily counts of fruits and vegetables, daily count of junk foods such as chips, ice cream, French fries, and fast food, and consumption of sugar-sweetened beverages. The cross-sectional analysis controlled for race/ethnicity, Women, Infants, and Children Program benefits, number of children at home, caregiver education level, and family income.

In adjusted analysis, more than an hour of TV time was significantly associated with junk food intake, with odds ratios of 1.12 for 90 minutes and 1.25 for 120 minutes (P < .05 for both). Similar associations were seen for TV times of 90 minutes and 120 minutes and intake of fast food and sugar-sweetened beverages.

Additionally, the researchers found that toddlers who watched TV during mealtimes were more than twice as likely to consume sugar-sweetened beverages (OR, 2.74), junk food (OR, 2.72), fast food (OR, 2.09), and only about half as likely to consume fruits and vegetables (OR, 0.62).

The study findings were limited by several factors including the cross-sectional design, the reliance on caregiver self-reports, potential for residual confounding, and the low average screen time, Dr. Lutz noted.

However, the results suggest that “increased screen TV time and mealtime TV were both associated with poor dietary practices in 2-year-old children,” she said.

Future research should include analysis of passive screen time, as well as the relationship between screen time and diet with other digital devices beyond TV, she added.
 

COVID drove screen time higher

The current study is especially important at this time because of the increased screen exposure for many young children in the wake of the ongoing pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. “Screen time use is up even more than before [the pandemic], and this study is a reminder to ask parents of young children about screen time and dietary history.”

Dr. Kinsella said she was not surprised by the study findings. In her practice, “I see families with more screen time use in general who also are more likely to have juice and junk food available. If kids had no access to screens, I believe they would still have access to unhealthy foods. I believe more research is needed into why screen time is so high in some families.”

The study received funding from NIH. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

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Denosumab boosts bone strength in glucocorticoid users

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Tue, 04/12/2022 - 10:38

Bone strength and microarchitecture remained stronger at 24 months after treatment with denosumab compared to risedronate, in a study of 110 adults using glucocorticoids.

Patients using glucocorticoids are at increased risk for vertebral and nonvertebral fractures at both the start of treatment or as treatment continues, wrote Piet Geusens, MD, of Maastricht University, the Netherlands, and colleagues.

Dr. Piet Geusens

Imaging data collected via high-resolution peripheral quantitative computed tomography (HR-pQCT) allow for the assessment of bone microarchitecture and strength, but specific data comparing the impact of bone treatment in patients using glucocorticoids are lacking, they said.

In a study published in the Journal of Bone and Mineral Research, the researchers identified a subset of 56 patients randomized to denosumab and 54 to risedronate patients out of a total of 590 patients who were enrolled in a phase 3 randomized, controlled trial of denosumab vs. risedronate for bone mineral density. The main results of the larger trial – presented at EULAR 2018 – showed greater increases in bone strength with denosumab over risedronate in patients receiving glucocorticoids.

In the current study, the researchers reviewed HR-pQCT scans of the distal radius and tibia at baseline, 12 months, and 24 months. Bone strength and microarchitecture were defined in terms of failure load (FL) as a primary outcome. Patients also were divided into subpopulations of those initiating glucocorticoid treatment (GC-I) and continuing treatment (GC-C).

Baseline characteristics were mainly balanced among the treatment groups within the GC-I and GC-C categories.

Among the GC-I patients, in the denosumab group, FL increased significantly from baseline to 12 months at the radius at tibia (1.8% and 1.7%, respectively) but did not change significantly in the risedronate group, which translated to a significant treatment difference between the drugs of 3.3% for radius and 2.5% for tibia.



At 24 months, the radius measure of FL was unchanged from baseline in denosumab patients but significantly decreased in risedronate patients, with a difference of –4.1%, which translated to a significant between-treatment difference at the radius of 5.6% (P < .001). Changes at the tibia were not significantly different between the groups at 24 months.

Among the GC-C patients, FL was unchanged from baseline to 12 months for both the denosumab and risedronate groups. However, FL significantly increased with denosumab (4.3%) and remained unchanged in the risedronate group.

The researchers also found significant differences between denosumab and risedronate in percentage changes in cortical bone mineral density, and less prominent changes and differences in trabecular bone mineral density.

The study findings were limited by several factors including the use of the HR-pQCT scanner, which limits the measurement of trabecular microarchitecture, and the use of only standard HR-pQCT parameters, which do not allow insight into endosteal changes, and the inability to correct for multiplicity of data, the researchers noted.

However, the results support the superiority of denosumab over risedronate for preventing FL and total bone mineral density loss at the radius and tibia in new glucocorticoid users, and for increasing FL and total bone mineral density at the radius in long-term glucocorticoid users, they said.

Denosumab therefore could be a useful therapeutic option and could inform decision-making in patients initiating GC-therapy or on long-term GC-therapy, they concluded.

The study was supported by Amgen. Dr. Geusens disclosed grants from Amgen, Celgene, Lilly, Merck, Pfizer, Roche, UCB, Fresenius, Mylan, and Sandoz, and grants and other funding from AbbVie, outside the current study.

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Bone strength and microarchitecture remained stronger at 24 months after treatment with denosumab compared to risedronate, in a study of 110 adults using glucocorticoids.

Patients using glucocorticoids are at increased risk for vertebral and nonvertebral fractures at both the start of treatment or as treatment continues, wrote Piet Geusens, MD, of Maastricht University, the Netherlands, and colleagues.

Dr. Piet Geusens

Imaging data collected via high-resolution peripheral quantitative computed tomography (HR-pQCT) allow for the assessment of bone microarchitecture and strength, but specific data comparing the impact of bone treatment in patients using glucocorticoids are lacking, they said.

In a study published in the Journal of Bone and Mineral Research, the researchers identified a subset of 56 patients randomized to denosumab and 54 to risedronate patients out of a total of 590 patients who were enrolled in a phase 3 randomized, controlled trial of denosumab vs. risedronate for bone mineral density. The main results of the larger trial – presented at EULAR 2018 – showed greater increases in bone strength with denosumab over risedronate in patients receiving glucocorticoids.

In the current study, the researchers reviewed HR-pQCT scans of the distal radius and tibia at baseline, 12 months, and 24 months. Bone strength and microarchitecture were defined in terms of failure load (FL) as a primary outcome. Patients also were divided into subpopulations of those initiating glucocorticoid treatment (GC-I) and continuing treatment (GC-C).

Baseline characteristics were mainly balanced among the treatment groups within the GC-I and GC-C categories.

Among the GC-I patients, in the denosumab group, FL increased significantly from baseline to 12 months at the radius at tibia (1.8% and 1.7%, respectively) but did not change significantly in the risedronate group, which translated to a significant treatment difference between the drugs of 3.3% for radius and 2.5% for tibia.



At 24 months, the radius measure of FL was unchanged from baseline in denosumab patients but significantly decreased in risedronate patients, with a difference of –4.1%, which translated to a significant between-treatment difference at the radius of 5.6% (P < .001). Changes at the tibia were not significantly different between the groups at 24 months.

Among the GC-C patients, FL was unchanged from baseline to 12 months for both the denosumab and risedronate groups. However, FL significantly increased with denosumab (4.3%) and remained unchanged in the risedronate group.

The researchers also found significant differences between denosumab and risedronate in percentage changes in cortical bone mineral density, and less prominent changes and differences in trabecular bone mineral density.

The study findings were limited by several factors including the use of the HR-pQCT scanner, which limits the measurement of trabecular microarchitecture, and the use of only standard HR-pQCT parameters, which do not allow insight into endosteal changes, and the inability to correct for multiplicity of data, the researchers noted.

However, the results support the superiority of denosumab over risedronate for preventing FL and total bone mineral density loss at the radius and tibia in new glucocorticoid users, and for increasing FL and total bone mineral density at the radius in long-term glucocorticoid users, they said.

Denosumab therefore could be a useful therapeutic option and could inform decision-making in patients initiating GC-therapy or on long-term GC-therapy, they concluded.

The study was supported by Amgen. Dr. Geusens disclosed grants from Amgen, Celgene, Lilly, Merck, Pfizer, Roche, UCB, Fresenius, Mylan, and Sandoz, and grants and other funding from AbbVie, outside the current study.

Bone strength and microarchitecture remained stronger at 24 months after treatment with denosumab compared to risedronate, in a study of 110 adults using glucocorticoids.

Patients using glucocorticoids are at increased risk for vertebral and nonvertebral fractures at both the start of treatment or as treatment continues, wrote Piet Geusens, MD, of Maastricht University, the Netherlands, and colleagues.

Dr. Piet Geusens

Imaging data collected via high-resolution peripheral quantitative computed tomography (HR-pQCT) allow for the assessment of bone microarchitecture and strength, but specific data comparing the impact of bone treatment in patients using glucocorticoids are lacking, they said.

In a study published in the Journal of Bone and Mineral Research, the researchers identified a subset of 56 patients randomized to denosumab and 54 to risedronate patients out of a total of 590 patients who were enrolled in a phase 3 randomized, controlled trial of denosumab vs. risedronate for bone mineral density. The main results of the larger trial – presented at EULAR 2018 – showed greater increases in bone strength with denosumab over risedronate in patients receiving glucocorticoids.

In the current study, the researchers reviewed HR-pQCT scans of the distal radius and tibia at baseline, 12 months, and 24 months. Bone strength and microarchitecture were defined in terms of failure load (FL) as a primary outcome. Patients also were divided into subpopulations of those initiating glucocorticoid treatment (GC-I) and continuing treatment (GC-C).

Baseline characteristics were mainly balanced among the treatment groups within the GC-I and GC-C categories.

Among the GC-I patients, in the denosumab group, FL increased significantly from baseline to 12 months at the radius at tibia (1.8% and 1.7%, respectively) but did not change significantly in the risedronate group, which translated to a significant treatment difference between the drugs of 3.3% for radius and 2.5% for tibia.



At 24 months, the radius measure of FL was unchanged from baseline in denosumab patients but significantly decreased in risedronate patients, with a difference of –4.1%, which translated to a significant between-treatment difference at the radius of 5.6% (P < .001). Changes at the tibia were not significantly different between the groups at 24 months.

Among the GC-C patients, FL was unchanged from baseline to 12 months for both the denosumab and risedronate groups. However, FL significantly increased with denosumab (4.3%) and remained unchanged in the risedronate group.

The researchers also found significant differences between denosumab and risedronate in percentage changes in cortical bone mineral density, and less prominent changes and differences in trabecular bone mineral density.

The study findings were limited by several factors including the use of the HR-pQCT scanner, which limits the measurement of trabecular microarchitecture, and the use of only standard HR-pQCT parameters, which do not allow insight into endosteal changes, and the inability to correct for multiplicity of data, the researchers noted.

However, the results support the superiority of denosumab over risedronate for preventing FL and total bone mineral density loss at the radius and tibia in new glucocorticoid users, and for increasing FL and total bone mineral density at the radius in long-term glucocorticoid users, they said.

Denosumab therefore could be a useful therapeutic option and could inform decision-making in patients initiating GC-therapy or on long-term GC-therapy, they concluded.

The study was supported by Amgen. Dr. Geusens disclosed grants from Amgen, Celgene, Lilly, Merck, Pfizer, Roche, UCB, Fresenius, Mylan, and Sandoz, and grants and other funding from AbbVie, outside the current study.

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Children and teens with food allergies face quality-of-life issues

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Tue, 04/05/2022 - 16:42

Children and adolescents with food allergies appear to fare worse physically, socially, and emotionally, and have poorer overall health-related quality of life (HRQL) than their food allergy–free peers, a new systematic review suggests.

