New U.S. data show that the incidence of colorectal cancer (CRC) is on the rise among people aged 50–54 years, mirroring the well-documented increases in early-onset CRC in persons younger than 50 years.

“It’s likely that the factors contributing to CRC at age 50–54 years are the same factors that contribute to early-onset CRC, which has increased in parallel,” Caitlin Murphy, PhD, MPH, with the University of Texas Health Science Center at Houston, said in an interview.

“Many studies published in just the last year show that the well-known risk factors of CRC in older adults, such as obesity or sedentary lifestyle, are risk factors of CRC in younger adults. Growing evidence also suggests that early life exposures, or exposures in childhood, infancy, or even in the womb, play an important role,” Dr. Murphy said.

The study was published online October 28 in Gastroenterology .

Dr. Murphy and colleagues examined trends in age-specific CRC incidence rates for individuals aged 45–49, 50–54, and 55–59 years using the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) program.

During the period 1992–2018, there were a total of 101,609 cases of CRC among adults aged 45–59 years.

Further analysis showed that the CRC incidence rates rose from 23.4 to 34.0 per 100,000 among people aged 45–49 years and from 46.4 to 63.8 per 100,000 among those aged 50–54 years.

Conversely, incidence rates decreased among individuals aged 55–59 years, from 81.7 to 63.7 per 100,000 persons.

“Because of this opposing trend, or decreasing rates for age 55–59 years and increasing rates for age 50–54 years, incidence rates for the two age groups were nearly identical in 2016–18,” the researchers write.

They also found a “clear pattern” of increasing CRC incidence among adults in their early 50s, supporting the hypothesis that incidence rates increase at older ages as higher-risk generations mature, the researchers note.

These data send a clear message, Dr. Murphy told this news organization.

“Don’t delay colorectal cancer screening. Encourage on-time screening by discussing screening with patients before they reach the recommended age to initiate screening. The U.S. Preventive Services Task Force now recommends initiating average-risk screening at age 45 years,” Dr. Murphy said.
 

Concerning but not surprising

Rebecca Siegel, MPH, scientific director of Surveillance Research at the American Cancer Society, in Atlanta, who wasn’t involved in the study, said the results are “not surprising” and mirror the results of a 2017 study that showed that the incidence of CRC was increasing among individuals aged 50–54 years, as reported.

What’s “concerning,” Ms. Siegel said, is that people in this age group “have been recommended to be screened for CRC for decades. Hopefully, because the age to begin screening has been lowered from 50 to 45 years, this uptick will eventually flatten.”

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, in Norfolk, Va., who also wasn’t involved in the study, said the increasing incidence is “concerning in this younger population, and similar to what is seen recently for the 45- to 49-year-old population.

“Recent data have linked dietary influences in the early development of precancerous colon polyps and colon cancer. The increased ingestion of processed foods and sugary beverages, most of which contain high fructose corn syrup, is very likely involved in the pathogenesis to explain these striking epidemiologic shifts,” Dr. Johnson said in an interview.

“These concerns will likely be compounded by the COVID-related adverse effects on people [in terms of] appropriate, timely colorectal cancer screening,” Dr. Johnson added.

The study was supported by the National Cancer Institute at the National Institutes of Health. Dr. Murphy has consulted for Freenome. Ms. Siegel and Dr. Johnson have reported no relevant financial relationships.

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

New U.S. data show that the incidence of colorectal cancer (CRC) is on the rise among people aged 50–54 years, mirroring the well-documented increases in early-onset CRC in persons younger than 50 years.

“It’s likely that the factors contributing to CRC at age 50–54 years are the same factors that contribute to early-onset CRC, which has increased in parallel,” Caitlin Murphy, PhD, MPH, with the University of Texas Health Science Center at Houston, said in an interview.

“Many studies published in just the last year show that the well-known risk factors of CRC in older adults, such as obesity or sedentary lifestyle, are risk factors of CRC in younger adults. Growing evidence also suggests that early life exposures, or exposures in childhood, infancy, or even in the womb, play an important role,” Dr. Murphy said.

The study was published online October 28 in Gastroenterology .

Dr. Murphy and colleagues examined trends in age-specific CRC incidence rates for individuals aged 45–49, 50–54, and 55–59 years using the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) program.

During the period 1992–2018, there were a total of 101,609 cases of CRC among adults aged 45–59 years.

Further analysis showed that the CRC incidence rates rose from 23.4 to 34.0 per 100,000 among people aged 45–49 years and from 46.4 to 63.8 per 100,000 among those aged 50–54 years.

Conversely, incidence rates decreased among individuals aged 55–59 years, from 81.7 to 63.7 per 100,000 persons.

“Because of this opposing trend, or decreasing rates for age 55–59 years and increasing rates for age 50–54 years, incidence rates for the two age groups were nearly identical in 2016–18,” the researchers write.

They also found a “clear pattern” of increasing CRC incidence among adults in their early 50s, supporting the hypothesis that incidence rates increase at older ages as higher-risk generations mature, the researchers note.

These data send a clear message, Dr. Murphy told this news organization.

“Don’t delay colorectal cancer screening. Encourage on-time screening by discussing screening with patients before they reach the recommended age to initiate screening. The U.S. Preventive Services Task Force now recommends initiating average-risk screening at age 45 years,” Dr. Murphy said.
 

Concerning but not surprising

Rebecca Siegel, MPH, scientific director of Surveillance Research at the American Cancer Society, in Atlanta, who wasn’t involved in the study, said the results are “not surprising” and mirror the results of a 2017 study that showed that the incidence of CRC was increasing among individuals aged 50–54 years, as reported.

What’s “concerning,” Ms. Siegel said, is that people in this age group “have been recommended to be screened for CRC for decades. Hopefully, because the age to begin screening has been lowered from 50 to 45 years, this uptick will eventually flatten.”

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, in Norfolk, Va., who also wasn’t involved in the study, said the increasing incidence is “concerning in this younger population, and similar to what is seen recently for the 45- to 49-year-old population.

“Recent data have linked dietary influences in the early development of precancerous colon polyps and colon cancer. The increased ingestion of processed foods and sugary beverages, most of which contain high fructose corn syrup, is very likely involved in the pathogenesis to explain these striking epidemiologic shifts,” Dr. Johnson said in an interview.

“These concerns will likely be compounded by the COVID-related adverse effects on people [in terms of] appropriate, timely colorectal cancer screening,” Dr. Johnson added.

The study was supported by the National Cancer Institute at the National Institutes of Health. Dr. Murphy has consulted for Freenome. Ms. Siegel and Dr. Johnson have reported no relevant financial relationships.

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

New U.S. data show that the incidence of colorectal cancer (CRC) is on the rise among people aged 50–54 years, mirroring the well-documented increases in early-onset CRC in persons younger than 50 years.

“It’s likely that the factors contributing to CRC at age 50–54 years are the same factors that contribute to early-onset CRC, which has increased in parallel,” Caitlin Murphy, PhD, MPH, with the University of Texas Health Science Center at Houston, said in an interview.

“Many studies published in just the last year show that the well-known risk factors of CRC in older adults, such as obesity or sedentary lifestyle, are risk factors of CRC in younger adults. Growing evidence also suggests that early life exposures, or exposures in childhood, infancy, or even in the womb, play an important role,” Dr. Murphy said.

The study was published online October 28 in Gastroenterology .

Dr. Murphy and colleagues examined trends in age-specific CRC incidence rates for individuals aged 45–49, 50–54, and 55–59 years using the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) program.

During the period 1992–2018, there were a total of 101,609 cases of CRC among adults aged 45–59 years.

Further analysis showed that the CRC incidence rates rose from 23.4 to 34.0 per 100,000 among people aged 45–49 years and from 46.4 to 63.8 per 100,000 among those aged 50–54 years.

Conversely, incidence rates decreased among individuals aged 55–59 years, from 81.7 to 63.7 per 100,000 persons.

“Because of this opposing trend, or decreasing rates for age 55–59 years and increasing rates for age 50–54 years, incidence rates for the two age groups were nearly identical in 2016–18,” the researchers write.

They also found a “clear pattern” of increasing CRC incidence among adults in their early 50s, supporting the hypothesis that incidence rates increase at older ages as higher-risk generations mature, the researchers note.

These data send a clear message, Dr. Murphy told this news organization.

“Don’t delay colorectal cancer screening. Encourage on-time screening by discussing screening with patients before they reach the recommended age to initiate screening. The U.S. Preventive Services Task Force now recommends initiating average-risk screening at age 45 years,” Dr. Murphy said.
 

Concerning but not surprising

Rebecca Siegel, MPH, scientific director of Surveillance Research at the American Cancer Society, in Atlanta, who wasn’t involved in the study, said the results are “not surprising” and mirror the results of a 2017 study that showed that the incidence of CRC was increasing among individuals aged 50–54 years, as reported.

What’s “concerning,” Ms. Siegel said, is that people in this age group “have been recommended to be screened for CRC for decades. Hopefully, because the age to begin screening has been lowered from 50 to 45 years, this uptick will eventually flatten.”

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, in Norfolk, Va., who also wasn’t involved in the study, said the increasing incidence is “concerning in this younger population, and similar to what is seen recently for the 45- to 49-year-old population.

“Recent data have linked dietary influences in the early development of precancerous colon polyps and colon cancer. The increased ingestion of processed foods and sugary beverages, most of which contain high fructose corn syrup, is very likely involved in the pathogenesis to explain these striking epidemiologic shifts,” Dr. Johnson said in an interview.

“These concerns will likely be compounded by the COVID-related adverse effects on people [in terms of] appropriate, timely colorectal cancer screening,” Dr. Johnson added.

The study was supported by the National Cancer Institute at the National Institutes of Health. Dr. Murphy has consulted for Freenome. Ms. Siegel and Dr. Johnson have reported no relevant financial relationships.

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

Cognitive-behavioral therapy (CBT) is linked to a significantly reduced risk of depression in patients with insomnia, new research shows.

Insomnia affects over 50% of older adults, and insomnia contributes to a twofold greater risk for major depression, investigators noted.

“We show that by treating insomnia with a simple behavioral approach called Cognitive Behavioral Therapy for Insomnia, or CBT-I, you can reduce the likelihood of developing depression by over 50%,” lead author Michael R. Irwin, MD, Cousins Distinguished Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, said in an interview.

The study is unique in that the treatment “is not just reducing depression, it’s preventing depression,” Dr. Irwin added.

The findings were published online Nov. 24 in JAMA Psychiatry.
 

Primary outcome met

The study included 291 patients aged 60 years and older (mean age, 70 years; 58% women) with confirmed insomnia disorder and no major depression within the previous 12 months.

All were randomly assigned to receive either CBT-I or Sleep Education Therapy (SET).

CBT-I is a first-line treatment for insomnia that includes five components: cognitive therapy targeting dysfunctional thoughts about sleep, stimulus control, sleep restriction, sleep hygiene, and relaxation.

SET provides information on behavioral and environmental factors contributing to poor sleep. While sleep education provides tips on improving sleep, CBT-I helps patients implement those changes and behaviors, Dr. Irwin noted.

Both interventions were delivered by trained personnel in weekly 120-minute group sessions for 2 months, consistent with the format and duration of most CBT-I trials.

The primary outcome was time to incident or recurrent major depressive disorder as diagnosed by the Structured Clinical Interview of the DSM-5 every 6 months during 36 months of follow-up. A monthly Patient Health Questionnaire 9 (PHQ-9) was used to screen for depressive symptoms.

Results showed depression occurred in 12.2% of the CBT-I group versus 25.9% of the SET group. The hazard ratio (HR) for depression in the CBT-I group compared with the SET group was 0.51 (95% confidence interval, 0.29-0.88; P = .02). The number needed to treat to prevent incident or recurrent depression was 7.3.

After adjustment for factors affecting depression risk such as sex, educational level, income, comorbidity, and history of depression, the HR for depression in the CBT-I group versus the SET group was 0.45 (95% CI, 0.23-0.86; P = .02).

Treatment with CBT-I yielded an annual 4.1% incidence of depression, which is similar to the population rate and half the rate in SET, which was 8.6%.
 

‘Remission is key’

The secondary outcome was sustained remission of insomnia disorder. The investigators found a greater proportion of the CBT-I group than the SET group achieved remission after treatment (50.7% vs. 37.7%; 95% CI, 0.10-0.93; P = .02).

“Remission is really key to the benefits that we’re seeing,” said Dr. Irwin.

Inflammation may explain why insomnia raises the risk for depression, he noted. “We know sleep disturbance can lead to inflammation and we also know inflammation can produce depression,” Dr. Irwin said.

It is also possible insomnia leads to an impaired pleasure or reward system, which is linked to depression, he added.

The authors noted that because insomnia is associated with suicidal ideation and dementia, CBT-I may reduce risk for suicide or cognitive decline.

While 8-week CBT-I treatments are readily available, “unfortunately, most clinicians will prescribe medications,” said Dr. Irwin. He noted that in older adults, drugs are linked to adverse events such as falls and cognitive problems.

These new results “really argue that psychology and psychiatry need to be fully integrated into what we call collaborative care models,” Dr. Irwin said.

There were no adverse events during treatment, and none of the serious events that occurred during follow-up were attributed to the trial.
 

Convincing argument?

Commenting on the findings for this news organization, Philip R. Muskin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, said the study was “nicely written” and the authors put forward “a very convincing argument” for CBT-I to prevent depression.

“It’s eye opening in that it’s a robust study; it’s carefully done; subjects were followed for a long period of time, and it’s an accessible treatment,” said Dr. Muskin, who was not involved with the research.

The study also shows “it’s possible to intervene in something we know is a risk factor in elderly people,” he added. “We think of older people as being less malleable to these kinds of things, but they’re not. They clearly participated, and there wasn’t a huge dropout rate.”

Dr. Muskin noted that less than half of the older participants were married or had a partner. He would have liked more information on this status because being widowed or divorced, as well as when this life change occurred, could affect vulnerability to depression.

The authors of an accompanying editorial called the study “seminal,” and noted that insomnia treatment possibly preventing depressive disorders is a “major finding.”

Proving this preventive strategy is effective in older adults will be important because “insomnia and depression are highly prevalent in this population and the uptake of both preventive and treatment services is low,” wrote Pim Cuijpers, PhD, department of clinical, neuro, and developmental psychology, Amsterdam Public Health Research Institute, and Charles F. Reynolds III, MD, department of psychiatry, University of Pittsburgh.

If the reduced rates of depression observed in the study could be generalized to the total population with insomnia, “the incidence of major depression could be reduced considerably,” they wrote.

“Can we prevent depression through interventions aimed at procrastination in college students, interventions aimed at perfectionism in perinatal women, stress management training for employees, social skills training in adolescents?” they asked.

This approach to preventing depressive disorders “offers all kinds of new opportunities to develop and test indirect interventions” for problems that are significantly associated with the onset of depression, the editorialists wrote.

The study was funded by a grant from the National Institute on Aging to the University of California, which partially supported the authors’ salaries. Dr. Irwin, Dr. Muskin, and Dr. Cuijpers have reported no relevant financial relationships. Dr. Reynolds reported being coinventor of the Pittsburgh Sleep Quality Index, for which he receives royalties.

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

Cognitive-behavioral therapy (CBT) is linked to a significantly reduced risk of depression in patients with insomnia, new research shows.

Insomnia affects over 50% of older adults, and insomnia contributes to a twofold greater risk for major depression, investigators noted.

“We show that by treating insomnia with a simple behavioral approach called Cognitive Behavioral Therapy for Insomnia, or CBT-I, you can reduce the likelihood of developing depression by over 50%,” lead author Michael R. Irwin, MD, Cousins Distinguished Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, said in an interview.

The study is unique in that the treatment “is not just reducing depression, it’s preventing depression,” Dr. Irwin added.

The findings were published online Nov. 24 in JAMA Psychiatry.
 

Primary outcome met

The study included 291 patients aged 60 years and older (mean age, 70 years; 58% women) with confirmed insomnia disorder and no major depression within the previous 12 months.

All were randomly assigned to receive either CBT-I or Sleep Education Therapy (SET).

CBT-I is a first-line treatment for insomnia that includes five components: cognitive therapy targeting dysfunctional thoughts about sleep, stimulus control, sleep restriction, sleep hygiene, and relaxation.

