Disposable duodenoscopes have one irrefutable advantage over their reusable counterparts: They definitively solve the problem of scope-related multidrug-resistant organism (MDRO) infections. Yet they also come with trade-offs, such as increased cost and medical waste, which has triggered pushback from skeptical endoscopists. How endoscopists weigh their differing concerns will ultimately determine the uptake of these devices going forward, according to Andrew S. Ross, MD, medical director for strategic growth at Virginia Mason Medical Center, Seattle.

“What would you pay to not have to deal with the scope infection issue at all?” Dr. Ross asked during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. “I think that x-factor is going to depend [on] who you’re talking to and how much they really believe in [duodenoscope-related infection] as an issue.”

Dr. Ross explained that some endoscopists doubt the clinical relevance of duodenoscope-related MDRO infections, possibly because of a lack of direct experience.

“There still is a prevailing sentiment among some endoscopists that duodenoscope infection is really not a problem,” Dr. Ross said. “Or [they may say,]: ‘We haven’t had that issue here in our medical center, so therefore it is not a problem.’ ”

In fact, the exact magnitude of the problem remains unknown.

“In the end, we have an unquantifiable risk to patients wherever [reusable duodenoscopes] are used,” Dr. Ross said.
 

Just how common are scope-related MDRO infections?

According to V. Raman Muthusamy, MD, AGAF, immediate former chair of the AGA Center for GI Innovation and Technology, and director of endoscopy at the University of California, Los Angeles Health System, scope-related MDRO infections are “relatively uncommon,” but they do occur.

MDRO infections are generally linked with contaminated endoscopes, but duodenoscopes are the most common culprit because they pose a unique risk.

“Traditionally, when outbreaks have occurred [with nonduodenoscopes], it has usually been due to a breach in the reprocessing protocol,” Dr. Muthusamy said in an interview. “But with duodenoscopes, we’ve found that that does not appear to be necessary, and that in many cases there are no identified breaches, and yet there are still outbreaks.”

Dr. Muthusamy, the first endoscopist to test a disposable duodenoscope in a human patient, noted that it’s challenging to definitively prove infection from a reusable scope. Citing an Executive Summary from the Food and Drug Administration, he said, “We know it’s happened 300-400 times over the past decade or so,” with infection rates peaking in 2014-2016 and steadily declining since then.

Approximately 5% of reprocessed duodenoscopes harbor pathogenic bacteria, according to Dr. Muthusamy, but the rate of infection is significantly lower.

“[The use of a contaminated duodenoscope] doesn’t mean a patient will actually get sick ... but it does mean the potential exists, obviously,” he said. “It just shows that these devices are hard to clean and a fraction of people have the potential of becoming ill. It’s our goal to improve on those numbers, and really try to eliminate the risk of this problem, as best we can.”
 

Infection isn’t the only concern

There are several potential ways to tackle the issue of scope-related infections, Dr. Ross said during his presentation, including designing devices that are easier to clean and optimizing the cleaning process; however, the only definitive solution is to eliminate cleaning altogether.

This is where disposable duodenoscopes come in.

At present, there are two such FDA-approved devices, the Ascope Duodeno from Ambu and the Exalt Model D from Boston Scientific, both of which Dr. Ross characterized as being “in their infancy.”

Studies testing the Exalt Model D suggest that performance compares favorably with reusable duodenoscopes.

“The scope works in a benchtop model, it works in a lab, and it seems to be functional in expert hands,” Dr. Ross said. “With inexperienced users, we also see that this device works, albeit with a rate of crossover that may approach up to 10%. So, a functional, disposable scope has been produced.”

Despite availability, several pain points may slow adoption, Dr. Ross said, including reluctance to use new technology, skepticism about the clinical impact of scope-related infections, environmental concerns of increased medical waste, and increased cost.

On this latter topic, Dr. Ross pointed out that the true cost of a reusable scope goes beyond the purchase or lease price to include repair costs, reprocessing costs, and, potentially, the cost of litigation from scope-related infection.

“If you have an outbreak in your medical center, you can rest assured that you will have some litigation exposure,” Dr. Ross said.
 

Fitting disposable duodenoscopes into routine practice

Currently, both FDA-approved disposable duodenoscopes are covered by outpatient pass-through reimbursement for Medicare, and in October, both will be covered on an inpatient basis, according to Dr. Ross.

