Marcia Frellick

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.

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.

Wearing a brace at night is an effective alternative for moderate adolescent idiopathic scoliosis (AIS) if the patient rejects wearing a brace full time, 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.

Wearing a brace at night is an effective alternative for moderate adolescent idiopathic scoliosis (AIS) if the patient rejects wearing a brace full time, 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.

Wearing a brace at night is an effective alternative for moderate adolescent idiopathic scoliosis (AIS) if the patient rejects wearing a brace full time, 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.

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.

Bone Health Technologies

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.

Bone Health Technologies

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.

Bone Health Technologies

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 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.

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.

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.

A cluster of ocular presentation of syphilis has experts questioning whether this rare finding suggests the bacterium has mutated, according to a report by the Centers for Disease Control and Prevention.

With the incidence of syphilis infection in women increasing in the United States, experts are asking clinicians to be on the lookout for unusual ocular presentations. 

“This is the first time such a cluster has been reported in the US,” the International Society for Infectious Diseases posted on ProMED. 

Five women in Southwest Michigan who had a common male sex partner developed syphilis infections in their eyes. No new cases have been found related to these five cases after the women and the man received medical care. 

If left untreated, the bacterium, Treponema pallidum, can infect the eyes, the ears, and the central nervous system.

The women, identified as non-Hispanic White, were aged 40-60 years and were not infected with HIV. They were diagnosed with early-stage syphilis and all were hospitalized and treated with intravenous penicillin. Routes of sexual exposure among the women included anal (40%), oral (40%), and vaginal (100%), the report states.

The common male sex partner they all met online was found to have early latent syphilis but never developed ocular syphilis. 

It is not the eyes that are being exposed. Rather, it is an ocular presentation brought about by a systemic infection carried through the bloodstream after sexual exposure, explains William Nettleton, MD, MPH, medical director of the Kalamazoo and Calhoun public health departments in Michigan and lead author of the report.

“If we screen, identify, and treat syphilis promptly, we can prevent systemic manifestations,” he says. 

Clinicians should be aware that the ocular manifestations can come at different stages of syphilis. “For patients you think may have ocular syphilis,” Dr. Nettleton says, “an immediate ophthalmologic evaluation is indicated.” 

Symptoms Differed

The five women presented with a variety of symptoms. 

Multiple attempts to contact the male partner by telephone and text were made by Michigan Department of Health and Human Services, but he did not respond. Local public health physicians reviewed the man’s electronic health record and discovered that he had sought care at a hospital emergency department in January 2022 for ulcerative penile and anal lesions. 

He reported having multiple female sex partners during the previous 12 months but declined to disclose their identities; he reported no male or transgender sexual contact, according to the CDC report. Eventually he agreed to an evaluation, was found to have early latent syphilis, and was treated with penicillin. 

Cases of syphilis have been soaring in the United States in recent years, reaching a 70-year high.

A version of this article appeared on Medscape.com.

A cluster of ocular presentation of syphilis has experts questioning whether this rare finding suggests the bacterium has mutated, according to a report by the Centers for Disease Control and Prevention.

With the incidence of syphilis infection in women increasing in the United States, experts are asking clinicians to be on the lookout for unusual ocular presentations. 

“This is the first time such a cluster has been reported in the US,” the International Society for Infectious Diseases posted on ProMED. 

Five women in Southwest Michigan who had a common male sex partner developed syphilis infections in their eyes. No new cases have been found related to these five cases after the women and the man received medical care. 

If left untreated, the bacterium, Treponema pallidum, can infect the eyes, the ears, and the central nervous system.

The women, identified as non-Hispanic White, were aged 40-60 years and were not infected with HIV. They were diagnosed with early-stage syphilis and all were hospitalized and treated with intravenous penicillin. Routes of sexual exposure among the women included anal (40%), oral (40%), and vaginal (100%), the report states.

The common male sex partner they all met online was found to have early latent syphilis but never developed ocular syphilis. 

It is not the eyes that are being exposed. Rather, it is an ocular presentation brought about by a systemic infection carried through the bloodstream after sexual exposure, explains William Nettleton, MD, MPH, medical director of the Kalamazoo and Calhoun public health departments in Michigan and lead author of the report.

“If we screen, identify, and treat syphilis promptly, we can prevent systemic manifestations,” he says. 

Clinicians should be aware that the ocular manifestations can come at different stages of syphilis. “For patients you think may have ocular syphilis,” Dr. Nettleton says, “an immediate ophthalmologic evaluation is indicated.” 

Symptoms Differed

The five women presented with a variety of symptoms. 

Multiple attempts to contact the male partner by telephone and text were made by Michigan Department of Health and Human Services, but he did not respond. Local public health physicians reviewed the man’s electronic health record and discovered that he had sought care at a hospital emergency department in January 2022 for ulcerative penile and anal lesions. 

