Musculoskeletal Disorders

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Obesity and diabetes increase the risk for complications following joint surgeries like total hip replacement, but can semaglutide and related drugs help?

The question has massive implications. More than 450,000 total hip arthroplasty (THA) procedures are performed annually in the United States, with the number expected to grow to 850,000 by 2030. Obesity is the leading reason for the increase. Semaglutide and other glucagon-like peptide 1 (GLP-1) receptor agonists can lead to dramatic and rapid weight loss, in addition to controlling diabetes, so researchers have wondered if the medications might improve outcomes in patients undergoing joint surgery. 

Two studies presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) sought to answer the question — but reached different conclusions. 

One study of THA patients taking semaglutide found fewer 90-day readmissions for diabetes and fewer prosthetic joint infections at the 2-year mark. Another found similar outcomes on the need for revision surgery, infections, and many other postsurgery metrics in people who took the GLP-1 receptor agonist and those who did not. Neither study had outside funding.
 

Study: Fewer Infections, Readmissions

For their study, Matthew Magruder, MD, a third-year orthopedic resident at Maimonides Medical Center’s Department of Orthopaedic Surgery and Rehabilitation in New York City, and his colleagues used an administrative claim database (PearlDiver) to identify THA patients who underwent the surgery between January 1, 2020, to October 31, 2021, when semaglutide was approved for the treatment of diabetes but not yet for obesity. The researchers found 9465 patients who had had a primary THA, of whom 1653 had received a prescription for semaglutide.

In total, 84.9% of those on semaglutide had obesity, as did 85.2% of those not on the medication.

Dr. Magruder’s group looked at medical complications such as deep vein thrombosis, myocardial infarction, hypoglycemia, and pulmonary embolism within 90 days of surgery, implant-related complications 2 years after the procedure, rates of readmission within 90 days of the procedure, length of stay in the hospital, and costs of care. 

They found that patients taking semaglutide were less likely to be readmitted to the hospital within 90 days of THA (6.2% vs 8.8%; P <.01) and experienced fewer joint infections (1.6% vs 2.9%; P <.01). No significant differences were found in the other outcomes.

Among the potential concerns involving the use of GLP-1 receptor agonists in patients undergoing surgery are their potential to cause hypoglycemia and the risk for aspiration during anesthesia. But those issues did not emerge in the analysis.

“We concluded that this was preliminary evidence that using semaglutide at the time of surgery was safe and potentially effective at reducing complications,” said Dr. Magruder, whose team published their findings in The Journal of Arthroplasty.
 

Study: Semaglutide Has No Effect on Postop Complications

In another study presented at the AAOS meeting, researchers found that rates of complications after THA were similar in patients with obesity who took semaglutide and those who did not. That information could be helpful for clinicians who have been reluctant to perform THA procedures in patients who also have had bariatric surgery, said Daniel E. Pereira, MD, a resident at Washington University in St. Louis and the first author of the study.

A recent retrospective review found that patients who had bariatric surgery have worse implant survivorship and higher rates of dislocation than do those with a naturally low or high body mass index (BMI). 

Pereira and his colleagues used a national database, with deidentified patient records, originally finding 42,410 patients. After matching, they evaluated 616 in each cohort: those who took semaglutide and those who did not. The average age was 62.7 years; average BMI was 35.5. 

Both groups had a similar risk for a range of complications including revision surgery, infection of the new joint and surgical site, opioid-related disorders, pulmonary embolism, deep vein thrombosis, and mortality. 

“We didn’t observe anything significant [between groups] in terms of the complications,” said David Momtaz, MPH, a fourth-year medical student at the University of Texas Health Science Center at San Antonio, who helped conduct the research. 

Dr. Pereira said he hoped the results would end the hesitation he observes, partly due to a lack of research, among some physicians about prescribing semaglutide before THA in appropriate patients. “Our preliminary evidence suggests there is no need to withhold THA in patients who successfully lost weight on semaglutide,” he said.
 

Expert Perspective: Not Unexpected

Peter Hanson, MD, an orthopedic surgeon and orthopedic medical director at Sharp Grossmont Hospital in La Mesa, California, who specializes in hip and knee replacement, said he was unsurprised by the findings. 

The patients he has observed on GLP-1 receptor agonists lose weight, he said, and a few even to the point of not needing a replacement. A recent study found that every 1% decrease in weight was associated with a 2% reduced risk for knee replacement in those with knee osteoarthritis or at risk for it, and every 1% drop in weight was associated with a 3% reduced risk for THA.

“I always advise my overweight patient to lose at least 30 pounds, even if their BMI is less than 40, like many in these studies,” Dr. Hanson said. If a patient’s doctor prescribes semaglutide or another GLP-1 receptor agonist, “I am very supportive, and we postpone surgery until the weight loss is maximized,” he added.

Drs. Magruder, Pereira, Momtaz, and Hanson have no disclosures.

A version of this article appeared on Medscape.com.

Obesity and diabetes increase the risk for complications following joint surgeries like total hip replacement, but can semaglutide and related drugs help?

The question has massive implications. More than 450,000 total hip arthroplasty (THA) procedures are performed annually in the United States, with the number expected to grow to 850,000 by 2030. Obesity is the leading reason for the increase. Semaglutide and other glucagon-like peptide 1 (GLP-1) receptor agonists can lead to dramatic and rapid weight loss, in addition to controlling diabetes, so researchers have wondered if the medications might improve outcomes in patients undergoing joint surgery. 

Two studies presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) sought to answer the question — but reached different conclusions. 

One study of THA patients taking semaglutide found fewer 90-day readmissions for diabetes and fewer prosthetic joint infections at the 2-year mark. Another found similar outcomes on the need for revision surgery, infections, and many other postsurgery metrics in people who took the GLP-1 receptor agonist and those who did not. Neither study had outside funding.
 

Study: Fewer Infections, Readmissions

For their study, Matthew Magruder, MD, a third-year orthopedic resident at Maimonides Medical Center’s Department of Orthopaedic Surgery and Rehabilitation in New York City, and his colleagues used an administrative claim database (PearlDiver) to identify THA patients who underwent the surgery between January 1, 2020, to October 31, 2021, when semaglutide was approved for the treatment of diabetes but not yet for obesity. The researchers found 9465 patients who had had a primary THA, of whom 1653 had received a prescription for semaglutide.

In total, 84.9% of those on semaglutide had obesity, as did 85.2% of those not on the medication.

Dr. Magruder’s group looked at medical complications such as deep vein thrombosis, myocardial infarction, hypoglycemia, and pulmonary embolism within 90 days of surgery, implant-related complications 2 years after the procedure, rates of readmission within 90 days of the procedure, length of stay in the hospital, and costs of care. 

They found that patients taking semaglutide were less likely to be readmitted to the hospital within 90 days of THA (6.2% vs 8.8%; P <.01) and experienced fewer joint infections (1.6% vs 2.9%; P <.01). No significant differences were found in the other outcomes.

Among the potential concerns involving the use of GLP-1 receptor agonists in patients undergoing surgery are their potential to cause hypoglycemia and the risk for aspiration during anesthesia. But those issues did not emerge in the analysis.

“We concluded that this was preliminary evidence that using semaglutide at the time of surgery was safe and potentially effective at reducing complications,” said Dr. Magruder, whose team published their findings in The Journal of Arthroplasty.
 

Study: Semaglutide Has No Effect on Postop Complications

In another study presented at the AAOS meeting, researchers found that rates of complications after THA were similar in patients with obesity who took semaglutide and those who did not. That information could be helpful for clinicians who have been reluctant to perform THA procedures in patients who also have had bariatric surgery, said Daniel E. Pereira, MD, a resident at Washington University in St. Louis and the first author of the study.

A recent retrospective review found that patients who had bariatric surgery have worse implant survivorship and higher rates of dislocation than do those with a naturally low or high body mass index (BMI). 

Pereira and his colleagues used a national database, with deidentified patient records, originally finding 42,410 patients. After matching, they evaluated 616 in each cohort: those who took semaglutide and those who did not. The average age was 62.7 years; average BMI was 35.5. 

Both groups had a similar risk for a range of complications including revision surgery, infection of the new joint and surgical site, opioid-related disorders, pulmonary embolism, deep vein thrombosis, and mortality. 

“We didn’t observe anything significant [between groups] in terms of the complications,” said David Momtaz, MPH, a fourth-year medical student at the University of Texas Health Science Center at San Antonio, who helped conduct the research. 

Dr. Pereira said he hoped the results would end the hesitation he observes, partly due to a lack of research, among some physicians about prescribing semaglutide before THA in appropriate patients. “Our preliminary evidence suggests there is no need to withhold THA in patients who successfully lost weight on semaglutide,” he said.
 

Expert Perspective: Not Unexpected

Peter Hanson, MD, an orthopedic surgeon and orthopedic medical director at Sharp Grossmont Hospital in La Mesa, California, who specializes in hip and knee replacement, said he was unsurprised by the findings. 

The patients he has observed on GLP-1 receptor agonists lose weight, he said, and a few even to the point of not needing a replacement. A recent study found that every 1% decrease in weight was associated with a 2% reduced risk for knee replacement in those with knee osteoarthritis or at risk for it, and every 1% drop in weight was associated with a 3% reduced risk for THA.

“I always advise my overweight patient to lose at least 30 pounds, even if their BMI is less than 40, like many in these studies,” Dr. Hanson said. If a patient’s doctor prescribes semaglutide or another GLP-1 receptor agonist, “I am very supportive, and we postpone surgery until the weight loss is maximized,” he added.

Drs. Magruder, Pereira, Momtaz, and Hanson have no disclosures.

A version of this article appeared on Medscape.com.

Obesity and diabetes increase the risk for complications following joint surgeries like total hip replacement, but can semaglutide and related drugs help?

The question has massive implications. More than 450,000 total hip arthroplasty (THA) procedures are performed annually in the United States, with the number expected to grow to 850,000 by 2030. Obesity is the leading reason for the increase. Semaglutide and other glucagon-like peptide 1 (GLP-1) receptor agonists can lead to dramatic and rapid weight loss, in addition to controlling diabetes, so researchers have wondered if the medications might improve outcomes in patients undergoing joint surgery. 

