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Higher Prostate Cancer Rates Seen in Black Men, but Advanced Cases Similar to White Men
There was a substantial difference in prostate cancer diagnosis across ethnic groups: 25% of Black men with a raised PSA were diagnosed with prostate cancer within 1 year of being tested, compared with 20% of White men and 13% of Asian men, in the analysis of a large primary care cohort in the United Kingdom.
Incidence of advanced prostate cancer for Asian men with a raised PSA result was 4.5%, compared with 7.5% for White men and 7.0% for Black men.
Men included in the study were aged 40 and older and had no prior cancer diagnosis. Their ethnicity and PSA test result were logged in a national dataset between 2010 and 2017.
The study of more than 730,000 men, published in BMC Medicine, didn’t explore reasons for the differences, but experts offer their thoughts on what led to the findings and what these results imply.
Why the Higher Diagnosis Rates but Not More Advanced Disease in Black Men?
Lead author Liz Down, a graduate research assistant at the University of Exeter, Exeter, England, suggests the higher diagnosis rates but not more advanced disease in Black men may be linked to genetic variations.
Her team’s studies have shown that Black men in the United Kingdom and United States have higher levels of PSA. The PSA value is used to identify patients who might benefit from specialist investigation, and current guidelines in the UK and US don’t distinguish between ethnic groups.
As most men have slow-growing prostate cancer, this may lead to a disproportionately higher number of Black men being diagnosed with prostate cancer, she said.
“One possible interpretation,” Ms. Down notes, “is that prostate cancer follows a similar trajectory in Black and White men. What is different, however, is that Black men have higher PSA levels.”
As to why the advanced-cancer incidence is similar in Black and White patients in the study, Daniel George, MD, director of genitourinary oncology at Duke Cancer Institute in Durham, North Carolina, says it’s important to understand that the Black men in this study “are not necessarily representative of the Black population at large.”
In this study, “they’re a little bit more healthcare inclined,” Dr. George notes. The study population is actively seeking the PSA test. Their socioeconomic profile might be closer to their White counterparts’, and that may make results more similar, he said.
“It’s possible that because this is a screening and not just men coming in for symptoms or cause, that we’re not seeing as much advanced disease,” he continued.
Amar Kishan, MD, chief of the genitourinary oncology service at University of California Los Angeles (UCLA) Health, says the genomic factors and environmental stressors that lead to elevated PSA counts don’t necessarily translate into aggressiveness of disease.
Why do Different Races have Different Prostate Cancer Risk?
Dr. George points out that the study also highlights that Asian men were significantly less likely to be diagnosed with prostate cancer within 1 year of the test.
The reasons for differences in prostate risk by race are complex, he notes. There are some clues that biologic factors may be at work. For instance, early puberty has a link to prostate cancer as it does to breast cancer, and height is also associated with a greater risk of prostate cancer, Dr. George said.
It’s not necessarily a racial association but there are some biological factors associated with prostate cancer later in life, he explained. “These may be enriched in certain populations, including northern Europeans and patients with African ancestries.”
The study also notes that Black men are more likely to die from prostate cancer than are White men, and Asian men are less likely than White or Black men to die from it.
Ms. Down said the difference in prostate cancer mortality between Black vs White men, in particular, may be related to a number of factors, and age, and lifetime risk of prostate cancer may play a major role, at least in the UK.
Should There Be Different ‘Normal’ PSA Levels for Different Races?
Dr. George says there is likely a need to change the system because a PSA level in one race may not signal the same risk it does in another. So medicine probably needs to standardize what a “normal” PSA is by race, he says, adding that he is a coauthor of an upcoming paper regarding that issue.
The lowest instances of prostate cancer were in Asian patients so this isn’t just a Black and White issue, Dr. George notes. “Being able to establish benchmarks by race and ethnicity is something that is probably needed in the field,” he says.
Dr. Kishan, on the other hand, says data from this study are not enough to support differentiating PSA levels based on race. He noted a limitation of the study is that it was not able to calculate the false-negative rate of PSA tests.
What are the Implications for Treating and Screening for Prostate Cancer
Dr. Kishan says there may be a role for increased intensity of screening, whether at an earlier age or with different intervals, but prostate cancer treatment should not differ by race.
“Our prior study, as well as others,” he says, “have shown that when you balance Black and White patients for every factor that might impact prognosis other than race — such as age, disease aggressiveness, etc. — Black men actually tend to have better outcomes than White men. Thus, it would mean potentially overtreating (i.e., causing unnecessary side effects) to increase treatment intensity purely based on race with the available data.”
According to the paper, prostate cancer incidence in men with higher PSA levels increases with increasing age, even when using age-adjusted thresholds.
Dr. George says we know from this study and other studies as well that Black men are more likely to be diagnosed with prostate at a younger age. “Therefore, we probably need to be thinking about screening Black men starting at a younger age. These are the men who are most likely to benefit from an intervention — patients who have life expectancies of 20 years or more.”
What are the Downsides to Overdiagnosing Prostate Cancer in Men?
“It’s one of the biggest concerns that men have in proactively seeking healthcare,” Dr. George says. “They’re more likely to undergo treatment for this disease if they’re getting screened because (clinicians are) more likely to find it.”
Some of those men, he says, are going to undergo treatment for disease that won’t ultimately kill them, but may cause complications the men shouldn’t have had at all or otherwise may have had later.
“Overtreatment is a real concern. That’s why active surveillance is so important to minimize overtreatment of patients by finding out which cancers are low risk for progression and which are becoming more aggressive,” Dr. George says.
Authors of the study write that “the potential for overdiagnosis and the subsequent psychological and physical impact of diagnosis and treatment is an important consideration.”
All authors of the new paper received financial support from Cancer Research UK, the National Institute for Health and Care Research (NIHR), and the Higgins family for the submitted work.
Dr. George reports no relevant financial relationships.
Dr. Kishan reports consulting fees and speaking honoraria from Varian Medical Systems, Janssen, and Boston Scientific; research funding from PointBioPharma, Lantheus, and Janssen; and serving on advisory boards for Lantheus, Janssen and Boston Scientific.
There was a substantial difference in prostate cancer diagnosis across ethnic groups: 25% of Black men with a raised PSA were diagnosed with prostate cancer within 1 year of being tested, compared with 20% of White men and 13% of Asian men, in the analysis of a large primary care cohort in the United Kingdom.
Incidence of advanced prostate cancer for Asian men with a raised PSA result was 4.5%, compared with 7.5% for White men and 7.0% for Black men.
Men included in the study were aged 40 and older and had no prior cancer diagnosis. Their ethnicity and PSA test result were logged in a national dataset between 2010 and 2017.
The study of more than 730,000 men, published in BMC Medicine, didn’t explore reasons for the differences, but experts offer their thoughts on what led to the findings and what these results imply.
Why the Higher Diagnosis Rates but Not More Advanced Disease in Black Men?
Lead author Liz Down, a graduate research assistant at the University of Exeter, Exeter, England, suggests the higher diagnosis rates but not more advanced disease in Black men may be linked to genetic variations.
Her team’s studies have shown that Black men in the United Kingdom and United States have higher levels of PSA. The PSA value is used to identify patients who might benefit from specialist investigation, and current guidelines in the UK and US don’t distinguish between ethnic groups.
As most men have slow-growing prostate cancer, this may lead to a disproportionately higher number of Black men being diagnosed with prostate cancer, she said.
“One possible interpretation,” Ms. Down notes, “is that prostate cancer follows a similar trajectory in Black and White men. What is different, however, is that Black men have higher PSA levels.”
As to why the advanced-cancer incidence is similar in Black and White patients in the study, Daniel George, MD, director of genitourinary oncology at Duke Cancer Institute in Durham, North Carolina, says it’s important to understand that the Black men in this study “are not necessarily representative of the Black population at large.”
In this study, “they’re a little bit more healthcare inclined,” Dr. George notes. The study population is actively seeking the PSA test. Their socioeconomic profile might be closer to their White counterparts’, and that may make results more similar, he said.
“It’s possible that because this is a screening and not just men coming in for symptoms or cause, that we’re not seeing as much advanced disease,” he continued.
Amar Kishan, MD, chief of the genitourinary oncology service at University of California Los Angeles (UCLA) Health, says the genomic factors and environmental stressors that lead to elevated PSA counts don’t necessarily translate into aggressiveness of disease.
Why do Different Races have Different Prostate Cancer Risk?
Dr. George points out that the study also highlights that Asian men were significantly less likely to be diagnosed with prostate cancer within 1 year of the test.
The reasons for differences in prostate risk by race are complex, he notes. There are some clues that biologic factors may be at work. For instance, early puberty has a link to prostate cancer as it does to breast cancer, and height is also associated with a greater risk of prostate cancer, Dr. George said.
It’s not necessarily a racial association but there are some biological factors associated with prostate cancer later in life, he explained. “These may be enriched in certain populations, including northern Europeans and patients with African ancestries.”
The study also notes that Black men are more likely to die from prostate cancer than are White men, and Asian men are less likely than White or Black men to die from it.
Ms. Down said the difference in prostate cancer mortality between Black vs White men, in particular, may be related to a number of factors, and age, and lifetime risk of prostate cancer may play a major role, at least in the UK.
Should There Be Different ‘Normal’ PSA Levels for Different Races?
Dr. George says there is likely a need to change the system because a PSA level in one race may not signal the same risk it does in another. So medicine probably needs to standardize what a “normal” PSA is by race, he says, adding that he is a coauthor of an upcoming paper regarding that issue.
The lowest instances of prostate cancer were in Asian patients so this isn’t just a Black and White issue, Dr. George notes. “Being able to establish benchmarks by race and ethnicity is something that is probably needed in the field,” he says.
Dr. Kishan, on the other hand, says data from this study are not enough to support differentiating PSA levels based on race. He noted a limitation of the study is that it was not able to calculate the false-negative rate of PSA tests.
What are the Implications for Treating and Screening for Prostate Cancer
Dr. Kishan says there may be a role for increased intensity of screening, whether at an earlier age or with different intervals, but prostate cancer treatment should not differ by race.
“Our prior study, as well as others,” he says, “have shown that when you balance Black and White patients for every factor that might impact prognosis other than race — such as age, disease aggressiveness, etc. — Black men actually tend to have better outcomes than White men. Thus, it would mean potentially overtreating (i.e., causing unnecessary side effects) to increase treatment intensity purely based on race with the available data.”
According to the paper, prostate cancer incidence in men with higher PSA levels increases with increasing age, even when using age-adjusted thresholds.
Dr. George says we know from this study and other studies as well that Black men are more likely to be diagnosed with prostate at a younger age. “Therefore, we probably need to be thinking about screening Black men starting at a younger age. These are the men who are most likely to benefit from an intervention — patients who have life expectancies of 20 years or more.”
What are the Downsides to Overdiagnosing Prostate Cancer in Men?
“It’s one of the biggest concerns that men have in proactively seeking healthcare,” Dr. George says. “They’re more likely to undergo treatment for this disease if they’re getting screened because (clinicians are) more likely to find it.”
Some of those men, he says, are going to undergo treatment for disease that won’t ultimately kill them, but may cause complications the men shouldn’t have had at all or otherwise may have had later.
“Overtreatment is a real concern. That’s why active surveillance is so important to minimize overtreatment of patients by finding out which cancers are low risk for progression and which are becoming more aggressive,” Dr. George says.
Authors of the study write that “the potential for overdiagnosis and the subsequent psychological and physical impact of diagnosis and treatment is an important consideration.”
All authors of the new paper received financial support from Cancer Research UK, the National Institute for Health and Care Research (NIHR), and the Higgins family for the submitted work.
Dr. George reports no relevant financial relationships.
Dr. Kishan reports consulting fees and speaking honoraria from Varian Medical Systems, Janssen, and Boston Scientific; research funding from PointBioPharma, Lantheus, and Janssen; and serving on advisory boards for Lantheus, Janssen and Boston Scientific.
There was a substantial difference in prostate cancer diagnosis across ethnic groups: 25% of Black men with a raised PSA were diagnosed with prostate cancer within 1 year of being tested, compared with 20% of White men and 13% of Asian men, in the analysis of a large primary care cohort in the United Kingdom.
Incidence of advanced prostate cancer for Asian men with a raised PSA result was 4.5%, compared with 7.5% for White men and 7.0% for Black men.
Men included in the study were aged 40 and older and had no prior cancer diagnosis. Their ethnicity and PSA test result were logged in a national dataset between 2010 and 2017.
The study of more than 730,000 men, published in BMC Medicine, didn’t explore reasons for the differences, but experts offer their thoughts on what led to the findings and what these results imply.
Why the Higher Diagnosis Rates but Not More Advanced Disease in Black Men?
Lead author Liz Down, a graduate research assistant at the University of Exeter, Exeter, England, suggests the higher diagnosis rates but not more advanced disease in Black men may be linked to genetic variations.
Her team’s studies have shown that Black men in the United Kingdom and United States have higher levels of PSA. The PSA value is used to identify patients who might benefit from specialist investigation, and current guidelines in the UK and US don’t distinguish between ethnic groups.
As most men have slow-growing prostate cancer, this may lead to a disproportionately higher number of Black men being diagnosed with prostate cancer, she said.
“One possible interpretation,” Ms. Down notes, “is that prostate cancer follows a similar trajectory in Black and White men. What is different, however, is that Black men have higher PSA levels.”
As to why the advanced-cancer incidence is similar in Black and White patients in the study, Daniel George, MD, director of genitourinary oncology at Duke Cancer Institute in Durham, North Carolina, says it’s important to understand that the Black men in this study “are not necessarily representative of the Black population at large.”
In this study, “they’re a little bit more healthcare inclined,” Dr. George notes. The study population is actively seeking the PSA test. Their socioeconomic profile might be closer to their White counterparts’, and that may make results more similar, he said.
“It’s possible that because this is a screening and not just men coming in for symptoms or cause, that we’re not seeing as much advanced disease,” he continued.
Amar Kishan, MD, chief of the genitourinary oncology service at University of California Los Angeles (UCLA) Health, says the genomic factors and environmental stressors that lead to elevated PSA counts don’t necessarily translate into aggressiveness of disease.
Why do Different Races have Different Prostate Cancer Risk?
Dr. George points out that the study also highlights that Asian men were significantly less likely to be diagnosed with prostate cancer within 1 year of the test.
The reasons for differences in prostate risk by race are complex, he notes. There are some clues that biologic factors may be at work. For instance, early puberty has a link to prostate cancer as it does to breast cancer, and height is also associated with a greater risk of prostate cancer, Dr. George said.
It’s not necessarily a racial association but there are some biological factors associated with prostate cancer later in life, he explained. “These may be enriched in certain populations, including northern Europeans and patients with African ancestries.”
The study also notes that Black men are more likely to die from prostate cancer than are White men, and Asian men are less likely than White or Black men to die from it.
Ms. Down said the difference in prostate cancer mortality between Black vs White men, in particular, may be related to a number of factors, and age, and lifetime risk of prostate cancer may play a major role, at least in the UK.
Should There Be Different ‘Normal’ PSA Levels for Different Races?
Dr. George says there is likely a need to change the system because a PSA level in one race may not signal the same risk it does in another. So medicine probably needs to standardize what a “normal” PSA is by race, he says, adding that he is a coauthor of an upcoming paper regarding that issue.
The lowest instances of prostate cancer were in Asian patients so this isn’t just a Black and White issue, Dr. George notes. “Being able to establish benchmarks by race and ethnicity is something that is probably needed in the field,” he says.
Dr. Kishan, on the other hand, says data from this study are not enough to support differentiating PSA levels based on race. He noted a limitation of the study is that it was not able to calculate the false-negative rate of PSA tests.
What are the Implications for Treating and Screening for Prostate Cancer
Dr. Kishan says there may be a role for increased intensity of screening, whether at an earlier age or with different intervals, but prostate cancer treatment should not differ by race.
“Our prior study, as well as others,” he says, “have shown that when you balance Black and White patients for every factor that might impact prognosis other than race — such as age, disease aggressiveness, etc. — Black men actually tend to have better outcomes than White men. Thus, it would mean potentially overtreating (i.e., causing unnecessary side effects) to increase treatment intensity purely based on race with the available data.”
According to the paper, prostate cancer incidence in men with higher PSA levels increases with increasing age, even when using age-adjusted thresholds.
