Pain

Patients who received a first prescription for medicinal cannabis for chronic pain were more likely to have new onset of arrhythmia – bradyarrhythmia, tachyarrhythmia, or a conduction disorder – within 6 months than were similar nonusers, in a new case-control study.

VladK213/Getty Images

There were no between-group differences in the incidence of heart failure or acute coronary syndrome.

The researchers identified 5,071 patients in a national Danish registry who had filled at least one prescription for medicinal cannabis for chronic pain and matched each patient with five patients of the same sex, age range, and type of chronic pain who did not receive this therapy.

The relative risk for arrhythmia was 83% higher in those who used medicinal cannabis than it was in the other patients, study author Nina Nouhravesh, MD, told this news organization in an email.

However, the absolute risks for arrhythmia were slight – a 0.86% risk (95% confidence interval, 0.61%-1.1%) in medicinal cannabis users versus a 0.47% risk (95% CI, 0.38%-0.56%) in those who did not use medicinal cannabis.

“Since medical cannabis is a relatively new drug for a large market of patients with chronic pain, it is important to investigate and report serious side effects,” said Dr. Nouhravesh, from Gentofte University Hospital, Denmark.

The study results, she said, suggest that “there may be a previously unreported risk of arrhythmias following medical cannabis use.”

“Even though the absolute risk difference is small, both patients and physicians should have as much information as possible when weighing up the pros and cons of any treatment,” Dr. Nouhravesh said, adding that “the findings of this study raise concerns for both legal and illegal [cannabis] use worldwide.”

The results will be presented at the annual European Society of Cardiology (ESC) Congress 2022.
 

Too soon to tell?

However, Brian Olshansky, MD, who was not involved with this research, cautions that it is important to consider several study limitations before drawing clinical implications.

“Other data and reports have considered the possibility of arrhythmias in relationship to marijuana use, and the data go in both directions,” Dr. Olshansky, a clinical cardiac electrophysiologist and professor emeritus at University of Iowa Hospitals, Iowa City, pointed out in an email.

“Importantly, arrhythmias, by themselves, are not necessarily consequential,” he stressed. “In any case,” he added, the risks in the current study are “extraordinarily small.”

Sinus bradycardia, sinus tachycardia, and premature atrial or ventricular contractions could be totally benign, he said. On the other hand, arrhythmias may indicate the presence of atrial fibrillation, atrial flutter, ventricular tachycardia, and ventricular fibrillation, which are potentially dangerous.

There may be a specific “high risk” group who can develop potentially serious arrhythmias, Dr. Olshansky suggested.

“There is no evidence that any of these patients underwent or required any treatment for their arrhythmia or that stopping or starting the cannabinoids affected the arrhythmia one way or the other,” he said. “In addition, there is no dose/arrhythmia relationship.”

More patients in the medicinal cannabis group than in the nonuser group were also taking opioids (49% vs. 30%), nonsteroidal anti-inflammatory drugs (24% vs. 19%), antiepileptics (35% vs. 23%), or tricyclic antidepressants (11% vs. 4%), he noted.

In summary, according to Dr. Olshansky, “these data pose no obvious health concern and provide no vital knowledge for physicians prescribing cannabis.”

“My concern is that the information will be overblown,” he cautioned. “If the cannabinoid actually has benefit in terms of pain reduction, its use may be mitigated based on the fear of an arrhythmia that may occur – but the risk of an arrhythmia, in any event, is very small and undefined in terms of its seriousness.”
 

Cancer, musculoskeletal, and neurologic pain

For this analysis, the researchers identified 1.8 million patients in Denmark who were diagnosed with chronic pain between 2018 and 2021.

Of those, around 5,000 patients had claimed at least one prescription of medicinal cannabis (dronabinol 29%, cannabinoids 46%, or cannabidiol 25%).

The patients had a median age of 60 years, and 63% were women.

The cannabis users had been prescribed this therapy for musculoskeletal (35%), cancer (18%), neurological (14%), or other (33%) pain, Dr. Nouhravesh said. 

The researchers and Dr. Olshansky have no relevant financial disclosures.  

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

Patients who received a first prescription for medicinal cannabis for chronic pain were more likely to have new onset of arrhythmia – bradyarrhythmia, tachyarrhythmia, or a conduction disorder – within 6 months than were similar nonusers, in a new case-control study.

VladK213/Getty Images

There were no between-group differences in the incidence of heart failure or acute coronary syndrome.

The researchers identified 5,071 patients in a national Danish registry who had filled at least one prescription for medicinal cannabis for chronic pain and matched each patient with five patients of the same sex, age range, and type of chronic pain who did not receive this therapy.

The relative risk for arrhythmia was 83% higher in those who used medicinal cannabis than it was in the other patients, study author Nina Nouhravesh, MD, told this news organization in an email.

However, the absolute risks for arrhythmia were slight – a 0.86% risk (95% confidence interval, 0.61%-1.1%) in medicinal cannabis users versus a 0.47% risk (95% CI, 0.38%-0.56%) in those who did not use medicinal cannabis.

“Since medical cannabis is a relatively new drug for a large market of patients with chronic pain, it is important to investigate and report serious side effects,” said Dr. Nouhravesh, from Gentofte University Hospital, Denmark.

The study results, she said, suggest that “there may be a previously unreported risk of arrhythmias following medical cannabis use.”

“Even though the absolute risk difference is small, both patients and physicians should have as much information as possible when weighing up the pros and cons of any treatment,” Dr. Nouhravesh said, adding that “the findings of this study raise concerns for both legal and illegal [cannabis] use worldwide.”

The results will be presented at the annual European Society of Cardiology (ESC) Congress 2022.
 

Too soon to tell?

However, Brian Olshansky, MD, who was not involved with this research, cautions that it is important to consider several study limitations before drawing clinical implications.

“Other data and reports have considered the possibility of arrhythmias in relationship to marijuana use, and the data go in both directions,” Dr. Olshansky, a clinical cardiac electrophysiologist and professor emeritus at University of Iowa Hospitals, Iowa City, pointed out in an email.

“Importantly, arrhythmias, by themselves, are not necessarily consequential,” he stressed. “In any case,” he added, the risks in the current study are “extraordinarily small.”

Sinus bradycardia, sinus tachycardia, and premature atrial or ventricular contractions could be totally benign, he said. On the other hand, arrhythmias may indicate the presence of atrial fibrillation, atrial flutter, ventricular tachycardia, and ventricular fibrillation, which are potentially dangerous.

There may be a specific “high risk” group who can develop potentially serious arrhythmias, Dr. Olshansky suggested.

“There is no evidence that any of these patients underwent or required any treatment for their arrhythmia or that stopping or starting the cannabinoids affected the arrhythmia one way or the other,” he said. “In addition, there is no dose/arrhythmia relationship.”

More patients in the medicinal cannabis group than in the nonuser group were also taking opioids (49% vs. 30%), nonsteroidal anti-inflammatory drugs (24% vs. 19%), antiepileptics (35% vs. 23%), or tricyclic antidepressants (11% vs. 4%), he noted.

In summary, according to Dr. Olshansky, “these data pose no obvious health concern and provide no vital knowledge for physicians prescribing cannabis.”

“My concern is that the information will be overblown,” he cautioned. “If the cannabinoid actually has benefit in terms of pain reduction, its use may be mitigated based on the fear of an arrhythmia that may occur – but the risk of an arrhythmia, in any event, is very small and undefined in terms of its seriousness.”
 

Cancer, musculoskeletal, and neurologic pain

For this analysis, the researchers identified 1.8 million patients in Denmark who were diagnosed with chronic pain between 2018 and 2021.

Of those, around 5,000 patients had claimed at least one prescription of medicinal cannabis (dronabinol 29%, cannabinoids 46%, or cannabidiol 25%).

The patients had a median age of 60 years, and 63% were women.

The cannabis users had been prescribed this therapy for musculoskeletal (35%), cancer (18%), neurological (14%), or other (33%) pain, Dr. Nouhravesh said. 

The researchers and Dr. Olshansky have no relevant financial disclosures.  

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

Patients who received a first prescription for medicinal cannabis for chronic pain were more likely to have new onset of arrhythmia – bradyarrhythmia, tachyarrhythmia, or a conduction disorder – within 6 months than were similar nonusers, in a new case-control study.

VladK213/Getty Images

There were no between-group differences in the incidence of heart failure or acute coronary syndrome.

The researchers identified 5,071 patients in a national Danish registry who had filled at least one prescription for medicinal cannabis for chronic pain and matched each patient with five patients of the same sex, age range, and type of chronic pain who did not receive this therapy.

The relative risk for arrhythmia was 83% higher in those who used medicinal cannabis than it was in the other patients, study author Nina Nouhravesh, MD, told this news organization in an email.

However, the absolute risks for arrhythmia were slight – a 0.86% risk (95% confidence interval, 0.61%-1.1%) in medicinal cannabis users versus a 0.47% risk (95% CI, 0.38%-0.56%) in those who did not use medicinal cannabis.

“Since medical cannabis is a relatively new drug for a large market of patients with chronic pain, it is important to investigate and report serious side effects,” said Dr. Nouhravesh, from Gentofte University Hospital, Denmark.

The study results, she said, suggest that “there may be a previously unreported risk of arrhythmias following medical cannabis use.”

“Even though the absolute risk difference is small, both patients and physicians should have as much information as possible when weighing up the pros and cons of any treatment,” Dr. Nouhravesh said, adding that “the findings of this study raise concerns for both legal and illegal [cannabis] use worldwide.”

The results will be presented at the annual European Society of Cardiology (ESC) Congress 2022.
 

Too soon to tell?

However, Brian Olshansky, MD, who was not involved with this research, cautions that it is important to consider several study limitations before drawing clinical implications.