“Findings from the current review suggest that food allergy has a negative impact on the HRQL of children and teens, particularly older children and those with severe food allergy,” the authors wrote. “By comparison, the link between food allergy and psychosocial functioning is less clear.

“Evidence from the qualitative literature suggests that the burden of childhood food allergy largely stems from worries surrounding exposures outside of the home and the social consequences of the condition,” they added.

Lead study author Michael A. Golding, a research coordinator at Children’s Hospital Research Institute of Manitoba in Winnipeg, Canada, and colleagues searched PubMed, Scopus, PsycInfo, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases on several days between November 2019 and March 2021 for peer-reviewed articles published in English in any year.  

They reviewed articles focused on HRQL, psychological health, or social well-being in children and teens with food allergy from birth through 19 years of age. Food allergy comprised both immunoglobulin E (IgE)-mediated food allergies and non-IgE-mediated allergies, including food protein–induced enterocolitis, enteropathy, and proctocolitis.

From the 3,789 publications the researchers screened, they included 8,202 patients in 45 studies in their quantitative synthesis and 186 patients in 9 studies in their qualitative synthesis. Using a segregated, mixed research synthesis design, they analyzed and synthesized the quantitative and qualitative articles separately, then integrated those findings.
 

Navigating through many challenges

The authors found that food allergy lowered the young people’s HRQL. In 11 of the 14 studies (78%) that included a comparison group, young patients with food allergy showed significantly lower HRQL in at least one domain. Most significant differences occurred in domains related to total HRQL (66%), social functioning (58%), emotional functioning (54%), and physical functioning (54%). 

Parents were often more likely than their children to perceive that the child’s food allergy was causing problems.

Between 20% and 32% of children reported bullying related to their food allergy. Many children reported that their allergy sometimes isolated them from their classmates.

Many children described feeling comfortable at home but worried in places where they had less control, such as school, restaurants, or when traveling.

Children and teens tended to downplay their limitations and the negative impacts of their condition.

Older children who had been diagnosed early in life tended to accept managing their food allergy as a way of life, whereas those diagnosed when they were older reported the need to adapt, accept, and grieve the loss of foods and experiences.

“This study highlights the importance of addressing the underlying impact that food allergy can have on patients’ mental health and social functioning,” Kelly Marie O’Shea, MD, assistant professor of allergy and immunology at University of Michigan Health in Ann Arbor, said in an interview.

“While it has been shown previously that food-allergic patients have lower HRQL, this systematic review aptly reveals that for children and teens with food allergy, overall quality of life, including psychosocial functioning, can also be negatively affected,” said Dr. O’Shea, who was not involved in the study.

“Symptoms of anxiety and depression are reported at higher rates in the food-allergic population, and social limitations have been shown to play a role,” she explained. “However, as revealed in this study, longitudinal and appropriately controlled studies to investigate the impact of food allergy on psychosocial outcomes in children and teens are scarce.”

Robert Alan Wood, MD, professor of pediatrics at Johns Hopkins University and director of pediatric allergy and immunology at Johns Hopkins Children’s Center, Baltimore, told this news organization that the effects of food allergy on mental health are not fully appreciated by the public or by many clinicians.

“These findings emphasize the need to recognize the emotional consequences of food allergy and to take steps to be proactive in managing these issues among our patients,” said Dr. Wood, who was not associated with the study.
 

More research is needed

The authors noted that more research is needed to examine links between food allergy, HRQL, and psychosocial outcome; links between food allergy and bullying; and how challenges change over time. They recommend exploring the relative impacts of specific types of food allergy and whether specific traits in young people with food allergy make them more susceptible to its psychological effects. They also call for efforts to identify and help young people with food allergy overcome their many challenges.

The study was funded by the Canadian Institutes for Health Research, the Children’s Hospital Research Institute of Manitoba, and the University of Manitoba.

Study senior author Jennifer L. P. Protudjer, PhD, reported involvement with Canada’s National Food Allergy Action Plan and Allied Health at the Canadian Society of Allergy and Clinical Immunology, and receipt of fees from Novartis. The remaining authors, as well as Dr. O’Shea and Dr. Wood, reported no relevant financial relationships.

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

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Children and adolescents with food allergies appear to fare worse physically, socially, and emotionally, and have poorer overall health-related quality of life (HRQL) than their food allergy–free peers, a new systematic review suggests.

“Findings from the current review suggest that food allergy has a negative impact on the HRQL of children and teens, particularly older children and those with severe food allergy,” the authors wrote. “By comparison, the link between food allergy and psychosocial functioning is less clear.

“Evidence from the qualitative literature suggests that the burden of childhood food allergy largely stems from worries surrounding exposures outside of the home and the social consequences of the condition,” they added.

Lead study author Michael A. Golding, a research coordinator at Children’s Hospital Research Institute of Manitoba in Winnipeg, Canada, and colleagues searched PubMed, Scopus, PsycInfo, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases on several days between November 2019 and March 2021 for peer-reviewed articles published in English in any year.  

They reviewed articles focused on HRQL, psychological health, or social well-being in children and teens with food allergy from birth through 19 years of age. Food allergy comprised both immunoglobulin E (IgE)-mediated food allergies and non-IgE-mediated allergies, including food protein–induced enterocolitis, enteropathy, and proctocolitis.

From the 3,789 publications the researchers screened, they included 8,202 patients in 45 studies in their quantitative synthesis and 186 patients in 9 studies in their qualitative synthesis. Using a segregated, mixed research synthesis design, they analyzed and synthesized the quantitative and qualitative articles separately, then integrated those findings.
 

Navigating through many challenges

The authors found that food allergy lowered the young people’s HRQL. In 11 of the 14 studies (78%) that included a comparison group, young patients with food allergy showed significantly lower HRQL in at least one domain. Most significant differences occurred in domains related to total HRQL (66%), social functioning (58%), emotional functioning (54%), and physical functioning (54%). 

Parents were often more likely than their children to perceive that the child’s food allergy was causing problems.

Between 20% and 32% of children reported bullying related to their food allergy. Many children reported that their allergy sometimes isolated them from their classmates.

Many children described feeling comfortable at home but worried in places where they had less control, such as school, restaurants, or when traveling.

Children and teens tended to downplay their limitations and the negative impacts of their condition.

Older children who had been diagnosed early in life tended to accept managing their food allergy as a way of life, whereas those diagnosed when they were older reported the need to adapt, accept, and grieve the loss of foods and experiences.

“This study highlights the importance of addressing the underlying impact that food allergy can have on patients’ mental health and social functioning,” Kelly Marie O’Shea, MD, assistant professor of allergy and immunology at University of Michigan Health in Ann Arbor, said in an interview.

“While it has been shown previously that food-allergic patients have lower HRQL, this systematic review aptly reveals that for children and teens with food allergy, overall quality of life, including psychosocial functioning, can also be negatively affected,” said Dr. O’Shea, who was not involved in the study.

“Symptoms of anxiety and depression are reported at higher rates in the food-allergic population, and social limitations have been shown to play a role,” she explained. “However, as revealed in this study, longitudinal and appropriately controlled studies to investigate the impact of food allergy on psychosocial outcomes in children and teens are scarce.”

Robert Alan Wood, MD, professor of pediatrics at Johns Hopkins University and director of pediatric allergy and immunology at Johns Hopkins Children’s Center, Baltimore, told this news organization that the effects of food allergy on mental health are not fully appreciated by the public or by many clinicians.

“These findings emphasize the need to recognize the emotional consequences of food allergy and to take steps to be proactive in managing these issues among our patients,” said Dr. Wood, who was not associated with the study.
 

More research is needed

The authors noted that more research is needed to examine links between food allergy, HRQL, and psychosocial outcome; links between food allergy and bullying; and how challenges change over time. They recommend exploring the relative impacts of specific types of food allergy and whether specific traits in young people with food allergy make them more susceptible to its psychological effects. They also call for efforts to identify and help young people with food allergy overcome their many challenges.

The study was funded by the Canadian Institutes for Health Research, the Children’s Hospital Research Institute of Manitoba, and the University of Manitoba.

Study senior author Jennifer L. P. Protudjer, PhD, reported involvement with Canada’s National Food Allergy Action Plan and Allied Health at the Canadian Society of Allergy and Clinical Immunology, and receipt of fees from Novartis. The remaining authors, as well as Dr. O’Shea and Dr. Wood, reported no relevant financial relationships.

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

Children and adolescents with food allergies appear to fare worse physically, socially, and emotionally, and have poorer overall health-related quality of life (HRQL) than their food allergy–free peers, a new systematic review suggests.

“Findings from the current review suggest that food allergy has a negative impact on the HRQL of children and teens, particularly older children and those with severe food allergy,” the authors wrote. “By comparison, the link between food allergy and psychosocial functioning is less clear.

“Evidence from the qualitative literature suggests that the burden of childhood food allergy largely stems from worries surrounding exposures outside of the home and the social consequences of the condition,” they added.

Lead study author Michael A. Golding, a research coordinator at Children’s Hospital Research Institute of Manitoba in Winnipeg, Canada, and colleagues searched PubMed, Scopus, PsycInfo, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases on several days between November 2019 and March 2021 for peer-reviewed articles published in English in any year.  

They reviewed articles focused on HRQL, psychological health, or social well-being in children and teens with food allergy from birth through 19 years of age. Food allergy comprised both immunoglobulin E (IgE)-mediated food allergies and non-IgE-mediated allergies, including food protein–induced enterocolitis, enteropathy, and proctocolitis.

From the 3,789 publications the researchers screened, they included 8,202 patients in 45 studies in their quantitative synthesis and 186 patients in 9 studies in their qualitative synthesis. Using a segregated, mixed research synthesis design, they analyzed and synthesized the quantitative and qualitative articles separately, then integrated those findings.
 

Navigating through many challenges

The authors found that food allergy lowered the young people’s HRQL. In 11 of the 14 studies (78%) that included a comparison group, young patients with food allergy showed significantly lower HRQL in at least one domain. Most significant differences occurred in domains related to total HRQL (66%), social functioning (58%), emotional functioning (54%), and physical functioning (54%). 

Parents were often more likely than their children to perceive that the child’s food allergy was causing problems.

Between 20% and 32% of children reported bullying related to their food allergy. Many children reported that their allergy sometimes isolated them from their classmates.

Many children described feeling comfortable at home but worried in places where they had less control, such as school, restaurants, or when traveling.

Children and teens tended to downplay their limitations and the negative impacts of their condition.

Older children who had been diagnosed early in life tended to accept managing their food allergy as a way of life, whereas those diagnosed when they were older reported the need to adapt, accept, and grieve the loss of foods and experiences.

“This study highlights the importance of addressing the underlying impact that food allergy can have on patients’ mental health and social functioning,” Kelly Marie O’Shea, MD, assistant professor of allergy and immunology at University of Michigan Health in Ann Arbor, said in an interview.

“While it has been shown previously that food-allergic patients have lower HRQL, this systematic review aptly reveals that for children and teens with food allergy, overall quality of life, including psychosocial functioning, can also be negatively affected,” said Dr. O’Shea, who was not involved in the study.

“Symptoms of anxiety and depression are reported at higher rates in the food-allergic population, and social limitations have been shown to play a role,” she explained. “However, as revealed in this study, longitudinal and appropriately controlled studies to investigate the impact of food allergy on psychosocial outcomes in children and teens are scarce.”

Robert Alan Wood, MD, professor of pediatrics at Johns Hopkins University and director of pediatric allergy and immunology at Johns Hopkins Children’s Center, Baltimore, told this news organization that the effects of food allergy on mental health are not fully appreciated by the public or by many clinicians.