Two studies presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) sought to answer the question — but reached different conclusions. 

One study of THA patients taking semaglutide found fewer 90-day readmissions for diabetes and fewer prosthetic joint infections at the 2-year mark. Another found similar outcomes on the need for revision surgery, infections, and many other postsurgery metrics in people who took the GLP-1 receptor agonist and those who did not. Neither study had outside funding.
 

Study: Fewer Infections, Readmissions

For their study, Matthew Magruder, MD, a third-year orthopedic resident at Maimonides Medical Center’s Department of Orthopaedic Surgery and Rehabilitation in New York City, and his colleagues used an administrative claim database (PearlDiver) to identify THA patients who underwent the surgery between January 1, 2020, to October 31, 2021, when semaglutide was approved for the treatment of diabetes but not yet for obesity. The researchers found 9465 patients who had had a primary THA, of whom 1653 had received a prescription for semaglutide.

In total, 84.9% of those on semaglutide had obesity, as did 85.2% of those not on the medication.

Dr. Magruder’s group looked at medical complications such as deep vein thrombosis, myocardial infarction, hypoglycemia, and pulmonary embolism within 90 days of surgery, implant-related complications 2 years after the procedure, rates of readmission within 90 days of the procedure, length of stay in the hospital, and costs of care. 

They found that patients taking semaglutide were less likely to be readmitted to the hospital within 90 days of THA (6.2% vs 8.8%; P <.01) and experienced fewer joint infections (1.6% vs 2.9%; P <.01). No significant differences were found in the other outcomes.

Among the potential concerns involving the use of GLP-1 receptor agonists in patients undergoing surgery are their potential to cause hypoglycemia and the risk for aspiration during anesthesia. But those issues did not emerge in the analysis.

“We concluded that this was preliminary evidence that using semaglutide at the time of surgery was safe and potentially effective at reducing complications,” said Dr. Magruder, whose team published their findings in The Journal of Arthroplasty.
 

Study: Semaglutide Has No Effect on Postop Complications

In another study presented at the AAOS meeting, researchers found that rates of complications after THA were similar in patients with obesity who took semaglutide and those who did not. That information could be helpful for clinicians who have been reluctant to perform THA procedures in patients who also have had bariatric surgery, said Daniel E. Pereira, MD, a resident at Washington University in St. Louis and the first author of the study.

A recent retrospective review found that patients who had bariatric surgery have worse implant survivorship and higher rates of dislocation than do those with a naturally low or high body mass index (BMI). 

Pereira and his colleagues used a national database, with deidentified patient records, originally finding 42,410 patients. After matching, they evaluated 616 in each cohort: those who took semaglutide and those who did not. The average age was 62.7 years; average BMI was 35.5. 

Both groups had a similar risk for a range of complications including revision surgery, infection of the new joint and surgical site, opioid-related disorders, pulmonary embolism, deep vein thrombosis, and mortality. 

“We didn’t observe anything significant [between groups] in terms of the complications,” said David Momtaz, MPH, a fourth-year medical student at the University of Texas Health Science Center at San Antonio, who helped conduct the research. 

Dr. Pereira said he hoped the results would end the hesitation he observes, partly due to a lack of research, among some physicians about prescribing semaglutide before THA in appropriate patients. “Our preliminary evidence suggests there is no need to withhold THA in patients who successfully lost weight on semaglutide,” he said.
 

Expert Perspective: Not Unexpected

Peter Hanson, MD, an orthopedic surgeon and orthopedic medical director at Sharp Grossmont Hospital in La Mesa, California, who specializes in hip and knee replacement, said he was unsurprised by the findings. 

The patients he has observed on GLP-1 receptor agonists lose weight, he said, and a few even to the point of not needing a replacement. A recent study found that every 1% decrease in weight was associated with a 2% reduced risk for knee replacement in those with knee osteoarthritis or at risk for it, and every 1% drop in weight was associated with a 3% reduced risk for THA.

“I always advise my overweight patient to lose at least 30 pounds, even if their BMI is less than 40, like many in these studies,” Dr. Hanson said. If a patient’s doctor prescribes semaglutide or another GLP-1 receptor agonist, “I am very supportive, and we postpone surgery until the weight loss is maximized,” he added.

Drs. Magruder, Pereira, Momtaz, and Hanson have no disclosures.

A version of this article appeared on Medscape.com.

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.

TOPLINE:

Higher scores on the dietary inflammatory index in patients with knee osteoarthritis (KOA) were associated with an increased risk of experiencing greater pain over 10 years of follow-up.

METHODOLOGY:

• The researchers recruited 944 adults aged 50-80 years from the community; the mean age at baseline was 62.9 years, 51% were female, the mean body mass index was 27.9 kg/m2, and 60% had radiographic KOA at baseline.
• Magnetic resonance imaging was used to identify structural changes in the knee based on cartilage volume and bone marrow lesions at baseline and follow-up; knee pain was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain questionnaire.
• Dietary inflammation was measured using energy-adjusted dietary inflammatory index (E-DII) scores based on nutritional information from the Food-Frequency Questionnaire (FFQ).

TAKEAWAY: 

• Over a follow-up period of 10.7 years, higher E-DII scores were positively associated with increased pain scores (beta = 0.21) after adjustment for age, sex, body mass index, steps per day, education, emotional problems, employment status, comorbidities, and radiographic KOA.
• E-DII scores were not associated with tibial cartilage volume loss or overall bone marrow loss.
• Patients with higher E-DII scores had a significantly higher risk of being on a moderate pain trajectory (relative risk ratio, 1.19), compared with those who followed a minimal pain trajectory over the follow-up period.

IN PRACTICE:

“An anti-inflammatory diet may reduce pain among KOA patients. Future trials investigating the potential of an anti-inflammatory diet for pain relief in KOA are warranted,” the researchers wrote. 

SOURCE:

The lead author on the study was Canchen Ma, PhD, of the University of Tasmania, Hobart, Australia. The study was published online in Arthritis Care & Research. 

LIMITATIONS:

The study used a relatively small number of nutrients from the FFQ to calculate the E-DII scores; participants also exhibited a narrower range of E-DII scores than previous studies. The researchers were unable to account for pharmacologic or preventive treatments. 

DISCLOSURES:

The study was supported by the National Health and Medical Research Council of Australia (NHMRC) and Arthritis Australia. Several authors received support from the National Heart Foundation Fellowship, the NHMRC Leadership Fellowship, the NHMRC Practitioner Fellowship, and the NHMRC Early Career Fellowship. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher scores on the dietary inflammatory index in patients with knee osteoarthritis (KOA) were associated with an increased risk of experiencing greater pain over 10 years of follow-up.

METHODOLOGY:

• The researchers recruited 944 adults aged 50-80 years from the community; the mean age at baseline was 62.9 years, 51% were female, the mean body mass index was 27.9 kg/m2, and 60% had radiographic KOA at baseline.
• Magnetic resonance imaging was used to identify structural changes in the knee based on cartilage volume and bone marrow lesions at baseline and follow-up; knee pain was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain questionnaire.
• Dietary inflammation was measured using energy-adjusted dietary inflammatory index (E-DII) scores based on nutritional information from the Food-Frequency Questionnaire (FFQ).

TAKEAWAY: 

• Over a follow-up period of 10.7 years, higher E-DII scores were positively associated with increased pain scores (beta = 0.21) after adjustment for age, sex, body mass index, steps per day, education, emotional problems, employment status, comorbidities, and radiographic KOA.
• E-DII scores were not associated with tibial cartilage volume loss or overall bone marrow loss.
• Patients with higher E-DII scores had a significantly higher risk of being on a moderate pain trajectory (relative risk ratio, 1.19), compared with those who followed a minimal pain trajectory over the follow-up period.

IN PRACTICE:

“An anti-inflammatory diet may reduce pain among KOA patients. Future trials investigating the potential of an anti-inflammatory diet for pain relief in KOA are warranted,” the researchers wrote. 

SOURCE:

The lead author on the study was Canchen Ma, PhD, of the University of Tasmania, Hobart, Australia. The study was published online in Arthritis Care & Research. 

LIMITATIONS:

The study used a relatively small number of nutrients from the FFQ to calculate the E-DII scores; participants also exhibited a narrower range of E-DII scores than previous studies. The researchers were unable to account for pharmacologic or preventive treatments. 

DISCLOSURES:

The study was supported by the National Health and Medical Research Council of Australia (NHMRC) and Arthritis Australia. Several authors received support from the National Heart Foundation Fellowship, the NHMRC Leadership Fellowship, the NHMRC Practitioner Fellowship, and the NHMRC Early Career Fellowship. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher scores on the dietary inflammatory index in patients with knee osteoarthritis (KOA) were associated with an increased risk of experiencing greater pain over 10 years of follow-up.

METHODOLOGY:

• The researchers recruited 944 adults aged 50-80 years from the community; the mean age at baseline was 62.9 years, 51% were female, the mean body mass index was 27.9 kg/m2, and 60% had radiographic KOA at baseline.
• Magnetic resonance imaging was used to identify structural changes in the knee based on cartilage volume and bone marrow lesions at baseline and follow-up; knee pain was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain questionnaire.
• Dietary inflammation was measured using energy-adjusted dietary inflammatory index (E-DII) scores based on nutritional information from the Food-Frequency Questionnaire (FFQ).

TAKEAWAY: 

• Over a follow-up period of 10.7 years, higher E-DII scores were positively associated with increased pain scores (beta = 0.21) after adjustment for age, sex, body mass index, steps per day, education, emotional problems, employment status, comorbidities, and radiographic KOA.
• E-DII scores were not associated with tibial cartilage volume loss or overall bone marrow loss.
• Patients with higher E-DII scores had a significantly higher risk of being on a moderate pain trajectory (relative risk ratio, 1.19), compared with those who followed a minimal pain trajectory over the follow-up period.

IN PRACTICE:

“An anti-inflammatory diet may reduce pain among KOA patients. Future trials investigating the potential of an anti-inflammatory diet for pain relief in KOA are warranted,” the researchers wrote. 