“Other data and reports have considered the possibility of arrhythmias in relationship to marijuana use, and the data go in both directions,” Dr. Olshansky, a clinical cardiac electrophysiologist and professor emeritus at University of Iowa Hospitals, Iowa City, pointed out in an email.

“Importantly, arrhythmias, by themselves, are not necessarily consequential,” he stressed. “In any case,” he added, the risks in the current study are “extraordinarily small.”

Sinus bradycardia, sinus tachycardia, and premature atrial or ventricular contractions could be totally benign, he said. On the other hand, arrhythmias may indicate the presence of atrial fibrillation, atrial flutter, ventricular tachycardia, and ventricular fibrillation, which are potentially dangerous.

There may be a specific “high risk” group who can develop potentially serious arrhythmias, Dr. Olshansky suggested.

“There is no evidence that any of these patients underwent or required any treatment for their arrhythmia or that stopping or starting the cannabinoids affected the arrhythmia one way or the other,” he said. “In addition, there is no dose/arrhythmia relationship.”

More patients in the medicinal cannabis group than in the nonuser group were also taking opioids (49% vs. 30%), nonsteroidal anti-inflammatory drugs (24% vs. 19%), antiepileptics (35% vs. 23%), or tricyclic antidepressants (11% vs. 4%), he noted.

In summary, according to Dr. Olshansky, “these data pose no obvious health concern and provide no vital knowledge for physicians prescribing cannabis.”

“My concern is that the information will be overblown,” he cautioned. “If the cannabinoid actually has benefit in terms of pain reduction, its use may be mitigated based on the fear of an arrhythmia that may occur – but the risk of an arrhythmia, in any event, is very small and undefined in terms of its seriousness.”
 

Cancer, musculoskeletal, and neurologic pain

For this analysis, the researchers identified 1.8 million patients in Denmark who were diagnosed with chronic pain between 2018 and 2021.

Of those, around 5,000 patients had claimed at least one prescription of medicinal cannabis (dronabinol 29%, cannabinoids 46%, or cannabidiol 25%).

The patients had a median age of 60 years, and 63% were women.

The cannabis users had been prescribed this therapy for musculoskeletal (35%), cancer (18%), neurological (14%), or other (33%) pain, Dr. Nouhravesh said. 

The researchers and Dr. Olshansky have no relevant financial disclosures.  

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

People with diabetes who take nonsteroidal anti-inflammatory drugs even on a short-term basis may have about a 50% greater risk of developing heart failure, according to results from a national registry study of more than 330,000 patients to be presented at the annual congress of the European Society of Cardiology.

“According to data from this study, even short-term NSAID use – within 28 days – in patients with type 2 diabetes mellitus are associated with an increased risk of first-time heart failure hospitalization,” lead author Anders Holt, MD, said in an interview.

“Further, it seems that patients above 79 years of age or with elevated hemoglobin A1c levels, along with new users of NSAIDs, are particularly susceptible.” He added that no such association was found in patients below age 65 years with normal A1c levels.

Dr. Holt has a dual appointment as a cardiologist at Copenhagen University and Herlev-Gentofte Hospital in Hellerup, Denmark, and the department of epidemiology and biostatistics at the University of Auckland (New Zealand). Jarl Emmanuel Strange, MD, PhD, a fellow at Copenhagen University, is to present the abstract on Aug. 26.

“This is quite an important observation given that, unfortunately, NSAIDs continue to be prescribed rather easily to people with diabetes and these agents do have risk,” said Rodica Busui, MD, PhD, codirector of the JDRF Center of Excellence at the University of Michigan, Ann Arbor, and president-elect for medicine and science of the American Diabetes Association. Dr. Busui is also lead author of an ADA/American College of Cardiology consensus report on heart failure in diabetes.

The study hypothesized that fluid retention “is a known but underappreciated side effect” of NSAID use and that short-term NSAID use could lead to heart failure in patients with type 2 diabetes, which has been linked to subclinical cardiomyopathy and kidney dysfunction.

“According to this study and particularly the subgroups analyses, it seems that incident heart failure associated with short-term NSAID use could be more than ‘just fluid overload,’ ” Dr. Holt said. “Further investigations into the specific mechanisms causing these associations are warranted.”

The study identified 331,189 patients with type 2 diabetes in nationwide Danish registries from 1998 to 2018. Median age was 62 years, and 23,308 (7%) were hospitalized with heart failure during follow-up, Dr. Holt said. Of them, 16% claimed at least one NSAID prescription within 2 years and 3% claimed they had at least three prescriptions.

Study follow-up started 120 days after the first-time type 2 diabetes diagnosis and focused on patients who had no previous diagnosis of heart failure or rheumatologic disease. The investigators reported on patients who had one, two, three or four prescriptions for NSAID within a year of starting follow-up.

The study used a case-crossover design, which, the abstract stated, “uses each individual as his or her own control making it suitable to study the effect of short-term exposure on immediate events while mitigating unmeasured confounding.”

Dr. Holt noted that short-term NSAID use was linked to increased risk of heart failure hospitalization (odds ratio, 1.43; 95% confidence interval, 1.27-1.63). The investigators identified even greater risks in three subgroups: age of at least 80 years (OR, 1.78; 95% CI, 1.39-2.28), elevated A1c levels treated with one or less antidiabetic medication (OR 1.68; 95% CI, 1-2.88), and patients without previous NSAID use (OR, 2.71; 95% CI, 1.78-4.23).

In the cohort, celecoxib and naproxen were rarely used (0.4 and 0.9%, respectively), while 3.3% of patients took diclofenac or 12.2% ibuprofen. The latter two NSAIDs had ORs of 1.48 and 1.46, respectively, for hospitalization for new-onset heart failure using 28-day exposure windows (95% CI for both, 1.1­-2 and 1.26-1.69). No increased risk emerged for celecoxib or naproxen.

“High age and A1c levels and being a new user were tied to the strongest associations, along with known use of RASi [renin-angiotensin system inhibitors] and diuretics,” Dr. Holt said. “On the contrary, it seemed safe – from our data – to prescribe short-term NSAIDs for patients below 65 years of age and patients with normal A1c levels.

“Interestingly,” he added, “subclinical structural heart disease among patients with type 2 diabetes could play an important role.”

The findings are noteworthy, Dr. Busui said. “Although there are some limitations with the study design in general when one looks at data extracted from registers, the very large sample size and the fact that the Danish national register captures data in a standardized fashion does make the findings very relevant, especially now that we have confirmed that heart failure is the most prevalent cardiovascular complication in people with diabetes, as we have highlighted in the most recent ADA/ACC consensus on heart failure in diabetes.”

The study received funding from the Danish Heart Foundation and a number of private foundations. Dr. Holt and colleagues have no disclosures. Dr. Busui disclosed relationships with AstraZeneca, Boehringer Ingelheim–Lilly Alliance, Novo Nordisk, Averitas Pharma, Nevro, Regenacy Pharmaceuticals and Roche Diagnostics.

 

People with diabetes who take nonsteroidal anti-inflammatory drugs even on a short-term basis may have about a 50% greater risk of developing heart failure, according to results from a national registry study of more than 330,000 patients to be presented at the annual congress of the European Society of Cardiology.

“According to data from this study, even short-term NSAID use – within 28 days – in patients with type 2 diabetes mellitus are associated with an increased risk of first-time heart failure hospitalization,” lead author Anders Holt, MD, said in an interview.

“Further, it seems that patients above 79 years of age or with elevated hemoglobin A1c levels, along with new users of NSAIDs, are particularly susceptible.” He added that no such association was found in patients below age 65 years with normal A1c levels.

Dr. Holt has a dual appointment as a cardiologist at Copenhagen University and Herlev-Gentofte Hospital in Hellerup, Denmark, and the department of epidemiology and biostatistics at the University of Auckland (New Zealand). Jarl Emmanuel Strange, MD, PhD, a fellow at Copenhagen University, is to present the abstract on Aug. 26.

“This is quite an important observation given that, unfortunately, NSAIDs continue to be prescribed rather easily to people with diabetes and these agents do have risk,” said Rodica Busui, MD, PhD, codirector of the JDRF Center of Excellence at the University of Michigan, Ann Arbor, and president-elect for medicine and science of the American Diabetes Association. Dr. Busui is also lead author of an ADA/American College of Cardiology consensus report on heart failure in diabetes.

The study hypothesized that fluid retention “is a known but underappreciated side effect” of NSAID use and that short-term NSAID use could lead to heart failure in patients with type 2 diabetes, which has been linked to subclinical cardiomyopathy and kidney dysfunction.

“According to this study and particularly the subgroups analyses, it seems that incident heart failure associated with short-term NSAID use could be more than ‘just fluid overload,’ ” Dr. Holt said. “Further investigations into the specific mechanisms causing these associations are warranted.”

The study identified 331,189 patients with type 2 diabetes in nationwide Danish registries from 1998 to 2018. Median age was 62 years, and 23,308 (7%) were hospitalized with heart failure during follow-up, Dr. Holt said. Of them, 16% claimed at least one NSAID prescription within 2 years and 3% claimed they had at least three prescriptions.

Study follow-up started 120 days after the first-time type 2 diabetes diagnosis and focused on patients who had no previous diagnosis of heart failure or rheumatologic disease. The investigators reported on patients who had one, two, three or four prescriptions for NSAID within a year of starting follow-up.

The study used a case-crossover design, which, the abstract stated, “uses each individual as his or her own control making it suitable to study the effect of short-term exposure on immediate events while mitigating unmeasured confounding.”