“These findings emphasize the need to recognize the emotional consequences of food allergy and to take steps to be proactive in managing these issues among our patients,” said Dr. Wood, who was not associated with the study.
 

More research is needed

The authors noted that more research is needed to examine links between food allergy, HRQL, and psychosocial outcome; links between food allergy and bullying; and how challenges change over time. They recommend exploring the relative impacts of specific types of food allergy and whether specific traits in young people with food allergy make them more susceptible to its psychological effects. They also call for efforts to identify and help young people with food allergy overcome their many challenges.

The study was funded by the Canadian Institutes for Health Research, the Children’s Hospital Research Institute of Manitoba, and the University of Manitoba.

Study senior author Jennifer L. P. Protudjer, PhD, reported involvement with Canada’s National Food Allergy Action Plan and Allied Health at the Canadian Society of Allergy and Clinical Immunology, and receipt of fees from Novartis. The remaining authors, as well as Dr. O’Shea and Dr. Wood, reported no relevant financial relationships.

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

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The vegan diet is popular but not automatically healthy

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A vegetarian or vegan diet is said to be particularly popular among girls and young women. But despite what some people think, these diets, especially vegan diets, are not automatically healthy. A vegan diet can lead to nutritional deficits as a result of the limited choice of foods. These deficits can cause clinically relevant symptoms if they are not balanced out. One of the things to keep in mind is the need for a sufficient amount of vitamins B12 and B6, as well as vitamin D, explains nutritional scientist Bettina Dörr, PhD, from Munich, who specializes in how nutritional science is applied in everyday practice.

Vegetarian and vegan diets

According to Dr. Dörr, vegetarian diets can be categorized into the following main types:

  • Ovo-lacto vegetarian (excludes meat and fish).
  • Ovo vegetarian (excludes meat, fish, and dairy products).
  • Lacto vegetarian (excludes meat, fish, and eggs).
  • Vegan (excludes meat, fish, eggs, dairy products, and honey).
  • Raw vegan (excludes meat, fish, eggs, dairy products, honey, and heated food).

The following are additional groups:

  • Fruitarians want to eat only plant products that do not result in any damage to the plant itself (apples and nuts, for example, but not carrots or potatoes).
  • Pescatarians exclude meat but still eat fish or seafood.
  • Dirty vegetarians avoid meat and fish but, according to Dr. Dörr, they do not pay particular attention to their diet and eat lots of ready-made and confectionery products.
  • Flexitarians value a balanced diet and eat meat or fish in moderation, but not particularly often.

Another diet is the orthorexic diet. Followers of this diet force themselves to have a healthy diet and are afraid of getting sick from unhealthy food. As the nutritional scientist explains, orthorexic persons set their own definitions of what is healthy. While some refrain from certain foods (e.g., household sugar), others eliminate whole food groups and eat nothing but raw food. Compulsive behavior can appear in specific methods of food preparation or adherence to fixed meal schedules.

The overwhelming majority of orthorexic persons are young women. As shown in a study from the University of Göttingen, orthorexic behavior is displayed above all in active women who play sports, particularly high-performance athletes. Children can also be affected by orthorexia if their parents are.

Critical nutrients

When following a vegan diet, it is possible to ingest sufficient critical nutrients, even with plant-based foods, according to Dr. Dörr. The prerequisite for this is good knowledge regarding food and nutrients. However, it is increasingly the case that foods are “simply left out,” without consideration of the consequences. This factor should be considered when providing medical advice.

Some of the important nutrients in this respect are proteins and vitamins B6, B12, and D.

Proteins

Girls need 0.9 g/kg per day of protein. For a person whose body weight is 60 kg, this corresponds to 54 g. The daily protein requirement for a person who weighs 60 kg can be fulfilled through a vegan diet. According to Dr. Dörr, 54 g of protein is contained in 300 g of tofu, 350 g of cooked soybeans, 350 g of hazelnuts, 750 g of whole grain bread (15 slices at 50 g each), 750 g of cooked lentils, and 1 kg of white beans.

 

 

Vitamin B6

Vitamin B6 (pyridoxine) has, Dr. Dörr explains, multiple metabolic functions, especially in the metabolization of amino acids, and is important from a neurologic perspective. For girls, the vitamin is important for hormone metabolism. Data show that approximately 14% of girls aged 14-18 years ingest less than the recommended amount of vitamin B6. For vegans, the percentage of those with insufficient intake is even higher, since vitamin B6 has low bioavailability in plant-based foods. For girls, there is the additional factor of oral contraceptives. There are indications that those who use oral contraceptives containing estrogen have lower levels of pyridoxal-5’-phosphate (PLP), a marker for vitamin B6. Since the PLP-dependent enzymes are essential for the synthesis of hormones such as serotonin, symptoms such as depressive moods, increased irritability, nervousness, and loss of libido can indicate a vitamin B6 deficiency.

The daily B6 requirement for girls is 1.4 mg and can be fulfilled, for example, by consuming 200 g of hazelnuts, 200 g of walnuts, 400 g of bananas (two to three bananas, depending on weight), 700 g of cooked green beans, 1 kg of cooked potatoes, and 1.4 kg of oats.

Vitamin B12

Since vitamin B12 is not present in plant-based food, following a vegan diet in the long term can result in deficiency unless dietary supplements are taken. When researching the choices of various dietary supplements, it should be taken into consideration that the utilization of vitamin B12 from plant-based sources such as algae, seaweed, and fungi is not necessarily a given. Careful selection and regular monitoring of B12 status is recommended.

Vitamin D

According to Dr. Dörr, evidence has increased in recent years that vitamin D is crucial not only for the bones but also for numerous metabolic processes. The fact is that foods are barely capable of covering the vitamin D requirement in amounts that can be expected to be consumed. Vegan foods are not able to contribute to the supply of vitamin D, since considerable amounts are present only in food of an animal origin. The decision to take supplements and in what amounts should be made on the basis of one’s condition.

Minerals

Calcium, iodine, iron, selenium, and zinc are not easily available in sufficient quantities from a purely plant-based diet. Plant-based foods usually contain lower quantities of these minerals than do foods of animal origin, and the minerals from plant-based sources have lower bioavailability. According to Dr. Dörr, current evidence suggests that a vegan diet can have negative effects on bone health. In an ongoing cross-sectional study, ultrasound measurements of the heel bone are being made, and biomarkers in the blood and urine are being measured. On average, people who follow a vegan diet have lower ultrasound readings than those of omnivores.

The European Prospective Investigation into Cancer and Nutrition (EPIC) study from Great Britain, which involved almost 55,000 people, revealed that vegans had a 43% higher risk of fracture, compared to meat eaters.

An important nutrient, especially for cell development, is choline, which, Dr. Dörr explains, can be absorbed mainly through eating eggs, fish, meat, and dairy products. There is increasing evidence that a vegan diet is not able to supply sufficient quantities of choline, particularly if requirements increase, such as during pregnancy and breastfeeding. Evidence has grown that women who wish to conceive a child benefit not only from a sufficient intake of folate intake for the prevention of neural tube defects and for favorable fetal development but also from sufficient quantities of choline (the recommended daily amount for pregnant women is 480 mg).

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

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A vegetarian or vegan diet is said to be particularly popular among girls and young women. But despite what some people think, these diets, especially vegan diets, are not automatically healthy. A vegan diet can lead to nutritional deficits as a result of the limited choice of foods. These deficits can cause clinically relevant symptoms if they are not balanced out. One of the things to keep in mind is the need for a sufficient amount of vitamins B12 and B6, as well as vitamin D, explains nutritional scientist Bettina Dörr, PhD, from Munich, who specializes in how nutritional science is applied in everyday practice.

Vegetarian and vegan diets

According to Dr. Dörr, vegetarian diets can be categorized into the following main types:

  • Ovo-lacto vegetarian (excludes meat and fish).
  • Ovo vegetarian (excludes meat, fish, and dairy products).
  • Lacto vegetarian (excludes meat, fish, and eggs).
  • Vegan (excludes meat, fish, eggs, dairy products, and honey).
  • Raw vegan (excludes meat, fish, eggs, dairy products, honey, and heated food).

The following are additional groups:

  • Fruitarians want to eat only plant products that do not result in any damage to the plant itself (apples and nuts, for example, but not carrots or potatoes).
  • Pescatarians exclude meat but still eat fish or seafood.
  • Dirty vegetarians avoid meat and fish but, according to Dr. Dörr, they do not pay particular attention to their diet and eat lots of ready-made and confectionery products.
  • Flexitarians value a balanced diet and eat meat or fish in moderation, but not particularly often.

Another diet is the orthorexic diet. Followers of this diet force themselves to have a healthy diet and are afraid of getting sick from unhealthy food. As the nutritional scientist explains, orthorexic persons set their own definitions of what is healthy. While some refrain from certain foods (e.g., household sugar), others eliminate whole food groups and eat nothing but raw food. Compulsive behavior can appear in specific methods of food preparation or adherence to fixed meal schedules.

The overwhelming majority of orthorexic persons are young women. As shown in a study from the University of Göttingen, orthorexic behavior is displayed above all in active women who play sports, particularly high-performance athletes. Children can also be affected by orthorexia if their parents are.

Critical nutrients

When following a vegan diet, it is possible to ingest sufficient critical nutrients, even with plant-based foods, according to Dr. Dörr. The prerequisite for this is good knowledge regarding food and nutrients. However, it is increasingly the case that foods are “simply left out,” without consideration of the consequences. This factor should be considered when providing medical advice.

Some of the important nutrients in this respect are proteins and vitamins B6, B12, and D.

Proteins

Girls need 0.9 g/kg per day of protein. For a person whose body weight is 60 kg, this corresponds to 54 g. The daily protein requirement for a person who weighs 60 kg can be fulfilled through a vegan diet. According to Dr. Dörr, 54 g of protein is contained in 300 g of tofu, 350 g of cooked soybeans, 350 g of hazelnuts, 750 g of whole grain bread (15 slices at 50 g each), 750 g of cooked lentils, and 1 kg of white beans.

 

 

Vitamin B6

Vitamin B6 (pyridoxine) has, Dr. Dörr explains, multiple metabolic functions, especially in the metabolization of amino acids, and is important from a neurologic perspective. For girls, the vitamin is important for hormone metabolism. Data show that approximately 14% of girls aged 14-18 years ingest less than the recommended amount of vitamin B6. For vegans, the percentage of those with insufficient intake is even higher, since vitamin B6 has low bioavailability in plant-based foods. For girls, there is the additional factor of oral contraceptives. There are indications that those who use oral contraceptives containing estrogen have lower levels of pyridoxal-5’-phosphate (PLP), a marker for vitamin B6. Since the PLP-dependent enzymes are essential for the synthesis of hormones such as serotonin, symptoms such as depressive moods, increased irritability, nervousness, and loss of libido can indicate a vitamin B6 deficiency.

The daily B6 requirement for girls is 1.4 mg and can be fulfilled, for example, by consuming 200 g of hazelnuts, 200 g of walnuts, 400 g of bananas (two to three bananas, depending on weight), 700 g of cooked green beans, 1 kg of cooked potatoes, and 1.4 kg of oats.

Vitamin B12

Since vitamin B12 is not present in plant-based food, following a vegan diet in the long term can result in deficiency unless dietary supplements are taken. When researching the choices of various dietary supplements, it should be taken into consideration that the utilization of vitamin B12 from plant-based sources such as algae, seaweed, and fungi is not necessarily a given. Careful selection and regular monitoring of B12 status is recommended.

Vitamin D

According to Dr. Dörr, evidence has increased in recent years that vitamin D is crucial not only for the bones but also for numerous metabolic processes. The fact is that foods are barely capable of covering the vitamin D requirement in amounts that can be expected to be consumed. Vegan foods are not able to contribute to the supply of vitamin D, since considerable amounts are present only in food of an animal origin. The decision to take supplements and in what amounts should be made on the basis of one’s condition.

