Clinician Reviews

One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.

The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.

The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.

By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.

The study was published online in JAMA Cardiology.

The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.

For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.

“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.

“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.

“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.

After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.

The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.

Risk higher with vaccination than infection?

For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.

Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.

Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.

“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”

The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.

“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.

The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.

“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.

Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions. 

But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.

Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.

What to advise patients?

In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.

They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.

They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.

“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.

But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.

The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.

“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.

Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.

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

One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.

The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.

The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.

By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.

The study was published online in JAMA Cardiology.

The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.

For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.

“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.

“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.

“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.

After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.

The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.

Risk higher with vaccination than infection?

For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.

Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.

Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.

“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”

The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.

“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.

The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.

“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.

Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions. 

But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.

Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.

What to advise patients?

In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.

They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.

They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.

“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.

But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.

The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.

“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.

Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.

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

One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.

The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.

The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.

By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.

The study was published online in JAMA Cardiology.

The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.

For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.

“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.

“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.

“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.

After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.

The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.

Risk higher with vaccination than infection?

For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.

Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.

Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.

“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”

The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.

“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.

The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.

“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.

Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions. 

But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.

Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.

What to advise patients?

In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.

They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.

They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.

“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.

But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.

The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.

“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.

Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.

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

More than 50% of obese adolescents met criteria for depression, which also was associated with several components of metabolic syndrome, based on data from 160 individuals.

Previous research shows that the metabolic consequences of obesity are worsened with the coexistence of depression in adults, but a similar relationship in obese adolescents has not been explored, according to Nisha Gupta, a medical student at the University of Texas Health Science Center, Houston, and colleagues.

“This relationship is explained by an overactive stress response and adoption of unhealthy lifestyle habits,” both of which increased during the COVID-19 pandemic, the researchers noted in their abstract.

In a study presented at the Pediatric Academic Societies annual meeting, the researchers reviewed data from 160 obese adolescents seen at a pediatric weight management clinic between July 1, 2018, and Dec. 3, 2021. The data included anthropometric, clinical, and laboratory information. Depression was assessed using the Patient Health Questionnaire–9 (PHQ-9). The goal of the study was to compare the prevalence of metabolic syndrome components in obese youth with and without diagnosed depression.

Overall, 46% of the patients had PHQ-9 scores less than 5, which was defined as no clinically significant depression. A total of 26% had current or prior diagnoses of depression, and 25% met the criteria for moderate to severe depression, with PHQ-9 scores of 10 or higher. Notably, 18% of individuals with no prior history of depression met criteria for moderate to severe depression, the researchers wrote.

Teens who reported daytime fatigue or trouble sleeping, and those who reported eating out seven or more times a week had higher scores than those without these reports.

In laboratory analyses, higher PHQ-9 scores were significantly associated with increasing weight, body mass index, body fat percentage, diastolic blood pressure, and fasting blood insulin (P < .02 for all).

The study findings were limited by the relatively small sample size, the researchers noted. However, the results suggest that depression is common, but often underdiagnosed in obese adolescents, and depression screening should be part of obesity management.
 

Study highlights need to screen

The current study is important because of the overall increase in obesity in the United States, which extends to children and teens, Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.

“With skyrocketing rates of obesity among children and teens over the last decades, we are seeing more ‘adult’ diseases seep into the younger ages, including type 2 diabetes, high blood pressure and now, depression,” he said.

“The results are a wake-up call for the need for better system-wide prevention and management of obesity in adolescents and the importance of screening and managing depression in obese teenagers,” he emphasized.

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

More than 50% of obese adolescents met criteria for depression, which also was associated with several components of metabolic syndrome, based on data from 160 individuals.

Previous research shows that the metabolic consequences of obesity are worsened with the coexistence of depression in adults, but a similar relationship in obese adolescents has not been explored, according to Nisha Gupta, a medical student at the University of Texas Health Science Center, Houston, and colleagues.

“This relationship is explained by an overactive stress response and adoption of unhealthy lifestyle habits,” both of which increased during the COVID-19 pandemic, the researchers noted in their abstract.

In a study presented at the Pediatric Academic Societies annual meeting, the researchers reviewed data from 160 obese adolescents seen at a pediatric weight management clinic between July 1, 2018, and Dec. 3, 2021. The data included anthropometric, clinical, and laboratory information. Depression was assessed using the Patient Health Questionnaire–9 (PHQ-9). The goal of the study was to compare the prevalence of metabolic syndrome components in obese youth with and without diagnosed depression.

Overall, 46% of the patients had PHQ-9 scores less than 5, which was defined as no clinically significant depression. A total of 26% had current or prior diagnoses of depression, and 25% met the criteria for moderate to severe depression, with PHQ-9 scores of 10 or higher. Notably, 18% of individuals with no prior history of depression met criteria for moderate to severe depression, the researchers wrote.

Teens who reported daytime fatigue or trouble sleeping, and those who reported eating out seven or more times a week had higher scores than those without these reports.

In laboratory analyses, higher PHQ-9 scores were significantly associated with increasing weight, body mass index, body fat percentage, diastolic blood pressure, and fasting blood insulin (P < .02 for all).

The study findings were limited by the relatively small sample size, the researchers noted. However, the results suggest that depression is common, but often underdiagnosed in obese adolescents, and depression screening should be part of obesity management.
 

Study highlights need to screen

The current study is important because of the overall increase in obesity in the United States, which extends to children and teens, Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.

“With skyrocketing rates of obesity among children and teens over the last decades, we are seeing more ‘adult’ diseases seep into the younger ages, including type 2 diabetes, high blood pressure and now, depression,” he said.

“The results are a wake-up call for the need for better system-wide prevention and management of obesity in adolescents and the importance of screening and managing depression in obese teenagers,” he emphasized.

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

More than 50% of obese adolescents met criteria for depression, which also was associated with several components of metabolic syndrome, based on data from 160 individuals.

Previous research shows that the metabolic consequences of obesity are worsened with the coexistence of depression in adults, but a similar relationship in obese adolescents has not been explored, according to Nisha Gupta, a medical student at the University of Texas Health Science Center, Houston, and colleagues.

“This relationship is explained by an overactive stress response and adoption of unhealthy lifestyle habits,” both of which increased during the COVID-19 pandemic, the researchers noted in their abstract.

In a study presented at the Pediatric Academic Societies annual meeting, the researchers reviewed data from 160 obese adolescents seen at a pediatric weight management clinic between July 1, 2018, and Dec. 3, 2021. The data included anthropometric, clinical, and laboratory information. Depression was assessed using the Patient Health Questionnaire–9 (PHQ-9). The goal of the study was to compare the prevalence of metabolic syndrome components in obese youth with and without diagnosed depression.

Overall, 46% of the patients had PHQ-9 scores less than 5, which was defined as no clinically significant depression. A total of 26% had current or prior diagnoses of depression, and 25% met the criteria for moderate to severe depression, with PHQ-9 scores of 10 or higher. Notably, 18% of individuals with no prior history of depression met criteria for moderate to severe depression, the researchers wrote.

Teens who reported daytime fatigue or trouble sleeping, and those who reported eating out seven or more times a week had higher scores than those without these reports.

In laboratory analyses, higher PHQ-9 scores were significantly associated with increasing weight, body mass index, body fat percentage, diastolic blood pressure, and fasting blood insulin (P < .02 for all).

The study findings were limited by the relatively small sample size, the researchers noted. However, the results suggest that depression is common, but often underdiagnosed in obese adolescents, and depression screening should be part of obesity management.
 

Study highlights need to screen

The current study is important because of the overall increase in obesity in the United States, which extends to children and teens, Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.

“With skyrocketing rates of obesity among children and teens over the last decades, we are seeing more ‘adult’ diseases seep into the younger ages, including type 2 diabetes, high blood pressure and now, depression,” he said.

“The results are a wake-up call for the need for better system-wide prevention and management of obesity in adolescents and the importance of screening and managing depression in obese teenagers,” he emphasized.

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

A small new study of women suggests that adopting a low-fat vegan diet and then eliminating remaining trigger foods may dramatically reduce symptoms of rheumatoid arthritis (RA) within months. After 16 weeks, the mean Disease Activity Score in 28 joints (DAS28) decreased from 4.5 to 2.5 (P < .001), and the mean number of swollen joints dipped from 7.0 to 3.3 (P = .03).

The study was published in the American Journal of Lifestyle Medicine. It’s not clear whether the vegan diet or the restriction of trigger foods – or both or neither – was helpful. Significant weight loss in the diet group could have played a role in reducing symptoms.

galitskaya / iStock / Getty Images

Still, the dietary strategy is “a life-changing experience for people,” lead author Neal D. Barnard, MD, an internal medicine specialist and adjunct professor of medicine at George Washington University, Washington, D.C, and president of the Physicians Committee for Responsible Medicine, said in an interview. “Doctors should know about it, and they should try it themselves.”

The researchers launched the study to determine the feasibility of a “practical and easy-to-prescribe diet” without caloric limits, Dr. Barnard said. “People have done a variety of studies where they’ve looked at diet changes, often with fasting, and the quality has been variable.”

There’s no consensus in the medical literature on which dietary approach is best for patients with RA. A 2021 systematic review by Philippa and colleagues found positive results for the Mediterranean diet, high doses of omega-3 fatty acids, vitamin D supplementation, and sodium restriction. Fasting had significant but temporary effects, and the reviewers noted “outcomes from vegetarian, elimination, peptide, or elemental diets suggested that responses are very individualized.”

For the new randomized, crossover study, researchers assigned 44 women to one of two diet phases. After 16 weeks, they had a 4-week washout period, then began the other 16-week phase. A total of 32 patients completed the study, and they had a mean age of 57 years. Overall, 66% were White, 16% were Black, and 79% held a college degree or graduate degree.

In the 16-week intervention phase, participants went on a low-fat vegan diet. After 4 weeks, they eliminated common RA trigger foods such as grains with gluten, nuts, citrus fruits, and chocolate. After week 7, the subjects added back the trigger foods one by one, keeping them in their diet if they didn’t seem to cause pain.

In the 16-week placebo phase, the women took a supplement that they were told contained omega-3 oils and vitamin E. However, the amounts of omega-3 and vitamin E were very low and had no apparent effect.

Participants in the diet phase attended weekly 1-hour dietary support-group sessions. Thirty-two women completed the full study.

Average DAS28 scores fell in the diet phase, compared with the supplement phase (treatment effect, 1.8 [95% confidence interval [CI], 3.2 to 0.4]; P = .01), as did swollen joints (treatment effect, –4.2 [95% CI, –8.3 to –0.1], P = .047).

While the researchers reported dips in the DAS28 score and swollen joints, “the reductions in the number of painful and tender joints did not reach statistical significance (treatment effects, –4.1 [95% CI, –8.7 to +0.5]; P = .08; and –1.8 [95% CI, –5.5 to +1.9]; P = .41, respectively).”

Mean body weight fell by 6.5 kg among those in the diet group, while those in the placebo group gained 0.8 kg (treatment effect, –7.3 kg [95% CI, –9.4 to –5.1]; P < .001).

The researchers noted “the presumed mechanisms by which diets such [as this intervention strategy] reduce joint symptoms relate to the removal of inflammatory elements of an omnivorous diet, the presence of anti-inflammatory constituents in a plant-based diet, and diet-induced reductions in gut permeability that may, in turn, reduce the passage of antigens into circulation.”

Patients tolerate the diet well, Dr. Barnard said. “It’s practical for day-to-day life, and you don’t have to check into a fasting hospital.”

Elliott O’Donovan Photography

The message for physicians, he said, is to encourage patients to try changing their eating patterns before turning to medication. “It’s a good idea for anyone to have a chance to try a diet change,” he said. “You’ll know within a matter of weeks whether it will work.”

Vegan diets are also cheaper than diets with meat and dairy, he added.