Dr. George says we know from this study and other studies as well that Black men are more likely to be diagnosed with prostate at a younger age. “Therefore, we probably need to be thinking about screening Black men starting at a younger age. These are the men who are most likely to benefit from an intervention — patients who have life expectancies of 20 years or more.”
What are the Downsides to Overdiagnosing Prostate Cancer in Men?
“It’s one of the biggest concerns that men have in proactively seeking healthcare,” Dr. George says. “They’re more likely to undergo treatment for this disease if they’re getting screened because (clinicians are) more likely to find it.”
Some of those men, he says, are going to undergo treatment for disease that won’t ultimately kill them, but may cause complications the men shouldn’t have had at all or otherwise may have had later.
“Overtreatment is a real concern. That’s why active surveillance is so important to minimize overtreatment of patients by finding out which cancers are low risk for progression and which are becoming more aggressive,” Dr. George says.
Authors of the study write that “the potential for overdiagnosis and the subsequent psychological and physical impact of diagnosis and treatment is an important consideration.”
All authors of the new paper received financial support from Cancer Research UK, the National Institute for Health and Care Research (NIHR), and the Higgins family for the submitted work.
Dr. George reports no relevant financial relationships.
Dr. Kishan reports consulting fees and speaking honoraria from Varian Medical Systems, Janssen, and Boston Scientific; research funding from PointBioPharma, Lantheus, and Janssen; and serving on advisory boards for Lantheus, Janssen and Boston Scientific.
FROM BMC MEDICINE
Few Pediatricians Comfortable Treating Youth With OUD
An estimated 1 in 100 adolescents ages 12-17 years in the United States have an opioid use disorder (OUD). But fewer than 5% of adolescents with OUD get buprenorphine or naltrexone, though the treatments are recommended by the American Academy of Pediatrics (AAP), new data show.
Meanwhile, adolescent drug overdose deaths more than doubled between 2019 and 2021, with most involving opioids.
Scott E. Hadland, MD, MPH, with the Division of Adolescent and Young Adult Medicine at Mass General for Children in Boston, and colleagues detailed the extent of the treatment gap and barriers to prescribing and caring for youth with OUD in primary care in a research letter published February 26 in JAMA Pediatrics.
Dr. Hadland’s team mailed 1,681 US pediatricians a survey and the response rate was 43.0%. Researchers included in the sample 474 primary care pediatricians who care for adolescents.
Who Should Treat OUD?
Most respondents (average age, 49.5; 74.0% female) agreed or strongly agreed that it is their responsibility to identify substance use disorders (93.9%) and refer patients to treatment (97.4%).
Fewer agreed or strongly agreed that it is their responsibility to treat substance use disorders (20.3%) or prescribe medications (12.4%). Fewer than half of the respondents said they felt prepared or very prepared to counsel adolescents on opioid use (48.3%) compared with those comfortable counseling on alcohol (87.1%), cannabis (81.7%), and e-cigarette use (80.1%; P < .001).
Pediatricians were less likely to provide counseling (63.0%) and more likely to refer patients to care off-site (71.8%) for opioid use than for alcohol (87.7% and 51.7%); cannabis (88.9% and 45.4%); or e-cigarette use (91.6% and 26.5%) (P < .001 for all comparisons).
Training Lacking in Residency Programs
“These results reveal an opportunity for greater workforce training in line with a 2019 survey showing fewer than 1 in 3 US pediatric residency programs included education on prescribing OUD medications,” the authors wrote. Training focused on treating OUD in primary care, including prescribing medications and addressing possible misperceptions, may be needed,” they noted.
The survey predated the elimination in 2023 of the federal buprenorphine waiver requirement, which made prescribing buprenorphine easier, so these results do not reflect any changes from that elimination, they wrote.
Sharon Levy, MD, MPH, chief of the Division of Addiction Medicine at Boston Children’s Hospital and professor of pediatrics at Harvard Medical School in Boston, who was not part of this study, said more education on addiction medicine is needed for general pediatricians.
She said it’s time to push beyond the current framework of Screening, Brief Intervention, Referral to Treatment (SBIRT), because that doesn’t include “prescribing medications to manage withdrawal or suppress cravings or the use of lab testing, both of which could be accomplished in primary care.”
Dr. Levy said she considers substance use disorders the same way she considers other chronic conditions: Most patients can be treated in primary care. “Specialty care and higher levels of care need to be available for patients who are most complicated and/or having a flare of their condition.”
“In my opinion, most teens with opioid use disorder can and should be treated in primary care. I worry about referring teens with opioid use disorder to get medication somewhere else because there are few places that deliver this service to this age group. Additionally, teens and families are not always willing to pursue a referral, and many will get lost along the way.”
Promising Models
At Boston Children’s, she said, the Division of Addiction Medicine has created a consultation call line that primary care providers can call for help with any questions about teen substance use.
After running the consultation for about a year, she said, the program wanted to add ways to help patients directly and hired and trained social workers who can see pediatric patients with substance use problems for counseling via telemedicine. “The program also now supports group therapy for pediatric patients and parents, so that primary care providers can refer patients directly to group therapy,” Dr. Levy said.
The growth of telehealth since the pandemic may allow for new models of care.
“For example, now our Adolescent Substance Use and Addiction Program at Boston Children’s Hospital can provide services, including medication induction and follow-up, virtually,” Dr. Levy said. “This allows us to treat young people anywhere in the state. There have been instances in which a primary care provider referred us patients with OUD and then partnered with us, including performing physicals for teens who could not get to Boston to see us in person. At the end of the day, the more models we can come up with the better.”
Dr. Hadland reported honoraria from the AAP outside the submitted work. Two coauthors reported receiving salary support from the AAP during the conduct of the study. A coauthor reported serving as the chair of the AAP Committee on Substance Use and Prevention outside the submitted work. This work was supported by a grant from the Conrad N. Hilton Foundation via the AAP. Dr. Sharon Levy’s husband, Ofer Levy, MD, PhD, is director of the Precision Vaccines Program at Boston Children’s Hospital.
An estimated 1 in 100 adolescents ages 12-17 years in the United States have an opioid use disorder (OUD). But fewer than 5% of adolescents with OUD get buprenorphine or naltrexone, though the treatments are recommended by the American Academy of Pediatrics (AAP), new data show.
Meanwhile, adolescent drug overdose deaths more than doubled between 2019 and 2021, with most involving opioids.
Scott E. Hadland, MD, MPH, with the Division of Adolescent and Young Adult Medicine at Mass General for Children in Boston, and colleagues detailed the extent of the treatment gap and barriers to prescribing and caring for youth with OUD in primary care in a research letter published February 26 in JAMA Pediatrics.
Dr. Hadland’s team mailed 1,681 US pediatricians a survey and the response rate was 43.0%. Researchers included in the sample 474 primary care pediatricians who care for adolescents.
Who Should Treat OUD?
Most respondents (average age, 49.5; 74.0% female) agreed or strongly agreed that it is their responsibility to identify substance use disorders (93.9%) and refer patients to treatment (97.4%).
Fewer agreed or strongly agreed that it is their responsibility to treat substance use disorders (20.3%) or prescribe medications (12.4%). Fewer than half of the respondents said they felt prepared or very prepared to counsel adolescents on opioid use (48.3%) compared with those comfortable counseling on alcohol (87.1%), cannabis (81.7%), and e-cigarette use (80.1%; P < .001).
Pediatricians were less likely to provide counseling (63.0%) and more likely to refer patients to care off-site (71.8%) for opioid use than for alcohol (87.7% and 51.7%); cannabis (88.9% and 45.4%); or e-cigarette use (91.6% and 26.5%) (P < .001 for all comparisons).
Training Lacking in Residency Programs
“These results reveal an opportunity for greater workforce training in line with a 2019 survey showing fewer than 1 in 3 US pediatric residency programs included education on prescribing OUD medications,” the authors wrote. Training focused on treating OUD in primary care, including prescribing medications and addressing possible misperceptions, may be needed,” they noted.
The survey predated the elimination in 2023 of the federal buprenorphine waiver requirement, which made prescribing buprenorphine easier, so these results do not reflect any changes from that elimination, they wrote.
Sharon Levy, MD, MPH, chief of the Division of Addiction Medicine at Boston Children’s Hospital and professor of pediatrics at Harvard Medical School in Boston, who was not part of this study, said more education on addiction medicine is needed for general pediatricians.
She said it’s time to push beyond the current framework of Screening, Brief Intervention, Referral to Treatment (SBIRT), because that doesn’t include “prescribing medications to manage withdrawal or suppress cravings or the use of lab testing, both of which could be accomplished in primary care.”
Dr. Levy said she considers substance use disorders the same way she considers other chronic conditions: Most patients can be treated in primary care. “Specialty care and higher levels of care need to be available for patients who are most complicated and/or having a flare of their condition.”
“In my opinion, most teens with opioid use disorder can and should be treated in primary care. I worry about referring teens with opioid use disorder to get medication somewhere else because there are few places that deliver this service to this age group. Additionally, teens and families are not always willing to pursue a referral, and many will get lost along the way.”
Promising Models
At Boston Children’s, she said, the Division of Addiction Medicine has created a consultation call line that primary care providers can call for help with any questions about teen substance use.
After running the consultation for about a year, she said, the program wanted to add ways to help patients directly and hired and trained social workers who can see pediatric patients with substance use problems for counseling via telemedicine. “The program also now supports group therapy for pediatric patients and parents, so that primary care providers can refer patients directly to group therapy,” Dr. Levy said.
The growth of telehealth since the pandemic may allow for new models of care.
“For example, now our Adolescent Substance Use and Addiction Program at Boston Children’s Hospital can provide services, including medication induction and follow-up, virtually,” Dr. Levy said. “This allows us to treat young people anywhere in the state. There have been instances in which a primary care provider referred us patients with OUD and then partnered with us, including performing physicals for teens who could not get to Boston to see us in person. At the end of the day, the more models we can come up with the better.”
Dr. Hadland reported honoraria from the AAP outside the submitted work. Two coauthors reported receiving salary support from the AAP during the conduct of the study. A coauthor reported serving as the chair of the AAP Committee on Substance Use and Prevention outside the submitted work. This work was supported by a grant from the Conrad N. Hilton Foundation via the AAP. Dr. Sharon Levy’s husband, Ofer Levy, MD, PhD, is director of the Precision Vaccines Program at Boston Children’s Hospital.
An estimated 1 in 100 adolescents ages 12-17 years in the United States have an opioid use disorder (OUD). But fewer than 5% of adolescents with OUD get buprenorphine or naltrexone, though the treatments are recommended by the American Academy of Pediatrics (AAP), new data show.
Meanwhile, adolescent drug overdose deaths more than doubled between 2019 and 2021, with most involving opioids.
Scott E. Hadland, MD, MPH, with the Division of Adolescent and Young Adult Medicine at Mass General for Children in Boston, and colleagues detailed the extent of the treatment gap and barriers to prescribing and caring for youth with OUD in primary care in a research letter published February 26 in JAMA Pediatrics.
Dr. Hadland’s team mailed 1,681 US pediatricians a survey and the response rate was 43.0%. Researchers included in the sample 474 primary care pediatricians who care for adolescents.
Who Should Treat OUD?
Most respondents (average age, 49.5; 74.0% female) agreed or strongly agreed that it is their responsibility to identify substance use disorders (93.9%) and refer patients to treatment (97.4%).
Fewer agreed or strongly agreed that it is their responsibility to treat substance use disorders (20.3%) or prescribe medications (12.4%). Fewer than half of the respondents said they felt prepared or very prepared to counsel adolescents on opioid use (48.3%) compared with those comfortable counseling on alcohol (87.1%), cannabis (81.7%), and e-cigarette use (80.1%; P < .001).
Pediatricians were less likely to provide counseling (63.0%) and more likely to refer patients to care off-site (71.8%) for opioid use than for alcohol (87.7% and 51.7%); cannabis (88.9% and 45.4%); or e-cigarette use (91.6% and 26.5%) (P < .001 for all comparisons).
Training Lacking in Residency Programs
“These results reveal an opportunity for greater workforce training in line with a 2019 survey showing fewer than 1 in 3 US pediatric residency programs included education on prescribing OUD medications,” the authors wrote. Training focused on treating OUD in primary care, including prescribing medications and addressing possible misperceptions, may be needed,” they noted.
The survey predated the elimination in 2023 of the federal buprenorphine waiver requirement, which made prescribing buprenorphine easier, so these results do not reflect any changes from that elimination, they wrote.
Sharon Levy, MD, MPH, chief of the Division of Addiction Medicine at Boston Children’s Hospital and professor of pediatrics at Harvard Medical School in Boston, who was not part of this study, said more education on addiction medicine is needed for general pediatricians.
She said it’s time to push beyond the current framework of Screening, Brief Intervention, Referral to Treatment (SBIRT), because that doesn’t include “prescribing medications to manage withdrawal or suppress cravings or the use of lab testing, both of which could be accomplished in primary care.”
Dr. Levy said she considers substance use disorders the same way she considers other chronic conditions: Most patients can be treated in primary care. “Specialty care and higher levels of care need to be available for patients who are most complicated and/or having a flare of their condition.”
“In my opinion, most teens with opioid use disorder can and should be treated in primary care. I worry about referring teens with opioid use disorder to get medication somewhere else because there are few places that deliver this service to this age group. Additionally, teens and families are not always willing to pursue a referral, and many will get lost along the way.”
Promising Models
At Boston Children’s, she said, the Division of Addiction Medicine has created a consultation call line that primary care providers can call for help with any questions about teen substance use.
After running the consultation for about a year, she said, the program wanted to add ways to help patients directly and hired and trained social workers who can see pediatric patients with substance use problems for counseling via telemedicine. “The program also now supports group therapy for pediatric patients and parents, so that primary care providers can refer patients directly to group therapy,” Dr. Levy said.
The growth of telehealth since the pandemic may allow for new models of care.
“For example, now our Adolescent Substance Use and Addiction Program at Boston Children’s Hospital can provide services, including medication induction and follow-up, virtually,” Dr. Levy said. “This allows us to treat young people anywhere in the state. There have been instances in which a primary care provider referred us patients with OUD and then partnered with us, including performing physicals for teens who could not get to Boston to see us in person. At the end of the day, the more models we can come up with the better.”
Dr. Hadland reported honoraria from the AAP outside the submitted work. Two coauthors reported receiving salary support from the AAP during the conduct of the study. A coauthor reported serving as the chair of the AAP Committee on Substance Use and Prevention outside the submitted work. This work was supported by a grant from the Conrad N. Hilton Foundation via the AAP. Dr. Sharon Levy’s husband, Ofer Levy, MD, PhD, is director of the Precision Vaccines Program at Boston Children’s Hospital.
FROM JAMA PEDIATRICS
Most Sudden Infant Deaths Occur in Shared Sleep Space
, according to new data published online in Pediatrics.
SUID occur in infants less than 1 year old. The deaths happen without an obvious cause before investigation and account for 3,400 deaths per year in the United States.
Alexa B. Erck Lambert, MPH, Maternal and Infant Health Branch of the Centers for Disease Control and Prevention (CDC), led the study that examined 7,595 such deaths in 23 US jurisdictions from 2011 to 2020, using data from the CDC’s SUID Case Registry.
The researchers reported that the prevalence of surface sharing ranges from 34% to 64% among living infants and about 50% among SUID.
Common Factors
They found common factors when infants share sleep space compared with infants who did not. Those who shared space, for example, were often 0-3 months old; publicly insured; non-Hispanic Black; found in an adult bed, couch, or chair; exposed to maternal cigarette smoking prenatally; and supervised by a parent when they died or had a supervisor who was impaired by drugs or alcohol at the time of death.
Having a supervisor who was impaired by drugs or alcohol was much more common among sharing (16.3%) than nonsharing infants (4.7%).
The American Academy of Pediatrics (AAP) guidance says a safe sleep environment for infants includes a place to sleep on a nonshared sleep surface (in a crib or bassinet) without soft bedding, and lying on the back facing up.
Most Who Died had Multiple Unsafe Sleep Factors
At least 76% of all SUID had multiple unsafe sleep factors present, regardless of whether the infants shared sleep space. Unsafe sleep factors include an inclined or soft sleep surface, sleeping on the side or stomach, sleeping with soft or loose bedding or objects, not breastfeeding, prenatal or environmental exposure to cigarette smoke, and overheating.