Dr. Holt noted that short-term NSAID use was linked to increased risk of heart failure hospitalization (odds ratio, 1.43; 95% confidence interval, 1.27-1.63). The investigators identified even greater risks in three subgroups: age of at least 80 years (OR, 1.78; 95% CI, 1.39-2.28), elevated A1c levels treated with one or less antidiabetic medication (OR 1.68; 95% CI, 1-2.88), and patients without previous NSAID use (OR, 2.71; 95% CI, 1.78-4.23).

In the cohort, celecoxib and naproxen were rarely used (0.4 and 0.9%, respectively), while 3.3% of patients took diclofenac or 12.2% ibuprofen. The latter two NSAIDs had ORs of 1.48 and 1.46, respectively, for hospitalization for new-onset heart failure using 28-day exposure windows (95% CI for both, 1.1­-2 and 1.26-1.69). No increased risk emerged for celecoxib or naproxen.

“High age and A1c levels and being a new user were tied to the strongest associations, along with known use of RASi [renin-angiotensin system inhibitors] and diuretics,” Dr. Holt said. “On the contrary, it seemed safe – from our data – to prescribe short-term NSAIDs for patients below 65 years of age and patients with normal A1c levels.

“Interestingly,” he added, “subclinical structural heart disease among patients with type 2 diabetes could play an important role.”

The findings are noteworthy, Dr. Busui said. “Although there are some limitations with the study design in general when one looks at data extracted from registers, the very large sample size and the fact that the Danish national register captures data in a standardized fashion does make the findings very relevant, especially now that we have confirmed that heart failure is the most prevalent cardiovascular complication in people with diabetes, as we have highlighted in the most recent ADA/ACC consensus on heart failure in diabetes.”

The study received funding from the Danish Heart Foundation and a number of private foundations. Dr. Holt and colleagues have no disclosures. Dr. Busui disclosed relationships with AstraZeneca, Boehringer Ingelheim–Lilly Alliance, Novo Nordisk, Averitas Pharma, Nevro, Regenacy Pharmaceuticals and Roche Diagnostics.

 

People with diabetes who take nonsteroidal anti-inflammatory drugs even on a short-term basis may have about a 50% greater risk of developing heart failure, according to results from a national registry study of more than 330,000 patients to be presented at the annual congress of the European Society of Cardiology.

“According to data from this study, even short-term NSAID use – within 28 days – in patients with type 2 diabetes mellitus are associated with an increased risk of first-time heart failure hospitalization,” lead author Anders Holt, MD, said in an interview.

“Further, it seems that patients above 79 years of age or with elevated hemoglobin A1c levels, along with new users of NSAIDs, are particularly susceptible.” He added that no such association was found in patients below age 65 years with normal A1c levels.

Dr. Holt has a dual appointment as a cardiologist at Copenhagen University and Herlev-Gentofte Hospital in Hellerup, Denmark, and the department of epidemiology and biostatistics at the University of Auckland (New Zealand). Jarl Emmanuel Strange, MD, PhD, a fellow at Copenhagen University, is to present the abstract on Aug. 26.

“This is quite an important observation given that, unfortunately, NSAIDs continue to be prescribed rather easily to people with diabetes and these agents do have risk,” said Rodica Busui, MD, PhD, codirector of the JDRF Center of Excellence at the University of Michigan, Ann Arbor, and president-elect for medicine and science of the American Diabetes Association. Dr. Busui is also lead author of an ADA/American College of Cardiology consensus report on heart failure in diabetes.

The study hypothesized that fluid retention “is a known but underappreciated side effect” of NSAID use and that short-term NSAID use could lead to heart failure in patients with type 2 diabetes, which has been linked to subclinical cardiomyopathy and kidney dysfunction.

“According to this study and particularly the subgroups analyses, it seems that incident heart failure associated with short-term NSAID use could be more than ‘just fluid overload,’ ” Dr. Holt said. “Further investigations into the specific mechanisms causing these associations are warranted.”

The study identified 331,189 patients with type 2 diabetes in nationwide Danish registries from 1998 to 2018. Median age was 62 years, and 23,308 (7%) were hospitalized with heart failure during follow-up, Dr. Holt said. Of them, 16% claimed at least one NSAID prescription within 2 years and 3% claimed they had at least three prescriptions.

Study follow-up started 120 days after the first-time type 2 diabetes diagnosis and focused on patients who had no previous diagnosis of heart failure or rheumatologic disease. The investigators reported on patients who had one, two, three or four prescriptions for NSAID within a year of starting follow-up.

The study used a case-crossover design, which, the abstract stated, “uses each individual as his or her own control making it suitable to study the effect of short-term exposure on immediate events while mitigating unmeasured confounding.”

Dr. Holt noted that short-term NSAID use was linked to increased risk of heart failure hospitalization (odds ratio, 1.43; 95% confidence interval, 1.27-1.63). The investigators identified even greater risks in three subgroups: age of at least 80 years (OR, 1.78; 95% CI, 1.39-2.28), elevated A1c levels treated with one or less antidiabetic medication (OR 1.68; 95% CI, 1-2.88), and patients without previous NSAID use (OR, 2.71; 95% CI, 1.78-4.23).

In the cohort, celecoxib and naproxen were rarely used (0.4 and 0.9%, respectively), while 3.3% of patients took diclofenac or 12.2% ibuprofen. The latter two NSAIDs had ORs of 1.48 and 1.46, respectively, for hospitalization for new-onset heart failure using 28-day exposure windows (95% CI for both, 1.1­-2 and 1.26-1.69). No increased risk emerged for celecoxib or naproxen.

“High age and A1c levels and being a new user were tied to the strongest associations, along with known use of RASi [renin-angiotensin system inhibitors] and diuretics,” Dr. Holt said. “On the contrary, it seemed safe – from our data – to prescribe short-term NSAIDs for patients below 65 years of age and patients with normal A1c levels.

“Interestingly,” he added, “subclinical structural heart disease among patients with type 2 diabetes could play an important role.”

The findings are noteworthy, Dr. Busui said. “Although there are some limitations with the study design in general when one looks at data extracted from registers, the very large sample size and the fact that the Danish national register captures data in a standardized fashion does make the findings very relevant, especially now that we have confirmed that heart failure is the most prevalent cardiovascular complication in people with diabetes, as we have highlighted in the most recent ADA/ACC consensus on heart failure in diabetes.”

The study received funding from the Danish Heart Foundation and a number of private foundations. Dr. Holt and colleagues have no disclosures. Dr. Busui disclosed relationships with AstraZeneca, Boehringer Ingelheim–Lilly Alliance, Novo Nordisk, Averitas Pharma, Nevro, Regenacy Pharmaceuticals and Roche Diagnostics.

 

The Food and Drug Administration has approved Abbott Laboratories’ new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy for the treatment of patients with chronic pain, the company announced Aug. 23.

The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.

“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.

The system also has therapy settings accessed with a mobile device.

Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
 

Game changer?

The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.

More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.

Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.

“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.

“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.

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

The Food and Drug Administration has approved Abbott Laboratories’ new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy for the treatment of patients with chronic pain, the company announced Aug. 23.

The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.

“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.

The system also has therapy settings accessed with a mobile device.

Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
 

Game changer?

The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.

More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.

Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.

“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.

“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.

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

The Food and Drug Administration has approved Abbott Laboratories’ new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy for the treatment of patients with chronic pain, the company announced Aug. 23.

The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.

“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.

The system also has therapy settings accessed with a mobile device.

Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
 

Game changer?

The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.

More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.

Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.

“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.

“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.

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

Ultrasound-guided nerve blocks for preoperative pain management after hip fracture provide improvements over conventional anesthesia including greater pain reduction and fewer adverse events, results from a meta-analysis published in BMC Anesthesiology show.

With the caveat that the quality of evidence in most trials in the analysis is low owing to a lack of blinding and other factors, “our review suggests that, among patients suffering from a hip fracture, a preoperative ultrasound-guided peripheral nerve block is associated with a significant pain reduction and reduced need for systemic analgesics compared to conventional analgesia,” reported the authors.

“Our results may also indicate a lower risk of delirium, serious adverse events and higher patient satisfaction in patients receiving an ultrasound-guided peripheral nerve block,” they added.

Because hip fractures commonly affect older populations and those who are frail, treatment of the substantial pain that can occur perioperatively is a challenge.

Peripheral nerve blocks have been shown to reduce pain within 30 minutes of the block placement; however, most studies have primarily included blocks that use anatomic landmarks or nerve stimulation for guidance. However, the use of ultrasound guidance with the nerve block should improve efficacy, the authors noted.

“It seems intuitive that using ultrasound-guidance should be more effective than using a blind technique, since it allows a trained physician to deposit the local anesthetic with much more precision,” they wrote.

To evaluate the data from studies that have looked at ultrasound-guided peripheral nerve blocks, Oskar Wilborg Exsteen, of the department of anesthesiology and intensive care, Copenhagen University Hospital and Nordsjællands Hospital, Hillerød, Denmark, and colleagues identified 12 randomized controlled trials, involving a combined total of 976 participants, for the meta-analysis.

The studies included 509 participants who received ultrasound-guided peripheral nerve blocks, specifically the femoral nerve block and fascia iliaca block, and 476 who were randomly assigned to control groups.

Overall, those treated with the nerve blocks showed significantly greater reductions in pain measured closest to 2 hours of block placement, compared with conventional analgesia, with a mean reduction of 2.26 points on the Visual Analogue Scale (VAS) (range, 0-10; P < .001).

Ultrasound-guided peripheral nerve block use was associated with lower preoperative usage of analgesic intravenous morphine equivalents in milligram, reported in four of the trials (random effects model mean difference, –5.34; P = .003).

Delirium was also significantly lower with the nerve blocks (risk ratio, 0.6; P = 0.03), as were serious adverse events, compared with standard analgesia (RR, 0.33; P = .006), whereas patient satisfaction was significantly higher with the nerve blocks (mean VAS difference, 25.9 [score 0-100]; P < .001).