SET provides information on behavioral and environmental factors contributing to poor sleep. While sleep education provides tips on improving sleep, CBT-I helps patients implement those changes and behaviors, Dr. Irwin noted.

Both interventions were delivered by trained personnel in weekly 120-minute group sessions for 2 months, consistent with the format and duration of most CBT-I trials.

The primary outcome was time to incident or recurrent major depressive disorder as diagnosed by the Structured Clinical Interview of the DSM-5 every 6 months during 36 months of follow-up. A monthly Patient Health Questionnaire 9 (PHQ-9) was used to screen for depressive symptoms.

Results showed depression occurred in 12.2% of the CBT-I group versus 25.9% of the SET group. The hazard ratio (HR) for depression in the CBT-I group compared with the SET group was 0.51 (95% confidence interval, 0.29-0.88; P = .02). The number needed to treat to prevent incident or recurrent depression was 7.3.

After adjustment for factors affecting depression risk such as sex, educational level, income, comorbidity, and history of depression, the HR for depression in the CBT-I group versus the SET group was 0.45 (95% CI, 0.23-0.86; P = .02).

Treatment with CBT-I yielded an annual 4.1% incidence of depression, which is similar to the population rate and half the rate in SET, which was 8.6%.
 

‘Remission is key’

The secondary outcome was sustained remission of insomnia disorder. The investigators found a greater proportion of the CBT-I group than the SET group achieved remission after treatment (50.7% vs. 37.7%; 95% CI, 0.10-0.93; P = .02).

“Remission is really key to the benefits that we’re seeing,” said Dr. Irwin.

Inflammation may explain why insomnia raises the risk for depression, he noted. “We know sleep disturbance can lead to inflammation and we also know inflammation can produce depression,” Dr. Irwin said.

It is also possible insomnia leads to an impaired pleasure or reward system, which is linked to depression, he added.

The authors noted that because insomnia is associated with suicidal ideation and dementia, CBT-I may reduce risk for suicide or cognitive decline.

While 8-week CBT-I treatments are readily available, “unfortunately, most clinicians will prescribe medications,” said Dr. Irwin. He noted that in older adults, drugs are linked to adverse events such as falls and cognitive problems.

These new results “really argue that psychology and psychiatry need to be fully integrated into what we call collaborative care models,” Dr. Irwin said.

There were no adverse events during treatment, and none of the serious events that occurred during follow-up were attributed to the trial.
 

Convincing argument?

Commenting on the findings for this news organization, Philip R. Muskin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, said the study was “nicely written” and the authors put forward “a very convincing argument” for CBT-I to prevent depression.

“It’s eye opening in that it’s a robust study; it’s carefully done; subjects were followed for a long period of time, and it’s an accessible treatment,” said Dr. Muskin, who was not involved with the research.

The study also shows “it’s possible to intervene in something we know is a risk factor in elderly people,” he added. “We think of older people as being less malleable to these kinds of things, but they’re not. They clearly participated, and there wasn’t a huge dropout rate.”

Dr. Muskin noted that less than half of the older participants were married or had a partner. He would have liked more information on this status because being widowed or divorced, as well as when this life change occurred, could affect vulnerability to depression.

The authors of an accompanying editorial called the study “seminal,” and noted that insomnia treatment possibly preventing depressive disorders is a “major finding.”

Proving this preventive strategy is effective in older adults will be important because “insomnia and depression are highly prevalent in this population and the uptake of both preventive and treatment services is low,” wrote Pim Cuijpers, PhD, department of clinical, neuro, and developmental psychology, Amsterdam Public Health Research Institute, and Charles F. Reynolds III, MD, department of psychiatry, University of Pittsburgh.

If the reduced rates of depression observed in the study could be generalized to the total population with insomnia, “the incidence of major depression could be reduced considerably,” they wrote.

“Can we prevent depression through interventions aimed at procrastination in college students, interventions aimed at perfectionism in perinatal women, stress management training for employees, social skills training in adolescents?” they asked.

This approach to preventing depressive disorders “offers all kinds of new opportunities to develop and test indirect interventions” for problems that are significantly associated with the onset of depression, the editorialists wrote.

The study was funded by a grant from the National Institute on Aging to the University of California, which partially supported the authors’ salaries. Dr. Irwin, Dr. Muskin, and Dr. Cuijpers have reported no relevant financial relationships. Dr. Reynolds reported being coinventor of the Pittsburgh Sleep Quality Index, for which he receives royalties.

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

Cognitive-behavioral therapy (CBT) is linked to a significantly reduced risk of depression in patients with insomnia, new research shows.

Insomnia affects over 50% of older adults, and insomnia contributes to a twofold greater risk for major depression, investigators noted.

“We show that by treating insomnia with a simple behavioral approach called Cognitive Behavioral Therapy for Insomnia, or CBT-I, you can reduce the likelihood of developing depression by over 50%,” lead author Michael R. Irwin, MD, Cousins Distinguished Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, said in an interview.

The study is unique in that the treatment “is not just reducing depression, it’s preventing depression,” Dr. Irwin added.

The findings were published online Nov. 24 in JAMA Psychiatry.
 

Primary outcome met

The study included 291 patients aged 60 years and older (mean age, 70 years; 58% women) with confirmed insomnia disorder and no major depression within the previous 12 months.

All were randomly assigned to receive either CBT-I or Sleep Education Therapy (SET).

CBT-I is a first-line treatment for insomnia that includes five components: cognitive therapy targeting dysfunctional thoughts about sleep, stimulus control, sleep restriction, sleep hygiene, and relaxation.

SET provides information on behavioral and environmental factors contributing to poor sleep. While sleep education provides tips on improving sleep, CBT-I helps patients implement those changes and behaviors, Dr. Irwin noted.

Both interventions were delivered by trained personnel in weekly 120-minute group sessions for 2 months, consistent with the format and duration of most CBT-I trials.

The primary outcome was time to incident or recurrent major depressive disorder as diagnosed by the Structured Clinical Interview of the DSM-5 every 6 months during 36 months of follow-up. A monthly Patient Health Questionnaire 9 (PHQ-9) was used to screen for depressive symptoms.

Results showed depression occurred in 12.2% of the CBT-I group versus 25.9% of the SET group. The hazard ratio (HR) for depression in the CBT-I group compared with the SET group was 0.51 (95% confidence interval, 0.29-0.88; P = .02). The number needed to treat to prevent incident or recurrent depression was 7.3.

After adjustment for factors affecting depression risk such as sex, educational level, income, comorbidity, and history of depression, the HR for depression in the CBT-I group versus the SET group was 0.45 (95% CI, 0.23-0.86; P = .02).

Treatment with CBT-I yielded an annual 4.1% incidence of depression, which is similar to the population rate and half the rate in SET, which was 8.6%.
 

‘Remission is key’

The secondary outcome was sustained remission of insomnia disorder. The investigators found a greater proportion of the CBT-I group than the SET group achieved remission after treatment (50.7% vs. 37.7%; 95% CI, 0.10-0.93; P = .02).

“Remission is really key to the benefits that we’re seeing,” said Dr. Irwin.

Inflammation may explain why insomnia raises the risk for depression, he noted. “We know sleep disturbance can lead to inflammation and we also know inflammation can produce depression,” Dr. Irwin said.

It is also possible insomnia leads to an impaired pleasure or reward system, which is linked to depression, he added.

The authors noted that because insomnia is associated with suicidal ideation and dementia, CBT-I may reduce risk for suicide or cognitive decline.

While 8-week CBT-I treatments are readily available, “unfortunately, most clinicians will prescribe medications,” said Dr. Irwin. He noted that in older adults, drugs are linked to adverse events such as falls and cognitive problems.

These new results “really argue that psychology and psychiatry need to be fully integrated into what we call collaborative care models,” Dr. Irwin said.

There were no adverse events during treatment, and none of the serious events that occurred during follow-up were attributed to the trial.
 

Convincing argument?

Commenting on the findings for this news organization, Philip R. Muskin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, said the study was “nicely written” and the authors put forward “a very convincing argument” for CBT-I to prevent depression.

“It’s eye opening in that it’s a robust study; it’s carefully done; subjects were followed for a long period of time, and it’s an accessible treatment,” said Dr. Muskin, who was not involved with the research.

The study also shows “it’s possible to intervene in something we know is a risk factor in elderly people,” he added. “We think of older people as being less malleable to these kinds of things, but they’re not. They clearly participated, and there wasn’t a huge dropout rate.”

Dr. Muskin noted that less than half of the older participants were married or had a partner. He would have liked more information on this status because being widowed or divorced, as well as when this life change occurred, could affect vulnerability to depression.

The authors of an accompanying editorial called the study “seminal,” and noted that insomnia treatment possibly preventing depressive disorders is a “major finding.”

Proving this preventive strategy is effective in older adults will be important because “insomnia and depression are highly prevalent in this population and the uptake of both preventive and treatment services is low,” wrote Pim Cuijpers, PhD, department of clinical, neuro, and developmental psychology, Amsterdam Public Health Research Institute, and Charles F. Reynolds III, MD, department of psychiatry, University of Pittsburgh.

If the reduced rates of depression observed in the study could be generalized to the total population with insomnia, “the incidence of major depression could be reduced considerably,” they wrote.

“Can we prevent depression through interventions aimed at procrastination in college students, interventions aimed at perfectionism in perinatal women, stress management training for employees, social skills training in adolescents?” they asked.

This approach to preventing depressive disorders “offers all kinds of new opportunities to develop and test indirect interventions” for problems that are significantly associated with the onset of depression, the editorialists wrote.

The study was funded by a grant from the National Institute on Aging to the University of California, which partially supported the authors’ salaries. Dr. Irwin, Dr. Muskin, and Dr. Cuijpers have reported no relevant financial relationships. Dr. Reynolds reported being coinventor of the Pittsburgh Sleep Quality Index, for which he receives royalties.

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

Municipal budget allocations can affect severe maternal morbidity (SMM) rates, a cross-sectional study published in JAMA Network Open reported.

Led by Felix M. Muchomba, PhD, an assistant professor at Rutgers University School of Social Work in New Brunswick, N.J., the study found that local expenditures on fire and ambulance, transportation, health, housing, and libraries were negatively associated with SMM. Specifically, annual per-capita expenditures of $1,000 and higher in these categories were associated with a 35.4%-67.3% lower risk of SMM: odds ratios, 0.33 (95% confidence interval, 0.15-0.72) to 0.65 (95% CI, 0.46-0.91).

In contrast, expenditures on police were positively associated with SMM: OR, 1.15 (95% CI, 1.04-1.28).

In the first study of environmental services spending and SMM done at the municipal level – others have focused on state and county funding – Dr. Muchomba’s group analyzed 2008-2018 birth files linked to maternal hospital discharge records and U.S. Census municipal expenditures data.

The study’s cohort comprised 1,001,410 mothers giving birth in New Jersey hospitals with a mean age of 29.8 years. Of these,10.9 % were Asian, 14.8% were Black, 28.0% were Hispanic, and 44.7% were White.

Per-capita municipal expenditures were reviewed for a broad range of city services: education, public health, fire and ambulance, parks, recreation, natural resources, housing, community development, public welfare; police; transportation, and libraries. “Each year municipalities spend about $600 billion nationwide on local services, investing far more than counties do,” Dr. Muchomba said.

Among developed nations, the United States has a rate of high maternal morbidity, a determinant of maternal mortality, and New Jersey has one of the highest rates in the country, although, paradoxically, it has one of the lowest state poverty rates and one of the highest state income levels, he added, said explaining the impetus for the study.

Previous research has found that state and local investment in non–health specific services can reduce infant mortality rates (IMR). Last year, for example, a national study of 2000-2016 data led by Neal D. Goldstein, PhD, MRI, an assistant professor of epidemiology and biostatistics at Drexel University in Philadelphia, reported that a $0.30 per-person increase in environmental spending was associated with a decrease of 0.03 deaths per 1,000 live births, and a $0.73 per-person increase in social services spending was associated with a decrease of 0.02 deaths per 1,000 live births. “IMR is reflective of, and amenable to broad social, economic, and health care delivery contexts within a society. State and local governments, via increased social and environmental expenditures, have the potential to reduce, albeit not eliminate, IMR disparities,” Dr. Goldstein’s group wrote in Pediatrics.

According to Aimee J. Palumbo, PhD, MPH, an assistant professor in the department of epidemiology & biostatistics in the College of Public Health at Temple University in Philadelphia, who was not involved in the study, the current study’s results are broadly consistent with those of the Goldstein study, of which she is a coauthor, in that it shows spending on public welfare is associated with better outcomes following birth.

“This analysis, however, is done at the municipality level, which allows it to evaluate variations in spending that occur at more local levels, rather than the state level like ours,” she said in an interview. “The researchers are also able to control for individual-level factors,” which is good as it is really suggestive of the impact that spending has on outcomes after controlling for some individual characteristics.”

Both studies speak to the importance of exploring funding for social services and specific programs that affect health, Dr. Palumbo added.

Services that affect nonmedical determinants of health broadly affect how people live their daily lives, Dr. Muchomba said – where they live, how they get to work and to medical appointments, where they shop, how they engage in recreation.

“Housing is very important for mothers since it provides a safe space to shelter during pregnancy and during recovery from childbirth. It’s a safe place to store medications and to prepare healthy food,” he continued. “But much of the housing in New Jersey is very expensive, and some mothers may have to decide between paying the rent and buying healthy food.”

In other benefits, local services spending provides transportation to jobs and health care, bus shelters, effective waste management, viable sidewalks, safe crosswalks, and public exercise venues that help to reduce obesity.

The category that Dr. Muchomba is most often asked about is libraries. “Why libraries? Our hypothesis is that libraries provide some low-income people with their only access to computers and the Internet. They’re a major resource for information and a proxy for the delivery of other services,” he said. In addition, many libraries offer English as a second language classes, which may increase health literacy among immigrants.

A major objective of the 2020 Maternal Health Action Plan of the U.S. Department of Health & Human Services is to better target resources by identifying problem spots for maternal morbidity and mortality. “Our findings strongly suggest that surveillance at the municipal level, a level rarely considered in studies of health outcomes, would be important for success in such efforts,” the authors wrote.

Dr. Muchomba believes doctors can have a role to play in targeting of spending for local services that can reduce maternal morbidity and mortality. “Many physicians are engaged in community health outreach efforts. As respected people in the community, they need to be aware of these other determinants of health that may be driving maternal morbidity rates in their communities.”

This research was supported by the Robert Wood Johnson Foundation, the National Center for Advancing Translational Sciences, the U.S. Department of Health & Human Services Health Resources and Service Administration and the Child Health Institute of New Jersey. Dr. Muchomba reported a grant from Eunice Kennedy Shriver National Institute of Child Health and Human Development outside of the submitted work. Dr. Palumbo had no potential competing interests to disclose.

Municipal budget allocations can affect severe maternal morbidity (SMM) rates, a cross-sectional study published in JAMA Network Open reported.

Led by Felix M. Muchomba, PhD, an assistant professor at Rutgers University School of Social Work in New Brunswick, N.J., the study found that local expenditures on fire and ambulance, transportation, health, housing, and libraries were negatively associated with SMM. Specifically, annual per-capita expenditures of $1,000 and higher in these categories were associated with a 35.4%-67.3% lower risk of SMM: odds ratios, 0.33 (95% confidence interval, 0.15-0.72) to 0.65 (95% CI, 0.46-0.91).

In contrast, expenditures on police were positively associated with SMM: OR, 1.15 (95% CI, 1.04-1.28).

In the first study of environmental services spending and SMM done at the municipal level – others have focused on state and county funding – Dr. Muchomba’s group analyzed 2008-2018 birth files linked to maternal hospital discharge records and U.S. Census municipal expenditures data.

The study’s cohort comprised 1,001,410 mothers giving birth in New Jersey hospitals with a mean age of 29.8 years. Of these,10.9 % were Asian, 14.8% were Black, 28.0% were Hispanic, and 44.7% were White.

Per-capita municipal expenditures were reviewed for a broad range of city services: education, public health, fire and ambulance, parks, recreation, natural resources, housing, community development, public welfare; police; transportation, and libraries. “Each year municipalities spend about $600 billion nationwide on local services, investing far more than counties do,” Dr. Muchomba said.