“I think the big question regarding pass-through reimbursement is what happens when the codes get revalued,” he said. “How long will the additional reimbursement stay in place?”

For now, Dr. Ross suggested that endoscopists reach for disposable duodenoscopes in unique scenarios, such as weekend or night procedures, to avoid calling in a scope-reprocessing technician; or in operating room cases when the scope enters a sterile field. Disposable scopes should also be considered for patients with known MDROs, he added, and conversely, for patients who are immunocompromised or critically ill and “can least afford a scope-related infection.”

Ultimately, the role of disposable duodenoscopes may be decided by the patients themselves, Dr. Ross concluded.

“Certainly, patients know about this – they may come in and demand the use of a single-use scope in certain situations,” Dr. Ross said. “We have to remember when we’re bringing any new technology into the marketplace that while it’s important to understand the input and perspectives of multiple stakeholders, the single-most important stakeholder at the end of the day are our patients.”

Dr. Ross disclosed a relationship with Boston Scientific. Dr. Muthusamy disclosed a relationship with Boston Scientific and Medivators.

Disposable duodenoscopes have one irrefutable advantage over their reusable counterparts: They definitively solve the problem of scope-related multidrug-resistant organism (MDRO) infections. Yet they also come with trade-offs, such as increased cost and medical waste, which has triggered pushback from skeptical endoscopists. How endoscopists weigh their differing concerns will ultimately determine the uptake of these devices going forward, according to Andrew S. Ross, MD, medical director for strategic growth at Virginia Mason Medical Center, Seattle.

“What would you pay to not have to deal with the scope infection issue at all?” Dr. Ross asked during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. “I think that x-factor is going to depend [on] who you’re talking to and how much they really believe in [duodenoscope-related infection] as an issue.”

Dr. Ross explained that some endoscopists doubt the clinical relevance of duodenoscope-related MDRO infections, possibly because of a lack of direct experience.

“There still is a prevailing sentiment among some endoscopists that duodenoscope infection is really not a problem,” Dr. Ross said. “Or [they may say,]: ‘We haven’t had that issue here in our medical center, so therefore it is not a problem.’ ”

In fact, the exact magnitude of the problem remains unknown.

“In the end, we have an unquantifiable risk to patients wherever [reusable duodenoscopes] are used,” Dr. Ross said.
 

Just how common are scope-related MDRO infections?

According to V. Raman Muthusamy, MD, AGAF, immediate former chair of the AGA Center for GI Innovation and Technology, and director of endoscopy at the University of California, Los Angeles Health System, scope-related MDRO infections are “relatively uncommon,” but they do occur.

MDRO infections are generally linked with contaminated endoscopes, but duodenoscopes are the most common culprit because they pose a unique risk.

“Traditionally, when outbreaks have occurred [with nonduodenoscopes], it has usually been due to a breach in the reprocessing protocol,” Dr. Muthusamy said in an interview. “But with duodenoscopes, we’ve found that that does not appear to be necessary, and that in many cases there are no identified breaches, and yet there are still outbreaks.”

Dr. Muthusamy, the first endoscopist to test a disposable duodenoscope in a human patient, noted that it’s challenging to definitively prove infection from a reusable scope. Citing an Executive Summary from the Food and Drug Administration, he said, “We know it’s happened 300-400 times over the past decade or so,” with infection rates peaking in 2014-2016 and steadily declining since then.

Approximately 5% of reprocessed duodenoscopes harbor pathogenic bacteria, according to Dr. Muthusamy, but the rate of infection is significantly lower.

“[The use of a contaminated duodenoscope] doesn’t mean a patient will actually get sick ... but it does mean the potential exists, obviously,” he said. “It just shows that these devices are hard to clean and a fraction of people have the potential of becoming ill. It’s our goal to improve on those numbers, and really try to eliminate the risk of this problem, as best we can.”
 

Infection isn’t the only concern

There are several potential ways to tackle the issue of scope-related infections, Dr. Ross said during his presentation, including designing devices that are easier to clean and optimizing the cleaning process; however, the only definitive solution is to eliminate cleaning altogether.

This is where disposable duodenoscopes come in.

At present, there are two such FDA-approved devices, the Ascope Duodeno from Ambu and the Exalt Model D from Boston Scientific, both of which Dr. Ross characterized as being “in their infancy.”