Seven of the studies had monitored for serious adverse events or complications related to the nerve blocks, but none reported any complications directly related to the ultrasound-guided peripheral nerve blocks.

Owing to the inability to conduct blinded comparisons, clinical heterogeneity, and other caveats, the quality of evidence was ultimately judged to be “low” or “very low”; however, the observed benefits are nevertheless relevant, the authors concluded.

“Despite the low quality of evidence, ultrasound-guided blocks were associated with benefits compared to conventional systemic analgesia,” they said.

Key caveats include that the morphine reductions observed with the nerve blocks were not substantial, they noted. “The opioid-sparing effect seems small and may be of less clinical importance.” The decreases in opioid consumption, as well as pain reduction in the analysis, are in fact similar to those observed with conventional, peripheral nerve blocks that did not use ultrasound guidance, compared with standard pain management.

No trials were identified that directly compared ultrasound-guided peripheral nerve blocks with nerve block techniques that didn’t use ultrasound.

However, the other noted improvements carry more weight, the authors said.

“The potential for higher patient satisfaction and reduction in serious adverse events and delirium may be of clinical importance,” they wrote.
 

Ultrasound-guided peripheral nerve blocks not always accessible

Of note, the use of ultrasound-guided peripheral nerve blocks appears to be somewhat low, with one observational trend study of national data in the United States showing that, among patients receiving a peripheral nerve block for hip arthroplasty, only 3.2% of the procedures were performed using ultrasound guidance.

Stephen C. Haskins, MD, a coauthor on that study, said that the low utilization underscores that, in real-world practice, an ultrasound-guided approach isn’t always convenient.

“I think our findings demonstrate a common misconception that exists for those of us that work at academic institutions and/or within the ivory towers of regional anesthesia, which is that everyone is performing cutting edge ultrasound-guided techniques for all procedures,” Dr. Haskins, an associate attending anesthesiologist and chief medical diversity officer with the department of anesthesiology, critical care & pain management at the Hospital for Special Surgery in New York, said in an interview.

However, “there are many limitations to use of ultrasound for these blocks, including limited access to machines, limited access to training, and limited interest and support from our surgical colleagues,” he explained.

“Ultimately, the best nerve block is the one performed in a timely and successful fashion, regardless of technique,” he said. “But we will continue to see a trend towards ultrasound use in the future due to increasing access in the form of portability and affordability.”

Haskins noted that newer ultrasound-guided nerve blocks that were not reviewed in the study, such as the pericapsular nerve group block, regional block, and supra-inguinal fascia iliaca block, which provide additional benefits such as avoiding quadriceps weakness.

Jeff Gadsden, MD, chief of the orthopedics, plastic, and regional anesthesiology division at Duke University Medical Center, Durham, N.C., agreed, noting that much has changed since some of the older studies in the analysis, that date back to 2010.

“A fascia iliaca block done in 2022 looks a lot different than it did in 2012, and we would expect it to be more consistent, reliable and longer-lasting with current techniques and technology,” he said in an interview. “So, if anything, I would expect the findings of this analysis to undersell the benefits of peripheral nerve blocks in this population.”

Although the quality of evidence in the meta-analysis is described as “low,” the downsides of the procedures are few, and “the potential benefits [of ultrasound-guided peripheral nerve blocks] are just too good to ignore,” Dr. Gadsden emphasized.

“If we can avoid or reduce opioids in this population and at the same time reduce the acute pain from the injury, there is no question that the incidence of delirium will go down,” he said. “Delirium is associated with a number of poor outcomes following hip fracture, including increased mortality.

“The bottom line is that the risk/benefit ratio is so far in favor of performing the blocks that even in the face of ‘modest’ levels of evidence, we should all be doing these.”

The authors, Dr. Haskins, and Dr. Gadsden had no disclosures relating to the study to report.

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

Ultrasound-guided nerve blocks for preoperative pain management after hip fracture provide improvements over conventional anesthesia including greater pain reduction and fewer adverse events, results from a meta-analysis published in BMC Anesthesiology show.

With the caveat that the quality of evidence in most trials in the analysis is low owing to a lack of blinding and other factors, “our review suggests that, among patients suffering from a hip fracture, a preoperative ultrasound-guided peripheral nerve block is associated with a significant pain reduction and reduced need for systemic analgesics compared to conventional analgesia,” reported the authors.

“Our results may also indicate a lower risk of delirium, serious adverse events and higher patient satisfaction in patients receiving an ultrasound-guided peripheral nerve block,” they added.

Because hip fractures commonly affect older populations and those who are frail, treatment of the substantial pain that can occur perioperatively is a challenge.

Peripheral nerve blocks have been shown to reduce pain within 30 minutes of the block placement; however, most studies have primarily included blocks that use anatomic landmarks or nerve stimulation for guidance. However, the use of ultrasound guidance with the nerve block should improve efficacy, the authors noted.

“It seems intuitive that using ultrasound-guidance should be more effective than using a blind technique, since it allows a trained physician to deposit the local anesthetic with much more precision,” they wrote.

To evaluate the data from studies that have looked at ultrasound-guided peripheral nerve blocks, Oskar Wilborg Exsteen, of the department of anesthesiology and intensive care, Copenhagen University Hospital and Nordsjællands Hospital, Hillerød, Denmark, and colleagues identified 12 randomized controlled trials, involving a combined total of 976 participants, for the meta-analysis.

The studies included 509 participants who received ultrasound-guided peripheral nerve blocks, specifically the femoral nerve block and fascia iliaca block, and 476 who were randomly assigned to control groups.

Overall, those treated with the nerve blocks showed significantly greater reductions in pain measured closest to 2 hours of block placement, compared with conventional analgesia, with a mean reduction of 2.26 points on the Visual Analogue Scale (VAS) (range, 0-10; P < .001).

Ultrasound-guided peripheral nerve block use was associated with lower preoperative usage of analgesic intravenous morphine equivalents in milligram, reported in four of the trials (random effects model mean difference, –5.34; P = .003).

Delirium was also significantly lower with the nerve blocks (risk ratio, 0.6; P = 0.03), as were serious adverse events, compared with standard analgesia (RR, 0.33; P = .006), whereas patient satisfaction was significantly higher with the nerve blocks (mean VAS difference, 25.9 [score 0-100]; P < .001).

Seven of the studies had monitored for serious adverse events or complications related to the nerve blocks, but none reported any complications directly related to the ultrasound-guided peripheral nerve blocks.

Owing to the inability to conduct blinded comparisons, clinical heterogeneity, and other caveats, the quality of evidence was ultimately judged to be “low” or “very low”; however, the observed benefits are nevertheless relevant, the authors concluded.

“Despite the low quality of evidence, ultrasound-guided blocks were associated with benefits compared to conventional systemic analgesia,” they said.

Key caveats include that the morphine reductions observed with the nerve blocks were not substantial, they noted. “The opioid-sparing effect seems small and may be of less clinical importance.” The decreases in opioid consumption, as well as pain reduction in the analysis, are in fact similar to those observed with conventional, peripheral nerve blocks that did not use ultrasound guidance, compared with standard pain management.

No trials were identified that directly compared ultrasound-guided peripheral nerve blocks with nerve block techniques that didn’t use ultrasound.

However, the other noted improvements carry more weight, the authors said.

“The potential for higher patient satisfaction and reduction in serious adverse events and delirium may be of clinical importance,” they wrote.
 

Ultrasound-guided peripheral nerve blocks not always accessible

Of note, the use of ultrasound-guided peripheral nerve blocks appears to be somewhat low, with one observational trend study of national data in the United States showing that, among patients receiving a peripheral nerve block for hip arthroplasty, only 3.2% of the procedures were performed using ultrasound guidance.

Stephen C. Haskins, MD, a coauthor on that study, said that the low utilization underscores that, in real-world practice, an ultrasound-guided approach isn’t always convenient.

“I think our findings demonstrate a common misconception that exists for those of us that work at academic institutions and/or within the ivory towers of regional anesthesia, which is that everyone is performing cutting edge ultrasound-guided techniques for all procedures,” Dr. Haskins, an associate attending anesthesiologist and chief medical diversity officer with the department of anesthesiology, critical care & pain management at the Hospital for Special Surgery in New York, said in an interview.

However, “there are many limitations to use of ultrasound for these blocks, including limited access to machines, limited access to training, and limited interest and support from our surgical colleagues,” he explained.

“Ultimately, the best nerve block is the one performed in a timely and successful fashion, regardless of technique,” he said. “But we will continue to see a trend towards ultrasound use in the future due to increasing access in the form of portability and affordability.”

Haskins noted that newer ultrasound-guided nerve blocks that were not reviewed in the study, such as the pericapsular nerve group block, regional block, and supra-inguinal fascia iliaca block, which provide additional benefits such as avoiding quadriceps weakness.

Jeff Gadsden, MD, chief of the orthopedics, plastic, and regional anesthesiology division at Duke University Medical Center, Durham, N.C., agreed, noting that much has changed since some of the older studies in the analysis, that date back to 2010.

“A fascia iliaca block done in 2022 looks a lot different than it did in 2012, and we would expect it to be more consistent, reliable and longer-lasting with current techniques and technology,” he said in an interview. “So, if anything, I would expect the findings of this analysis to undersell the benefits of peripheral nerve blocks in this population.”

Although the quality of evidence in the meta-analysis is described as “low,” the downsides of the procedures are few, and “the potential benefits [of ultrasound-guided peripheral nerve blocks] are just too good to ignore,” Dr. Gadsden emphasized.

“If we can avoid or reduce opioids in this population and at the same time reduce the acute pain from the injury, there is no question that the incidence of delirium will go down,” he said. “Delirium is associated with a number of poor outcomes following hip fracture, including increased mortality.