Sharing sleep space combined with parents’ smoking and maternal alcohol or drug use greatly increases risk of sudden infant death, the authors noted.
Sharing More Common With Multiples
Among SUID, surface sharing was more common among multiples than singletons and more common in an adult bed than in the same crib. The authors noted that parents often cite financial reasons for such arrangements.
However, AAP recommends multiples sleep on separate surfaces. The authors say pediatricians and other healthcare providers should be aware of free crib distribution programs. A study by Hauck et al. found “crib distribution and safe sleep education positively influence knowledge and practices about safe sleep.”
Robin Haynes, PhD, who studies causes underlying the pathology of SIDS at Boston Children’s Hospital, pointed to the Cribs for Kids website as a place for parents and clinicians to start for help with providing separate sleeping surfaces.
Dr. Haynes said the large number of infants included is a strength of the study. The findings help confirm the risk of sharing a sleep surface, she said, but the details on characteristics of sleep-sharing environments provide “novel insight into this problem,” she said.
“For basic researchers,” Dr. Haynes said, “it reiterates that most cases of sudden and unexpected infant deaths are exposed to multiple risk factors. It also highlights the role that young infant age and maternal smoking have as risk factors that contribute to biological vulnerabilities in infants.”
The results also give clinicians more information on characteristics of bedsharing families and some of the factors related to bedsharing, including socioeconomic and behavioral factors, she said. She highlighted the higher risk of SUID when drug or alcohol impairment is involved while bedsharing.
“All of this information is really important and helps clinicians shape the safe sleep messages to families,” she said.
The study authors and Dr. Haynes report no relevant financial relationships.
, according to new data published online in Pediatrics.
SUID occur in infants less than 1 year old. The deaths happen without an obvious cause before investigation and account for 3,400 deaths per year in the United States.
Alexa B. Erck Lambert, MPH, Maternal and Infant Health Branch of the Centers for Disease Control and Prevention (CDC), led the study that examined 7,595 such deaths in 23 US jurisdictions from 2011 to 2020, using data from the CDC’s SUID Case Registry.
The researchers reported that the prevalence of surface sharing ranges from 34% to 64% among living infants and about 50% among SUID.
Common Factors
They found common factors when infants share sleep space compared with infants who did not. Those who shared space, for example, were often 0-3 months old; publicly insured; non-Hispanic Black; found in an adult bed, couch, or chair; exposed to maternal cigarette smoking prenatally; and supervised by a parent when they died or had a supervisor who was impaired by drugs or alcohol at the time of death.
Having a supervisor who was impaired by drugs or alcohol was much more common among sharing (16.3%) than nonsharing infants (4.7%).
The American Academy of Pediatrics (AAP) guidance says a safe sleep environment for infants includes a place to sleep on a nonshared sleep surface (in a crib or bassinet) without soft bedding, and lying on the back facing up.
Most Who Died had Multiple Unsafe Sleep Factors
At least 76% of all SUID had multiple unsafe sleep factors present, regardless of whether the infants shared sleep space. Unsafe sleep factors include an inclined or soft sleep surface, sleeping on the side or stomach, sleeping with soft or loose bedding or objects, not breastfeeding, prenatal or environmental exposure to cigarette smoke, and overheating.
Sharing sleep space combined with parents’ smoking and maternal alcohol or drug use greatly increases risk of sudden infant death, the authors noted.
Sharing More Common With Multiples
Among SUID, surface sharing was more common among multiples than singletons and more common in an adult bed than in the same crib. The authors noted that parents often cite financial reasons for such arrangements.
However, AAP recommends multiples sleep on separate surfaces. The authors say pediatricians and other healthcare providers should be aware of free crib distribution programs. A study by Hauck et al. found “crib distribution and safe sleep education positively influence knowledge and practices about safe sleep.”
Robin Haynes, PhD, who studies causes underlying the pathology of SIDS at Boston Children’s Hospital, pointed to the Cribs for Kids website as a place for parents and clinicians to start for help with providing separate sleeping surfaces.
Dr. Haynes said the large number of infants included is a strength of the study. The findings help confirm the risk of sharing a sleep surface, she said, but the details on characteristics of sleep-sharing environments provide “novel insight into this problem,” she said.
“For basic researchers,” Dr. Haynes said, “it reiterates that most cases of sudden and unexpected infant deaths are exposed to multiple risk factors. It also highlights the role that young infant age and maternal smoking have as risk factors that contribute to biological vulnerabilities in infants.”
The results also give clinicians more information on characteristics of bedsharing families and some of the factors related to bedsharing, including socioeconomic and behavioral factors, she said. She highlighted the higher risk of SUID when drug or alcohol impairment is involved while bedsharing.
“All of this information is really important and helps clinicians shape the safe sleep messages to families,” she said.
The study authors and Dr. Haynes report no relevant financial relationships.
, according to new data published online in Pediatrics.
SUID occur in infants less than 1 year old. The deaths happen without an obvious cause before investigation and account for 3,400 deaths per year in the United States.
Alexa B. Erck Lambert, MPH, Maternal and Infant Health Branch of the Centers for Disease Control and Prevention (CDC), led the study that examined 7,595 such deaths in 23 US jurisdictions from 2011 to 2020, using data from the CDC’s SUID Case Registry.
The researchers reported that the prevalence of surface sharing ranges from 34% to 64% among living infants and about 50% among SUID.
Common Factors
They found common factors when infants share sleep space compared with infants who did not. Those who shared space, for example, were often 0-3 months old; publicly insured; non-Hispanic Black; found in an adult bed, couch, or chair; exposed to maternal cigarette smoking prenatally; and supervised by a parent when they died or had a supervisor who was impaired by drugs or alcohol at the time of death.
Having a supervisor who was impaired by drugs or alcohol was much more common among sharing (16.3%) than nonsharing infants (4.7%).
The American Academy of Pediatrics (AAP) guidance says a safe sleep environment for infants includes a place to sleep on a nonshared sleep surface (in a crib or bassinet) without soft bedding, and lying on the back facing up.
Most Who Died had Multiple Unsafe Sleep Factors
At least 76% of all SUID had multiple unsafe sleep factors present, regardless of whether the infants shared sleep space. Unsafe sleep factors include an inclined or soft sleep surface, sleeping on the side or stomach, sleeping with soft or loose bedding or objects, not breastfeeding, prenatal or environmental exposure to cigarette smoke, and overheating.
Sharing sleep space combined with parents’ smoking and maternal alcohol or drug use greatly increases risk of sudden infant death, the authors noted.
Sharing More Common With Multiples
Among SUID, surface sharing was more common among multiples than singletons and more common in an adult bed than in the same crib. The authors noted that parents often cite financial reasons for such arrangements.
However, AAP recommends multiples sleep on separate surfaces. The authors say pediatricians and other healthcare providers should be aware of free crib distribution programs. A study by Hauck et al. found “crib distribution and safe sleep education positively influence knowledge and practices about safe sleep.”
Robin Haynes, PhD, who studies causes underlying the pathology of SIDS at Boston Children’s Hospital, pointed to the Cribs for Kids website as a place for parents and clinicians to start for help with providing separate sleeping surfaces.
Dr. Haynes said the large number of infants included is a strength of the study. The findings help confirm the risk of sharing a sleep surface, she said, but the details on characteristics of sleep-sharing environments provide “novel insight into this problem,” she said.
“For basic researchers,” Dr. Haynes said, “it reiterates that most cases of sudden and unexpected infant deaths are exposed to multiple risk factors. It also highlights the role that young infant age and maternal smoking have as risk factors that contribute to biological vulnerabilities in infants.”
The results also give clinicians more information on characteristics of bedsharing families and some of the factors related to bedsharing, including socioeconomic and behavioral factors, she said. She highlighted the higher risk of SUID when drug or alcohol impairment is involved while bedsharing.
“All of this information is really important and helps clinicians shape the safe sleep messages to families,” she said.
The study authors and Dr. Haynes report no relevant financial relationships.
FROM PEDIATRICS
Surgery Shows Longer-Term Benefits for Dupuytren Contracture
Dupuytren contracture can be treated with three invasive methods, but new data from a randomized controlled trial show better 2-year success rates for surgery than for needle fasciotomy and collagenase injection, despite retreatments.
The common hereditary disorder affects the palmar fascia in middle-aged and older people, more often men. The disease typically affects the ring and little fingers and they may curl toward the palm. The disease can’t be cured, but can be eased.
Findings of the study, led by Mikko Petteri Räisänen, MD, with the Department of Orthopedics, Traumatology and Hand Surgery, Kuopio University Hospital, Kuopio, and Tampere University, Tampere, both in Finland, were published online in Annals of Internal Medicine.
Initially, Outcomes Similar
Initially, in the multisite, randomized controlled, outcome assessor–blinded, superiority trial, the outcomes were similar among the treatments, the authors write, but at 2 years only the surgery group maintained the success rate.
The primary outcome was more than 50% contracture release and patients reaching the patient-acceptable symptom state. Secondary outcomes included hand function, pain, patient satisfaction, quality of life, finger flexion, residual contracture angle, risk for retreatment, and serious adverse events.
A total of 292 (97%) and 284 (94%) patients completed the 3-month and 2-year follow ups, respectively.
Success rates at 3 months were similar: 71% (95% CI, 62%-80%) for surgery; 73% (95% CI, 64%-82%) for needle fasciotomy; and 73% (95% CI, 64%-82%) for collagenase injection.
At 2 Years, Surgery Superior
At 2 years, however, surgery had superior success rates. Surgery success rates vs needle fasciotomy were 78% vs 50% (adjusted risk difference, 0.30; 95% CI, 0.17-0.43).
Surgery success rates vs collagenase injection were 78% vs 65% (aRD, 0.13; 95% CI, 0.01-0.26).
“Secondary analyses paralleled with the primary analysis,” the authors write.
Patients may choose surgery despite initial morbidity which includes potential time off work and higher costs than the other options if the long-term outcome is better, the authors write.
“Collagenase is likely a viable alternative to needle fasciotomy only if its costs are substantially reduced,” the authors write.
A strength of the study is its generalizability, as researchers recruited patients in a setting with universal healthcare where few people seek care outside public hospitals.
Another strength of the trial is that the blinded outcome assessors measured the contracture angles with the participant’s hand covered by a rubber glove and patients were instructed not to reveal their treatment group to the assessor.
Some Physicians Offer Noninvasive Treatments First
Family physician Shannon Scott, DO, medical director of the Midwestern University Multispecialty Clinic in Scottsdale, Arizona, treats many patients with the contracture.
In her practice, patients come to her seeking noninvasive options first. But if they are not satisfied with their hand function after noninvasive treatments such as osteopathic manipulative treatment, physical therapy, and a home exercise program, the next steps are the choices compared in the study. The findings of this randomized controlled trial, she says, will help her in counseling patients choosing among those options.
“What’s important for me as a family physician to understand is more about the path that led to this decision” to seek more invasive treatment and whether the patients in the study had first completed a course of noninvasive care, Dr. Scott says.
The condition, especially in the population most affected — older adults — can greatly affect activities of daily living, she noted. Patients may also often have other conditions contributing to the symptoms of Dupuytren contracture in the neck, arm, or shoulder, for instance, that limit range of motion or cause pain. Addressing those symptoms noninvasively may help relieve the contracture, she says.
Asking patients about their goals is essential, Dr. Scott says. “What patients are looking for is function and the definition for one patient may be different than the level of function for another. Many patients get to a desired level of function with nonsurgical options first.”
A First for the Comparison
Dawn LaPorte, MD, a hand surgeon at Johns Hopkins Medicine in Baltimore, Maryland, who also was not part of the study, says although surgery was thought to have better long-term success rates, this is the first time the data have been able to show that at 2 years.
She added that the results are particularly striking because the endpoint was a 50% release when surgeons hope for a complete release. Even with the 50% release outcome at 2 years, surgery had better success.
She noted that the authors plan to look at outcomes at 5 and 10 years, but, she says, “the fact that surgery is already significantly better at 2 years really says a lot.”
Treatments Have Tradeoffs
She says the conclusions may change the discussions physicians have with patients.
Collagenase injections are an office procedure, and there’s no anesthesia. “There’s usually no lost time from work, and they can use their hand pretty normally the following day,” Dr. LaPorte says. One downside, compared with surgery, is that there may be a more frequent recurrence rate. Patients may have a skin tear that usually heals over a couple of weeks, she added.
Additionally, “the collagenase drug is very expensive,” she notes, so preapproval is important so that the patient doesn’t have to pay out of pocket.
Needle fasciotomy can also be done in the office without anesthesia. There’s less time off work than with surgery.
“With both that and the injection, they should see release of the contracture right away,” Dr. LaPorte says, but the concern is a quicker recurrence rate.
While surgery isn’t a cure, she says, and there is a lower recurrence rate, it typically means time off work, anesthesia, and an incision to heal, and may mean postoperative therapy.
The study was funded by the Research Council of Finland. Disclosures are available with the full text.
Dr. LaPorte and Dr. Scott report no relevant financial relationships.
Dupuytren contracture can be treated with three invasive methods, but new data from a randomized controlled trial show better 2-year success rates for surgery than for needle fasciotomy and collagenase injection, despite retreatments.
The common hereditary disorder affects the palmar fascia in middle-aged and older people, more often men. The disease typically affects the ring and little fingers and they may curl toward the palm. The disease can’t be cured, but can be eased.
Findings of the study, led by Mikko Petteri Räisänen, MD, with the Department of Orthopedics, Traumatology and Hand Surgery, Kuopio University Hospital, Kuopio, and Tampere University, Tampere, both in Finland, were published online in Annals of Internal Medicine.
Initially, Outcomes Similar
Initially, in the multisite, randomized controlled, outcome assessor–blinded, superiority trial, the outcomes were similar among the treatments, the authors write, but at 2 years only the surgery group maintained the success rate.
The primary outcome was more than 50% contracture release and patients reaching the patient-acceptable symptom state. Secondary outcomes included hand function, pain, patient satisfaction, quality of life, finger flexion, residual contracture angle, risk for retreatment, and serious adverse events.
A total of 292 (97%) and 284 (94%) patients completed the 3-month and 2-year follow ups, respectively.
Success rates at 3 months were similar: 71% (95% CI, 62%-80%) for surgery; 73% (95% CI, 64%-82%) for needle fasciotomy; and 73% (95% CI, 64%-82%) for collagenase injection.
At 2 Years, Surgery Superior
At 2 years, however, surgery had superior success rates. Surgery success rates vs needle fasciotomy were 78% vs 50% (adjusted risk difference, 0.30; 95% CI, 0.17-0.43).
Surgery success rates vs collagenase injection were 78% vs 65% (aRD, 0.13; 95% CI, 0.01-0.26).
“Secondary analyses paralleled with the primary analysis,” the authors write.
Patients may choose surgery despite initial morbidity which includes potential time off work and higher costs than the other options if the long-term outcome is better, the authors write.
“Collagenase is likely a viable alternative to needle fasciotomy only if its costs are substantially reduced,” the authors write.
A strength of the study is its generalizability, as researchers recruited patients in a setting with universal healthcare where few people seek care outside public hospitals.
Another strength of the trial is that the blinded outcome assessors measured the contracture angles with the participant’s hand covered by a rubber glove and patients were instructed not to reveal their treatment group to the assessor.
Some Physicians Offer Noninvasive Treatments First
Family physician Shannon Scott, DO, medical director of the Midwestern University Multispecialty Clinic in Scottsdale, Arizona, treats many patients with the contracture.
In her practice, patients come to her seeking noninvasive options first. But if they are not satisfied with their hand function after noninvasive treatments such as osteopathic manipulative treatment, physical therapy, and a home exercise program, the next steps are the choices compared in the study. The findings of this randomized controlled trial, she says, will help her in counseling patients choosing among those options.
“What’s important for me as a family physician to understand is more about the path that led to this decision” to seek more invasive treatment and whether the patients in the study had first completed a course of noninvasive care, Dr. Scott says.
The condition, especially in the population most affected — older adults — can greatly affect activities of daily living, she noted. Patients may also often have other conditions contributing to the symptoms of Dupuytren contracture in the neck, arm, or shoulder, for instance, that limit range of motion or cause pain. Addressing those symptoms noninvasively may help relieve the contracture, she says.