The study has various limitations. It began with 44 participants, but 12 failed to complete it for various reasons. Four participants who were assigned to the diet phase first refused to resume their regular diets during the next phase. It’s not clear if the lost weight is most responsible for the diet’s benefits, Harvard Medical School rheumatologist Daniel H. Solomon, MD, MPH, said in an interview. In his review of the study findings, Dr. Solomon said that another possibility is that certain aspects of the diet – and not the full diet – were responsible.

A small new study of women suggests that adopting a low-fat vegan diet and then eliminating remaining trigger foods may dramatically reduce symptoms of rheumatoid arthritis (RA) within months. After 16 weeks, the mean Disease Activity Score in 28 joints (DAS28) decreased from 4.5 to 2.5 (P < .001), and the mean number of swollen joints dipped from 7.0 to 3.3 (P = .03).

The study was published in the American Journal of Lifestyle Medicine. It’s not clear whether the vegan diet or the restriction of trigger foods – or both or neither – was helpful. Significant weight loss in the diet group could have played a role in reducing symptoms.

galitskaya / iStock / Getty Images

Still, the dietary strategy is “a life-changing experience for people,” lead author Neal D. Barnard, MD, an internal medicine specialist and adjunct professor of medicine at George Washington University, Washington, D.C, and president of the Physicians Committee for Responsible Medicine, said in an interview. “Doctors should know about it, and they should try it themselves.”

The researchers launched the study to determine the feasibility of a “practical and easy-to-prescribe diet” without caloric limits, Dr. Barnard said. “People have done a variety of studies where they’ve looked at diet changes, often with fasting, and the quality has been variable.”

There’s no consensus in the medical literature on which dietary approach is best for patients with RA. A 2021 systematic review by Philippa and colleagues found positive results for the Mediterranean diet, high doses of omega-3 fatty acids, vitamin D supplementation, and sodium restriction. Fasting had significant but temporary effects, and the reviewers noted “outcomes from vegetarian, elimination, peptide, or elemental diets suggested that responses are very individualized.”

For the new randomized, crossover study, researchers assigned 44 women to one of two diet phases. After 16 weeks, they had a 4-week washout period, then began the other 16-week phase. A total of 32 patients completed the study, and they had a mean age of 57 years. Overall, 66% were White, 16% were Black, and 79% held a college degree or graduate degree.

In the 16-week intervention phase, participants went on a low-fat vegan diet. After 4 weeks, they eliminated common RA trigger foods such as grains with gluten, nuts, citrus fruits, and chocolate. After week 7, the subjects added back the trigger foods one by one, keeping them in their diet if they didn’t seem to cause pain.

In the 16-week placebo phase, the women took a supplement that they were told contained omega-3 oils and vitamin E. However, the amounts of omega-3 and vitamin E were very low and had no apparent effect.

Participants in the diet phase attended weekly 1-hour dietary support-group sessions. Thirty-two women completed the full study.

Average DAS28 scores fell in the diet phase, compared with the supplement phase (treatment effect, 1.8 [95% confidence interval [CI], 3.2 to 0.4]; P = .01), as did swollen joints (treatment effect, –4.2 [95% CI, –8.3 to –0.1], P = .047).

While the researchers reported dips in the DAS28 score and swollen joints, “the reductions in the number of painful and tender joints did not reach statistical significance (treatment effects, –4.1 [95% CI, –8.7 to +0.5]; P = .08; and –1.8 [95% CI, –5.5 to +1.9]; P = .41, respectively).”

Mean body weight fell by 6.5 kg among those in the diet group, while those in the placebo group gained 0.8 kg (treatment effect, –7.3 kg [95% CI, –9.4 to –5.1]; P < .001).

The researchers noted “the presumed mechanisms by which diets such [as this intervention strategy] reduce joint symptoms relate to the removal of inflammatory elements of an omnivorous diet, the presence of anti-inflammatory constituents in a plant-based diet, and diet-induced reductions in gut permeability that may, in turn, reduce the passage of antigens into circulation.”

Patients tolerate the diet well, Dr. Barnard said. “It’s practical for day-to-day life, and you don’t have to check into a fasting hospital.”

Elliott O’Donovan Photography

The message for physicians, he said, is to encourage patients to try changing their eating patterns before turning to medication. “It’s a good idea for anyone to have a chance to try a diet change,” he said. “You’ll know within a matter of weeks whether it will work.”

Vegan diets are also cheaper than diets with meat and dairy, he added.

The study has various limitations. It began with 44 participants, but 12 failed to complete it for various reasons. Four participants who were assigned to the diet phase first refused to resume their regular diets during the next phase. It’s not clear if the lost weight is most responsible for the diet’s benefits, Harvard Medical School rheumatologist Daniel H. Solomon, MD, MPH, said in an interview. In his review of the study findings, Dr. Solomon said that another possibility is that certain aspects of the diet – and not the full diet – were responsible.

A small new study of women suggests that adopting a low-fat vegan diet and then eliminating remaining trigger foods may dramatically reduce symptoms of rheumatoid arthritis (RA) within months. After 16 weeks, the mean Disease Activity Score in 28 joints (DAS28) decreased from 4.5 to 2.5 (P < .001), and the mean number of swollen joints dipped from 7.0 to 3.3 (P = .03).

The study was published in the American Journal of Lifestyle Medicine. It’s not clear whether the vegan diet or the restriction of trigger foods – or both or neither – was helpful. Significant weight loss in the diet group could have played a role in reducing symptoms.

galitskaya / iStock / Getty Images

Still, the dietary strategy is “a life-changing experience for people,” lead author Neal D. Barnard, MD, an internal medicine specialist and adjunct professor of medicine at George Washington University, Washington, D.C, and president of the Physicians Committee for Responsible Medicine, said in an interview. “Doctors should know about it, and they should try it themselves.”

The researchers launched the study to determine the feasibility of a “practical and easy-to-prescribe diet” without caloric limits, Dr. Barnard said. “People have done a variety of studies where they’ve looked at diet changes, often with fasting, and the quality has been variable.”

There’s no consensus in the medical literature on which dietary approach is best for patients with RA. A 2021 systematic review by Philippa and colleagues found positive results for the Mediterranean diet, high doses of omega-3 fatty acids, vitamin D supplementation, and sodium restriction. Fasting had significant but temporary effects, and the reviewers noted “outcomes from vegetarian, elimination, peptide, or elemental diets suggested that responses are very individualized.”

For the new randomized, crossover study, researchers assigned 44 women to one of two diet phases. After 16 weeks, they had a 4-week washout period, then began the other 16-week phase. A total of 32 patients completed the study, and they had a mean age of 57 years. Overall, 66% were White, 16% were Black, and 79% held a college degree or graduate degree.

In the 16-week intervention phase, participants went on a low-fat vegan diet. After 4 weeks, they eliminated common RA trigger foods such as grains with gluten, nuts, citrus fruits, and chocolate. After week 7, the subjects added back the trigger foods one by one, keeping them in their diet if they didn’t seem to cause pain.

In the 16-week placebo phase, the women took a supplement that they were told contained omega-3 oils and vitamin E. However, the amounts of omega-3 and vitamin E were very low and had no apparent effect.

Participants in the diet phase attended weekly 1-hour dietary support-group sessions. Thirty-two women completed the full study.

Average DAS28 scores fell in the diet phase, compared with the supplement phase (treatment effect, 1.8 [95% confidence interval [CI], 3.2 to 0.4]; P = .01), as did swollen joints (treatment effect, –4.2 [95% CI, –8.3 to –0.1], P = .047).

While the researchers reported dips in the DAS28 score and swollen joints, “the reductions in the number of painful and tender joints did not reach statistical significance (treatment effects, –4.1 [95% CI, –8.7 to +0.5]; P = .08; and –1.8 [95% CI, –5.5 to +1.9]; P = .41, respectively).”

Mean body weight fell by 6.5 kg among those in the diet group, while those in the placebo group gained 0.8 kg (treatment effect, –7.3 kg [95% CI, –9.4 to –5.1]; P < .001).

The researchers noted “the presumed mechanisms by which diets such [as this intervention strategy] reduce joint symptoms relate to the removal of inflammatory elements of an omnivorous diet, the presence of anti-inflammatory constituents in a plant-based diet, and diet-induced reductions in gut permeability that may, in turn, reduce the passage of antigens into circulation.”

Patients tolerate the diet well, Dr. Barnard said. “It’s practical for day-to-day life, and you don’t have to check into a fasting hospital.”

Elliott O’Donovan Photography

The message for physicians, he said, is to encourage patients to try changing their eating patterns before turning to medication. “It’s a good idea for anyone to have a chance to try a diet change,” he said. “You’ll know within a matter of weeks whether it will work.”

Vegan diets are also cheaper than diets with meat and dairy, he added.

The study has various limitations. It began with 44 participants, but 12 failed to complete it for various reasons. Four participants who were assigned to the diet phase first refused to resume their regular diets during the next phase. It’s not clear if the lost weight is most responsible for the diet’s benefits, Harvard Medical School rheumatologist Daniel H. Solomon, MD, MPH, said in an interview. In his review of the study findings, Dr. Solomon said that another possibility is that certain aspects of the diet – and not the full diet – were responsible.

The Centers for Disease Control and Prevention is considering what to tell the public about second booster shots with mRNA vaccinations for COVID-19.

The U.S. Food and Drug Administration in March authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people aged 50 and older and certain immunocompromised adults, even though many top infectious disease experts questioned the need before the agency’s decision.

In a meeting April 20, the CDC asked its Advisory Committee on Immunization Practices to discuss second booster shots, but did not ask the group of experts to vote on formal recommendations.

Instead, the experts talked about the potential timing of additional COVID-19 vaccines for those who already have had three shots, and challenges for vaccination efforts that likely will arise as the pandemic persists.

ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, said she’s concerned about the potential for “booster fatigue.”

“A vaccination program that’s going to require boosting large proportions of the population every 4-6 months is really not sustainable and probably not something that most people want to participate in,” she said.

The benefit of additional COVID-19 shots for now appears to be smaller than what people get from the initial doses, Dr. Bell said.

Earlier in the meeting, CDC staff presented estimates about how well the COVID-19 vaccines work to prevent one case of hospitalization from the disease over 4 months among people aged 50 and older.

The major gain in preventing hospitalizations occurs with the first vaccination series and then wanes, the CDC said.

It appears that one hospitalization is prevented for every 135 people who get the first round of COVID-19 vaccinations. But it takes 674 people getting a first booster dose to prevent one hospitalization. A second booster prevents one hospitalization for every 1,205 people vaccinated.

Dr. Bell said she’s concerned about considering additional doses for “smaller and smaller return and creating an impression that we don’t have a very effective vaccination program,” even though the CDC’s data show a clear benefit.
 

Reasons to get a second booster

Elisha Hall, PhD, RD, of the CDC presented slides with some factors to help determine the urgency for a person to get a second booster:

• Having certain underlying medical conditions that increase the risk of severe COVID-19 illness.
• Being moderately or severely immunocompromised.
• Living with someone who is immunocompromised, at increased risk for severe disease, or who cannot be vaccinated because of age or contraindication.
• Being at increased risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as through occupational, institutional, or other activities (e.g., travel or large gatherings).
• Living or working in an area where there is a medium or high level of COVID-19 in the community.

In contrast, people might want to wait if they had been infected with SARS-CoV-2 within the past 3 months, Dr. Hall said in her presentation. Another reason for delay might be a concern that a booster dose may be more important later in the year.

The experts also addressed public confusion over boosters. For the Pfizer and Moderna mRNA vaccines, a second booster is a fourth dose, but for those who received the one-shot J&J vaccine, the second booster is a third dose.

Going forward, it may be easier to refer to subsequent doses as “annual boosters,” the CDC’s Sara Oliver, MD, MSPH, told the panel. It will be important to keep language about subsequent vaccinations clear and easy for the public to follow, she said.