“The bottom line is that the risk/benefit ratio is so far in favor of performing the blocks that even in the face of ‘modest’ levels of evidence, we should all be doing these.”

The authors, Dr. Haskins, and Dr. Gadsden had no disclosures relating to the study to report.

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

Ultrasound-guided nerve blocks for preoperative pain management after hip fracture provide improvements over conventional anesthesia including greater pain reduction and fewer adverse events, results from a meta-analysis published in BMC Anesthesiology show.

With the caveat that the quality of evidence in most trials in the analysis is low owing to a lack of blinding and other factors, “our review suggests that, among patients suffering from a hip fracture, a preoperative ultrasound-guided peripheral nerve block is associated with a significant pain reduction and reduced need for systemic analgesics compared to conventional analgesia,” reported the authors.

“Our results may also indicate a lower risk of delirium, serious adverse events and higher patient satisfaction in patients receiving an ultrasound-guided peripheral nerve block,” they added.

Because hip fractures commonly affect older populations and those who are frail, treatment of the substantial pain that can occur perioperatively is a challenge.

Peripheral nerve blocks have been shown to reduce pain within 30 minutes of the block placement; however, most studies have primarily included blocks that use anatomic landmarks or nerve stimulation for guidance. However, the use of ultrasound guidance with the nerve block should improve efficacy, the authors noted.

“It seems intuitive that using ultrasound-guidance should be more effective than using a blind technique, since it allows a trained physician to deposit the local anesthetic with much more precision,” they wrote.

To evaluate the data from studies that have looked at ultrasound-guided peripheral nerve blocks, Oskar Wilborg Exsteen, of the department of anesthesiology and intensive care, Copenhagen University Hospital and Nordsjællands Hospital, Hillerød, Denmark, and colleagues identified 12 randomized controlled trials, involving a combined total of 976 participants, for the meta-analysis.

The studies included 509 participants who received ultrasound-guided peripheral nerve blocks, specifically the femoral nerve block and fascia iliaca block, and 476 who were randomly assigned to control groups.

Overall, those treated with the nerve blocks showed significantly greater reductions in pain measured closest to 2 hours of block placement, compared with conventional analgesia, with a mean reduction of 2.26 points on the Visual Analogue Scale (VAS) (range, 0-10; P < .001).

Ultrasound-guided peripheral nerve block use was associated with lower preoperative usage of analgesic intravenous morphine equivalents in milligram, reported in four of the trials (random effects model mean difference, –5.34; P = .003).

Delirium was also significantly lower with the nerve blocks (risk ratio, 0.6; P = 0.03), as were serious adverse events, compared with standard analgesia (RR, 0.33; P = .006), whereas patient satisfaction was significantly higher with the nerve blocks (mean VAS difference, 25.9 [score 0-100]; P < .001).

Seven of the studies had monitored for serious adverse events or complications related to the nerve blocks, but none reported any complications directly related to the ultrasound-guided peripheral nerve blocks.

Owing to the inability to conduct blinded comparisons, clinical heterogeneity, and other caveats, the quality of evidence was ultimately judged to be “low” or “very low”; however, the observed benefits are nevertheless relevant, the authors concluded.

“Despite the low quality of evidence, ultrasound-guided blocks were associated with benefits compared to conventional systemic analgesia,” they said.

Key caveats include that the morphine reductions observed with the nerve blocks were not substantial, they noted. “The opioid-sparing effect seems small and may be of less clinical importance.” The decreases in opioid consumption, as well as pain reduction in the analysis, are in fact similar to those observed with conventional, peripheral nerve blocks that did not use ultrasound guidance, compared with standard pain management.

No trials were identified that directly compared ultrasound-guided peripheral nerve blocks with nerve block techniques that didn’t use ultrasound.

However, the other noted improvements carry more weight, the authors said.

“The potential for higher patient satisfaction and reduction in serious adverse events and delirium may be of clinical importance,” they wrote.
 

Ultrasound-guided peripheral nerve blocks not always accessible

Of note, the use of ultrasound-guided peripheral nerve blocks appears to be somewhat low, with one observational trend study of national data in the United States showing that, among patients receiving a peripheral nerve block for hip arthroplasty, only 3.2% of the procedures were performed using ultrasound guidance.

Stephen C. Haskins, MD, a coauthor on that study, said that the low utilization underscores that, in real-world practice, an ultrasound-guided approach isn’t always convenient.

“I think our findings demonstrate a common misconception that exists for those of us that work at academic institutions and/or within the ivory towers of regional anesthesia, which is that everyone is performing cutting edge ultrasound-guided techniques for all procedures,” Dr. Haskins, an associate attending anesthesiologist and chief medical diversity officer with the department of anesthesiology, critical care & pain management at the Hospital for Special Surgery in New York, said in an interview.

However, “there are many limitations to use of ultrasound for these blocks, including limited access to machines, limited access to training, and limited interest and support from our surgical colleagues,” he explained.

“Ultimately, the best nerve block is the one performed in a timely and successful fashion, regardless of technique,” he said. “But we will continue to see a trend towards ultrasound use in the future due to increasing access in the form of portability and affordability.”

Haskins noted that newer ultrasound-guided nerve blocks that were not reviewed in the study, such as the pericapsular nerve group block, regional block, and supra-inguinal fascia iliaca block, which provide additional benefits such as avoiding quadriceps weakness.

Jeff Gadsden, MD, chief of the orthopedics, plastic, and regional anesthesiology division at Duke University Medical Center, Durham, N.C., agreed, noting that much has changed since some of the older studies in the analysis, that date back to 2010.

“A fascia iliaca block done in 2022 looks a lot different than it did in 2012, and we would expect it to be more consistent, reliable and longer-lasting with current techniques and technology,” he said in an interview. “So, if anything, I would expect the findings of this analysis to undersell the benefits of peripheral nerve blocks in this population.”

Although the quality of evidence in the meta-analysis is described as “low,” the downsides of the procedures are few, and “the potential benefits [of ultrasound-guided peripheral nerve blocks] are just too good to ignore,” Dr. Gadsden emphasized.

“If we can avoid or reduce opioids in this population and at the same time reduce the acute pain from the injury, there is no question that the incidence of delirium will go down,” he said. “Delirium is associated with a number of poor outcomes following hip fracture, including increased mortality.

“The bottom line is that the risk/benefit ratio is so far in favor of performing the blocks that even in the face of ‘modest’ levels of evidence, we should all be doing these.”

The authors, Dr. Haskins, and Dr. Gadsden had no disclosures relating to the study to report.

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

New research provides novel insight into how mindfulness alters pain-related activity in the brain, in findings that point to more targeted pain management.

In a randomized trial, more than 100 healthy individuals were assigned to an 8-week mindfulness-based stress reduction (MBSR) program, a health improvement program (HEP) of the same length, or a waiting list.

Scanning participants’ brains during a heat-based stimulus pain task showed those who completed the MBSR had a reduction in a brain signature linked to the sensory intensity of pain.

A complex condition

Dr. Wielgosz told this news organization that pain is “complex,” with multiple stages and several phases between the time signals are sent from pain receptors and the experience of pain.

“The way that mindfulness affects pain processing has more to do with the way the brain interprets pain signals.”

The investigators note that understanding the neurocognitive mechanisms underlying the efficacy of nonpharmacologic pain interventions is a “high-priority objective for improving pain treatment.”

Evidence from brief laboratory interventions and cross-sectional studies suggests that mindfulness training is associated with alterations in both sensory processing and cognitive-emotional regulatory networks, the investigators note.

“However, no such study has yet been conducted on a standardized, full-length, and widely used clinical intervention, such as MBSR,” they add.
 

Thermal pain task

The randomized, active-control trial included 115 healthy, meditation-naive individuals (61.7% women; average age, 48.3 years). Just over half (58%) had a graduate degree and their mean score on the Hollingshead index was 58.3, indicting a higher socioeconomic status.

All were randomly assigned to an 8-week MBSR course, an 8-week HEP course as an active control group, or a waiting-list control group with no intervention.

The MBSR involved instruction and practice in continuous focused attention on the breath, bodily sensations, and mental content while in seated postures, walking, and doing yoga.

The HEP matched the MBSR in terms of its length, structure, and nonspecific therapeutic elements, which included a supportive group atmosphere, expert instruction, and positive expectancy for benefit.

To examine the interventions’ effect on the pain experience, participants underwent a pain task in which they had 20 thermal stimuli applied to the inside of the left wrist for 12 seconds, including 8 seconds at peak temperature.

The stimuli were separated by a distractor task and intervals for cued anticipation, recovery, and subjective ratings of intensity and unpleasantness on a scale of 0-20.

During the task, participants underwent MRI to assess the neurologic pain signature (NPS) and the stimulus intensity independent pain signature-1 (SIIPS-1) within the brain.

The NPS is activated by various types of pain stimuli, while responding minimally or not at all to “emotionally evocative stimuli” relating to pain or to placebo treatment, the researchers note.

In contrast, the SIIPS-1 is activated in response to aspects of pain unrelated to the stimulus itself. It incorporates a “broader range of cognitive and emotional modulatory circuits,” including those related to expectancy and cognitive processes to modulate the pain experience.
 

Neural signatures

Results showed that in all groups, age was significantly negatively associated with both NPS (P = .001) and SIIPS-1 response (P < .001), although not subjective pain reports, and was subsequently included in all analyses of neural signatures.

Persons in the MBSR group had a significant decrease in the NPS, compared with those in the HEP group (P = .05), and from pre- to postintervention assessments (P = .023).

Those in the MBSR group also had “marginal” decreases in the NPS vs. the waiting list group (P = .096), and in the SIIPS-1 relative to both the HEP (P = .089) and waiting list groups (P = .087).