SOURCE:

The lead author on the study was Canchen Ma, PhD, of the University of Tasmania, Hobart, Australia. The study was published online in Arthritis Care & Research. 

LIMITATIONS:

The study used a relatively small number of nutrients from the FFQ to calculate the E-DII scores; participants also exhibited a narrower range of E-DII scores than previous studies. The researchers were unable to account for pharmacologic or preventive treatments. 

DISCLOSURES:

The study was supported by the National Health and Medical Research Council of Australia (NHMRC) and Arthritis Australia. Several authors received support from the National Heart Foundation Fellowship, the NHMRC Leadership Fellowship, the NHMRC Practitioner Fellowship, and the NHMRC Early Career Fellowship. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

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.

Bone health begins in childhood, particularly during the rapid bone accrual phase of puberty, which is essential for attaining optimal peak bone mass. Peak bone mass is achieved in early adult life and affects both immediate and future fracture risk. Genetic, nutritional, exercise-related, and hormonal factors, and certain diseases and medications, have deleterious effects on bone health.

In addition, emerging data suggest that certain manmade chemicals known as per- and polyfluoroalkyl substances (PFAS) may affect bone accrual during this important period and potentially increase the risk for osteoporosis in adulthood. Osteoporosis refers to increased fracture risk because of low bone density and affects a large proportion of postmenopausal women and older men.

New evidence comes from a recent study conducted by investigators from the Keck School of Medicine, who examined the impact of exposure to PFAS on skeletal outcomes in youth. Of note, participants were primarily Hispanic; this population has a higher risk for osteoporosis in adulthood. PFAS are manmade chemicals with water- and grease-resistant properties. They are used in a variety of products, such as nonstick cookware, food packaging, water-repellent clothing, stain-resistant fabrics, carpets, and in certain industrial processes. They are pervasive in the environment, in wildlife, and in humans.

Use and production of certain PFAS, such as perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA),  have decreased over the past two decades, with a significant reduction in blood concentrations of these chemicals. However, they can be resistant to degradation and have very long half-lives. As a consequence, these «forever chemicals» continue to linger in the environment. Also, the risk for exposure to other PFAS persists, and almost every individual has detectable levels of PFAS in blood.

Scientists are still learning about the impact of environmental chemicals on bone health. In contrast, other factors that may jeopardize pubertal bone accrual and peak bone mass acquisition have been studied extensively, with guidelines for management of the consequent poor skeletal health.

For PFAS, studies have reported deleterious effects on various body systems, such as the liver, immune system, thyroid, and the developing brain. The limited data related to bone suggest negative associations between certain, but not all, PFAS and bone density — ie, the higher the exposure, the worse the impact on bone health.

PFAS may affect health through alterations in the endocrine system. They have been associated with lower levels of testosterone and downregulation of its receptor (and testosterone is known to modulate bone formation and bone loss). On the other hand, some PFAS are estrogenic, which should be beneficial to bone. A direct impact of PFAS on pathways regulating activity of osteoblasts (bone-forming cells) and osteoclasts (bone-resorbing cells) has also been postulated, with conflicting results.

Previous research on PFAS and human bone health has found mixed results. In adolescents, Xiong and colleagues  reported negative associations of PFOS, PFOA, and perfluorononanoic acid (PFNA), but not perfluorohexane sulfonic acid (PFHxS), levels with bone density at various sites, mostly in females. Carwile and associates  reported similar negative associations of blood concentrations of PFOA and PFOS and urinary concentrations of phthalates with bone density in adolescents, but only in males. Lin and coworkers also reported negative associations of PFOA and bone density in adult premenopausal women, but found no associations of PFOA and PFOS concentrations with self-reported fractures, suggesting questionable biological significance of these findings. These were all cross-sectional studies and did not report on the impact of these chemicals on longitudinal bone accrual.

In the recent study, Beglarian and colleagues examined the impact of PFAS on longitudinal changes in bone density in adolescents, drawn from the Study of Latino Adolescents at Risk of Type 2 Diabetes (SOLAR) cohort and young adults from the Southern California Children’s Health Study (CHS) cohort. They found that in adolescents, higher baseline concentrations of PFOS predicted lower bone accrual over time. In young adults, there was a similar negative association of PFOS concentrations and bone density at baseline, but not with longitudinal bone accrual. In this study, other PFAS were not associated with bone outcomes.

Overall, research appears to suggest that PFOA, PFOS, and PFNA may have deleterious effects on bone density and bone accrual over time. However, data are not consistent across studies and across sexes, and more research is necessary to conclusively define the impact of these chemicals on skeletal health, particularly during the critical pubertal years of maximal bone accrual. In the meantime, continued efforts are necessary to reduce to concentrations of these PFAS in the environment.

Dr. Misra disclosed ties with AbbVie, Sanofi, and Ipsen.
 

A version of this article appeared on Medscape.com.

Bone health begins in childhood, particularly during the rapid bone accrual phase of puberty, which is essential for attaining optimal peak bone mass. Peak bone mass is achieved in early adult life and affects both immediate and future fracture risk. Genetic, nutritional, exercise-related, and hormonal factors, and certain diseases and medications, have deleterious effects on bone health.

In addition, emerging data suggest that certain manmade chemicals known as per- and polyfluoroalkyl substances (PFAS) may affect bone accrual during this important period and potentially increase the risk for osteoporosis in adulthood. Osteoporosis refers to increased fracture risk because of low bone density and affects a large proportion of postmenopausal women and older men.

New evidence comes from a recent study conducted by investigators from the Keck School of Medicine, who examined the impact of exposure to PFAS on skeletal outcomes in youth. Of note, participants were primarily Hispanic; this population has a higher risk for osteoporosis in adulthood. PFAS are manmade chemicals with water- and grease-resistant properties. They are used in a variety of products, such as nonstick cookware, food packaging, water-repellent clothing, stain-resistant fabrics, carpets, and in certain industrial processes. They are pervasive in the environment, in wildlife, and in humans.

Use and production of certain PFAS, such as perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA),  have decreased over the past two decades, with a significant reduction in blood concentrations of these chemicals. However, they can be resistant to degradation and have very long half-lives. As a consequence, these «forever chemicals» continue to linger in the environment. Also, the risk for exposure to other PFAS persists, and almost every individual has detectable levels of PFAS in blood.

Scientists are still learning about the impact of environmental chemicals on bone health. In contrast, other factors that may jeopardize pubertal bone accrual and peak bone mass acquisition have been studied extensively, with guidelines for management of the consequent poor skeletal health.

For PFAS, studies have reported deleterious effects on various body systems, such as the liver, immune system, thyroid, and the developing brain. The limited data related to bone suggest negative associations between certain, but not all, PFAS and bone density — ie, the higher the exposure, the worse the impact on bone health.

PFAS may affect health through alterations in the endocrine system. They have been associated with lower levels of testosterone and downregulation of its receptor (and testosterone is known to modulate bone formation and bone loss). On the other hand, some PFAS are estrogenic, which should be beneficial to bone. A direct impact of PFAS on pathways regulating activity of osteoblasts (bone-forming cells) and osteoclasts (bone-resorbing cells) has also been postulated, with conflicting results.

Previous research on PFAS and human bone health has found mixed results. In adolescents, Xiong and colleagues  reported negative associations of PFOS, PFOA, and perfluorononanoic acid (PFNA), but not perfluorohexane sulfonic acid (PFHxS), levels with bone density at various sites, mostly in females. Carwile and associates  reported similar negative associations of blood concentrations of PFOA and PFOS and urinary concentrations of phthalates with bone density in adolescents, but only in males. Lin and coworkers also reported negative associations of PFOA and bone density in adult premenopausal women, but found no associations of PFOA and PFOS concentrations with self-reported fractures, suggesting questionable biological significance of these findings. These were all cross-sectional studies and did not report on the impact of these chemicals on longitudinal bone accrual.

In the recent study, Beglarian and colleagues examined the impact of PFAS on longitudinal changes in bone density in adolescents, drawn from the Study of Latino Adolescents at Risk of Type 2 Diabetes (SOLAR) cohort and young adults from the Southern California Children’s Health Study (CHS) cohort. They found that in adolescents, higher baseline concentrations of PFOS predicted lower bone accrual over time. In young adults, there was a similar negative association of PFOS concentrations and bone density at baseline, but not with longitudinal bone accrual. In this study, other PFAS were not associated with bone outcomes.

Overall, research appears to suggest that PFOA, PFOS, and PFNA may have deleterious effects on bone density and bone accrual over time. However, data are not consistent across studies and across sexes, and more research is necessary to conclusively define the impact of these chemicals on skeletal health, particularly during the critical pubertal years of maximal bone accrual. In the meantime, continued efforts are necessary to reduce to concentrations of these PFAS in the environment.

Dr. Misra disclosed ties with AbbVie, Sanofi, and Ipsen.
 

A version of this article appeared on Medscape.com.

Bone health begins in childhood, particularly during the rapid bone accrual phase of puberty, which is essential for attaining optimal peak bone mass. Peak bone mass is achieved in early adult life and affects both immediate and future fracture risk. Genetic, nutritional, exercise-related, and hormonal factors, and certain diseases and medications, have deleterious effects on bone health.

In addition, emerging data suggest that certain manmade chemicals known as per- and polyfluoroalkyl substances (PFAS) may affect bone accrual during this important period and potentially increase the risk for osteoporosis in adulthood. Osteoporosis refers to increased fracture risk because of low bone density and affects a large proportion of postmenopausal women and older men.

New evidence comes from a recent study conducted by investigators from the Keck School of Medicine, who examined the impact of exposure to PFAS on skeletal outcomes in youth. Of note, participants were primarily Hispanic; this population has a higher risk for osteoporosis in adulthood. PFAS are manmade chemicals with water- and grease-resistant properties. They are used in a variety of products, such as nonstick cookware, food packaging, water-repellent clothing, stain-resistant fabrics, carpets, and in certain industrial processes. They are pervasive in the environment, in wildlife, and in humans.

Use and production of certain PFAS, such as perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA),  have decreased over the past two decades, with a significant reduction in blood concentrations of these chemicals. However, they can be resistant to degradation and have very long half-lives. As a consequence, these «forever chemicals» continue to linger in the environment. Also, the risk for exposure to other PFAS persists, and almost every individual has detectable levels of PFAS in blood.