Asking patients about their goals is essential, Dr. Scott says. “What patients are looking for is function and the definition for one patient may be different than the level of function for another. Many patients get to a desired level of function with nonsurgical options first.”
A First for the Comparison
Dawn LaPorte, MD, a hand surgeon at Johns Hopkins Medicine in Baltimore, Maryland, who also was not part of the study, says although surgery was thought to have better long-term success rates, this is the first time the data have been able to show that at 2 years.
She added that the results are particularly striking because the endpoint was a 50% release when surgeons hope for a complete release. Even with the 50% release outcome at 2 years, surgery had better success.
She noted that the authors plan to look at outcomes at 5 and 10 years, but, she says, “the fact that surgery is already significantly better at 2 years really says a lot.”
Treatments Have Tradeoffs
She says the conclusions may change the discussions physicians have with patients.
Collagenase injections are an office procedure, and there’s no anesthesia. “There’s usually no lost time from work, and they can use their hand pretty normally the following day,” Dr. LaPorte says. One downside, compared with surgery, is that there may be a more frequent recurrence rate. Patients may have a skin tear that usually heals over a couple of weeks, she added.
Additionally, “the collagenase drug is very expensive,” she notes, so preapproval is important so that the patient doesn’t have to pay out of pocket.
Needle fasciotomy can also be done in the office without anesthesia. There’s less time off work than with surgery.
“With both that and the injection, they should see release of the contracture right away,” Dr. LaPorte says, but the concern is a quicker recurrence rate.
While surgery isn’t a cure, she says, and there is a lower recurrence rate, it typically means time off work, anesthesia, and an incision to heal, and may mean postoperative therapy.
The study was funded by the Research Council of Finland. Disclosures are available with the full text.
Dr. LaPorte and Dr. Scott report no relevant financial relationships.
Dupuytren contracture can be treated with three invasive methods, but new data from a randomized controlled trial show better 2-year success rates for surgery than for needle fasciotomy and collagenase injection, despite retreatments.
The common hereditary disorder affects the palmar fascia in middle-aged and older people, more often men. The disease typically affects the ring and little fingers and they may curl toward the palm. The disease can’t be cured, but can be eased.
Findings of the study, led by Mikko Petteri Räisänen, MD, with the Department of Orthopedics, Traumatology and Hand Surgery, Kuopio University Hospital, Kuopio, and Tampere University, Tampere, both in Finland, were published online in Annals of Internal Medicine.
Initially, Outcomes Similar
Initially, in the multisite, randomized controlled, outcome assessor–blinded, superiority trial, the outcomes were similar among the treatments, the authors write, but at 2 years only the surgery group maintained the success rate.
The primary outcome was more than 50% contracture release and patients reaching the patient-acceptable symptom state. Secondary outcomes included hand function, pain, patient satisfaction, quality of life, finger flexion, residual contracture angle, risk for retreatment, and serious adverse events.
A total of 292 (97%) and 284 (94%) patients completed the 3-month and 2-year follow ups, respectively.
Success rates at 3 months were similar: 71% (95% CI, 62%-80%) for surgery; 73% (95% CI, 64%-82%) for needle fasciotomy; and 73% (95% CI, 64%-82%) for collagenase injection.
At 2 Years, Surgery Superior
At 2 years, however, surgery had superior success rates. Surgery success rates vs needle fasciotomy were 78% vs 50% (adjusted risk difference, 0.30; 95% CI, 0.17-0.43).
Surgery success rates vs collagenase injection were 78% vs 65% (aRD, 0.13; 95% CI, 0.01-0.26).
“Secondary analyses paralleled with the primary analysis,” the authors write.
Patients may choose surgery despite initial morbidity which includes potential time off work and higher costs than the other options if the long-term outcome is better, the authors write.
“Collagenase is likely a viable alternative to needle fasciotomy only if its costs are substantially reduced,” the authors write.
A strength of the study is its generalizability, as researchers recruited patients in a setting with universal healthcare where few people seek care outside public hospitals.
Another strength of the trial is that the blinded outcome assessors measured the contracture angles with the participant’s hand covered by a rubber glove and patients were instructed not to reveal their treatment group to the assessor.
Some Physicians Offer Noninvasive Treatments First
Family physician Shannon Scott, DO, medical director of the Midwestern University Multispecialty Clinic in Scottsdale, Arizona, treats many patients with the contracture.
In her practice, patients come to her seeking noninvasive options first. But if they are not satisfied with their hand function after noninvasive treatments such as osteopathic manipulative treatment, physical therapy, and a home exercise program, the next steps are the choices compared in the study. The findings of this randomized controlled trial, she says, will help her in counseling patients choosing among those options.
“What’s important for me as a family physician to understand is more about the path that led to this decision” to seek more invasive treatment and whether the patients in the study had first completed a course of noninvasive care, Dr. Scott says.
The condition, especially in the population most affected — older adults — can greatly affect activities of daily living, she noted. Patients may also often have other conditions contributing to the symptoms of Dupuytren contracture in the neck, arm, or shoulder, for instance, that limit range of motion or cause pain. Addressing those symptoms noninvasively may help relieve the contracture, she says.
Asking patients about their goals is essential, Dr. Scott says. “What patients are looking for is function and the definition for one patient may be different than the level of function for another. Many patients get to a desired level of function with nonsurgical options first.”
A First for the Comparison
Dawn LaPorte, MD, a hand surgeon at Johns Hopkins Medicine in Baltimore, Maryland, who also was not part of the study, says although surgery was thought to have better long-term success rates, this is the first time the data have been able to show that at 2 years.
She added that the results are particularly striking because the endpoint was a 50% release when surgeons hope for a complete release. Even with the 50% release outcome at 2 years, surgery had better success.
She noted that the authors plan to look at outcomes at 5 and 10 years, but, she says, “the fact that surgery is already significantly better at 2 years really says a lot.”
Treatments Have Tradeoffs
She says the conclusions may change the discussions physicians have with patients.
Collagenase injections are an office procedure, and there’s no anesthesia. “There’s usually no lost time from work, and they can use their hand pretty normally the following day,” Dr. LaPorte says. One downside, compared with surgery, is that there may be a more frequent recurrence rate. Patients may have a skin tear that usually heals over a couple of weeks, she added.
Additionally, “the collagenase drug is very expensive,” she notes, so preapproval is important so that the patient doesn’t have to pay out of pocket.
Needle fasciotomy can also be done in the office without anesthesia. There’s less time off work than with surgery.
“With both that and the injection, they should see release of the contracture right away,” Dr. LaPorte says, but the concern is a quicker recurrence rate.
While surgery isn’t a cure, she says, and there is a lower recurrence rate, it typically means time off work, anesthesia, and an incision to heal, and may mean postoperative therapy.
The study was funded by the Research Council of Finland. Disclosures are available with the full text.
Dr. LaPorte and Dr. Scott report no relevant financial relationships.
FROM ANNALS OF INTERNAL MEDICINE
Bivalent COVID Vaccine Protected Children, Adolescents
Children and adolescents ages 5-17 who received a bivalent COVID-19 mRNA vaccine were less likely to become infected with SARS-CoV-2 compared with those who were unvaccinated or received only the monovalent COVID-19 vaccine, according to new data published February 6 in JAMA.
“All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations,” wrote the authors, led by Leora R. Feldstein, PhD, with the US Centers for Disease Control and Prevention (CDC) in Atlanta.
By the end of 2023, at least 911 youths ages 5-17 had died from COVID-related causes.
Researchers found that compared with participants who did not receive the COVID-19 vaccine or got monovalent-only doses 180 days or more before, the adjusted vaccine effectiveness of a bivalent COVID-19 vaccine dose against SARS-CoV-2 infection was 51.3% (95% confidence interval [CI], 23.6%-71.9%) 7-60 days after vaccination. Relative effectiveness was 62.4% (95% CI, 38.5%-81.1%) 61-150 days after vaccination. The researchers said the confidence intervals were wide because of the small sample size.
The information can help inform public health strategies, the authors noted, especially as new variants emerge.
Bivalent Dose Recommended in Fall of 2022
Bivalent mRNA COVID vaccines were recommended in the United States for children and adolescents ages 12 years or older on Sept. 1, 2022, and for children ages 5-11 on Oct. 12, 2022, when Omicron BA.4/5 types were the predominant circulating variant.
The study included 2,959 participants who completed periodic surveys (answering questions on demographics, household details, chronic medical conditions, and COVID-19 symptoms) and submitted weekly self-collected nasal swabs (whether or not they had symptoms). Those in the study submitted additional nasal swabs if they developed any symptoms.
Median adherence to weekly upper respiratory specimen swabbing was high throughout the study period at 93.8%.
Data from Sept. 4, 2022, to Jan. 31, 2023, were combined from three prospective US cohort studies at six sites. In addition to the surveys, researchers used information from state immunization information systems and electronic medical records.
Most of the Infected Were Unvaccinated or Had Monovalent Vax
Of the 426 participants (14.4% of the combined cohorts) infected with SARS-CoV-2, 383 (89.9%) were either unvaccinated or received monovalent vaccine doses only.
Calculations were adjusted for age, sex, race, ethnicity, health conditions, prior SARS-CoV-2 infections, geographic location, proportion of circulating variants by site, and local virus prevalence.
Participants living in Oregon, for example, had the highest uptake of bivalent COVID-19 vaccine (56.2%), whereas those in Texas had the lowest (2.4%). Participants reporting Hispanic ethnicity had lower bivalent uptake (17.1%) compared with non-Hispanic participants of all races (27.1%).
Of the 2,207 participants who did not receive a bivalent dose, 24.2% were unvaccinated and 1,672 (75.8%) received at least 1 monovalent dose.
The researchers said they saw no sign of waning effectiveness 61-150 days (the limit for this analysis) after receipt of the bivalent COVID-19 vaccine.
They wrote that continuation of the cohorts will allow study of waning patterns, which could help inform vaccine recommendations.
Among the limitations of the study are that testing methods and the COVID-19 symptoms surveyed varied among the three cohorts, so there may be some differences in defining infection or symptomatic COVID. In addition, the researchers were not able to account for the social vulnerability index and immunocompromised status, which could have affected vaccine uptake and risk of SARS-CoV-2 infection.
This study was supported by the National Center for Immunization and Respiratory Diseases, US Centers for Disease Control and Prevention, and by the National Institute of Allergy and Infectious Diseases. Coauthor Dr. Caban-Martinez reported grants from the Florida Firefighter Cancer Initiative and the Florida Department of Health. Coauthors Dr. Chu, Dr. Englund, Dr. Martin, and Dr. Monto reported receiving personal fees or grants from multiple pharmaceutical companies. Dr. Hegmann reported being the editor of the American College of Occupational and Environmental Medicine practice guidelines. Coauthor Dr. Gaglani reported serving as cochair of the infectious diseases and immunization committee and the respiratory syncytial virus task force lead for the Texas Pediatric Society and the Texas Chapter of the American Academy of Pediatrics. No other disclosures were reported.
Children and adolescents ages 5-17 who received a bivalent COVID-19 mRNA vaccine were less likely to become infected with SARS-CoV-2 compared with those who were unvaccinated or received only the monovalent COVID-19 vaccine, according to new data published February 6 in JAMA.
“All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations,” wrote the authors, led by Leora R. Feldstein, PhD, with the US Centers for Disease Control and Prevention (CDC) in Atlanta.
By the end of 2023, at least 911 youths ages 5-17 had died from COVID-related causes.
Researchers found that compared with participants who did not receive the COVID-19 vaccine or got monovalent-only doses 180 days or more before, the adjusted vaccine effectiveness of a bivalent COVID-19 vaccine dose against SARS-CoV-2 infection was 51.3% (95% confidence interval [CI], 23.6%-71.9%) 7-60 days after vaccination. Relative effectiveness was 62.4% (95% CI, 38.5%-81.1%) 61-150 days after vaccination. The researchers said the confidence intervals were wide because of the small sample size.
The information can help inform public health strategies, the authors noted, especially as new variants emerge.
Bivalent Dose Recommended in Fall of 2022
Bivalent mRNA COVID vaccines were recommended in the United States for children and adolescents ages 12 years or older on Sept. 1, 2022, and for children ages 5-11 on Oct. 12, 2022, when Omicron BA.4/5 types were the predominant circulating variant.
The study included 2,959 participants who completed periodic surveys (answering questions on demographics, household details, chronic medical conditions, and COVID-19 symptoms) and submitted weekly self-collected nasal swabs (whether or not they had symptoms). Those in the study submitted additional nasal swabs if they developed any symptoms.
Median adherence to weekly upper respiratory specimen swabbing was high throughout the study period at 93.8%.
Data from Sept. 4, 2022, to Jan. 31, 2023, were combined from three prospective US cohort studies at six sites. In addition to the surveys, researchers used information from state immunization information systems and electronic medical records.
Most of the Infected Were Unvaccinated or Had Monovalent Vax
Of the 426 participants (14.4% of the combined cohorts) infected with SARS-CoV-2, 383 (89.9%) were either unvaccinated or received monovalent vaccine doses only.
Calculations were adjusted for age, sex, race, ethnicity, health conditions, prior SARS-CoV-2 infections, geographic location, proportion of circulating variants by site, and local virus prevalence.
Participants living in Oregon, for example, had the highest uptake of bivalent COVID-19 vaccine (56.2%), whereas those in Texas had the lowest (2.4%). Participants reporting Hispanic ethnicity had lower bivalent uptake (17.1%) compared with non-Hispanic participants of all races (27.1%).
Of the 2,207 participants who did not receive a bivalent dose, 24.2% were unvaccinated and 1,672 (75.8%) received at least 1 monovalent dose.
The researchers said they saw no sign of waning effectiveness 61-150 days (the limit for this analysis) after receipt of the bivalent COVID-19 vaccine.
They wrote that continuation of the cohorts will allow study of waning patterns, which could help inform vaccine recommendations.
Among the limitations of the study are that testing methods and the COVID-19 symptoms surveyed varied among the three cohorts, so there may be some differences in defining infection or symptomatic COVID. In addition, the researchers were not able to account for the social vulnerability index and immunocompromised status, which could have affected vaccine uptake and risk of SARS-CoV-2 infection.
This study was supported by the National Center for Immunization and Respiratory Diseases, US Centers for Disease Control and Prevention, and by the National Institute of Allergy and Infectious Diseases. Coauthor Dr. Caban-Martinez reported grants from the Florida Firefighter Cancer Initiative and the Florida Department of Health. Coauthors Dr. Chu, Dr. Englund, Dr. Martin, and Dr. Monto reported receiving personal fees or grants from multiple pharmaceutical companies. Dr. Hegmann reported being the editor of the American College of Occupational and Environmental Medicine practice guidelines. Coauthor Dr. Gaglani reported serving as cochair of the infectious diseases and immunization committee and the respiratory syncytial virus task force lead for the Texas Pediatric Society and the Texas Chapter of the American Academy of Pediatrics. No other disclosures were reported.
Children and adolescents ages 5-17 who received a bivalent COVID-19 mRNA vaccine were less likely to become infected with SARS-CoV-2 compared with those who were unvaccinated or received only the monovalent COVID-19 vaccine, according to new data published February 6 in JAMA.
“All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations,” wrote the authors, led by Leora R. Feldstein, PhD, with the US Centers for Disease Control and Prevention (CDC) in Atlanta.
By the end of 2023, at least 911 youths ages 5-17 had died from COVID-related causes.
Researchers found that compared with participants who did not receive the COVID-19 vaccine or got monovalent-only doses 180 days or more before, the adjusted vaccine effectiveness of a bivalent COVID-19 vaccine dose against SARS-CoV-2 infection was 51.3% (95% confidence interval [CI], 23.6%-71.9%) 7-60 days after vaccination. Relative effectiveness was 62.4% (95% CI, 38.5%-81.1%) 61-150 days after vaccination. The researchers said the confidence intervals were wide because of the small sample size.
The information can help inform public health strategies, the authors noted, especially as new variants emerge.
Bivalent Dose Recommended in Fall of 2022
Bivalent mRNA COVID vaccines were recommended in the United States for children and adolescents ages 12 years or older on Sept. 1, 2022, and for children ages 5-11 on Oct. 12, 2022, when Omicron BA.4/5 types were the predominant circulating variant.