Among developed nations, the United States has a rate of high maternal morbidity, a determinant of maternal mortality, and New Jersey has one of the highest rates in the country, although, paradoxically, it has one of the lowest state poverty rates and one of the highest state income levels, he added, said explaining the impetus for the study.

Previous research has found that state and local investment in non–health specific services can reduce infant mortality rates (IMR). Last year, for example, a national study of 2000-2016 data led by Neal D. Goldstein, PhD, MRI, an assistant professor of epidemiology and biostatistics at Drexel University in Philadelphia, reported that a $0.30 per-person increase in environmental spending was associated with a decrease of 0.03 deaths per 1,000 live births, and a $0.73 per-person increase in social services spending was associated with a decrease of 0.02 deaths per 1,000 live births. “IMR is reflective of, and amenable to broad social, economic, and health care delivery contexts within a society. State and local governments, via increased social and environmental expenditures, have the potential to reduce, albeit not eliminate, IMR disparities,” Dr. Goldstein’s group wrote in Pediatrics.

According to Aimee J. Palumbo, PhD, MPH, an assistant professor in the department of epidemiology & biostatistics in the College of Public Health at Temple University in Philadelphia, who was not involved in the study, the current study’s results are broadly consistent with those of the Goldstein study, of which she is a coauthor, in that it shows spending on public welfare is associated with better outcomes following birth.

“This analysis, however, is done at the municipality level, which allows it to evaluate variations in spending that occur at more local levels, rather than the state level like ours,” she said in an interview. “The researchers are also able to control for individual-level factors,” which is good as it is really suggestive of the impact that spending has on outcomes after controlling for some individual characteristics.”

Both studies speak to the importance of exploring funding for social services and specific programs that affect health, Dr. Palumbo added.

Services that affect nonmedical determinants of health broadly affect how people live their daily lives, Dr. Muchomba said – where they live, how they get to work and to medical appointments, where they shop, how they engage in recreation.

“Housing is very important for mothers since it provides a safe space to shelter during pregnancy and during recovery from childbirth. It’s a safe place to store medications and to prepare healthy food,” he continued. “But much of the housing in New Jersey is very expensive, and some mothers may have to decide between paying the rent and buying healthy food.”

In other benefits, local services spending provides transportation to jobs and health care, bus shelters, effective waste management, viable sidewalks, safe crosswalks, and public exercise venues that help to reduce obesity.

The category that Dr. Muchomba is most often asked about is libraries. “Why libraries? Our hypothesis is that libraries provide some low-income people with their only access to computers and the Internet. They’re a major resource for information and a proxy for the delivery of other services,” he said. In addition, many libraries offer English as a second language classes, which may increase health literacy among immigrants.

A major objective of the 2020 Maternal Health Action Plan of the U.S. Department of Health & Human Services is to better target resources by identifying problem spots for maternal morbidity and mortality. “Our findings strongly suggest that surveillance at the municipal level, a level rarely considered in studies of health outcomes, would be important for success in such efforts,” the authors wrote.

Dr. Muchomba believes doctors can have a role to play in targeting of spending for local services that can reduce maternal morbidity and mortality. “Many physicians are engaged in community health outreach efforts. As respected people in the community, they need to be aware of these other determinants of health that may be driving maternal morbidity rates in their communities.”

This research was supported by the Robert Wood Johnson Foundation, the National Center for Advancing Translational Sciences, the U.S. Department of Health & Human Services Health Resources and Service Administration and the Child Health Institute of New Jersey. Dr. Muchomba reported a grant from Eunice Kennedy Shriver National Institute of Child Health and Human Development outside of the submitted work. Dr. Palumbo had no potential competing interests to disclose.

Municipal budget allocations can affect severe maternal morbidity (SMM) rates, a cross-sectional study published in JAMA Network Open reported.

Led by Felix M. Muchomba, PhD, an assistant professor at Rutgers University School of Social Work in New Brunswick, N.J., the study found that local expenditures on fire and ambulance, transportation, health, housing, and libraries were negatively associated with SMM. Specifically, annual per-capita expenditures of $1,000 and higher in these categories were associated with a 35.4%-67.3% lower risk of SMM: odds ratios, 0.33 (95% confidence interval, 0.15-0.72) to 0.65 (95% CI, 0.46-0.91).

In contrast, expenditures on police were positively associated with SMM: OR, 1.15 (95% CI, 1.04-1.28).

In the first study of environmental services spending and SMM done at the municipal level – others have focused on state and county funding – Dr. Muchomba’s group analyzed 2008-2018 birth files linked to maternal hospital discharge records and U.S. Census municipal expenditures data.

The study’s cohort comprised 1,001,410 mothers giving birth in New Jersey hospitals with a mean age of 29.8 years. Of these,10.9 % were Asian, 14.8% were Black, 28.0% were Hispanic, and 44.7% were White.

Per-capita municipal expenditures were reviewed for a broad range of city services: education, public health, fire and ambulance, parks, recreation, natural resources, housing, community development, public welfare; police; transportation, and libraries. “Each year municipalities spend about $600 billion nationwide on local services, investing far more than counties do,” Dr. Muchomba said.

Among developed nations, the United States has a rate of high maternal morbidity, a determinant of maternal mortality, and New Jersey has one of the highest rates in the country, although, paradoxically, it has one of the lowest state poverty rates and one of the highest state income levels, he added, said explaining the impetus for the study.

Previous research has found that state and local investment in non–health specific services can reduce infant mortality rates (IMR). Last year, for example, a national study of 2000-2016 data led by Neal D. Goldstein, PhD, MRI, an assistant professor of epidemiology and biostatistics at Drexel University in Philadelphia, reported that a $0.30 per-person increase in environmental spending was associated with a decrease of 0.03 deaths per 1,000 live births, and a $0.73 per-person increase in social services spending was associated with a decrease of 0.02 deaths per 1,000 live births. “IMR is reflective of, and amenable to broad social, economic, and health care delivery contexts within a society. State and local governments, via increased social and environmental expenditures, have the potential to reduce, albeit not eliminate, IMR disparities,” Dr. Goldstein’s group wrote in Pediatrics.

According to Aimee J. Palumbo, PhD, MPH, an assistant professor in the department of epidemiology & biostatistics in the College of Public Health at Temple University in Philadelphia, who was not involved in the study, the current study’s results are broadly consistent with those of the Goldstein study, of which she is a coauthor, in that it shows spending on public welfare is associated with better outcomes following birth.

“This analysis, however, is done at the municipality level, which allows it to evaluate variations in spending that occur at more local levels, rather than the state level like ours,” she said in an interview. “The researchers are also able to control for individual-level factors,” which is good as it is really suggestive of the impact that spending has on outcomes after controlling for some individual characteristics.”

Both studies speak to the importance of exploring funding for social services and specific programs that affect health, Dr. Palumbo added.

Services that affect nonmedical determinants of health broadly affect how people live their daily lives, Dr. Muchomba said – where they live, how they get to work and to medical appointments, where they shop, how they engage in recreation.

“Housing is very important for mothers since it provides a safe space to shelter during pregnancy and during recovery from childbirth. It’s a safe place to store medications and to prepare healthy food,” he continued. “But much of the housing in New Jersey is very expensive, and some mothers may have to decide between paying the rent and buying healthy food.”

In other benefits, local services spending provides transportation to jobs and health care, bus shelters, effective waste management, viable sidewalks, safe crosswalks, and public exercise venues that help to reduce obesity.

The category that Dr. Muchomba is most often asked about is libraries. “Why libraries? Our hypothesis is that libraries provide some low-income people with their only access to computers and the Internet. They’re a major resource for information and a proxy for the delivery of other services,” he said. In addition, many libraries offer English as a second language classes, which may increase health literacy among immigrants.

A major objective of the 2020 Maternal Health Action Plan of the U.S. Department of Health & Human Services is to better target resources by identifying problem spots for maternal morbidity and mortality. “Our findings strongly suggest that surveillance at the municipal level, a level rarely considered in studies of health outcomes, would be important for success in such efforts,” the authors wrote.

Dr. Muchomba believes doctors can have a role to play in targeting of spending for local services that can reduce maternal morbidity and mortality. “Many physicians are engaged in community health outreach efforts. As respected people in the community, they need to be aware of these other determinants of health that may be driving maternal morbidity rates in their communities.”

This research was supported by the Robert Wood Johnson Foundation, the National Center for Advancing Translational Sciences, the U.S. Department of Health & Human Services Health Resources and Service Administration and the Child Health Institute of New Jersey. Dr. Muchomba reported a grant from Eunice Kennedy Shriver National Institute of Child Health and Human Development outside of the submitted work. Dr. Palumbo had no potential competing interests to disclose.

Gynecologists have experience managing human papillomavirus–associated diseases of the lower genital tract. However, HPV also causes warty disease, dysplasia, and carcinoma of the head and neck. Risk factors for head and neck cancer include smoking and smokeless tobacco use, alcohol consumption, periodontal disease, radiation exposure, and HPV. The incidence of HPV-associated head and neck cancer is rising, particularly among men, at a rate of 2.7% per year.¹ The incidence of HPV-associated squamous cell carcinoma of the oropharynx now surpasses that of cervical cancer. Concerns exist regarding occupational exposure to HPV by health care providers (HCP) who perform smoke-generating procedures on HPV-infected tissues, and the potential for them to develop head and neck pathology.

In March of 2020, the American Society for Colposcopy and Cervical Pathology made the recommendation that clinicians who are routinely exposed to HPV should protect themselves against the sequela of occupationally acquired HPV by receiving the HPV vaccine.² They advocate for the “complete provider team” including physicians, advanced practice providers, nurses, operative technicians, and residents and fellows to be considered for protective vaccination.

Similar to disease patterns in the genital tract, different strains of HPV have differing propensity to cause benign, premalignant, and malignant disease states. HPV 6 and 11 are more commonly associated with warty disease in the nares, pharynx, and tonsillar tissues. HPV 16, 18, 31, and 33 (most commonly 16) are considered high risk for carcinoma formation, particularly of the tonsils and base of the tongue.

The procedures most implicated in occupational HPV exposure include ablative procedures for anogenital warts, laser ablation of vaginal and vulvar dysplasia, and electrosurgical excisional procedures for cervical dysplasia. Smoke plumes from HPV-associated procedures are known to contain HPV for both laser and electrocautery sources.³ A study of 134 patients undergoing surgical procedures for laser ablation of HPV-infected tissues detected concordant strains of HPV in approximately 30% of smoke plumes and approximately 1.5% of surgeons’ nares.⁴ Not all procedures appear to carry the same risk. Electrocoagulation procedures appear to yield fewer postprocedural positive mucosal swabs for HPV, compared with those taken after CO₂ laser.⁵

Animal studies have shown that papilloma virus procured from smoke plume has the capacity to generate disease. When 10 calves were inoculated with bovine papillary virus obtained from smoke plumes from laser ablation of bovine papillomavirus lesions, all calves manifested BPV fibropapilloma lesions at the sites of inoculation.⁶

There appears to be an increased incidence of HPV-associated head and neck disease among surgeons who perform procedures on HPV tissues, and there have been multiple case reports that have cited examples of HPV-associated benign and malignant disease among HCPs with frequent occupational exposure to HPV anogenital ablative and excisional procedures.⁷ While these observations are not proof of causation, they are cause for concern.

While the ASCCP guidelines advocate for HPV vaccination as a strategy for prevention of occupationally related HPV-associated disease, there are other strategies in place to minimize risk. The CDC guidelines for environmental infection control in health care facilities include the following recommendations:

• In settings where surgical lasers are used, wear appropriate personnel protective equipment (PPE), including N95 or N100 respirators to minimize exposure to laser plumes.
• Use central wall suction units with in-line filters to evacuate minimal laser plumes.
• Use a mechanical smoke evaluation system with a high efficiency filter to manage the generation of large amounts of laser plume, when ablating tissue infected with HPV.
• Use local exhaust ventilation (LEV).⁸

When closely adhered to, these methods appear to provide high-level protection. Data suggest that, when HCPs can access appropriate protective equipment, risks for HPV exposure are low. However, this is more feasible for larger hospital facilities, and may be more limited in outpatient settings. This has led to the consideration of background protection in the form of HPV vaccination for at-risk HCPs. This is analogous to mandates for HCPs to receive hepatitis B vaccination despite the concomitant practice of universal precautions in health care settings. Preventative strategies are typically most efficacious when performed in concert.

After nearly 2 decades of widespread use, we have confidence in the safety of the HPV vaccination. Its benefit through age 45 has been established, leading to the 2018 FDA approval for the 9-valent HPV vaccine, Guardisil-9, for this expanded age group. It would seem logical that systematic administration of the HPV vaccine for at-risk HCPs would be both feasible and safe. There are well-established systems for administering vaccines for HCPs in all health care systems. Perhaps health system administrators should consider routinely offering HPV vaccination for at-risk employees as part of their occupational health care responsibilities. One important caveat being the cost and efficacy of HPV vaccination in this group has not been not established.

In the meantime, it is critical that gynecology providers be aware of their risk for occupational exposure to HPV when using laser and electrocautery techniques on HPV-infected tissues and the potential for them developing head and neck pathology. They should strictly adhere to preventative measures such as use of fit-tested N-95 respirators, mechanical smoke evacuators with high-efficiency filters and work in environments with adequate room ventilation. We all should individually evaluate what role HPV vaccination may play for us in augmenting our own safety.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Van Dyne EA et al. MMWR Morb Mortal Wkly Rep. 2018 Aug 24;67(33):918-24.

2. ASCCP. ASCCP recommends HPV vaccination for providers.

3. Fox-Lewis A et al. Occup Environ Med. 2020 Dec;77(12):809-17.

4. Zhou Q et al. Cancer Manag Res. 2019;11:3643-54

5. Bergbrant I et al. Acta Derm Venereol. 1994 Sep;74(5):393-5.

6. Garden J et al. Arch Dermatol. 2002 Oct;138(10):1303-7.

7. Harrison R, Huh W. Obstet Gynecol. 2020;136:663-5.

8. CDC. 1996. DHHS (NIOSH) Publication Number 96-128.

Gynecologists have experience managing human papillomavirus–associated diseases of the lower genital tract. However, HPV also causes warty disease, dysplasia, and carcinoma of the head and neck. Risk factors for head and neck cancer include smoking and smokeless tobacco use, alcohol consumption, periodontal disease, radiation exposure, and HPV. The incidence of HPV-associated head and neck cancer is rising, particularly among men, at a rate of 2.7% per year.¹ The incidence of HPV-associated squamous cell carcinoma of the oropharynx now surpasses that of cervical cancer. Concerns exist regarding occupational exposure to HPV by health care providers (HCP) who perform smoke-generating procedures on HPV-infected tissues, and the potential for them to develop head and neck pathology.

In March of 2020, the American Society for Colposcopy and Cervical Pathology made the recommendation that clinicians who are routinely exposed to HPV should protect themselves against the sequela of occupationally acquired HPV by receiving the HPV vaccine.² They advocate for the “complete provider team” including physicians, advanced practice providers, nurses, operative technicians, and residents and fellows to be considered for protective vaccination.

Similar to disease patterns in the genital tract, different strains of HPV have differing propensity to cause benign, premalignant, and malignant disease states. HPV 6 and 11 are more commonly associated with warty disease in the nares, pharynx, and tonsillar tissues. HPV 16, 18, 31, and 33 (most commonly 16) are considered high risk for carcinoma formation, particularly of the tonsils and base of the tongue.

