MDedge Pediatrics

A dose-response relationship exists between number of years playing hockey and risk and severity of chronic traumatic encephalopathy (CTE), new research suggests. Early results from a study that examined donor brains showed that each additional year of ice hockey play increased the risk for CTE by 23%.

This information should be on the “radar” of all clinicians, said coinvestigator Jesse Mez, MD, associate professor of neurology at Boston University. “When they’re talking to kids and families and parents about playing contact sports, they should discuss the benefits as well as the risks so all that information can be taken into consideration.”

Dr. Mez noted that clinicians should also consider the amount of hockey played when assessing patients for thinking and memory trouble later in life. “CTE could be in the differential diagnosis,” he said.

The study findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

Football data

CTE is a neurodegenerative disease associated with repetitive hits to the head. In previous research, the investigators showed that the more that athletes play American football, the more likely they are to develop CTE.

“Hockey, like football, involves repetitive head impacts as part of the game,” said Dr. Mez. “So we hypothesized that we would see a similar type of dose-response relationship in hockey.”

From two brain banks – the Veterans Affairs–Boston University–Concussion Legacy Foundation and the Framingham Heart Study – the researchers accessed 74 consecutive brains from donors who had played ice hockey. They collected information about hockey play during “pretty comprehensive” interviews with next of kin, Dr. Mez reported.

The study participants ranged in age from 13 to 91 years. The cause of death varied; most died with end-stage dementia and neurodegenerative disease, but some died of cardiovascular disease, and others from accidents.

For 9% of the individuals, the highest level of play was a youth league; 34% had reached the high school level, 30% reached the juniors/college level, and 26% played professionally. In addition, 46% played another contact sport – including 43% who played American football.

Primary outcomes included evidence of CTE from stage 0 (no CTE) to stage IV and severity of CTE, which was defined by the amount of neurofibrillary tangle (NFT) burden in 11 brain regions. For this burden, the score ranged from 0 (absent) to 3 (severe) in each region for a total range of 0-33.

Dr. Mez noted that, in CTE, tau protein accumulates abnormally. “It typically begins in the cortex in the frontal lobe and then spreads to other parts of the brain, including to the medial temporal structures, and is widespread by stage IV.”

The researchers estimated the association of duration of ice hockey play in years with each neuropathologic outcome and adjusted for age at death and duration of football play.
 

Consistent findings

Results showed that, of the 74 donors, 40 (54%) had CTE. Each additional year of hockey play corresponded to increased chances for having CTE (odds ratio, 1.23; 95% confidence interval, 11%-36%; P < .01). This increase in risk is similar to that which was found with football players, Dr. Mez noted. This was somewhat surprising, as hockey involves fewer “hits” than football.

“Hits are not as quintessential to the game of hockey as they are in football, where contacts occur with nearly every play,” he said. “In football, you have several hundred impacts over the course of a season.”

Researchers also found a 15% increase in odds for increasing one CTE stage (95% CI, 8%-22%; P < .01), and a .03 standard deviation increase in cumulative NFT burden (95% CI, 0.01-0.05; P < .01).

Dr. Mez noted that the fact that the results were consistent across different outcomes “improves the validity” of the findings.

In a sensitivity analysis that excluded participants who also played football, estimates “were pretty similar” to those in the full analysis, said Dr. Mez.

The investigators have not yet examined the effect of level of hockey play, such as professionally or at the college level, on CTE risk. However, in football players, they found that level of play is another “valuable predictor of CTE pathology,” Dr. Mez said, adding that level of play, position played, and years of play “are all probably contributing” to CTE risk.

Asking about years of play is useful in a clinical setting. “It’s very easy for a clinician to ask patients how many years of hockey they played,” said Dr. Mez.

Overall, the new results are important, as “millions of individuals” play contact sports, whether that is hockey, football, or European soccer, he added. “And for all sports, there seems to be this relationship between more play and risk of this disease.”
 

‘Skewed’ population?

Commenting on the findings, Frank Conidi, MD, director, Florida Center for Health and Sports Neurology, Port St. Lucie, said he was surprised the investigators found a 23% per year increase in risk for CTE among hockey players.

Dr. Conidi has played hockey himself and works with the Florida Panthers of the National Hockey League. In his practice, he treats retired professional football players who have neurodegenerative disorders. From his experience, the number of repetitive direct head impacts in football is significantly higher than in hockey. “Most of the forces seen in hockey are from hits to the body, where the force is transferred to the head,” said Dr. Conidi, who was not involved with the research.

He noted differences in the way hockey is played around the world. In European countries, for example, the ice surface is relatively large and the emphasis tends to be more on skill than hitting.

“It would have been interesting to have the study group analyze the data based on where the athlete grew up,” he said. Dr. Conidi would also like to know when the participants played hockey. “The game is vastly different now than it was in the 1970s, ‘80s, and early ‘90s, when there was more fighting, less protective gear, and more hitting in general.”

As is the case for most studies of CTE in athletes, the study population is “skewed” because the participants likely had neurocognitive and other problems that led to their decision to donate their brain, said Dr. Conidi.

He also doesn’t believe the study should be the sole factor in a decision to continue or stop playing hockey. “We are still in the infancy stages of understanding the effects of high-impact sports on athletes’ brains.”

The study received funding from the National Institute of Neurological Diseases and Stroke and the National Institute on Aging. Dr. Mez and Dr. Conidi have reported no relevant financial relationships.

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

A dose-response relationship exists between number of years playing hockey and risk and severity of chronic traumatic encephalopathy (CTE), new research suggests. Early results from a study that examined donor brains showed that each additional year of ice hockey play increased the risk for CTE by 23%.

This information should be on the “radar” of all clinicians, said coinvestigator Jesse Mez, MD, associate professor of neurology at Boston University. “When they’re talking to kids and families and parents about playing contact sports, they should discuss the benefits as well as the risks so all that information can be taken into consideration.”

Dr. Mez noted that clinicians should also consider the amount of hockey played when assessing patients for thinking and memory trouble later in life. “CTE could be in the differential diagnosis,” he said.

The study findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

Football data

CTE is a neurodegenerative disease associated with repetitive hits to the head. In previous research, the investigators showed that the more that athletes play American football, the more likely they are to develop CTE.

“Hockey, like football, involves repetitive head impacts as part of the game,” said Dr. Mez. “So we hypothesized that we would see a similar type of dose-response relationship in hockey.”

From two brain banks – the Veterans Affairs–Boston University–Concussion Legacy Foundation and the Framingham Heart Study – the researchers accessed 74 consecutive brains from donors who had played ice hockey. They collected information about hockey play during “pretty comprehensive” interviews with next of kin, Dr. Mez reported.

The study participants ranged in age from 13 to 91 years. The cause of death varied; most died with end-stage dementia and neurodegenerative disease, but some died of cardiovascular disease, and others from accidents.

For 9% of the individuals, the highest level of play was a youth league; 34% had reached the high school level, 30% reached the juniors/college level, and 26% played professionally. In addition, 46% played another contact sport – including 43% who played American football.

Primary outcomes included evidence of CTE from stage 0 (no CTE) to stage IV and severity of CTE, which was defined by the amount of neurofibrillary tangle (NFT) burden in 11 brain regions. For this burden, the score ranged from 0 (absent) to 3 (severe) in each region for a total range of 0-33.

Dr. Mez noted that, in CTE, tau protein accumulates abnormally. “It typically begins in the cortex in the frontal lobe and then spreads to other parts of the brain, including to the medial temporal structures, and is widespread by stage IV.”

The researchers estimated the association of duration of ice hockey play in years with each neuropathologic outcome and adjusted for age at death and duration of football play.
 

Consistent findings

Results showed that, of the 74 donors, 40 (54%) had CTE. Each additional year of hockey play corresponded to increased chances for having CTE (odds ratio, 1.23; 95% confidence interval, 11%-36%; P < .01). This increase in risk is similar to that which was found with football players, Dr. Mez noted. This was somewhat surprising, as hockey involves fewer “hits” than football.

“Hits are not as quintessential to the game of hockey as they are in football, where contacts occur with nearly every play,” he said. “In football, you have several hundred impacts over the course of a season.”

Researchers also found a 15% increase in odds for increasing one CTE stage (95% CI, 8%-22%; P < .01), and a .03 standard deviation increase in cumulative NFT burden (95% CI, 0.01-0.05; P < .01).

Dr. Mez noted that the fact that the results were consistent across different outcomes “improves the validity” of the findings.

In a sensitivity analysis that excluded participants who also played football, estimates “were pretty similar” to those in the full analysis, said Dr. Mez.

The investigators have not yet examined the effect of level of hockey play, such as professionally or at the college level, on CTE risk. However, in football players, they found that level of play is another “valuable predictor of CTE pathology,” Dr. Mez said, adding that level of play, position played, and years of play “are all probably contributing” to CTE risk.

Asking about years of play is useful in a clinical setting. “It’s very easy for a clinician to ask patients how many years of hockey they played,” said Dr. Mez.

Overall, the new results are important, as “millions of individuals” play contact sports, whether that is hockey, football, or European soccer, he added. “And for all sports, there seems to be this relationship between more play and risk of this disease.”
 

‘Skewed’ population?

Commenting on the findings, Frank Conidi, MD, director, Florida Center for Health and Sports Neurology, Port St. Lucie, said he was surprised the investigators found a 23% per year increase in risk for CTE among hockey players.

Dr. Conidi has played hockey himself and works with the Florida Panthers of the National Hockey League. In his practice, he treats retired professional football players who have neurodegenerative disorders. From his experience, the number of repetitive direct head impacts in football is significantly higher than in hockey. “Most of the forces seen in hockey are from hits to the body, where the force is transferred to the head,” said Dr. Conidi, who was not involved with the research.

He noted differences in the way hockey is played around the world. In European countries, for example, the ice surface is relatively large and the emphasis tends to be more on skill than hitting.

“It would have been interesting to have the study group analyze the data based on where the athlete grew up,” he said. Dr. Conidi would also like to know when the participants played hockey. “The game is vastly different now than it was in the 1970s, ‘80s, and early ‘90s, when there was more fighting, less protective gear, and more hitting in general.”

As is the case for most studies of CTE in athletes, the study population is “skewed” because the participants likely had neurocognitive and other problems that led to their decision to donate their brain, said Dr. Conidi.

He also doesn’t believe the study should be the sole factor in a decision to continue or stop playing hockey. “We are still in the infancy stages of understanding the effects of high-impact sports on athletes’ brains.”

The study received funding from the National Institute of Neurological Diseases and Stroke and the National Institute on Aging. Dr. Mez and Dr. Conidi have reported no relevant financial relationships.

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

A dose-response relationship exists between number of years playing hockey and risk and severity of chronic traumatic encephalopathy (CTE), new research suggests. Early results from a study that examined donor brains showed that each additional year of ice hockey play increased the risk for CTE by 23%.

This information should be on the “radar” of all clinicians, said coinvestigator Jesse Mez, MD, associate professor of neurology at Boston University. “When they’re talking to kids and families and parents about playing contact sports, they should discuss the benefits as well as the risks so all that information can be taken into consideration.”

Dr. Mez noted that clinicians should also consider the amount of hockey played when assessing patients for thinking and memory trouble later in life. “CTE could be in the differential diagnosis,” he said.

The study findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

Football data

CTE is a neurodegenerative disease associated with repetitive hits to the head. In previous research, the investigators showed that the more that athletes play American football, the more likely they are to develop CTE.

“Hockey, like football, involves repetitive head impacts as part of the game,” said Dr. Mez. “So we hypothesized that we would see a similar type of dose-response relationship in hockey.”

From two brain banks – the Veterans Affairs–Boston University–Concussion Legacy Foundation and the Framingham Heart Study – the researchers accessed 74 consecutive brains from donors who had played ice hockey. They collected information about hockey play during “pretty comprehensive” interviews with next of kin, Dr. Mez reported.