Minerals

Calcium, iodine, iron, selenium, and zinc are not easily available in sufficient quantities from a purely plant-based diet. Plant-based foods usually contain lower quantities of these minerals than do foods of animal origin, and the minerals from plant-based sources have lower bioavailability. According to Dr. Dörr, current evidence suggests that a vegan diet can have negative effects on bone health. In an ongoing cross-sectional study, ultrasound measurements of the heel bone are being made, and biomarkers in the blood and urine are being measured. On average, people who follow a vegan diet have lower ultrasound readings than those of omnivores.

The European Prospective Investigation into Cancer and Nutrition (EPIC) study from Great Britain, which involved almost 55,000 people, revealed that vegans had a 43% higher risk of fracture, compared to meat eaters.

An important nutrient, especially for cell development, is choline, which, Dr. Dörr explains, can be absorbed mainly through eating eggs, fish, meat, and dairy products. There is increasing evidence that a vegan diet is not able to supply sufficient quantities of choline, particularly if requirements increase, such as during pregnancy and breastfeeding. Evidence has grown that women who wish to conceive a child benefit not only from a sufficient intake of folate intake for the prevention of neural tube defects and for favorable fetal development but also from sufficient quantities of choline (the recommended daily amount for pregnant women is 480 mg).

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

 

A vegetarian or vegan diet is said to be particularly popular among girls and young women. But despite what some people think, these diets, especially vegan diets, are not automatically healthy. A vegan diet can lead to nutritional deficits as a result of the limited choice of foods. These deficits can cause clinically relevant symptoms if they are not balanced out. One of the things to keep in mind is the need for a sufficient amount of vitamins B12 and B6, as well as vitamin D, explains nutritional scientist Bettina Dörr, PhD, from Munich, who specializes in how nutritional science is applied in everyday practice.

Vegetarian and vegan diets

According to Dr. Dörr, vegetarian diets can be categorized into the following main types:

  • Ovo-lacto vegetarian (excludes meat and fish).
  • Ovo vegetarian (excludes meat, fish, and dairy products).
  • Lacto vegetarian (excludes meat, fish, and eggs).
  • Vegan (excludes meat, fish, eggs, dairy products, and honey).
  • Raw vegan (excludes meat, fish, eggs, dairy products, honey, and heated food).

The following are additional groups:

  • Fruitarians want to eat only plant products that do not result in any damage to the plant itself (apples and nuts, for example, but not carrots or potatoes).
  • Pescatarians exclude meat but still eat fish or seafood.
  • Dirty vegetarians avoid meat and fish but, according to Dr. Dörr, they do not pay particular attention to their diet and eat lots of ready-made and confectionery products.
  • Flexitarians value a balanced diet and eat meat or fish in moderation, but not particularly often.

Another diet is the orthorexic diet. Followers of this diet force themselves to have a healthy diet and are afraid of getting sick from unhealthy food. As the nutritional scientist explains, orthorexic persons set their own definitions of what is healthy. While some refrain from certain foods (e.g., household sugar), others eliminate whole food groups and eat nothing but raw food. Compulsive behavior can appear in specific methods of food preparation or adherence to fixed meal schedules.

The overwhelming majority of orthorexic persons are young women. As shown in a study from the University of Göttingen, orthorexic behavior is displayed above all in active women who play sports, particularly high-performance athletes. Children can also be affected by orthorexia if their parents are.

Critical nutrients

When following a vegan diet, it is possible to ingest sufficient critical nutrients, even with plant-based foods, according to Dr. Dörr. The prerequisite for this is good knowledge regarding food and nutrients. However, it is increasingly the case that foods are “simply left out,” without consideration of the consequences. This factor should be considered when providing medical advice.

Some of the important nutrients in this respect are proteins and vitamins B6, B12, and D.

Proteins

Girls need 0.9 g/kg per day of protein. For a person whose body weight is 60 kg, this corresponds to 54 g. The daily protein requirement for a person who weighs 60 kg can be fulfilled through a vegan diet. According to Dr. Dörr, 54 g of protein is contained in 300 g of tofu, 350 g of cooked soybeans, 350 g of hazelnuts, 750 g of whole grain bread (15 slices at 50 g each), 750 g of cooked lentils, and 1 kg of white beans.

 

 

Vitamin B6

Vitamin B6 (pyridoxine) has, Dr. Dörr explains, multiple metabolic functions, especially in the metabolization of amino acids, and is important from a neurologic perspective. For girls, the vitamin is important for hormone metabolism. Data show that approximately 14% of girls aged 14-18 years ingest less than the recommended amount of vitamin B6. For vegans, the percentage of those with insufficient intake is even higher, since vitamin B6 has low bioavailability in plant-based foods. For girls, there is the additional factor of oral contraceptives. There are indications that those who use oral contraceptives containing estrogen have lower levels of pyridoxal-5’-phosphate (PLP), a marker for vitamin B6. Since the PLP-dependent enzymes are essential for the synthesis of hormones such as serotonin, symptoms such as depressive moods, increased irritability, nervousness, and loss of libido can indicate a vitamin B6 deficiency.

The daily B6 requirement for girls is 1.4 mg and can be fulfilled, for example, by consuming 200 g of hazelnuts, 200 g of walnuts, 400 g of bananas (two to three bananas, depending on weight), 700 g of cooked green beans, 1 kg of cooked potatoes, and 1.4 kg of oats.

Vitamin B12

Since vitamin B12 is not present in plant-based food, following a vegan diet in the long term can result in deficiency unless dietary supplements are taken. When researching the choices of various dietary supplements, it should be taken into consideration that the utilization of vitamin B12 from plant-based sources such as algae, seaweed, and fungi is not necessarily a given. Careful selection and regular monitoring of B12 status is recommended.

Vitamin D

According to Dr. Dörr, evidence has increased in recent years that vitamin D is crucial not only for the bones but also for numerous metabolic processes. The fact is that foods are barely capable of covering the vitamin D requirement in amounts that can be expected to be consumed. Vegan foods are not able to contribute to the supply of vitamin D, since considerable amounts are present only in food of an animal origin. The decision to take supplements and in what amounts should be made on the basis of one’s condition.

Minerals

Calcium, iodine, iron, selenium, and zinc are not easily available in sufficient quantities from a purely plant-based diet. Plant-based foods usually contain lower quantities of these minerals than do foods of animal origin, and the minerals from plant-based sources have lower bioavailability. According to Dr. Dörr, current evidence suggests that a vegan diet can have negative effects on bone health. In an ongoing cross-sectional study, ultrasound measurements of the heel bone are being made, and biomarkers in the blood and urine are being measured. On average, people who follow a vegan diet have lower ultrasound readings than those of omnivores.

The European Prospective Investigation into Cancer and Nutrition (EPIC) study from Great Britain, which involved almost 55,000 people, revealed that vegans had a 43% higher risk of fracture, compared to meat eaters.

An important nutrient, especially for cell development, is choline, which, Dr. Dörr explains, can be absorbed mainly through eating eggs, fish, meat, and dairy products. There is increasing evidence that a vegan diet is not able to supply sufficient quantities of choline, particularly if requirements increase, such as during pregnancy and breastfeeding. Evidence has grown that women who wish to conceive a child benefit not only from a sufficient intake of folate intake for the prevention of neural tube defects and for favorable fetal development but also from sufficient quantities of choline (the recommended daily amount for pregnant women is 480 mg).

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

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Managing overuse of food IgE panels: Multiple approaches needed

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Mon, 03/07/2022 - 10:26

 

PHOENIX – For at least a decade, professional allergy and pediatrics societies have urged against using food IgE tests unless the patient has a history consistent with potential IgE-mediated food allergies. Yet virtually every health system offers these blood tests, and their inappropriate use – especially of panels that measure many allergens at once – remains a huge problem.

Beyond wasteful spending, excessive food IgE testing can lead patients to worry needlessly and to avoid foods they aren’t allergic to. For babies and toddlers, avoidance can drive up the risk of developing allergies to those foods later in life – a consequence that was convincingly proven by the LEAP study but has still not translated to a widespread change in practice.

“I think we all know that there’s just a lot of system-wide resistance to making these changes, and we don’t completely understand why,” Nicholas Hartog, MD, an allergist with Spectrum Health in Grand Rapids, Mich., told this news organization.

At the American Academy of Allergy, Asthma & Immunology annual meeting, one of Dr. Hartog’s residents, Courtney Cotter, DO, presented a poster detailing their team’s retrospective review of food panel ordering practices across Spectrum Health, a large, multispecialty physician group in west Michigan.

The team combed Epic health records to evaluate food IgE ordering from January 2016 to December 2021. They tracked monthly figures for the number of patients who underwent food IgE tests, the percentage of tested patients for whom food panels were available, and the number of food panels and total number of food IgE tests ordered. They compared average rates from the final 3 months with rates from the first 3 months, which predated the August 2016 establishment of an academic pediatric allergy/immunology department.

Initially, Dr. Hartog and his colleagues focused on educating doctors on appropriate use of food IgE tests through informal conversations and lectures, but, he said, “It’s really difficult to change physician behavior, so sometimes we have to go about it by making it hard to do the wrong thing.”

To that end, the team tried to eliminate the food panels. However, some lab staff feared the possibility of losing revenue if physicians decided to order these tests elsewhere. After more negotiations, the laboratory agreed in December 2019 to restrict and rework food IgE testing by dropping the number of panels from nine to two and by restricting the number of foods in those panels. For example, in the basic panel, “we limited it to just four allergens, so even if you order a panel, you’re not getting 20 results,” Dr. Hartog told this news organization. “I finally found a friendly pathologist who was very on board with this positive change.”

In December 2020, the team implemented yet another strategy: Epic alerts. Each time doctors request a food panel, they receive a pop-up message stating that panel tests are not recommended and asking if they wish to proceed.

The multipronged effort had a modest impact on the number of food panels ordered per month, which dipped from 112.7 to 84.7 for the first and last 3 months of the study. Monthly totals of individual food IgE tests showed a steeper drop, decreasing from 2,379 to 1,180 in the initial and final 3-month periods – a change Dr. Hartog attributes to the revamped food panels. They estimated the cost savings at around $40 per patient, “and we were getting on average about 200 patients a month, so it adds up,” he said.

But the Epic alerts seemed to have little effect. Over the duration of the study, the monthly number of IgE tests ordered per clinician did not change. Neither did the percentage of patients evaluated with a food panel. “The alerts pop up, but people are still ordering,” Dr. Hartog said.

On the whole, the analysis shows that, “despite major efforts to educate providers and the public about these things, it is rampantly disregarded and is a huge problem for our specialty and is likely causing harm to patients,” said allergist-immunologist Gerald Lee, MD, of Emory University in Atlanta.

Dr. Lee said that a common scenario for inappropriate food IgE testing is severe eczema. Many parents request blood tests because they assume their child’s skin condition is driven by food allergies. When the child turns up positive to various foods on panel tests, which have high false-positive rates, the physician may recommend eliminating those foods to improve the skin rash – which “actually delays introduction of the food and potentially increases the risk for food allergy,” Dr. Lee said. “That was a common practice when I was in fellowship (2011) and is widely prevalent today.”

Edwin Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill, agrees that food IgE panels are wasteful and harmful. However, he thinks the solution is not to tell primary care physicians and pediatricians to stop using the tests. “We’re insinuating that they’re being used inappropriately, but the problem is that these are people that are patient facing, the patients are asking a question, and the appropriate tests aren’t there,” Dr. Kim said. “A big part of that problem is that the tests we have available to us are not good enough.”