The procedures most implicated in occupational HPV exposure include ablative procedures for anogenital warts, laser ablation of vaginal and vulvar dysplasia, and electrosurgical excisional procedures for cervical dysplasia. Smoke plumes from HPV-associated procedures are known to contain HPV for both laser and electrocautery sources.³ A study of 134 patients undergoing surgical procedures for laser ablation of HPV-infected tissues detected concordant strains of HPV in approximately 30% of smoke plumes and approximately 1.5% of surgeons’ nares.⁴ Not all procedures appear to carry the same risk. Electrocoagulation procedures appear to yield fewer postprocedural positive mucosal swabs for HPV, compared with those taken after CO₂ laser.⁵

Animal studies have shown that papilloma virus procured from smoke plume has the capacity to generate disease. When 10 calves were inoculated with bovine papillary virus obtained from smoke plumes from laser ablation of bovine papillomavirus lesions, all calves manifested BPV fibropapilloma lesions at the sites of inoculation.⁶

There appears to be an increased incidence of HPV-associated head and neck disease among surgeons who perform procedures on HPV tissues, and there have been multiple case reports that have cited examples of HPV-associated benign and malignant disease among HCPs with frequent occupational exposure to HPV anogenital ablative and excisional procedures.⁷ While these observations are not proof of causation, they are cause for concern.

While the ASCCP guidelines advocate for HPV vaccination as a strategy for prevention of occupationally related HPV-associated disease, there are other strategies in place to minimize risk. The CDC guidelines for environmental infection control in health care facilities include the following recommendations:

• In settings where surgical lasers are used, wear appropriate personnel protective equipment (PPE), including N95 or N100 respirators to minimize exposure to laser plumes.
• Use central wall suction units with in-line filters to evacuate minimal laser plumes.
• Use a mechanical smoke evaluation system with a high efficiency filter to manage the generation of large amounts of laser plume, when ablating tissue infected with HPV.
• Use local exhaust ventilation (LEV).⁸

When closely adhered to, these methods appear to provide high-level protection. Data suggest that, when HCPs can access appropriate protective equipment, risks for HPV exposure are low. However, this is more feasible for larger hospital facilities, and may be more limited in outpatient settings. This has led to the consideration of background protection in the form of HPV vaccination for at-risk HCPs. This is analogous to mandates for HCPs to receive hepatitis B vaccination despite the concomitant practice of universal precautions in health care settings. Preventative strategies are typically most efficacious when performed in concert.

After nearly 2 decades of widespread use, we have confidence in the safety of the HPV vaccination. Its benefit through age 45 has been established, leading to the 2018 FDA approval for the 9-valent HPV vaccine, Guardisil-9, for this expanded age group. It would seem logical that systematic administration of the HPV vaccine for at-risk HCPs would be both feasible and safe. There are well-established systems for administering vaccines for HCPs in all health care systems. Perhaps health system administrators should consider routinely offering HPV vaccination for at-risk employees as part of their occupational health care responsibilities. One important caveat being the cost and efficacy of HPV vaccination in this group has not been not established.

In the meantime, it is critical that gynecology providers be aware of their risk for occupational exposure to HPV when using laser and electrocautery techniques on HPV-infected tissues and the potential for them developing head and neck pathology. They should strictly adhere to preventative measures such as use of fit-tested N-95 respirators, mechanical smoke evacuators with high-efficiency filters and work in environments with adequate room ventilation. We all should individually evaluate what role HPV vaccination may play for us in augmenting our own safety.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Van Dyne EA et al. MMWR Morb Mortal Wkly Rep. 2018 Aug 24;67(33):918-24.

2. ASCCP. ASCCP recommends HPV vaccination for providers.

3. Fox-Lewis A et al. Occup Environ Med. 2020 Dec;77(12):809-17.

4. Zhou Q et al. Cancer Manag Res. 2019;11:3643-54

5. Bergbrant I et al. Acta Derm Venereol. 1994 Sep;74(5):393-5.

6. Garden J et al. Arch Dermatol. 2002 Oct;138(10):1303-7.

7. Harrison R, Huh W. Obstet Gynecol. 2020;136:663-5.

8. CDC. 1996. DHHS (NIOSH) Publication Number 96-128.

Gynecologists have experience managing human papillomavirus–associated diseases of the lower genital tract. However, HPV also causes warty disease, dysplasia, and carcinoma of the head and neck. Risk factors for head and neck cancer include smoking and smokeless tobacco use, alcohol consumption, periodontal disease, radiation exposure, and HPV. The incidence of HPV-associated head and neck cancer is rising, particularly among men, at a rate of 2.7% per year.¹ The incidence of HPV-associated squamous cell carcinoma of the oropharynx now surpasses that of cervical cancer. Concerns exist regarding occupational exposure to HPV by health care providers (HCP) who perform smoke-generating procedures on HPV-infected tissues, and the potential for them to develop head and neck pathology.

In March of 2020, the American Society for Colposcopy and Cervical Pathology made the recommendation that clinicians who are routinely exposed to HPV should protect themselves against the sequela of occupationally acquired HPV by receiving the HPV vaccine.² They advocate for the “complete provider team” including physicians, advanced practice providers, nurses, operative technicians, and residents and fellows to be considered for protective vaccination.

Similar to disease patterns in the genital tract, different strains of HPV have differing propensity to cause benign, premalignant, and malignant disease states. HPV 6 and 11 are more commonly associated with warty disease in the nares, pharynx, and tonsillar tissues. HPV 16, 18, 31, and 33 (most commonly 16) are considered high risk for carcinoma formation, particularly of the tonsils and base of the tongue.

The procedures most implicated in occupational HPV exposure include ablative procedures for anogenital warts, laser ablation of vaginal and vulvar dysplasia, and electrosurgical excisional procedures for cervical dysplasia. Smoke plumes from HPV-associated procedures are known to contain HPV for both laser and electrocautery sources.³ A study of 134 patients undergoing surgical procedures for laser ablation of HPV-infected tissues detected concordant strains of HPV in approximately 30% of smoke plumes and approximately 1.5% of surgeons’ nares.⁴ Not all procedures appear to carry the same risk. Electrocoagulation procedures appear to yield fewer postprocedural positive mucosal swabs for HPV, compared with those taken after CO₂ laser.⁵

Animal studies have shown that papilloma virus procured from smoke plume has the capacity to generate disease. When 10 calves were inoculated with bovine papillary virus obtained from smoke plumes from laser ablation of bovine papillomavirus lesions, all calves manifested BPV fibropapilloma lesions at the sites of inoculation.⁶

There appears to be an increased incidence of HPV-associated head and neck disease among surgeons who perform procedures on HPV tissues, and there have been multiple case reports that have cited examples of HPV-associated benign and malignant disease among HCPs with frequent occupational exposure to HPV anogenital ablative and excisional procedures.⁷ While these observations are not proof of causation, they are cause for concern.

While the ASCCP guidelines advocate for HPV vaccination as a strategy for prevention of occupationally related HPV-associated disease, there are other strategies in place to minimize risk. The CDC guidelines for environmental infection control in health care facilities include the following recommendations:

• In settings where surgical lasers are used, wear appropriate personnel protective equipment (PPE), including N95 or N100 respirators to minimize exposure to laser plumes.
• Use central wall suction units with in-line filters to evacuate minimal laser plumes.
• Use a mechanical smoke evaluation system with a high efficiency filter to manage the generation of large amounts of laser plume, when ablating tissue infected with HPV.
• Use local exhaust ventilation (LEV).⁸

When closely adhered to, these methods appear to provide high-level protection. Data suggest that, when HCPs can access appropriate protective equipment, risks for HPV exposure are low. However, this is more feasible for larger hospital facilities, and may be more limited in outpatient settings. This has led to the consideration of background protection in the form of HPV vaccination for at-risk HCPs. This is analogous to mandates for HCPs to receive hepatitis B vaccination despite the concomitant practice of universal precautions in health care settings. Preventative strategies are typically most efficacious when performed in concert.

After nearly 2 decades of widespread use, we have confidence in the safety of the HPV vaccination. Its benefit through age 45 has been established, leading to the 2018 FDA approval for the 9-valent HPV vaccine, Guardisil-9, for this expanded age group. It would seem logical that systematic administration of the HPV vaccine for at-risk HCPs would be both feasible and safe. There are well-established systems for administering vaccines for HCPs in all health care systems. Perhaps health system administrators should consider routinely offering HPV vaccination for at-risk employees as part of their occupational health care responsibilities. One important caveat being the cost and efficacy of HPV vaccination in this group has not been not established.

In the meantime, it is critical that gynecology providers be aware of their risk for occupational exposure to HPV when using laser and electrocautery techniques on HPV-infected tissues and the potential for them developing head and neck pathology. They should strictly adhere to preventative measures such as use of fit-tested N-95 respirators, mechanical smoke evacuators with high-efficiency filters and work in environments with adequate room ventilation. We all should individually evaluate what role HPV vaccination may play for us in augmenting our own safety.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Van Dyne EA et al. MMWR Morb Mortal Wkly Rep. 2018 Aug 24;67(33):918-24.

2. ASCCP. ASCCP recommends HPV vaccination for providers.

3. Fox-Lewis A et al. Occup Environ Med. 2020 Dec;77(12):809-17.

4. Zhou Q et al. Cancer Manag Res. 2019;11:3643-54

5. Bergbrant I et al. Acta Derm Venereol. 1994 Sep;74(5):393-5.

6. Garden J et al. Arch Dermatol. 2002 Oct;138(10):1303-7.

7. Harrison R, Huh W. Obstet Gynecol. 2020;136:663-5.

8. CDC. 1996. DHHS (NIOSH) Publication Number 96-128.

Pfizer announced on Nov. 22 that its COVID-19 vaccine provided long-term protection against the virus in a late-stage clinical trial among adolescents ages 12-15.

A two-dose series was 100% effective against COVID-19, which was measured between 7 days and 4 months after the second dose.

“As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine safety and effectiveness profile in adolescents,” Albert Bourla, PhD, chairman and CEO of Pfizer, said in a statement.

The clinical trial researchers found no serious safety concerns while following patients for 6 months. The adverse events were consistent with other clinical safety data for the vaccine, the company said.

Pfizer will incorporate the data into its submissions for full regulatory approval of the vaccine for ages 12-15 in the United States and worldwide.

The company will request clearance for a 30-mcg dose of the vaccines for ages 12 and older. The shot received FDA emergency use authorization for ages 12-15 in May and full approval for ages 16 and older in August.

The study included 2,228 clinical trial participants who were monitored between November 2020 and September 2021. There were 30 confirmed symptomatic cases of COVID-19 in the placebo group that didn’t receive the vaccine and 0 COVID-19 cases among the vaccinated group.

The efficacy was consistently high across gender, race, ethnicity, and health conditions, the company said.

“This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed,” Mr. Bourla said. “We look forward to sharing these data with the FDA and other regulators.”

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

Pfizer announced on Nov. 22 that its COVID-19 vaccine provided long-term protection against the virus in a late-stage clinical trial among adolescents ages 12-15.

A two-dose series was 100% effective against COVID-19, which was measured between 7 days and 4 months after the second dose.

“As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine safety and effectiveness profile in adolescents,” Albert Bourla, PhD, chairman and CEO of Pfizer, said in a statement.

The clinical trial researchers found no serious safety concerns while following patients for 6 months. The adverse events were consistent with other clinical safety data for the vaccine, the company said.

Pfizer will incorporate the data into its submissions for full regulatory approval of the vaccine for ages 12-15 in the United States and worldwide.

The company will request clearance for a 30-mcg dose of the vaccines for ages 12 and older. The shot received FDA emergency use authorization for ages 12-15 in May and full approval for ages 16 and older in August.

The study included 2,228 clinical trial participants who were monitored between November 2020 and September 2021. There were 30 confirmed symptomatic cases of COVID-19 in the placebo group that didn’t receive the vaccine and 0 COVID-19 cases among the vaccinated group.

The efficacy was consistently high across gender, race, ethnicity, and health conditions, the company said.

“This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed,” Mr. Bourla said. “We look forward to sharing these data with the FDA and other regulators.”

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

Pfizer announced on Nov. 22 that its COVID-19 vaccine provided long-term protection against the virus in a late-stage clinical trial among adolescents ages 12-15.

A two-dose series was 100% effective against COVID-19, which was measured between 7 days and 4 months after the second dose.

“As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine safety and effectiveness profile in adolescents,” Albert Bourla, PhD, chairman and CEO of Pfizer, said in a statement.

The clinical trial researchers found no serious safety concerns while following patients for 6 months. The adverse events were consistent with other clinical safety data for the vaccine, the company said.

Pfizer will incorporate the data into its submissions for full regulatory approval of the vaccine for ages 12-15 in the United States and worldwide.

The company will request clearance for a 30-mcg dose of the vaccines for ages 12 and older. The shot received FDA emergency use authorization for ages 12-15 in May and full approval for ages 16 and older in August.

The study included 2,228 clinical trial participants who were monitored between November 2020 and September 2021. There were 30 confirmed symptomatic cases of COVID-19 in the placebo group that didn’t receive the vaccine and 0 COVID-19 cases among the vaccinated group.

The efficacy was consistently high across gender, race, ethnicity, and health conditions, the company said.

“This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed,” Mr. Bourla said. “We look forward to sharing these data with the FDA and other regulators.”

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

Although the estimated annual number of measles deaths decreased 94% from 2000 to 2020, the COVID-19 pandemic took a toll on both measles vaccination and surveillance, according to a recent report in Morbidity and Mortality Weekly Report.

The number of World Health Organization member states that achieved more than 90% coverage with the first dose of the measles vaccine (MCV1) declined 37% from 2019 to 2020. In 2020, 23 million infants did not receive MCV1 through routine immunization services, and another 93 million were affected by the postponement of mass immunizations or supplementary immunization activities because of the pandemic. Also, endemic transmission was reestablished in nine countries that had previously eliminated measles.

But perhaps the most overlooked aspect of COVID-19 is its effect on surveillance.

“The entire COVID pandemic really put a lot of strain on the surveillance systems, not only for measles but for all vaccine-preventable disease, because there’s a lot of overlap in the staff who work for surveillance,” said Katrina Kretsinger, MD, a medical epidemiologist at the Centers for Disease Control and Prevention, who contributed to the MMWR report.

Because of the stress on the systems, a lot fewer specimens were tested, she said in an interview. And it’s not just measles that is at risk. This has had an impact on the Global Polio Eradication Initiative, which lost staff.

In addition, many vaccination campaigns “were postponed and curtailed throughout 2020,” Dr. Kretsinger said. The strengthening of surveillance systems – and immunization systems, more broadly – needs to be a priority.

“It’s not clear that the children who were missed during that year were subsequently caught up,” she explained. Having a “cohort of children who have missed measles vaccine creates the reservoir of susceptibility that will provide the nidus for the next big outbreak.”

Measles is the indicator disease. That could mean a resurgence of other vaccine-preventable diseases as well.

This report “was written by some of the world’s experts in measles, and it raises concerns about potential resurgence of measles,” said Walter Orenstein, MD, professor of medicine, epidemiology, global health, and pediatrics at Emory University, Atlanta. “Measles is sort of a canary in the coal mine. If you look at vaccine-preventable diseases, measles is probably the most contagious, so the herd-immunity threshold is highest. Usually on the order of 92%-94% immunity is needed to stop transmission.”

“Measles is the indicator disease,” he said in an interview. “That could mean a resurgence of other vaccine-preventable diseases as well.” Outbreaks don’t just affect the countries where infections are occurring, they “also affect our own domestic health security.”

“Some sort of periodic intensified routine immunization” would be helpful, said Dr. Kretsinger, who recommends “going through and selectively doing some sort of intensified efforts to catch children up early for the entire range of vaccines that they may have missed.”

“Some of these capture campaigns in areas that are thought to have the major problem would be very, very important,” agreed Dr. Orenstein. “A school entry check is one way of trying to look at kids, let’s say at 4-6 years of age, in schools around the world,” offering doses if they’re unvaccinated or inadequately vaccinated. “Another is to try to improve surveillance and try to understand if the cases are vaccine failure or failure to vaccinate.”

“Where the health systems are the most fragile is where those gaps will be the last to be filled, if they are at all, and where we have the basic concerns,” Dr. Kretsinger explained.

“Years ago, WHO recognized that vaccine hesitancy is a top global health threat,” said Dr. Orenstein. “People may not see these diseases so they don’t mean much to them. Since vaccines, we’re victims of our own success.” There’s also a lot of incorrect information circulating.

“We need to realize – and it’s been shown with COVID – that a decision not to vaccinate is not just a decision for your own child. It’s a community decision,” he pointed out. “It’s not my freedom to drive drunk, because not only do I put myself at risk, but others can’t control the car. We have speed limits and other examples where we restrict personal choice because it can adversely affect individuals.”