In subjective pain ratings, the MBSR group showed a marginal decrease, compared with the waiting list group (P = .078), and from the pre- to postintervention assessments (P = .028).

The HEP group also had marginal decreases in pain unpleasantness vs. the waiting list group (P = .043), and from the pre- to postintervention assessments for pain intensity (P = .046) and unpleasantness (P = .007).

The researchers also assessed 30 long-term meditators who had undertaken at least 3 years of formal experience with meditation, including participating in multiple intensive retreats and ongoing daily practice, and compared them with meditation-naive individuals.

Long-term meditators reported significantly less pain intensity and unpleasantness than those who had not undergone the training (P < .001).

In addition, a higher number of practice hours during a retreat was linked to a greater reduction in pain ratings. This association remained even after adjustment for gender and respiration rate.

However, the number of daily practice hours was not significantly associated with pain ratings among long-term meditators.

Although there were no average differences in neural signature responses between long-term meditators and individuals who were naive to the technique, there was an inverse relationship between hours on retreat and SIIPS-1 response (P = .027).
 

‘We’re seeing the biology change’

Commenting for this news organization, Fadel Zeidan, PhD, associate professor of anesthesiology, University of California, San Diego, said that in attenuating the experience of pain, mindfulness engages “very novel” mechanisms.

However, the “most remarkable thing about this study” is that the pain effect occurred when the participants were not meditating, “which gives rise to the notion that mental training is just like physical training,” said Dr. Zeidan, who was not involved with the research.

He noted that the notion was not appreciated previously, “because we weren’t able to see the changes,” as they were based on self-report alone.

However, combining those reports with brain imaging and other objective methods means that “we’re actually seeing the biology change,” Dr. Zeidan said.

He added that mindfulness is different from other techniques for modulating the pain experience, because it is self-facilitated.

“People can learn this technique, ideally, for free online. They can learn the recipe, and it’s one of the only techniques out there that can be used immediately to assuage one’s own pain,” he said.

“There’s nothing else out there on this planet that could immediately reduce one’s own pain. You have to wait 45 minutes for Tylenol, distraction can only work for so long, and you can’t really placebo yourself,” Dr. Zeidan added.

The study was funded by a National Center for Complementary and Alternative Medicine grant, National Institute of Mental Health grants, a Fetzer Institute grant, and a John Templeton Foundation grant, as well as a core grant to the Waisman Center from the National Institute of Child Health and Human Development to Albee Messing. Dr. Wielgosz and Dr. Zeidan have reported no relevant financial relationships. Disclosures for the coinvestigators are listed in the original article.

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

New research provides novel insight into how mindfulness alters pain-related activity in the brain, in findings that point to more targeted pain management.

In a randomized trial, more than 100 healthy individuals were assigned to an 8-week mindfulness-based stress reduction (MBSR) program, a health improvement program (HEP) of the same length, or a waiting list.

Scanning participants’ brains during a heat-based stimulus pain task showed those who completed the MBSR had a reduction in a brain signature linked to the sensory intensity of pain.

A complex condition

Dr. Wielgosz told this news organization that pain is “complex,” with multiple stages and several phases between the time signals are sent from pain receptors and the experience of pain.

“The way that mindfulness affects pain processing has more to do with the way the brain interprets pain signals.”

The investigators note that understanding the neurocognitive mechanisms underlying the efficacy of nonpharmacologic pain interventions is a “high-priority objective for improving pain treatment.”

Evidence from brief laboratory interventions and cross-sectional studies suggests that mindfulness training is associated with alterations in both sensory processing and cognitive-emotional regulatory networks, the investigators note.

“However, no such study has yet been conducted on a standardized, full-length, and widely used clinical intervention, such as MBSR,” they add.
 

Thermal pain task

The randomized, active-control trial included 115 healthy, meditation-naive individuals (61.7% women; average age, 48.3 years). Just over half (58%) had a graduate degree and their mean score on the Hollingshead index was 58.3, indicting a higher socioeconomic status.

All were randomly assigned to an 8-week MBSR course, an 8-week HEP course as an active control group, or a waiting-list control group with no intervention.

The MBSR involved instruction and practice in continuous focused attention on the breath, bodily sensations, and mental content while in seated postures, walking, and doing yoga.

The HEP matched the MBSR in terms of its length, structure, and nonspecific therapeutic elements, which included a supportive group atmosphere, expert instruction, and positive expectancy for benefit.

To examine the interventions’ effect on the pain experience, participants underwent a pain task in which they had 20 thermal stimuli applied to the inside of the left wrist for 12 seconds, including 8 seconds at peak temperature.

The stimuli were separated by a distractor task and intervals for cued anticipation, recovery, and subjective ratings of intensity and unpleasantness on a scale of 0-20.

During the task, participants underwent MRI to assess the neurologic pain signature (NPS) and the stimulus intensity independent pain signature-1 (SIIPS-1) within the brain.

The NPS is activated by various types of pain stimuli, while responding minimally or not at all to “emotionally evocative stimuli” relating to pain or to placebo treatment, the researchers note.

In contrast, the SIIPS-1 is activated in response to aspects of pain unrelated to the stimulus itself. It incorporates a “broader range of cognitive and emotional modulatory circuits,” including those related to expectancy and cognitive processes to modulate the pain experience.
 

Neural signatures

Results showed that in all groups, age was significantly negatively associated with both NPS (P = .001) and SIIPS-1 response (P < .001), although not subjective pain reports, and was subsequently included in all analyses of neural signatures.

Persons in the MBSR group had a significant decrease in the NPS, compared with those in the HEP group (P = .05), and from pre- to postintervention assessments (P = .023).

Those in the MBSR group also had “marginal” decreases in the NPS vs. the waiting list group (P = .096), and in the SIIPS-1 relative to both the HEP (P = .089) and waiting list groups (P = .087).

In subjective pain ratings, the MBSR group showed a marginal decrease, compared with the waiting list group (P = .078), and from the pre- to postintervention assessments (P = .028).

The HEP group also had marginal decreases in pain unpleasantness vs. the waiting list group (P = .043), and from the pre- to postintervention assessments for pain intensity (P = .046) and unpleasantness (P = .007).

The researchers also assessed 30 long-term meditators who had undertaken at least 3 years of formal experience with meditation, including participating in multiple intensive retreats and ongoing daily practice, and compared them with meditation-naive individuals.

Long-term meditators reported significantly less pain intensity and unpleasantness than those who had not undergone the training (P < .001).

In addition, a higher number of practice hours during a retreat was linked to a greater reduction in pain ratings. This association remained even after adjustment for gender and respiration rate.

However, the number of daily practice hours was not significantly associated with pain ratings among long-term meditators.

Although there were no average differences in neural signature responses between long-term meditators and individuals who were naive to the technique, there was an inverse relationship between hours on retreat and SIIPS-1 response (P = .027).
 

‘We’re seeing the biology change’

Commenting for this news organization, Fadel Zeidan, PhD, associate professor of anesthesiology, University of California, San Diego, said that in attenuating the experience of pain, mindfulness engages “very novel” mechanisms.

However, the “most remarkable thing about this study” is that the pain effect occurred when the participants were not meditating, “which gives rise to the notion that mental training is just like physical training,” said Dr. Zeidan, who was not involved with the research.

He noted that the notion was not appreciated previously, “because we weren’t able to see the changes,” as they were based on self-report alone.

However, combining those reports with brain imaging and other objective methods means that “we’re actually seeing the biology change,” Dr. Zeidan said.

He added that mindfulness is different from other techniques for modulating the pain experience, because it is self-facilitated.

“People can learn this technique, ideally, for free online. They can learn the recipe, and it’s one of the only techniques out there that can be used immediately to assuage one’s own pain,” he said.

“There’s nothing else out there on this planet that could immediately reduce one’s own pain. You have to wait 45 minutes for Tylenol, distraction can only work for so long, and you can’t really placebo yourself,” Dr. Zeidan added.

The study was funded by a National Center for Complementary and Alternative Medicine grant, National Institute of Mental Health grants, a Fetzer Institute grant, and a John Templeton Foundation grant, as well as a core grant to the Waisman Center from the National Institute of Child Health and Human Development to Albee Messing. Dr. Wielgosz and Dr. Zeidan have reported no relevant financial relationships. Disclosures for the coinvestigators are listed in the original article.

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

New research provides novel insight into how mindfulness alters pain-related activity in the brain, in findings that point to more targeted pain management.

In a randomized trial, more than 100 healthy individuals were assigned to an 8-week mindfulness-based stress reduction (MBSR) program, a health improvement program (HEP) of the same length, or a waiting list.

Scanning participants’ brains during a heat-based stimulus pain task showed those who completed the MBSR had a reduction in a brain signature linked to the sensory intensity of pain.

A complex condition

Dr. Wielgosz told this news organization that pain is “complex,” with multiple stages and several phases between the time signals are sent from pain receptors and the experience of pain.

“The way that mindfulness affects pain processing has more to do with the way the brain interprets pain signals.”

The investigators note that understanding the neurocognitive mechanisms underlying the efficacy of nonpharmacologic pain interventions is a “high-priority objective for improving pain treatment.”

Evidence from brief laboratory interventions and cross-sectional studies suggests that mindfulness training is associated with alterations in both sensory processing and cognitive-emotional regulatory networks, the investigators note.

“However, no such study has yet been conducted on a standardized, full-length, and widely used clinical intervention, such as MBSR,” they add.
 

Thermal pain task

The randomized, active-control trial included 115 healthy, meditation-naive individuals (61.7% women; average age, 48.3 years). Just over half (58%) had a graduate degree and their mean score on the Hollingshead index was 58.3, indicting a higher socioeconomic status.