Dr. Oliver also said there’s already been a drop-off in the acceptance of second rounds of COVID-19 vaccinations. CDC data show that 77% of people in the United States have had at least one dose of a COVID-19 vaccine, but only 66% of the population is fully vaccinated, and only 45% have had a first booster dose.

In her presentation, Dr. Oliver said the top priority in COVID-19 vaccination efforts remains initial vaccinations for people who haven’t gotten them.
 

Kids younger than 5

During the public comment session of the CDC meeting, several people called on the FDA to move quickly to expand authorization of COVID-19 vaccines to children aged 5 years and younger.

“We know that many parents and caregivers and health care providers are anxious to have COVID vaccines available” for young children, said Doran Fink, MD, PhD, a deputy director of the FDA’s vaccines division.

He said the agency is working to be ready to authorize the shots for young children while it awaits research results from the manufacturers.

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

The Centers for Disease Control and Prevention is considering what to tell the public about second booster shots with mRNA vaccinations for COVID-19.

The U.S. Food and Drug Administration in March authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people aged 50 and older and certain immunocompromised adults, even though many top infectious disease experts questioned the need before the agency’s decision.

In a meeting April 20, the CDC asked its Advisory Committee on Immunization Practices to discuss second booster shots, but did not ask the group of experts to vote on formal recommendations.

Instead, the experts talked about the potential timing of additional COVID-19 vaccines for those who already have had three shots, and challenges for vaccination efforts that likely will arise as the pandemic persists.

ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, said she’s concerned about the potential for “booster fatigue.”

“A vaccination program that’s going to require boosting large proportions of the population every 4-6 months is really not sustainable and probably not something that most people want to participate in,” she said.

The benefit of additional COVID-19 shots for now appears to be smaller than what people get from the initial doses, Dr. Bell said.

Earlier in the meeting, CDC staff presented estimates about how well the COVID-19 vaccines work to prevent one case of hospitalization from the disease over 4 months among people aged 50 and older.

The major gain in preventing hospitalizations occurs with the first vaccination series and then wanes, the CDC said.

It appears that one hospitalization is prevented for every 135 people who get the first round of COVID-19 vaccinations. But it takes 674 people getting a first booster dose to prevent one hospitalization. A second booster prevents one hospitalization for every 1,205 people vaccinated.

Dr. Bell said she’s concerned about considering additional doses for “smaller and smaller return and creating an impression that we don’t have a very effective vaccination program,” even though the CDC’s data show a clear benefit.
 

Reasons to get a second booster

Elisha Hall, PhD, RD, of the CDC presented slides with some factors to help determine the urgency for a person to get a second booster:

• Having certain underlying medical conditions that increase the risk of severe COVID-19 illness.
• Being moderately or severely immunocompromised.
• Living with someone who is immunocompromised, at increased risk for severe disease, or who cannot be vaccinated because of age or contraindication.
• Being at increased risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as through occupational, institutional, or other activities (e.g., travel or large gatherings).
• Living or working in an area where there is a medium or high level of COVID-19 in the community.

In contrast, people might want to wait if they had been infected with SARS-CoV-2 within the past 3 months, Dr. Hall said in her presentation. Another reason for delay might be a concern that a booster dose may be more important later in the year.

The experts also addressed public confusion over boosters. For the Pfizer and Moderna mRNA vaccines, a second booster is a fourth dose, but for those who received the one-shot J&J vaccine, the second booster is a third dose.

Going forward, it may be easier to refer to subsequent doses as “annual boosters,” the CDC’s Sara Oliver, MD, MSPH, told the panel. It will be important to keep language about subsequent vaccinations clear and easy for the public to follow, she said.

Dr. Oliver also said there’s already been a drop-off in the acceptance of second rounds of COVID-19 vaccinations. CDC data show that 77% of people in the United States have had at least one dose of a COVID-19 vaccine, but only 66% of the population is fully vaccinated, and only 45% have had a first booster dose.

In her presentation, Dr. Oliver said the top priority in COVID-19 vaccination efforts remains initial vaccinations for people who haven’t gotten them.
 

Kids younger than 5

During the public comment session of the CDC meeting, several people called on the FDA to move quickly to expand authorization of COVID-19 vaccines to children aged 5 years and younger.

“We know that many parents and caregivers and health care providers are anxious to have COVID vaccines available” for young children, said Doran Fink, MD, PhD, a deputy director of the FDA’s vaccines division.

He said the agency is working to be ready to authorize the shots for young children while it awaits research results from the manufacturers.

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

The Centers for Disease Control and Prevention is considering what to tell the public about second booster shots with mRNA vaccinations for COVID-19.

The U.S. Food and Drug Administration in March authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people aged 50 and older and certain immunocompromised adults, even though many top infectious disease experts questioned the need before the agency’s decision.

In a meeting April 20, the CDC asked its Advisory Committee on Immunization Practices to discuss second booster shots, but did not ask the group of experts to vote on formal recommendations.

Instead, the experts talked about the potential timing of additional COVID-19 vaccines for those who already have had three shots, and challenges for vaccination efforts that likely will arise as the pandemic persists.

ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, said she’s concerned about the potential for “booster fatigue.”

“A vaccination program that’s going to require boosting large proportions of the population every 4-6 months is really not sustainable and probably not something that most people want to participate in,” she said.

The benefit of additional COVID-19 shots for now appears to be smaller than what people get from the initial doses, Dr. Bell said.

Earlier in the meeting, CDC staff presented estimates about how well the COVID-19 vaccines work to prevent one case of hospitalization from the disease over 4 months among people aged 50 and older.

The major gain in preventing hospitalizations occurs with the first vaccination series and then wanes, the CDC said.

It appears that one hospitalization is prevented for every 135 people who get the first round of COVID-19 vaccinations. But it takes 674 people getting a first booster dose to prevent one hospitalization. A second booster prevents one hospitalization for every 1,205 people vaccinated.

Dr. Bell said she’s concerned about considering additional doses for “smaller and smaller return and creating an impression that we don’t have a very effective vaccination program,” even though the CDC’s data show a clear benefit.
 

Reasons to get a second booster

Elisha Hall, PhD, RD, of the CDC presented slides with some factors to help determine the urgency for a person to get a second booster:

• Having certain underlying medical conditions that increase the risk of severe COVID-19 illness.
• Being moderately or severely immunocompromised.
• Living with someone who is immunocompromised, at increased risk for severe disease, or who cannot be vaccinated because of age or contraindication.
• Being at increased risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as through occupational, institutional, or other activities (e.g., travel or large gatherings).
• Living or working in an area where there is a medium or high level of COVID-19 in the community.

In contrast, people might want to wait if they had been infected with SARS-CoV-2 within the past 3 months, Dr. Hall said in her presentation. Another reason for delay might be a concern that a booster dose may be more important later in the year.

The experts also addressed public confusion over boosters. For the Pfizer and Moderna mRNA vaccines, a second booster is a fourth dose, but for those who received the one-shot J&J vaccine, the second booster is a third dose.

Going forward, it may be easier to refer to subsequent doses as “annual boosters,” the CDC’s Sara Oliver, MD, MSPH, told the panel. It will be important to keep language about subsequent vaccinations clear and easy for the public to follow, she said.

Dr. Oliver also said there’s already been a drop-off in the acceptance of second rounds of COVID-19 vaccinations. CDC data show that 77% of people in the United States have had at least one dose of a COVID-19 vaccine, but only 66% of the population is fully vaccinated, and only 45% have had a first booster dose.

In her presentation, Dr. Oliver said the top priority in COVID-19 vaccination efforts remains initial vaccinations for people who haven’t gotten them.
 

Kids younger than 5

During the public comment session of the CDC meeting, several people called on the FDA to move quickly to expand authorization of COVID-19 vaccines to children aged 5 years and younger.

“We know that many parents and caregivers and health care providers are anxious to have COVID vaccines available” for young children, said Doran Fink, MD, PhD, a deputy director of the FDA’s vaccines division.

He said the agency is working to be ready to authorize the shots for young children while it awaits research results from the manufacturers.

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

About 30% of COVID-19 patients developed the condition known as long COVID, University of California, Los Angeles, researchers said in a study published in the Journal of General Internal Medicine.

The UCLA researchers studied 1,038 people enrolled in the UCLA COVID Ambulatory Program between April 2020 and February 2021 and found that 309 developed long COVID.

A long-COVID diagnosis came if a patient answering a questionnaire reported persistent symptoms 60-90 days after they were infected or hospitalized. The most persistent symptoms were fatigue (31%) and shortness of breath (15%) in hospitalized participants. Among outpatients, 16% reported losing sense of smell.

The study’s findings differ from earlier research. The University of California, Davis, for example, estimated that 10% of COVID-19 patients develop long-haul symptoms. A 2021 study from Penn State University found that more than half of worldwide COVID-19 patients would develop long COVID.

Part of the discrepancy can blamed on the fact there is no official, widely accepted definition of long COVID. The Centers for Disease Control and Prevention has said it means patients who experience “new, returning, or ongoing health problems 4 or more weeks after an initial infection” the coronavirus. The UCLA study, meanwhile, included patients still having symptoms 60-90 days after infection.

Still, the UCLA research team looked at demographics and clinical characteristics in an attempt to develop effective treatments.

People with a history of hospitalization, diabetes, and higher body mass index were most likely to develop long COVID, the researchers said. The kind of insurance the patients had also seemed to be a factor, though the researchers didn’t offer a reason why.

“Surprisingly, patients with commercial insurance had double the likelihood of developing [long COVID] compared to patients with Medicaid,” they wrote. “This association will be important to explore further to understand if insurance status in this group is representing unmeasured demographic factors or exposures.”

Older age and socioeconomic status were not associated with long COVID in the study – a surprise because those characteristics are often linked with severe illness and higher risk of death from COVID-19.

Weaknesses in the study included the subjective nature of how patients rated their symptoms and the limited number of symptoms evaluated.

“This study illustrates the need to follow diverse patient populations ... to understand the long COVID disease trajectory and evaluate how individual factors such as preexisting comorbidities, sociodemographic factors, vaccination status and virus variant type affect type and persistence of long COVID symptoms,” said Sun Yoo, MD, health sciences assistant clinical professor at UCLA.

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

About 30% of COVID-19 patients developed the condition known as long COVID, University of California, Los Angeles, researchers said in a study published in the Journal of General Internal Medicine.

The UCLA researchers studied 1,038 people enrolled in the UCLA COVID Ambulatory Program between April 2020 and February 2021 and found that 309 developed long COVID.

A long-COVID diagnosis came if a patient answering a questionnaire reported persistent symptoms 60-90 days after they were infected or hospitalized. The most persistent symptoms were fatigue (31%) and shortness of breath (15%) in hospitalized participants. Among outpatients, 16% reported losing sense of smell.

The study’s findings differ from earlier research. The University of California, Davis, for example, estimated that 10% of COVID-19 patients develop long-haul symptoms. A 2021 study from Penn State University found that more than half of worldwide COVID-19 patients would develop long COVID.

Part of the discrepancy can blamed on the fact there is no official, widely accepted definition of long COVID. The Centers for Disease Control and Prevention has said it means patients who experience “new, returning, or ongoing health problems 4 or more weeks after an initial infection” the coronavirus. The UCLA study, meanwhile, included patients still having symptoms 60-90 days after infection.

Still, the UCLA research team looked at demographics and clinical characteristics in an attempt to develop effective treatments.

People with a history of hospitalization, diabetes, and higher body mass index were most likely to develop long COVID, the researchers said. The kind of insurance the patients had also seemed to be a factor, though the researchers didn’t offer a reason why.

“Surprisingly, patients with commercial insurance had double the likelihood of developing [long COVID] compared to patients with Medicaid,” they wrote. “This association will be important to explore further to understand if insurance status in this group is representing unmeasured demographic factors or exposures.”