The study participants ranged in age from 13 to 91 years. The cause of death varied; most died with end-stage dementia and neurodegenerative disease, but some died of cardiovascular disease, and others from accidents.

For 9% of the individuals, the highest level of play was a youth league; 34% had reached the high school level, 30% reached the juniors/college level, and 26% played professionally. In addition, 46% played another contact sport – including 43% who played American football.

Primary outcomes included evidence of CTE from stage 0 (no CTE) to stage IV and severity of CTE, which was defined by the amount of neurofibrillary tangle (NFT) burden in 11 brain regions. For this burden, the score ranged from 0 (absent) to 3 (severe) in each region for a total range of 0-33.

Dr. Mez noted that, in CTE, tau protein accumulates abnormally. “It typically begins in the cortex in the frontal lobe and then spreads to other parts of the brain, including to the medial temporal structures, and is widespread by stage IV.”

The researchers estimated the association of duration of ice hockey play in years with each neuropathologic outcome and adjusted for age at death and duration of football play.
 

Consistent findings

Results showed that, of the 74 donors, 40 (54%) had CTE. Each additional year of hockey play corresponded to increased chances for having CTE (odds ratio, 1.23; 95% confidence interval, 11%-36%; P < .01). This increase in risk is similar to that which was found with football players, Dr. Mez noted. This was somewhat surprising, as hockey involves fewer “hits” than football.

“Hits are not as quintessential to the game of hockey as they are in football, where contacts occur with nearly every play,” he said. “In football, you have several hundred impacts over the course of a season.”

Researchers also found a 15% increase in odds for increasing one CTE stage (95% CI, 8%-22%; P < .01), and a .03 standard deviation increase in cumulative NFT burden (95% CI, 0.01-0.05; P < .01).

Dr. Mez noted that the fact that the results were consistent across different outcomes “improves the validity” of the findings.

In a sensitivity analysis that excluded participants who also played football, estimates “were pretty similar” to those in the full analysis, said Dr. Mez.

The investigators have not yet examined the effect of level of hockey play, such as professionally or at the college level, on CTE risk. However, in football players, they found that level of play is another “valuable predictor of CTE pathology,” Dr. Mez said, adding that level of play, position played, and years of play “are all probably contributing” to CTE risk.

Asking about years of play is useful in a clinical setting. “It’s very easy for a clinician to ask patients how many years of hockey they played,” said Dr. Mez.

Overall, the new results are important, as “millions of individuals” play contact sports, whether that is hockey, football, or European soccer, he added. “And for all sports, there seems to be this relationship between more play and risk of this disease.”
 

‘Skewed’ population?

Commenting on the findings, Frank Conidi, MD, director, Florida Center for Health and Sports Neurology, Port St. Lucie, said he was surprised the investigators found a 23% per year increase in risk for CTE among hockey players.

Dr. Conidi has played hockey himself and works with the Florida Panthers of the National Hockey League. In his practice, he treats retired professional football players who have neurodegenerative disorders. From his experience, the number of repetitive direct head impacts in football is significantly higher than in hockey. “Most of the forces seen in hockey are from hits to the body, where the force is transferred to the head,” said Dr. Conidi, who was not involved with the research.

He noted differences in the way hockey is played around the world. In European countries, for example, the ice surface is relatively large and the emphasis tends to be more on skill than hitting.

“It would have been interesting to have the study group analyze the data based on where the athlete grew up,” he said. Dr. Conidi would also like to know when the participants played hockey. “The game is vastly different now than it was in the 1970s, ‘80s, and early ‘90s, when there was more fighting, less protective gear, and more hitting in general.”

As is the case for most studies of CTE in athletes, the study population is “skewed” because the participants likely had neurocognitive and other problems that led to their decision to donate their brain, said Dr. Conidi.

He also doesn’t believe the study should be the sole factor in a decision to continue or stop playing hockey. “We are still in the infancy stages of understanding the effects of high-impact sports on athletes’ brains.”

The study received funding from the National Institute of Neurological Diseases and Stroke and the National Institute on Aging. Dr. Mez and Dr. Conidi have reported no relevant financial relationships.

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

The Ohio House of Representatives recently passed a bill that would enable patients to use drug manufacturer coupons and other co-pay assistance as payment toward their annual deductible.

According to the Kaiser Family Foundation, approximately 1 in 4 Americans have difficulty paying for their prescription drugs, while almost half of U.S. adults report difficulty paying out-of-pocket costs not covered by their health insurance.

Supporting the bill that restricts co-pay accumulators are groups such as the Ohio State Medical Association, the Crohn’s and Colitis Foundation, Susan C. Komen, the National Multiple Sclerosis Society, and the American Diabetes Association. The bill faced opposition from health insurers and pharmacy benefit managers, reported The Columbus Dispatch.

“The debate on the management of rising drug costs between manufacturers and insurers unfortunately leaves patients caught in the middle, and practices like co-pay accumulators can have a devastating impact,” Monica Hueckel, senior director of government relations for the Ohio State Medical Association, told this news organization.

“Patients often do not even know about these policies until the coupons are no longer usable. As you can imagine, for patients with expensive medications and/or high deductible health plans, the impact is disastrous,” she said.

Ohio State Representative Susan Manchester, who co-sponsored the bill, told The Columbus Dispatch that the legislation “is needed to assist our constituents who find themselves increasingly subjected to more out-of-pocket costs as part of their insurance coverage.”

Other states blocking health insurers’ co-pay policies

With the passage of the bill, Ohio joins 12 states and Puerto Rico in preventing the use of health insurers’ co-pays to increase patients’ out-of-pocket costs, reported The Columbus Dispatch; 15 states are also considering this type of legislation.

Eighty-three percent of patients are in plans that include a co-pay accumulator, according to consulting firm Avalere, which wrote that, beginning in 2023, the Center for Medicare & Medicaid Services requires patients with Medicaid to receive “the full value of co-pay assistance” on drugs.

According to the National Conference of State Legislatures, co-pay adjustment programs present challenges for patients, with plans that include high cost sharing or co-insurance whereby a patient pays a percentage of the cost instead of a flat amount.

For example, with a co-pay adjustment policy, a patient with a $2,000 deductible plan couldn’t use a $500 coupon toward meeting the deductible, writes the National Conference of State Legislatures. Conversely, a patient in a plan without a co-pay adjustment policy could use the coupon to satisfy their annual deductible.

Patients with complex conditions, such as cancer, rheumatoid arthritis, and diabetes, which often require expensive medications, may have little choice but to fork over the unexpected co-pays, according to the organization that represents state legislatures in the United States.

The bill now moves to the Ohio Senate, reported The Columbus Dispatch.

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

The Ohio House of Representatives recently passed a bill that would enable patients to use drug manufacturer coupons and other co-pay assistance as payment toward their annual deductible.

According to the Kaiser Family Foundation, approximately 1 in 4 Americans have difficulty paying for their prescription drugs, while almost half of U.S. adults report difficulty paying out-of-pocket costs not covered by their health insurance.

Supporting the bill that restricts co-pay accumulators are groups such as the Ohio State Medical Association, the Crohn’s and Colitis Foundation, Susan C. Komen, the National Multiple Sclerosis Society, and the American Diabetes Association. The bill faced opposition from health insurers and pharmacy benefit managers, reported The Columbus Dispatch.

“The debate on the management of rising drug costs between manufacturers and insurers unfortunately leaves patients caught in the middle, and practices like co-pay accumulators can have a devastating impact,” Monica Hueckel, senior director of government relations for the Ohio State Medical Association, told this news organization.

“Patients often do not even know about these policies until the coupons are no longer usable. As you can imagine, for patients with expensive medications and/or high deductible health plans, the impact is disastrous,” she said.

Ohio State Representative Susan Manchester, who co-sponsored the bill, told The Columbus Dispatch that the legislation “is needed to assist our constituents who find themselves increasingly subjected to more out-of-pocket costs as part of their insurance coverage.”

Other states blocking health insurers’ co-pay policies

With the passage of the bill, Ohio joins 12 states and Puerto Rico in preventing the use of health insurers’ co-pays to increase patients’ out-of-pocket costs, reported The Columbus Dispatch; 15 states are also considering this type of legislation.

Eighty-three percent of patients are in plans that include a co-pay accumulator, according to consulting firm Avalere, which wrote that, beginning in 2023, the Center for Medicare & Medicaid Services requires patients with Medicaid to receive “the full value of co-pay assistance” on drugs.

According to the National Conference of State Legislatures, co-pay adjustment programs present challenges for patients, with plans that include high cost sharing or co-insurance whereby a patient pays a percentage of the cost instead of a flat amount.

For example, with a co-pay adjustment policy, a patient with a $2,000 deductible plan couldn’t use a $500 coupon toward meeting the deductible, writes the National Conference of State Legislatures. Conversely, a patient in a plan without a co-pay adjustment policy could use the coupon to satisfy their annual deductible.

Patients with complex conditions, such as cancer, rheumatoid arthritis, and diabetes, which often require expensive medications, may have little choice but to fork over the unexpected co-pays, according to the organization that represents state legislatures in the United States.

The bill now moves to the Ohio Senate, reported The Columbus Dispatch.

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

The Ohio House of Representatives recently passed a bill that would enable patients to use drug manufacturer coupons and other co-pay assistance as payment toward their annual deductible.

According to the Kaiser Family Foundation, approximately 1 in 4 Americans have difficulty paying for their prescription drugs, while almost half of U.S. adults report difficulty paying out-of-pocket costs not covered by their health insurance.

Supporting the bill that restricts co-pay accumulators are groups such as the Ohio State Medical Association, the Crohn’s and Colitis Foundation, Susan C. Komen, the National Multiple Sclerosis Society, and the American Diabetes Association. The bill faced opposition from health insurers and pharmacy benefit managers, reported The Columbus Dispatch.

“The debate on the management of rising drug costs between manufacturers and insurers unfortunately leaves patients caught in the middle, and practices like co-pay accumulators can have a devastating impact,” Monica Hueckel, senior director of government relations for the Ohio State Medical Association, told this news organization.

“Patients often do not even know about these policies until the coupons are no longer usable. As you can imagine, for patients with expensive medications and/or high deductible health plans, the impact is disastrous,” she said.

Ohio State Representative Susan Manchester, who co-sponsored the bill, told The Columbus Dispatch that the legislation “is needed to assist our constituents who find themselves increasingly subjected to more out-of-pocket costs as part of their insurance coverage.”

Other states blocking health insurers’ co-pay policies

With the passage of the bill, Ohio joins 12 states and Puerto Rico in preventing the use of health insurers’ co-pays to increase patients’ out-of-pocket costs, reported The Columbus Dispatch; 15 states are also considering this type of legislation.

Eighty-three percent of patients are in plans that include a co-pay accumulator, according to consulting firm Avalere, which wrote that, beginning in 2023, the Center for Medicare & Medicaid Services requires patients with Medicaid to receive “the full value of co-pay assistance” on drugs.

According to the National Conference of State Legislatures, co-pay adjustment programs present challenges for patients, with plans that include high cost sharing or co-insurance whereby a patient pays a percentage of the cost instead of a flat amount.

For example, with a co-pay adjustment policy, a patient with a $2,000 deductible plan couldn’t use a $500 coupon toward meeting the deductible, writes the National Conference of State Legislatures. Conversely, a patient in a plan without a co-pay adjustment policy could use the coupon to satisfy their annual deductible.

Patients with complex conditions, such as cancer, rheumatoid arthritis, and diabetes, which often require expensive medications, may have little choice but to fork over the unexpected co-pays, according to the organization that represents state legislatures in the United States.

The bill now moves to the Ohio Senate, reported The Columbus Dispatch.