The study included 2,959 participants who completed periodic surveys (answering questions on demographics, household details, chronic medical conditions, and COVID-19 symptoms) and submitted weekly self-collected nasal swabs (whether or not they had symptoms). Those in the study submitted additional nasal swabs if they developed any symptoms.
Median adherence to weekly upper respiratory specimen swabbing was high throughout the study period at 93.8%.
Data from Sept. 4, 2022, to Jan. 31, 2023, were combined from three prospective US cohort studies at six sites. In addition to the surveys, researchers used information from state immunization information systems and electronic medical records.
Most of the Infected Were Unvaccinated or Had Monovalent Vax
Of the 426 participants (14.4% of the combined cohorts) infected with SARS-CoV-2, 383 (89.9%) were either unvaccinated or received monovalent vaccine doses only.
Calculations were adjusted for age, sex, race, ethnicity, health conditions, prior SARS-CoV-2 infections, geographic location, proportion of circulating variants by site, and local virus prevalence.
Participants living in Oregon, for example, had the highest uptake of bivalent COVID-19 vaccine (56.2%), whereas those in Texas had the lowest (2.4%). Participants reporting Hispanic ethnicity had lower bivalent uptake (17.1%) compared with non-Hispanic participants of all races (27.1%).
Of the 2,207 participants who did not receive a bivalent dose, 24.2% were unvaccinated and 1,672 (75.8%) received at least 1 monovalent dose.
The researchers said they saw no sign of waning effectiveness 61-150 days (the limit for this analysis) after receipt of the bivalent COVID-19 vaccine.
They wrote that continuation of the cohorts will allow study of waning patterns, which could help inform vaccine recommendations.
Among the limitations of the study are that testing methods and the COVID-19 symptoms surveyed varied among the three cohorts, so there may be some differences in defining infection or symptomatic COVID. In addition, the researchers were not able to account for the social vulnerability index and immunocompromised status, which could have affected vaccine uptake and risk of SARS-CoV-2 infection.
This study was supported by the National Center for Immunization and Respiratory Diseases, US Centers for Disease Control and Prevention, and by the National Institute of Allergy and Infectious Diseases. Coauthor Dr. Caban-Martinez reported grants from the Florida Firefighter Cancer Initiative and the Florida Department of Health. Coauthors Dr. Chu, Dr. Englund, Dr. Martin, and Dr. Monto reported receiving personal fees or grants from multiple pharmaceutical companies. Dr. Hegmann reported being the editor of the American College of Occupational and Environmental Medicine practice guidelines. Coauthor Dr. Gaglani reported serving as cochair of the infectious diseases and immunization committee and the respiratory syncytial virus task force lead for the Texas Pediatric Society and the Texas Chapter of the American Academy of Pediatrics. No other disclosures were reported.
FROM JAMA
Night Bracing: A Good Alternative for Adolescent Scoliosis
, new research suggests.
In the randomized Conservative Treatment for Adolescent Idiopathic Scoliosis (CONTRAIS) trial, researchers, led by Anastasios Charalampidis, MD, PhD, with the Department of Clinical Science, Intervention and Technology at Karolinska Institutet in Stockholm, Sweden, tested whether a group using self-managed physical activity combined with either nighttime bracing for 8 hours or scoliosis-specific exercise achieved better results than a control group doing self-managed physical activity alone for 1 hour per day in preventing Cobb angle progression in moderate-grade AIS.
Findings of the trial, conducted in 6 public hospitals across Sweden, were published online in JAMA Network Open.
Night Bracing More Effective Than Comparison Arms
In the trial of 135 patients, aged 9-17 years, who were skeletally immature with moderate AIS, researchers found that night bracing plus self-managed physical activity prevented curve progression of more than 6 degrees (treatment success) to a significantly greater extent than did either self-managed physical activity alone or scoliosis-specific exercise.
A secondary outcome of curve progression was the number of patients who had surgery up until 2 years after the primary outcome.
The average age of patients was 12.7 years and most (82%) were female. Patients with treatment failure (curve progression of more than 6 degrees) had the option to transition to a full-time brace until skeletal maturity. That option resulted in similar frequency of surgery independent of initial treatment, according to the paper.
AIS is a structural deformity of the spinal column, affecting otherwise healthy children and adolescents during their growth spurt.
Previous studies have suggested that full-time bracing is effective in treating moderate-grade AIS. But the physical distress and psychological side effects that some experience can cause low adherence or rejection of the treatment.
The authors wrote that, “To our knowledge, there have been no randomized clinical trials investigating night bracing versus a control group.”
In this trial, treatment success was seen in 34 of 45 patients (76%) in the nighttime-bracing group and in 24 of 45 patients (53%) in the physical activity–alone group (odds ratio [OR], 2.7; 95% CI, 1.1-6.6). Success occurred in 26 of 45 patients (58%) in the scoliosis-specific exercise group (OR for scoliosis-specific exercise vs physical activity alone, 1.2; 95% CI, 0.5-2.8).
Adverse Events
Patients and clinicians could respond to an open-ended question regarding adverse events at each 6-month follow-up. Nineteen adverse events were reported in 15 patients between the start of the study up until the primary outcome was reached.
In the night-bracing group, there were 16 adverse events reported among 12 patients. They were: trunk pressure and skin problems (n = 10); sleeping problems (n = 2); emotional problems (n = 1); shoulder/neck pain (n = 2); and unspecified AEs (n = 1). In the scoliosis-specific exercise group, 3 adverse events were reported in 3 patients (pain during treatment (n = 1), muscle strain (n = 1), and low back pain (n = 1). No adverse events were reported in the physical activity alone group.
In an invited commentary, Kosei Nagata, MD, PhD, with the Department of Orthopaedic Surgery and Spinal Surgery at The University of Tokyo Hospital in Tokyo, Japan, said the study makes two important points.
“First, it was reaffirmed that the basis of scoliosis treatment is bracing and not a specific exercise therapy,” he wrote. “Second, nighttime bracing can be an effective alternative intervention for patients rejecting full-time bracing.”
He emphasized, however, that nighttime bracing alone is not enough to achieve success. In this study, bracing was combined with exercise. And the number of hours worn is important.
“Physicians should explain to patients with AIS and to their guardians the significant association between hours of brace wear and treatment success,” Dr. Nagata wrote. He pointed out that, in a previous randomized clinical trial in 2013 by Weinstein et al., patients were instructed to wear a brace for at least 18 hours a day. The treatment success rates of brace-wearing patients were 40% for less than 6 hours each day; 70% for 6-12 hours each day, and 90% for more than 13 hours each day, which suggests that full-time bracing is optimal.
However, he added that physicians should keep in mind the sensitivities of youth and effect on their self-esteem when prescribing bracing, as many adolescents will have a fear of ridicule.
“The goals of bracing treatment for AIS are manifold: avoiding surgical treatment, preventing future back pain, maintaining respiratory function, and reducing the psychological impact of the deformity,” Dr. Nagata wrote. “Physicians should understand these aspects and take a balanced view of patients who refuse full-time bracing.”
He added that future improvements in design of the braces and less rigid alternatives will be important.
The trial was funded by the Swedish Research Council and by the Stockholm County Council, the Swedish Society of Spinal Surgeons, the Karolinska Institutet and the Crown Princess Lovisas Foundation. Study coauthor Paul Gerdhem, MD, PhD, reports grants from the Karolinska Institutet beyond his usual salary during the study and personal fees for lectures from DePuy Synthes and grants from Philips Healthcare paid to the institution outside the submitted work. No other disclosures were reported. Dr. Nagata reported no relevant financial relationships.
, new research suggests.
In the randomized Conservative Treatment for Adolescent Idiopathic Scoliosis (CONTRAIS) trial, researchers, led by Anastasios Charalampidis, MD, PhD, with the Department of Clinical Science, Intervention and Technology at Karolinska Institutet in Stockholm, Sweden, tested whether a group using self-managed physical activity combined with either nighttime bracing for 8 hours or scoliosis-specific exercise achieved better results than a control group doing self-managed physical activity alone for 1 hour per day in preventing Cobb angle progression in moderate-grade AIS.
Findings of the trial, conducted in 6 public hospitals across Sweden, were published online in JAMA Network Open.
Night Bracing More Effective Than Comparison Arms
In the trial of 135 patients, aged 9-17 years, who were skeletally immature with moderate AIS, researchers found that night bracing plus self-managed physical activity prevented curve progression of more than 6 degrees (treatment success) to a significantly greater extent than did either self-managed physical activity alone or scoliosis-specific exercise.
A secondary outcome of curve progression was the number of patients who had surgery up until 2 years after the primary outcome.
The average age of patients was 12.7 years and most (82%) were female. Patients with treatment failure (curve progression of more than 6 degrees) had the option to transition to a full-time brace until skeletal maturity. That option resulted in similar frequency of surgery independent of initial treatment, according to the paper.
AIS is a structural deformity of the spinal column, affecting otherwise healthy children and adolescents during their growth spurt.
Previous studies have suggested that full-time bracing is effective in treating moderate-grade AIS. But the physical distress and psychological side effects that some experience can cause low adherence or rejection of the treatment.
The authors wrote that, “To our knowledge, there have been no randomized clinical trials investigating night bracing versus a control group.”
In this trial, treatment success was seen in 34 of 45 patients (76%) in the nighttime-bracing group and in 24 of 45 patients (53%) in the physical activity–alone group (odds ratio [OR], 2.7; 95% CI, 1.1-6.6). Success occurred in 26 of 45 patients (58%) in the scoliosis-specific exercise group (OR for scoliosis-specific exercise vs physical activity alone, 1.2; 95% CI, 0.5-2.8).
Adverse Events
Patients and clinicians could respond to an open-ended question regarding adverse events at each 6-month follow-up. Nineteen adverse events were reported in 15 patients between the start of the study up until the primary outcome was reached.
In the night-bracing group, there were 16 adverse events reported among 12 patients. They were: trunk pressure and skin problems (n = 10); sleeping problems (n = 2); emotional problems (n = 1); shoulder/neck pain (n = 2); and unspecified AEs (n = 1). In the scoliosis-specific exercise group, 3 adverse events were reported in 3 patients (pain during treatment (n = 1), muscle strain (n = 1), and low back pain (n = 1). No adverse events were reported in the physical activity alone group.
In an invited commentary, Kosei Nagata, MD, PhD, with the Department of Orthopaedic Surgery and Spinal Surgery at The University of Tokyo Hospital in Tokyo, Japan, said the study makes two important points.
“First, it was reaffirmed that the basis of scoliosis treatment is bracing and not a specific exercise therapy,” he wrote. “Second, nighttime bracing can be an effective alternative intervention for patients rejecting full-time bracing.”
He emphasized, however, that nighttime bracing alone is not enough to achieve success. In this study, bracing was combined with exercise. And the number of hours worn is important.
“Physicians should explain to patients with AIS and to their guardians the significant association between hours of brace wear and treatment success,” Dr. Nagata wrote. He pointed out that, in a previous randomized clinical trial in 2013 by Weinstein et al., patients were instructed to wear a brace for at least 18 hours a day. The treatment success rates of brace-wearing patients were 40% for less than 6 hours each day; 70% for 6-12 hours each day, and 90% for more than 13 hours each day, which suggests that full-time bracing is optimal.
However, he added that physicians should keep in mind the sensitivities of youth and effect on their self-esteem when prescribing bracing, as many adolescents will have a fear of ridicule.
“The goals of bracing treatment for AIS are manifold: avoiding surgical treatment, preventing future back pain, maintaining respiratory function, and reducing the psychological impact of the deformity,” Dr. Nagata wrote. “Physicians should understand these aspects and take a balanced view of patients who refuse full-time bracing.”
He added that future improvements in design of the braces and less rigid alternatives will be important.
The trial was funded by the Swedish Research Council and by the Stockholm County Council, the Swedish Society of Spinal Surgeons, the Karolinska Institutet and the Crown Princess Lovisas Foundation. Study coauthor Paul Gerdhem, MD, PhD, reports grants from the Karolinska Institutet beyond his usual salary during the study and personal fees for lectures from DePuy Synthes and grants from Philips Healthcare paid to the institution outside the submitted work. No other disclosures were reported. Dr. Nagata reported no relevant financial relationships.
, new research suggests.
In the randomized Conservative Treatment for Adolescent Idiopathic Scoliosis (CONTRAIS) trial, researchers, led by Anastasios Charalampidis, MD, PhD, with the Department of Clinical Science, Intervention and Technology at Karolinska Institutet in Stockholm, Sweden, tested whether a group using self-managed physical activity combined with either nighttime bracing for 8 hours or scoliosis-specific exercise achieved better results than a control group doing self-managed physical activity alone for 1 hour per day in preventing Cobb angle progression in moderate-grade AIS.
Findings of the trial, conducted in 6 public hospitals across Sweden, were published online in JAMA Network Open.
Night Bracing More Effective Than Comparison Arms
In the trial of 135 patients, aged 9-17 years, who were skeletally immature with moderate AIS, researchers found that night bracing plus self-managed physical activity prevented curve progression of more than 6 degrees (treatment success) to a significantly greater extent than did either self-managed physical activity alone or scoliosis-specific exercise.
A secondary outcome of curve progression was the number of patients who had surgery up until 2 years after the primary outcome.
The average age of patients was 12.7 years and most (82%) were female. Patients with treatment failure (curve progression of more than 6 degrees) had the option to transition to a full-time brace until skeletal maturity. That option resulted in similar frequency of surgery independent of initial treatment, according to the paper.
AIS is a structural deformity of the spinal column, affecting otherwise healthy children and adolescents during their growth spurt.
Previous studies have suggested that full-time bracing is effective in treating moderate-grade AIS. But the physical distress and psychological side effects that some experience can cause low adherence or rejection of the treatment.
The authors wrote that, “To our knowledge, there have been no randomized clinical trials investigating night bracing versus a control group.”
In this trial, treatment success was seen in 34 of 45 patients (76%) in the nighttime-bracing group and in 24 of 45 patients (53%) in the physical activity–alone group (odds ratio [OR], 2.7; 95% CI, 1.1-6.6). Success occurred in 26 of 45 patients (58%) in the scoliosis-specific exercise group (OR for scoliosis-specific exercise vs physical activity alone, 1.2; 95% CI, 0.5-2.8).
Adverse Events
Patients and clinicians could respond to an open-ended question regarding adverse events at each 6-month follow-up. Nineteen adverse events were reported in 15 patients between the start of the study up until the primary outcome was reached.
In the night-bracing group, there were 16 adverse events reported among 12 patients. They were: trunk pressure and skin problems (n = 10); sleeping problems (n = 2); emotional problems (n = 1); shoulder/neck pain (n = 2); and unspecified AEs (n = 1). In the scoliosis-specific exercise group, 3 adverse events were reported in 3 patients (pain during treatment (n = 1), muscle strain (n = 1), and low back pain (n = 1). No adverse events were reported in the physical activity alone group.
In an invited commentary, Kosei Nagata, MD, PhD, with the Department of Orthopaedic Surgery and Spinal Surgery at The University of Tokyo Hospital in Tokyo, Japan, said the study makes two important points.
“First, it was reaffirmed that the basis of scoliosis treatment is bracing and not a specific exercise therapy,” he wrote. “Second, nighttime bracing can be an effective alternative intervention for patients rejecting full-time bracing.”
He emphasized, however, that nighttime bracing alone is not enough to achieve success. In this study, bracing was combined with exercise. And the number of hours worn is important.
“Physicians should explain to patients with AIS and to their guardians the significant association between hours of brace wear and treatment success,” Dr. Nagata wrote. He pointed out that, in a previous randomized clinical trial in 2013 by Weinstein et al., patients were instructed to wear a brace for at least 18 hours a day. The treatment success rates of brace-wearing patients were 40% for less than 6 hours each day; 70% for 6-12 hours each day, and 90% for more than 13 hours each day, which suggests that full-time bracing is optimal.
However, he added that physicians should keep in mind the sensitivities of youth and effect on their self-esteem when prescribing bracing, as many adolescents will have a fear of ridicule.
“The goals of bracing treatment for AIS are manifold: avoiding surgical treatment, preventing future back pain, maintaining respiratory function, and reducing the psychological impact of the deformity,” Dr. Nagata wrote. “Physicians should understand these aspects and take a balanced view of patients who refuse full-time bracing.”
He added that future improvements in design of the braces and less rigid alternatives will be important.