Older age and socioeconomic status were not associated with long COVID in the study – a surprise because those characteristics are often linked with severe illness and higher risk of death from COVID-19.

Weaknesses in the study included the subjective nature of how patients rated their symptoms and the limited number of symptoms evaluated.

“This study illustrates the need to follow diverse patient populations ... to understand the long COVID disease trajectory and evaluate how individual factors such as preexisting comorbidities, sociodemographic factors, vaccination status and virus variant type affect type and persistence of long COVID symptoms,” said Sun Yoo, MD, health sciences assistant clinical professor at UCLA.

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

About 30% of COVID-19 patients developed the condition known as long COVID, University of California, Los Angeles, researchers said in a study published in the Journal of General Internal Medicine.

The UCLA researchers studied 1,038 people enrolled in the UCLA COVID Ambulatory Program between April 2020 and February 2021 and found that 309 developed long COVID.

A long-COVID diagnosis came if a patient answering a questionnaire reported persistent symptoms 60-90 days after they were infected or hospitalized. The most persistent symptoms were fatigue (31%) and shortness of breath (15%) in hospitalized participants. Among outpatients, 16% reported losing sense of smell.

The study’s findings differ from earlier research. The University of California, Davis, for example, estimated that 10% of COVID-19 patients develop long-haul symptoms. A 2021 study from Penn State University found that more than half of worldwide COVID-19 patients would develop long COVID.

Part of the discrepancy can blamed on the fact there is no official, widely accepted definition of long COVID. The Centers for Disease Control and Prevention has said it means patients who experience “new, returning, or ongoing health problems 4 or more weeks after an initial infection” the coronavirus. The UCLA study, meanwhile, included patients still having symptoms 60-90 days after infection.

Still, the UCLA research team looked at demographics and clinical characteristics in an attempt to develop effective treatments.

People with a history of hospitalization, diabetes, and higher body mass index were most likely to develop long COVID, the researchers said. The kind of insurance the patients had also seemed to be a factor, though the researchers didn’t offer a reason why.

“Surprisingly, patients with commercial insurance had double the likelihood of developing [long COVID] compared to patients with Medicaid,” they wrote. “This association will be important to explore further to understand if insurance status in this group is representing unmeasured demographic factors or exposures.”

Older age and socioeconomic status were not associated with long COVID in the study – a surprise because those characteristics are often linked with severe illness and higher risk of death from COVID-19.

Weaknesses in the study included the subjective nature of how patients rated their symptoms and the limited number of symptoms evaluated.

“This study illustrates the need to follow diverse patient populations ... to understand the long COVID disease trajectory and evaluate how individual factors such as preexisting comorbidities, sociodemographic factors, vaccination status and virus variant type affect type and persistence of long COVID symptoms,” said Sun Yoo, MD, health sciences assistant clinical professor at UCLA.

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

Not so fast! Daily fasting with calorie restriction may not lead to shedding more pounds than just cutting back on calories, according to the authors of a new study.

Over the course of a year, study participants who ate only from 8:00 a.m. to 4:00 p.m. did not lose significantly more weight than individuals who ate whenever they wanted, nor did they achieve significantly greater improvements in other obesity-related health measures like body mass index (BMI) or metabolic risk, reported lead author Deying Liu, MD, of Nanfang Hospital, Southern Medical University, Guangzhou, China, and colleagues.

“[Daily fasting] has gained popularity because it is a weight-loss strategy that is simple to follow, which may enhance adherence,” Dr. Liu and colleagues wrote in the New England Journal of Medicine. However, “the long-term efficacy and safety of time-restricted eating as a weight-loss strategy are still uncertain, and the long-term effects on weight loss of time-restricted eating as compared with daily calorie restriction alone have not been fully explored.”

To learn more, Dr. Liu and colleagues recruited 139 adult patients with BMIs between 28 and 45. Individuals with serious medical conditions, such as malignant tumors, diabetes, chronic kidney disease, and others were excluded. Other exclusion criteria included smoking, ongoing participation in a weight-loss program, GI surgery within the prior year, use of medications that impact energy balance and weight, and planned or current pregnancy.

All participants were advised to eat calorie-restricted diets, with ranges of 1,500-1,800 kcal per day for men and 1,200-1,500 kcal per day for women. To determine the added impact of fasting, participants were randomized in a 1:1 ratio into time-restricted (fasting) or non–time-restricted (nonfasting) groups, in which fasting participants ate only during an 8-hour window from 8:00 a.m. to 4:00 p.m., whereas nonfasting participants ate whenever they wanted.

At 6 months and 12 months, participants were re-evaluated for changes in weight, body fat, BMI, blood pressure, lean body mass, and metabolic risk factors, including glucose level, triglycerides, blood pressure, and others.
 

Caloric intake restriction seems to explain most of beneficial effects

At one-year follow-up, 118 participants (84.9%) remained in the study. Although members of the fasting group lost slightly more weight on average than those in the non-fasting group (mean, 8.0 kg vs. 6.3 kg), the difference between groups was not statistically significant (95% confidence interval, −4.0 to 0.4; P = .11).

Most of the other obesity-related health measures also trended toward favoring the fasting group, but again, none of these improvements was statistically significant. Weight circumference at 1 year, for example, decreased by a mean of 9.4 cm in the fasting group versus 8.8 cm in the nonfasting group, a net difference of 1.8 cm (95% CI, –4.0 to 0.5).

“We found that the two weight-loss regimens that we evaluated had similar success in patients with obesity, regardless of whether they reduced their calorie consumption through time-restricted eating or through calorie restriction alone,” Dr. Liu and colleagues concluded.

Principal investigator Huijie Zhang MD, PhD, professor, chief physician, and deputy director of the department of endocrinology and metabolism at Nafang Hospital, noted that their findings are “consistent with the findings in previous studies.”

“Our data suggest that caloric intake restriction explained most of the beneficial effects of a time-restricted eating regimen,” Dr. Zhang said.

Still, Dr. Zhang called time-restricted eating “a viable and sustainable approach for a person who wants to lose weight.”

More work is needed, Dr. Zhang said, to uncover the impact of fasting in “diverse groups,” including patients with chronic disease like diabetes and cardiovascular disease. Investigators should also conduct studies to compare outcomes between men and women, and evaluate the effects of other fasting durations.
 

Can trial be applied to a wider population?

According to Blandine Laferrère, MD, PhD, and Satchidananda Panda, PhD, of Columbia University Irving Medical Center, New York, and the Salk Institute for Biological Studies, La Jolla, Calif., respectively, “the results of the trial suggest that calorie restriction combined with time restriction, when delivered with intensive coaching and monitoring, is an approach that is as safe, sustainable, and effective for weight loss as calorie restriction alone.”

Yet Dr. Laferrère and Dr. Panda also expressed skepticism about broader implementation of a similar regime.

“The applicability of this trial to wider populations is debatable,” they wrote in an accompanying editorial. “The short time period for eating at baseline may be specific to the population studied, since investigators outside China have reported longer time windows. The rigorous coaching and monitoring by trial staff also leaves open the question of whether time-restricted eating is easier to adhere to than intentional calorie restriction. Such cost-benefit analyses are important for the assessment of the scalability of a lifestyle intervention.”
 

Duration is trial’s greatest strength

Kristina Varady, PhD, professor of nutrition in the department of kinesiology and nutrition at the University of Illinois at Chicago, said the “key strength” of the trial was its duration, at 12 months, making it the longest time-restricted eating trial to date”; however, she was critical of the design.

“Quite frankly, I’m surprised this study got into such a high-caliber medical journal,” Dr. Varady said in a written comment. “It doesn’t even have a control group! It goes to show how popular these diets are and how much people want to know about them.”

She also noted that “the study was flawed in that it didn’t really look at the effects of true time-restricted eating.” According to Dr. Varady, combining calorie restriction with time-restricted eating “kind of defeats the purpose” of a time-restricted diet.

“The main benefit of time-restricted eating is that you don’t need to count calories in order to lose weight,” Dr. Varady said, citing two of her own studies from 2018 and 2020. “Just by limiting the eating window to 8 hours per day, people naturally cut out 300-500 calories per day. That’s why people like [time-restricted eating] so much.”

Dr. Varady was also “very surprised” at the adherence data. At 1 year, approximately 85% of the patients were still following the protocol, a notably higher rate than most dietary intervention studies, which typically report adherence rates of 50-60%, she said. The high adherence rate was particularly unexpected because of the 8:00 a.m.–4:00 p.m. eating window, Dr. Varady added, since that meant skipping “the family/social meal every evening over 1 whole year!”

The study was funded by the National Key Research and Development Project and others. The study investigators reported no conflicts of interest. Dr. Varady disclosed author fees from the Hachette Book group for her book “The Every Other Day Diet.”

Not so fast! Daily fasting with calorie restriction may not lead to shedding more pounds than just cutting back on calories, according to the authors of a new study.

Over the course of a year, study participants who ate only from 8:00 a.m. to 4:00 p.m. did not lose significantly more weight than individuals who ate whenever they wanted, nor did they achieve significantly greater improvements in other obesity-related health measures like body mass index (BMI) or metabolic risk, reported lead author Deying Liu, MD, of Nanfang Hospital, Southern Medical University, Guangzhou, China, and colleagues.

“[Daily fasting] has gained popularity because it is a weight-loss strategy that is simple to follow, which may enhance adherence,” Dr. Liu and colleagues wrote in the New England Journal of Medicine. However, “the long-term efficacy and safety of time-restricted eating as a weight-loss strategy are still uncertain, and the long-term effects on weight loss of time-restricted eating as compared with daily calorie restriction alone have not been fully explored.”

To learn more, Dr. Liu and colleagues recruited 139 adult patients with BMIs between 28 and 45. Individuals with serious medical conditions, such as malignant tumors, diabetes, chronic kidney disease, and others were excluded. Other exclusion criteria included smoking, ongoing participation in a weight-loss program, GI surgery within the prior year, use of medications that impact energy balance and weight, and planned or current pregnancy.

All participants were advised to eat calorie-restricted diets, with ranges of 1,500-1,800 kcal per day for men and 1,200-1,500 kcal per day for women. To determine the added impact of fasting, participants were randomized in a 1:1 ratio into time-restricted (fasting) or non–time-restricted (nonfasting) groups, in which fasting participants ate only during an 8-hour window from 8:00 a.m. to 4:00 p.m., whereas nonfasting participants ate whenever they wanted.

At 6 months and 12 months, participants were re-evaluated for changes in weight, body fat, BMI, blood pressure, lean body mass, and metabolic risk factors, including glucose level, triglycerides, blood pressure, and others.
 

Caloric intake restriction seems to explain most of beneficial effects

At one-year follow-up, 118 participants (84.9%) remained in the study. Although members of the fasting group lost slightly more weight on average than those in the non-fasting group (mean, 8.0 kg vs. 6.3 kg), the difference between groups was not statistically significant (95% confidence interval, −4.0 to 0.4; P = .11).

Most of the other obesity-related health measures also trended toward favoring the fasting group, but again, none of these improvements was statistically significant. Weight circumference at 1 year, for example, decreased by a mean of 9.4 cm in the fasting group versus 8.8 cm in the nonfasting group, a net difference of 1.8 cm (95% CI, –4.0 to 0.5).

“We found that the two weight-loss regimens that we evaluated had similar success in patients with obesity, regardless of whether they reduced their calorie consumption through time-restricted eating or through calorie restriction alone,” Dr. Liu and colleagues concluded.

Principal investigator Huijie Zhang MD, PhD, professor, chief physician, and deputy director of the department of endocrinology and metabolism at Nafang Hospital, noted that their findings are “consistent with the findings in previous studies.”

“Our data suggest that caloric intake restriction explained most of the beneficial effects of a time-restricted eating regimen,” Dr. Zhang said.

Still, Dr. Zhang called time-restricted eating “a viable and sustainable approach for a person who wants to lose weight.”