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

DENVER – An investigational once-daily oral neuroactive steroid is linked to significant improvement in quality of life (QoL) and well-being in patients with major depressive disorder (MDD), new research shows.

In a phase 3 trial that included more than 500 adult patients with MDD, those who received zuranolone for 14 days showed greater improvement at day 15 across numerous QoL outcomes, compared with their counterparts in the placebo group.

In addition, combined analysis of four zuranolone clinical trials showed “mental well-being and functioning improved to near general population norm levels” for the active-treatment group, reported the researchers, led by Anita H. Clayton, MD, chair and professor of psychiatry, University of Virginia, Charlottesville.

“Based on these integrated analyses, the benefit of treatment with zuranolone may extend beyond reduction in depressive symptoms to include potential improvement in quality of life and overall health, as perceived by patients,” they add.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

First oral formulation

Zuranolone represents the second entry in the new class of neuroactive steroid drugs, which modulate GABA-A receptor activity – but it would be the first to have an oral formulation. Brexanolone, which was approved by the Food and Drug Administration in 2019 for postpartum depression, is administered through continuous IV infusion over 60 hours.

As previously reported by this news organization, zuranolone improved depressive symptoms as early as day 3, achieving the primary endpoint of significantly greater reduction in scores on the 17-item Hamilton Rating Scale for Depression from baseline to day 15 versus placebo (P = .014).

In the new analysis, patient-reported measures of functional health and well-being were assessed in the WATERFALL trial. It included 266 patients with MDD who were treated with zuranolone 50 mg daily for 2 weeks and 268 patients with MDD who were treated with placebo.

The study used the Short Form–36 (SF-36v2), which covers a wide range of patient-reported measures, including physical function, bodily pain, general health, vitality, social function, and “role-emotional” symptoms.

Results showed that although the treatment and placebo groups had similar baseline SF-36v2 scores, those receiving zuranolone reported significantly greater improvements at day 15 in almost all of the assessment’s domains, including physical function (treatment difference, 0.8), general health (1.0), vitality (3.1), social functioning (1.1), and role-emotional symptoms (1.5; for all comparisons, P < .05). The only exceptions were in role-physical symptoms and bodily pain.

In measures that included physical function, bodily pain, and general health, the patients achieved improvements at day 15 that were consistent with normal levels, with the improvement in vitality considered clinically meaningful versus placebo.

Integrated data

In further analysis of integrated data from four zuranolone clinical trials in the NEST and LANDSCAPE programs for patients with MDD and postpartum depression, results showed similar improvements at day 15 for zuranolone in QoL and overall health across all of the SF-36v2 functioning and well-being domains (P <.05), with the exceptions of physical measure and bodily pain.

By day 42, all of the domains showed significantly greater improvement with zuranolone versus placebo (all, P <.05).

Among the strongest score improvements in the integrated trials were measures in social functioning, which improved from baseline scores of 29.66 to 42.82 on day 15 and to 43.59 on day 42.

Emotional domain scores improved from 24.43 at baseline to 39.13 on day 15 and to 39.82 on day 42. For mental health, the integrated scores for the zuranolone group improved from 27.13 at baseline to 42.40 on day 15 and 42.62 on day 42.

Of note, the baseline scores for mental health represented just 54.3% of those in the normal population; with the increase at day 15, the level was 84.8% of the normal population.

“Across four completed placebo-controlled NEST and LANDSCAPE clinical trials, patient reports of functional health and well-being as assessed by the SF-36v2 indicated substantial impairment at baseline compared to the population norm,” the researchers reported.

The improvements are especially important in light of the fact that in some patients with MDD, functional improvement is a top priority.

“Patients have often prioritized returning to their usual level of functioning over reduction in depressive symptoms, and functional recovery has been associated with better prognosis of depression,” the investigators wrote.

Zuranolone trials have shown that treatment-emergent adverse events (AEs) occur among about 60% of patients, versus about 44% with placebo. The most common AEs are somnolence, dizziness, headache, sedation, and diarrhea, with no increases in suicidal ideation or withdrawal.

The rates of severe AEs are low, and they are observed in about 3% of patients, versus 1.1% with placebo, the researchers noted.

Further, as opposed to serotonergic antidepressants such as SNRIs and SSRIs, zuranolone does not appear to have the undesirable side effects of decreased libido and sexual dysfunction, they added.
 

Clinically meaningful?

Andrew J. Cutler, MD, clinical associate professor of psychiatry at State University of New York, Syracuse, said the data are “very significant” for a number of reasons.

“We need more options to treat depression, especially ones with novel mechanisms of action and faster onset of efficacy, such as zuranolone,” said Dr. Cutler, who was not involved in the current study. He has coauthored other studies on zuranolone.

Regarding the study’s QoL outcomes, “while improvement in depressive symptoms is very important, what really matters to patients is improvement in function and quality of life,” Dr. Cutler noted.

Also commenting on the study, Jonathan E. Alpert, MD, PhD, chair of the department of psychiatry and behavioral sciences and professor of psychiatry, neuroscience, and pediatrics at Albert Einstein College of Medicine, New York, said the investigational drug could represent an important addition to the armamentarium for treating depression.

“Zuranolone has good oral bioavailability and would represent the first neuroactive steroid antidepressant available in oral form and, indeed, the first non–monoamine-based antidepressant available in oral form,” he said in an interview.

Courtesy Dr. Jonathan E. Alpert

Dr. Alpert was not involved in the research and has no relationship with the drug’s development.

He noted that although there are modest differences between the patients who received zuranolone and those who received placebo in the trials, “this may have been related to high placebo response rates, which often complicate antidepressant trials.

“Further research is needed to determine whether differences between zuranolone and placebo are clinically meaningful, though the separation between drug and placebo on the primary endpoint, as well as some other measures, such as quality of life measures, is promising,” Dr. Alpert said.

However, he added that comparisons with other active antidepressants in terms of efficacy and tolerability remain to be seen.

“Given the large number of individuals with major depressive disorder who have incomplete response to or do not tolerate monoaminergic antidepressants, the development of agents that leverage novel nonmonoaminergic mechanisms is important,” Dr. Alpert concluded.

The study was funded by Sage Therapeutics and Biogen. Dr. Cutler has been involved in research of zuranolone for Sage Therapeutics. Dr. Alpert has reported no relevant financial relationships.

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

DENVER – An investigational once-daily oral neuroactive steroid is linked to significant improvement in quality of life (QoL) and well-being in patients with major depressive disorder (MDD), new research shows.

In a phase 3 trial that included more than 500 adult patients with MDD, those who received zuranolone for 14 days showed greater improvement at day 15 across numerous QoL outcomes, compared with their counterparts in the placebo group.

In addition, combined analysis of four zuranolone clinical trials showed “mental well-being and functioning improved to near general population norm levels” for the active-treatment group, reported the researchers, led by Anita H. Clayton, MD, chair and professor of psychiatry, University of Virginia, Charlottesville.

“Based on these integrated analyses, the benefit of treatment with zuranolone may extend beyond reduction in depressive symptoms to include potential improvement in quality of life and overall health, as perceived by patients,” they add.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

First oral formulation

Zuranolone represents the second entry in the new class of neuroactive steroid drugs, which modulate GABA-A receptor activity – but it would be the first to have an oral formulation. Brexanolone, which was approved by the Food and Drug Administration in 2019 for postpartum depression, is administered through continuous IV infusion over 60 hours.

As previously reported by this news organization, zuranolone improved depressive symptoms as early as day 3, achieving the primary endpoint of significantly greater reduction in scores on the 17-item Hamilton Rating Scale for Depression from baseline to day 15 versus placebo (P = .014).

In the new analysis, patient-reported measures of functional health and well-being were assessed in the WATERFALL trial. It included 266 patients with MDD who were treated with zuranolone 50 mg daily for 2 weeks and 268 patients with MDD who were treated with placebo.

The study used the Short Form–36 (SF-36v2), which covers a wide range of patient-reported measures, including physical function, bodily pain, general health, vitality, social function, and “role-emotional” symptoms.

Results showed that although the treatment and placebo groups had similar baseline SF-36v2 scores, those receiving zuranolone reported significantly greater improvements at day 15 in almost all of the assessment’s domains, including physical function (treatment difference, 0.8), general health (1.0), vitality (3.1), social functioning (1.1), and role-emotional symptoms (1.5; for all comparisons, P < .05). The only exceptions were in role-physical symptoms and bodily pain.

In measures that included physical function, bodily pain, and general health, the patients achieved improvements at day 15 that were consistent with normal levels, with the improvement in vitality considered clinically meaningful versus placebo.

Integrated data

In further analysis of integrated data from four zuranolone clinical trials in the NEST and LANDSCAPE programs for patients with MDD and postpartum depression, results showed similar improvements at day 15 for zuranolone in QoL and overall health across all of the SF-36v2 functioning and well-being domains (P <.05), with the exceptions of physical measure and bodily pain.

By day 42, all of the domains showed significantly greater improvement with zuranolone versus placebo (all, P <.05).

Among the strongest score improvements in the integrated trials were measures in social functioning, which improved from baseline scores of 29.66 to 42.82 on day 15 and to 43.59 on day 42.

Emotional domain scores improved from 24.43 at baseline to 39.13 on day 15 and to 39.82 on day 42. For mental health, the integrated scores for the zuranolone group improved from 27.13 at baseline to 42.40 on day 15 and 42.62 on day 42.

Of note, the baseline scores for mental health represented just 54.3% of those in the normal population; with the increase at day 15, the level was 84.8% of the normal population.

“Across four completed placebo-controlled NEST and LANDSCAPE clinical trials, patient reports of functional health and well-being as assessed by the SF-36v2 indicated substantial impairment at baseline compared to the population norm,” the researchers reported.

The improvements are especially important in light of the fact that in some patients with MDD, functional improvement is a top priority.

“Patients have often prioritized returning to their usual level of functioning over reduction in depressive symptoms, and functional recovery has been associated with better prognosis of depression,” the investigators wrote.

Zuranolone trials have shown that treatment-emergent adverse events (AEs) occur among about 60% of patients, versus about 44% with placebo. The most common AEs are somnolence, dizziness, headache, sedation, and diarrhea, with no increases in suicidal ideation or withdrawal.

The rates of severe AEs are low, and they are observed in about 3% of patients, versus 1.1% with placebo, the researchers noted.

Further, as opposed to serotonergic antidepressants such as SNRIs and SSRIs, zuranolone does not appear to have the undesirable side effects of decreased libido and sexual dysfunction, they added.
 

Clinically meaningful?

Andrew J. Cutler, MD, clinical associate professor of psychiatry at State University of New York, Syracuse, said the data are “very significant” for a number of reasons.

“We need more options to treat depression, especially ones with novel mechanisms of action and faster onset of efficacy, such as zuranolone,” said Dr. Cutler, who was not involved in the current study. He has coauthored other studies on zuranolone.

Regarding the study’s QoL outcomes, “while improvement in depressive symptoms is very important, what really matters to patients is improvement in function and quality of life,” Dr. Cutler noted.

Also commenting on the study, Jonathan E. Alpert, MD, PhD, chair of the department of psychiatry and behavioral sciences and professor of psychiatry, neuroscience, and pediatrics at Albert Einstein College of Medicine, New York, said the investigational drug could represent an important addition to the armamentarium for treating depression.

“Zuranolone has good oral bioavailability and would represent the first neuroactive steroid antidepressant available in oral form and, indeed, the first non–monoamine-based antidepressant available in oral form,” he said in an interview.

Courtesy Dr. Jonathan E. Alpert

Dr. Alpert was not involved in the research and has no relationship with the drug’s development.

He noted that although there are modest differences between the patients who received zuranolone and those who received placebo in the trials, “this may have been related to high placebo response rates, which often complicate antidepressant trials.