“My favorite line is vaccines don’t save lives, vaccinations save lives,” Dr. Orenstein said. “The vaccine dose that remains in the vial is 0% effective, no matter what the clinical trials show. And the issue, I think, is that we need to determine how to convince the hesitant to get confident enough to accept vaccination. For that, there is behavioral research; there’s a whole bunch of things that need to be supported. Just purchasing the vaccine doesn’t get it into the bodies.”

Dr. Kretsinger and Dr. Orenstein disclosed no relevant financial relationships .

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

Although the estimated annual number of measles deaths decreased 94% from 2000 to 2020, the COVID-19 pandemic took a toll on both measles vaccination and surveillance, according to a recent report in Morbidity and Mortality Weekly Report.

The number of World Health Organization member states that achieved more than 90% coverage with the first dose of the measles vaccine (MCV1) declined 37% from 2019 to 2020. In 2020, 23 million infants did not receive MCV1 through routine immunization services, and another 93 million were affected by the postponement of mass immunizations or supplementary immunization activities because of the pandemic. Also, endemic transmission was reestablished in nine countries that had previously eliminated measles.

But perhaps the most overlooked aspect of COVID-19 is its effect on surveillance.

“The entire COVID pandemic really put a lot of strain on the surveillance systems, not only for measles but for all vaccine-preventable disease, because there’s a lot of overlap in the staff who work for surveillance,” said Katrina Kretsinger, MD, a medical epidemiologist at the Centers for Disease Control and Prevention, who contributed to the MMWR report.

Because of the stress on the systems, a lot fewer specimens were tested, she said in an interview. And it’s not just measles that is at risk. This has had an impact on the Global Polio Eradication Initiative, which lost staff.

In addition, many vaccination campaigns “were postponed and curtailed throughout 2020,” Dr. Kretsinger said. The strengthening of surveillance systems – and immunization systems, more broadly – needs to be a priority.

“It’s not clear that the children who were missed during that year were subsequently caught up,” she explained. Having a “cohort of children who have missed measles vaccine creates the reservoir of susceptibility that will provide the nidus for the next big outbreak.”

Measles is the indicator disease. That could mean a resurgence of other vaccine-preventable diseases as well.

This report “was written by some of the world’s experts in measles, and it raises concerns about potential resurgence of measles,” said Walter Orenstein, MD, professor of medicine, epidemiology, global health, and pediatrics at Emory University, Atlanta. “Measles is sort of a canary in the coal mine. If you look at vaccine-preventable diseases, measles is probably the most contagious, so the herd-immunity threshold is highest. Usually on the order of 92%-94% immunity is needed to stop transmission.”

“Measles is the indicator disease,” he said in an interview. “That could mean a resurgence of other vaccine-preventable diseases as well.” Outbreaks don’t just affect the countries where infections are occurring, they “also affect our own domestic health security.”

“Some sort of periodic intensified routine immunization” would be helpful, said Dr. Kretsinger, who recommends “going through and selectively doing some sort of intensified efforts to catch children up early for the entire range of vaccines that they may have missed.”

“Some of these capture campaigns in areas that are thought to have the major problem would be very, very important,” agreed Dr. Orenstein. “A school entry check is one way of trying to look at kids, let’s say at 4-6 years of age, in schools around the world,” offering doses if they’re unvaccinated or inadequately vaccinated. “Another is to try to improve surveillance and try to understand if the cases are vaccine failure or failure to vaccinate.”

“Where the health systems are the most fragile is where those gaps will be the last to be filled, if they are at all, and where we have the basic concerns,” Dr. Kretsinger explained.

“Years ago, WHO recognized that vaccine hesitancy is a top global health threat,” said Dr. Orenstein. “People may not see these diseases so they don’t mean much to them. Since vaccines, we’re victims of our own success.” There’s also a lot of incorrect information circulating.

“We need to realize – and it’s been shown with COVID – that a decision not to vaccinate is not just a decision for your own child. It’s a community decision,” he pointed out. “It’s not my freedom to drive drunk, because not only do I put myself at risk, but others can’t control the car. We have speed limits and other examples where we restrict personal choice because it can adversely affect individuals.”

“My favorite line is vaccines don’t save lives, vaccinations save lives,” Dr. Orenstein said. “The vaccine dose that remains in the vial is 0% effective, no matter what the clinical trials show. And the issue, I think, is that we need to determine how to convince the hesitant to get confident enough to accept vaccination. For that, there is behavioral research; there’s a whole bunch of things that need to be supported. Just purchasing the vaccine doesn’t get it into the bodies.”

Dr. Kretsinger and Dr. Orenstein disclosed no relevant financial relationships .

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

Although the estimated annual number of measles deaths decreased 94% from 2000 to 2020, the COVID-19 pandemic took a toll on both measles vaccination and surveillance, according to a recent report in Morbidity and Mortality Weekly Report.

The number of World Health Organization member states that achieved more than 90% coverage with the first dose of the measles vaccine (MCV1) declined 37% from 2019 to 2020. In 2020, 23 million infants did not receive MCV1 through routine immunization services, and another 93 million were affected by the postponement of mass immunizations or supplementary immunization activities because of the pandemic. Also, endemic transmission was reestablished in nine countries that had previously eliminated measles.

But perhaps the most overlooked aspect of COVID-19 is its effect on surveillance.

“The entire COVID pandemic really put a lot of strain on the surveillance systems, not only for measles but for all vaccine-preventable disease, because there’s a lot of overlap in the staff who work for surveillance,” said Katrina Kretsinger, MD, a medical epidemiologist at the Centers for Disease Control and Prevention, who contributed to the MMWR report.

Because of the stress on the systems, a lot fewer specimens were tested, she said in an interview. And it’s not just measles that is at risk. This has had an impact on the Global Polio Eradication Initiative, which lost staff.

In addition, many vaccination campaigns “were postponed and curtailed throughout 2020,” Dr. Kretsinger said. The strengthening of surveillance systems – and immunization systems, more broadly – needs to be a priority.

“It’s not clear that the children who were missed during that year were subsequently caught up,” she explained. Having a “cohort of children who have missed measles vaccine creates the reservoir of susceptibility that will provide the nidus for the next big outbreak.”

Measles is the indicator disease. That could mean a resurgence of other vaccine-preventable diseases as well.

This report “was written by some of the world’s experts in measles, and it raises concerns about potential resurgence of measles,” said Walter Orenstein, MD, professor of medicine, epidemiology, global health, and pediatrics at Emory University, Atlanta. “Measles is sort of a canary in the coal mine. If you look at vaccine-preventable diseases, measles is probably the most contagious, so the herd-immunity threshold is highest. Usually on the order of 92%-94% immunity is needed to stop transmission.”

“Measles is the indicator disease,” he said in an interview. “That could mean a resurgence of other vaccine-preventable diseases as well.” Outbreaks don’t just affect the countries where infections are occurring, they “also affect our own domestic health security.”

“Some sort of periodic intensified routine immunization” would be helpful, said Dr. Kretsinger, who recommends “going through and selectively doing some sort of intensified efforts to catch children up early for the entire range of vaccines that they may have missed.”

“Some of these capture campaigns in areas that are thought to have the major problem would be very, very important,” agreed Dr. Orenstein. “A school entry check is one way of trying to look at kids, let’s say at 4-6 years of age, in schools around the world,” offering doses if they’re unvaccinated or inadequately vaccinated. “Another is to try to improve surveillance and try to understand if the cases are vaccine failure or failure to vaccinate.”

“Where the health systems are the most fragile is where those gaps will be the last to be filled, if they are at all, and where we have the basic concerns,” Dr. Kretsinger explained.

“Years ago, WHO recognized that vaccine hesitancy is a top global health threat,” said Dr. Orenstein. “People may not see these diseases so they don’t mean much to them. Since vaccines, we’re victims of our own success.” There’s also a lot of incorrect information circulating.

“We need to realize – and it’s been shown with COVID – that a decision not to vaccinate is not just a decision for your own child. It’s a community decision,” he pointed out. “It’s not my freedom to drive drunk, because not only do I put myself at risk, but others can’t control the car. We have speed limits and other examples where we restrict personal choice because it can adversely affect individuals.”

“My favorite line is vaccines don’t save lives, vaccinations save lives,” Dr. Orenstein said. “The vaccine dose that remains in the vial is 0% effective, no matter what the clinical trials show. And the issue, I think, is that we need to determine how to convince the hesitant to get confident enough to accept vaccination. For that, there is behavioral research; there’s a whole bunch of things that need to be supported. Just purchasing the vaccine doesn’t get it into the bodies.”

Dr. Kretsinger and Dr. Orenstein disclosed no relevant financial relationships .

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

A number of clinical trials in gynecologic cancers have opened in recent months. Maybe one of your patients could benefit from being enrolled.

Uterine precancer (endometrial intraepithelial neoplasia). A phase 2 study sponsored by the National Cancer Institute is seeking adults with endometrial intraepithelial neoplasia (also called complex atypical hyperplasia or atypical hyperplasia) who are scheduled for hysterectomy within 3 months. Researchers are using the window of opportunity before an already-scheduled hysterectomy to see whether adding metformin to megestrol acetate, a treatment standard for nonsurgical patients, increases the effectiveness of megestrol in slowing this type of neoplasia. Participants will receive twice-daily oral medication for 4 weeks then undergo hysterectomy. The trial aims to enroll 50 participants. It began recruiting on Sept. 21 at its Northwestern University site in Evanston, Ill.; sites in California, Colorado, and North Carolina are also planned. The primary outcome is the change in endometrial cell proliferation. Overall survival (OS) and quality of life (QoL) will not be measured. .

Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, who is not involved in this trial, was approached for comment. “This is an interesting study concept, and patients with endometrial atypical hyperplasia may certainly wish to consider participation,” Dr. Markman said. He noted the “limited sample size” of the study.

Advanced, recurrent or refractory ovarian, fallopian, and endometrial cancers overexpressing folate receptor (FR)–alpha. Patients with these types of cancers are eligible for a phase 1/2 study of a new-concept targeted therapy called ELU-001. The molecular structure of ELU001 – called a C’Dot drug conjugate – consists of a drug “payload” riding with an FR-alpha–targeting molecule. For the first 28 days of the study, patients will receive escalating intravenous doses of ELU001 to determine the highest tolerated dose of the drug. All participants will then receive the selected dose for up to 12 months until lesions disappear (complete response) or there is a 30% decrease in the sum of the tumors’ longest diameter (partial response). This “basket” study – a trial involving a “basket” of different cancers with one genetic target – is hosted by New Experimental Therapeutics of San Antonio, which started recruitment for 166 patients on Sept. 13. Neither OS nor QoL will be tracked. .

Dr. Markman commented: “There is considerable interest in examining antineoplastic agents directed to tumor antigens overexpressed in ovarian cancer.”

Locally recurrent, unresectable, or metastatic cervical or endometrial cancer positive for PD-L1. Adults with these types of cancers are invited to join another basket trial, this time testing MK-7684A, a new coformulation of pembrolizumab (Keytruda) and the investigational drug vibostolimab. Most participants will receive intravenous infusions of either MK-7684A, MK-7684A plus chemotherapy, or pembrolizumab alone every 3 weeks for up to 3 years. One group will be given MK-7684A every 3 weeks plus paclitaxel weekly. People with endometrial cancer will also take a daily capsule of lenvatinib (Lenvima). The primary outcomes are response rate and progression-free survival; OS and QoL are secondary outcomes. The study opened on Sept. 16 and hopes to recruit 480 participants in eight countries with several different cancers, including cervical and endometrial cancers. U.S. patients can join at the City of Hope National Medical Center, Duarte, Calif. .

Persistent or recurrent rare epithelial tumors of the ovary, fallopian tube, or peritoneum. Adults with these cancers are sought for a phase 2 trial comparing four targeted-therapy regimens. Participants will receive either ipatasertib plus paclitaxel (Taxol); cobimetinib (Cotellic); trastuzumab emtansine (Kadcyla); or atezolizumab (Tecentriq) plus bevacizumab (Avastin) for up to 5 years until disease progression or unacceptable toxicity. Ipatasertib and cobimetinib are oral medications; all the others are administered intravenously on schedules that vary from once every 3 weeks (atezolizumab, trastuzumab) to weekly infusions 3 weeks out of 4 (paclitaxel). The study opened on Oct. 7 and hopes to enroll 200 participants at sites in Arizona, California, Minnesota, Missouri, Texas, Virginia, and worldwide. OS will be tracked, QoL will not. 

Dr. Markman commented: “This is an interesting early study of the potential efficacy of a novel AKT inhibitor [ipatasertib] in rare gynecologic cancers.”

Platinum-resistant or refractory high-grade serous ovarian cancer. Adult women whose high-grade serous ovarian cancer is platinum resistant or refractory and who do not have germline BRCA mutations are sought for a phase 3 study comparing alpelisib (Piqray) plus olaparib (Lynparza) to investigator’s choice of chemotherapy. Alpelisib is approved for breast cancer in combination with fulvestrant; olaparib is approved for advanced ovarian cancer in platinum-responsive patients and/or those with BRCA- or HRD-positive tumors, so this study could lead to labeling changes for these drugs. Participants will either take daily oral doses of alpelisib plus olaparib or receive intravenous chemo on the appropriate schedules for approximately 2 years. Progression-free survival is the primary outcome measure; OS and QoL are secondary outcomes. The trial opened on July 2 and hopes to recruit 358 individuals in Singapore, Australia, Europe, and the United States (Arizona, Illinois, and Texas). .

All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).

Dr. Markman is not involved with any of these trials. He is a regular contributor to Medscape Oncology. He has received income in an amount equal to or greater than $250 from Genentech, AstraZeneca Celgene, Clovis, Amgen.

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

A number of clinical trials in gynecologic cancers have opened in recent months. Maybe one of your patients could benefit from being enrolled.

Uterine precancer (endometrial intraepithelial neoplasia). A phase 2 study sponsored by the National Cancer Institute is seeking adults with endometrial intraepithelial neoplasia (also called complex atypical hyperplasia or atypical hyperplasia) who are scheduled for hysterectomy within 3 months. Researchers are using the window of opportunity before an already-scheduled hysterectomy to see whether adding metformin to megestrol acetate, a treatment standard for nonsurgical patients, increases the effectiveness of megestrol in slowing this type of neoplasia. Participants will receive twice-daily oral medication for 4 weeks then undergo hysterectomy. The trial aims to enroll 50 participants. It began recruiting on Sept. 21 at its Northwestern University site in Evanston, Ill.; sites in California, Colorado, and North Carolina are also planned. The primary outcome is the change in endometrial cell proliferation. Overall survival (OS) and quality of life (QoL) will not be measured. .

Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, who is not involved in this trial, was approached for comment. “This is an interesting study concept, and patients with endometrial atypical hyperplasia may certainly wish to consider participation,” Dr. Markman said. He noted the “limited sample size” of the study.

Advanced, recurrent or refractory ovarian, fallopian, and endometrial cancers overexpressing folate receptor (FR)–alpha. Patients with these types of cancers are eligible for a phase 1/2 study of a new-concept targeted therapy called ELU-001. The molecular structure of ELU001 – called a C’Dot drug conjugate – consists of a drug “payload” riding with an FR-alpha–targeting molecule. For the first 28 days of the study, patients will receive escalating intravenous doses of ELU001 to determine the highest tolerated dose of the drug. All participants will then receive the selected dose for up to 12 months until lesions disappear (complete response) or there is a 30% decrease in the sum of the tumors’ longest diameter (partial response). This “basket” study – a trial involving a “basket” of different cancers with one genetic target – is hosted by New Experimental Therapeutics of San Antonio, which started recruitment for 166 patients on Sept. 13. Neither OS nor QoL will be tracked. .

Dr. Markman commented: “There is considerable interest in examining antineoplastic agents directed to tumor antigens overexpressed in ovarian cancer.”