More work is needed, Dr. Zhang said, to uncover the impact of fasting in “diverse groups,” including patients with chronic disease like diabetes and cardiovascular disease. Investigators should also conduct studies to compare outcomes between men and women, and evaluate the effects of other fasting durations.
 

Can trial be applied to a wider population?

According to Blandine Laferrère, MD, PhD, and Satchidananda Panda, PhD, of Columbia University Irving Medical Center, New York, and the Salk Institute for Biological Studies, La Jolla, Calif., respectively, “the results of the trial suggest that calorie restriction combined with time restriction, when delivered with intensive coaching and monitoring, is an approach that is as safe, sustainable, and effective for weight loss as calorie restriction alone.”

Yet Dr. Laferrère and Dr. Panda also expressed skepticism about broader implementation of a similar regime.

“The applicability of this trial to wider populations is debatable,” they wrote in an accompanying editorial. “The short time period for eating at baseline may be specific to the population studied, since investigators outside China have reported longer time windows. The rigorous coaching and monitoring by trial staff also leaves open the question of whether time-restricted eating is easier to adhere to than intentional calorie restriction. Such cost-benefit analyses are important for the assessment of the scalability of a lifestyle intervention.”
 

Duration is trial’s greatest strength

Kristina Varady, PhD, professor of nutrition in the department of kinesiology and nutrition at the University of Illinois at Chicago, said the “key strength” of the trial was its duration, at 12 months, making it the longest time-restricted eating trial to date”; however, she was critical of the design.

“Quite frankly, I’m surprised this study got into such a high-caliber medical journal,” Dr. Varady said in a written comment. “It doesn’t even have a control group! It goes to show how popular these diets are and how much people want to know about them.”

She also noted that “the study was flawed in that it didn’t really look at the effects of true time-restricted eating.” According to Dr. Varady, combining calorie restriction with time-restricted eating “kind of defeats the purpose” of a time-restricted diet.

“The main benefit of time-restricted eating is that you don’t need to count calories in order to lose weight,” Dr. Varady said, citing two of her own studies from 2018 and 2020. “Just by limiting the eating window to 8 hours per day, people naturally cut out 300-500 calories per day. That’s why people like [time-restricted eating] so much.”

Dr. Varady was also “very surprised” at the adherence data. At 1 year, approximately 85% of the patients were still following the protocol, a notably higher rate than most dietary intervention studies, which typically report adherence rates of 50-60%, she said. The high adherence rate was particularly unexpected because of the 8:00 a.m.–4:00 p.m. eating window, Dr. Varady added, since that meant skipping “the family/social meal every evening over 1 whole year!”

The study was funded by the National Key Research and Development Project and others. The study investigators reported no conflicts of interest. Dr. Varady disclosed author fees from the Hachette Book group for her book “The Every Other Day Diet.”

Not so fast! Daily fasting with calorie restriction may not lead to shedding more pounds than just cutting back on calories, according to the authors of a new study.

Over the course of a year, study participants who ate only from 8:00 a.m. to 4:00 p.m. did not lose significantly more weight than individuals who ate whenever they wanted, nor did they achieve significantly greater improvements in other obesity-related health measures like body mass index (BMI) or metabolic risk, reported lead author Deying Liu, MD, of Nanfang Hospital, Southern Medical University, Guangzhou, China, and colleagues.

“[Daily fasting] has gained popularity because it is a weight-loss strategy that is simple to follow, which may enhance adherence,” Dr. Liu and colleagues wrote in the New England Journal of Medicine. However, “the long-term efficacy and safety of time-restricted eating as a weight-loss strategy are still uncertain, and the long-term effects on weight loss of time-restricted eating as compared with daily calorie restriction alone have not been fully explored.”

To learn more, Dr. Liu and colleagues recruited 139 adult patients with BMIs between 28 and 45. Individuals with serious medical conditions, such as malignant tumors, diabetes, chronic kidney disease, and others were excluded. Other exclusion criteria included smoking, ongoing participation in a weight-loss program, GI surgery within the prior year, use of medications that impact energy balance and weight, and planned or current pregnancy.

All participants were advised to eat calorie-restricted diets, with ranges of 1,500-1,800 kcal per day for men and 1,200-1,500 kcal per day for women. To determine the added impact of fasting, participants were randomized in a 1:1 ratio into time-restricted (fasting) or non–time-restricted (nonfasting) groups, in which fasting participants ate only during an 8-hour window from 8:00 a.m. to 4:00 p.m., whereas nonfasting participants ate whenever they wanted.

At 6 months and 12 months, participants were re-evaluated for changes in weight, body fat, BMI, blood pressure, lean body mass, and metabolic risk factors, including glucose level, triglycerides, blood pressure, and others.
 

Caloric intake restriction seems to explain most of beneficial effects

At one-year follow-up, 118 participants (84.9%) remained in the study. Although members of the fasting group lost slightly more weight on average than those in the non-fasting group (mean, 8.0 kg vs. 6.3 kg), the difference between groups was not statistically significant (95% confidence interval, −4.0 to 0.4; P = .11).

Most of the other obesity-related health measures also trended toward favoring the fasting group, but again, none of these improvements was statistically significant. Weight circumference at 1 year, for example, decreased by a mean of 9.4 cm in the fasting group versus 8.8 cm in the nonfasting group, a net difference of 1.8 cm (95% CI, –4.0 to 0.5).

“We found that the two weight-loss regimens that we evaluated had similar success in patients with obesity, regardless of whether they reduced their calorie consumption through time-restricted eating or through calorie restriction alone,” Dr. Liu and colleagues concluded.

Principal investigator Huijie Zhang MD, PhD, professor, chief physician, and deputy director of the department of endocrinology and metabolism at Nafang Hospital, noted that their findings are “consistent with the findings in previous studies.”

“Our data suggest that caloric intake restriction explained most of the beneficial effects of a time-restricted eating regimen,” Dr. Zhang said.

Still, Dr. Zhang called time-restricted eating “a viable and sustainable approach for a person who wants to lose weight.”

More work is needed, Dr. Zhang said, to uncover the impact of fasting in “diverse groups,” including patients with chronic disease like diabetes and cardiovascular disease. Investigators should also conduct studies to compare outcomes between men and women, and evaluate the effects of other fasting durations.
 

Can trial be applied to a wider population?

According to Blandine Laferrère, MD, PhD, and Satchidananda Panda, PhD, of Columbia University Irving Medical Center, New York, and the Salk Institute for Biological Studies, La Jolla, Calif., respectively, “the results of the trial suggest that calorie restriction combined with time restriction, when delivered with intensive coaching and monitoring, is an approach that is as safe, sustainable, and effective for weight loss as calorie restriction alone.”

Yet Dr. Laferrère and Dr. Panda also expressed skepticism about broader implementation of a similar regime.

“The applicability of this trial to wider populations is debatable,” they wrote in an accompanying editorial. “The short time period for eating at baseline may be specific to the population studied, since investigators outside China have reported longer time windows. The rigorous coaching and monitoring by trial staff also leaves open the question of whether time-restricted eating is easier to adhere to than intentional calorie restriction. Such cost-benefit analyses are important for the assessment of the scalability of a lifestyle intervention.”
 

Duration is trial’s greatest strength

Kristina Varady, PhD, professor of nutrition in the department of kinesiology and nutrition at the University of Illinois at Chicago, said the “key strength” of the trial was its duration, at 12 months, making it the longest time-restricted eating trial to date”; however, she was critical of the design.

“Quite frankly, I’m surprised this study got into such a high-caliber medical journal,” Dr. Varady said in a written comment. “It doesn’t even have a control group! It goes to show how popular these diets are and how much people want to know about them.”

She also noted that “the study was flawed in that it didn’t really look at the effects of true time-restricted eating.” According to Dr. Varady, combining calorie restriction with time-restricted eating “kind of defeats the purpose” of a time-restricted diet.

“The main benefit of time-restricted eating is that you don’t need to count calories in order to lose weight,” Dr. Varady said, citing two of her own studies from 2018 and 2020. “Just by limiting the eating window to 8 hours per day, people naturally cut out 300-500 calories per day. That’s why people like [time-restricted eating] so much.”

Dr. Varady was also “very surprised” at the adherence data. At 1 year, approximately 85% of the patients were still following the protocol, a notably higher rate than most dietary intervention studies, which typically report adherence rates of 50-60%, she said. The high adherence rate was particularly unexpected because of the 8:00 a.m.–4:00 p.m. eating window, Dr. Varady added, since that meant skipping “the family/social meal every evening over 1 whole year!”

The study was funded by the National Key Research and Development Project and others. The study investigators reported no conflicts of interest. Dr. Varady disclosed author fees from the Hachette Book group for her book “The Every Other Day Diet.”

Peripheral muscle fatigue was the most common cause of exercise limitation in patients recovered from COVID-19 regardless of disease severity, in a study of nearly 300 individuals.

The source and magnitude of exercise intolerance in post–COVID-19 patients has not been well studied, said Mauricio Milani, MD, of Fitcordis Exercise Medicine Clinic, Brasilia, Brazil, in a presentation at the annual congress of the European Association of Preventive Cardiology.

Midas Anim/Shutterstock

To assess exercise intolerance, the researchers performed cardiopulmonary exercise testing (CPET) on 144 adults who had recovered from COVID-19 and 144 matched controls who had not had COVID-19. The average age of the participants was 43 years, and 57% were male. COVID-19 was defined as mild, moderate, or severe in 60%, 21%, and 19% of the cases, respectively.

Residual symptoms were present in 41% of cases. CPET was performed at roughly 14 weeks after disease onset.

Among the COVID-19 patients, most of the CPET limitations (92%) were caused by muscle fatigue; cardiovascular limitations were noted in 2%, and pulmonary limitations were noted in 6%.

Data from the post-COVID CPET showed differences in peak oxygen consumption, as well as the first and second ventilatory thresholds (VT1 and VT2) between COVID-19 patients and controls, and with lower values related to higher illness severities, Dr. Milani said. Heart rate also varied according to illness severity, with lower values significantly related to higher illness severities and significant differences between COVID patients and controls.

A total of 42 individuals with COVID-19 had previous CPET data for comparison (27 with mild disease and 15 with moderate or severe disease), Dr. Milani said. In the subgroup with mild disease, the only significant difference in CPET results before and after COVID-19 was peak speed. In the moderate/severe group, the researchers observed higher reductions in peak speed and also reductions in oxygen consumption at peak and thresholds.

However, peak oxygen flows were not different before and after COVID-19 in either the mild or moderate/severe subgroups, Dr. Milani said.

The study findings were limited in part by the relatively small study population; however, the results indicate that peripheral muscle fatigue is the primary etiology in exercise limitation in post–COVID-19 patients.

“Our data suggest that treatment should emphasize comprehensive rehabilitation programs, including aerobic and muscle strengthening components,” Dr. Milani concluded.

COVID challenges remain unclear

“After COVID, patients often display a postviral syndrome with a wide range of symptoms,” Matthew Martinez, MD, a sports cardiologist at the Atlantic Health System in Morristown, N.J., in an interview said. “These conditions frequently lead to a sense of tiredness and weakness, pain, difficulty concentrating, and headaches that linger after the viral infection has cleared,” and these symptoms may continue for weeks.

However, this scenario is not unique to COVID-19: “This study confirms the importance of muscle fatigue in recovery,” said Dr. Martinez. “Recovery from viral illness requires hydration, sleep and slow progression return to exercise.” Consequently, Dr. Martinez said he was not surprised by the current study findings.

The take-home message for clinicians is to be aware that COVID-19 can have postviral syndrome, as is common after other infections, Dr. Martinez noted. The findings provide a starting point for discussing concerns with patients and explaining that a slow return to normal with usual care is expected. “Time to recovery will vary by individual,” he said. “Additional research is needed to identify which specific therapies are most important to help reduce time to recovery, and what new therapies could be developed to help facilitate muscle fatigue recovery and reduce time needed to recover.”