The trial was funded by the Swedish Research Council and by the Stockholm County Council, the Swedish Society of Spinal Surgeons, the Karolinska Institutet and the Crown Princess Lovisas Foundation. Study coauthor Paul Gerdhem, MD, PhD, reports grants from the Karolinska Institutet beyond his usual salary during the study and personal fees for lectures from DePuy Synthes and grants from Philips Healthcare paid to the institution outside the submitted work. No other disclosures were reported. Dr. Nagata reported no relevant financial relationships.
FROM JAMA NETWORK OPEN
Vibrating Belt Receives Approval to Help Women With Osteopenia Keep Bone Strength
The US Food and Drug Administration (FDA) has approved a wearable belt device for postmenopausal women with osteopenia, the precursor to osteoporosis, according to the company’s manufacturer, Bone Health Technologies.
According to the company, the device (Osteoboost) is the first nonpharmacologic device-based, prescription-only treatment for postmenopausal women with low bone density. It has not been tested for ability to reduce fracture risk.
The device is worn around the hips and delivers calibrated mild vibrations to the hips and lumbar spine to help preserve bone strength and density. A vibration pack is mounted to the back of the belt.
FDA approval, announced on January 18, was based on the findings of a National Institutes of Health–funded double-blinded, sham-controlled study of 126 women with low bone density conducted at the University of Nebraska Medical Center in Omaha. The data were shared at the 2023 Endocrine Society and American Society for Bone and Mineral Research annual meetings and published in the Journal of the Endocrine Society.
Lead investigator Laura D. Bilek, PT, PhD, associate dean for research and associate professor at the University of Nebraska, and colleagues wrote that the primary outcome measurement was the change in vertebral strength measured by CT scans for women who used the device a minimum of three times per week compared with a sham group who wore a belt that emitted sound but had no vibrations.
Compressive strength and volumetric density of the first lumbar vertebra were analyzed.
In the active-belt group, women lost, on average, 0.48% bone strength, while those in the sham group lost nearly 2.84% (P = .014), about five times as much. Results also showed that participants in the active treatment group who used the device three times per week lost 0.29% bone mineral density (BMD) compared with the 1.97% BMD lost in the control group. No adverse events were reported in the study.
Sonali Khandelwal, MD, a rheumatologist at Rush University in Chicago, told this news organization there’s considerable fear among some patients about long-term use of available medications for bone health, “so any modality that is nontherapeutic — not a pill — is always exciting.”
The endpoints of the study are one good measure, she said, but she emphasized that it will be important to show that the improved bone density from the belt that is described in this study “is a true marker of decreased fracture risk.”
Because there are no apparent side effects, she said it may be effective in combination with weight-bearing exercise, vitamin D and calcium, and/or medication, depending on severity of bone loss.
Current medications on the market for osteoporosis have been shown to improve bone strength and reduce fracture risk, she noted.
“It could help; I just don’t think we have enough evidence that it will completely treat the bone loss,” Dr. Khandelwal said.
She said she sees the potential population most interested in the belt as premenopausal women with a family history of bone loss who may not meet the level of bone loss for medical management but are interested in prevention.
“I also think of individuals who might already meet medication needs but are completely averse to being on medication,” she said. The bulk of her practice is treating bone loss, she said, estimating that 20% of her patients do not want to be on medication.
Bone Health Technologies CEO Laura Yecies, MBA, told this news organization the company has not yet set the price for the device and noted that because it will be available by prescription only, out-of-pocket costs and copays will differ. She said the company expects to begin shipping later this year. Requests for update notifications can be made at the company’s website.
Dr. Bilek told this news organization the device was tested for a year, so it’s unclear how long people with osteopenia would need to wear the belt for maximum benefit.
The theory behind the mechanism of action, she said, “is that the vibration actually inhibits the cells [osteoclasts] that take away bone mass.”
The researchers included only postmenopausal women with osteopenia in the study, but Dr. Bilek said she would like to test the device on other groups, such as men with prostate cancer getting testosterone-blocking therapy, which can result in loss of bone density. An estimated 34 million people in the United States have osteopenia.
Dr. Bilek said a next step for the study is to enroll a more diverse cohort at an additional center to test the device because most of the women in this one were White.
She noted that women’s bone mass peaks at age 30 and then starts to decline.
“When women hit menopause, there’s a really rapid decline [in bone strength] for the next 5-7 years and then the decline levels off. If we can slow that decline, hopefully that woman’s bone density is maintained at a higher level throughout their life,” Dr. Bilek said.
Dr. Bilek is a scientific adviser to Bone Health Technologies. She and many coauthors of the study received grants or fees from the company and own stock in or are employees of the company. Ms. Yecies is the founder and CEO of Bone Health Technologies. Dr. Khandelwal had no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved a wearable belt device for postmenopausal women with osteopenia, the precursor to osteoporosis, according to the company’s manufacturer, Bone Health Technologies.
According to the company, the device (Osteoboost) is the first nonpharmacologic device-based, prescription-only treatment for postmenopausal women with low bone density. It has not been tested for ability to reduce fracture risk.
The device is worn around the hips and delivers calibrated mild vibrations to the hips and lumbar spine to help preserve bone strength and density. A vibration pack is mounted to the back of the belt.
FDA approval, announced on January 18, was based on the findings of a National Institutes of Health–funded double-blinded, sham-controlled study of 126 women with low bone density conducted at the University of Nebraska Medical Center in Omaha. The data were shared at the 2023 Endocrine Society and American Society for Bone and Mineral Research annual meetings and published in the Journal of the Endocrine Society.
Lead investigator Laura D. Bilek, PT, PhD, associate dean for research and associate professor at the University of Nebraska, and colleagues wrote that the primary outcome measurement was the change in vertebral strength measured by CT scans for women who used the device a minimum of three times per week compared with a sham group who wore a belt that emitted sound but had no vibrations.
Compressive strength and volumetric density of the first lumbar vertebra were analyzed.
In the active-belt group, women lost, on average, 0.48% bone strength, while those in the sham group lost nearly 2.84% (P = .014), about five times as much. Results also showed that participants in the active treatment group who used the device three times per week lost 0.29% bone mineral density (BMD) compared with the 1.97% BMD lost in the control group. No adverse events were reported in the study.
Sonali Khandelwal, MD, a rheumatologist at Rush University in Chicago, told this news organization there’s considerable fear among some patients about long-term use of available medications for bone health, “so any modality that is nontherapeutic — not a pill — is always exciting.”
The endpoints of the study are one good measure, she said, but she emphasized that it will be important to show that the improved bone density from the belt that is described in this study “is a true marker of decreased fracture risk.”
Because there are no apparent side effects, she said it may be effective in combination with weight-bearing exercise, vitamin D and calcium, and/or medication, depending on severity of bone loss.
Current medications on the market for osteoporosis have been shown to improve bone strength and reduce fracture risk, she noted.
“It could help; I just don’t think we have enough evidence that it will completely treat the bone loss,” Dr. Khandelwal said.
She said she sees the potential population most interested in the belt as premenopausal women with a family history of bone loss who may not meet the level of bone loss for medical management but are interested in prevention.
“I also think of individuals who might already meet medication needs but are completely averse to being on medication,” she said. The bulk of her practice is treating bone loss, she said, estimating that 20% of her patients do not want to be on medication.
Bone Health Technologies CEO Laura Yecies, MBA, told this news organization the company has not yet set the price for the device and noted that because it will be available by prescription only, out-of-pocket costs and copays will differ. She said the company expects to begin shipping later this year. Requests for update notifications can be made at the company’s website.
Dr. Bilek told this news organization the device was tested for a year, so it’s unclear how long people with osteopenia would need to wear the belt for maximum benefit.
The theory behind the mechanism of action, she said, “is that the vibration actually inhibits the cells [osteoclasts] that take away bone mass.”
The researchers included only postmenopausal women with osteopenia in the study, but Dr. Bilek said she would like to test the device on other groups, such as men with prostate cancer getting testosterone-blocking therapy, which can result in loss of bone density. An estimated 34 million people in the United States have osteopenia.
Dr. Bilek said a next step for the study is to enroll a more diverse cohort at an additional center to test the device because most of the women in this one were White.
She noted that women’s bone mass peaks at age 30 and then starts to decline.
“When women hit menopause, there’s a really rapid decline [in bone strength] for the next 5-7 years and then the decline levels off. If we can slow that decline, hopefully that woman’s bone density is maintained at a higher level throughout their life,” Dr. Bilek said.
Dr. Bilek is a scientific adviser to Bone Health Technologies. She and many coauthors of the study received grants or fees from the company and own stock in or are employees of the company. Ms. Yecies is the founder and CEO of Bone Health Technologies. Dr. Khandelwal had no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved a wearable belt device for postmenopausal women with osteopenia, the precursor to osteoporosis, according to the company’s manufacturer, Bone Health Technologies.
According to the company, the device (Osteoboost) is the first nonpharmacologic device-based, prescription-only treatment for postmenopausal women with low bone density. It has not been tested for ability to reduce fracture risk.
The device is worn around the hips and delivers calibrated mild vibrations to the hips and lumbar spine to help preserve bone strength and density. A vibration pack is mounted to the back of the belt.
FDA approval, announced on January 18, was based on the findings of a National Institutes of Health–funded double-blinded, sham-controlled study of 126 women with low bone density conducted at the University of Nebraska Medical Center in Omaha. The data were shared at the 2023 Endocrine Society and American Society for Bone and Mineral Research annual meetings and published in the Journal of the Endocrine Society.
Lead investigator Laura D. Bilek, PT, PhD, associate dean for research and associate professor at the University of Nebraska, and colleagues wrote that the primary outcome measurement was the change in vertebral strength measured by CT scans for women who used the device a minimum of three times per week compared with a sham group who wore a belt that emitted sound but had no vibrations.
Compressive strength and volumetric density of the first lumbar vertebra were analyzed.
In the active-belt group, women lost, on average, 0.48% bone strength, while those in the sham group lost nearly 2.84% (P = .014), about five times as much. Results also showed that participants in the active treatment group who used the device three times per week lost 0.29% bone mineral density (BMD) compared with the 1.97% BMD lost in the control group. No adverse events were reported in the study.
Sonali Khandelwal, MD, a rheumatologist at Rush University in Chicago, told this news organization there’s considerable fear among some patients about long-term use of available medications for bone health, “so any modality that is nontherapeutic — not a pill — is always exciting.”
The endpoints of the study are one good measure, she said, but she emphasized that it will be important to show that the improved bone density from the belt that is described in this study “is a true marker of decreased fracture risk.”
Because there are no apparent side effects, she said it may be effective in combination with weight-bearing exercise, vitamin D and calcium, and/or medication, depending on severity of bone loss.
Current medications on the market for osteoporosis have been shown to improve bone strength and reduce fracture risk, she noted.
“It could help; I just don’t think we have enough evidence that it will completely treat the bone loss,” Dr. Khandelwal said.
She said she sees the potential population most interested in the belt as premenopausal women with a family history of bone loss who may not meet the level of bone loss for medical management but are interested in prevention.
“I also think of individuals who might already meet medication needs but are completely averse to being on medication,” she said. The bulk of her practice is treating bone loss, she said, estimating that 20% of her patients do not want to be on medication.
Bone Health Technologies CEO Laura Yecies, MBA, told this news organization the company has not yet set the price for the device and noted that because it will be available by prescription only, out-of-pocket costs and copays will differ. She said the company expects to begin shipping later this year. Requests for update notifications can be made at the company’s website.
Dr. Bilek told this news organization the device was tested for a year, so it’s unclear how long people with osteopenia would need to wear the belt for maximum benefit.
The theory behind the mechanism of action, she said, “is that the vibration actually inhibits the cells [osteoclasts] that take away bone mass.”
The researchers included only postmenopausal women with osteopenia in the study, but Dr. Bilek said she would like to test the device on other groups, such as men with prostate cancer getting testosterone-blocking therapy, which can result in loss of bone density. An estimated 34 million people in the United States have osteopenia.
Dr. Bilek said a next step for the study is to enroll a more diverse cohort at an additional center to test the device because most of the women in this one were White.
She noted that women’s bone mass peaks at age 30 and then starts to decline.
“When women hit menopause, there’s a really rapid decline [in bone strength] for the next 5-7 years and then the decline levels off. If we can slow that decline, hopefully that woman’s bone density is maintained at a higher level throughout their life,” Dr. Bilek said.
Dr. Bilek is a scientific adviser to Bone Health Technologies. She and many coauthors of the study received grants or fees from the company and own stock in or are employees of the company. Ms. Yecies is the founder and CEO of Bone Health Technologies. Dr. Khandelwal had no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Buprenorphine Slightly Less Risky than Methadone for Fetal Malformation
Buprenorphine use, compared with methadone use, in pregnancy has been linked with a slightly lower risk of major congenital malformations in a new study of medications for opioid use disorder (OUD).
Elizabeth A. Suarez, PhD, MPH, with the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues published the findings in JAMA Internal Medicine.
The lower risk for buprenorphine was small (risk ratio, 0.82; 95% confidence interval [CI], 0.69-0.97), and methadone use should not be ruled out on that basis, the authors wrote. For some women, particularly those on stable treatment before pregnancy or women who do not respond well to buprenorphine, methadone may be the better choice, they explained.
Either Medication Better Than Not Treating
The authors noted that either medication “is strongly recommended over untreated OUD during pregnancy.”
JAMA Internal Medicine Deputy Editor Deborah Grady, MD, MPH, with the Department of Medicine, University of California, San Francisco, emphasized that recommendation in an editor’s note, highlighting that treatment for OUD is critical to prevent infections, overdose, and death in pregnant women as well as neonatal opioid withdrawal syndrome and fetal death.
She stressed that internists and other primary care physicians have a key role in ensuring pregnant women with OUD receive appropriate treatment.
Given the importance of the issue, she wrote, “we have taken the unusual step of publishing two accompanying invited commentaries.”
Two developments may help increase use of buprenorphine, the study authors wrote. One is a recent study showing lower risk of adverse neonatal outcomes when buprenorphine is used during pregnancy compared with methadone. Another is the removal last year of the prescribing waiver for buprenorphine.
Study Included Medicaid Data Over 18 Years
The population-based cohort study used data from publicly insured Medicaid beneficiaries from 2000 to 2018. Pregnancies with enrollment from 90 days before pregnancy through 1 month after delivery and first-trimester use of buprenorphine or methadone were included (n = 13,360). The data were linked with infants’ health data.
The study group included 9,514 pregnancies with first-trimester buprenorphine exposure and 3,846 with methadone exposure. The risk of malformations overall was 50.9 (95% CI, 46.5-55.3) per 1000 pregnancies for buprenorphine and 60.6 (95% CI, 53.0-68.1) per 1000 pregnancies for methadone.
Major malformations were any cardiac malformations, ventricular septal defect, secundum atrial septal defect/nonprematurity-related patent foramen ovale, neural tube defects, oral clefts, and clubfoot.
Two Invited Commentaries Urge Caution in Interpretation
The two invited commentaries Dr. Grady mentioned in her editor’s note point both to the importance of the team’s findings and the need for better understanding of factors that may affect the choice of which OUD medication to use.
A commentary by Max Jordan Nguemeni Tiako, MD, MS, with the Department of Medicine, Brigham and Women’s Hospital, and colleagues, said that while the Suarez et al. data are important to share with patients, “the ultimate treatment decision must be the result of shared decision-making between a knowledgeable clinician and the patient, rather than promoting one medication over another.”
They urge putting the findings in context given the study population, which comprises a relatively stable group of women with OUD, most of whom were taking OUD medications before they got pregnant. The study sample excludes a substantial number of women who are chronically underinsured or uninsured, Dr. Tiako’s team wrote, because those included were enrolled in Medicaid for 3 consecutive months before pregnancy.
“We urge caution when extrapolating these findings to newly pregnant individuals with untreated OUD,” they wrote.
Both Medications are Safe
Cara Poland, MD, MEd, with the Henry Ford Health + Michigan State University Health Sciences in Grand Rapids, and coauthors, added in another commentary that Suarez et al. didn’t include a comparison between the population-level congenital defect rate and the defect rate for people using medications for OUD in pregnancy.
That comparison, they wrote, would have better illustrated the safety of medications for OUD “instead of simply comparing two medications with long-standing safety data.”