All were randomly assigned to an 8-week MBSR course, an 8-week HEP course as an active control group, or a waiting-list control group with no intervention.

The MBSR involved instruction and practice in continuous focused attention on the breath, bodily sensations, and mental content while in seated postures, walking, and doing yoga.

The HEP matched the MBSR in terms of its length, structure, and nonspecific therapeutic elements, which included a supportive group atmosphere, expert instruction, and positive expectancy for benefit.

To examine the interventions’ effect on the pain experience, participants underwent a pain task in which they had 20 thermal stimuli applied to the inside of the left wrist for 12 seconds, including 8 seconds at peak temperature.

The stimuli were separated by a distractor task and intervals for cued anticipation, recovery, and subjective ratings of intensity and unpleasantness on a scale of 0-20.

During the task, participants underwent MRI to assess the neurologic pain signature (NPS) and the stimulus intensity independent pain signature-1 (SIIPS-1) within the brain.

The NPS is activated by various types of pain stimuli, while responding minimally or not at all to “emotionally evocative stimuli” relating to pain or to placebo treatment, the researchers note.

In contrast, the SIIPS-1 is activated in response to aspects of pain unrelated to the stimulus itself. It incorporates a “broader range of cognitive and emotional modulatory circuits,” including those related to expectancy and cognitive processes to modulate the pain experience.
 

Neural signatures

Results showed that in all groups, age was significantly negatively associated with both NPS (P = .001) and SIIPS-1 response (P < .001), although not subjective pain reports, and was subsequently included in all analyses of neural signatures.

Persons in the MBSR group had a significant decrease in the NPS, compared with those in the HEP group (P = .05), and from pre- to postintervention assessments (P = .023).

Those in the MBSR group also had “marginal” decreases in the NPS vs. the waiting list group (P = .096), and in the SIIPS-1 relative to both the HEP (P = .089) and waiting list groups (P = .087).

In subjective pain ratings, the MBSR group showed a marginal decrease, compared with the waiting list group (P = .078), and from the pre- to postintervention assessments (P = .028).

The HEP group also had marginal decreases in pain unpleasantness vs. the waiting list group (P = .043), and from the pre- to postintervention assessments for pain intensity (P = .046) and unpleasantness (P = .007).

The researchers also assessed 30 long-term meditators who had undertaken at least 3 years of formal experience with meditation, including participating in multiple intensive retreats and ongoing daily practice, and compared them with meditation-naive individuals.

Long-term meditators reported significantly less pain intensity and unpleasantness than those who had not undergone the training (P < .001).

In addition, a higher number of practice hours during a retreat was linked to a greater reduction in pain ratings. This association remained even after adjustment for gender and respiration rate.

However, the number of daily practice hours was not significantly associated with pain ratings among long-term meditators.

Although there were no average differences in neural signature responses between long-term meditators and individuals who were naive to the technique, there was an inverse relationship between hours on retreat and SIIPS-1 response (P = .027).
 

‘We’re seeing the biology change’

Commenting for this news organization, Fadel Zeidan, PhD, associate professor of anesthesiology, University of California, San Diego, said that in attenuating the experience of pain, mindfulness engages “very novel” mechanisms.

However, the “most remarkable thing about this study” is that the pain effect occurred when the participants were not meditating, “which gives rise to the notion that mental training is just like physical training,” said Dr. Zeidan, who was not involved with the research.

He noted that the notion was not appreciated previously, “because we weren’t able to see the changes,” as they were based on self-report alone.

However, combining those reports with brain imaging and other objective methods means that “we’re actually seeing the biology change,” Dr. Zeidan said.

He added that mindfulness is different from other techniques for modulating the pain experience, because it is self-facilitated.

“People can learn this technique, ideally, for free online. They can learn the recipe, and it’s one of the only techniques out there that can be used immediately to assuage one’s own pain,” he said.

“There’s nothing else out there on this planet that could immediately reduce one’s own pain. You have to wait 45 minutes for Tylenol, distraction can only work for so long, and you can’t really placebo yourself,” Dr. Zeidan added.

The study was funded by a National Center for Complementary and Alternative Medicine grant, National Institute of Mental Health grants, a Fetzer Institute grant, and a John Templeton Foundation grant, as well as a core grant to the Waisman Center from the National Institute of Child Health and Human Development to Albee Messing. Dr. Wielgosz and Dr. Zeidan have reported no relevant financial relationships. Disclosures for the coinvestigators are listed in the original article.

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

I’m pretty sure my ancestors came from Europe. And, as far as I know, I have no relatives in Australia. But, I must have some cosmic relationship with the Land Down Under because as I review articles for these columns I have an uncanny attraction to those coming out of Australia. Most of them are about sleep, one of my obsessions, and in general they address simple questions that no one has thought to ask.

My most recent Australia-based nugget appeared in the August edition of Pediatrics.

The researchers in Sidney were seeking to define “growing pains” by embarking on an extensive review of the medical literature. Beginning with thousands of articles, they winnowed these down to 145 studies. They found “there was extremely poor consensus between studies.” The most consistent components were the lower limb, bilaterality, evening onset, a normal physical assessment, and an episodic or recurrent course. However, all of these factors were mentioned in 50% or less of the articles they reviewed. The investigators wisely concluded that clinicians “should be wary of relying on the diagnosis to direct treatment decisions.”

This may seem like one small step for pediatrics. You may have reassured parents that none of your patients ever died of “growing pains” and the condition would eventually resolve. Hopefully, you were correct and that your case rate fatality is zero. But I suspect it wouldn’t take too long to unearth a wealth of malpractices cases in which another pediatrician’s patient died with an illness whose eventual discovery was tragically delayed by a period of false reassurance and diagnosis that the child merely had growing pains.

I can’t remember which of my sage instructors told me to never use “growing pains” as a diagnosis. It may have just been something I stumbled upon as my clinical experience grew. While holding firm to my commitment to never use it as a diagnosis, it became abundantly clear that I was seeing a large group of children (toddlers to early adolescents) who were experiencing lower leg pains in the early evening, often bad enough to wake them.

It took a bit longer to discover that most often these painful episodes occurred in children who were acutely or chronically sleep deprived. Occasionally, the pain would come on days in which the child had been unusually physically active. However, in most cases there was little correlation with lower limb activity.

I will admit that my observations were colored by my growing obsession that sleep deprivation is the root of many evils, including the phenomenon known as attention-deficit/hyperactivity disorder. I was even bold enough to include it in my one of the books I have written (Is My Child Overtired? Simon & Schuster, 2001). Nonetheless, I am still convinced that every investigation of a child with evening leg pains should include a thorough history of the child’s sleep history.

The bottom line is that these Australian researchers have done us a great favor with their research. However, I think they should have made a bolder statement in their conclusion. It is clear to me that “growing pains” should be removed as a diagnosis and no longer be reimbursed by third-party payers.

The void created by that action should spur some research into a better-defined diagnosis of the condition. If you want to use my tack and label it “nocturnal leg pains of childhood” and suggest better sleep hygiene, I will be flattered. But more importantly, take the time to take a good history, do a thorough exam, and then follow up, follow up, follow up, until the problem resolves.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I’m pretty sure my ancestors came from Europe. And, as far as I know, I have no relatives in Australia. But, I must have some cosmic relationship with the Land Down Under because as I review articles for these columns I have an uncanny attraction to those coming out of Australia. Most of them are about sleep, one of my obsessions, and in general they address simple questions that no one has thought to ask.

My most recent Australia-based nugget appeared in the August edition of Pediatrics.

The researchers in Sidney were seeking to define “growing pains” by embarking on an extensive review of the medical literature. Beginning with thousands of articles, they winnowed these down to 145 studies. They found “there was extremely poor consensus between studies.” The most consistent components were the lower limb, bilaterality, evening onset, a normal physical assessment, and an episodic or recurrent course. However, all of these factors were mentioned in 50% or less of the articles they reviewed. The investigators wisely concluded that clinicians “should be wary of relying on the diagnosis to direct treatment decisions.”

This may seem like one small step for pediatrics. You may have reassured parents that none of your patients ever died of “growing pains” and the condition would eventually resolve. Hopefully, you were correct and that your case rate fatality is zero. But I suspect it wouldn’t take too long to unearth a wealth of malpractices cases in which another pediatrician’s patient died with an illness whose eventual discovery was tragically delayed by a period of false reassurance and diagnosis that the child merely had growing pains.

I can’t remember which of my sage instructors told me to never use “growing pains” as a diagnosis. It may have just been something I stumbled upon as my clinical experience grew. While holding firm to my commitment to never use it as a diagnosis, it became abundantly clear that I was seeing a large group of children (toddlers to early adolescents) who were experiencing lower leg pains in the early evening, often bad enough to wake them.

It took a bit longer to discover that most often these painful episodes occurred in children who were acutely or chronically sleep deprived. Occasionally, the pain would come on days in which the child had been unusually physically active. However, in most cases there was little correlation with lower limb activity.

I will admit that my observations were colored by my growing obsession that sleep deprivation is the root of many evils, including the phenomenon known as attention-deficit/hyperactivity disorder. I was even bold enough to include it in my one of the books I have written (Is My Child Overtired? Simon & Schuster, 2001). Nonetheless, I am still convinced that every investigation of a child with evening leg pains should include a thorough history of the child’s sleep history.

The bottom line is that these Australian researchers have done us a great favor with their research. However, I think they should have made a bolder statement in their conclusion. It is clear to me that “growing pains” should be removed as a diagnosis and no longer be reimbursed by third-party payers.