The Spectrum Health analysis did not examine ICD codes associated with the food IgE tests or track which physicians ordered the tests. A 2016 retrospective review published in Pediatrics did evaluate ordering practices by specialty and found that primary care providers ordered “significantly more food allergen panels, tests for uncommon causes of food allergy, and generate higher cost per patient compared with allergists.”

Given the immense challenges with implementing system-wide changes, sometimes it can help to educate parents and families. “When you sit down and take 2 or 3 minutes to explain why this is a bad test and that I care about your kid but just don’t want inappropriate testing, they’re okay with it. They understand,” Dr. Hartog said. “When I teach residents, I make sure to emphasize that we have these conversations all the time.”

Dr. Hartog reports financial relationships with Binding Site (speaker), Regeneron (advisory board), Genentech (advisory board), Horizon Pharmaceuticals (advisory board, consulting, speaker), Takeda (speaker, advisory board) and Pharming Healthcare (advisory board, scientific steering committee, consulting), though none related to food allergy. Dr. Lee has disclosed no relevant financial relationships. Dr. Kim reports consultancy with Aimmune Therapeutics, Allako, AllerGenis, Belhaven Pharma, DBV Technologies, Duke Clinical Research Institute, and Nutricia; advisory board membership with ALK, DBV Technologies, Kenota Health, and Ukko; and grant support from the National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network; the National Center for Complementary and Integrative Health; Food Allergy Research and Education; and the Wallace Research Foundation.

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

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PHOENIX – For at least a decade, professional allergy and pediatrics societies have urged against using food IgE tests unless the patient has a history consistent with potential IgE-mediated food allergies. Yet virtually every health system offers these blood tests, and their inappropriate use – especially of panels that measure many allergens at once – remains a huge problem.

Beyond wasteful spending, excessive food IgE testing can lead patients to worry needlessly and to avoid foods they aren’t allergic to. For babies and toddlers, avoidance can drive up the risk of developing allergies to those foods later in life – a consequence that was convincingly proven by the LEAP study but has still not translated to a widespread change in practice.

“I think we all know that there’s just a lot of system-wide resistance to making these changes, and we don’t completely understand why,” Nicholas Hartog, MD, an allergist with Spectrum Health in Grand Rapids, Mich., told this news organization.

At the American Academy of Allergy, Asthma & Immunology annual meeting, one of Dr. Hartog’s residents, Courtney Cotter, DO, presented a poster detailing their team’s retrospective review of food panel ordering practices across Spectrum Health, a large, multispecialty physician group in west Michigan.

The team combed Epic health records to evaluate food IgE ordering from January 2016 to December 2021. They tracked monthly figures for the number of patients who underwent food IgE tests, the percentage of tested patients for whom food panels were available, and the number of food panels and total number of food IgE tests ordered. They compared average rates from the final 3 months with rates from the first 3 months, which predated the August 2016 establishment of an academic pediatric allergy/immunology department.

Initially, Dr. Hartog and his colleagues focused on educating doctors on appropriate use of food IgE tests through informal conversations and lectures, but, he said, “It’s really difficult to change physician behavior, so sometimes we have to go about it by making it hard to do the wrong thing.”

To that end, the team tried to eliminate the food panels. However, some lab staff feared the possibility of losing revenue if physicians decided to order these tests elsewhere. After more negotiations, the laboratory agreed in December 2019 to restrict and rework food IgE testing by dropping the number of panels from nine to two and by restricting the number of foods in those panels. For example, in the basic panel, “we limited it to just four allergens, so even if you order a panel, you’re not getting 20 results,” Dr. Hartog told this news organization. “I finally found a friendly pathologist who was very on board with this positive change.”

In December 2020, the team implemented yet another strategy: Epic alerts. Each time doctors request a food panel, they receive a pop-up message stating that panel tests are not recommended and asking if they wish to proceed.

The multipronged effort had a modest impact on the number of food panels ordered per month, which dipped from 112.7 to 84.7 for the first and last 3 months of the study. Monthly totals of individual food IgE tests showed a steeper drop, decreasing from 2,379 to 1,180 in the initial and final 3-month periods – a change Dr. Hartog attributes to the revamped food panels. They estimated the cost savings at around $40 per patient, “and we were getting on average about 200 patients a month, so it adds up,” he said.

But the Epic alerts seemed to have little effect. Over the duration of the study, the monthly number of IgE tests ordered per clinician did not change. Neither did the percentage of patients evaluated with a food panel. “The alerts pop up, but people are still ordering,” Dr. Hartog said.

On the whole, the analysis shows that, “despite major efforts to educate providers and the public about these things, it is rampantly disregarded and is a huge problem for our specialty and is likely causing harm to patients,” said allergist-immunologist Gerald Lee, MD, of Emory University in Atlanta.

Dr. Lee said that a common scenario for inappropriate food IgE testing is severe eczema. Many parents request blood tests because they assume their child’s skin condition is driven by food allergies. When the child turns up positive to various foods on panel tests, which have high false-positive rates, the physician may recommend eliminating those foods to improve the skin rash – which “actually delays introduction of the food and potentially increases the risk for food allergy,” Dr. Lee said. “That was a common practice when I was in fellowship (2011) and is widely prevalent today.”

Edwin Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill, agrees that food IgE panels are wasteful and harmful. However, he thinks the solution is not to tell primary care physicians and pediatricians to stop using the tests. “We’re insinuating that they’re being used inappropriately, but the problem is that these are people that are patient facing, the patients are asking a question, and the appropriate tests aren’t there,” Dr. Kim said. “A big part of that problem is that the tests we have available to us are not good enough.”

The Spectrum Health analysis did not examine ICD codes associated with the food IgE tests or track which physicians ordered the tests. A 2016 retrospective review published in Pediatrics did evaluate ordering practices by specialty and found that primary care providers ordered “significantly more food allergen panels, tests for uncommon causes of food allergy, and generate higher cost per patient compared with allergists.”

Given the immense challenges with implementing system-wide changes, sometimes it can help to educate parents and families. “When you sit down and take 2 or 3 minutes to explain why this is a bad test and that I care about your kid but just don’t want inappropriate testing, they’re okay with it. They understand,” Dr. Hartog said. “When I teach residents, I make sure to emphasize that we have these conversations all the time.”

Dr. Hartog reports financial relationships with Binding Site (speaker), Regeneron (advisory board), Genentech (advisory board), Horizon Pharmaceuticals (advisory board, consulting, speaker), Takeda (speaker, advisory board) and Pharming Healthcare (advisory board, scientific steering committee, consulting), though none related to food allergy. Dr. Lee has disclosed no relevant financial relationships. Dr. Kim reports consultancy with Aimmune Therapeutics, Allako, AllerGenis, Belhaven Pharma, DBV Technologies, Duke Clinical Research Institute, and Nutricia; advisory board membership with ALK, DBV Technologies, Kenota Health, and Ukko; and grant support from the National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network; the National Center for Complementary and Integrative Health; Food Allergy Research and Education; and the Wallace Research Foundation.

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

 

PHOENIX – For at least a decade, professional allergy and pediatrics societies have urged against using food IgE tests unless the patient has a history consistent with potential IgE-mediated food allergies. Yet virtually every health system offers these blood tests, and their inappropriate use – especially of panels that measure many allergens at once – remains a huge problem.

Beyond wasteful spending, excessive food IgE testing can lead patients to worry needlessly and to avoid foods they aren’t allergic to. For babies and toddlers, avoidance can drive up the risk of developing allergies to those foods later in life – a consequence that was convincingly proven by the LEAP study but has still not translated to a widespread change in practice.

“I think we all know that there’s just a lot of system-wide resistance to making these changes, and we don’t completely understand why,” Nicholas Hartog, MD, an allergist with Spectrum Health in Grand Rapids, Mich., told this news organization.

At the American Academy of Allergy, Asthma & Immunology annual meeting, one of Dr. Hartog’s residents, Courtney Cotter, DO, presented a poster detailing their team’s retrospective review of food panel ordering practices across Spectrum Health, a large, multispecialty physician group in west Michigan.

The team combed Epic health records to evaluate food IgE ordering from January 2016 to December 2021. They tracked monthly figures for the number of patients who underwent food IgE tests, the percentage of tested patients for whom food panels were available, and the number of food panels and total number of food IgE tests ordered. They compared average rates from the final 3 months with rates from the first 3 months, which predated the August 2016 establishment of an academic pediatric allergy/immunology department.

Initially, Dr. Hartog and his colleagues focused on educating doctors on appropriate use of food IgE tests through informal conversations and lectures, but, he said, “It’s really difficult to change physician behavior, so sometimes we have to go about it by making it hard to do the wrong thing.”

To that end, the team tried to eliminate the food panels. However, some lab staff feared the possibility of losing revenue if physicians decided to order these tests elsewhere. After more negotiations, the laboratory agreed in December 2019 to restrict and rework food IgE testing by dropping the number of panels from nine to two and by restricting the number of foods in those panels. For example, in the basic panel, “we limited it to just four allergens, so even if you order a panel, you’re not getting 20 results,” Dr. Hartog told this news organization. “I finally found a friendly pathologist who was very on board with this positive change.”

In December 2020, the team implemented yet another strategy: Epic alerts. Each time doctors request a food panel, they receive a pop-up message stating that panel tests are not recommended and asking if they wish to proceed.

The multipronged effort had a modest impact on the number of food panels ordered per month, which dipped from 112.7 to 84.7 for the first and last 3 months of the study. Monthly totals of individual food IgE tests showed a steeper drop, decreasing from 2,379 to 1,180 in the initial and final 3-month periods – a change Dr. Hartog attributes to the revamped food panels. They estimated the cost savings at around $40 per patient, “and we were getting on average about 200 patients a month, so it adds up,” he said.

But the Epic alerts seemed to have little effect. Over the duration of the study, the monthly number of IgE tests ordered per clinician did not change. Neither did the percentage of patients evaluated with a food panel. “The alerts pop up, but people are still ordering,” Dr. Hartog said.

On the whole, the analysis shows that, “despite major efforts to educate providers and the public about these things, it is rampantly disregarded and is a huge problem for our specialty and is likely causing harm to patients,” said allergist-immunologist Gerald Lee, MD, of Emory University in Atlanta.

Dr. Lee said that a common scenario for inappropriate food IgE testing is severe eczema. Many parents request blood tests because they assume their child’s skin condition is driven by food allergies. When the child turns up positive to various foods on panel tests, which have high false-positive rates, the physician may recommend eliminating those foods to improve the skin rash – which “actually delays introduction of the food and potentially increases the risk for food allergy,” Dr. Lee said. “That was a common practice when I was in fellowship (2011) and is widely prevalent today.”

Edwin Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill, agrees that food IgE panels are wasteful and harmful. However, he thinks the solution is not to tell primary care physicians and pediatricians to stop using the tests. “We’re insinuating that they’re being used inappropriately, but the problem is that these are people that are patient facing, the patients are asking a question, and the appropriate tests aren’t there,” Dr. Kim said. “A big part of that problem is that the tests we have available to us are not good enough.”

The Spectrum Health analysis did not examine ICD codes associated with the food IgE tests or track which physicians ordered the tests. A 2016 retrospective review published in Pediatrics did evaluate ordering practices by specialty and found that primary care providers ordered “significantly more food allergen panels, tests for uncommon causes of food allergy, and generate higher cost per patient compared with allergists.”

Given the immense challenges with implementing system-wide changes, sometimes it can help to educate parents and families. “When you sit down and take 2 or 3 minutes to explain why this is a bad test and that I care about your kid but just don’t want inappropriate testing, they’re okay with it. They understand,” Dr. Hartog said. “When I teach residents, I make sure to emphasize that we have these conversations all the time.”