Locally recurrent, unresectable, or metastatic cervical or endometrial cancer positive for PD-L1. Adults with these types of cancers are invited to join another basket trial, this time testing MK-7684A, a new coformulation of pembrolizumab (Keytruda) and the investigational drug vibostolimab. Most participants will receive intravenous infusions of either MK-7684A, MK-7684A plus chemotherapy, or pembrolizumab alone every 3 weeks for up to 3 years. One group will be given MK-7684A every 3 weeks plus paclitaxel weekly. People with endometrial cancer will also take a daily capsule of lenvatinib (Lenvima). The primary outcomes are response rate and progression-free survival; OS and QoL are secondary outcomes. The study opened on Sept. 16 and hopes to recruit 480 participants in eight countries with several different cancers, including cervical and endometrial cancers. U.S. patients can join at the City of Hope National Medical Center, Duarte, Calif. .

Persistent or recurrent rare epithelial tumors of the ovary, fallopian tube, or peritoneum. Adults with these cancers are sought for a phase 2 trial comparing four targeted-therapy regimens. Participants will receive either ipatasertib plus paclitaxel (Taxol); cobimetinib (Cotellic); trastuzumab emtansine (Kadcyla); or atezolizumab (Tecentriq) plus bevacizumab (Avastin) for up to 5 years until disease progression or unacceptable toxicity. Ipatasertib and cobimetinib are oral medications; all the others are administered intravenously on schedules that vary from once every 3 weeks (atezolizumab, trastuzumab) to weekly infusions 3 weeks out of 4 (paclitaxel). The study opened on Oct. 7 and hopes to enroll 200 participants at sites in Arizona, California, Minnesota, Missouri, Texas, Virginia, and worldwide. OS will be tracked, QoL will not. 

Dr. Markman commented: “This is an interesting early study of the potential efficacy of a novel AKT inhibitor [ipatasertib] in rare gynecologic cancers.”

Platinum-resistant or refractory high-grade serous ovarian cancer. Adult women whose high-grade serous ovarian cancer is platinum resistant or refractory and who do not have germline BRCA mutations are sought for a phase 3 study comparing alpelisib (Piqray) plus olaparib (Lynparza) to investigator’s choice of chemotherapy. Alpelisib is approved for breast cancer in combination with fulvestrant; olaparib is approved for advanced ovarian cancer in platinum-responsive patients and/or those with BRCA- or HRD-positive tumors, so this study could lead to labeling changes for these drugs. Participants will either take daily oral doses of alpelisib plus olaparib or receive intravenous chemo on the appropriate schedules for approximately 2 years. Progression-free survival is the primary outcome measure; OS and QoL are secondary outcomes. The trial opened on July 2 and hopes to recruit 358 individuals in Singapore, Australia, Europe, and the United States (Arizona, Illinois, and Texas). .

All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).

Dr. Markman is not involved with any of these trials. He is a regular contributor to Medscape Oncology. He has received income in an amount equal to or greater than $250 from Genentech, AstraZeneca Celgene, Clovis, Amgen.

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

A number of clinical trials in gynecologic cancers have opened in recent months. Maybe one of your patients could benefit from being enrolled.

Uterine precancer (endometrial intraepithelial neoplasia). A phase 2 study sponsored by the National Cancer Institute is seeking adults with endometrial intraepithelial neoplasia (also called complex atypical hyperplasia or atypical hyperplasia) who are scheduled for hysterectomy within 3 months. Researchers are using the window of opportunity before an already-scheduled hysterectomy to see whether adding metformin to megestrol acetate, a treatment standard for nonsurgical patients, increases the effectiveness of megestrol in slowing this type of neoplasia. Participants will receive twice-daily oral medication for 4 weeks then undergo hysterectomy. The trial aims to enroll 50 participants. It began recruiting on Sept. 21 at its Northwestern University site in Evanston, Ill.; sites in California, Colorado, and North Carolina are also planned. The primary outcome is the change in endometrial cell proliferation. Overall survival (OS) and quality of life (QoL) will not be measured. .

Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, who is not involved in this trial, was approached for comment. “This is an interesting study concept, and patients with endometrial atypical hyperplasia may certainly wish to consider participation,” Dr. Markman said. He noted the “limited sample size” of the study.

Advanced, recurrent or refractory ovarian, fallopian, and endometrial cancers overexpressing folate receptor (FR)–alpha. Patients with these types of cancers are eligible for a phase 1/2 study of a new-concept targeted therapy called ELU-001. The molecular structure of ELU001 – called a C’Dot drug conjugate – consists of a drug “payload” riding with an FR-alpha–targeting molecule. For the first 28 days of the study, patients will receive escalating intravenous doses of ELU001 to determine the highest tolerated dose of the drug. All participants will then receive the selected dose for up to 12 months until lesions disappear (complete response) or there is a 30% decrease in the sum of the tumors’ longest diameter (partial response). This “basket” study – a trial involving a “basket” of different cancers with one genetic target – is hosted by New Experimental Therapeutics of San Antonio, which started recruitment for 166 patients on Sept. 13. Neither OS nor QoL will be tracked. .

Dr. Markman commented: “There is considerable interest in examining antineoplastic agents directed to tumor antigens overexpressed in ovarian cancer.”

Locally recurrent, unresectable, or metastatic cervical or endometrial cancer positive for PD-L1. Adults with these types of cancers are invited to join another basket trial, this time testing MK-7684A, a new coformulation of pembrolizumab (Keytruda) and the investigational drug vibostolimab. Most participants will receive intravenous infusions of either MK-7684A, MK-7684A plus chemotherapy, or pembrolizumab alone every 3 weeks for up to 3 years. One group will be given MK-7684A every 3 weeks plus paclitaxel weekly. People with endometrial cancer will also take a daily capsule of lenvatinib (Lenvima). The primary outcomes are response rate and progression-free survival; OS and QoL are secondary outcomes. The study opened on Sept. 16 and hopes to recruit 480 participants in eight countries with several different cancers, including cervical and endometrial cancers. U.S. patients can join at the City of Hope National Medical Center, Duarte, Calif. .

Persistent or recurrent rare epithelial tumors of the ovary, fallopian tube, or peritoneum. Adults with these cancers are sought for a phase 2 trial comparing four targeted-therapy regimens. Participants will receive either ipatasertib plus paclitaxel (Taxol); cobimetinib (Cotellic); trastuzumab emtansine (Kadcyla); or atezolizumab (Tecentriq) plus bevacizumab (Avastin) for up to 5 years until disease progression or unacceptable toxicity. Ipatasertib and cobimetinib are oral medications; all the others are administered intravenously on schedules that vary from once every 3 weeks (atezolizumab, trastuzumab) to weekly infusions 3 weeks out of 4 (paclitaxel). The study opened on Oct. 7 and hopes to enroll 200 participants at sites in Arizona, California, Minnesota, Missouri, Texas, Virginia, and worldwide. OS will be tracked, QoL will not. 

Dr. Markman commented: “This is an interesting early study of the potential efficacy of a novel AKT inhibitor [ipatasertib] in rare gynecologic cancers.”

Platinum-resistant or refractory high-grade serous ovarian cancer. Adult women whose high-grade serous ovarian cancer is platinum resistant or refractory and who do not have germline BRCA mutations are sought for a phase 3 study comparing alpelisib (Piqray) plus olaparib (Lynparza) to investigator’s choice of chemotherapy. Alpelisib is approved for breast cancer in combination with fulvestrant; olaparib is approved for advanced ovarian cancer in platinum-responsive patients and/or those with BRCA- or HRD-positive tumors, so this study could lead to labeling changes for these drugs. Participants will either take daily oral doses of alpelisib plus olaparib or receive intravenous chemo on the appropriate schedules for approximately 2 years. Progression-free survival is the primary outcome measure; OS and QoL are secondary outcomes. The trial opened on July 2 and hopes to recruit 358 individuals in Singapore, Australia, Europe, and the United States (Arizona, Illinois, and Texas). .

All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).

Dr. Markman is not involved with any of these trials. He is a regular contributor to Medscape Oncology. He has received income in an amount equal to or greater than $250 from Genentech, AstraZeneca Celgene, Clovis, Amgen.

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

A new tool designed by psychiatrists to help guide nutritional counseling in patients with schizophrenia spectrum disorders (SSD) has been released.

Lisovskaya/ThinkStock

The worksheet and clinician guide were developed using results from a recent scoping review on the relationship between diet and mental health in patients with SSD, and a feedback process involving a focus group with psychiatrists and individuals who had lived experience with psychosis.

“Mental health clinicians already have the training to help our patients make behavioral changes,” lead author Laura LaChance, MD, lecturer, department of psychiatry, and a psychiatrist at St. Mary’s Hospital Centre, McGill University, Montreal, said in an interview.

“We work every day with patients to help them to reduce their substance use, improve their sleep, take medications, etc., and nutrition should be added to the radar [since] eating well for mental health is part of self-care and can be included in mental health treatment plans,” she said.

The paper was published online Nov. 10 in BMC Psychiatry.
 

Nutrition frequently ignored

Dr. LaChance noted that “nutrition is largely absent from mental health training programs and often ignored in clinical practice.”

The investigators “wanted to create a tool to help incorporate basic nutritional counseling into the care of individuals with severe mental illness.” They wanted the tool “to be simple enough to understand for patients and simple enough to use for mental health care professionals who don’t have any official nutrition training.”

The team developed a worksheet that includes dietary recommendations, the majority of which are supported by the scoping review and consistent with Canada’s Food Guide. The review “identified all of the published literature related to the relationship between diet and psychiatric symptoms of SSD,” synthesizing the results of 822 prior articles.

It promotes the addition of nutritious food rather than the restriction of calories or individual foods and does not contradict generally accepted recommendations for weight management. It is suitable for all patients including those with low or normal body mass index and provides psychoeducation about the importance of quality nutrition as a determinant of mental health.
 

Positive tone

The worksheet was informed by social cognitive theory, which “highlights the important role of goal setting and behavior contracting, reinforcement, self-control, social norms, attitudes, and self-efficacy.”

It provides “basic education about important nutrition principles” as well as “very simple recommendations to increase knowledge about healthy eating” and “actionable tips for individuals to incorporate.” The researchers used a “positive” tone and included motivational interviewing questions.

“Delivery of the intervention by the patient’s mental health care provider is by design, in an attempt to address the widely held misbelief that nutrition intervention is of limited importance to mental health care and begin to change norms,” Dr. LaChance said.

The worksheet addresses monetary barriers to healthy eating; offers practical tips to “increase perceived control and self-efficacy”; is written in simple, accessible, nontechnical language; and includes foods from a range of cultural backgrounds.

To ensure that the worksheet and clinical guide met the needs of the target population, the researchers conducted a focus group with five psychiatrists and individual phone interviews with people who live with psychosis (n = 6).

Participants with psychosis were evenly divided between male and female and six age groups were represented: younger than 20 years; 21-30 years; 31-40 years; 41-50 years; 51-50 years; and older than 60 years. Of these participants, half scored in the “limited literacy” range, based on a nutritional literacy assessment tool (the Newest Vital Sign [NVS]).

A revised version of the worksheet, taking participants’ feedback into account, was mailed to all participants, who then provided further feedback on the revised version.


 

‘Unspoken area’

The clinician guide contains not only an overview and a suggested agenda to steer discussion, but also a sample visual representation of the recommended relative proportions of different food categories in an ideal meal as well as sample meals, a budgeting discussion, and a list of goals.

A closing statement encourages the clinician to “keep the messaging positive, celebrate small victories, and provide encouragement.”

Specific dietary recommendations include choosing complex carbohydrates and healthy fats, reducing highly processed foods and sugar, adding vegetables and fruits to meals and snacks, and eating protein-rich foods throughout the day.

A “noteworthy theme” that emerged in discussions with psychiatrists as well as participants with SSD was “the lack of nutrition training in medical education and psychiatric residency and the general absence of nutritional counseling in this field of medicine.”

One participant described nutrition as “definitely an unspoken area” in schizophrenia – especially in institutional settings, where “you are overloaded with sugars, not healthy grain, not complex grain. You get white bread sandwiches, shitty juice.”
 

Powerful tool

Commenting on the paper for this news organization, Uma Naidoo, MD, director of nutritional and lifestyle psychiatry, Massachusetts General Hospital, and a nutrition educator at Harvard Medical School, both in Boston, said she appreciates that this paper “is seeking methods to expand treatment options for those with SSD and improve provider understanding/knowledge of therapeutic foods.”

She called the pilot evaluation “notably small,” but added that it “provides results to suggest that scaling this worksheet/guide may hold promise to better provide nutritional counseling to those with psychiatric illness.”

Dr. Naidoo, also a chef and the author of “This Is Your Brain on Food,” who was not involved in the study said, “I’ve seen the power of food as medicine in my own hospital practice and do believe that food is one of the most powerful tools we have in supporting mental fitness and emotional well-being.”

The project was funded by the Canadian CAM Research Fund. Dr. LaChance and Dr. Naidoo have disclosed no relevant financial relationships.

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

A new tool designed by psychiatrists to help guide nutritional counseling in patients with schizophrenia spectrum disorders (SSD) has been released.

Lisovskaya/ThinkStock

The worksheet and clinician guide were developed using results from a recent scoping review on the relationship between diet and mental health in patients with SSD, and a feedback process involving a focus group with psychiatrists and individuals who had lived experience with psychosis.

“Mental health clinicians already have the training to help our patients make behavioral changes,” lead author Laura LaChance, MD, lecturer, department of psychiatry, and a psychiatrist at St. Mary’s Hospital Centre, McGill University, Montreal, said in an interview.

“We work every day with patients to help them to reduce their substance use, improve their sleep, take medications, etc., and nutrition should be added to the radar [since] eating well for mental health is part of self-care and can be included in mental health treatment plans,” she said.

The paper was published online Nov. 10 in BMC Psychiatry.
 

Nutrition frequently ignored

Dr. LaChance noted that “nutrition is largely absent from mental health training programs and often ignored in clinical practice.”

The investigators “wanted to create a tool to help incorporate basic nutritional counseling into the care of individuals with severe mental illness.” They wanted the tool “to be simple enough to understand for patients and simple enough to use for mental health care professionals who don’t have any official nutrition training.”

The team developed a worksheet that includes dietary recommendations, the majority of which are supported by the scoping review and consistent with Canada’s Food Guide. The review “identified all of the published literature related to the relationship between diet and psychiatric symptoms of SSD,” synthesizing the results of 822 prior articles.

It promotes the addition of nutritious food rather than the restriction of calories or individual foods and does not contradict generally accepted recommendations for weight management. It is suitable for all patients including those with low or normal body mass index and provides psychoeducation about the importance of quality nutrition as a determinant of mental health.
 

Positive tone

The worksheet was informed by social cognitive theory, which “highlights the important role of goal setting and behavior contracting, reinforcement, self-control, social norms, attitudes, and self-efficacy.”

It provides “basic education about important nutrition principles” as well as “very simple recommendations to increase knowledge about healthy eating” and “actionable tips for individuals to incorporate.” The researchers used a “positive” tone and included motivational interviewing questions.

“Delivery of the intervention by the patient’s mental health care provider is by design, in an attempt to address the widely held misbelief that nutrition intervention is of limited importance to mental health care and begin to change norms,” Dr. LaChance said.

The worksheet addresses monetary barriers to healthy eating; offers practical tips to “increase perceived control and self-efficacy”; is written in simple, accessible, nontechnical language; and includes foods from a range of cultural backgrounds.

To ensure that the worksheet and clinical guide met the needs of the target population, the researchers conducted a focus group with five psychiatrists and individual phone interviews with people who live with psychosis (n = 6).

Participants with psychosis were evenly divided between male and female and six age groups were represented: younger than 20 years; 21-30 years; 31-40 years; 41-50 years; 51-50 years; and older than 60 years. Of these participants, half scored in the “limited literacy” range, based on a nutritional literacy assessment tool (the Newest Vital Sign [NVS]).

A revised version of the worksheet, taking participants’ feedback into account, was mailed to all participants, who then provided further feedback on the revised version.


 

‘Unspoken area’

The clinician guide contains not only an overview and a suggested agenda to steer discussion, but also a sample visual representation of the recommended relative proportions of different food categories in an ideal meal as well as sample meals, a budgeting discussion, and a list of goals.

A closing statement encourages the clinician to “keep the messaging positive, celebrate small victories, and provide encouragement.”

Specific dietary recommendations include choosing complex carbohydrates and healthy fats, reducing highly processed foods and sugar, adding vegetables and fruits to meals and snacks, and eating protein-rich foods throughout the day.