He reported having multiple female sex partners during the previous 12 months but declined to disclose their identities; he reported no male or transgender sexual contact, according to the CDC report. Eventually he agreed to an evaluation, was found to have early latent syphilis, and was treated with penicillin. 

Cases of syphilis have been soaring in the United States in recent years, reaching a 70-year high.

A version of this article appeared on Medscape.com.

A cluster of ocular presentation of syphilis has experts questioning whether this rare finding suggests the bacterium has mutated, according to a report by the Centers for Disease Control and Prevention.

With the incidence of syphilis infection in women increasing in the United States, experts are asking clinicians to be on the lookout for unusual ocular presentations. 

“This is the first time such a cluster has been reported in the US,” the International Society for Infectious Diseases posted on ProMED. 

Five women in Southwest Michigan who had a common male sex partner developed syphilis infections in their eyes. No new cases have been found related to these five cases after the women and the man received medical care. 

If left untreated, the bacterium, Treponema pallidum, can infect the eyes, the ears, and the central nervous system.

The women, identified as non-Hispanic White, were aged 40-60 years and were not infected with HIV. They were diagnosed with early-stage syphilis and all were hospitalized and treated with intravenous penicillin. Routes of sexual exposure among the women included anal (40%), oral (40%), and vaginal (100%), the report states.

The common male sex partner they all met online was found to have early latent syphilis but never developed ocular syphilis. 

It is not the eyes that are being exposed. Rather, it is an ocular presentation brought about by a systemic infection carried through the bloodstream after sexual exposure, explains William Nettleton, MD, MPH, medical director of the Kalamazoo and Calhoun public health departments in Michigan and lead author of the report.

“If we screen, identify, and treat syphilis promptly, we can prevent systemic manifestations,” he says. 

Clinicians should be aware that the ocular manifestations can come at different stages of syphilis. “For patients you think may have ocular syphilis,” Dr. Nettleton says, “an immediate ophthalmologic evaluation is indicated.” 

Symptoms Differed

The five women presented with a variety of symptoms. 

Multiple attempts to contact the male partner by telephone and text were made by Michigan Department of Health and Human Services, but he did not respond. Local public health physicians reviewed the man’s electronic health record and discovered that he had sought care at a hospital emergency department in January 2022 for ulcerative penile and anal lesions. 

He reported having multiple female sex partners during the previous 12 months but declined to disclose their identities; he reported no male or transgender sexual contact, according to the CDC report. Eventually he agreed to an evaluation, was found to have early latent syphilis, and was treated with penicillin. 

Cases of syphilis have been soaring in the United States in recent years, reaching a 70-year high.

A version of this article appeared on Medscape.com.

Isotretinoin users have no increased risk of suicide or psychiatric conditions on a population level, a meta-analysis of 25 studies that included 1.6 million patients suggests.

Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.

The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I² [measuring heterogeneity] = 77%) in 11 studies.
 

Less likely to attempt suicide

Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I² = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I² = 23%) following treatment.

Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I² = 0%).

Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
 

“Two things can be true”

John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.

Dr. Barbieri

The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.

In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”

He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.

“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”

Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.

In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
 

What a meta-analysis might miss

In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.

They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”

Far from the “final word”

Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”

Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.

Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.

Isotretinoin users have no increased risk of suicide or psychiatric conditions on a population level, a meta-analysis of 25 studies that included 1.6 million patients suggests.

Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.

The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I² [measuring heterogeneity] = 77%) in 11 studies.
 

Less likely to attempt suicide

Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I² = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I² = 23%) following treatment.

Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I² = 0%).

Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
 

“Two things can be true”

John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.

Dr. Barbieri

The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.

In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”

He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.

“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”

Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.

In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
 

What a meta-analysis might miss

In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.

They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”

Far from the “final word”

Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”

Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.

Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.

Isotretinoin users have no increased risk of suicide or psychiatric conditions on a population level, a meta-analysis of 25 studies that included 1.6 million patients suggests.

Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.

The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I² [measuring heterogeneity] = 77%) in 11 studies.
 

Less likely to attempt suicide

Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I² = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I² = 23%) following treatment.

Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I² = 0%).

Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
 

“Two things can be true”

John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.

Dr. Barbieri

The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.

In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”

He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.

“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”

Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.

In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
 

What a meta-analysis might miss

In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.

They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”

Far from the “final word”

Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”

Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.

Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.

ANAHEIM, CALIF. – Gargling and nasal rinsing with saltwater several times a day appeared to be associated with significantly lower COVID-19 hospitalization rates in a small, randomized, double-blind, controlled study.

“The hypothesis was that interventions that target the upper respiratory tract may reduce the frequency and duration of upper respiratory symptoms associated with COVID-19,” said Sebastian Espinoza, first author of the study; he is with Trinity University, San Antonio.