Dr. Hartog reports financial relationships with Binding Site (speaker), Regeneron (advisory board), Genentech (advisory board), Horizon Pharmaceuticals (advisory board, consulting, speaker), Takeda (speaker, advisory board) and Pharming Healthcare (advisory board, scientific steering committee, consulting), though none related to food allergy. Dr. Lee has disclosed no relevant financial relationships. Dr. Kim reports consultancy with Aimmune Therapeutics, Allako, AllerGenis, Belhaven Pharma, DBV Technologies, Duke Clinical Research Institute, and Nutricia; advisory board membership with ALK, DBV Technologies, Kenota Health, and Ukko; and grant support from the National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network; the National Center for Complementary and Integrative Health; Food Allergy Research and Education; and the Wallace Research Foundation.

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

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Strangulation deaths spur FDA alert on pediatric enteral feeding kits

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Thu, 02/10/2022 - 16:30

Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.

The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.

Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.


“When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety,” the FDA warned.

Parents should be aware of the risk and avoid leaving tubing where infants or children can become entangled, to the extent that is possible. They also should tell their child’s health care provider if their child has ever been tangled in the tubing and discuss precautions to ensure that tubing does not get wrapped around the neck, as well as any related concerns.

Enteral feeding sets provide nutrition to people who are unable meet their nutritional needs by eating or swallowing. Tubing delivers nutrition formulas, using gravity or a pump, directly to the stomach or small intestine through the nose, mouth, or an opening in the abdomen.

The two reported deaths involved children under the age of 2 years who were found with tubing wrapped around their necks after brief periods when their caregivers were not directly monitoring them. One report described the unsupervised period as about 10 minutes.

“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur,” according to the alert. “It is also possible that some cases have not been reported to the FDA.”

Parents and health care providers can report injuries caused by these devices to the FDA.

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

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Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.

The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.

Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.


“When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety,” the FDA warned.

Parents should be aware of the risk and avoid leaving tubing where infants or children can become entangled, to the extent that is possible. They also should tell their child’s health care provider if their child has ever been tangled in the tubing and discuss precautions to ensure that tubing does not get wrapped around the neck, as well as any related concerns.

Enteral feeding sets provide nutrition to people who are unable meet their nutritional needs by eating or swallowing. Tubing delivers nutrition formulas, using gravity or a pump, directly to the stomach or small intestine through the nose, mouth, or an opening in the abdomen.

The two reported deaths involved children under the age of 2 years who were found with tubing wrapped around their necks after brief periods when their caregivers were not directly monitoring them. One report described the unsupervised period as about 10 minutes.

“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur,” according to the alert. “It is also possible that some cases have not been reported to the FDA.”

Parents and health care providers can report injuries caused by these devices to the FDA.

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

Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.

The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.

Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.


“When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety,” the FDA warned.

Parents should be aware of the risk and avoid leaving tubing where infants or children can become entangled, to the extent that is possible. They also should tell their child’s health care provider if their child has ever been tangled in the tubing and discuss precautions to ensure that tubing does not get wrapped around the neck, as well as any related concerns.

Enteral feeding sets provide nutrition to people who are unable meet their nutritional needs by eating or swallowing. Tubing delivers nutrition formulas, using gravity or a pump, directly to the stomach or small intestine through the nose, mouth, or an opening in the abdomen.

The two reported deaths involved children under the age of 2 years who were found with tubing wrapped around their necks after brief periods when their caregivers were not directly monitoring them. One report described the unsupervised period as about 10 minutes.

“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur,” according to the alert. “It is also possible that some cases have not been reported to the FDA.”

Parents and health care providers can report injuries caused by these devices to the FDA.

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

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USDA announces stricter standards for school nutrition

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Wed, 02/09/2022 - 10:12

The U.S. Department of Agriculture has announced new changes to school nutrition standards for the next 2 school years, which will reinstate health goals that were rolled back during the Trump administration.

The Biden administration is also tightening rules for fat and salt content in foods after restrictions were eased during the pandemic, according to the Washington Post.

“Nutritious school meals give America’s children the foundation for successful, healthy lives,” Tom Vilsack, the U.S. agriculture secretary, said in a statement on Feb. 4.

“We applaud schools’ heroic efforts throughout the challenges of this pandemic to continue serving kids the most nutritious meals possible,” he said. “The standards we’re putting in place of the next 2 school years will help schools transition to a future that builds on the tremendous strides they’ve made improving school meal nutrition over the past decade.”

For the 2022-2023 school year, schools and childcare providers will be required to offer low-fat or nonfat unflavored milks and limit the fat in sweet flavored milks. In addition, at least 80% of the grains served during school breakfasts and lunches each week must be considered rich in whole grains.

For the 2023-2024 school year, the weekly sodium limit for school lunches will be decreased by 10%.

The changes mark a shift from the Trump administration, which eased policies on whole grains, nonfat milk, and sodium, the newspaper reported. Then the pandemic forced additional changes as school districts scrambled to package meals for students. The USDA granted extra flexibility and eased some guidelines to ensure that children could be fed while schools were closed or focused on remote learning.

Now the USDA is updating the nutrition standards to “give schools clear expectations for gradual transition from current pandemic operations to more nutritious meals,” Stacy Dean, the USDA’s deputy undersecretary for food, nutrition, and consumer services, told reporters.

The Biden administration’s changes represent a shift back to Obama-era nutrition standards from 2012, according to the Post. But some nutrition advocates have said the new changes don’t address enough issues, such as added sugars. Fruit and vegetable requirements, for instance, will remain the same as the 2012 standards.

That said, some advocates have said the transition could be tough as schools move out of pandemic-era protocols. The School Nutrition Association, which represents school food service manufacturers and professionals, has urged Congress to provide additional support and waiver extensions for the next school year.

“School nutrition professionals are frantic just trying to get enough food on the tray for our students amid relentless supply chain disruptions and labor shortages,” Beth Wallace, the association’s president, told the Washington Post.

The shift will likely require a balancing act and slow transition. The USDA has been consulting with stakeholders for months to determine how to move toward stricter school nutrition standards while also acknowledging the pandemic, supply chain disruptions, and labor shortages.

“This approach is really going to help move forward the nutrition of the meals and allows the schools to continue to function effectively,” Geri Henchy, director of nutrition policy at the Food Research and Action Center, told the Post.

“Schools can’t make big changes at this point because of the supply chain and staffing,” she said. “They have a lot of waivers at this point that are helping them, and this balances the needs of all the different sectors.”

The USDA plans to issue a proposed rule in fall 2022 to update nutrition standards for the future, the department said in its announcement, which would be finalized for the 2024-2025 school year.

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

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The U.S. Department of Agriculture has announced new changes to school nutrition standards for the next 2 school years, which will reinstate health goals that were rolled back during the Trump administration.

The Biden administration is also tightening rules for fat and salt content in foods after restrictions were eased during the pandemic, according to the Washington Post.

“Nutritious school meals give America’s children the foundation for successful, healthy lives,” Tom Vilsack, the U.S. agriculture secretary, said in a statement on Feb. 4.

“We applaud schools’ heroic efforts throughout the challenges of this pandemic to continue serving kids the most nutritious meals possible,” he said. “The standards we’re putting in place of the next 2 school years will help schools transition to a future that builds on the tremendous strides they’ve made improving school meal nutrition over the past decade.”

For the 2022-2023 school year, schools and childcare providers will be required to offer low-fat or nonfat unflavored milks and limit the fat in sweet flavored milks. In addition, at least 80% of the grains served during school breakfasts and lunches each week must be considered rich in whole grains.

For the 2023-2024 school year, the weekly sodium limit for school lunches will be decreased by 10%.

The changes mark a shift from the Trump administration, which eased policies on whole grains, nonfat milk, and sodium, the newspaper reported. Then the pandemic forced additional changes as school districts scrambled to package meals for students. The USDA granted extra flexibility and eased some guidelines to ensure that children could be fed while schools were closed or focused on remote learning.

Now the USDA is updating the nutrition standards to “give schools clear expectations for gradual transition from current pandemic operations to more nutritious meals,” Stacy Dean, the USDA’s deputy undersecretary for food, nutrition, and consumer services, told reporters.

The Biden administration’s changes represent a shift back to Obama-era nutrition standards from 2012, according to the Post. But some nutrition advocates have said the new changes don’t address enough issues, such as added sugars. Fruit and vegetable requirements, for instance, will remain the same as the 2012 standards.

That said, some advocates have said the transition could be tough as schools move out of pandemic-era protocols. The School Nutrition Association, which represents school food service manufacturers and professionals, has urged Congress to provide additional support and waiver extensions for the next school year.

“School nutrition professionals are frantic just trying to get enough food on the tray for our students amid relentless supply chain disruptions and labor shortages,” Beth Wallace, the association’s president, told the Washington Post.

The shift will likely require a balancing act and slow transition. The USDA has been consulting with stakeholders for months to determine how to move toward stricter school nutrition standards while also acknowledging the pandemic, supply chain disruptions, and labor shortages.

“This approach is really going to help move forward the nutrition of the meals and allows the schools to continue to function effectively,” Geri Henchy, director of nutrition policy at the Food Research and Action Center, told the Post.

“Schools can’t make big changes at this point because of the supply chain and staffing,” she said. “They have a lot of waivers at this point that are helping them, and this balances the needs of all the different sectors.”

The USDA plans to issue a proposed rule in fall 2022 to update nutrition standards for the future, the department said in its announcement, which would be finalized for the 2024-2025 school year.

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

The U.S. Department of Agriculture has announced new changes to school nutrition standards for the next 2 school years, which will reinstate health goals that were rolled back during the Trump administration.

The Biden administration is also tightening rules for fat and salt content in foods after restrictions were eased during the pandemic, according to the Washington Post.

“Nutritious school meals give America’s children the foundation for successful, healthy lives,” Tom Vilsack, the U.S. agriculture secretary, said in a statement on Feb. 4.

“We applaud schools’ heroic efforts throughout the challenges of this pandemic to continue serving kids the most nutritious meals possible,” he said. “The standards we’re putting in place of the next 2 school years will help schools transition to a future that builds on the tremendous strides they’ve made improving school meal nutrition over the past decade.”

For the 2022-2023 school year, schools and childcare providers will be required to offer low-fat or nonfat unflavored milks and limit the fat in sweet flavored milks. In addition, at least 80% of the grains served during school breakfasts and lunches each week must be considered rich in whole grains.

For the 2023-2024 school year, the weekly sodium limit for school lunches will be decreased by 10%.

The changes mark a shift from the Trump administration, which eased policies on whole grains, nonfat milk, and sodium, the newspaper reported. Then the pandemic forced additional changes as school districts scrambled to package meals for students. The USDA granted extra flexibility and eased some guidelines to ensure that children could be fed while schools were closed or focused on remote learning.

Now the USDA is updating the nutrition standards to “give schools clear expectations for gradual transition from current pandemic operations to more nutritious meals,” Stacy Dean, the USDA’s deputy undersecretary for food, nutrition, and consumer services, told reporters.

The Biden administration’s changes represent a shift back to Obama-era nutrition standards from 2012, according to the Post. But some nutrition advocates have said the new changes don’t address enough issues, such as added sugars. Fruit and vegetable requirements, for instance, will remain the same as the 2012 standards.

That said, some advocates have said the transition could be tough as schools move out of pandemic-era protocols. The School Nutrition Association, which represents school food service manufacturers and professionals, has urged Congress to provide additional support and waiver extensions for the next school year.

“School nutrition professionals are frantic just trying to get enough food on the tray for our students amid relentless supply chain disruptions and labor shortages,” Beth Wallace, the association’s president, told the Washington Post.