When a clinician starts a woman on medication for OUD in pregnancy, it’s important to understand several factors, including individual access to and comfort with different treatment approaches, they noted. It’s also important to weigh whether changing medications is worth the potential drawbacks of disrupting their well-managed care.
They wrote that the paper by Suarez et al. does not make the case for switching medications based on their findings.
Internists, they added, are ideal experts to explain risk of fetal abnormalities in the wider context of supporting engagement with continuous medication for OUD.
“In the absence of other concerns, switching medications (methadone to buprenorphine) or — worse — discontinuing [medication for] OUD because of this study runs counter to the substantial evidence regarding the safety of these medications during pregnancy,” Dr. Poland’s team wrote. “No treatment is without risk in pregnancy.”
This study was supported by the National Institute on Drug Abuse. In the Suarez et al. study, coauthors Dr. Hernández-Díaz, Dr. Gray, Dr. Connery, Dr. Zhu, and Dr. Huybrechts reported grants, personal fees and consulting payments from several pharmaceutical companies. Dr. Grady reports no relevant financial relationships in her editor’s note. No relevant financial relationships were reported by authors of the Tiako et al. commentary.
Regarding the commentary by Poland et al., grants were reported from the Michigan Health Endowment Fund, the Michigan Department of Health and Human Services, the National Institute on Drug Abuse and Blue Cross Blue Shield of Michigan outside the submitted work. No other disclosures were reported.
Buprenorphine use, compared with methadone use, in pregnancy has been linked with a slightly lower risk of major congenital malformations in a new study of medications for opioid use disorder (OUD).
Elizabeth A. Suarez, PhD, MPH, with the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues published the findings in JAMA Internal Medicine.
The lower risk for buprenorphine was small (risk ratio, 0.82; 95% confidence interval [CI], 0.69-0.97), and methadone use should not be ruled out on that basis, the authors wrote. For some women, particularly those on stable treatment before pregnancy or women who do not respond well to buprenorphine, methadone may be the better choice, they explained.
Either Medication Better Than Not Treating
The authors noted that either medication “is strongly recommended over untreated OUD during pregnancy.”
JAMA Internal Medicine Deputy Editor Deborah Grady, MD, MPH, with the Department of Medicine, University of California, San Francisco, emphasized that recommendation in an editor’s note, highlighting that treatment for OUD is critical to prevent infections, overdose, and death in pregnant women as well as neonatal opioid withdrawal syndrome and fetal death.
She stressed that internists and other primary care physicians have a key role in ensuring pregnant women with OUD receive appropriate treatment.
Given the importance of the issue, she wrote, “we have taken the unusual step of publishing two accompanying invited commentaries.”
Two developments may help increase use of buprenorphine, the study authors wrote. One is a recent study showing lower risk of adverse neonatal outcomes when buprenorphine is used during pregnancy compared with methadone. Another is the removal last year of the prescribing waiver for buprenorphine.
Study Included Medicaid Data Over 18 Years
The population-based cohort study used data from publicly insured Medicaid beneficiaries from 2000 to 2018. Pregnancies with enrollment from 90 days before pregnancy through 1 month after delivery and first-trimester use of buprenorphine or methadone were included (n = 13,360). The data were linked with infants’ health data.
The study group included 9,514 pregnancies with first-trimester buprenorphine exposure and 3,846 with methadone exposure. The risk of malformations overall was 50.9 (95% CI, 46.5-55.3) per 1000 pregnancies for buprenorphine and 60.6 (95% CI, 53.0-68.1) per 1000 pregnancies for methadone.
Major malformations were any cardiac malformations, ventricular septal defect, secundum atrial septal defect/nonprematurity-related patent foramen ovale, neural tube defects, oral clefts, and clubfoot.
Two Invited Commentaries Urge Caution in Interpretation
The two invited commentaries Dr. Grady mentioned in her editor’s note point both to the importance of the team’s findings and the need for better understanding of factors that may affect the choice of which OUD medication to use.
A commentary by Max Jordan Nguemeni Tiako, MD, MS, with the Department of Medicine, Brigham and Women’s Hospital, and colleagues, said that while the Suarez et al. data are important to share with patients, “the ultimate treatment decision must be the result of shared decision-making between a knowledgeable clinician and the patient, rather than promoting one medication over another.”
They urge putting the findings in context given the study population, which comprises a relatively stable group of women with OUD, most of whom were taking OUD medications before they got pregnant. The study sample excludes a substantial number of women who are chronically underinsured or uninsured, Dr. Tiako’s team wrote, because those included were enrolled in Medicaid for 3 consecutive months before pregnancy.
“We urge caution when extrapolating these findings to newly pregnant individuals with untreated OUD,” they wrote.
Both Medications are Safe
Cara Poland, MD, MEd, with the Henry Ford Health + Michigan State University Health Sciences in Grand Rapids, and coauthors, added in another commentary that Suarez et al. didn’t include a comparison between the population-level congenital defect rate and the defect rate for people using medications for OUD in pregnancy.
That comparison, they wrote, would have better illustrated the safety of medications for OUD “instead of simply comparing two medications with long-standing safety data.”
When a clinician starts a woman on medication for OUD in pregnancy, it’s important to understand several factors, including individual access to and comfort with different treatment approaches, they noted. It’s also important to weigh whether changing medications is worth the potential drawbacks of disrupting their well-managed care.
They wrote that the paper by Suarez et al. does not make the case for switching medications based on their findings.
Internists, they added, are ideal experts to explain risk of fetal abnormalities in the wider context of supporting engagement with continuous medication for OUD.
“In the absence of other concerns, switching medications (methadone to buprenorphine) or — worse — discontinuing [medication for] OUD because of this study runs counter to the substantial evidence regarding the safety of these medications during pregnancy,” Dr. Poland’s team wrote. “No treatment is without risk in pregnancy.”
This study was supported by the National Institute on Drug Abuse. In the Suarez et al. study, coauthors Dr. Hernández-Díaz, Dr. Gray, Dr. Connery, Dr. Zhu, and Dr. Huybrechts reported grants, personal fees and consulting payments from several pharmaceutical companies. Dr. Grady reports no relevant financial relationships in her editor’s note. No relevant financial relationships were reported by authors of the Tiako et al. commentary.
Regarding the commentary by Poland et al., grants were reported from the Michigan Health Endowment Fund, the Michigan Department of Health and Human Services, the National Institute on Drug Abuse and Blue Cross Blue Shield of Michigan outside the submitted work. No other disclosures were reported.
Buprenorphine use, compared with methadone use, in pregnancy has been linked with a slightly lower risk of major congenital malformations in a new study of medications for opioid use disorder (OUD).
Elizabeth A. Suarez, PhD, MPH, with the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues published the findings in JAMA Internal Medicine.
The lower risk for buprenorphine was small (risk ratio, 0.82; 95% confidence interval [CI], 0.69-0.97), and methadone use should not be ruled out on that basis, the authors wrote. For some women, particularly those on stable treatment before pregnancy or women who do not respond well to buprenorphine, methadone may be the better choice, they explained.
Either Medication Better Than Not Treating
The authors noted that either medication “is strongly recommended over untreated OUD during pregnancy.”
JAMA Internal Medicine Deputy Editor Deborah Grady, MD, MPH, with the Department of Medicine, University of California, San Francisco, emphasized that recommendation in an editor’s note, highlighting that treatment for OUD is critical to prevent infections, overdose, and death in pregnant women as well as neonatal opioid withdrawal syndrome and fetal death.
She stressed that internists and other primary care physicians have a key role in ensuring pregnant women with OUD receive appropriate treatment.
Given the importance of the issue, she wrote, “we have taken the unusual step of publishing two accompanying invited commentaries.”
Two developments may help increase use of buprenorphine, the study authors wrote. One is a recent study showing lower risk of adverse neonatal outcomes when buprenorphine is used during pregnancy compared with methadone. Another is the removal last year of the prescribing waiver for buprenorphine.
Study Included Medicaid Data Over 18 Years
The population-based cohort study used data from publicly insured Medicaid beneficiaries from 2000 to 2018. Pregnancies with enrollment from 90 days before pregnancy through 1 month after delivery and first-trimester use of buprenorphine or methadone were included (n = 13,360). The data were linked with infants’ health data.
The study group included 9,514 pregnancies with first-trimester buprenorphine exposure and 3,846 with methadone exposure. The risk of malformations overall was 50.9 (95% CI, 46.5-55.3) per 1000 pregnancies for buprenorphine and 60.6 (95% CI, 53.0-68.1) per 1000 pregnancies for methadone.
Major malformations were any cardiac malformations, ventricular septal defect, secundum atrial septal defect/nonprematurity-related patent foramen ovale, neural tube defects, oral clefts, and clubfoot.
Two Invited Commentaries Urge Caution in Interpretation
The two invited commentaries Dr. Grady mentioned in her editor’s note point both to the importance of the team’s findings and the need for better understanding of factors that may affect the choice of which OUD medication to use.
A commentary by Max Jordan Nguemeni Tiako, MD, MS, with the Department of Medicine, Brigham and Women’s Hospital, and colleagues, said that while the Suarez et al. data are important to share with patients, “the ultimate treatment decision must be the result of shared decision-making between a knowledgeable clinician and the patient, rather than promoting one medication over another.”
They urge putting the findings in context given the study population, which comprises a relatively stable group of women with OUD, most of whom were taking OUD medications before they got pregnant. The study sample excludes a substantial number of women who are chronically underinsured or uninsured, Dr. Tiako’s team wrote, because those included were enrolled in Medicaid for 3 consecutive months before pregnancy.
“We urge caution when extrapolating these findings to newly pregnant individuals with untreated OUD,” they wrote.
Both Medications are Safe
Cara Poland, MD, MEd, with the Henry Ford Health + Michigan State University Health Sciences in Grand Rapids, and coauthors, added in another commentary that Suarez et al. didn’t include a comparison between the population-level congenital defect rate and the defect rate for people using medications for OUD in pregnancy.
That comparison, they wrote, would have better illustrated the safety of medications for OUD “instead of simply comparing two medications with long-standing safety data.”
When a clinician starts a woman on medication for OUD in pregnancy, it’s important to understand several factors, including individual access to and comfort with different treatment approaches, they noted. It’s also important to weigh whether changing medications is worth the potential drawbacks of disrupting their well-managed care.
They wrote that the paper by Suarez et al. does not make the case for switching medications based on their findings.
Internists, they added, are ideal experts to explain risk of fetal abnormalities in the wider context of supporting engagement with continuous medication for OUD.
“In the absence of other concerns, switching medications (methadone to buprenorphine) or — worse — discontinuing [medication for] OUD because of this study runs counter to the substantial evidence regarding the safety of these medications during pregnancy,” Dr. Poland’s team wrote. “No treatment is without risk in pregnancy.”
This study was supported by the National Institute on Drug Abuse. In the Suarez et al. study, coauthors Dr. Hernández-Díaz, Dr. Gray, Dr. Connery, Dr. Zhu, and Dr. Huybrechts reported grants, personal fees and consulting payments from several pharmaceutical companies. Dr. Grady reports no relevant financial relationships in her editor’s note. No relevant financial relationships were reported by authors of the Tiako et al. commentary.
Regarding the commentary by Poland et al., grants were reported from the Michigan Health Endowment Fund, the Michigan Department of Health and Human Services, the National Institute on Drug Abuse and Blue Cross Blue Shield of Michigan outside the submitted work. No other disclosures were reported.
FROM JAMA INTERNAL MEDICINE
Autoimmune Diseases and Perinatal Depression May Share Two-Way Link
Women with autoimmune disease are more likely to have perinatal depression (PND), according to findings from a new study that also suggested the reverse relationship is true: Women with a history of PND have a higher risk of developing autoimmune disease.
The research, published online on January 9, 2024, in Molecular Psychiatry, was led by Emma Bränn, PhD, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.
The researchers used data from the Swedish Medical Birth Register and identified all women who had given birth in Sweden between 2001 and 2013. Out of the group of approximately 815,000 women and 1.3 million pregnancies, just more than 55,000 women had been diagnosed with depression during their pregnancy or within a year after delivery.
The researchers then compared the incidence of 41 autoimmune diseases in women who had and did not have PND. They controlled for factors including genetic makeup and childhood environment.
Results indicated that women with autoimmune disease were 30% more likely to have PND (odds ratio, 1.30; 95% CI, 1.25-1.35). Conversely, women with PND were 30% more likely than women with no PND to develop an autoimmune disease (hazard ratio, 1.30; 95% CI, 1.25-1.36).
A sibling comparison helped confirm the results by controlling for some shared genetic and early life environmental factors related to the household in which sisters grew up.
Potential Shared Biological Mechanisms
The association was independent of psychiatric comorbidities, suggesting there may be shared biological mechanisms.
Dr. Bränn told this news organization that the research team wanted to do the study because previous research has shown involvement of the immune system in depression, with similarities in both the symptoms of immune system–activated diseases and depression and the molecular pathways activated by the immune system.
“Adding on top of the tremendous changes in the immune system that we see in the body of the woman during the perinatal period, we hypothesized that autoimmune diseases could be associated to perinatal depression,” she said. “This had also been shown in some previous literature but not to the extent as what we have investigated in this paper.”
She said their results help make a case for counseling women at several points in healthcare interactions — before and after conception and childbirth — and in rheumatology visits to inform women with autoimmune diseases who are contemplating motherhood of the association with developing PND. The results may also demonstrate a need for monitoring women in these groups for depression or autoimmune disease.
Fred Miller, MD, PhD, retired Scientist Emeritus of the Environmental Autoimmunity Group at the National Institute of Environmental Health Sciences, who was not part of the study, said the results seem plausible as they build on early work that demonstrated selected associations between autoimmune conditions and mental illness.
“These associations may be the result of shared genetic and environmental risk factors, including stress, hormonal changes, medications, and the proinflammatory states that can lead to both,” he said.
The novelty, he said, is in the relatively strong associations of PND with autoimmune disease overall and with specific autoimmune diseases.
Strong Link Found With Multiple Sclerosis (MS)
According to the paper, a significant positive bidirectional link was found for autoimmune thyroid disease, psoriasis, MS, ulcerative colitis, and celiac disease.
Researchers found a particularly strong association — double the risk in both directions — between PND and MS.
Dr. Miller said though it is unclear from this study why the association of PND with MS was stronger than with other autoimmune diseases, people with MS are known to be at a high risk for depression in general. That may come from greater shared genetic and environmental risk factors, he added.
Additionally, MS is one of the more common autoimmune diseases, he noted, so the population is larger for study.
He said he was surprised the researchers didn’t investigate medication use because medications used in depression have immunologic effects and medications used in autoimmune diseases could have effects on mental conditions.
The study has implications for clinicians in a wide variety of specialties, Dr. Miller noted.
“It suggests that caregivers be more alert to the signs of developing autoimmune disease in women with perinatal depression and to the signs of developing perinatal depression in those with autoimmune disease,” Dr. Miller said, “so that appropriate screening, diagnostics, and interventions may be undertaken.”
The researchers say they will continue to examine the long-term effects of depression during pregnancy and in the year after childbirth.
“Depression during this sensitive period can have serious consequences for both the mother and the baby,” Dr. Bränn said. “We hope that our results will help decision-makers to steer funding toward maternal healthcare so that more women can get help and support in time.”
The study was financed by Karolinska Institute, Forte (the Swedish Research Council for Health, Working Life and Welfare), the Swedish Research Council, and the Icelandic Research Fund.
The researchers and Dr. Miller reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Women with autoimmune disease are more likely to have perinatal depression (PND), according to findings from a new study that also suggested the reverse relationship is true: Women with a history of PND have a higher risk of developing autoimmune disease.
The research, published online on January 9, 2024, in Molecular Psychiatry, was led by Emma Bränn, PhD, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.
The researchers used data from the Swedish Medical Birth Register and identified all women who had given birth in Sweden between 2001 and 2013. Out of the group of approximately 815,000 women and 1.3 million pregnancies, just more than 55,000 women had been diagnosed with depression during their pregnancy or within a year after delivery.
The researchers then compared the incidence of 41 autoimmune diseases in women who had and did not have PND. They controlled for factors including genetic makeup and childhood environment.
Results indicated that women with autoimmune disease were 30% more likely to have PND (odds ratio, 1.30; 95% CI, 1.25-1.35). Conversely, women with PND were 30% more likely than women with no PND to develop an autoimmune disease (hazard ratio, 1.30; 95% CI, 1.25-1.36).