The void created by that action should spur some research into a better-defined diagnosis of the condition. If you want to use my tack and label it “nocturnal leg pains of childhood” and suggest better sleep hygiene, I will be flattered. But more importantly, take the time to take a good history, do a thorough exam, and then follow up, follow up, follow up, until the problem resolves.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I’m pretty sure my ancestors came from Europe. And, as far as I know, I have no relatives in Australia. But, I must have some cosmic relationship with the Land Down Under because as I review articles for these columns I have an uncanny attraction to those coming out of Australia. Most of them are about sleep, one of my obsessions, and in general they address simple questions that no one has thought to ask.

My most recent Australia-based nugget appeared in the August edition of Pediatrics.

The researchers in Sidney were seeking to define “growing pains” by embarking on an extensive review of the medical literature. Beginning with thousands of articles, they winnowed these down to 145 studies. They found “there was extremely poor consensus between studies.” The most consistent components were the lower limb, bilaterality, evening onset, a normal physical assessment, and an episodic or recurrent course. However, all of these factors were mentioned in 50% or less of the articles they reviewed. The investigators wisely concluded that clinicians “should be wary of relying on the diagnosis to direct treatment decisions.”

This may seem like one small step for pediatrics. You may have reassured parents that none of your patients ever died of “growing pains” and the condition would eventually resolve. Hopefully, you were correct and that your case rate fatality is zero. But I suspect it wouldn’t take too long to unearth a wealth of malpractices cases in which another pediatrician’s patient died with an illness whose eventual discovery was tragically delayed by a period of false reassurance and diagnosis that the child merely had growing pains.

I can’t remember which of my sage instructors told me to never use “growing pains” as a diagnosis. It may have just been something I stumbled upon as my clinical experience grew. While holding firm to my commitment to never use it as a diagnosis, it became abundantly clear that I was seeing a large group of children (toddlers to early adolescents) who were experiencing lower leg pains in the early evening, often bad enough to wake them.

It took a bit longer to discover that most often these painful episodes occurred in children who were acutely or chronically sleep deprived. Occasionally, the pain would come on days in which the child had been unusually physically active. However, in most cases there was little correlation with lower limb activity.

I will admit that my observations were colored by my growing obsession that sleep deprivation is the root of many evils, including the phenomenon known as attention-deficit/hyperactivity disorder. I was even bold enough to include it in my one of the books I have written (Is My Child Overtired? Simon & Schuster, 2001). Nonetheless, I am still convinced that every investigation of a child with evening leg pains should include a thorough history of the child’s sleep history.

The bottom line is that these Australian researchers have done us a great favor with their research. However, I think they should have made a bolder statement in their conclusion. It is clear to me that “growing pains” should be removed as a diagnosis and no longer be reimbursed by third-party payers.

The void created by that action should spur some research into a better-defined diagnosis of the condition. If you want to use my tack and label it “nocturnal leg pains of childhood” and suggest better sleep hygiene, I will be flattered. But more importantly, take the time to take a good history, do a thorough exam, and then follow up, follow up, follow up, until the problem resolves.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Just about every child hears it growing up: An ache in the leg? “Growing pains.” A dull pain in the side? “Growing pains.”

The catch-all phrase for random pains that children and teens have is so common that it even inspired the name of a 1980s sitcom. Yet when scientists dug into the evidence to find out what growing pains actually are, they found out that no one really knows. The definitions were as random and all over the place as the very pains that kids complain about, the researchers report in the journal Pediatrics.

Although some studies have suggested that up to a third of children have growing pains, the term has long seemed more like folk medicine than an actual medical diagnosis. Even so, parents, teachers, and doctors frequently use it when they have no other obvious answer to a particular pain a child or teen might describe.

A group of researchers at the University of Sydney in Australia wanted to find out if there was any research offering a more precise definition or criteria. They combed through eight databases for any papers that mentioned growing pains or growth pains in children or adolescents. They found 145 studies and set out to look for common ground: Where do growing pains occur? At what age do they start? Are there any patterns? Risk factors? Common clinical features? Relationships to particular activities?

What they found was that there is “no consensus whatsoever as to what growing pains really are, what they mean, how they’re defined, and how they should be diagnosed,” coauthor Steven J. Kamper, PhD, explained in a video about the findings. “The definitions were really variable, really vague, and sometimes downright contradictory,” he said. “Some studies would suggest growing pains happen in the arms, some in the lower limbs only. Some said it was about muscles, some about joints.”

The closest thing to consistency that they found was that exactly half the studies mentioned the pain being in the lower limbs. Nearly half (48%) described it as happening in the evening or nighttime, 42% said it was recurring, 35% reported it as occurring in youths with an otherwise normal physical exam, and 31% said the pain occurred on both sides of the body. Besides these, no other common feature was mentioned in more than 30% of the studies.

“Really curiously,” Dr. Kamper said, “more than 80% said nothing about the age at which these growing pains come on.” And 93% of the studies didn’t even mention growth as being related to the pain at all.

Several studies did acknowledge that the cause of growing pains is unknown, and several others considered it a diagnosis of exclusion – that is, it’s the diagnosis when everything else has been ruled out.

But that’s hardly a satisfactory explanation for kids and their families, so the researchers drew the only reasonable conclusion they could from what they found: “We think it’s important that the term is not used without some qualification or clarification, whether by researchers or clinicians,” Dr. Kamper said.

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

Just about every child hears it growing up: An ache in the leg? “Growing pains.” A dull pain in the side? “Growing pains.”

The catch-all phrase for random pains that children and teens have is so common that it even inspired the name of a 1980s sitcom. Yet when scientists dug into the evidence to find out what growing pains actually are, they found out that no one really knows. The definitions were as random and all over the place as the very pains that kids complain about, the researchers report in the journal Pediatrics.

Although some studies have suggested that up to a third of children have growing pains, the term has long seemed more like folk medicine than an actual medical diagnosis. Even so, parents, teachers, and doctors frequently use it when they have no other obvious answer to a particular pain a child or teen might describe.

A group of researchers at the University of Sydney in Australia wanted to find out if there was any research offering a more precise definition or criteria. They combed through eight databases for any papers that mentioned growing pains or growth pains in children or adolescents. They found 145 studies and set out to look for common ground: Where do growing pains occur? At what age do they start? Are there any patterns? Risk factors? Common clinical features? Relationships to particular activities?

What they found was that there is “no consensus whatsoever as to what growing pains really are, what they mean, how they’re defined, and how they should be diagnosed,” coauthor Steven J. Kamper, PhD, explained in a video about the findings. “The definitions were really variable, really vague, and sometimes downright contradictory,” he said. “Some studies would suggest growing pains happen in the arms, some in the lower limbs only. Some said it was about muscles, some about joints.”

The closest thing to consistency that they found was that exactly half the studies mentioned the pain being in the lower limbs. Nearly half (48%) described it as happening in the evening or nighttime, 42% said it was recurring, 35% reported it as occurring in youths with an otherwise normal physical exam, and 31% said the pain occurred on both sides of the body. Besides these, no other common feature was mentioned in more than 30% of the studies.

“Really curiously,” Dr. Kamper said, “more than 80% said nothing about the age at which these growing pains come on.” And 93% of the studies didn’t even mention growth as being related to the pain at all.

Several studies did acknowledge that the cause of growing pains is unknown, and several others considered it a diagnosis of exclusion – that is, it’s the diagnosis when everything else has been ruled out.

But that’s hardly a satisfactory explanation for kids and their families, so the researchers drew the only reasonable conclusion they could from what they found: “We think it’s important that the term is not used without some qualification or clarification, whether by researchers or clinicians,” Dr. Kamper said.

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

Just about every child hears it growing up: An ache in the leg? “Growing pains.” A dull pain in the side? “Growing pains.”

The catch-all phrase for random pains that children and teens have is so common that it even inspired the name of a 1980s sitcom. Yet when scientists dug into the evidence to find out what growing pains actually are, they found out that no one really knows. The definitions were as random and all over the place as the very pains that kids complain about, the researchers report in the journal Pediatrics.

Although some studies have suggested that up to a third of children have growing pains, the term has long seemed more like folk medicine than an actual medical diagnosis. Even so, parents, teachers, and doctors frequently use it when they have no other obvious answer to a particular pain a child or teen might describe.

A group of researchers at the University of Sydney in Australia wanted to find out if there was any research offering a more precise definition or criteria. They combed through eight databases for any papers that mentioned growing pains or growth pains in children or adolescents. They found 145 studies and set out to look for common ground: Where do growing pains occur? At what age do they start? Are there any patterns? Risk factors? Common clinical features? Relationships to particular activities?

What they found was that there is “no consensus whatsoever as to what growing pains really are, what they mean, how they’re defined, and how they should be diagnosed,” coauthor Steven J. Kamper, PhD, explained in a video about the findings. “The definitions were really variable, really vague, and sometimes downright contradictory,” he said. “Some studies would suggest growing pains happen in the arms, some in the lower limbs only. Some said it was about muscles, some about joints.”

The closest thing to consistency that they found was that exactly half the studies mentioned the pain being in the lower limbs. Nearly half (48%) described it as happening in the evening or nighttime, 42% said it was recurring, 35% reported it as occurring in youths with an otherwise normal physical exam, and 31% said the pain occurred on both sides of the body. Besides these, no other common feature was mentioned in more than 30% of the studies.

“Really curiously,” Dr. Kamper said, “more than 80% said nothing about the age at which these growing pains come on.” And 93% of the studies didn’t even mention growth as being related to the pain at all.

Several studies did acknowledge that the cause of growing pains is unknown, and several others considered it a diagnosis of exclusion – that is, it’s the diagnosis when everything else has been ruled out.

But that’s hardly a satisfactory explanation for kids and their families, so the researchers drew the only reasonable conclusion they could from what they found: “We think it’s important that the term is not used without some qualification or clarification, whether by researchers or clinicians,” Dr. Kamper said.

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