The study was supported by CAPES and CNPq. Dr. Milani had no financial conflicts to disclose. Dr. Martinez had no financial conflicts to disclose.

Peripheral muscle fatigue was the most common cause of exercise limitation in patients recovered from COVID-19 regardless of disease severity, in a study of nearly 300 individuals.

The source and magnitude of exercise intolerance in post–COVID-19 patients has not been well studied, said Mauricio Milani, MD, of Fitcordis Exercise Medicine Clinic, Brasilia, Brazil, in a presentation at the annual congress of the European Association of Preventive Cardiology.

Midas Anim/Shutterstock

To assess exercise intolerance, the researchers performed cardiopulmonary exercise testing (CPET) on 144 adults who had recovered from COVID-19 and 144 matched controls who had not had COVID-19. The average age of the participants was 43 years, and 57% were male. COVID-19 was defined as mild, moderate, or severe in 60%, 21%, and 19% of the cases, respectively.

Residual symptoms were present in 41% of cases. CPET was performed at roughly 14 weeks after disease onset.

Among the COVID-19 patients, most of the CPET limitations (92%) were caused by muscle fatigue; cardiovascular limitations were noted in 2%, and pulmonary limitations were noted in 6%.

Data from the post-COVID CPET showed differences in peak oxygen consumption, as well as the first and second ventilatory thresholds (VT1 and VT2) between COVID-19 patients and controls, and with lower values related to higher illness severities, Dr. Milani said. Heart rate also varied according to illness severity, with lower values significantly related to higher illness severities and significant differences between COVID patients and controls.

A total of 42 individuals with COVID-19 had previous CPET data for comparison (27 with mild disease and 15 with moderate or severe disease), Dr. Milani said. In the subgroup with mild disease, the only significant difference in CPET results before and after COVID-19 was peak speed. In the moderate/severe group, the researchers observed higher reductions in peak speed and also reductions in oxygen consumption at peak and thresholds.

However, peak oxygen flows were not different before and after COVID-19 in either the mild or moderate/severe subgroups, Dr. Milani said.

The study findings were limited in part by the relatively small study population; however, the results indicate that peripheral muscle fatigue is the primary etiology in exercise limitation in post–COVID-19 patients.

“Our data suggest that treatment should emphasize comprehensive rehabilitation programs, including aerobic and muscle strengthening components,” Dr. Milani concluded.

COVID challenges remain unclear

“After COVID, patients often display a postviral syndrome with a wide range of symptoms,” Matthew Martinez, MD, a sports cardiologist at the Atlantic Health System in Morristown, N.J., in an interview said. “These conditions frequently lead to a sense of tiredness and weakness, pain, difficulty concentrating, and headaches that linger after the viral infection has cleared,” and these symptoms may continue for weeks.

However, this scenario is not unique to COVID-19: “This study confirms the importance of muscle fatigue in recovery,” said Dr. Martinez. “Recovery from viral illness requires hydration, sleep and slow progression return to exercise.” Consequently, Dr. Martinez said he was not surprised by the current study findings.

The take-home message for clinicians is to be aware that COVID-19 can have postviral syndrome, as is common after other infections, Dr. Martinez noted. The findings provide a starting point for discussing concerns with patients and explaining that a slow return to normal with usual care is expected. “Time to recovery will vary by individual,” he said. “Additional research is needed to identify which specific therapies are most important to help reduce time to recovery, and what new therapies could be developed to help facilitate muscle fatigue recovery and reduce time needed to recover.”

The study was supported by CAPES and CNPq. Dr. Milani had no financial conflicts to disclose. Dr. Martinez had no financial conflicts to disclose.

Peripheral muscle fatigue was the most common cause of exercise limitation in patients recovered from COVID-19 regardless of disease severity, in a study of nearly 300 individuals.

The source and magnitude of exercise intolerance in post–COVID-19 patients has not been well studied, said Mauricio Milani, MD, of Fitcordis Exercise Medicine Clinic, Brasilia, Brazil, in a presentation at the annual congress of the European Association of Preventive Cardiology.

Midas Anim/Shutterstock

To assess exercise intolerance, the researchers performed cardiopulmonary exercise testing (CPET) on 144 adults who had recovered from COVID-19 and 144 matched controls who had not had COVID-19. The average age of the participants was 43 years, and 57% were male. COVID-19 was defined as mild, moderate, or severe in 60%, 21%, and 19% of the cases, respectively.

Residual symptoms were present in 41% of cases. CPET was performed at roughly 14 weeks after disease onset.

Among the COVID-19 patients, most of the CPET limitations (92%) were caused by muscle fatigue; cardiovascular limitations were noted in 2%, and pulmonary limitations were noted in 6%.

Data from the post-COVID CPET showed differences in peak oxygen consumption, as well as the first and second ventilatory thresholds (VT1 and VT2) between COVID-19 patients and controls, and with lower values related to higher illness severities, Dr. Milani said. Heart rate also varied according to illness severity, with lower values significantly related to higher illness severities and significant differences between COVID patients and controls.

A total of 42 individuals with COVID-19 had previous CPET data for comparison (27 with mild disease and 15 with moderate or severe disease), Dr. Milani said. In the subgroup with mild disease, the only significant difference in CPET results before and after COVID-19 was peak speed. In the moderate/severe group, the researchers observed higher reductions in peak speed and also reductions in oxygen consumption at peak and thresholds.

However, peak oxygen flows were not different before and after COVID-19 in either the mild or moderate/severe subgroups, Dr. Milani said.

The study findings were limited in part by the relatively small study population; however, the results indicate that peripheral muscle fatigue is the primary etiology in exercise limitation in post–COVID-19 patients.

“Our data suggest that treatment should emphasize comprehensive rehabilitation programs, including aerobic and muscle strengthening components,” Dr. Milani concluded.

COVID challenges remain unclear

“After COVID, patients often display a postviral syndrome with a wide range of symptoms,” Matthew Martinez, MD, a sports cardiologist at the Atlantic Health System in Morristown, N.J., in an interview said. “These conditions frequently lead to a sense of tiredness and weakness, pain, difficulty concentrating, and headaches that linger after the viral infection has cleared,” and these symptoms may continue for weeks.

However, this scenario is not unique to COVID-19: “This study confirms the importance of muscle fatigue in recovery,” said Dr. Martinez. “Recovery from viral illness requires hydration, sleep and slow progression return to exercise.” Consequently, Dr. Martinez said he was not surprised by the current study findings.

The take-home message for clinicians is to be aware that COVID-19 can have postviral syndrome, as is common after other infections, Dr. Martinez noted. The findings provide a starting point for discussing concerns with patients and explaining that a slow return to normal with usual care is expected. “Time to recovery will vary by individual,” he said. “Additional research is needed to identify which specific therapies are most important to help reduce time to recovery, and what new therapies could be developed to help facilitate muscle fatigue recovery and reduce time needed to recover.”

The study was supported by CAPES and CNPq. Dr. Milani had no financial conflicts to disclose. Dr. Martinez had no financial conflicts to disclose.

During the first year of the pandemic, at least four people in Michigan were infected with a coronavirus variant that has been found in mink.

The cluster, which previously included three cases, marks the first known instance of likely animal-to-human “spillover” of the virus in the United States, according to the New York Times. All four people fully recovered.

Two of the infected people were employees of a mink farm in Michigan that had an outbreak in October 2020. The other two people didn’t have known links to the farm, which may mean that the coronavirus variant among mink may have been circulating more widely among residents in that area during that time.

Virus samples from all four people contained two mutations that may show signs of an adaptation to mink. The mutations have also been documented in farmed mink in Europe and people with connections to those farms.

“This, in addition to the mink farmworkers testing positive for COVID-19 after the mink herd had begun experiencing illness and increased mortality, suggests that the most likely hypothesis is that the workers were infected after contact with mink on the farm,” Casey Barton Behravesh, DVM, who directs the Centers for Disease Control and Prevention’s One Health Office, told the newspaper.

But researchers are unable to prove the cause, she noted.

“Because there are few genetic sequences available from the communities around the farm, it is impossible to know for sure whether the mutations came from mink on the farm or were already circulating in the community,” she said.

In August 2020, the U.S. Department of Agriculture announced the first confirmed COVID-19 case in mink at farms in Utah, followed by a case in Wisconsin. Worldwide, the coronavirus has been detected in mink on farms in the Netherlands, Denmark, Poland, and Spain.

In early October 2020, Michigan officials announced that the coronavirus had been detected in mink on a local farm. Several of the animals had died. The CDC helped to investigate the outbreak by collecting samples from animals, farmworkers, and residents in the community.

By March 2021, the CDC had updated its website to note that a “small number of people” had contracted a coronavirus variant that “contained unique mink-related mutations.”

In April 2021, the Detroit Free Press and the Documenting COVID-19 project first reported on the first three cases – two farmworkers and a taxidermist who didn’t have a connection to the mink farm. This week, the news outlets reported an update that the fourth case was the taxidermist’s wife.

Earlier this month, National Geographic first reported on the fourth human case based on government documents about the mink farm outbreak.

Overall, animal-to-human transmission is rare, but the CDC is continuing to monitor potential coronavirus cases in wildlife, livestock, and zoo animals for new variants and virus reservoirs, the Times reported.

“These results highlight the importance of routinely studying the genetic material of SARS-CoV-2 in susceptible animal populations like mink, as well as in people,” the CDC wrote.

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

During the first year of the pandemic, at least four people in Michigan were infected with a coronavirus variant that has been found in mink.

The cluster, which previously included three cases, marks the first known instance of likely animal-to-human “spillover” of the virus in the United States, according to the New York Times. All four people fully recovered.

Two of the infected people were employees of a mink farm in Michigan that had an outbreak in October 2020. The other two people didn’t have known links to the farm, which may mean that the coronavirus variant among mink may have been circulating more widely among residents in that area during that time.

Virus samples from all four people contained two mutations that may show signs of an adaptation to mink. The mutations have also been documented in farmed mink in Europe and people with connections to those farms.

“This, in addition to the mink farmworkers testing positive for COVID-19 after the mink herd had begun experiencing illness and increased mortality, suggests that the most likely hypothesis is that the workers were infected after contact with mink on the farm,” Casey Barton Behravesh, DVM, who directs the Centers for Disease Control and Prevention’s One Health Office, told the newspaper.

But researchers are unable to prove the cause, she noted.

“Because there are few genetic sequences available from the communities around the farm, it is impossible to know for sure whether the mutations came from mink on the farm or were already circulating in the community,” she said.

In August 2020, the U.S. Department of Agriculture announced the first confirmed COVID-19 case in mink at farms in Utah, followed by a case in Wisconsin. Worldwide, the coronavirus has been detected in mink on farms in the Netherlands, Denmark, Poland, and Spain.

In early October 2020, Michigan officials announced that the coronavirus had been detected in mink on a local farm. Several of the animals had died. The CDC helped to investigate the outbreak by collecting samples from animals, farmworkers, and residents in the community.

By March 2021, the CDC had updated its website to note that a “small number of people” had contracted a coronavirus variant that “contained unique mink-related mutations.”

In April 2021, the Detroit Free Press and the Documenting COVID-19 project first reported on the first three cases – two farmworkers and a taxidermist who didn’t have a connection to the mink farm. This week, the news outlets reported an update that the fourth case was the taxidermist’s wife.

Earlier this month, National Geographic first reported on the fourth human case based on government documents about the mink farm outbreak.

Overall, animal-to-human transmission is rare, but the CDC is continuing to monitor potential coronavirus cases in wildlife, livestock, and zoo animals for new variants and virus reservoirs, the Times reported.

“These results highlight the importance of routinely studying the genetic material of SARS-CoV-2 in susceptible animal populations like mink, as well as in people,” the CDC wrote.