Scientists are still learning about the impact of environmental chemicals on bone health. In contrast, other factors that may jeopardize pubertal bone accrual and peak bone mass acquisition have been studied extensively, with guidelines for management of the consequent poor skeletal health.

For PFAS, studies have reported deleterious effects on various body systems, such as the liver, immune system, thyroid, and the developing brain. The limited data related to bone suggest negative associations between certain, but not all, PFAS and bone density — ie, the higher the exposure, the worse the impact on bone health.

PFAS may affect health through alterations in the endocrine system. They have been associated with lower levels of testosterone and downregulation of its receptor (and testosterone is known to modulate bone formation and bone loss). On the other hand, some PFAS are estrogenic, which should be beneficial to bone. A direct impact of PFAS on pathways regulating activity of osteoblasts (bone-forming cells) and osteoclasts (bone-resorbing cells) has also been postulated, with conflicting results.

Previous research on PFAS and human bone health has found mixed results. In adolescents, Xiong and colleagues  reported negative associations of PFOS, PFOA, and perfluorononanoic acid (PFNA), but not perfluorohexane sulfonic acid (PFHxS), levels with bone density at various sites, mostly in females. Carwile and associates  reported similar negative associations of blood concentrations of PFOA and PFOS and urinary concentrations of phthalates with bone density in adolescents, but only in males. Lin and coworkers also reported negative associations of PFOA and bone density in adult premenopausal women, but found no associations of PFOA and PFOS concentrations with self-reported fractures, suggesting questionable biological significance of these findings. These were all cross-sectional studies and did not report on the impact of these chemicals on longitudinal bone accrual.

In the recent study, Beglarian and colleagues examined the impact of PFAS on longitudinal changes in bone density in adolescents, drawn from the Study of Latino Adolescents at Risk of Type 2 Diabetes (SOLAR) cohort and young adults from the Southern California Children’s Health Study (CHS) cohort. They found that in adolescents, higher baseline concentrations of PFOS predicted lower bone accrual over time. In young adults, there was a similar negative association of PFOS concentrations and bone density at baseline, but not with longitudinal bone accrual. In this study, other PFAS were not associated with bone outcomes.

Overall, research appears to suggest that PFOA, PFOS, and PFNA may have deleterious effects on bone density and bone accrual over time. However, data are not consistent across studies and across sexes, and more research is necessary to conclusively define the impact of these chemicals on skeletal health, particularly during the critical pubertal years of maximal bone accrual. In the meantime, continued efforts are necessary to reduce to concentrations of these PFAS in the environment.

Dr. Misra disclosed ties with AbbVie, Sanofi, and Ipsen.
 

A version of this article appeared on Medscape.com.

A recently published prospective study in JAMA Network Open identified a significant association between children’s bone health and their proximity to green areas.

The literature emphasized the benefits of childhood exposure to green spaces for neurocognitive, social, behavioral, and mental development, as well as well-being. In addition, such exposure is linked to lower body mass index, increased physical activity, and reduced risks for overweight, obesity, and hypertension. However, specific data on bone mineral density implications are limited.

To address this gap, Hanne Sleurs, PhD, a researcher at the Universiteit Hasselt in Belgium, and colleagues followed the bone health of 327 participants from birth to 4-6 years and examined correlations with individuals’ exposure to green areas. Data collection occurred from October 2014 to July 2021.

Green spaces were categorized as high (vegetation height > 3 m), low (vegetation height ≤ 3 m), and mixed (combination of both). The distances of green spaces from participants’ residences ranged from a radius of 100 m to 3 km. Radial bone mineral density assessment was conducted using quantitative ultrasound during follow-up consultations.

The scientists found that participants frequently exposed to high and mixed vegetation areas within a 500-m radius of their homes had significantly higher bone mineral density than those at other distances or those frequenting spaces with different vegetation. In addition, access to larger green spaces with mixed and high vegetation within a 1-km radius was significantly associated with a lower likelihood of low bone density in children.

“These findings illustrate the positive impact on bone health of early childhood exposure to green areas near their homes during critical growth and development periods, with long-term implications,” wrote the researchers.

The results aligned with those of a prior study in which authors noted factors contributing to families’ frequent park visits, including shorter distances, safety, and park organization, as well as the natural diversity and activities offered.

One hypothesis explaining improved bone density in children visiting green areas was increased physical activity practiced in these locations. The mechanical load from exercise can activate signaling pathways favoring bone development. Literature also gathered data on the influence of green areas on young populations engaging in physical activities, showing positive outcomes.

According to the study authors, the findings are crucial for public health because they emphasize the need for urban investments in accessible green spaces as a strategy for fracture and osteoporosis prevention. In the long term, such initiatives translate to reduced public health expenses, along with physical and emotional gains in communities adopting environmental strategies, they concluded.

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

A recently published prospective study in JAMA Network Open identified a significant association between children’s bone health and their proximity to green areas.

The literature emphasized the benefits of childhood exposure to green spaces for neurocognitive, social, behavioral, and mental development, as well as well-being. In addition, such exposure is linked to lower body mass index, increased physical activity, and reduced risks for overweight, obesity, and hypertension. However, specific data on bone mineral density implications are limited.

To address this gap, Hanne Sleurs, PhD, a researcher at the Universiteit Hasselt in Belgium, and colleagues followed the bone health of 327 participants from birth to 4-6 years and examined correlations with individuals’ exposure to green areas. Data collection occurred from October 2014 to July 2021.

Green spaces were categorized as high (vegetation height > 3 m), low (vegetation height ≤ 3 m), and mixed (combination of both). The distances of green spaces from participants’ residences ranged from a radius of 100 m to 3 km. Radial bone mineral density assessment was conducted using quantitative ultrasound during follow-up consultations.

The scientists found that participants frequently exposed to high and mixed vegetation areas within a 500-m radius of their homes had significantly higher bone mineral density than those at other distances or those frequenting spaces with different vegetation. In addition, access to larger green spaces with mixed and high vegetation within a 1-km radius was significantly associated with a lower likelihood of low bone density in children.

“These findings illustrate the positive impact on bone health of early childhood exposure to green areas near their homes during critical growth and development periods, with long-term implications,” wrote the researchers.

The results aligned with those of a prior study in which authors noted factors contributing to families’ frequent park visits, including shorter distances, safety, and park organization, as well as the natural diversity and activities offered.

One hypothesis explaining improved bone density in children visiting green areas was increased physical activity practiced in these locations. The mechanical load from exercise can activate signaling pathways favoring bone development. Literature also gathered data on the influence of green areas on young populations engaging in physical activities, showing positive outcomes.

According to the study authors, the findings are crucial for public health because they emphasize the need for urban investments in accessible green spaces as a strategy for fracture and osteoporosis prevention. In the long term, such initiatives translate to reduced public health expenses, along with physical and emotional gains in communities adopting environmental strategies, they concluded.

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

A recently published prospective study in JAMA Network Open identified a significant association between children’s bone health and their proximity to green areas.

The literature emphasized the benefits of childhood exposure to green spaces for neurocognitive, social, behavioral, and mental development, as well as well-being. In addition, such exposure is linked to lower body mass index, increased physical activity, and reduced risks for overweight, obesity, and hypertension. However, specific data on bone mineral density implications are limited.

To address this gap, Hanne Sleurs, PhD, a researcher at the Universiteit Hasselt in Belgium, and colleagues followed the bone health of 327 participants from birth to 4-6 years and examined correlations with individuals’ exposure to green areas. Data collection occurred from October 2014 to July 2021.

Green spaces were categorized as high (vegetation height > 3 m), low (vegetation height ≤ 3 m), and mixed (combination of both). The distances of green spaces from participants’ residences ranged from a radius of 100 m to 3 km. Radial bone mineral density assessment was conducted using quantitative ultrasound during follow-up consultations.

The scientists found that participants frequently exposed to high and mixed vegetation areas within a 500-m radius of their homes had significantly higher bone mineral density than those at other distances or those frequenting spaces with different vegetation. In addition, access to larger green spaces with mixed and high vegetation within a 1-km radius was significantly associated with a lower likelihood of low bone density in children.

“These findings illustrate the positive impact on bone health of early childhood exposure to green areas near their homes during critical growth and development periods, with long-term implications,” wrote the researchers.

The results aligned with those of a prior study in which authors noted factors contributing to families’ frequent park visits, including shorter distances, safety, and park organization, as well as the natural diversity and activities offered.

One hypothesis explaining improved bone density in children visiting green areas was increased physical activity practiced in these locations. The mechanical load from exercise can activate signaling pathways favoring bone development. Literature also gathered data on the influence of green areas on young populations engaging in physical activities, showing positive outcomes.

According to the study authors, the findings are crucial for public health because they emphasize the need for urban investments in accessible green spaces as a strategy for fracture and osteoporosis prevention. In the long term, such initiatives translate to reduced public health expenses, along with physical and emotional gains in communities adopting environmental strategies, they concluded.

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

TOPLINE:

Intra-articular corticosteroid (IACS) injections pose a minimal risk of accelerating diabetes for most people, despite temporarily elevating blood glucose levels, according to a study published in Clinical Diabetes.

METHODOLOGY:

• Almost half of Americans with diabetes have arthritis, so glycemic control is a concern for many receiving IACS injections.
• IACS injections are known to cause short-term hyperglycemia, but their long-term effects on glycemic control are not well studied.
• For the retrospective cohort study, researchers at Mayo Clinic in Rochester, Minnesota, used electronic health records from 1169 adults who had received an IACS injection in one large joint between 2012 and 2018.
• They analyzed data on A1C levels for study participants from 18 months before and after the injections.
• Researchers assessed if participants had a greater-than-expected (defined as an increase of more than 0.5% above expected) concentration of A1C after the injection, and examined rates of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in the 30 days following an injection.

TAKEAWAY:

• Nearly 16% of people experienced a greater-than-expected A1C level after receiving an injection.
• A1C levels rose by an average of 1.2% in the greater-than-expected group, but decreased by an average of 0.2% in the average group.
• One patient had an episode of severe hyperglycemia that was linked to the injection.
• A baseline level of A1C above 8% was the only factor associated with a greater-than-expected increase in the marker after an IACS injection.