A “noteworthy theme” that emerged in discussions with psychiatrists as well as participants with SSD was “the lack of nutrition training in medical education and psychiatric residency and the general absence of nutritional counseling in this field of medicine.”

One participant described nutrition as “definitely an unspoken area” in schizophrenia – especially in institutional settings, where “you are overloaded with sugars, not healthy grain, not complex grain. You get white bread sandwiches, shitty juice.”
 

Powerful tool

Commenting on the paper for this news organization, Uma Naidoo, MD, director of nutritional and lifestyle psychiatry, Massachusetts General Hospital, and a nutrition educator at Harvard Medical School, both in Boston, said she appreciates that this paper “is seeking methods to expand treatment options for those with SSD and improve provider understanding/knowledge of therapeutic foods.”

She called the pilot evaluation “notably small,” but added that it “provides results to suggest that scaling this worksheet/guide may hold promise to better provide nutritional counseling to those with psychiatric illness.”

Dr. Naidoo, also a chef and the author of “This Is Your Brain on Food,” who was not involved in the study said, “I’ve seen the power of food as medicine in my own hospital practice and do believe that food is one of the most powerful tools we have in supporting mental fitness and emotional well-being.”

The project was funded by the Canadian CAM Research Fund. Dr. LaChance and Dr. Naidoo have disclosed no relevant financial relationships.

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

A new tool designed by psychiatrists to help guide nutritional counseling in patients with schizophrenia spectrum disorders (SSD) has been released.

Lisovskaya/ThinkStock

The worksheet and clinician guide were developed using results from a recent scoping review on the relationship between diet and mental health in patients with SSD, and a feedback process involving a focus group with psychiatrists and individuals who had lived experience with psychosis.

“Mental health clinicians already have the training to help our patients make behavioral changes,” lead author Laura LaChance, MD, lecturer, department of psychiatry, and a psychiatrist at St. Mary’s Hospital Centre, McGill University, Montreal, said in an interview.

“We work every day with patients to help them to reduce their substance use, improve their sleep, take medications, etc., and nutrition should be added to the radar [since] eating well for mental health is part of self-care and can be included in mental health treatment plans,” she said.

The paper was published online Nov. 10 in BMC Psychiatry.
 

Nutrition frequently ignored

Dr. LaChance noted that “nutrition is largely absent from mental health training programs and often ignored in clinical practice.”

The investigators “wanted to create a tool to help incorporate basic nutritional counseling into the care of individuals with severe mental illness.” They wanted the tool “to be simple enough to understand for patients and simple enough to use for mental health care professionals who don’t have any official nutrition training.”

The team developed a worksheet that includes dietary recommendations, the majority of which are supported by the scoping review and consistent with Canada’s Food Guide. The review “identified all of the published literature related to the relationship between diet and psychiatric symptoms of SSD,” synthesizing the results of 822 prior articles.

It promotes the addition of nutritious food rather than the restriction of calories or individual foods and does not contradict generally accepted recommendations for weight management. It is suitable for all patients including those with low or normal body mass index and provides psychoeducation about the importance of quality nutrition as a determinant of mental health.
 

Positive tone

The worksheet was informed by social cognitive theory, which “highlights the important role of goal setting and behavior contracting, reinforcement, self-control, social norms, attitudes, and self-efficacy.”

It provides “basic education about important nutrition principles” as well as “very simple recommendations to increase knowledge about healthy eating” and “actionable tips for individuals to incorporate.” The researchers used a “positive” tone and included motivational interviewing questions.

“Delivery of the intervention by the patient’s mental health care provider is by design, in an attempt to address the widely held misbelief that nutrition intervention is of limited importance to mental health care and begin to change norms,” Dr. LaChance said.

The worksheet addresses monetary barriers to healthy eating; offers practical tips to “increase perceived control and self-efficacy”; is written in simple, accessible, nontechnical language; and includes foods from a range of cultural backgrounds.

To ensure that the worksheet and clinical guide met the needs of the target population, the researchers conducted a focus group with five psychiatrists and individual phone interviews with people who live with psychosis (n = 6).

Participants with psychosis were evenly divided between male and female and six age groups were represented: younger than 20 years; 21-30 years; 31-40 years; 41-50 years; 51-50 years; and older than 60 years. Of these participants, half scored in the “limited literacy” range, based on a nutritional literacy assessment tool (the Newest Vital Sign [NVS]).

A revised version of the worksheet, taking participants’ feedback into account, was mailed to all participants, who then provided further feedback on the revised version.


 

‘Unspoken area’

The clinician guide contains not only an overview and a suggested agenda to steer discussion, but also a sample visual representation of the recommended relative proportions of different food categories in an ideal meal as well as sample meals, a budgeting discussion, and a list of goals.

A closing statement encourages the clinician to “keep the messaging positive, celebrate small victories, and provide encouragement.”

Specific dietary recommendations include choosing complex carbohydrates and healthy fats, reducing highly processed foods and sugar, adding vegetables and fruits to meals and snacks, and eating protein-rich foods throughout the day.

A “noteworthy theme” that emerged in discussions with psychiatrists as well as participants with SSD was “the lack of nutrition training in medical education and psychiatric residency and the general absence of nutritional counseling in this field of medicine.”

One participant described nutrition as “definitely an unspoken area” in schizophrenia – especially in institutional settings, where “you are overloaded with sugars, not healthy grain, not complex grain. You get white bread sandwiches, shitty juice.”
 

Powerful tool

Commenting on the paper for this news organization, Uma Naidoo, MD, director of nutritional and lifestyle psychiatry, Massachusetts General Hospital, and a nutrition educator at Harvard Medical School, both in Boston, said she appreciates that this paper “is seeking methods to expand treatment options for those with SSD and improve provider understanding/knowledge of therapeutic foods.”

She called the pilot evaluation “notably small,” but added that it “provides results to suggest that scaling this worksheet/guide may hold promise to better provide nutritional counseling to those with psychiatric illness.”

Dr. Naidoo, also a chef and the author of “This Is Your Brain on Food,” who was not involved in the study said, “I’ve seen the power of food as medicine in my own hospital practice and do believe that food is one of the most powerful tools we have in supporting mental fitness and emotional well-being.”

The project was funded by the Canadian CAM Research Fund. Dr. LaChance and Dr. Naidoo have disclosed no relevant financial relationships.

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

Hypertension is associated with more than a twofold increased risk of developing late-onset epilepsy even in patients who have not had a previous stroke, new research suggests.

After excluding individuals with normal blood pressure who were taking antihypertensive medication, investigators found hypertension was linked to an almost 2.5-fold higher risk of epilepsy.

“Our findings further expand upon our knowledge of the negative effects hypertension has on brain health and, regarding epilepsy, that effect may be starting even in midlife,” said co–lead author Maria Stefanidou, MD, MSc, of Boston University.

“Practicing clinicians should be vigilant to diagnose hypertension, discuss with patients all potential long-term brain health outcomes, and need for treatment. Furthermore, in those presenting with new-onset epilepsy later in life, screening for potentially undiagnosed hypertension should be included in the initial workup,” she said.

The study was published online Nov. 17, 2021, in Epilepsia.
 

Unknown etiology

“New-onset epilepsy risk increases with increasing age over the age of 65 and can affect 15-20 per 1,000 older individuals. Although the most common causes for seizures in this age group are prior history of stroke and presence of dementia, for about 30%-40% of patients, the etiology of seizures remains unknown,” Dr. Stefanidou said.

“We wanted to study if modifiable vascular risk factors that are known to contribute both to vascular brain aging and to neurodegeneration may directly predict the development of epilepsy, even in the absence of clinical stroke or dementia,” she added.

To investigate, the researchers turned to data from participants in the Offspring Cohort of the Framingham Health Study (FHS). The original FHS was an ongoing longitudinal community-based study that first began in 1948. Offspring of the original cohort and their spouses (n = 5,124) were enrolled in the Offspring Cohort in 1971, with surveillance of these second-generation participants based on exam visits occurring every 4 years.

The study included participants who had attended exam 5 (1991-1995), were age 45 years or older, had available vascular risk factor (VRF) data, and available follow-up data on epilepsy status (n = 2,986; mean age, 58 years; 48% male).

The investigators conducted two statistical analyses. In the primary model, they adjusted for age and gender, while in a secondary model they also adjusted for prevalent and interim stroke. They also conducted an analysis that excluded participants treated with antihypertensive medication and had normal blood pressure.
 

Plausible mechanisms

During a mean follow-up of 19.2 years, 55 incident epilepsy cases were identified. The mean age of these patients was 73.8 years.

In the primary model, hypertension was associated with an almost twofold higher risk of developing epilepsy (hazard ratio, 1.97; 95% confidence interval, 1.13-3.45; P = .017).

Interestingly, the Framingham Stroke Risk Profile – a calculation based on an array of factors, including age/sex, systolic blood pressure, antihypertensive therapy, diabetes, history of cardiovascular disease, atrial fibrillation, and cigarette smoking – was not associated with incident epilepsy, and there was no other significant associated between any of the other VRFs when looked at independently.

When the researchers adjusted for prevalent and interim stroke, they continued to find an almost twofold higher risk of developing epilepsy (HR 1.93; 95% CI, 1.10-3.37; P = .022). An analysis that adjusted for competing risk of death obtained similar findings (HR, 1.98; 95% CI, 1.03-3.81; P = .042).

The model that excluded patients receiving antihypertensive treatment, whose blood pressure readings were normal (n = 2,162; 50 incident epilepsy cases) showed an even stronger association (HR, 2.44; 95% CI, 1.36-4.35; P = .003).

“Our results are based on an epidemiological, observational study, therefore our findings point to an association between hypertension and new-onset epilepsy later in life,” said Dr. Stefanidou.

She noted that because it was an observational study, “a cause-effect relationship cannot be established based on these results, but there is growing evidence from our, as well as other, similar cohorts that hypertension, a modifiable vascular risk factor, may indeed be an independent predictor of late-onset epilepsy.”

There are “plausible mechanisms” that support both a direct, and indirect, role of hypertension – for example, through accumulation of small vessel disease in the brain – but further research will be necessary to elucidate the exact mechanisms involved in the process,” she added.
 

‘Welcome addition’

In a joint comment, Hedley C.A. Emsley, PhD, professor of clinical neuroscience, Lancaster (England) University, and Jasmine Wall, MBBChir, academic clinical fellow in neurology, Lancaster University, described the study as a “welcome addition to this field,” noting that the Framingham Heart Study “lends itself well to an embedded observational study of this nature of late-onset epilepsy.”

Dr. Emsley and Dr. Wall, who were not involved in the research, said that the “apparent magnitude of increased late-onset epilepsy risk association with hypertension in the Stefanidou et al study is quite striking,” even allowing for the “relatively small sample size,” since their analysis and findings appear to “withstand exclusion of individuals who became normotensive on antihypertensive treatment.”

They noted that in recent years there has been a growing body of evidence highlighting the importance of hypertension in late-onset epilepsy epileptogenesis with subclinical cerebrovascular diseases, including “otherwise occult cerebral small vessel disease believed to be a frequent cause.”

The mechanisms “remain unclear,” but they could potentially include diffuse cerebral microangiopathy, structural and physiological changes, and/or blood-brain barrier dysfunction and leakage, they suggested.

“Although there is no current consensus over an age threshold that defines ‘late onset,’ we would argue that age thresholds used in such studies of late-onset epilepsy should be lower, to avoid missing younger adults at risk through vascular mechanisms,” Dr. Emsley and Dr. Wall added.

The study authors suggest that “potential pathophysiologic mechanisms can further be explored in future experimental studies and clinical trials.”

This study was funded by grants from the National Institutes of Health and Finding a Cure for Epilepsy/Seizures. Dr. Stefanidou disclosed relevant financial relationships. Dr. Emsley and Dr. Wall disclosed no relevant financial relationships.

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

Hypertension is associated with more than a twofold increased risk of developing late-onset epilepsy even in patients who have not had a previous stroke, new research suggests.

After excluding individuals with normal blood pressure who were taking antihypertensive medication, investigators found hypertension was linked to an almost 2.5-fold higher risk of epilepsy.

“Our findings further expand upon our knowledge of the negative effects hypertension has on brain health and, regarding epilepsy, that effect may be starting even in midlife,” said co–lead author Maria Stefanidou, MD, MSc, of Boston University.

“Practicing clinicians should be vigilant to diagnose hypertension, discuss with patients all potential long-term brain health outcomes, and need for treatment. Furthermore, in those presenting with new-onset epilepsy later in life, screening for potentially undiagnosed hypertension should be included in the initial workup,” she said.

The study was published online Nov. 17, 2021, in Epilepsia.
 

Unknown etiology

“New-onset epilepsy risk increases with increasing age over the age of 65 and can affect 15-20 per 1,000 older individuals. Although the most common causes for seizures in this age group are prior history of stroke and presence of dementia, for about 30%-40% of patients, the etiology of seizures remains unknown,” Dr. Stefanidou said.

“We wanted to study if modifiable vascular risk factors that are known to contribute both to vascular brain aging and to neurodegeneration may directly predict the development of epilepsy, even in the absence of clinical stroke or dementia,” she added.

To investigate, the researchers turned to data from participants in the Offspring Cohort of the Framingham Health Study (FHS). The original FHS was an ongoing longitudinal community-based study that first began in 1948. Offspring of the original cohort and their spouses (n = 5,124) were enrolled in the Offspring Cohort in 1971, with surveillance of these second-generation participants based on exam visits occurring every 4 years.

The study included participants who had attended exam 5 (1991-1995), were age 45 years or older, had available vascular risk factor (VRF) data, and available follow-up data on epilepsy status (n = 2,986; mean age, 58 years; 48% male).

The investigators conducted two statistical analyses. In the primary model, they adjusted for age and gender, while in a secondary model they also adjusted for prevalent and interim stroke. They also conducted an analysis that excluded participants treated with antihypertensive medication and had normal blood pressure.
 

Plausible mechanisms

During a mean follow-up of 19.2 years, 55 incident epilepsy cases were identified. The mean age of these patients was 73.8 years.

In the primary model, hypertension was associated with an almost twofold higher risk of developing epilepsy (hazard ratio, 1.97; 95% confidence interval, 1.13-3.45; P = .017).

Interestingly, the Framingham Stroke Risk Profile – a calculation based on an array of factors, including age/sex, systolic blood pressure, antihypertensive therapy, diabetes, history of cardiovascular disease, atrial fibrillation, and cigarette smoking – was not associated with incident epilepsy, and there was no other significant associated between any of the other VRFs when looked at independently.

When the researchers adjusted for prevalent and interim stroke, they continued to find an almost twofold higher risk of developing epilepsy (HR 1.93; 95% CI, 1.10-3.37; P = .022). An analysis that adjusted for competing risk of death obtained similar findings (HR, 1.98; 95% CI, 1.03-3.81; P = .042).

The model that excluded patients receiving antihypertensive treatment, whose blood pressure readings were normal (n = 2,162; 50 incident epilepsy cases) showed an even stronger association (HR, 2.44; 95% CI, 1.36-4.35; P = .003).

“Our results are based on an epidemiological, observational study, therefore our findings point to an association between hypertension and new-onset epilepsy later in life,” said Dr. Stefanidou.

She noted that because it was an observational study, “a cause-effect relationship cannot be established based on these results, but there is growing evidence from our, as well as other, similar cohorts that hypertension, a modifiable vascular risk factor, may indeed be an independent predictor of late-onset epilepsy.”

There are “plausible mechanisms” that support both a direct, and indirect, role of hypertension – for example, through accumulation of small vessel disease in the brain – but further research will be necessary to elucidate the exact mechanisms involved in the process,” she added.
 

‘Welcome addition’

In a joint comment, Hedley C.A. Emsley, PhD, professor of clinical neuroscience, Lancaster (England) University, and Jasmine Wall, MBBChir, academic clinical fellow in neurology, Lancaster University, described the study as a “welcome addition to this field,” noting that the Framingham Heart Study “lends itself well to an embedded observational study of this nature of late-onset epilepsy.”