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

During the first year of the pandemic, at least four people in Michigan were infected with a coronavirus variant that has been found in mink.

The cluster, which previously included three cases, marks the first known instance of likely animal-to-human “spillover” of the virus in the United States, according to the New York Times. All four people fully recovered.

Two of the infected people were employees of a mink farm in Michigan that had an outbreak in October 2020. The other two people didn’t have known links to the farm, which may mean that the coronavirus variant among mink may have been circulating more widely among residents in that area during that time.

Virus samples from all four people contained two mutations that may show signs of an adaptation to mink. The mutations have also been documented in farmed mink in Europe and people with connections to those farms.

“This, in addition to the mink farmworkers testing positive for COVID-19 after the mink herd had begun experiencing illness and increased mortality, suggests that the most likely hypothesis is that the workers were infected after contact with mink on the farm,” Casey Barton Behravesh, DVM, who directs the Centers for Disease Control and Prevention’s One Health Office, told the newspaper.

But researchers are unable to prove the cause, she noted.

“Because there are few genetic sequences available from the communities around the farm, it is impossible to know for sure whether the mutations came from mink on the farm or were already circulating in the community,” she said.

In August 2020, the U.S. Department of Agriculture announced the first confirmed COVID-19 case in mink at farms in Utah, followed by a case in Wisconsin. Worldwide, the coronavirus has been detected in mink on farms in the Netherlands, Denmark, Poland, and Spain.

In early October 2020, Michigan officials announced that the coronavirus had been detected in mink on a local farm. Several of the animals had died. The CDC helped to investigate the outbreak by collecting samples from animals, farmworkers, and residents in the community.

By March 2021, the CDC had updated its website to note that a “small number of people” had contracted a coronavirus variant that “contained unique mink-related mutations.”

In April 2021, the Detroit Free Press and the Documenting COVID-19 project first reported on the first three cases – two farmworkers and a taxidermist who didn’t have a connection to the mink farm. This week, the news outlets reported an update that the fourth case was the taxidermist’s wife.

Earlier this month, National Geographic first reported on the fourth human case based on government documents about the mink farm outbreak.

Overall, animal-to-human transmission is rare, but the CDC is continuing to monitor potential coronavirus cases in wildlife, livestock, and zoo animals for new variants and virus reservoirs, the Times reported.

“These results highlight the importance of routinely studying the genetic material of SARS-CoV-2 in susceptible animal populations like mink, as well as in people,” the CDC wrote.

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

Inadequate pain relief was recorded in 68.8% of a sample of people with hip or knee OA who participated in the population-based EpiReumaPt study, researchers reported at the OARSI 2022 World Congress.

“This can be explained by a lack of effectiveness of current management strategies, low uptake of recommended interventions by health care professionals, and also by low adherence by patients to medication and lifestyle interventions,” said Daniela Sofia Albino Costa, MSc, a PhD student at NOVA University Lisbon.

BackyardProduction/Thinkstock

In addition to looking at the prevalence of inadequate pain relief ­– defined as a score of 5 or higher on the Numeric Pain Rating Scale (NPRS) – the study she presented at the congress, which was sponsored by the Osteoarthritis Research Society International, looked at the predictors for inadequate pain control.

It was found that being female, obesity, and having multimorbidity doubled the risk of inadequate versus adequate pain control, with respective odds ratios of 2.32 (P < .001), 2.26 (P = .006), and 2.07 (P = .001). Overweight was also associated with an increased odds ratio for poor pain control (OR, 1.84; P = .0035).

“We found that patients with inadequate pain relief also have a low performance on activities of daily living and a low quality of life,” Ms. Costa said.

Nearly one-third (29%) of patients in the inadequate pain relief group (n = 765) took medication, versus 15% of patients in the adequate pain relief group (n = 270). This was mostly NSAIDs, but also included analgesics and antipyretics, and in a few cases (4.8% vs. 1.3%), simple opioids.

“We know that current care is not concordant with recommendations,” said Ms. Costa, noting that medication being used as first-line treatment and core nonpharmacologic interventions are being offered to less than half of patients who are eligible.

In addition, the rate for total joint replacement has increased globally, and pain is an important predictor for this.

“So, we need to evaluate pain control and current management offered to people with hip or knee arthritis to identify to identify areas for improvement,” Ms. Costa said.

High rates of prescription opioid use before TKA

In a separate study also presented at the congress, Daniel Rhon, DPT, DSc, director of musculoskeletal research in primary care at Brooke Army Medical Center in San Antonio, gave a worrying glimpse of high rates of opioid use in the 4 years before total knee arthroplasty (TKA).

Using data from the U.S. Military Health System, the records of all individuals who had a knee replacement procedure between January 2017 and December 2018 were studied, to identify and characterize the use of prescription opioids.

Of the 46,362 individuals, 52.9% had prior opioid use, despite the fact that “opioids are not recommended for the management of knee OA,” said Dr. Rhon.

He also reported that as many as 40% of those who had at least one prescription for opioids had received a high-potency drug, such as fentanyl or oxycodone. The mean age of participants overall was 65 years, with a higher mean for those receiving opioids than those who did not (68 vs. 61.5 years). Data on sex and ethnicity were not available in time for presentation at the congress.

“Most of these individuals are getting these opioid prescriptions probably within 6 months, which maybe aligns with escalation of pain and maybe the decision to have that knee replacement,” Dr. Rhon said. Individuals that used opioids filled their most recent prescription a median of 146 days before TKA to surgery, with a mean of 317 days.

“You can’t always link the reason for the opioid prescription, that’s not really clear in the database,” he admitted; however, an analysis was performed to check if other surgeries had been performed that may have warranted the opioid treatment. The results revealed that very few of the opioid users (4%-7%) had undergone another type of surgical procedure.

“So, we feel a little bit better, that these findings weren’t for other surgical procedures,” said Dr. Rhon. He added that future qualitative research was needed to understand why health care professionals were prescribing opioids, and why patients felt like they needed them.

“That’s bad,” Haxby Abbott, PhD, DPT, a research professor at the University of Otago, Dunedin, New Zealand, commented on Twitter.

Dr. Abbott, who was not involved in the study, added: “We’ve done a similar study of the whole NZ population [currently under review] – similar to Australia and not nearly as bad as you found. That needs urgent attention.”
 

Sharp rise in opioid use 2 years before TKA

Lower rates of opioid use before TKA were seen in two European cohorts, at 43% in England and 33% in Sweden, as reported by Clara Hellberg, PhD, MD, of Lund (Sweden) University. However, rates had increased over a 10-year study period from a respective 23% and 16%, with a sharp increase in use in the 2 years before knee replacement.

The analysis was based on 49,043 patients from the English national database Clinical Practice Research Datalink, and 5,955 patients from the Swedish Skåne Healthcare register who had undergone total knee replacement between 2015 and 2019 and were matched by age, sex and general practice to individuals not undergoing knee replacement.

The prevalence ratio for using opioids over a 10-year period increased from 1.6 to 2.7 in England, and from 1.6 to 2.6 in Sweden.

“While the overall prevalence of opioid use was higher in England, the majority of both cases and controls were using weak opioids,” Dr. Hellberg said.

“Codeine was classified as a weak opioid, whereas morphine was classified as a strong opioid,” she added.

In contrast, the proportion of people using strong opioids in Sweden was greater than in England, she said.

The high opioid use found in the study highlights “the need for better opioid stewardship, and the availability of acceptable, effective alternatives,” Dr. Hellberg and associates concluded in their abstract.

The study presented by Ms. Costa was funded by the Portuguese national funding agency for science, research and technology and by an independent research grant from Pfizer. Dr. Rhon acknowledged grant funding from the National Institutes of Health and the U.S. Department of Defense. Dr. Hellberg had no conflicts of interest to disclose.

Inadequate pain relief was recorded in 68.8% of a sample of people with hip or knee OA who participated in the population-based EpiReumaPt study, researchers reported at the OARSI 2022 World Congress.

“This can be explained by a lack of effectiveness of current management strategies, low uptake of recommended interventions by health care professionals, and also by low adherence by patients to medication and lifestyle interventions,” said Daniela Sofia Albino Costa, MSc, a PhD student at NOVA University Lisbon.

BackyardProduction/Thinkstock

In addition to looking at the prevalence of inadequate pain relief ­– defined as a score of 5 or higher on the Numeric Pain Rating Scale (NPRS) – the study she presented at the congress, which was sponsored by the Osteoarthritis Research Society International, looked at the predictors for inadequate pain control.

It was found that being female, obesity, and having multimorbidity doubled the risk of inadequate versus adequate pain control, with respective odds ratios of 2.32 (P < .001), 2.26 (P = .006), and 2.07 (P = .001). Overweight was also associated with an increased odds ratio for poor pain control (OR, 1.84; P = .0035).

“We found that patients with inadequate pain relief also have a low performance on activities of daily living and a low quality of life,” Ms. Costa said.

Nearly one-third (29%) of patients in the inadequate pain relief group (n = 765) took medication, versus 15% of patients in the adequate pain relief group (n = 270). This was mostly NSAIDs, but also included analgesics and antipyretics, and in a few cases (4.8% vs. 1.3%), simple opioids.

“We know that current care is not concordant with recommendations,” said Ms. Costa, noting that medication being used as first-line treatment and core nonpharmacologic interventions are being offered to less than half of patients who are eligible.

In addition, the rate for total joint replacement has increased globally, and pain is an important predictor for this.

“So, we need to evaluate pain control and current management offered to people with hip or knee arthritis to identify to identify areas for improvement,” Ms. Costa said.

High rates of prescription opioid use before TKA

In a separate study also presented at the congress, Daniel Rhon, DPT, DSc, director of musculoskeletal research in primary care at Brooke Army Medical Center in San Antonio, gave a worrying glimpse of high rates of opioid use in the 4 years before total knee arthroplasty (TKA).

Using data from the U.S. Military Health System, the records of all individuals who had a knee replacement procedure between January 2017 and December 2018 were studied, to identify and characterize the use of prescription opioids.

Of the 46,362 individuals, 52.9% had prior opioid use, despite the fact that “opioids are not recommended for the management of knee OA,” said Dr. Rhon.

He also reported that as many as 40% of those who had at least one prescription for opioids had received a high-potency drug, such as fentanyl or oxycodone. The mean age of participants overall was 65 years, with a higher mean for those receiving opioids than those who did not (68 vs. 61.5 years). Data on sex and ethnicity were not available in time for presentation at the congress.

“Most of these individuals are getting these opioid prescriptions probably within 6 months, which maybe aligns with escalation of pain and maybe the decision to have that knee replacement,” Dr. Rhon said. Individuals that used opioids filled their most recent prescription a median of 146 days before TKA to surgery, with a mean of 317 days.

“You can’t always link the reason for the opioid prescription, that’s not really clear in the database,” he admitted; however, an analysis was performed to check if other surgeries had been performed that may have warranted the opioid treatment. The results revealed that very few of the opioid users (4%-7%) had undergone another type of surgical procedure.

“So, we feel a little bit better, that these findings weren’t for other surgical procedures,” said Dr. Rhon. He added that future qualitative research was needed to understand why health care professionals were prescribing opioids, and why patients felt like they needed them.

“That’s bad,” Haxby Abbott, PhD, DPT, a research professor at the University of Otago, Dunedin, New Zealand, commented on Twitter.

Dr. Abbott, who was not involved in the study, added: “We’ve done a similar study of the whole NZ population [currently under review] – similar to Australia and not nearly as bad as you found. That needs urgent attention.”
 

Sharp rise in opioid use 2 years before TKA

Lower rates of opioid use before TKA were seen in two European cohorts, at 43% in England and 33% in Sweden, as reported by Clara Hellberg, PhD, MD, of Lund (Sweden) University. However, rates had increased over a 10-year study period from a respective 23% and 16%, with a sharp increase in use in the 2 years before knee replacement.