A sibling comparison helped confirm the results by controlling for some shared genetic and early life environmental factors related to the household in which sisters grew up.
Potential Shared Biological Mechanisms
The association was independent of psychiatric comorbidities, suggesting there may be shared biological mechanisms.
Dr. Bränn told this news organization that the research team wanted to do the study because previous research has shown involvement of the immune system in depression, with similarities in both the symptoms of immune system–activated diseases and depression and the molecular pathways activated by the immune system.
“Adding on top of the tremendous changes in the immune system that we see in the body of the woman during the perinatal period, we hypothesized that autoimmune diseases could be associated to perinatal depression,” she said. “This had also been shown in some previous literature but not to the extent as what we have investigated in this paper.”
She said their results help make a case for counseling women at several points in healthcare interactions — before and after conception and childbirth — and in rheumatology visits to inform women with autoimmune diseases who are contemplating motherhood of the association with developing PND. The results may also demonstrate a need for monitoring women in these groups for depression or autoimmune disease.
Fred Miller, MD, PhD, retired Scientist Emeritus of the Environmental Autoimmunity Group at the National Institute of Environmental Health Sciences, who was not part of the study, said the results seem plausible as they build on early work that demonstrated selected associations between autoimmune conditions and mental illness.
“These associations may be the result of shared genetic and environmental risk factors, including stress, hormonal changes, medications, and the proinflammatory states that can lead to both,” he said.
The novelty, he said, is in the relatively strong associations of PND with autoimmune disease overall and with specific autoimmune diseases.
Strong Link Found With Multiple Sclerosis (MS)
According to the paper, a significant positive bidirectional link was found for autoimmune thyroid disease, psoriasis, MS, ulcerative colitis, and celiac disease.
Researchers found a particularly strong association — double the risk in both directions — between PND and MS.
Dr. Miller said though it is unclear from this study why the association of PND with MS was stronger than with other autoimmune diseases, people with MS are known to be at a high risk for depression in general. That may come from greater shared genetic and environmental risk factors, he added.
Additionally, MS is one of the more common autoimmune diseases, he noted, so the population is larger for study.
He said he was surprised the researchers didn’t investigate medication use because medications used in depression have immunologic effects and medications used in autoimmune diseases could have effects on mental conditions.
The study has implications for clinicians in a wide variety of specialties, Dr. Miller noted.
“It suggests that caregivers be more alert to the signs of developing autoimmune disease in women with perinatal depression and to the signs of developing perinatal depression in those with autoimmune disease,” Dr. Miller said, “so that appropriate screening, diagnostics, and interventions may be undertaken.”
The researchers say they will continue to examine the long-term effects of depression during pregnancy and in the year after childbirth.
“Depression during this sensitive period can have serious consequences for both the mother and the baby,” Dr. Bränn said. “We hope that our results will help decision-makers to steer funding toward maternal healthcare so that more women can get help and support in time.”
The study was financed by Karolinska Institute, Forte (the Swedish Research Council for Health, Working Life and Welfare), the Swedish Research Council, and the Icelandic Research Fund.
The researchers and Dr. Miller reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Women with autoimmune disease are more likely to have perinatal depression (PND), according to findings from a new study that also suggested the reverse relationship is true: Women with a history of PND have a higher risk of developing autoimmune disease.
The research, published online on January 9, 2024, in Molecular Psychiatry, was led by Emma Bränn, PhD, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.
The researchers used data from the Swedish Medical Birth Register and identified all women who had given birth in Sweden between 2001 and 2013. Out of the group of approximately 815,000 women and 1.3 million pregnancies, just more than 55,000 women had been diagnosed with depression during their pregnancy or within a year after delivery.
The researchers then compared the incidence of 41 autoimmune diseases in women who had and did not have PND. They controlled for factors including genetic makeup and childhood environment.
Results indicated that women with autoimmune disease were 30% more likely to have PND (odds ratio, 1.30; 95% CI, 1.25-1.35). Conversely, women with PND were 30% more likely than women with no PND to develop an autoimmune disease (hazard ratio, 1.30; 95% CI, 1.25-1.36).
A sibling comparison helped confirm the results by controlling for some shared genetic and early life environmental factors related to the household in which sisters grew up.
Potential Shared Biological Mechanisms
The association was independent of psychiatric comorbidities, suggesting there may be shared biological mechanisms.
Dr. Bränn told this news organization that the research team wanted to do the study because previous research has shown involvement of the immune system in depression, with similarities in both the symptoms of immune system–activated diseases and depression and the molecular pathways activated by the immune system.
“Adding on top of the tremendous changes in the immune system that we see in the body of the woman during the perinatal period, we hypothesized that autoimmune diseases could be associated to perinatal depression,” she said. “This had also been shown in some previous literature but not to the extent as what we have investigated in this paper.”
She said their results help make a case for counseling women at several points in healthcare interactions — before and after conception and childbirth — and in rheumatology visits to inform women with autoimmune diseases who are contemplating motherhood of the association with developing PND. The results may also demonstrate a need for monitoring women in these groups for depression or autoimmune disease.
Fred Miller, MD, PhD, retired Scientist Emeritus of the Environmental Autoimmunity Group at the National Institute of Environmental Health Sciences, who was not part of the study, said the results seem plausible as they build on early work that demonstrated selected associations between autoimmune conditions and mental illness.
“These associations may be the result of shared genetic and environmental risk factors, including stress, hormonal changes, medications, and the proinflammatory states that can lead to both,” he said.
The novelty, he said, is in the relatively strong associations of PND with autoimmune disease overall and with specific autoimmune diseases.
Strong Link Found With Multiple Sclerosis (MS)
According to the paper, a significant positive bidirectional link was found for autoimmune thyroid disease, psoriasis, MS, ulcerative colitis, and celiac disease.
Researchers found a particularly strong association — double the risk in both directions — between PND and MS.
Dr. Miller said though it is unclear from this study why the association of PND with MS was stronger than with other autoimmune diseases, people with MS are known to be at a high risk for depression in general. That may come from greater shared genetic and environmental risk factors, he added.
Additionally, MS is one of the more common autoimmune diseases, he noted, so the population is larger for study.
He said he was surprised the researchers didn’t investigate medication use because medications used in depression have immunologic effects and medications used in autoimmune diseases could have effects on mental conditions.
The study has implications for clinicians in a wide variety of specialties, Dr. Miller noted.
“It suggests that caregivers be more alert to the signs of developing autoimmune disease in women with perinatal depression and to the signs of developing perinatal depression in those with autoimmune disease,” Dr. Miller said, “so that appropriate screening, diagnostics, and interventions may be undertaken.”
The researchers say they will continue to examine the long-term effects of depression during pregnancy and in the year after childbirth.
“Depression during this sensitive period can have serious consequences for both the mother and the baby,” Dr. Bränn said. “We hope that our results will help decision-makers to steer funding toward maternal healthcare so that more women can get help and support in time.”
The study was financed by Karolinska Institute, Forte (the Swedish Research Council for Health, Working Life and Welfare), the Swedish Research Council, and the Icelandic Research Fund.
The researchers and Dr. Miller reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM MOLECULAR PSYCHIATRY
Musculoskeletal Symptoms Often Misattributed to Prior Tick Bites
Non–Lyme disease, tick-borne illnesses — such as spotted fever group rickettsiosis (SFGR), ehrlichiosis, and alpha-gal syndrome (AGS) — are emerging public health threats, but whether prior tick exposures are responsible for long-term complications, such as musculoskeletal symptoms or osteoarthritis, has been unclear.
Many patients attribute their nonspecific long-term symptoms, such as musculoskeletal pain, to previous illnesses from tick bites, note authors of a study published in JAMA Network Open. But the researchers, led by Diana L. Zychowski, MD, MPH, with the Division of Infectious Diseases at the University of North Carolina at Chapel Hill, found that Ehrlichia or Rickettsia seropositivity was not associated with chronic musculoskeletal symptoms, though they write that “further investigation into the pathogenesis of [alpha-gal] syndrome is needed.”
Tick-Borne Illness Cases Multiplying
Cases of tick-borne illness (TBD) in the United States have multiplied in recent years. More than 50,000 cases of TBD in the United States were reported in 2019, which doubled the number of cases over the previous 2 decades, the authors note.
Most of the cases are Lyme disease, but others — including SFGR and ehrlichiosis — represent an important public health threat, especially in southeastern states, the authors write. Cases of ehrlichiosis, for example, transmitted by the lone star tick, soared more than 10-fold since 2000.
The goal of this study was to evaluate whether there was an association between prior exposure to TBDs endemic to the southeastern United States and chronic musculoskeletal symptoms and radiographic measures of osteoarthritis.
Researchers analyzed 488 blood samples from the fourth visit (2017-2018) of the Johnston County Osteoarthritis (JoCo OA) project, an ongoing population-based study in Johnston County, North Carolina. JoCo OA participants include noninstitutionalized White and Black Johnston County residents 45 years old or older with osteoarthritis.
They measured seroprevalence of Rickettsia- and Ehrlichia-specific immunoglobulin G (IgG) as well as alpha-gal immunoglobulin E (IgE) in patient samples. Only alpha-gal IgE was linked in the study with knee pain, aching, or stiffness. Antibodies to Rickettsia, Ehrlichia, and alpha-gal were not associated with radiographic, symptomatic knee osteoarthritis.
“To our knowledge,” the authors write, “this study was the first population-based seroprevalence study of SFGR, Ehrlichia, and [alpha]-gal.”
The study also found a high prevalence of TBD exposure in the cohort. More than a third (36.5%) had either an alpha-gal IgE level greater than 0.1 IU/mL, a positive test for SFGR IgG antibodies, or a positive test for Ehrlichia IgG antibodies.
Given that not every tick carries an infectious pathogen, the findings show human-tick interactions are common, they write.
“These findings suggest that substantial investment is required to examine the pathogenesis of these TBDs and interventions to reduce human-tick interactions,” the authors conclude.
This study was funded by a Creativity Hub Award from the University of North Carolina Office of the Vice Chancellor for Research. The JoCo OA project is supported in part by grants from the Association of Schools of Public Health/Centers for Disease Control and Prevention (CDC); and grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Authors reported grants from the National Institutes of Health, the CDC, and several pharmaceutical companies.
Non–Lyme disease, tick-borne illnesses — such as spotted fever group rickettsiosis (SFGR), ehrlichiosis, and alpha-gal syndrome (AGS) — are emerging public health threats, but whether prior tick exposures are responsible for long-term complications, such as musculoskeletal symptoms or osteoarthritis, has been unclear.
Many patients attribute their nonspecific long-term symptoms, such as musculoskeletal pain, to previous illnesses from tick bites, note authors of a study published in JAMA Network Open. But the researchers, led by Diana L. Zychowski, MD, MPH, with the Division of Infectious Diseases at the University of North Carolina at Chapel Hill, found that Ehrlichia or Rickettsia seropositivity was not associated with chronic musculoskeletal symptoms, though they write that “further investigation into the pathogenesis of [alpha-gal] syndrome is needed.”
Tick-Borne Illness Cases Multiplying
Cases of tick-borne illness (TBD) in the United States have multiplied in recent years. More than 50,000 cases of TBD in the United States were reported in 2019, which doubled the number of cases over the previous 2 decades, the authors note.
Most of the cases are Lyme disease, but others — including SFGR and ehrlichiosis — represent an important public health threat, especially in southeastern states, the authors write. Cases of ehrlichiosis, for example, transmitted by the lone star tick, soared more than 10-fold since 2000.
The goal of this study was to evaluate whether there was an association between prior exposure to TBDs endemic to the southeastern United States and chronic musculoskeletal symptoms and radiographic measures of osteoarthritis.
Researchers analyzed 488 blood samples from the fourth visit (2017-2018) of the Johnston County Osteoarthritis (JoCo OA) project, an ongoing population-based study in Johnston County, North Carolina. JoCo OA participants include noninstitutionalized White and Black Johnston County residents 45 years old or older with osteoarthritis.
They measured seroprevalence of Rickettsia- and Ehrlichia-specific immunoglobulin G (IgG) as well as alpha-gal immunoglobulin E (IgE) in patient samples. Only alpha-gal IgE was linked in the study with knee pain, aching, or stiffness. Antibodies to Rickettsia, Ehrlichia, and alpha-gal were not associated with radiographic, symptomatic knee osteoarthritis.
“To our knowledge,” the authors write, “this study was the first population-based seroprevalence study of SFGR, Ehrlichia, and [alpha]-gal.”
The study also found a high prevalence of TBD exposure in the cohort. More than a third (36.5%) had either an alpha-gal IgE level greater than 0.1 IU/mL, a positive test for SFGR IgG antibodies, or a positive test for Ehrlichia IgG antibodies.
Given that not every tick carries an infectious pathogen, the findings show human-tick interactions are common, they write.
“These findings suggest that substantial investment is required to examine the pathogenesis of these TBDs and interventions to reduce human-tick interactions,” the authors conclude.
This study was funded by a Creativity Hub Award from the University of North Carolina Office of the Vice Chancellor for Research. The JoCo OA project is supported in part by grants from the Association of Schools of Public Health/Centers for Disease Control and Prevention (CDC); and grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Authors reported grants from the National Institutes of Health, the CDC, and several pharmaceutical companies.
Non–Lyme disease, tick-borne illnesses — such as spotted fever group rickettsiosis (SFGR), ehrlichiosis, and alpha-gal syndrome (AGS) — are emerging public health threats, but whether prior tick exposures are responsible for long-term complications, such as musculoskeletal symptoms or osteoarthritis, has been unclear.
Many patients attribute their nonspecific long-term symptoms, such as musculoskeletal pain, to previous illnesses from tick bites, note authors of a study published in JAMA Network Open. But the researchers, led by Diana L. Zychowski, MD, MPH, with the Division of Infectious Diseases at the University of North Carolina at Chapel Hill, found that Ehrlichia or Rickettsia seropositivity was not associated with chronic musculoskeletal symptoms, though they write that “further investigation into the pathogenesis of [alpha-gal] syndrome is needed.”
Tick-Borne Illness Cases Multiplying
Cases of tick-borne illness (TBD) in the United States have multiplied in recent years. More than 50,000 cases of TBD in the United States were reported in 2019, which doubled the number of cases over the previous 2 decades, the authors note.
Most of the cases are Lyme disease, but others — including SFGR and ehrlichiosis — represent an important public health threat, especially in southeastern states, the authors write. Cases of ehrlichiosis, for example, transmitted by the lone star tick, soared more than 10-fold since 2000.
The goal of this study was to evaluate whether there was an association between prior exposure to TBDs endemic to the southeastern United States and chronic musculoskeletal symptoms and radiographic measures of osteoarthritis.
Researchers analyzed 488 blood samples from the fourth visit (2017-2018) of the Johnston County Osteoarthritis (JoCo OA) project, an ongoing population-based study in Johnston County, North Carolina. JoCo OA participants include noninstitutionalized White and Black Johnston County residents 45 years old or older with osteoarthritis.
They measured seroprevalence of Rickettsia- and Ehrlichia-specific immunoglobulin G (IgG) as well as alpha-gal immunoglobulin E (IgE) in patient samples. Only alpha-gal IgE was linked in the study with knee pain, aching, or stiffness. Antibodies to Rickettsia, Ehrlichia, and alpha-gal were not associated with radiographic, symptomatic knee osteoarthritis.
“To our knowledge,” the authors write, “this study was the first population-based seroprevalence study of SFGR, Ehrlichia, and [alpha]-gal.”
The study also found a high prevalence of TBD exposure in the cohort. More than a third (36.5%) had either an alpha-gal IgE level greater than 0.1 IU/mL, a positive test for SFGR IgG antibodies, or a positive test for Ehrlichia IgG antibodies.
Given that not every tick carries an infectious pathogen, the findings show human-tick interactions are common, they write.
“These findings suggest that substantial investment is required to examine the pathogenesis of these TBDs and interventions to reduce human-tick interactions,” the authors conclude.
This study was funded by a Creativity Hub Award from the University of North Carolina Office of the Vice Chancellor for Research. The JoCo OA project is supported in part by grants from the Association of Schools of Public Health/Centers for Disease Control and Prevention (CDC); and grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Authors reported grants from the National Institutes of Health, the CDC, and several pharmaceutical companies.
FROM JAMA NETWORK OPEN