The shift will likely require a balancing act and slow transition. The USDA has been consulting with stakeholders for months to determine how to move toward stricter school nutrition standards while also acknowledging the pandemic, supply chain disruptions, and labor shortages.

“This approach is really going to help move forward the nutrition of the meals and allows the schools to continue to function effectively,” Geri Henchy, director of nutrition policy at the Food Research and Action Center, told the Post.

“Schools can’t make big changes at this point because of the supply chain and staffing,” she said. “They have a lot of waivers at this point that are helping them, and this balances the needs of all the different sectors.”

The USDA plans to issue a proposed rule in fall 2022 to update nutrition standards for the future, the department said in its announcement, which would be finalized for the 2024-2025 school year.

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

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Open-label placebo improves symptoms in pediatric IBS and functional abdominal pain

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Wed, 02/02/2022 - 14:47

A spoonful of sugar helps the medicine go down – but what if the sugar is the medicine?

Nearly three in four children with irritable bowel syndrome (IBS) or unexplained abdominal pain reported at least a 30% improvement in discomfort after taking a regimen of sugar water they knew had no medicinal properties.

The findings, published online in JAMA Pediatrics on Jan. 31, 2022, also revealed that participants used significantly less rescue medications when taking the so-called “open-label placebo.” The magnitude of the effect was enough to meet one of the criteria from the Food and Drug Administration to approve drugs to treat IBS, which affects between 10% and 15% of U.S. children.

Although open-label placebo is not ready for clinical use, IBS expert Miranda van Tilburg, PhD, said she is “glad we have evidence” of a strong response in this patient population and that the results “may make clinicians rethink how they introduce treatments.

“By emphasizing their belief that a treatment may work, clinicians can harness the placebo effect,” Dr. van Tilburg, professor of medicine and vice chair of research at Marshall University, Huntington, W.Va., told this news organization.

Study leader Samuel Nurko, MD, MPH, the director of the functional abdominal pain program at Harvard Medical School, Boston, said placebo-controlled trials in patients with IBS and functional abdominal pain consistently show a “very high placebo response.” The question his group set out to answer, he said, was: “Can we get the pain symptoms of these children better by giving them placebo with no deception?”

Between 2015 and 2018, Dr. Nurko and colleagues randomly assigned 30 children and adolescents, aged 8-18 years, with IBS or functional abdominal pain to receive either an open-label inert liquid placebo – consisting of 85% sucrose, citric acid, purified water, and the preservative methyl paraben – twice daily for 3 weeks followed by 3 weeks with no placebo, or to follow the reverse sequence. Roughly half (53%) of the children had functional abdominal pain, and 47% had IBS as defined by Rome III criteria.

Researchers at the three participating clinical sites followed a standardized protocol for explaining the nature of placebo (“like sugar pills without medication”), telling participants that adults with conditions like theirs often benefit from placebo when they receive it as part of blinded, randomized clinical trials. Participants in the study were allowed to use hyoscyamine, an anticholinergic medication, as rescue treatment during the trial.

Dr. Nurko’s team reported that patients had a mean pain score of 39.9 on a 100-point visual analogue scale during the open-label placebo phase of the trial and a mean score of 45 during the control period. That difference was statistically significant (P = .03).

Participants took an average of two hyoscyamine pills during the placebo phase, compared with 3.8 pills during the 3-week period when they did not receive placebo (P < .001).

Nearly three-fourths (73.3%) of children in the study reported that open-label placebo improved their pain by over 30%, thus meeting one of the FDA’s criteria for clinical evaluation of drugs for IBS. Half said the placebo liquid cut their pain by more than 50%.

Dr. Nurko said the findings highlight the need to address “mind-body connections” in the management of gut-brain disorders. Like Dr. van Tilburg, he cautioned that open-label placebo “is not ready for widespread use. Placebo is complicated, and we need to understand the mechanism” underlying its efficacy.

“The idea is eventually we will be able to sort out the exact mechanism and harness it for clinical practice,” he added.

However, Dr. van Tilburg expressed that using placebo therapy to treat children and adolescents with these conditions could send the message that “the pain is not real or all in their heads. Children with chronic pain encounter a lot of stigma, and this kind of treatment may increase the feeling of not being believed. We should be careful to avoid this.”

The study was funded by the National Institutes of Health, the Swiss National Science Foundation, the Schwartz family fund, the Foundation for the Science of the Therapeutic Relationship, and the Morgan Family Foundation.

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

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A spoonful of sugar helps the medicine go down – but what if the sugar is the medicine?

Nearly three in four children with irritable bowel syndrome (IBS) or unexplained abdominal pain reported at least a 30% improvement in discomfort after taking a regimen of sugar water they knew had no medicinal properties.

The findings, published online in JAMA Pediatrics on Jan. 31, 2022, also revealed that participants used significantly less rescue medications when taking the so-called “open-label placebo.” The magnitude of the effect was enough to meet one of the criteria from the Food and Drug Administration to approve drugs to treat IBS, which affects between 10% and 15% of U.S. children.

Although open-label placebo is not ready for clinical use, IBS expert Miranda van Tilburg, PhD, said she is “glad we have evidence” of a strong response in this patient population and that the results “may make clinicians rethink how they introduce treatments.

“By emphasizing their belief that a treatment may work, clinicians can harness the placebo effect,” Dr. van Tilburg, professor of medicine and vice chair of research at Marshall University, Huntington, W.Va., told this news organization.

Study leader Samuel Nurko, MD, MPH, the director of the functional abdominal pain program at Harvard Medical School, Boston, said placebo-controlled trials in patients with IBS and functional abdominal pain consistently show a “very high placebo response.” The question his group set out to answer, he said, was: “Can we get the pain symptoms of these children better by giving them placebo with no deception?”

Between 2015 and 2018, Dr. Nurko and colleagues randomly assigned 30 children and adolescents, aged 8-18 years, with IBS or functional abdominal pain to receive either an open-label inert liquid placebo – consisting of 85% sucrose, citric acid, purified water, and the preservative methyl paraben – twice daily for 3 weeks followed by 3 weeks with no placebo, or to follow the reverse sequence. Roughly half (53%) of the children had functional abdominal pain, and 47% had IBS as defined by Rome III criteria.

Researchers at the three participating clinical sites followed a standardized protocol for explaining the nature of placebo (“like sugar pills without medication”), telling participants that adults with conditions like theirs often benefit from placebo when they receive it as part of blinded, randomized clinical trials. Participants in the study were allowed to use hyoscyamine, an anticholinergic medication, as rescue treatment during the trial.

Dr. Nurko’s team reported that patients had a mean pain score of 39.9 on a 100-point visual analogue scale during the open-label placebo phase of the trial and a mean score of 45 during the control period. That difference was statistically significant (P = .03).

Participants took an average of two hyoscyamine pills during the placebo phase, compared with 3.8 pills during the 3-week period when they did not receive placebo (P < .001).

Nearly three-fourths (73.3%) of children in the study reported that open-label placebo improved their pain by over 30%, thus meeting one of the FDA’s criteria for clinical evaluation of drugs for IBS. Half said the placebo liquid cut their pain by more than 50%.

Dr. Nurko said the findings highlight the need to address “mind-body connections” in the management of gut-brain disorders. Like Dr. van Tilburg, he cautioned that open-label placebo “is not ready for widespread use. Placebo is complicated, and we need to understand the mechanism” underlying its efficacy.

“The idea is eventually we will be able to sort out the exact mechanism and harness it for clinical practice,” he added.

However, Dr. van Tilburg expressed that using placebo therapy to treat children and adolescents with these conditions could send the message that “the pain is not real or all in their heads. Children with chronic pain encounter a lot of stigma, and this kind of treatment may increase the feeling of not being believed. We should be careful to avoid this.”

The study was funded by the National Institutes of Health, the Swiss National Science Foundation, the Schwartz family fund, the Foundation for the Science of the Therapeutic Relationship, and the Morgan Family Foundation.

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

A spoonful of sugar helps the medicine go down – but what if the sugar is the medicine?

Nearly three in four children with irritable bowel syndrome (IBS) or unexplained abdominal pain reported at least a 30% improvement in discomfort after taking a regimen of sugar water they knew had no medicinal properties.

The findings, published online in JAMA Pediatrics on Jan. 31, 2022, also revealed that participants used significantly less rescue medications when taking the so-called “open-label placebo.” The magnitude of the effect was enough to meet one of the criteria from the Food and Drug Administration to approve drugs to treat IBS, which affects between 10% and 15% of U.S. children.

Although open-label placebo is not ready for clinical use, IBS expert Miranda van Tilburg, PhD, said she is “glad we have evidence” of a strong response in this patient population and that the results “may make clinicians rethink how they introduce treatments.

“By emphasizing their belief that a treatment may work, clinicians can harness the placebo effect,” Dr. van Tilburg, professor of medicine and vice chair of research at Marshall University, Huntington, W.Va., told this news organization.

Study leader Samuel Nurko, MD, MPH, the director of the functional abdominal pain program at Harvard Medical School, Boston, said placebo-controlled trials in patients with IBS and functional abdominal pain consistently show a “very high placebo response.” The question his group set out to answer, he said, was: “Can we get the pain symptoms of these children better by giving them placebo with no deception?”

Between 2015 and 2018, Dr. Nurko and colleagues randomly assigned 30 children and adolescents, aged 8-18 years, with IBS or functional abdominal pain to receive either an open-label inert liquid placebo – consisting of 85% sucrose, citric acid, purified water, and the preservative methyl paraben – twice daily for 3 weeks followed by 3 weeks with no placebo, or to follow the reverse sequence. Roughly half (53%) of the children had functional abdominal pain, and 47% had IBS as defined by Rome III criteria.

Researchers at the three participating clinical sites followed a standardized protocol for explaining the nature of placebo (“like sugar pills without medication”), telling participants that adults with conditions like theirs often benefit from placebo when they receive it as part of blinded, randomized clinical trials. Participants in the study were allowed to use hyoscyamine, an anticholinergic medication, as rescue treatment during the trial.

Dr. Nurko’s team reported that patients had a mean pain score of 39.9 on a 100-point visual analogue scale during the open-label placebo phase of the trial and a mean score of 45 during the control period. That difference was statistically significant (P = .03).

Participants took an average of two hyoscyamine pills during the placebo phase, compared with 3.8 pills during the 3-week period when they did not receive placebo (P < .001).

Nearly three-fourths (73.3%) of children in the study reported that open-label placebo improved their pain by over 30%, thus meeting one of the FDA’s criteria for clinical evaluation of drugs for IBS. Half said the placebo liquid cut their pain by more than 50%.

Dr. Nurko said the findings highlight the need to address “mind-body connections” in the management of gut-brain disorders. Like Dr. van Tilburg, he cautioned that open-label placebo “is not ready for widespread use. Placebo is complicated, and we need to understand the mechanism” underlying its efficacy.

“The idea is eventually we will be able to sort out the exact mechanism and harness it for clinical practice,” he added.

However, Dr. van Tilburg expressed that using placebo therapy to treat children and adolescents with these conditions could send the message that “the pain is not real or all in their heads. Children with chronic pain encounter a lot of stigma, and this kind of treatment may increase the feeling of not being believed. We should be careful to avoid this.”

The study was funded by the National Institutes of Health, the Swiss National Science Foundation, the Schwartz family fund, the Foundation for the Science of the Therapeutic Relationship, and the Morgan Family Foundation.