“Further research is needed to determine whether differences between zuranolone and placebo are clinically meaningful, though the separation between drug and placebo on the primary endpoint, as well as some other measures, such as quality of life measures, is promising,” Dr. Alpert said.

However, he added that comparisons with other active antidepressants in terms of efficacy and tolerability remain to be seen.

“Given the large number of individuals with major depressive disorder who have incomplete response to or do not tolerate monoaminergic antidepressants, the development of agents that leverage novel nonmonoaminergic mechanisms is important,” Dr. Alpert concluded.

The study was funded by Sage Therapeutics and Biogen. Dr. Cutler has been involved in research of zuranolone for Sage Therapeutics. Dr. Alpert has reported no relevant financial relationships.

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

DENVER – An investigational once-daily oral neuroactive steroid is linked to significant improvement in quality of life (QoL) and well-being in patients with major depressive disorder (MDD), new research shows.

In a phase 3 trial that included more than 500 adult patients with MDD, those who received zuranolone for 14 days showed greater improvement at day 15 across numerous QoL outcomes, compared with their counterparts in the placebo group.

In addition, combined analysis of four zuranolone clinical trials showed “mental well-being and functioning improved to near general population norm levels” for the active-treatment group, reported the researchers, led by Anita H. Clayton, MD, chair and professor of psychiatry, University of Virginia, Charlottesville.

“Based on these integrated analyses, the benefit of treatment with zuranolone may extend beyond reduction in depressive symptoms to include potential improvement in quality of life and overall health, as perceived by patients,” they add.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

First oral formulation

Zuranolone represents the second entry in the new class of neuroactive steroid drugs, which modulate GABA-A receptor activity – but it would be the first to have an oral formulation. Brexanolone, which was approved by the Food and Drug Administration in 2019 for postpartum depression, is administered through continuous IV infusion over 60 hours.

As previously reported by this news organization, zuranolone improved depressive symptoms as early as day 3, achieving the primary endpoint of significantly greater reduction in scores on the 17-item Hamilton Rating Scale for Depression from baseline to day 15 versus placebo (P = .014).

In the new analysis, patient-reported measures of functional health and well-being were assessed in the WATERFALL trial. It included 266 patients with MDD who were treated with zuranolone 50 mg daily for 2 weeks and 268 patients with MDD who were treated with placebo.

The study used the Short Form–36 (SF-36v2), which covers a wide range of patient-reported measures, including physical function, bodily pain, general health, vitality, social function, and “role-emotional” symptoms.

Results showed that although the treatment and placebo groups had similar baseline SF-36v2 scores, those receiving zuranolone reported significantly greater improvements at day 15 in almost all of the assessment’s domains, including physical function (treatment difference, 0.8), general health (1.0), vitality (3.1), social functioning (1.1), and role-emotional symptoms (1.5; for all comparisons, P < .05). The only exceptions were in role-physical symptoms and bodily pain.

In measures that included physical function, bodily pain, and general health, the patients achieved improvements at day 15 that were consistent with normal levels, with the improvement in vitality considered clinically meaningful versus placebo.

Integrated data

In further analysis of integrated data from four zuranolone clinical trials in the NEST and LANDSCAPE programs for patients with MDD and postpartum depression, results showed similar improvements at day 15 for zuranolone in QoL and overall health across all of the SF-36v2 functioning and well-being domains (P <.05), with the exceptions of physical measure and bodily pain.

By day 42, all of the domains showed significantly greater improvement with zuranolone versus placebo (all, P <.05).

Among the strongest score improvements in the integrated trials were measures in social functioning, which improved from baseline scores of 29.66 to 42.82 on day 15 and to 43.59 on day 42.

Emotional domain scores improved from 24.43 at baseline to 39.13 on day 15 and to 39.82 on day 42. For mental health, the integrated scores for the zuranolone group improved from 27.13 at baseline to 42.40 on day 15 and 42.62 on day 42.

Of note, the baseline scores for mental health represented just 54.3% of those in the normal population; with the increase at day 15, the level was 84.8% of the normal population.

“Across four completed placebo-controlled NEST and LANDSCAPE clinical trials, patient reports of functional health and well-being as assessed by the SF-36v2 indicated substantial impairment at baseline compared to the population norm,” the researchers reported.

The improvements are especially important in light of the fact that in some patients with MDD, functional improvement is a top priority.

“Patients have often prioritized returning to their usual level of functioning over reduction in depressive symptoms, and functional recovery has been associated with better prognosis of depression,” the investigators wrote.

Zuranolone trials have shown that treatment-emergent adverse events (AEs) occur among about 60% of patients, versus about 44% with placebo. The most common AEs are somnolence, dizziness, headache, sedation, and diarrhea, with no increases in suicidal ideation or withdrawal.

The rates of severe AEs are low, and they are observed in about 3% of patients, versus 1.1% with placebo, the researchers noted.

Further, as opposed to serotonergic antidepressants such as SNRIs and SSRIs, zuranolone does not appear to have the undesirable side effects of decreased libido and sexual dysfunction, they added.
 

Clinically meaningful?

Andrew J. Cutler, MD, clinical associate professor of psychiatry at State University of New York, Syracuse, said the data are “very significant” for a number of reasons.

“We need more options to treat depression, especially ones with novel mechanisms of action and faster onset of efficacy, such as zuranolone,” said Dr. Cutler, who was not involved in the current study. He has coauthored other studies on zuranolone.

Regarding the study’s QoL outcomes, “while improvement in depressive symptoms is very important, what really matters to patients is improvement in function and quality of life,” Dr. Cutler noted.

Also commenting on the study, Jonathan E. Alpert, MD, PhD, chair of the department of psychiatry and behavioral sciences and professor of psychiatry, neuroscience, and pediatrics at Albert Einstein College of Medicine, New York, said the investigational drug could represent an important addition to the armamentarium for treating depression.

“Zuranolone has good oral bioavailability and would represent the first neuroactive steroid antidepressant available in oral form and, indeed, the first non–monoamine-based antidepressant available in oral form,” he said in an interview.

Courtesy Dr. Jonathan E. Alpert

Dr. Alpert was not involved in the research and has no relationship with the drug’s development.

He noted that although there are modest differences between the patients who received zuranolone and those who received placebo in the trials, “this may have been related to high placebo response rates, which often complicate antidepressant trials.

“Further research is needed to determine whether differences between zuranolone and placebo are clinically meaningful, though the separation between drug and placebo on the primary endpoint, as well as some other measures, such as quality of life measures, is promising,” Dr. Alpert said.

However, he added that comparisons with other active antidepressants in terms of efficacy and tolerability remain to be seen.

“Given the large number of individuals with major depressive disorder who have incomplete response to or do not tolerate monoaminergic antidepressants, the development of agents that leverage novel nonmonoaminergic mechanisms is important,” Dr. Alpert concluded.

The study was funded by Sage Therapeutics and Biogen. Dr. Cutler has been involved in research of zuranolone for Sage Therapeutics. Dr. Alpert has reported no relevant financial relationships.

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

The Biden administration has announced a massive federal effort to better understand, diagnose, and treat the crippling effects of long COVID.

The National Research Action Plan on Long COVID will gather experts from various agencies, including the Department of Defense and the Department of Veterans Affairs, to expand existing long-COVID clinics and broaden research on symptoms of the virus that persist long after infection.

“We’ll collaborate with academic, industry, state and local partners to better understand long COVID,” Health and Human Services Secretary Xavier Becerra said at a White House briefing April 5. “We need to work as aggressively as we can to make sure no American is left behind.”

The plan will build on the RECOVER Initiative, a $1.15 billion effort announced last year that will study long COVID.

The COVID-19 Response Team also announced that the United States will donate tens of millions of pediatric coronavirus vaccines to other countries. More than 20 countries have asked for the donations, the team said.

The United States has delivered more than 500 million vaccine doses to 114 countries.

Meanwhile, national COVID-19 numbers continue to fall. CDC Director Rochelle Walensky, MD, reported that average daily cases are down 4% this week to 25,000; hospitalizations have dropped 17% to 1,400 per day; and daily deaths are down to 570 a day, which is a decrease of about 17%.

New national estimates show that Omicron’s subvariant BA.2 now accounts for 72% of circulating variants nationally, she said.

Top infectious disease expert Anthony Fauci, MD, reported that recent data supports the need for a second booster among certain people 50 and older – a move authorized by the Food and Drug Administration and Centers for Disease Control and Prevention last week.

“The effectiveness of the first booster dose we know wanes over time, and growing evidence shows a second dose can restore vaccine effectiveness for certain populations,” he said.

Dr. Fauci reported findings from an Israeli study of more than 1 million people 60 and older, which showed that an additional booster dose after 4 months lowered the rate of infection by two times and lowered the rate of severe infection by more than four times.

Another study from Israeli scientists showed that out of half a million people 60 and older, a second booster after 4 months brought a 78% reduction in death, compared to those who received only the first boost.

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

The Biden administration has announced a massive federal effort to better understand, diagnose, and treat the crippling effects of long COVID.

The National Research Action Plan on Long COVID will gather experts from various agencies, including the Department of Defense and the Department of Veterans Affairs, to expand existing long-COVID clinics and broaden research on symptoms of the virus that persist long after infection.

“We’ll collaborate with academic, industry, state and local partners to better understand long COVID,” Health and Human Services Secretary Xavier Becerra said at a White House briefing April 5. “We need to work as aggressively as we can to make sure no American is left behind.”

The plan will build on the RECOVER Initiative, a $1.15 billion effort announced last year that will study long COVID.

The COVID-19 Response Team also announced that the United States will donate tens of millions of pediatric coronavirus vaccines to other countries. More than 20 countries have asked for the donations, the team said.

The United States has delivered more than 500 million vaccine doses to 114 countries.

Meanwhile, national COVID-19 numbers continue to fall. CDC Director Rochelle Walensky, MD, reported that average daily cases are down 4% this week to 25,000; hospitalizations have dropped 17% to 1,400 per day; and daily deaths are down to 570 a day, which is a decrease of about 17%.

New national estimates show that Omicron’s subvariant BA.2 now accounts for 72% of circulating variants nationally, she said.

Top infectious disease expert Anthony Fauci, MD, reported that recent data supports the need for a second booster among certain people 50 and older – a move authorized by the Food and Drug Administration and Centers for Disease Control and Prevention last week.

“The effectiveness of the first booster dose we know wanes over time, and growing evidence shows a second dose can restore vaccine effectiveness for certain populations,” he said.

Dr. Fauci reported findings from an Israeli study of more than 1 million people 60 and older, which showed that an additional booster dose after 4 months lowered the rate of infection by two times and lowered the rate of severe infection by more than four times.

Another study from Israeli scientists showed that out of half a million people 60 and older, a second booster after 4 months brought a 78% reduction in death, compared to those who received only the first boost.

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

The Biden administration has announced a massive federal effort to better understand, diagnose, and treat the crippling effects of long COVID.

The National Research Action Plan on Long COVID will gather experts from various agencies, including the Department of Defense and the Department of Veterans Affairs, to expand existing long-COVID clinics and broaden research on symptoms of the virus that persist long after infection.

“We’ll collaborate with academic, industry, state and local partners to better understand long COVID,” Health and Human Services Secretary Xavier Becerra said at a White House briefing April 5. “We need to work as aggressively as we can to make sure no American is left behind.”

The plan will build on the RECOVER Initiative, a $1.15 billion effort announced last year that will study long COVID.

The COVID-19 Response Team also announced that the United States will donate tens of millions of pediatric coronavirus vaccines to other countries. More than 20 countries have asked for the donations, the team said.

The United States has delivered more than 500 million vaccine doses to 114 countries.

Meanwhile, national COVID-19 numbers continue to fall. CDC Director Rochelle Walensky, MD, reported that average daily cases are down 4% this week to 25,000; hospitalizations have dropped 17% to 1,400 per day; and daily deaths are down to 570 a day, which is a decrease of about 17%.