Dr. Emsley and Dr. Wall, who were not involved in the research, said that the “apparent magnitude of increased late-onset epilepsy risk association with hypertension in the Stefanidou et al study is quite striking,” even allowing for the “relatively small sample size,” since their analysis and findings appear to “withstand exclusion of individuals who became normotensive on antihypertensive treatment.”

They noted that in recent years there has been a growing body of evidence highlighting the importance of hypertension in late-onset epilepsy epileptogenesis with subclinical cerebrovascular diseases, including “otherwise occult cerebral small vessel disease believed to be a frequent cause.”

The mechanisms “remain unclear,” but they could potentially include diffuse cerebral microangiopathy, structural and physiological changes, and/or blood-brain barrier dysfunction and leakage, they suggested.

“Although there is no current consensus over an age threshold that defines ‘late onset,’ we would argue that age thresholds used in such studies of late-onset epilepsy should be lower, to avoid missing younger adults at risk through vascular mechanisms,” Dr. Emsley and Dr. Wall added.

The study authors suggest that “potential pathophysiologic mechanisms can further be explored in future experimental studies and clinical trials.”

This study was funded by grants from the National Institutes of Health and Finding a Cure for Epilepsy/Seizures. Dr. Stefanidou disclosed relevant financial relationships. Dr. Emsley and Dr. Wall disclosed no relevant financial relationships.

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

Hypertension is associated with more than a twofold increased risk of developing late-onset epilepsy even in patients who have not had a previous stroke, new research suggests.

After excluding individuals with normal blood pressure who were taking antihypertensive medication, investigators found hypertension was linked to an almost 2.5-fold higher risk of epilepsy.

“Our findings further expand upon our knowledge of the negative effects hypertension has on brain health and, regarding epilepsy, that effect may be starting even in midlife,” said co–lead author Maria Stefanidou, MD, MSc, of Boston University.

“Practicing clinicians should be vigilant to diagnose hypertension, discuss with patients all potential long-term brain health outcomes, and need for treatment. Furthermore, in those presenting with new-onset epilepsy later in life, screening for potentially undiagnosed hypertension should be included in the initial workup,” she said.

The study was published online Nov. 17, 2021, in Epilepsia.
 

Unknown etiology

“New-onset epilepsy risk increases with increasing age over the age of 65 and can affect 15-20 per 1,000 older individuals. Although the most common causes for seizures in this age group are prior history of stroke and presence of dementia, for about 30%-40% of patients, the etiology of seizures remains unknown,” Dr. Stefanidou said.

“We wanted to study if modifiable vascular risk factors that are known to contribute both to vascular brain aging and to neurodegeneration may directly predict the development of epilepsy, even in the absence of clinical stroke or dementia,” she added.

To investigate, the researchers turned to data from participants in the Offspring Cohort of the Framingham Health Study (FHS). The original FHS was an ongoing longitudinal community-based study that first began in 1948. Offspring of the original cohort and their spouses (n = 5,124) were enrolled in the Offspring Cohort in 1971, with surveillance of these second-generation participants based on exam visits occurring every 4 years.

The study included participants who had attended exam 5 (1991-1995), were age 45 years or older, had available vascular risk factor (VRF) data, and available follow-up data on epilepsy status (n = 2,986; mean age, 58 years; 48% male).

The investigators conducted two statistical analyses. In the primary model, they adjusted for age and gender, while in a secondary model they also adjusted for prevalent and interim stroke. They also conducted an analysis that excluded participants treated with antihypertensive medication and had normal blood pressure.
 

Plausible mechanisms

During a mean follow-up of 19.2 years, 55 incident epilepsy cases were identified. The mean age of these patients was 73.8 years.

In the primary model, hypertension was associated with an almost twofold higher risk of developing epilepsy (hazard ratio, 1.97; 95% confidence interval, 1.13-3.45; P = .017).

Interestingly, the Framingham Stroke Risk Profile – a calculation based on an array of factors, including age/sex, systolic blood pressure, antihypertensive therapy, diabetes, history of cardiovascular disease, atrial fibrillation, and cigarette smoking – was not associated with incident epilepsy, and there was no other significant associated between any of the other VRFs when looked at independently.

When the researchers adjusted for prevalent and interim stroke, they continued to find an almost twofold higher risk of developing epilepsy (HR 1.93; 95% CI, 1.10-3.37; P = .022). An analysis that adjusted for competing risk of death obtained similar findings (HR, 1.98; 95% CI, 1.03-3.81; P = .042).

The model that excluded patients receiving antihypertensive treatment, whose blood pressure readings were normal (n = 2,162; 50 incident epilepsy cases) showed an even stronger association (HR, 2.44; 95% CI, 1.36-4.35; P = .003).

“Our results are based on an epidemiological, observational study, therefore our findings point to an association between hypertension and new-onset epilepsy later in life,” said Dr. Stefanidou.

She noted that because it was an observational study, “a cause-effect relationship cannot be established based on these results, but there is growing evidence from our, as well as other, similar cohorts that hypertension, a modifiable vascular risk factor, may indeed be an independent predictor of late-onset epilepsy.”

There are “plausible mechanisms” that support both a direct, and indirect, role of hypertension – for example, through accumulation of small vessel disease in the brain – but further research will be necessary to elucidate the exact mechanisms involved in the process,” she added.
 

‘Welcome addition’

In a joint comment, Hedley C.A. Emsley, PhD, professor of clinical neuroscience, Lancaster (England) University, and Jasmine Wall, MBBChir, academic clinical fellow in neurology, Lancaster University, described the study as a “welcome addition to this field,” noting that the Framingham Heart Study “lends itself well to an embedded observational study of this nature of late-onset epilepsy.”

Dr. Emsley and Dr. Wall, who were not involved in the research, said that the “apparent magnitude of increased late-onset epilepsy risk association with hypertension in the Stefanidou et al study is quite striking,” even allowing for the “relatively small sample size,” since their analysis and findings appear to “withstand exclusion of individuals who became normotensive on antihypertensive treatment.”

They noted that in recent years there has been a growing body of evidence highlighting the importance of hypertension in late-onset epilepsy epileptogenesis with subclinical cerebrovascular diseases, including “otherwise occult cerebral small vessel disease believed to be a frequent cause.”

The mechanisms “remain unclear,” but they could potentially include diffuse cerebral microangiopathy, structural and physiological changes, and/or blood-brain barrier dysfunction and leakage, they suggested.

“Although there is no current consensus over an age threshold that defines ‘late onset,’ we would argue that age thresholds used in such studies of late-onset epilepsy should be lower, to avoid missing younger adults at risk through vascular mechanisms,” Dr. Emsley and Dr. Wall added.

The study authors suggest that “potential pathophysiologic mechanisms can further be explored in future experimental studies and clinical trials.”

This study was funded by grants from the National Institutes of Health and Finding a Cure for Epilepsy/Seizures. Dr. Stefanidou disclosed relevant financial relationships. Dr. Emsley and Dr. Wall disclosed no relevant financial relationships.

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

Certain opioids are proving to be effective in treating a variety of itch conditions, according to Brian S. Kim, MD.

“We know that opioids or opiates do cause itch in a significant number of patients,” Dr. Kim, a dermatologist who is codirector of the Center for the Study of Itch & Sensory Disorders at Washington University, St. Louis, said during MedscapeLive’s annual Las Vegas Dermatology Seminar. “It’s thought to do this by way of acting as a pruritogen at times and stimulating sensory neurons [that] then activate the itch cascade. But it’s also been well known that endogenous kappa opioids can activate sensory neurons that can then suppress itch and gate out signals from these opiates, but perhaps other pruritogens as well.”

Multiple drugs differentially target kappa-opioid receptor (KOR) and mu-opioid receptor (MOR) pathways, he continued. For example, oral naltrexone is a MOR antagonist, oral nalfurafine and intravenous difelikefalin are KOR agonists, while intranasal butorphanol and oral nalbuphine have a dual mechanism.

Difelikefalin is the first Food and Drug Administration–approved treatment for uremic pruritus associated with dialysis, approved in August 2021 for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis; it is administered intravenously. During the 2021 annual congress of the European Academy of Dermatology and Venereology, Dr. Kim and colleagues presented findings from a phase 2 trial of 401 people with atopic dermatitis (AD) and moderate to severe pruritus, who were randomized to receive oral difelikefalin at a dose of 0.25 mg, 0.5 mg, or 1.0 mg, or placebo over a 12-week treatment period. The primary endpoint, change from baseline in Itch Numerical Rating Scale score, was not met in any of the difelikefalin dose groups in the overall study population, but patients with a body surface area of less than 10% experienced a significant improvement in itch at week 12 in the combined difelikefalin dose group in (P = .039). A significant reduction in itch with difelikefalin was seen in this group of patients with itch-dominant AD, as early as the second day of treatment.

In another trial, 373 hemodialysis patients with moderate or severe uremic pruritus were randomized in a 1: 1:1 ratio to nalbuphine extended-release tablets 120 mg, 60 mg, or placebo and treated for 8 weeks. The researchers found that nalbuphine 120 mg significantly reduced the itching intensity. Specifically, from a baseline numerical rate scale (NRS) of 6.9, the mean NRS declined by 3.5 and by 2.8 in the nalbuphine 120-mg and the placebo groups, respectively (P = .017).

In a separate, unpublished multicenter, randomized, phase 2/3 trial, researchers evaluated the safety and antipruritic efficacy of nalbuphine extended-release tablets dosed twice daily at 90 mg and 180 mg in 62 patients in the United States and Europe. The proportion of patients in the nalbuphine 180-mg arm who met 50% responder criteria at week 10 or last observed visit approached statistical significance (P = .083), and this arm met statistical significance for patients who completed treatment (P = .028).

Dr. Kim disclosed that he has served as a consultant for AbbVie, AstraZeneca, Cara Therapeutics, Galderma, GlaxoSmithKline, LEO Pharma, Lilly, Pfizer, Regeneron, Sanofi, Trevi Therapeutics. He also has conducted contracted research for Cara Therapeutics and LEO Pharma.

MedscapeLive and this news organization are owned by the same parent company.

[email protected]

Certain opioids are proving to be effective in treating a variety of itch conditions, according to Brian S. Kim, MD.

“We know that opioids or opiates do cause itch in a significant number of patients,” Dr. Kim, a dermatologist who is codirector of the Center for the Study of Itch & Sensory Disorders at Washington University, St. Louis, said during MedscapeLive’s annual Las Vegas Dermatology Seminar. “It’s thought to do this by way of acting as a pruritogen at times and stimulating sensory neurons [that] then activate the itch cascade. But it’s also been well known that endogenous kappa opioids can activate sensory neurons that can then suppress itch and gate out signals from these opiates, but perhaps other pruritogens as well.”

Multiple drugs differentially target kappa-opioid receptor (KOR) and mu-opioid receptor (MOR) pathways, he continued. For example, oral naltrexone is a MOR antagonist, oral nalfurafine and intravenous difelikefalin are KOR agonists, while intranasal butorphanol and oral nalbuphine have a dual mechanism.

Difelikefalin is the first Food and Drug Administration–approved treatment for uremic pruritus associated with dialysis, approved in August 2021 for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis; it is administered intravenously. During the 2021 annual congress of the European Academy of Dermatology and Venereology, Dr. Kim and colleagues presented findings from a phase 2 trial of 401 people with atopic dermatitis (AD) and moderate to severe pruritus, who were randomized to receive oral difelikefalin at a dose of 0.25 mg, 0.5 mg, or 1.0 mg, or placebo over a 12-week treatment period. The primary endpoint, change from baseline in Itch Numerical Rating Scale score, was not met in any of the difelikefalin dose groups in the overall study population, but patients with a body surface area of less than 10% experienced a significant improvement in itch at week 12 in the combined difelikefalin dose group in (P = .039). A significant reduction in itch with difelikefalin was seen in this group of patients with itch-dominant AD, as early as the second day of treatment.

In another trial, 373 hemodialysis patients with moderate or severe uremic pruritus were randomized in a 1: 1:1 ratio to nalbuphine extended-release tablets 120 mg, 60 mg, or placebo and treated for 8 weeks. The researchers found that nalbuphine 120 mg significantly reduced the itching intensity. Specifically, from a baseline numerical rate scale (NRS) of 6.9, the mean NRS declined by 3.5 and by 2.8 in the nalbuphine 120-mg and the placebo groups, respectively (P = .017).

In a separate, unpublished multicenter, randomized, phase 2/3 trial, researchers evaluated the safety and antipruritic efficacy of nalbuphine extended-release tablets dosed twice daily at 90 mg and 180 mg in 62 patients in the United States and Europe. The proportion of patients in the nalbuphine 180-mg arm who met 50% responder criteria at week 10 or last observed visit approached statistical significance (P = .083), and this arm met statistical significance for patients who completed treatment (P = .028).

Dr. Kim disclosed that he has served as a consultant for AbbVie, AstraZeneca, Cara Therapeutics, Galderma, GlaxoSmithKline, LEO Pharma, Lilly, Pfizer, Regeneron, Sanofi, Trevi Therapeutics. He also has conducted contracted research for Cara Therapeutics and LEO Pharma.

MedscapeLive and this news organization are owned by the same parent company.

[email protected]

Certain opioids are proving to be effective in treating a variety of itch conditions, according to Brian S. Kim, MD.

“We know that opioids or opiates do cause itch in a significant number of patients,” Dr. Kim, a dermatologist who is codirector of the Center for the Study of Itch & Sensory Disorders at Washington University, St. Louis, said during MedscapeLive’s annual Las Vegas Dermatology Seminar. “It’s thought to do this by way of acting as a pruritogen at times and stimulating sensory neurons [that] then activate the itch cascade. But it’s also been well known that endogenous kappa opioids can activate sensory neurons that can then suppress itch and gate out signals from these opiates, but perhaps other pruritogens as well.”

Multiple drugs differentially target kappa-opioid receptor (KOR) and mu-opioid receptor (MOR) pathways, he continued. For example, oral naltrexone is a MOR antagonist, oral nalfurafine and intravenous difelikefalin are KOR agonists, while intranasal butorphanol and oral nalbuphine have a dual mechanism.

Difelikefalin is the first Food and Drug Administration–approved treatment for uremic pruritus associated with dialysis, approved in August 2021 for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis; it is administered intravenously. During the 2021 annual congress of the European Academy of Dermatology and Venereology, Dr. Kim and colleagues presented findings from a phase 2 trial of 401 people with atopic dermatitis (AD) and moderate to severe pruritus, who were randomized to receive oral difelikefalin at a dose of 0.25 mg, 0.5 mg, or 1.0 mg, or placebo over a 12-week treatment period. The primary endpoint, change from baseline in Itch Numerical Rating Scale score, was not met in any of the difelikefalin dose groups in the overall study population, but patients with a body surface area of less than 10% experienced a significant improvement in itch at week 12 in the combined difelikefalin dose group in (P = .039). A significant reduction in itch with difelikefalin was seen in this group of patients with itch-dominant AD, as early as the second day of treatment.

In another trial, 373 hemodialysis patients with moderate or severe uremic pruritus were randomized in a 1: 1:1 ratio to nalbuphine extended-release tablets 120 mg, 60 mg, or placebo and treated for 8 weeks. The researchers found that nalbuphine 120 mg significantly reduced the itching intensity. Specifically, from a baseline numerical rate scale (NRS) of 6.9, the mean NRS declined by 3.5 and by 2.8 in the nalbuphine 120-mg and the placebo groups, respectively (P = .017).

In a separate, unpublished multicenter, randomized, phase 2/3 trial, researchers evaluated the safety and antipruritic efficacy of nalbuphine extended-release tablets dosed twice daily at 90 mg and 180 mg in 62 patients in the United States and Europe. The proportion of patients in the nalbuphine 180-mg arm who met 50% responder criteria at week 10 or last observed visit approached statistical significance (P = .083), and this arm met statistical significance for patients who completed treatment (P = .028).

Dr. Kim disclosed that he has served as a consultant for AbbVie, AstraZeneca, Cara Therapeutics, Galderma, GlaxoSmithKline, LEO Pharma, Lilly, Pfizer, Regeneron, Sanofi, Trevi Therapeutics. He also has conducted contracted research for Cara Therapeutics and LEO Pharma.

MedscapeLive and this news organization are owned by the same parent company.

[email protected]