IN PRACTICE:

“Although most patients do not experience an increase in A1C after IACS, clinicians should counsel patients with suboptimally controlled diabetes about risks of further hyperglycemia after IACS administration,” the researchers wrote. 

SOURCE: 

The study was led by Terin T. Sytsma, MD, of Mayo Clinic in Rochester, Minnesota.

LIMITATIONS: 

The study was retrospective and could not establish causation. In addition, the population was of residents from one county in Minnesota, and was not racially or ethnically diverse. Details about the injection, such as location and total dose, were not available. The study also did not include a control group. 

DISCLOSURES:

The study was funded by Mayo Clinic and the National Center for Advancing Translational Sciences. The authors reported no relevant disclosures.

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

TOPLINE:

Intra-articular corticosteroid (IACS) injections pose a minimal risk of accelerating diabetes for most people, despite temporarily elevating blood glucose levels, according to a study published in Clinical Diabetes.

METHODOLOGY:

• Almost half of Americans with diabetes have arthritis, so glycemic control is a concern for many receiving IACS injections.
• IACS injections are known to cause short-term hyperglycemia, but their long-term effects on glycemic control are not well studied.
• For the retrospective cohort study, researchers at Mayo Clinic in Rochester, Minnesota, used electronic health records from 1169 adults who had received an IACS injection in one large joint between 2012 and 2018.
• They analyzed data on A1C levels for study participants from 18 months before and after the injections.
• Researchers assessed if participants had a greater-than-expected (defined as an increase of more than 0.5% above expected) concentration of A1C after the injection, and examined rates of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in the 30 days following an injection.

TAKEAWAY:

• Nearly 16% of people experienced a greater-than-expected A1C level after receiving an injection.
• A1C levels rose by an average of 1.2% in the greater-than-expected group, but decreased by an average of 0.2% in the average group.
• One patient had an episode of severe hyperglycemia that was linked to the injection.
• A baseline level of A1C above 8% was the only factor associated with a greater-than-expected increase in the marker after an IACS injection.

IN PRACTICE:

“Although most patients do not experience an increase in A1C after IACS, clinicians should counsel patients with suboptimally controlled diabetes about risks of further hyperglycemia after IACS administration,” the researchers wrote. 

SOURCE: 

The study was led by Terin T. Sytsma, MD, of Mayo Clinic in Rochester, Minnesota.

LIMITATIONS: 

The study was retrospective and could not establish causation. In addition, the population was of residents from one county in Minnesota, and was not racially or ethnically diverse. Details about the injection, such as location and total dose, were not available. The study also did not include a control group. 

DISCLOSURES:

The study was funded by Mayo Clinic and the National Center for Advancing Translational Sciences. The authors reported no relevant disclosures.

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

TOPLINE:

Intra-articular corticosteroid (IACS) injections pose a minimal risk of accelerating diabetes for most people, despite temporarily elevating blood glucose levels, according to a study published in Clinical Diabetes.

METHODOLOGY:

• Almost half of Americans with diabetes have arthritis, so glycemic control is a concern for many receiving IACS injections.
• IACS injections are known to cause short-term hyperglycemia, but their long-term effects on glycemic control are not well studied.
• For the retrospective cohort study, researchers at Mayo Clinic in Rochester, Minnesota, used electronic health records from 1169 adults who had received an IACS injection in one large joint between 2012 and 2018.
• They analyzed data on A1C levels for study participants from 18 months before and after the injections.
• Researchers assessed if participants had a greater-than-expected (defined as an increase of more than 0.5% above expected) concentration of A1C after the injection, and examined rates of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in the 30 days following an injection.

TAKEAWAY:

• Nearly 16% of people experienced a greater-than-expected A1C level after receiving an injection.
• A1C levels rose by an average of 1.2% in the greater-than-expected group, but decreased by an average of 0.2% in the average group.
• One patient had an episode of severe hyperglycemia that was linked to the injection.
• A baseline level of A1C above 8% was the only factor associated with a greater-than-expected increase in the marker after an IACS injection.

IN PRACTICE:

“Although most patients do not experience an increase in A1C after IACS, clinicians should counsel patients with suboptimally controlled diabetes about risks of further hyperglycemia after IACS administration,” the researchers wrote. 

SOURCE: 

The study was led by Terin T. Sytsma, MD, of Mayo Clinic in Rochester, Minnesota.

LIMITATIONS: 

The study was retrospective and could not establish causation. In addition, the population was of residents from one county in Minnesota, and was not racially or ethnically diverse. Details about the injection, such as location and total dose, were not available. The study also did not include a control group. 

DISCLOSURES:

The study was funded by Mayo Clinic and the National Center for Advancing Translational Sciences. The authors reported no relevant disclosures.

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

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and fibromyalgia (FM) have overlapping neurologic symptoms — particularly profound fatigue. The similarity between these two conditions has led to the question of whether they are indeed distinct central nervous system (CNS) entities, or whether they exist along a spectrum and are actually two different manifestations of the same disease process.

A new study utilized a novel methodology — unbiased quantitative mass spectrometry-based proteomics — to investigate this question by analyzing cerebrospinal fluid (CSF) in a group of patients with ME/CFS and another group of patients diagnosed with both ME/CFS and FM.

Close to 2,100 proteins were identified, of which nearly 1,800 were common to both conditions.

“ME/CFS and fibromyalgia do not appear to be distinct entities, with respect to their cerebrospinal fluid proteins,” lead author Steven Schutzer, MD, professor of medicine, Rutgers New Jersey School of Medicine, told this news organization.

“Work is underway to solve the multiple mysteries of ME/CFS, fibromyalgia, and other neurologic-associated diseases,” he continued. “We have further affirmed that we have a precise objective discovery tool in our hands. Collectively studying multiple diseases brings clarity to each individual disease.”

The study was published in the December 2023 issue of Annals of Medicine.
 

Cutting-Edge Technology

“ME/CFS is characterized by disabling fatigue, and FM is an illness characterized by body-wide pain,” Dr. Schutzer said. These “medically unexplained” illnesses often coexist by current definitions, and the overlap between them has suggested that they may be part of the “same illness spectrum.”

But co-investigator Benjamin Natelson, MD, professor of neurology and director of the Pain and Fatigue Study Center, Mount Sinai, New York, and others found in previous research that there are distinct differences between the conditions, raising the possibility that there may be different pathophysiological processes.

“The physicians and scientists on our team have had longstanding interest in studying neurologic diseases with cutting-edge tools such as mass spectrometry applied to CSF,” Dr. Schutzer said. “We have had success using this message to distinguish diseases such as ME/CFS from post-treatment Lyme disease, multiple sclerosis, and healthy normal people.”

Dr. Schutzer explained that Dr. Natelson had acquired CSF samples from “well-characterized [ME/CFS] patients and controls.”

Since the cause of ME/CFS is “unknown,” it seemed “ripe to investigate it further with the discovery tool of mass spectrometry” by harnessing the “most advanced equipment in the country at the pacific Northwest National Laboratory, which is part of the US Department of Energy.”

Dr. Schutzer noted that it was the “merger of different clinical and laboratory expertise” that enabled them to address whether ME/CFS and FM are two distinct disease processes.

The choice of analyzing CSF is that it’s the fluid closest to the brain, he added. “A lot of people have studied ME/CFS peripherally because they don’t have access to spinal fluid or it’s easier to look peripherally in the blood, but that doesn’t mean that the blood is where the real ‘action’ is occurring.”

The researchers compared the CSF of 15 patients with ME/CFS only to 15 patients with ME/CFS+FM using mass spectrometry-based proteomics, which they had employed in previous research to see whether ME/CFS was distinct from persistent neurologic Lyme disease syndrome.

This technology has become the “method of choice and discovery tool to rapidly uncover protein biomarkers that can distinguish one disease from another,” the authors stated.

In particular, in unbiased quantitative mass spectrometry-based proteomics, the researchers do not have to know in advance what’s in a sample before studying it, Dr. Schutzer explained.
 

Shared Pathophysiology?

Both groups of patients were of similar age (41.3 ± 9.4 years and 40.1 ± 11.0 years, respectively), with no differences in gender or rates of current comorbid psychiatric diagnoses between the groups.

The researchers quantified a total of 2,083 proteins, including 1,789 that were specifically quantified in all of the CSF samples, regardless of the presence or absence of FM.

Several analyses (including an ANOVA analysis with adjusted P values, a Random Forest machine learning approach that looked at relative protein abundance changes between those with ME/CFS and ME/CFS+FM, and unsupervised hierarchical clustering analyses) did not find distinguishing differences between the groups.

“The sum of these results does not support the hypothesis that ME/CFS and ME/CFS+FM are distinct entities, as currently defined,” the authors stated.

They noted that both conditions are “medically unexplained,” with core symptoms of pain, fatigue, sleep problems, and cognitive difficulty. The fact that these two syndromes coexist so often has led to the assumption that the “similarities between them outweigh the differences,” they wrote.

They pointed to some differences between the conditions, including an increase in substance P in the CSF of FM patients, but not in ME/CFS patients reported by others. There are also some immunological, physiological and genetic differences.

But if the conclusion that the two illnesses may share a similar pathophysiological basis is supported by other research that includes FM-only patients as comparators to those with ME/CFS, “this would support the notion that the two illnesses fall along a common illness spectrum and may be approached as a single entity — with implications for both diagnosis and the development of new treatment approaches,” they concluded.
 

‘Noncontributory’ Findings

Commenting on the research, Robert G. Lahita, MD, PhD, director of the Institute for Autoimmune and Rheumatic Diseases, St. Joseph Health, Wayne, New Jersey, stated that he does not regard these diseases as neurologic but rather as rheumatologic.

“Most neurologists don’t see these diseases, but as a rheumatologist, I see them every day,” said Dr. Lahita, professor of medicine at Hackensack (New Jersey) Meridian School of Medicine and a clinical professor of medicine at Rutgers New Jersey Medical School, New Brunswick. “ME/CFS isn’t as common in my practice, but we do deal with many post-COVID patients who are afflicted mostly with ME/CFS.”