New national estimates show that Omicron’s subvariant BA.2 now accounts for 72% of circulating variants nationally, she said.

Top infectious disease expert Anthony Fauci, MD, reported that recent data supports the need for a second booster among certain people 50 and older – a move authorized by the Food and Drug Administration and Centers for Disease Control and Prevention last week.

“The effectiveness of the first booster dose we know wanes over time, and growing evidence shows a second dose can restore vaccine effectiveness for certain populations,” he said.

Dr. Fauci reported findings from an Israeli study of more than 1 million people 60 and older, which showed that an additional booster dose after 4 months lowered the rate of infection by two times and lowered the rate of severe infection by more than four times.

Another study from Israeli scientists showed that out of half a million people 60 and older, a second booster after 4 months brought a 78% reduction in death, compared to those who received only the first boost.

A version of this article first appeared on WebMD.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.

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.

A new COVID-19 variant has cropped up in the United Kingdom – a combination of the original Omicron strain and its subvariant BA.2 that may be more contagious than BA.2, ABC News reported.

As of last week, the U.K. Health Security Agency had found 637 cases of the variant, known as XE. The earliest case was found Jan. 19.

The new strain is known as a recombinant, which means it is a combination of two variants or viruses.

XE makes up less than 1% of sequenced cases in the United Kingdom so far, and there is no evidence yet that the strain leads to more severe disease or less vaccine protection.

“Right now, there’s really no public health concern,” John Brownstein, PhD, an epidemiologist and chief innovation officer at Boston Children’s Hospital, told ABC. “Recombinant variants happen over and over. In fact, the reason that this is the XE variant recombinant is that we’ve had XA, XB, XC, XD already, and none of those have turned out to be any real concern.”

A World Health Organization update published March 29 notes XE’s high transmissibility and says it may have a growth advantage of 10% over the BA.2 subvariant that now makes up more than 70% of cases in the United States.

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

A new COVID-19 variant has cropped up in the United Kingdom – a combination of the original Omicron strain and its subvariant BA.2 that may be more contagious than BA.2, ABC News reported.

As of last week, the U.K. Health Security Agency had found 637 cases of the variant, known as XE. The earliest case was found Jan. 19.

The new strain is known as a recombinant, which means it is a combination of two variants or viruses.

XE makes up less than 1% of sequenced cases in the United Kingdom so far, and there is no evidence yet that the strain leads to more severe disease or less vaccine protection.

“Right now, there’s really no public health concern,” John Brownstein, PhD, an epidemiologist and chief innovation officer at Boston Children’s Hospital, told ABC. “Recombinant variants happen over and over. In fact, the reason that this is the XE variant recombinant is that we’ve had XA, XB, XC, XD already, and none of those have turned out to be any real concern.”

A World Health Organization update published March 29 notes XE’s high transmissibility and says it may have a growth advantage of 10% over the BA.2 subvariant that now makes up more than 70% of cases in the United States.

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

A new COVID-19 variant has cropped up in the United Kingdom – a combination of the original Omicron strain and its subvariant BA.2 that may be more contagious than BA.2, ABC News reported.

As of last week, the U.K. Health Security Agency had found 637 cases of the variant, known as XE. The earliest case was found Jan. 19.

The new strain is known as a recombinant, which means it is a combination of two variants or viruses.

XE makes up less than 1% of sequenced cases in the United Kingdom so far, and there is no evidence yet that the strain leads to more severe disease or less vaccine protection.

“Right now, there’s really no public health concern,” John Brownstein, PhD, an epidemiologist and chief innovation officer at Boston Children’s Hospital, told ABC. “Recombinant variants happen over and over. In fact, the reason that this is the XE variant recombinant is that we’ve had XA, XB, XC, XD already, and none of those have turned out to be any real concern.”

A World Health Organization update published March 29 notes XE’s high transmissibility and says it may have a growth advantage of 10% over the BA.2 subvariant that now makes up more than 70% of cases in the United States.

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

Even as a number of states see increases in new COVID-19 cases among all ages, the trend remains downward for children, albeit at a slower pace than in recent weeks, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

New pediatric cases in the United States totaled 27,521 for the most recent week, March 25-31, down by 5.2% from the previous week. Earlier weekly declines, going backward through March and into late February, were 9.3%, 23%, 39.5%, and 46%, according to data collected by the AAP and CHA from state and territorial health agencies. The lowest weekly total recorded since the initial wave in 2020 was just under 8,500 during the week of June 18-24, 2021.

Reported COVID-19 cases in children now total over 12.8 million since the beginning of the pandemic in March 2020, and those infections represent 19.0% of all cases. That share of new cases has not increased in the last 7 weeks, the AAP and CHA noted in their weekly COVID report, suggesting that children have not been bearing a disproportionate share of the declining Omicron burden.

As for Omicron, the BA.2 subvariant now makes up about 55% of COVID-19 infections, the Centers for Disease Control and Prevention said in its COVID Data Tracker Weekly Review, and New York, Massachusetts, and New Jersey are among the states reporting BA.2-driven increases in new cases of as much as 30%, the New York Times said.

Rates of new cases for the latest week available (March 27 to April 2) and at their Omicron peaks in January were 11.3 per 100,000 and 1,011 per 100,000 (ages 0-4 years), 12.5 and 1,505 per 100,000 (5-11 years), 12.7 and 1,779 per 100,000 (12-15 years), and 13.1 and 1,982 per 100,000 (16-17 years), the CDC said on its COVID Data Tracker.

Hospitalization rates, however, were a bit of a mixed bag. The last 2 weeks (March 13-19 and March 20-26) of data available from the CDC’s COVID-NET show that hospitalizations were up slightly in children aged 0-4 years (1.3 per 100,000 to 1.4 per 100,000), down for 5- to 11-year-olds (0.6 to 0.2), and steady for those aged 12-17 (0.4 to 0.4). COVID-NET collects data from nearly 100 counties in 10 states and from a separate four-state network.

Vaccinations got a small boost in the last week, the first one since early February. Initial doses and completions climbed slightly in the 12- to 17-year-olds, while just first doses were up a bit among the 5- to 11-year-olds during the week of March 24-30, compared with the previous week, although both groups are still well below the highest counts recorded so far in 2022, which are, in turn, far short of 2021’s peaks, according to CDC data analyzed by the AAP.

Even as a number of states see increases in new COVID-19 cases among all ages, the trend remains downward for children, albeit at a slower pace than in recent weeks, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

New pediatric cases in the United States totaled 27,521 for the most recent week, March 25-31, down by 5.2% from the previous week. Earlier weekly declines, going backward through March and into late February, were 9.3%, 23%, 39.5%, and 46%, according to data collected by the AAP and CHA from state and territorial health agencies. The lowest weekly total recorded since the initial wave in 2020 was just under 8,500 during the week of June 18-24, 2021.

Reported COVID-19 cases in children now total over 12.8 million since the beginning of the pandemic in March 2020, and those infections represent 19.0% of all cases. That share of new cases has not increased in the last 7 weeks, the AAP and CHA noted in their weekly COVID report, suggesting that children have not been bearing a disproportionate share of the declining Omicron burden.

As for Omicron, the BA.2 subvariant now makes up about 55% of COVID-19 infections, the Centers for Disease Control and Prevention said in its COVID Data Tracker Weekly Review, and New York, Massachusetts, and New Jersey are among the states reporting BA.2-driven increases in new cases of as much as 30%, the New York Times said.

Rates of new cases for the latest week available (March 27 to April 2) and at their Omicron peaks in January were 11.3 per 100,000 and 1,011 per 100,000 (ages 0-4 years), 12.5 and 1,505 per 100,000 (5-11 years), 12.7 and 1,779 per 100,000 (12-15 years), and 13.1 and 1,982 per 100,000 (16-17 years), the CDC said on its COVID Data Tracker.

Hospitalization rates, however, were a bit of a mixed bag. The last 2 weeks (March 13-19 and March 20-26) of data available from the CDC’s COVID-NET show that hospitalizations were up slightly in children aged 0-4 years (1.3 per 100,000 to 1.4 per 100,000), down for 5- to 11-year-olds (0.6 to 0.2), and steady for those aged 12-17 (0.4 to 0.4). COVID-NET collects data from nearly 100 counties in 10 states and from a separate four-state network.

Vaccinations got a small boost in the last week, the first one since early February. Initial doses and completions climbed slightly in the 12- to 17-year-olds, while just first doses were up a bit among the 5- to 11-year-olds during the week of March 24-30, compared with the previous week, although both groups are still well below the highest counts recorded so far in 2022, which are, in turn, far short of 2021’s peaks, according to CDC data analyzed by the AAP.

Even as a number of states see increases in new COVID-19 cases among all ages, the trend remains downward for children, albeit at a slower pace than in recent weeks, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

New pediatric cases in the United States totaled 27,521 for the most recent week, March 25-31, down by 5.2% from the previous week. Earlier weekly declines, going backward through March and into late February, were 9.3%, 23%, 39.5%, and 46%, according to data collected by the AAP and CHA from state and territorial health agencies. The lowest weekly total recorded since the initial wave in 2020 was just under 8,500 during the week of June 18-24, 2021.

Reported COVID-19 cases in children now total over 12.8 million since the beginning of the pandemic in March 2020, and those infections represent 19.0% of all cases. That share of new cases has not increased in the last 7 weeks, the AAP and CHA noted in their weekly COVID report, suggesting that children have not been bearing a disproportionate share of the declining Omicron burden.

As for Omicron, the BA.2 subvariant now makes up about 55% of COVID-19 infections, the Centers for Disease Control and Prevention said in its COVID Data Tracker Weekly Review, and New York, Massachusetts, and New Jersey are among the states reporting BA.2-driven increases in new cases of as much as 30%, the New York Times said.

Rates of new cases for the latest week available (March 27 to April 2) and at their Omicron peaks in January were 11.3 per 100,000 and 1,011 per 100,000 (ages 0-4 years), 12.5 and 1,505 per 100,000 (5-11 years), 12.7 and 1,779 per 100,000 (12-15 years), and 13.1 and 1,982 per 100,000 (16-17 years), the CDC said on its COVID Data Tracker.

Hospitalization rates, however, were a bit of a mixed bag. The last 2 weeks (March 13-19 and March 20-26) of data available from the CDC’s COVID-NET show that hospitalizations were up slightly in children aged 0-4 years (1.3 per 100,000 to 1.4 per 100,000), down for 5- to 11-year-olds (0.6 to 0.2), and steady for those aged 12-17 (0.4 to 0.4). COVID-NET collects data from nearly 100 counties in 10 states and from a separate four-state network.

Vaccinations got a small boost in the last week, the first one since early February. Initial doses and completions climbed slightly in the 12- to 17-year-olds, while just first doses were up a bit among the 5- to 11-year-olds during the week of March 24-30, compared with the previous week, although both groups are still well below the highest counts recorded so far in 2022, which are, in turn, far short of 2021’s peaks, according to CDC data analyzed by the AAP.

There is a two-lane bridge in my town. It is quaint and picturesque, and when we first moved here, I would gaze out at the water as I drove, letting my mind wander along with the seagulls drifting alongside the car. Until one day, crossing back over, I passed a school bus stopped in the other lane, and instead of waving back, the driver gave me such a fierce look of disapproval I felt like I’d been to the principal’s office. What had I done?

I started paying more attention to the pattern of the other cars on the bridge. Although it appeared to be a standard two-lane width, the lanes weren’t quite wide enough if a school bus or large truck needed to cross at the same time as a car coming from the opposite direction. They had to wait until the other lane was clear. It was an unwritten rule of the town that if you saw a school bus on the other side, you stopped your car and yielded the bridge to the bus. It took me weeks to figure this out. When I did, I felt like I finally belonged in the community. Before, I’d been an outsider.