The analysis was based on 49,043 patients from the English national database Clinical Practice Research Datalink, and 5,955 patients from the Swedish Skåne Healthcare register who had undergone total knee replacement between 2015 and 2019 and were matched by age, sex and general practice to individuals not undergoing knee replacement.

The prevalence ratio for using opioids over a 10-year period increased from 1.6 to 2.7 in England, and from 1.6 to 2.6 in Sweden.

“While the overall prevalence of opioid use was higher in England, the majority of both cases and controls were using weak opioids,” Dr. Hellberg said.

“Codeine was classified as a weak opioid, whereas morphine was classified as a strong opioid,” she added.

In contrast, the proportion of people using strong opioids in Sweden was greater than in England, she said.

The high opioid use found in the study highlights “the need for better opioid stewardship, and the availability of acceptable, effective alternatives,” Dr. Hellberg and associates concluded in their abstract.

The study presented by Ms. Costa was funded by the Portuguese national funding agency for science, research and technology and by an independent research grant from Pfizer. Dr. Rhon acknowledged grant funding from the National Institutes of Health and the U.S. Department of Defense. Dr. Hellberg had no conflicts of interest to disclose.

Inadequate pain relief was recorded in 68.8% of a sample of people with hip or knee OA who participated in the population-based EpiReumaPt study, researchers reported at the OARSI 2022 World Congress.

“This can be explained by a lack of effectiveness of current management strategies, low uptake of recommended interventions by health care professionals, and also by low adherence by patients to medication and lifestyle interventions,” said Daniela Sofia Albino Costa, MSc, a PhD student at NOVA University Lisbon.

BackyardProduction/Thinkstock

In addition to looking at the prevalence of inadequate pain relief ­– defined as a score of 5 or higher on the Numeric Pain Rating Scale (NPRS) – the study she presented at the congress, which was sponsored by the Osteoarthritis Research Society International, looked at the predictors for inadequate pain control.

It was found that being female, obesity, and having multimorbidity doubled the risk of inadequate versus adequate pain control, with respective odds ratios of 2.32 (P < .001), 2.26 (P = .006), and 2.07 (P = .001). Overweight was also associated with an increased odds ratio for poor pain control (OR, 1.84; P = .0035).

“We found that patients with inadequate pain relief also have a low performance on activities of daily living and a low quality of life,” Ms. Costa said.

Nearly one-third (29%) of patients in the inadequate pain relief group (n = 765) took medication, versus 15% of patients in the adequate pain relief group (n = 270). This was mostly NSAIDs, but also included analgesics and antipyretics, and in a few cases (4.8% vs. 1.3%), simple opioids.

“We know that current care is not concordant with recommendations,” said Ms. Costa, noting that medication being used as first-line treatment and core nonpharmacologic interventions are being offered to less than half of patients who are eligible.

In addition, the rate for total joint replacement has increased globally, and pain is an important predictor for this.

“So, we need to evaluate pain control and current management offered to people with hip or knee arthritis to identify to identify areas for improvement,” Ms. Costa said.

High rates of prescription opioid use before TKA

In a separate study also presented at the congress, Daniel Rhon, DPT, DSc, director of musculoskeletal research in primary care at Brooke Army Medical Center in San Antonio, gave a worrying glimpse of high rates of opioid use in the 4 years before total knee arthroplasty (TKA).

Using data from the U.S. Military Health System, the records of all individuals who had a knee replacement procedure between January 2017 and December 2018 were studied, to identify and characterize the use of prescription opioids.

Of the 46,362 individuals, 52.9% had prior opioid use, despite the fact that “opioids are not recommended for the management of knee OA,” said Dr. Rhon.

He also reported that as many as 40% of those who had at least one prescription for opioids had received a high-potency drug, such as fentanyl or oxycodone. The mean age of participants overall was 65 years, with a higher mean for those receiving opioids than those who did not (68 vs. 61.5 years). Data on sex and ethnicity were not available in time for presentation at the congress.

“Most of these individuals are getting these opioid prescriptions probably within 6 months, which maybe aligns with escalation of pain and maybe the decision to have that knee replacement,” Dr. Rhon said. Individuals that used opioids filled their most recent prescription a median of 146 days before TKA to surgery, with a mean of 317 days.

“You can’t always link the reason for the opioid prescription, that’s not really clear in the database,” he admitted; however, an analysis was performed to check if other surgeries had been performed that may have warranted the opioid treatment. The results revealed that very few of the opioid users (4%-7%) had undergone another type of surgical procedure.

“So, we feel a little bit better, that these findings weren’t for other surgical procedures,” said Dr. Rhon. He added that future qualitative research was needed to understand why health care professionals were prescribing opioids, and why patients felt like they needed them.

“That’s bad,” Haxby Abbott, PhD, DPT, a research professor at the University of Otago, Dunedin, New Zealand, commented on Twitter.

Dr. Abbott, who was not involved in the study, added: “We’ve done a similar study of the whole NZ population [currently under review] – similar to Australia and not nearly as bad as you found. That needs urgent attention.”
 

Sharp rise in opioid use 2 years before TKA

Lower rates of opioid use before TKA were seen in two European cohorts, at 43% in England and 33% in Sweden, as reported by Clara Hellberg, PhD, MD, of Lund (Sweden) University. However, rates had increased over a 10-year study period from a respective 23% and 16%, with a sharp increase in use in the 2 years before knee replacement.

The analysis was based on 49,043 patients from the English national database Clinical Practice Research Datalink, and 5,955 patients from the Swedish Skåne Healthcare register who had undergone total knee replacement between 2015 and 2019 and were matched by age, sex and general practice to individuals not undergoing knee replacement.

The prevalence ratio for using opioids over a 10-year period increased from 1.6 to 2.7 in England, and from 1.6 to 2.6 in Sweden.

“While the overall prevalence of opioid use was higher in England, the majority of both cases and controls were using weak opioids,” Dr. Hellberg said.

“Codeine was classified as a weak opioid, whereas morphine was classified as a strong opioid,” she added.

In contrast, the proportion of people using strong opioids in Sweden was greater than in England, she said.

The high opioid use found in the study highlights “the need for better opioid stewardship, and the availability of acceptable, effective alternatives,” Dr. Hellberg and associates concluded in their abstract.

The study presented by Ms. Costa was funded by the Portuguese national funding agency for science, research and technology and by an independent research grant from Pfizer. Dr. Rhon acknowledged grant funding from the National Institutes of Health and the U.S. Department of Defense. Dr. Hellberg had no conflicts of interest to disclose.

Key takeaways

Metformin may be associated with a lower risk of neurodegenerative disease, in particular when the drug has been prescribed for at least 4 years, according to a systematic review and meta-analysis of longitudinal data.

However, the heterogeneity between the available studies and the potential heterogeneity of diagnostic criteria may mean that validation studies are needed.
 

Why is this important?

Data suggest that metformin, the most commonly prescribed antidiabetic drug, may be neuroprotective, while diabetes is associated with an excess risk of neurodegenerative disease. Results of studies conducted specifically to investigate the benefit of the antidiabetic drug on cognitive prognosis have been unclear. A meta-analysis was published in 2020, but it included cross-sectional and case-control studies. Given the long observation period needed to measure such an outcome, only cohort studies conducted over several years can provide reliable results. This new meta-analysis attempts to circumvent this limitation.

Methods

The meta-analysis was conducted using studies published up to March 2021 that met the inclusion criteria (population-based cohort studies published in English in which the administration of metformin and associated risk of exposure were reported).

Main results

Twelve studies were included in this analysis, of which eight were retrospective and 11 were considered to be of good methodologic quality. In total, 194,792 patients were included.

Pooled data showed that the relative risk associated with onset of neurodegenerative disease was 0.77 (95% CI, 0.67-0.88) for patients with diabetes taking metformin versus those not taking metformin. However, heterogeneity between studies was high (I2; 78.8%; P < .001).

The effect was greater with longer metformin use, with an RR of 0.29 (95% CI, 0.13-0.44) for those who took metformin for 4 years or more. Similarly, the studies conducted in Asian countries versus other locations suggested an added benefit for this population (RR, 0.69; 95% CI, 0.64-0.74).

Sensitivity analyses confirmed these results, and subtype analyses showed no difference according to the nature of the neurodegenerative disease.

A version of this article first appeared on Univadis.

Key takeaways

Metformin may be associated with a lower risk of neurodegenerative disease, in particular when the drug has been prescribed for at least 4 years, according to a systematic review and meta-analysis of longitudinal data.

However, the heterogeneity between the available studies and the potential heterogeneity of diagnostic criteria may mean that validation studies are needed.
 

Why is this important?

Data suggest that metformin, the most commonly prescribed antidiabetic drug, may be neuroprotective, while diabetes is associated with an excess risk of neurodegenerative disease. Results of studies conducted specifically to investigate the benefit of the antidiabetic drug on cognitive prognosis have been unclear. A meta-analysis was published in 2020, but it included cross-sectional and case-control studies. Given the long observation period needed to measure such an outcome, only cohort studies conducted over several years can provide reliable results. This new meta-analysis attempts to circumvent this limitation.

Methods

The meta-analysis was conducted using studies published up to March 2021 that met the inclusion criteria (population-based cohort studies published in English in which the administration of metformin and associated risk of exposure were reported).

Main results

Twelve studies were included in this analysis, of which eight were retrospective and 11 were considered to be of good methodologic quality. In total, 194,792 patients were included.

Pooled data showed that the relative risk associated with onset of neurodegenerative disease was 0.77 (95% CI, 0.67-0.88) for patients with diabetes taking metformin versus those not taking metformin. However, heterogeneity between studies was high (I2; 78.8%; P < .001).

The effect was greater with longer metformin use, with an RR of 0.29 (95% CI, 0.13-0.44) for those who took metformin for 4 years or more. Similarly, the studies conducted in Asian countries versus other locations suggested an added benefit for this population (RR, 0.69; 95% CI, 0.64-0.74).

Sensitivity analyses confirmed these results, and subtype analyses showed no difference according to the nature of the neurodegenerative disease.

A version of this article first appeared on Univadis.

Key takeaways

Metformin may be associated with a lower risk of neurodegenerative disease, in particular when the drug has been prescribed for at least 4 years, according to a systematic review and meta-analysis of longitudinal data.

However, the heterogeneity between the available studies and the potential heterogeneity of diagnostic criteria may mean that validation studies are needed.
 

Why is this important?

Data suggest that metformin, the most commonly prescribed antidiabetic drug, may be neuroprotective, while diabetes is associated with an excess risk of neurodegenerative disease. Results of studies conducted specifically to investigate the benefit of the antidiabetic drug on cognitive prognosis have been unclear. A meta-analysis was published in 2020, but it included cross-sectional and case-control studies. Given the long observation period needed to measure such an outcome, only cohort studies conducted over several years can provide reliable results. This new meta-analysis attempts to circumvent this limitation.

Methods

The meta-analysis was conducted using studies published up to March 2021 that met the inclusion criteria (population-based cohort studies published in English in which the administration of metformin and associated risk of exposure were reported).

Main results

Twelve studies were included in this analysis, of which eight were retrospective and 11 were considered to be of good methodologic quality. In total, 194,792 patients were included.

Pooled data showed that the relative risk associated with onset of neurodegenerative disease was 0.77 (95% CI, 0.67-0.88) for patients with diabetes taking metformin versus those not taking metformin. However, heterogeneity between studies was high (I2; 78.8%; P < .001).

The effect was greater with longer metformin use, with an RR of 0.29 (95% CI, 0.13-0.44) for those who took metformin for 4 years or more. Similarly, the studies conducted in Asian countries versus other locations suggested an added benefit for this population (RR, 0.69; 95% CI, 0.64-0.74).

Sensitivity analyses confirmed these results, and subtype analyses showed no difference according to the nature of the neurodegenerative disease.

A version of this article first appeared on Univadis.