He noted that an important reason for fatigue in FM is that patients generally don’t sleep, or their sleep is disrupted. This is different from the cause of fatigue in ME/CFS.

In addition, the small sample size and the lack of difference between males and females were both limitations of the current study, said Dr. Lahita, who was not involved in this research. “We know that FM disproportionately affects women — in my practice, for example, over 95% of the patients with FM are female — while ME/CFS affects both genders similarly.”

Using proteomics as a biomarker was also problematic, according to Dr. Lahita. “It would have been more valuable to investigate differences in cytokines, for example,” he suggested.

Ultimately, Dr. Lahita thinks that the study is “non-contributory to the field and, as complex as the analysis was, it does nothing to shed differentiate the two conditions or explain the syndromes themselves.”

He added that it would have been more valuable to compare ME/CFS not only to ME/CFS plus FM but also with FM without ME/CFS and to healthy controls, and perhaps to a group with an autoimmune condition, such as lupus or Hashimoto’s thyroiditis.

Dr. Schutzer acknowledged that a limitation of the current study is that his team was unable analyze the CSF of patients with only FM. He and his colleagues “combed the world’s labs” for existing CSF samples of patients with FM alone but were unable to obtain any. “We see this study as a ‘stepping stone’ and hope that future studies will include patients with FM who are willing to donate CSF samples that we can use for comparison,” he said.

The authors received support from the National Institutes of Health, National Institute of Allergy and Infectious Diseases, and National Institute of Neurological Disorders and Stroke. Dr. Schutzer, coauthors, and Dr. Lahita reported no relevant financial relationships.

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and fibromyalgia (FM) have overlapping neurologic symptoms — particularly profound fatigue. The similarity between these two conditions has led to the question of whether they are indeed distinct central nervous system (CNS) entities, or whether they exist along a spectrum and are actually two different manifestations of the same disease process.

A new study utilized a novel methodology — unbiased quantitative mass spectrometry-based proteomics — to investigate this question by analyzing cerebrospinal fluid (CSF) in a group of patients with ME/CFS and another group of patients diagnosed with both ME/CFS and FM.

Close to 2,100 proteins were identified, of which nearly 1,800 were common to both conditions.

“ME/CFS and fibromyalgia do not appear to be distinct entities, with respect to their cerebrospinal fluid proteins,” lead author Steven Schutzer, MD, professor of medicine, Rutgers New Jersey School of Medicine, told this news organization.

“Work is underway to solve the multiple mysteries of ME/CFS, fibromyalgia, and other neurologic-associated diseases,” he continued. “We have further affirmed that we have a precise objective discovery tool in our hands. Collectively studying multiple diseases brings clarity to each individual disease.”

The study was published in the December 2023 issue of Annals of Medicine.
 

Cutting-Edge Technology

“ME/CFS is characterized by disabling fatigue, and FM is an illness characterized by body-wide pain,” Dr. Schutzer said. These “medically unexplained” illnesses often coexist by current definitions, and the overlap between them has suggested that they may be part of the “same illness spectrum.”

But co-investigator Benjamin Natelson, MD, professor of neurology and director of the Pain and Fatigue Study Center, Mount Sinai, New York, and others found in previous research that there are distinct differences between the conditions, raising the possibility that there may be different pathophysiological processes.

“The physicians and scientists on our team have had longstanding interest in studying neurologic diseases with cutting-edge tools such as mass spectrometry applied to CSF,” Dr. Schutzer said. “We have had success using this message to distinguish diseases such as ME/CFS from post-treatment Lyme disease, multiple sclerosis, and healthy normal people.”

Dr. Schutzer explained that Dr. Natelson had acquired CSF samples from “well-characterized [ME/CFS] patients and controls.”

Since the cause of ME/CFS is “unknown,” it seemed “ripe to investigate it further with the discovery tool of mass spectrometry” by harnessing the “most advanced equipment in the country at the pacific Northwest National Laboratory, which is part of the US Department of Energy.”

Dr. Schutzer noted that it was the “merger of different clinical and laboratory expertise” that enabled them to address whether ME/CFS and FM are two distinct disease processes.

The choice of analyzing CSF is that it’s the fluid closest to the brain, he added. “A lot of people have studied ME/CFS peripherally because they don’t have access to spinal fluid or it’s easier to look peripherally in the blood, but that doesn’t mean that the blood is where the real ‘action’ is occurring.”

The researchers compared the CSF of 15 patients with ME/CFS only to 15 patients with ME/CFS+FM using mass spectrometry-based proteomics, which they had employed in previous research to see whether ME/CFS was distinct from persistent neurologic Lyme disease syndrome.

This technology has become the “method of choice and discovery tool to rapidly uncover protein biomarkers that can distinguish one disease from another,” the authors stated.

In particular, in unbiased quantitative mass spectrometry-based proteomics, the researchers do not have to know in advance what’s in a sample before studying it, Dr. Schutzer explained.
 

Shared Pathophysiology?

Both groups of patients were of similar age (41.3 ± 9.4 years and 40.1 ± 11.0 years, respectively), with no differences in gender or rates of current comorbid psychiatric diagnoses between the groups.

The researchers quantified a total of 2,083 proteins, including 1,789 that were specifically quantified in all of the CSF samples, regardless of the presence or absence of FM.

Several analyses (including an ANOVA analysis with adjusted P values, a Random Forest machine learning approach that looked at relative protein abundance changes between those with ME/CFS and ME/CFS+FM, and unsupervised hierarchical clustering analyses) did not find distinguishing differences between the groups.

“The sum of these results does not support the hypothesis that ME/CFS and ME/CFS+FM are distinct entities, as currently defined,” the authors stated.

They noted that both conditions are “medically unexplained,” with core symptoms of pain, fatigue, sleep problems, and cognitive difficulty. The fact that these two syndromes coexist so often has led to the assumption that the “similarities between them outweigh the differences,” they wrote.

They pointed to some differences between the conditions, including an increase in substance P in the CSF of FM patients, but not in ME/CFS patients reported by others. There are also some immunological, physiological and genetic differences.

But if the conclusion that the two illnesses may share a similar pathophysiological basis is supported by other research that includes FM-only patients as comparators to those with ME/CFS, “this would support the notion that the two illnesses fall along a common illness spectrum and may be approached as a single entity — with implications for both diagnosis and the development of new treatment approaches,” they concluded.
 

‘Noncontributory’ Findings

Commenting on the research, Robert G. Lahita, MD, PhD, director of the Institute for Autoimmune and Rheumatic Diseases, St. Joseph Health, Wayne, New Jersey, stated that he does not regard these diseases as neurologic but rather as rheumatologic.

“Most neurologists don’t see these diseases, but as a rheumatologist, I see them every day,” said Dr. Lahita, professor of medicine at Hackensack (New Jersey) Meridian School of Medicine and a clinical professor of medicine at Rutgers New Jersey Medical School, New Brunswick. “ME/CFS isn’t as common in my practice, but we do deal with many post-COVID patients who are afflicted mostly with ME/CFS.”

He noted that an important reason for fatigue in FM is that patients generally don’t sleep, or their sleep is disrupted. This is different from the cause of fatigue in ME/CFS.

In addition, the small sample size and the lack of difference between males and females were both limitations of the current study, said Dr. Lahita, who was not involved in this research. “We know that FM disproportionately affects women — in my practice, for example, over 95% of the patients with FM are female — while ME/CFS affects both genders similarly.”

Using proteomics as a biomarker was also problematic, according to Dr. Lahita. “It would have been more valuable to investigate differences in cytokines, for example,” he suggested.

Ultimately, Dr. Lahita thinks that the study is “non-contributory to the field and, as complex as the analysis was, it does nothing to shed differentiate the two conditions or explain the syndromes themselves.”

He added that it would have been more valuable to compare ME/CFS not only to ME/CFS plus FM but also with FM without ME/CFS and to healthy controls, and perhaps to a group with an autoimmune condition, such as lupus or Hashimoto’s thyroiditis.

Dr. Schutzer acknowledged that a limitation of the current study is that his team was unable analyze the CSF of patients with only FM. He and his colleagues “combed the world’s labs” for existing CSF samples of patients with FM alone but were unable to obtain any. “We see this study as a ‘stepping stone’ and hope that future studies will include patients with FM who are willing to donate CSF samples that we can use for comparison,” he said.

The authors received support from the National Institutes of Health, National Institute of Allergy and Infectious Diseases, and National Institute of Neurological Disorders and Stroke. Dr. Schutzer, coauthors, and Dr. Lahita reported no relevant financial relationships.

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and fibromyalgia (FM) have overlapping neurologic symptoms — particularly profound fatigue. The similarity between these two conditions has led to the question of whether they are indeed distinct central nervous system (CNS) entities, or whether they exist along a spectrum and are actually two different manifestations of the same disease process.

A new study utilized a novel methodology — unbiased quantitative mass spectrometry-based proteomics — to investigate this question by analyzing cerebrospinal fluid (CSF) in a group of patients with ME/CFS and another group of patients diagnosed with both ME/CFS and FM.

Close to 2,100 proteins were identified, of which nearly 1,800 were common to both conditions.

“ME/CFS and fibromyalgia do not appear to be distinct entities, with respect to their cerebrospinal fluid proteins,” lead author Steven Schutzer, MD, professor of medicine, Rutgers New Jersey School of Medicine, told this news organization.

“Work is underway to solve the multiple mysteries of ME/CFS, fibromyalgia, and other neurologic-associated diseases,” he continued. “We have further affirmed that we have a precise objective discovery tool in our hands. Collectively studying multiple diseases brings clarity to each individual disease.”

The study was published in the December 2023 issue of Annals of Medicine.
 

Cutting-Edge Technology

“ME/CFS is characterized by disabling fatigue, and FM is an illness characterized by body-wide pain,” Dr. Schutzer said. These “medically unexplained” illnesses often coexist by current definitions, and the overlap between them has suggested that they may be part of the “same illness spectrum.”

But co-investigator Benjamin Natelson, MD, professor of neurology and director of the Pain and Fatigue Study Center, Mount Sinai, New York, and others found in previous research that there are distinct differences between the conditions, raising the possibility that there may be different pathophysiological processes.