This got me thinking about culture. Every place has its unwritten rules, whether a community or a workplace. But how do we know the culture of a place? It’s pretty much impossible until we experience it for ourselves.

When I did figure out the bridge, I had a little bit of anger, to be honest. How was I supposed to know about the lanes? There weren’t any signs. Geez.

Now, when I approach the bridge, I don’t even think about it. I know what to do if I see a bus coming.

But sometimes I remember that time of confusion before I deciphered the unwritten rule. I still have a twinge of guilt for having done something wrong, even though it hadn’t been my fault.

It reminded me of a memory from medical training. I was an MS4, and my ER rotation was in a busy county hospital with a level I trauma center. To say that the place was chaotic would be an understatement.

On the first morning, I was shown the chart rack (yes, this was back in the day of paper charts). Charts were placed in the order that patients arrived. Med students and residents were to take a chart in chronological order, go triage and assess the patient, and then find an attending. Once finished, you put the chart back on the rack and picked up the next one. This was the extent of my orientation to the ER.

The days and weeks of the rotation flew by. It was a busy and exciting time. By the end of the month, I’d come to feel a part of the team.

Until one day, after finishing discharging a patient, an attending asked me, “Where’s the billing sheet?”

I had no idea what she was talking about. No one had ever shown me a billing sheet. But by this point, as an MS4, I knew well that if an attending asked you something you didn’t know the answer to, you shouldn’t just say that you didn’t know. You should try to figure out if you could at least approximate an answer first.

As I scrambled in my mind to figure out what she was asking me, she took one look at the apprehension in my eyes and asked again, raising her voice, “You haven’t been doing the billing sheets?”

I thought back to the first day of the rotation. The cursory 30-second orientation. Chart rack. Take one. See the patient. Put it back. See the next patient. Nothing about billing sheets.

“No,” I said. “No one ever told me about – ”

But the attending didn’t care that I hadn’t been instructed on the billing sheets. She ripped into me, yelling about how she couldn’t believe I’d been working there the entire month and was not doing the billing sheets. She showed me what they were and where they were supposed to be going and, in front of the whole staff, treated me like not only the biggest idiot she’d ever worked with but that the hospital had ever seen.

As she berated me, I thought about all the patients I’d seen that month. All the billing sheets I hadn’t placed in the pile. All the attendings who hadn’t gotten credit for the patients they’d staffed with me.

But how could I have known? I wanted to ask. How could I have known if nobody showed me or told me?

It was like the bridge. I was in a new environment and somehow expected to know the rules without anyone telling me; and when I didn’t know, people treated me like I’d done it the wrong way on purpose.

I didn’t end up saying anything more to that attending. What could I have said? She had already unleashed a mountain of her pent-up anger at me.

What I did decide in that moment was that I would never be an attending like that.

Like the bridge, this memory years later can still make me feel guilt and shame for doing something wrong. Even though it wasn’t my fault.

I was thinking about this recently with the Match. Thousands of freshly graduated medical students embarking on their new positions as interns in teaching hospitals across the country.

For anyone who, like me, struggled with the unwritten rules of the medical culture with each new rotation, remember to be kind to yourself. If someone treats you poorly for not knowing something, you are not an idiot. You’ve worked incredibly hard to get where you are, and you deserve to be there.

For attendings and more senior trainees, remember what it was like to be starting in a new place. We all make mistakes, and often it’s simply because of a lack of information.

Trainees shouldn’t have to suffer and be made to feel like outsiders until they figure out the unwritten rules of the place. They belong.
 

Dr. Lycette is medical director of Providence Oncology and Hematology Care Clinic, Seaside, Ore. She disclosed no relevant conflicts of interest. A version of this article first appeared on Medscape.com.

There is a two-lane bridge in my town. It is quaint and picturesque, and when we first moved here, I would gaze out at the water as I drove, letting my mind wander along with the seagulls drifting alongside the car. Until one day, crossing back over, I passed a school bus stopped in the other lane, and instead of waving back, the driver gave me such a fierce look of disapproval I felt like I’d been to the principal’s office. What had I done?

I started paying more attention to the pattern of the other cars on the bridge. Although it appeared to be a standard two-lane width, the lanes weren’t quite wide enough if a school bus or large truck needed to cross at the same time as a car coming from the opposite direction. They had to wait until the other lane was clear. It was an unwritten rule of the town that if you saw a school bus on the other side, you stopped your car and yielded the bridge to the bus. It took me weeks to figure this out. When I did, I felt like I finally belonged in the community. Before, I’d been an outsider.

This got me thinking about culture. Every place has its unwritten rules, whether a community or a workplace. But how do we know the culture of a place? It’s pretty much impossible until we experience it for ourselves.

When I did figure out the bridge, I had a little bit of anger, to be honest. How was I supposed to know about the lanes? There weren’t any signs. Geez.

Now, when I approach the bridge, I don’t even think about it. I know what to do if I see a bus coming.

But sometimes I remember that time of confusion before I deciphered the unwritten rule. I still have a twinge of guilt for having done something wrong, even though it hadn’t been my fault.

It reminded me of a memory from medical training. I was an MS4, and my ER rotation was in a busy county hospital with a level I trauma center. To say that the place was chaotic would be an understatement.

On the first morning, I was shown the chart rack (yes, this was back in the day of paper charts). Charts were placed in the order that patients arrived. Med students and residents were to take a chart in chronological order, go triage and assess the patient, and then find an attending. Once finished, you put the chart back on the rack and picked up the next one. This was the extent of my orientation to the ER.

The days and weeks of the rotation flew by. It was a busy and exciting time. By the end of the month, I’d come to feel a part of the team.

Until one day, after finishing discharging a patient, an attending asked me, “Where’s the billing sheet?”

I had no idea what she was talking about. No one had ever shown me a billing sheet. But by this point, as an MS4, I knew well that if an attending asked you something you didn’t know the answer to, you shouldn’t just say that you didn’t know. You should try to figure out if you could at least approximate an answer first.

As I scrambled in my mind to figure out what she was asking me, she took one look at the apprehension in my eyes and asked again, raising her voice, “You haven’t been doing the billing sheets?”

I thought back to the first day of the rotation. The cursory 30-second orientation. Chart rack. Take one. See the patient. Put it back. See the next patient. Nothing about billing sheets.

“No,” I said. “No one ever told me about – ”

But the attending didn’t care that I hadn’t been instructed on the billing sheets. She ripped into me, yelling about how she couldn’t believe I’d been working there the entire month and was not doing the billing sheets. She showed me what they were and where they were supposed to be going and, in front of the whole staff, treated me like not only the biggest idiot she’d ever worked with but that the hospital had ever seen.

As she berated me, I thought about all the patients I’d seen that month. All the billing sheets I hadn’t placed in the pile. All the attendings who hadn’t gotten credit for the patients they’d staffed with me.

But how could I have known? I wanted to ask. How could I have known if nobody showed me or told me?

It was like the bridge. I was in a new environment and somehow expected to know the rules without anyone telling me; and when I didn’t know, people treated me like I’d done it the wrong way on purpose.

I didn’t end up saying anything more to that attending. What could I have said? She had already unleashed a mountain of her pent-up anger at me.

What I did decide in that moment was that I would never be an attending like that.

Like the bridge, this memory years later can still make me feel guilt and shame for doing something wrong. Even though it wasn’t my fault.

I was thinking about this recently with the Match. Thousands of freshly graduated medical students embarking on their new positions as interns in teaching hospitals across the country.

For anyone who, like me, struggled with the unwritten rules of the medical culture with each new rotation, remember to be kind to yourself. If someone treats you poorly for not knowing something, you are not an idiot. You’ve worked incredibly hard to get where you are, and you deserve to be there.

For attendings and more senior trainees, remember what it was like to be starting in a new place. We all make mistakes, and often it’s simply because of a lack of information.

Trainees shouldn’t have to suffer and be made to feel like outsiders until they figure out the unwritten rules of the place. They belong.
 

Dr. Lycette is medical director of Providence Oncology and Hematology Care Clinic, Seaside, Ore. She disclosed no relevant conflicts of interest. A version of this article first appeared on Medscape.com.

There is a two-lane bridge in my town. It is quaint and picturesque, and when we first moved here, I would gaze out at the water as I drove, letting my mind wander along with the seagulls drifting alongside the car. Until one day, crossing back over, I passed a school bus stopped in the other lane, and instead of waving back, the driver gave me such a fierce look of disapproval I felt like I’d been to the principal’s office. What had I done?

I started paying more attention to the pattern of the other cars on the bridge. Although it appeared to be a standard two-lane width, the lanes weren’t quite wide enough if a school bus or large truck needed to cross at the same time as a car coming from the opposite direction. They had to wait until the other lane was clear. It was an unwritten rule of the town that if you saw a school bus on the other side, you stopped your car and yielded the bridge to the bus. It took me weeks to figure this out. When I did, I felt like I finally belonged in the community. Before, I’d been an outsider.

This got me thinking about culture. Every place has its unwritten rules, whether a community or a workplace. But how do we know the culture of a place? It’s pretty much impossible until we experience it for ourselves.

When I did figure out the bridge, I had a little bit of anger, to be honest. How was I supposed to know about the lanes? There weren’t any signs. Geez.

Now, when I approach the bridge, I don’t even think about it. I know what to do if I see a bus coming.

But sometimes I remember that time of confusion before I deciphered the unwritten rule. I still have a twinge of guilt for having done something wrong, even though it hadn’t been my fault.

It reminded me of a memory from medical training. I was an MS4, and my ER rotation was in a busy county hospital with a level I trauma center. To say that the place was chaotic would be an understatement.

On the first morning, I was shown the chart rack (yes, this was back in the day of paper charts). Charts were placed in the order that patients arrived. Med students and residents were to take a chart in chronological order, go triage and assess the patient, and then find an attending. Once finished, you put the chart back on the rack and picked up the next one. This was the extent of my orientation to the ER.

The days and weeks of the rotation flew by. It was a busy and exciting time. By the end of the month, I’d come to feel a part of the team.

Until one day, after finishing discharging a patient, an attending asked me, “Where’s the billing sheet?”

I had no idea what she was talking about. No one had ever shown me a billing sheet. But by this point, as an MS4, I knew well that if an attending asked you something you didn’t know the answer to, you shouldn’t just say that you didn’t know. You should try to figure out if you could at least approximate an answer first.

As I scrambled in my mind to figure out what she was asking me, she took one look at the apprehension in my eyes and asked again, raising her voice, “You haven’t been doing the billing sheets?”

I thought back to the first day of the rotation. The cursory 30-second orientation. Chart rack. Take one. See the patient. Put it back. See the next patient. Nothing about billing sheets.

“No,” I said. “No one ever told me about – ”

But the attending didn’t care that I hadn’t been instructed on the billing sheets. She ripped into me, yelling about how she couldn’t believe I’d been working there the entire month and was not doing the billing sheets. She showed me what they were and where they were supposed to be going and, in front of the whole staff, treated me like not only the biggest idiot she’d ever worked with but that the hospital had ever seen.

As she berated me, I thought about all the patients I’d seen that month. All the billing sheets I hadn’t placed in the pile. All the attendings who hadn’t gotten credit for the patients they’d staffed with me.

But how could I have known? I wanted to ask. How could I have known if nobody showed me or told me?

It was like the bridge. I was in a new environment and somehow expected to know the rules without anyone telling me; and when I didn’t know, people treated me like I’d done it the wrong way on purpose.

I didn’t end up saying anything more to that attending. What could I have said? She had already unleashed a mountain of her pent-up anger at me.

What I did decide in that moment was that I would never be an attending like that.

Like the bridge, this memory years later can still make me feel guilt and shame for doing something wrong. Even though it wasn’t my fault.

I was thinking about this recently with the Match. Thousands of freshly graduated medical students embarking on their new positions as interns in teaching hospitals across the country.