Adults aged 18-65 years who tested positive for SARS-CoV-2 on polymerase chain reaction (PCR) testing between 2020 and 2022 were randomly selected to use low- or high-dose saltwater regimens for 14 days at the Harris Health System, Houston. For patients to be included in the study, 14 days had to have elapsed since the onset of any symptoms associated with COVID.

The low dose was 2.13 grams of salt dissolved in 8 ounces of warm water, and the high dose was 6 grams. Participants gargled the saltwater and used it as a nasal rinse for 5 minutes four times a day.

Primary outcomes included frequency and duration of symptoms associated with SARS-CoV-2 infection; secondary outcomes included admission to the hospital or the intensive care unit, mechanical ventilatory support, or death.

The findings were presented in a poster at the annual meeting of the American College of Allergy, Asthma, and Immunology.

Fifty-eight people were randomly assigned to either the low-saline (n = 27) or the high-saline (n = 28) group; three patients were lost to follow-up in both these groups. The reference control population consisted of 9,398 people with confirmed SARS-CoV-2 infection. Rates of vaccination were similar for all participants.

Hospitalization rates in the low- (18.5%) and high- (21.4%) saline groups were significantly lower than in the reference control population (58.8%; P < .001). No significant differences were noted in other outcomes among these groups.

The average age of patients in the control population (n = 9,398) was 45 years. The average age was similar in the low- and high-saline groups. In the low-saline group (n = 27), the average age was 39, and in the high-saline group, the average age was 41.

In all three groups, body mass index was between 29.6 and 31.7.

Exclusion criteria included chronic hypertension or participation in another interventional study.
 

‘Low risk, small potential benefit’

Allergist Zach Rubin, MD, a spokesperson for the ACAAI, said in an interview that the findings are in line with other small studies that previously reported some benefit in using nasal saline irrigation and gargling to treat a SARS-CoV-2 infection.

“This is a type of intervention that is low risk with some small potential benefit,” he said.

The researchers did not evaluate the potential reason for the saline regimen’s association with fewer hospitalizations, but Dr. Rubin said, “It may be possible that nasal saline irrigation and gargling help improve viral clearance and reduce the risk of microaspiration into the lungs, so it may be possible that this intervention could reduce the risk of pneumonia, which is a major cause of hospitalization.”

Dr. Rubin, who is an allergist at Oak Brook Allergists, Ill., said, “I generally recommend nasal saline irrigation to my patients for allergic rhinitis and viral upper respiratory infections already. It can help reduce symptoms such as nasal congestion, rhinorrhea, postnasal drip, and sinus pain and pressure.”

The intervention may be reasonable beyond an adult population, he said.

“This could be used for pediatric patients as well, if they are developmentally ready to try this intervention,” he said.

Mr. Espinoza said further study is warranted, but he said that if confirmed in later trials, the simple intervention may be particularly helpful in low-resource settings.

Mr. Espinoza and Dr. Rubin have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

ANAHEIM, CALIF. – Gargling and nasal rinsing with saltwater several times a day appeared to be associated with significantly lower COVID-19 hospitalization rates in a small, randomized, double-blind, controlled study.

“The hypothesis was that interventions that target the upper respiratory tract may reduce the frequency and duration of upper respiratory symptoms associated with COVID-19,” said Sebastian Espinoza, first author of the study; he is with Trinity University, San Antonio.

Adults aged 18-65 years who tested positive for SARS-CoV-2 on polymerase chain reaction (PCR) testing between 2020 and 2022 were randomly selected to use low- or high-dose saltwater regimens for 14 days at the Harris Health System, Houston. For patients to be included in the study, 14 days had to have elapsed since the onset of any symptoms associated with COVID.

The low dose was 2.13 grams of salt dissolved in 8 ounces of warm water, and the high dose was 6 grams. Participants gargled the saltwater and used it as a nasal rinse for 5 minutes four times a day.

Primary outcomes included frequency and duration of symptoms associated with SARS-CoV-2 infection; secondary outcomes included admission to the hospital or the intensive care unit, mechanical ventilatory support, or death.

The findings were presented in a poster at the annual meeting of the American College of Allergy, Asthma, and Immunology.

Fifty-eight people were randomly assigned to either the low-saline (n = 27) or the high-saline (n = 28) group; three patients were lost to follow-up in both these groups. The reference control population consisted of 9,398 people with confirmed SARS-CoV-2 infection. Rates of vaccination were similar for all participants.

Hospitalization rates in the low- (18.5%) and high- (21.4%) saline groups were significantly lower than in the reference control population (58.8%; P < .001). No significant differences were noted in other outcomes among these groups.

The average age of patients in the control population (n = 9,398) was 45 years. The average age was similar in the low- and high-saline groups. In the low-saline group (n = 27), the average age was 39, and in the high-saline group, the average age was 41.