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

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Fossilized blood proteins from child illness may cause chalky teeth

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Changed
Fri, 01/07/2022 - 09:55

 

FROM FRONTIERS IN PHYSIOLOGY

Researchers have identified a potential cause of molar hypomineralization (MH), or “chalky teeth,” an underrecognized condition affecting one in five children worldwide. The discovery could lead to preventive medical therapies to reduce dental caries and extractions, they said.

According to a team led by biochemist Michael J. Hubbard, BDS, PhD, professor in the department of medicine, dentistry, and health sciences at the University of Melbourne, the “groundbreaking” research found that the failure of enamel to adequately harden is associated with exposure to serum albumin while teeth are developing. The blood protein “poisons” the growth of mineral crystals rather than injure the cells that deposit enamel, they reported.

The investigators, including researchers from Chile, said their findings hold promise for better clinical management of MH and open a new door into research on the broader pathogenesis and causes of the condition.

“We hope this breakthrough will eventually lead to medical prevention of MH, prompting global health benefits including major reductions in childhood tooth decay,” they wrote in an article published online Dec. 21 in Frontiers in Physiology.
 

More than cosmetic

Chalky teeth, characterized by discolored enamel spots, are not merely a cosmetic problem. The condition can lead to severe toothache, painful eating, tooth decay, and even abscesses and extractions. Although its triggers have eluded dental research for a century, Dr. Hubbard’s group said fossilized blood proteins such as albumin in the tooth appear to be at least one cause.

Biochemical evidence indicates that serum albumin surrounding developing teeth is normally excluded from enamel, Dr. Hubbard said in an interview. “Given that albumin binds strongly to hydroxyapatite-based mineral and blocks its growth, we infer that the epithelial barrier – the enamel-forming cells termed ameloblasts and normally responsible for excluding albumin – must break down in places in response to medical triggers.”

This breach enables localized infiltration of albumin, which then blocks further hardening of soft, immature enamel, leading to residual spots or patches of chalky enamel once the tooth eventually erupts into the mouth. “In other words, we infer that chalky enamel spots coincide with localized breaches of an epithelial barrier that are triggered by yet-to-be determined systemic insults,” he said.

Joseph Brofsky, DMD, section head of pediatric dentistry at North Shore LIJ Cohen Children’s Medical Center of New York, in Queens, agreed that that the definitive cause of MH has evaded identification for a hundred years. However, he expressed skepticism about the fossilized blood protein hypothesis.

“That’s a long shot. It’s a possibility, and I’m not ruling it out, but we’re not 100% sure,” said Dr. Brofsky, who was not involved in the research.

In his experience, MH is somewhat less prevalent in the United States, affecting about 1 in 10 children here, which is about half the global rate. “But it’s a problem, and we wish it would go away, but before we know beyond a reasonable doubt what causes this condition, it’s going to be hard to stop it.”

Most cases of MH involve hypomineralization of the 6-year molars, the first adult molars to erupt, but the process starts at birth. “For 6-year molars, normal hardening of dental enamel takes place from the early postnatal period through infancy,” Dr. Hubbard said.

The 2-year and 12-year molars are affected about half as frequently as their 6-year counterparts, “so this extends the medical-risk window out to early school days, and slightly back to the perinatal period for the 12-year and 2-year molars, respectively,” he said.

A critical question is which childhood illnesses are most likely to set the stage for MH, he added. “Forty-plus years of epidemiology have failed to nail a specific cause or causal association. But given the high prevalence of MH – 20% in otherwise healthy kids – naturally we suspect some common illnesses are the culprits,” he said. “But which diseases, which medications, and which combinations?”

Dr. Hubbard’s advice to pediatricians is to be alert to MH: “If you’re inspecting a child’s throat, then why not look at their back teeth, too – particularly when they’re getting their new molars at 2, 6, and 12 years?”

The study was supported by the Melbourne Research Unit for Facial Disorders Department of Pharmacology & Therapeutics, Department of Paediatrics, and Faculty of Medicine, Dentistry, and Health Sciences at the University of Melbourne. The authors and Dr. Brofsky have disclosed no relevant financial relationships.

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

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FROM FRONTIERS IN PHYSIOLOGY

Researchers have identified a potential cause of molar hypomineralization (MH), or “chalky teeth,” an underrecognized condition affecting one in five children worldwide. The discovery could lead to preventive medical therapies to reduce dental caries and extractions, they said.

According to a team led by biochemist Michael J. Hubbard, BDS, PhD, professor in the department of medicine, dentistry, and health sciences at the University of Melbourne, the “groundbreaking” research found that the failure of enamel to adequately harden is associated with exposure to serum albumin while teeth are developing. The blood protein “poisons” the growth of mineral crystals rather than injure the cells that deposit enamel, they reported.

The investigators, including researchers from Chile, said their findings hold promise for better clinical management of MH and open a new door into research on the broader pathogenesis and causes of the condition.

“We hope this breakthrough will eventually lead to medical prevention of MH, prompting global health benefits including major reductions in childhood tooth decay,” they wrote in an article published online Dec. 21 in Frontiers in Physiology.
 

More than cosmetic

Chalky teeth, characterized by discolored enamel spots, are not merely a cosmetic problem. The condition can lead to severe toothache, painful eating, tooth decay, and even abscesses and extractions. Although its triggers have eluded dental research for a century, Dr. Hubbard’s group said fossilized blood proteins such as albumin in the tooth appear to be at least one cause.

Biochemical evidence indicates that serum albumin surrounding developing teeth is normally excluded from enamel, Dr. Hubbard said in an interview. “Given that albumin binds strongly to hydroxyapatite-based mineral and blocks its growth, we infer that the epithelial barrier – the enamel-forming cells termed ameloblasts and normally responsible for excluding albumin – must break down in places in response to medical triggers.”

This breach enables localized infiltration of albumin, which then blocks further hardening of soft, immature enamel, leading to residual spots or patches of chalky enamel once the tooth eventually erupts into the mouth. “In other words, we infer that chalky enamel spots coincide with localized breaches of an epithelial barrier that are triggered by yet-to-be determined systemic insults,” he said.

Joseph Brofsky, DMD, section head of pediatric dentistry at North Shore LIJ Cohen Children’s Medical Center of New York, in Queens, agreed that that the definitive cause of MH has evaded identification for a hundred years. However, he expressed skepticism about the fossilized blood protein hypothesis.

“That’s a long shot. It’s a possibility, and I’m not ruling it out, but we’re not 100% sure,” said Dr. Brofsky, who was not involved in the research.

In his experience, MH is somewhat less prevalent in the United States, affecting about 1 in 10 children here, which is about half the global rate. “But it’s a problem, and we wish it would go away, but before we know beyond a reasonable doubt what causes this condition, it’s going to be hard to stop it.”

Most cases of MH involve hypomineralization of the 6-year molars, the first adult molars to erupt, but the process starts at birth. “For 6-year molars, normal hardening of dental enamel takes place from the early postnatal period through infancy,” Dr. Hubbard said.

The 2-year and 12-year molars are affected about half as frequently as their 6-year counterparts, “so this extends the medical-risk window out to early school days, and slightly back to the perinatal period for the 12-year and 2-year molars, respectively,” he said.

A critical question is which childhood illnesses are most likely to set the stage for MH, he added. “Forty-plus years of epidemiology have failed to nail a specific cause or causal association. But given the high prevalence of MH – 20% in otherwise healthy kids – naturally we suspect some common illnesses are the culprits,” he said. “But which diseases, which medications, and which combinations?”

Dr. Hubbard’s advice to pediatricians is to be alert to MH: “If you’re inspecting a child’s throat, then why not look at their back teeth, too – particularly when they’re getting their new molars at 2, 6, and 12 years?”

The study was supported by the Melbourne Research Unit for Facial Disorders Department of Pharmacology & Therapeutics, Department of Paediatrics, and Faculty of Medicine, Dentistry, and Health Sciences at the University of Melbourne. The authors and Dr. Brofsky have disclosed no relevant financial relationships.

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

 

FROM FRONTIERS IN PHYSIOLOGY

Researchers have identified a potential cause of molar hypomineralization (MH), or “chalky teeth,” an underrecognized condition affecting one in five children worldwide. The discovery could lead to preventive medical therapies to reduce dental caries and extractions, they said.

According to a team led by biochemist Michael J. Hubbard, BDS, PhD, professor in the department of medicine, dentistry, and health sciences at the University of Melbourne, the “groundbreaking” research found that the failure of enamel to adequately harden is associated with exposure to serum albumin while teeth are developing. The blood protein “poisons” the growth of mineral crystals rather than injure the cells that deposit enamel, they reported.

The investigators, including researchers from Chile, said their findings hold promise for better clinical management of MH and open a new door into research on the broader pathogenesis and causes of the condition.

“We hope this breakthrough will eventually lead to medical prevention of MH, prompting global health benefits including major reductions in childhood tooth decay,” they wrote in an article published online Dec. 21 in Frontiers in Physiology.
 

More than cosmetic

Chalky teeth, characterized by discolored enamel spots, are not merely a cosmetic problem. The condition can lead to severe toothache, painful eating, tooth decay, and even abscesses and extractions. Although its triggers have eluded dental research for a century, Dr. Hubbard’s group said fossilized blood proteins such as albumin in the tooth appear to be at least one cause.

Biochemical evidence indicates that serum albumin surrounding developing teeth is normally excluded from enamel, Dr. Hubbard said in an interview. “Given that albumin binds strongly to hydroxyapatite-based mineral and blocks its growth, we infer that the epithelial barrier – the enamel-forming cells termed ameloblasts and normally responsible for excluding albumin – must break down in places in response to medical triggers.”

This breach enables localized infiltration of albumin, which then blocks further hardening of soft, immature enamel, leading to residual spots or patches of chalky enamel once the tooth eventually erupts into the mouth. “In other words, we infer that chalky enamel spots coincide with localized breaches of an epithelial barrier that are triggered by yet-to-be determined systemic insults,” he said.

Joseph Brofsky, DMD, section head of pediatric dentistry at North Shore LIJ Cohen Children’s Medical Center of New York, in Queens, agreed that that the definitive cause of MH has evaded identification for a hundred years. However, he expressed skepticism about the fossilized blood protein hypothesis.

“That’s a long shot. It’s a possibility, and I’m not ruling it out, but we’re not 100% sure,” said Dr. Brofsky, who was not involved in the research.

In his experience, MH is somewhat less prevalent in the United States, affecting about 1 in 10 children here, which is about half the global rate. “But it’s a problem, and we wish it would go away, but before we know beyond a reasonable doubt what causes this condition, it’s going to be hard to stop it.”

Most cases of MH involve hypomineralization of the 6-year molars, the first adult molars to erupt, but the process starts at birth. “For 6-year molars, normal hardening of dental enamel takes place from the early postnatal period through infancy,” Dr. Hubbard said.

The 2-year and 12-year molars are affected about half as frequently as their 6-year counterparts, “so this extends the medical-risk window out to early school days, and slightly back to the perinatal period for the 12-year and 2-year molars, respectively,” he said.

A critical question is which childhood illnesses are most likely to set the stage for MH, he added. “Forty-plus years of epidemiology have failed to nail a specific cause or causal association. But given the high prevalence of MH – 20% in otherwise healthy kids – naturally we suspect some common illnesses are the culprits,” he said. “But which diseases, which medications, and which combinations?”

Dr. Hubbard’s advice to pediatricians is to be alert to MH: “If you’re inspecting a child’s throat, then why not look at their back teeth, too – particularly when they’re getting their new molars at 2, 6, and 12 years?”

The study was supported by the Melbourne Research Unit for Facial Disorders Department of Pharmacology & Therapeutics, Department of Paediatrics, and Faculty of Medicine, Dentistry, and Health Sciences at the University of Melbourne. The authors and Dr. Brofsky have disclosed no relevant financial relationships.

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

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