For anyone who, like me, struggled with the unwritten rules of the medical culture with each new rotation, remember to be kind to yourself. If someone treats you poorly for not knowing something, you are not an idiot. You’ve worked incredibly hard to get where you are, and you deserve to be there.

For attendings and more senior trainees, remember what it was like to be starting in a new place. We all make mistakes, and often it’s simply because of a lack of information.

Trainees shouldn’t have to suffer and be made to feel like outsiders until they figure out the unwritten rules of the place. They belong.
 

Dr. Lycette is medical director of Providence Oncology and Hematology Care Clinic, Seaside, Ore. She disclosed no relevant conflicts of interest. A version of this article first appeared on Medscape.com.

An investigational drug that blocks the dopamine-1 (D1) receptor reduces tics and is safe and well tolerated in children with Tourette syndrome, a new study shows.

Importantly, unlike current medications for the disorder, ecocipam does not lead to weight gain, anxiety, depression, or tardive dyskinesia, compared with placebo – a factor that may lead to better adherence.

For clinicians treating children with Tourette syndrome, the results suggest “help is on the way,” said study investigator Donald Gilbert, MD, professor of pediatrics and neurology, University of Cincinnati Children’s Hospital Medical Center.

“There may be a drug available with a new mechanism of action that is effective to suppress tics without causing weight gain or unwanted neuropsychiatric side effects,” Dr. Gilbert said.

The findings will be presented at the 2022 annual meeting of the American Academy of Neurology.
 

First-in-class agent

Tourette syndrome is a neurologic condition that causes sudden repetitive involuntary muscle movements and sounds known as tics. These movements typically develop in childhood and worsen during adolescence.

“There’s a risk of injury, such as to the neck, with tics in childhood, so it’s good to have something that makes tics less severe and less socially impairing in junior high,” said Dr. Gilbert.

While tics generally diminish by adulthood, “about 10% of the patients we see as kids persist into adulthood enough to need medical interventions,” said Dr. Gilbert.

Ecopipam is a first-in-class selective D1 receptor antagonist in clinical development for pediatric patients with Tourette syndrome. The compound was previously tested without success in schizophrenia and in obesity, the idea being that because dopamine is linked to pleasure or reward, blocking it might result in weight loss, said Dr. Gilbert.

However, earlier studies in Tourette syndrome suggested that ecopipam reduces tics in children and adults and had low metabolic and movement-related adverse effects.

Drugs currently used to treat tics include haloperidol, pimocide, and aripiprazole. All of these agents block the dopamine-2 (D2) receptor and can cause weight gain and tardive dyskinesia, said Dr. Gilbert.
 

Placebo-controlled trial

The new study included 149 patients with Tourette syndrome who had a score of at least 20 on the Yale Global Tic Severity Total Tic Score (YGTSS-TTS). The scale measures five aspects of motor and vocal tics: the number, frequency, intensity, complexity, and interference.

With that scale, intensity assesses whether tics cause injury, complexity evaluates the number of muscle group, and interference assesses whether tics interrupt functions, such as speaking or walking.

For each of the five areas, scores range from 0-5, with higher scores indicating greater severity. The motor and vocal parts have a maximum of 25 points each, for a maximum total of 50.

Participants were randomly assigned to receive once-daily oral ecopipam or placebo. A 4-week titration period was followed by an 8-week maintenance period and then a 1-week tapering period.

The primary endpoint was mean change from baseline to week 12 in scores on the YGTSS-TTS.

Results on the YGTSS-TTS showed a significant improvement in the ecopipam group, compared with placebo groups (least square [LS] mean difference: -3.44; 95% confidence interval: -6.09 to -0.79; P = .011).

The analysis indicated a 30% reduction, with an effect size of 0.48, which is “pretty good,” said Dr. Gilbert. “The amount of change is comparable to other drugs that are marketed” to treat tics.

The drug was effective for younger as well as older children. Among those aged 6-11 years, the LS mean difference was -4.95 (95% CI: -9.99 to 0.10; P = .054), and for those aged 12 to 17 years, the LS mean difference was -3.37 (95% CI: -6.51 to -0.24; P = .035).

A key secondary endpoint was the score on the Clinical Global Impression of Tourette Syndrome Severity, which Dr. Gilbert said is a more subjective measure of whether a patient’s life has improved. Here, the mean change at week 12 was significant (P = .001) for the treated group (improvement of 0.91 points), compared with the placebo group (improvement of 0.5 points).

Researchers also assessed safety and tolerability. Treatment-related adverse events (AEs) occurred in 34% of patients taking ecopipam and in 21% of those taking placebo. The most common AEs were headache (9.2%), fatigue (6.6%), somnolence (6.6%), and restlessness (5.3%).

There were no metabolic or movement-related AEs or treatment-related serious AEs.

“This drug doesn’t cause weight gain at all,” said Dr. Gilbert. He noted that there was also no difference in the groups in terms of rates of depression, anxiety, or tardive dyskinesia.
 

Significant tic reduction

Commenting on the findings, Jessica Frey, MD, a movement disorders fellow at the University of Florida, said the new double-blind, placebo-controlled study “is promising” in that it demonstrates significant tic reduction, compared with placebo without significant side effects.

“Ecopipam could potentially expand pharmacologic treatment options for children and adolescents with Tourette syndrome in the near future,” she said.

Dr. Frey will also be presenting results at the meeting of a study showing a significant correlation between tic severity and social media use among adolescents with Tourette syndrome during the COVID pandemic.

She noted that dopamine is an important neurotransmitter in the underlying pathophysiology of Tourette syndrome. In addition, although D2 receptor blockade can provide significant tic reduction, the “intolerable” side effects often linked to medications with this mechanism “can lead to discontinuation,” said Dr. Frey.

She also noted that ecopipam has previously been evaluated in an open-label study and a follow-up placebo-controlled study that demonstrated safety as well as significant tic reduction.

The study was supported by Emalex Biosciences. Dr. Gilbert and Dr. Frey report no relevant financial relationships.

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

An investigational drug that blocks the dopamine-1 (D1) receptor reduces tics and is safe and well tolerated in children with Tourette syndrome, a new study shows.

Importantly, unlike current medications for the disorder, ecocipam does not lead to weight gain, anxiety, depression, or tardive dyskinesia, compared with placebo – a factor that may lead to better adherence.

For clinicians treating children with Tourette syndrome, the results suggest “help is on the way,” said study investigator Donald Gilbert, MD, professor of pediatrics and neurology, University of Cincinnati Children’s Hospital Medical Center.

“There may be a drug available with a new mechanism of action that is effective to suppress tics without causing weight gain or unwanted neuropsychiatric side effects,” Dr. Gilbert said.

The findings will be presented at the 2022 annual meeting of the American Academy of Neurology.
 

First-in-class agent

Tourette syndrome is a neurologic condition that causes sudden repetitive involuntary muscle movements and sounds known as tics. These movements typically develop in childhood and worsen during adolescence.

“There’s a risk of injury, such as to the neck, with tics in childhood, so it’s good to have something that makes tics less severe and less socially impairing in junior high,” said Dr. Gilbert.

While tics generally diminish by adulthood, “about 10% of the patients we see as kids persist into adulthood enough to need medical interventions,” said Dr. Gilbert.

Ecopipam is a first-in-class selective D1 receptor antagonist in clinical development for pediatric patients with Tourette syndrome. The compound was previously tested without success in schizophrenia and in obesity, the idea being that because dopamine is linked to pleasure or reward, blocking it might result in weight loss, said Dr. Gilbert.

However, earlier studies in Tourette syndrome suggested that ecopipam reduces tics in children and adults and had low metabolic and movement-related adverse effects.

Drugs currently used to treat tics include haloperidol, pimocide, and aripiprazole. All of these agents block the dopamine-2 (D2) receptor and can cause weight gain and tardive dyskinesia, said Dr. Gilbert.
 

Placebo-controlled trial

The new study included 149 patients with Tourette syndrome who had a score of at least 20 on the Yale Global Tic Severity Total Tic Score (YGTSS-TTS). The scale measures five aspects of motor and vocal tics: the number, frequency, intensity, complexity, and interference.

With that scale, intensity assesses whether tics cause injury, complexity evaluates the number of muscle group, and interference assesses whether tics interrupt functions, such as speaking or walking.

For each of the five areas, scores range from 0-5, with higher scores indicating greater severity. The motor and vocal parts have a maximum of 25 points each, for a maximum total of 50.

Participants were randomly assigned to receive once-daily oral ecopipam or placebo. A 4-week titration period was followed by an 8-week maintenance period and then a 1-week tapering period.

The primary endpoint was mean change from baseline to week 12 in scores on the YGTSS-TTS.

Results on the YGTSS-TTS showed a significant improvement in the ecopipam group, compared with placebo groups (least square [LS] mean difference: -3.44; 95% confidence interval: -6.09 to -0.79; P = .011).

The analysis indicated a 30% reduction, with an effect size of 0.48, which is “pretty good,” said Dr. Gilbert. “The amount of change is comparable to other drugs that are marketed” to treat tics.

The drug was effective for younger as well as older children. Among those aged 6-11 years, the LS mean difference was -4.95 (95% CI: -9.99 to 0.10; P = .054), and for those aged 12 to 17 years, the LS mean difference was -3.37 (95% CI: -6.51 to -0.24; P = .035).

A key secondary endpoint was the score on the Clinical Global Impression of Tourette Syndrome Severity, which Dr. Gilbert said is a more subjective measure of whether a patient’s life has improved. Here, the mean change at week 12 was significant (P = .001) for the treated group (improvement of 0.91 points), compared with the placebo group (improvement of 0.5 points).

Researchers also assessed safety and tolerability. Treatment-related adverse events (AEs) occurred in 34% of patients taking ecopipam and in 21% of those taking placebo. The most common AEs were headache (9.2%), fatigue (6.6%), somnolence (6.6%), and restlessness (5.3%).

There were no metabolic or movement-related AEs or treatment-related serious AEs.

“This drug doesn’t cause weight gain at all,” said Dr. Gilbert. He noted that there was also no difference in the groups in terms of rates of depression, anxiety, or tardive dyskinesia.
 

Significant tic reduction

Commenting on the findings, Jessica Frey, MD, a movement disorders fellow at the University of Florida, said the new double-blind, placebo-controlled study “is promising” in that it demonstrates significant tic reduction, compared with placebo without significant side effects.

“Ecopipam could potentially expand pharmacologic treatment options for children and adolescents with Tourette syndrome in the near future,” she said.

Dr. Frey will also be presenting results at the meeting of a study showing a significant correlation between tic severity and social media use among adolescents with Tourette syndrome during the COVID pandemic.

She noted that dopamine is an important neurotransmitter in the underlying pathophysiology of Tourette syndrome. In addition, although D2 receptor blockade can provide significant tic reduction, the “intolerable” side effects often linked to medications with this mechanism “can lead to discontinuation,” said Dr. Frey.

She also noted that ecopipam has previously been evaluated in an open-label study and a follow-up placebo-controlled study that demonstrated safety as well as significant tic reduction.

The study was supported by Emalex Biosciences. Dr. Gilbert and Dr. Frey report no relevant financial relationships.

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

An investigational drug that blocks the dopamine-1 (D1) receptor reduces tics and is safe and well tolerated in children with Tourette syndrome, a new study shows.

Importantly, unlike current medications for the disorder, ecocipam does not lead to weight gain, anxiety, depression, or tardive dyskinesia, compared with placebo – a factor that may lead to better adherence.

For clinicians treating children with Tourette syndrome, the results suggest “help is on the way,” said study investigator Donald Gilbert, MD, professor of pediatrics and neurology, University of Cincinnati Children’s Hospital Medical Center.