In all three groups, body mass index was between 29.6 and 31.7.

Exclusion criteria included chronic hypertension or participation in another interventional study.
 

‘Low risk, small potential benefit’

Allergist Zach Rubin, MD, a spokesperson for the ACAAI, said in an interview that the findings are in line with other small studies that previously reported some benefit in using nasal saline irrigation and gargling to treat a SARS-CoV-2 infection.

“This is a type of intervention that is low risk with some small potential benefit,” he said.

The researchers did not evaluate the potential reason for the saline regimen’s association with fewer hospitalizations, but Dr. Rubin said, “It may be possible that nasal saline irrigation and gargling help improve viral clearance and reduce the risk of microaspiration into the lungs, so it may be possible that this intervention could reduce the risk of pneumonia, which is a major cause of hospitalization.”

Dr. Rubin, who is an allergist at Oak Brook Allergists, Ill., said, “I generally recommend nasal saline irrigation to my patients for allergic rhinitis and viral upper respiratory infections already. It can help reduce symptoms such as nasal congestion, rhinorrhea, postnasal drip, and sinus pain and pressure.”

The intervention may be reasonable beyond an adult population, he said.

“This could be used for pediatric patients as well, if they are developmentally ready to try this intervention,” he said.

Mr. Espinoza said further study is warranted, but he said that if confirmed in later trials, the simple intervention may be particularly helpful in low-resource settings.

Mr. Espinoza and Dr. Rubin have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

ANAHEIM, CALIF. – Gargling and nasal rinsing with saltwater several times a day appeared to be associated with significantly lower COVID-19 hospitalization rates in a small, randomized, double-blind, controlled study.

“The hypothesis was that interventions that target the upper respiratory tract may reduce the frequency and duration of upper respiratory symptoms associated with COVID-19,” said Sebastian Espinoza, first author of the study; he is with Trinity University, San Antonio.

Adults aged 18-65 years who tested positive for SARS-CoV-2 on polymerase chain reaction (PCR) testing between 2020 and 2022 were randomly selected to use low- or high-dose saltwater regimens for 14 days at the Harris Health System, Houston. For patients to be included in the study, 14 days had to have elapsed since the onset of any symptoms associated with COVID.

The low dose was 2.13 grams of salt dissolved in 8 ounces of warm water, and the high dose was 6 grams. Participants gargled the saltwater and used it as a nasal rinse for 5 minutes four times a day.

Primary outcomes included frequency and duration of symptoms associated with SARS-CoV-2 infection; secondary outcomes included admission to the hospital or the intensive care unit, mechanical ventilatory support, or death.

The findings were presented in a poster at the annual meeting of the American College of Allergy, Asthma, and Immunology.

Fifty-eight people were randomly assigned to either the low-saline (n = 27) or the high-saline (n = 28) group; three patients were lost to follow-up in both these groups. The reference control population consisted of 9,398 people with confirmed SARS-CoV-2 infection. Rates of vaccination were similar for all participants.

Hospitalization rates in the low- (18.5%) and high- (21.4%) saline groups were significantly lower than in the reference control population (58.8%; P < .001). No significant differences were noted in other outcomes among these groups.

The average age of patients in the control population (n = 9,398) was 45 years. The average age was similar in the low- and high-saline groups. In the low-saline group (n = 27), the average age was 39, and in the high-saline group, the average age was 41.

In all three groups, body mass index was between 29.6 and 31.7.

Exclusion criteria included chronic hypertension or participation in another interventional study.
 

‘Low risk, small potential benefit’

Allergist Zach Rubin, MD, a spokesperson for the ACAAI, said in an interview that the findings are in line with other small studies that previously reported some benefit in using nasal saline irrigation and gargling to treat a SARS-CoV-2 infection.

“This is a type of intervention that is low risk with some small potential benefit,” he said.

The researchers did not evaluate the potential reason for the saline regimen’s association with fewer hospitalizations, but Dr. Rubin said, “It may be possible that nasal saline irrigation and gargling help improve viral clearance and reduce the risk of microaspiration into the lungs, so it may be possible that this intervention could reduce the risk of pneumonia, which is a major cause of hospitalization.”

Dr. Rubin, who is an allergist at Oak Brook Allergists, Ill., said, “I generally recommend nasal saline irrigation to my patients for allergic rhinitis and viral upper respiratory infections already. It can help reduce symptoms such as nasal congestion, rhinorrhea, postnasal drip, and sinus pain and pressure.”

The intervention may be reasonable beyond an adult population, he said.

“This could be used for pediatric patients as well, if they are developmentally ready to try this intervention,” he said.

Mr. Espinoza said further study is warranted, but he said that if confirmed in later trials, the simple intervention may be particularly helpful in low-resource settings.

Mr. Espinoza and Dr. Rubin have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.