Studies testing the Exalt Model D suggest that performance compares favorably with reusable duodenoscopes.

“The scope works in a benchtop model, it works in a lab, and it seems to be functional in expert hands,” Dr. Ross said. “With inexperienced users, we also see that this device works, albeit with a rate of crossover that may approach up to 10%. So, a functional, disposable scope has been produced.”

Despite availability, several pain points may slow adoption, Dr. Ross said, including reluctance to use new technology, skepticism about the clinical impact of scope-related infections, environmental concerns of increased medical waste, and increased cost.

On this latter topic, Dr. Ross pointed out that the true cost of a reusable scope goes beyond the purchase or lease price to include repair costs, reprocessing costs, and, potentially, the cost of litigation from scope-related infection.

“If you have an outbreak in your medical center, you can rest assured that you will have some litigation exposure,” Dr. Ross said.
 

Fitting disposable duodenoscopes into routine practice

Currently, both FDA-approved disposable duodenoscopes are covered by outpatient pass-through reimbursement for Medicare, and in October, both will be covered on an inpatient basis, according to Dr. Ross.

“I think the big question regarding pass-through reimbursement is what happens when the codes get revalued,” he said. “How long will the additional reimbursement stay in place?”

For now, Dr. Ross suggested that endoscopists reach for disposable duodenoscopes in unique scenarios, such as weekend or night procedures, to avoid calling in a scope-reprocessing technician; or in operating room cases when the scope enters a sterile field. Disposable scopes should also be considered for patients with known MDROs, he added, and conversely, for patients who are immunocompromised or critically ill and “can least afford a scope-related infection.”

Ultimately, the role of disposable duodenoscopes may be decided by the patients themselves, Dr. Ross concluded.

“Certainly, patients know about this – they may come in and demand the use of a single-use scope in certain situations,” Dr. Ross said. “We have to remember when we’re bringing any new technology into the marketplace that while it’s important to understand the input and perspectives of multiple stakeholders, the single-most important stakeholder at the end of the day are our patients.”

Dr. Ross disclosed a relationship with Boston Scientific. Dr. Muthusamy disclosed a relationship with Boston Scientific and Medivators.

Disposable duodenoscopes have one irrefutable advantage over their reusable counterparts: They definitively solve the problem of scope-related multidrug-resistant organism (MDRO) infections. Yet they also come with trade-offs, such as increased cost and medical waste, which has triggered pushback from skeptical endoscopists. How endoscopists weigh their differing concerns will ultimately determine the uptake of these devices going forward, according to Andrew S. Ross, MD, medical director for strategic growth at Virginia Mason Medical Center, Seattle.

“What would you pay to not have to deal with the scope infection issue at all?” Dr. Ross asked during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. “I think that x-factor is going to depend [on] who you’re talking to and how much they really believe in [duodenoscope-related infection] as an issue.”

Dr. Ross explained that some endoscopists doubt the clinical relevance of duodenoscope-related MDRO infections, possibly because of a lack of direct experience.

“There still is a prevailing sentiment among some endoscopists that duodenoscope infection is really not a problem,” Dr. Ross said. “Or [they may say,]: ‘We haven’t had that issue here in our medical center, so therefore it is not a problem.’ ”

In fact, the exact magnitude of the problem remains unknown.

“In the end, we have an unquantifiable risk to patients wherever [reusable duodenoscopes] are used,” Dr. Ross said.
 

Just how common are scope-related MDRO infections?

According to V. Raman Muthusamy, MD, AGAF, immediate former chair of the AGA Center for GI Innovation and Technology, and director of endoscopy at the University of California, Los Angeles Health System, scope-related MDRO infections are “relatively uncommon,” but they do occur.

MDRO infections are generally linked with contaminated endoscopes, but duodenoscopes are the most common culprit because they pose a unique risk.

“Traditionally, when outbreaks have occurred [with nonduodenoscopes], it has usually been due to a breach in the reprocessing protocol,” Dr. Muthusamy said in an interview. “But with duodenoscopes, we’ve found that that does not appear to be necessary, and that in many cases there are no identified breaches, and yet there are still outbreaks.”