“There may be a drug available with a new mechanism of action that is effective to suppress tics without causing weight gain or unwanted neuropsychiatric side effects,” Dr. Gilbert said.

The findings will be presented at the 2022 annual meeting of the American Academy of Neurology.
 

First-in-class agent

Tourette syndrome is a neurologic condition that causes sudden repetitive involuntary muscle movements and sounds known as tics. These movements typically develop in childhood and worsen during adolescence.

“There’s a risk of injury, such as to the neck, with tics in childhood, so it’s good to have something that makes tics less severe and less socially impairing in junior high,” said Dr. Gilbert.

While tics generally diminish by adulthood, “about 10% of the patients we see as kids persist into adulthood enough to need medical interventions,” said Dr. Gilbert.

Ecopipam is a first-in-class selective D1 receptor antagonist in clinical development for pediatric patients with Tourette syndrome. The compound was previously tested without success in schizophrenia and in obesity, the idea being that because dopamine is linked to pleasure or reward, blocking it might result in weight loss, said Dr. Gilbert.

However, earlier studies in Tourette syndrome suggested that ecopipam reduces tics in children and adults and had low metabolic and movement-related adverse effects.

Drugs currently used to treat tics include haloperidol, pimocide, and aripiprazole. All of these agents block the dopamine-2 (D2) receptor and can cause weight gain and tardive dyskinesia, said Dr. Gilbert.
 

Placebo-controlled trial

The new study included 149 patients with Tourette syndrome who had a score of at least 20 on the Yale Global Tic Severity Total Tic Score (YGTSS-TTS). The scale measures five aspects of motor and vocal tics: the number, frequency, intensity, complexity, and interference.

With that scale, intensity assesses whether tics cause injury, complexity evaluates the number of muscle group, and interference assesses whether tics interrupt functions, such as speaking or walking.

For each of the five areas, scores range from 0-5, with higher scores indicating greater severity. The motor and vocal parts have a maximum of 25 points each, for a maximum total of 50.

Participants were randomly assigned to receive once-daily oral ecopipam or placebo. A 4-week titration period was followed by an 8-week maintenance period and then a 1-week tapering period.

The primary endpoint was mean change from baseline to week 12 in scores on the YGTSS-TTS.

Results on the YGTSS-TTS showed a significant improvement in the ecopipam group, compared with placebo groups (least square [LS] mean difference: -3.44; 95% confidence interval: -6.09 to -0.79; P = .011).

The analysis indicated a 30% reduction, with an effect size of 0.48, which is “pretty good,” said Dr. Gilbert. “The amount of change is comparable to other drugs that are marketed” to treat tics.

The drug was effective for younger as well as older children. Among those aged 6-11 years, the LS mean difference was -4.95 (95% CI: -9.99 to 0.10; P = .054), and for those aged 12 to 17 years, the LS mean difference was -3.37 (95% CI: -6.51 to -0.24; P = .035).

A key secondary endpoint was the score on the Clinical Global Impression of Tourette Syndrome Severity, which Dr. Gilbert said is a more subjective measure of whether a patient’s life has improved. Here, the mean change at week 12 was significant (P = .001) for the treated group (improvement of 0.91 points), compared with the placebo group (improvement of 0.5 points).

Researchers also assessed safety and tolerability. Treatment-related adverse events (AEs) occurred in 34% of patients taking ecopipam and in 21% of those taking placebo. The most common AEs were headache (9.2%), fatigue (6.6%), somnolence (6.6%), and restlessness (5.3%).

There were no metabolic or movement-related AEs or treatment-related serious AEs.

“This drug doesn’t cause weight gain at all,” said Dr. Gilbert. He noted that there was also no difference in the groups in terms of rates of depression, anxiety, or tardive dyskinesia.
 

Significant tic reduction

Commenting on the findings, Jessica Frey, MD, a movement disorders fellow at the University of Florida, said the new double-blind, placebo-controlled study “is promising” in that it demonstrates significant tic reduction, compared with placebo without significant side effects.

“Ecopipam could potentially expand pharmacologic treatment options for children and adolescents with Tourette syndrome in the near future,” she said.

Dr. Frey will also be presenting results at the meeting of a study showing a significant correlation between tic severity and social media use among adolescents with Tourette syndrome during the COVID pandemic.

She noted that dopamine is an important neurotransmitter in the underlying pathophysiology of Tourette syndrome. In addition, although D2 receptor blockade can provide significant tic reduction, the “intolerable” side effects often linked to medications with this mechanism “can lead to discontinuation,” said Dr. Frey.

She also noted that ecopipam has previously been evaluated in an open-label study and a follow-up placebo-controlled study that demonstrated safety as well as significant tic reduction.

The study was supported by Emalex Biosciences. Dr. Gilbert and Dr. Frey report no relevant financial relationships.

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

Overwhelming numbers of early puberty cases among girls have been reported during the pandemic, according a report copublished by the Washington Post and The Fuller Project.

Early puberty is uncommon, affecting about 1 in every 5,000 to 10,000 children, with cases about 10 times higher in girls than boys. But since the pandemic started, doctors and parents around the world have noted a substantial surge in early puberty.

In some cases, girls as young as 5 have begun developing breasts and girls younger than 8 have started menstruation.

“I noticed that quite a few of my [girl patients] got their period after a lockdown,” Adiaha Spinks-Franklin, MD, a pediatrician at Texas Children’s Hospital, Houston, told the news outlets.

The condition, also called precocious puberty, is defined as puberty-related changes earlier than normal or expected, which starts around age 8 for girls and age 9 for boys. It can sometimes be caused by genetic syndromes, central nervous system issues, or tumors on the ovaries, adrenal glands, pituitary gland, or brain.

Pediatricians across the world have reported more precocious puberty cases, the news outlets reported, including in the United States, India, Italy, and Turkey.

A recent study found that more than 300 girls were referred to five pediatric endocrinology centers in Italy between March and September 2020, as opposed to 140 referrals during the same time period in 2019.

In another study, a Turkish pediatric endocrinology clinic reported 58 cases during the first year of the pandemic, as compared with 66 total cases during the 3 previous years.

Early puberty tends to mean there are other mental and physical issues, though in most cases, an exact cause can’t be found. Doctors have tied the current uptick to the stress of the pandemic and lockdowns, including reduced physical activity and increased consumption of unhealthy food, which are things linked to a higher risk of early puberty.

“I think it’s directly related to the amount of stress that the children have gone through,” Vaishakhi Rustagi, MD, a pediatric endocrinologist in Delhi, India, told the news outlets.

In a typical year, Dr. Rustagi sees about 20 patients with early puberty. Since mid-2020, she’s seen more than 300 girls with the condition. Imaging scans and ultrasounds haven’t found tumors, and the cause has been mostly unidentifiable, though Dr. Rustagi attributed it to stress and grief.

“These children have lost family members,” she said.

Early puberty is known to increase depression, eating disorders, substance abuse, and antisocial behavior, the news outlets reported.

The main treatment for the condition, a form of hormone therapy known as gonadotropin-releasing hormone analogue therapy, is known to work very well. But some patients and families may not seek treatment because of a lack of awareness or stigmas that come with menstruation.

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

Overwhelming numbers of early puberty cases among girls have been reported during the pandemic, according a report copublished by the Washington Post and The Fuller Project.

Early puberty is uncommon, affecting about 1 in every 5,000 to 10,000 children, with cases about 10 times higher in girls than boys. But since the pandemic started, doctors and parents around the world have noted a substantial surge in early puberty.

In some cases, girls as young as 5 have begun developing breasts and girls younger than 8 have started menstruation.

“I noticed that quite a few of my [girl patients] got their period after a lockdown,” Adiaha Spinks-Franklin, MD, a pediatrician at Texas Children’s Hospital, Houston, told the news outlets.

The condition, also called precocious puberty, is defined as puberty-related changes earlier than normal or expected, which starts around age 8 for girls and age 9 for boys. It can sometimes be caused by genetic syndromes, central nervous system issues, or tumors on the ovaries, adrenal glands, pituitary gland, or brain.

Pediatricians across the world have reported more precocious puberty cases, the news outlets reported, including in the United States, India, Italy, and Turkey.

A recent study found that more than 300 girls were referred to five pediatric endocrinology centers in Italy between March and September 2020, as opposed to 140 referrals during the same time period in 2019.

In another study, a Turkish pediatric endocrinology clinic reported 58 cases during the first year of the pandemic, as compared with 66 total cases during the 3 previous years.

Early puberty tends to mean there are other mental and physical issues, though in most cases, an exact cause can’t be found. Doctors have tied the current uptick to the stress of the pandemic and lockdowns, including reduced physical activity and increased consumption of unhealthy food, which are things linked to a higher risk of early puberty.

“I think it’s directly related to the amount of stress that the children have gone through,” Vaishakhi Rustagi, MD, a pediatric endocrinologist in Delhi, India, told the news outlets.

In a typical year, Dr. Rustagi sees about 20 patients with early puberty. Since mid-2020, she’s seen more than 300 girls with the condition. Imaging scans and ultrasounds haven’t found tumors, and the cause has been mostly unidentifiable, though Dr. Rustagi attributed it to stress and grief.

“These children have lost family members,” she said.

Early puberty is known to increase depression, eating disorders, substance abuse, and antisocial behavior, the news outlets reported.

The main treatment for the condition, a form of hormone therapy known as gonadotropin-releasing hormone analogue therapy, is known to work very well. But some patients and families may not seek treatment because of a lack of awareness or stigmas that come with menstruation.

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

Overwhelming numbers of early puberty cases among girls have been reported during the pandemic, according a report copublished by the Washington Post and The Fuller Project.

Early puberty is uncommon, affecting about 1 in every 5,000 to 10,000 children, with cases about 10 times higher in girls than boys. But since the pandemic started, doctors and parents around the world have noted a substantial surge in early puberty.

In some cases, girls as young as 5 have begun developing breasts and girls younger than 8 have started menstruation.

“I noticed that quite a few of my [girl patients] got their period after a lockdown,” Adiaha Spinks-Franklin, MD, a pediatrician at Texas Children’s Hospital, Houston, told the news outlets.

The condition, also called precocious puberty, is defined as puberty-related changes earlier than normal or expected, which starts around age 8 for girls and age 9 for boys. It can sometimes be caused by genetic syndromes, central nervous system issues, or tumors on the ovaries, adrenal glands, pituitary gland, or brain.

Pediatricians across the world have reported more precocious puberty cases, the news outlets reported, including in the United States, India, Italy, and Turkey.

A recent study found that more than 300 girls were referred to five pediatric endocrinology centers in Italy between March and September 2020, as opposed to 140 referrals during the same time period in 2019.

In another study, a Turkish pediatric endocrinology clinic reported 58 cases during the first year of the pandemic, as compared with 66 total cases during the 3 previous years.

Early puberty tends to mean there are other mental and physical issues, though in most cases, an exact cause can’t be found. Doctors have tied the current uptick to the stress of the pandemic and lockdowns, including reduced physical activity and increased consumption of unhealthy food, which are things linked to a higher risk of early puberty.

“I think it’s directly related to the amount of stress that the children have gone through,” Vaishakhi Rustagi, MD, a pediatric endocrinologist in Delhi, India, told the news outlets.

In a typical year, Dr. Rustagi sees about 20 patients with early puberty. Since mid-2020, she’s seen more than 300 girls with the condition. Imaging scans and ultrasounds haven’t found tumors, and the cause has been mostly unidentifiable, though Dr. Rustagi attributed it to stress and grief.

“These children have lost family members,” she said.

Early puberty is known to increase depression, eating disorders, substance abuse, and antisocial behavior, the news outlets reported.

The main treatment for the condition, a form of hormone therapy known as gonadotropin-releasing hormone analogue therapy, is known to work very well. But some patients and families may not seek treatment because of a lack of awareness or stigmas that come with menstruation.

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