“The physicians and scientists on our team have had longstanding interest in studying neurologic diseases with cutting-edge tools such as mass spectrometry applied to CSF,” Dr. Schutzer said. “We have had success using this message to distinguish diseases such as ME/CFS from post-treatment Lyme disease, multiple sclerosis, and healthy normal people.”

Dr. Schutzer explained that Dr. Natelson had acquired CSF samples from “well-characterized [ME/CFS] patients and controls.”

Since the cause of ME/CFS is “unknown,” it seemed “ripe to investigate it further with the discovery tool of mass spectrometry” by harnessing the “most advanced equipment in the country at the pacific Northwest National Laboratory, which is part of the US Department of Energy.”

Dr. Schutzer noted that it was the “merger of different clinical and laboratory expertise” that enabled them to address whether ME/CFS and FM are two distinct disease processes.

The choice of analyzing CSF is that it’s the fluid closest to the brain, he added. “A lot of people have studied ME/CFS peripherally because they don’t have access to spinal fluid or it’s easier to look peripherally in the blood, but that doesn’t mean that the blood is where the real ‘action’ is occurring.”

The researchers compared the CSF of 15 patients with ME/CFS only to 15 patients with ME/CFS+FM using mass spectrometry-based proteomics, which they had employed in previous research to see whether ME/CFS was distinct from persistent neurologic Lyme disease syndrome.

This technology has become the “method of choice and discovery tool to rapidly uncover protein biomarkers that can distinguish one disease from another,” the authors stated.

In particular, in unbiased quantitative mass spectrometry-based proteomics, the researchers do not have to know in advance what’s in a sample before studying it, Dr. Schutzer explained.
 

Shared Pathophysiology?

Both groups of patients were of similar age (41.3 ± 9.4 years and 40.1 ± 11.0 years, respectively), with no differences in gender or rates of current comorbid psychiatric diagnoses between the groups.

The researchers quantified a total of 2,083 proteins, including 1,789 that were specifically quantified in all of the CSF samples, regardless of the presence or absence of FM.

Several analyses (including an ANOVA analysis with adjusted P values, a Random Forest machine learning approach that looked at relative protein abundance changes between those with ME/CFS and ME/CFS+FM, and unsupervised hierarchical clustering analyses) did not find distinguishing differences between the groups.

“The sum of these results does not support the hypothesis that ME/CFS and ME/CFS+FM are distinct entities, as currently defined,” the authors stated.

They noted that both conditions are “medically unexplained,” with core symptoms of pain, fatigue, sleep problems, and cognitive difficulty. The fact that these two syndromes coexist so often has led to the assumption that the “similarities between them outweigh the differences,” they wrote.

They pointed to some differences between the conditions, including an increase in substance P in the CSF of FM patients, but not in ME/CFS patients reported by others. There are also some immunological, physiological and genetic differences.

But if the conclusion that the two illnesses may share a similar pathophysiological basis is supported by other research that includes FM-only patients as comparators to those with ME/CFS, “this would support the notion that the two illnesses fall along a common illness spectrum and may be approached as a single entity — with implications for both diagnosis and the development of new treatment approaches,” they concluded.
 

‘Noncontributory’ Findings

Commenting on the research, Robert G. Lahita, MD, PhD, director of the Institute for Autoimmune and Rheumatic Diseases, St. Joseph Health, Wayne, New Jersey, stated that he does not regard these diseases as neurologic but rather as rheumatologic.

“Most neurologists don’t see these diseases, but as a rheumatologist, I see them every day,” said Dr. Lahita, professor of medicine at Hackensack (New Jersey) Meridian School of Medicine and a clinical professor of medicine at Rutgers New Jersey Medical School, New Brunswick. “ME/CFS isn’t as common in my practice, but we do deal with many post-COVID patients who are afflicted mostly with ME/CFS.”

He noted that an important reason for fatigue in FM is that patients generally don’t sleep, or their sleep is disrupted. This is different from the cause of fatigue in ME/CFS.

In addition, the small sample size and the lack of difference between males and females were both limitations of the current study, said Dr. Lahita, who was not involved in this research. “We know that FM disproportionately affects women — in my practice, for example, over 95% of the patients with FM are female — while ME/CFS affects both genders similarly.”

Using proteomics as a biomarker was also problematic, according to Dr. Lahita. “It would have been more valuable to investigate differences in cytokines, for example,” he suggested.

Ultimately, Dr. Lahita thinks that the study is “non-contributory to the field and, as complex as the analysis was, it does nothing to shed differentiate the two conditions or explain the syndromes themselves.”

He added that it would have been more valuable to compare ME/CFS not only to ME/CFS plus FM but also with FM without ME/CFS and to healthy controls, and perhaps to a group with an autoimmune condition, such as lupus or Hashimoto’s thyroiditis.

Dr. Schutzer acknowledged that a limitation of the current study is that his team was unable analyze the CSF of patients with only FM. He and his colleagues “combed the world’s labs” for existing CSF samples of patients with FM alone but were unable to obtain any. “We see this study as a ‘stepping stone’ and hope that future studies will include patients with FM who are willing to donate CSF samples that we can use for comparison,” he said.

The authors received support from the National Institutes of Health, National Institute of Allergy and Infectious Diseases, and National Institute of Neurological Disorders and Stroke. Dr. Schutzer, coauthors, and Dr. Lahita reported no relevant financial relationships.

Prophylactic treatment with zoledronic acid (ZA) in individuals at high genetic risk for Paget disease of the bone (PDB) can prevent the development or progression of the condition, according to a new study. The authors argued that the positive results from the trial suggest that individuals with a familial history of PDB should undergo genetic screening.

“If it’s positive, you should be able to have a bone scan and take it from there,” senior author Stuart Ralston, MBChB, MD, professor of rheumatology at the University of Edinburgh (Scotland), said in an interview.

Dr. Ralston

PDB is a chronic skeletal growth disorder that affects an estimated 1-3 million people in the United States and is most prevalent in individuals over 65 years old. Symptoms of the disease may not present until later stages when there is already skeletal damage that cannot be resolved by medications. Earlier intervention in individuals who have not yet shown signs of the condition could potentially halt disease progression, Dr. Ralston said.

Genetics plays a substantial role in PDB, especially pathogenic variants of the gene SQSTM1. An estimated 40%-50% of people with a familial history of PDB have these variants, according to the study, which are associated with earlier PDB onset and more severe disease.

However, it was unclear if early interventions in these higher-risk individuals may result in better health outcomes.

In this new study, published on December 20, 2023, in Annals of the Rheumatic Diseases, researchers recruited participants through family members already diagnosed with PDB who received treatment at outpatient clinics. Over 1400 individuals with PDB underwent genetic testing for pathogenic SQSTM1 variants. If they tested positive, their first-degree relatives — primarily children — were offered the same genetic test. In total, 350 relatives tested positive for these pathogenic SQSTM1 variants, and of these individuals, 222 agreed to participate in the trial.

At the beginning of the study, all participants received a radionuclide bone scan to screen for bone lesions. They also underwent testing for the bone resorption marker type I collagen C-terminal telopeptides (CTX) and the bone formation marker procollagen type I amino-terminal propeptide (P1NP).

Participants were then randomized to receive either a single intravenous infusion of 5 mg of ZA or placebo treatment. Researchers followed up with participants annually for a median of 84 months (7 years), and then baseline assessments were repeated.

A total of 90 individuals in the ZA treatment group and 90 individuals in the placebo group completed the trial.

Participants were, on average, 50 years old at the beginning of the study. In the ZA group, nine individuals had lesions detected in bone scans at baseline, compared with just one at the study’s end. In the placebo group, 12 individuals had detectable lesions at baseline, compared with 11 individuals at the study’s end.

While the proportion of individuals with lesions was similar between the two groups, there were about twice as many lesions overall in the placebo group, compared with the ZA group (29 vs 15), which researchers said was by chance. All but two lesions disappeared in the ZA group, compared with 26 lesions remaining in the placebo group (P < .0001).

“The bone scan reversal of abnormalities was amazing,” said Ralston, where eight of nine patients with lesions in the ZA group “had their bone scan evidence completely wiped out,” he said. “That’s a very powerful result.”

Both CTX and P1NP concentrations fell in the ZA group at 12 months and remained significantly lower than the placebo group throughout the study (P < .0001 for each).

Overall, the researchers reported that eight individuals in the placebo group and no individuals in the ZA group had a poor outcome, defined as new bone lesions or lesions that were unchanged or progressed (odds ratio, 0.08; P = .003). Two individuals in the placebo group developed lesions during the study, compared with none in the ZA group, but this difference was not statistically significant.

Importantly, there were no differences in adverse events between the two groups.

While only a small number of people in the study had legions — around 9% of participants — the effect of ZA is “dramatic,” Linda A. Russell, MD, director of the Osteoporosis and Metabolic Bone Health Center at the Hospital for Special Surgery in New York City, told this news organization.

While clinicians primarily diagnose PDB with X-rays or an alkaline phosphatase blood test, testing for SQSTM1 is a new way to understand if someone is at higher risk for the disease, she said.

“Now, it seems like [the test] is fairly easily available, so probably it’s something we can begin to incorporate into our armamentarium,” Dr. Russell said.

Individuals who test positive for pathogenic variants of SQSTM1 could then get a bone scan, while those who tested negative may not need any additional testing, she added.

Dr. Ralston and coauthors noted that the effect size shown in this study is similar to that of studies examining adjuvant bisphosphonate therapy for postmenopausal women with early breast cancer. That practice, they write, is now a part of the standard of care.

“We believe that a similar approach is now justified in people with a family history of PDB who test positive for SQSTM1 mutations,” they wrote.

However, it is not clear if all individuals with pathogenic SQSTM1 should receive ZA treatment or if treatment should be given to only those with bone lesions.

“Future research to gather the views of people with a family history of PDB will help to inform the most appropriate way forward,” the authors wrote.

The UK Medical Research Council and Arthritis Research UK funded the trial. Zoledronic acid and a placebo were supplied by Novartis. Dr. Ralston reported funding to his institution from Kyowa Kirin, UCB, the Paget’s Association, and the Royal Osteoporosis Society. Some coauthors reported financial relationships with pharmaceutical companies outside the trial. Dr. Russell had no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Prophylactic treatment with zoledronic acid (ZA) in individuals at high genetic risk for Paget disease of the bone (PDB) can prevent the development or progression of the condition, according to a new study. The authors argued that the positive results from the trial suggest that individuals with a familial history of PDB should undergo genetic screening.

“If it’s positive, you should be able to have a bone scan and take it from there,” senior author Stuart Ralston, MBChB, MD, professor of rheumatology at the University of Edinburgh (Scotland), said in an interview.

Dr. Ralston

PDB is a chronic skeletal growth disorder that affects an estimated 1-3 million people in the United States and is most prevalent in individuals over 65 years old. Symptoms of the disease may not present until later stages when there is already skeletal damage that cannot be resolved by medications. Earlier intervention in individuals who have not yet shown signs of the condition could potentially halt disease progression, Dr. Ralston said.

Genetics plays a substantial role in PDB, especially pathogenic variants of the gene SQSTM1. An estimated 40%-50% of people with a familial history of PDB have these variants, according to the study, which are associated with earlier PDB onset and more severe disease.

However, it was unclear if early interventions in these higher-risk individuals may result in better health outcomes.

In this new study, published on December 20, 2023, in Annals of the Rheumatic Diseases, researchers recruited participants through family members already diagnosed with PDB who received treatment at outpatient clinics. Over 1400 individuals with PDB underwent genetic testing for pathogenic SQSTM1 variants. If they tested positive, their first-degree relatives — primarily children — were offered the same genetic test. In total, 350 relatives tested positive for these pathogenic SQSTM1 variants, and of these individuals, 222 agreed to participate in the trial.

At the beginning of the study, all participants received a radionuclide bone scan to screen for bone lesions. They also underwent testing for the bone resorption marker type I collagen C-terminal telopeptides (CTX) and the bone formation marker procollagen type I amino-terminal propeptide (P1NP).

Participants were then randomized to receive either a single intravenous infusion of 5 mg of ZA or placebo treatment. Researchers followed up with participants annually for a median of 84 months (7 years), and then baseline assessments were repeated.

A total of 90 individuals in the ZA treatment group and 90 individuals in the placebo group completed the trial.

Participants were, on average, 50 years old at the beginning of the study. In the ZA group, nine individuals had lesions detected in bone scans at baseline, compared with just one at the study’s end. In the placebo group, 12 individuals had detectable lesions at baseline, compared with 11 individuals at the study’s end.

While the proportion of individuals with lesions was similar between the two groups, there were about twice as many lesions overall in the placebo group, compared with the ZA group (29 vs 15), which researchers said was by chance. All but two lesions disappeared in the ZA group, compared with 26 lesions remaining in the placebo group (P < .0001).

“The bone scan reversal of abnormalities was amazing,” said Ralston, where eight of nine patients with lesions in the ZA group “had their bone scan evidence completely wiped out,” he said. “That’s a very powerful result.”

Both CTX and P1NP concentrations fell in the ZA group at 12 months and remained significantly lower than the placebo group throughout the study (P < .0001 for each).

Overall, the researchers reported that eight individuals in the placebo group and no individuals in the ZA group had a poor outcome, defined as new bone lesions or lesions that were unchanged or progressed (odds ratio, 0.08; P = .003). Two individuals in the placebo group developed lesions during the study, compared with none in the ZA group, but this difference was not statistically significant.

Importantly, there were no differences in adverse events between the two groups.

While only a small number of people in the study had legions — around 9% of participants — the effect of ZA is “dramatic,” Linda A. Russell, MD, director of the Osteoporosis and Metabolic Bone Health Center at the Hospital for Special Surgery in New York City, told this news organization.

While clinicians primarily diagnose PDB with X-rays or an alkaline phosphatase blood test, testing for SQSTM1 is a new way to understand if someone is at higher risk for the disease, she said.

“Now, it seems like [the test] is fairly easily available, so probably it’s something we can begin to incorporate into our armamentarium,” Dr. Russell said.

Individuals who test positive for pathogenic variants of SQSTM1 could then get a bone scan, while those who tested negative may not need any additional testing, she added.

Dr. Ralston and coauthors noted that the effect size shown in this study is similar to that of studies examining adjuvant bisphosphonate therapy for postmenopausal women with early breast cancer. That practice, they write, is now a part of the standard of care.

“We believe that a similar approach is now justified in people with a family history of PDB who test positive for SQSTM1 mutations,” they wrote.

However, it is not clear if all individuals with pathogenic SQSTM1 should receive ZA treatment or if treatment should be given to only those with bone lesions.

“Future research to gather the views of people with a family history of PDB will help to inform the most appropriate way forward,” the authors wrote.

The UK Medical Research Council and Arthritis Research UK funded the trial. Zoledronic acid and a placebo were supplied by Novartis. Dr. Ralston reported funding to his institution from Kyowa Kirin, UCB, the Paget’s Association, and the Royal Osteoporosis Society. Some coauthors reported financial relationships with pharmaceutical companies outside the trial. Dr. Russell had no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Prophylactic treatment with zoledronic acid (ZA) in individuals at high genetic risk for Paget disease of the bone (PDB) can prevent the development or progression of the condition, according to a new study. The authors argued that the positive results from the trial suggest that individuals with a familial history of PDB should undergo genetic screening.

“If it’s positive, you should be able to have a bone scan and take it from there,” senior author Stuart Ralston, MBChB, MD, professor of rheumatology at the University of Edinburgh (Scotland), said in an interview.

Dr. Ralston

PDB is a chronic skeletal growth disorder that affects an estimated 1-3 million people in the United States and is most prevalent in individuals over 65 years old. Symptoms of the disease may not present until later stages when there is already skeletal damage that cannot be resolved by medications. Earlier intervention in individuals who have not yet shown signs of the condition could potentially halt disease progression, Dr. Ralston said.

Genetics plays a substantial role in PDB, especially pathogenic variants of the gene SQSTM1. An estimated 40%-50% of people with a familial history of PDB have these variants, according to the study, which are associated with earlier PDB onset and more severe disease.

However, it was unclear if early interventions in these higher-risk individuals may result in better health outcomes.

In this new study, published on December 20, 2023, in Annals of the Rheumatic Diseases, researchers recruited participants through family members already diagnosed with PDB who received treatment at outpatient clinics. Over 1400 individuals with PDB underwent genetic testing for pathogenic SQSTM1 variants. If they tested positive, their first-degree relatives — primarily children — were offered the same genetic test. In total, 350 relatives tested positive for these pathogenic SQSTM1 variants, and of these individuals, 222 agreed to participate in the trial.

At the beginning of the study, all participants received a radionuclide bone scan to screen for bone lesions. They also underwent testing for the bone resorption marker type I collagen C-terminal telopeptides (CTX) and the bone formation marker procollagen type I amino-terminal propeptide (P1NP).

Participants were then randomized to receive either a single intravenous infusion of 5 mg of ZA or placebo treatment. Researchers followed up with participants annually for a median of 84 months (7 years), and then baseline assessments were repeated.

A total of 90 individuals in the ZA treatment group and 90 individuals in the placebo group completed the trial.

Participants were, on average, 50 years old at the beginning of the study. In the ZA group, nine individuals had lesions detected in bone scans at baseline, compared with just one at the study’s end. In the placebo group, 12 individuals had detectable lesions at baseline, compared with 11 individuals at the study’s end.

While the proportion of individuals with lesions was similar between the two groups, there were about twice as many lesions overall in the placebo group, compared with the ZA group (29 vs 15), which researchers said was by chance. All but two lesions disappeared in the ZA group, compared with 26 lesions remaining in the placebo group (P < .0001).

“The bone scan reversal of abnormalities was amazing,” said Ralston, where eight of nine patients with lesions in the ZA group “had their bone scan evidence completely wiped out,” he said. “That’s a very powerful result.”

Both CTX and P1NP concentrations fell in the ZA group at 12 months and remained significantly lower than the placebo group throughout the study (P < .0001 for each).

Overall, the researchers reported that eight individuals in the placebo group and no individuals in the ZA group had a poor outcome, defined as new bone lesions or lesions that were unchanged or progressed (odds ratio, 0.08; P = .003). Two individuals in the placebo group developed lesions during the study, compared with none in the ZA group, but this difference was not statistically significant.

Importantly, there were no differences in adverse events between the two groups.

While only a small number of people in the study had legions — around 9% of participants — the effect of ZA is “dramatic,” Linda A. Russell, MD, director of the Osteoporosis and Metabolic Bone Health Center at the Hospital for Special Surgery in New York City, told this news organization.

While clinicians primarily diagnose PDB with X-rays or an alkaline phosphatase blood test, testing for SQSTM1 is a new way to understand if someone is at higher risk for the disease, she said.

“Now, it seems like [the test] is fairly easily available, so probably it’s something we can begin to incorporate into our armamentarium,” Dr. Russell said.

Individuals who test positive for pathogenic variants of SQSTM1 could then get a bone scan, while those who tested negative may not need any additional testing, she added.

Dr. Ralston and coauthors noted that the effect size shown in this study is similar to that of studies examining adjuvant bisphosphonate therapy for postmenopausal women with early breast cancer. That practice, they write, is now a part of the standard of care.

“We believe that a similar approach is now justified in people with a family history of PDB who test positive for SQSTM1 mutations,” they wrote.

However, it is not clear if all individuals with pathogenic SQSTM1 should receive ZA treatment or if treatment should be given to only those with bone lesions.

“Future research to gather the views of people with a family history of PDB will help to inform the most appropriate way forward,” the authors wrote.

The UK Medical Research Council and Arthritis Research UK funded the trial. Zoledronic acid and a placebo were supplied by Novartis. Dr. Ralston reported funding to his institution from Kyowa Kirin, UCB, the Paget’s Association, and the Royal Osteoporosis Society. Some coauthors reported financial relationships with pharmaceutical companies outside the trial. Dr. Russell had no relevant financial relationships.
 

A version of this article appeared on Medscape.com.