Dr. Muthusamy, the first endoscopist to test a disposable duodenoscope in a human patient, noted that it’s challenging to definitively prove infection from a reusable scope. Citing an Executive Summary from the Food and Drug Administration, he said, “We know it’s happened 300-400 times over the past decade or so,” with infection rates peaking in 2014-2016 and steadily declining since then.

Approximately 5% of reprocessed duodenoscopes harbor pathogenic bacteria, according to Dr. Muthusamy, but the rate of infection is significantly lower.

“[The use of a contaminated duodenoscope] doesn’t mean a patient will actually get sick ... but it does mean the potential exists, obviously,” he said. “It just shows that these devices are hard to clean and a fraction of people have the potential of becoming ill. It’s our goal to improve on those numbers, and really try to eliminate the risk of this problem, as best we can.”
 

Infection isn’t the only concern

There are several potential ways to tackle the issue of scope-related infections, Dr. Ross said during his presentation, including designing devices that are easier to clean and optimizing the cleaning process; however, the only definitive solution is to eliminate cleaning altogether.

This is where disposable duodenoscopes come in.

At present, there are two such FDA-approved devices, the Ascope Duodeno from Ambu and the Exalt Model D from Boston Scientific, both of which Dr. Ross characterized as being “in their infancy.”

Studies testing the Exalt Model D suggest that performance compares favorably with reusable duodenoscopes.

“The scope works in a benchtop model, it works in a lab, and it seems to be functional in expert hands,” Dr. Ross said. “With inexperienced users, we also see that this device works, albeit with a rate of crossover that may approach up to 10%. So, a functional, disposable scope has been produced.”

Despite availability, several pain points may slow adoption, Dr. Ross said, including reluctance to use new technology, skepticism about the clinical impact of scope-related infections, environmental concerns of increased medical waste, and increased cost.

On this latter topic, Dr. Ross pointed out that the true cost of a reusable scope goes beyond the purchase or lease price to include repair costs, reprocessing costs, and, potentially, the cost of litigation from scope-related infection.

“If you have an outbreak in your medical center, you can rest assured that you will have some litigation exposure,” Dr. Ross said.
 

Fitting disposable duodenoscopes into routine practice

Currently, both FDA-approved disposable duodenoscopes are covered by outpatient pass-through reimbursement for Medicare, and in October, both will be covered on an inpatient basis, according to Dr. Ross.

“I think the big question regarding pass-through reimbursement is what happens when the codes get revalued,” he said. “How long will the additional reimbursement stay in place?”

For now, Dr. Ross suggested that endoscopists reach for disposable duodenoscopes in unique scenarios, such as weekend or night procedures, to avoid calling in a scope-reprocessing technician; or in operating room cases when the scope enters a sterile field. Disposable scopes should also be considered for patients with known MDROs, he added, and conversely, for patients who are immunocompromised or critically ill and “can least afford a scope-related infection.”

Ultimately, the role of disposable duodenoscopes may be decided by the patients themselves, Dr. Ross concluded.

“Certainly, patients know about this – they may come in and demand the use of a single-use scope in certain situations,” Dr. Ross said. “We have to remember when we’re bringing any new technology into the marketplace that while it’s important to understand the input and perspectives of multiple stakeholders, the single-most important stakeholder at the end of the day are our patients.”

Dr. Ross disclosed a relationship with Boston Scientific. Dr. Muthusamy disclosed a relationship with Boston Scientific and Medivators.

Mothers with a history of COVID-19 exposure during pregnancy are not likely to transmit the infection to their newborns, based on data from more than 2,000 women.

“Uncertainty at the onset of the COVID-19 pandemic led to varying postnatal care recommendations for newborns exposed to SARS-CoV-2 in utero,” said Margaret H. Kyle, of Columbia University, New York, and colleagues.

The Columbia University Irving Medical Center, an early epicenter of the pandemic, allowed rooming-in and encouraged direct breastfeeding between infected mothers and their newborns while adopting extensive safety measures, the researchers said.

In a study presented at the virtual meeting of the Pediatric Academic Societies (Poster 141), the researchers conducted a retrospective chart review of all newborns born at the medical center from March 22, 2020, through August 7, 2020. The study was part of Columbia University’s ongoing COVID-19 Mother Baby Outcomes (COMBO) initiative to “describe the health and well-being of mother-infant dyads with and without prenatal SARS-CoV-2 infections,” according to the researchers.

During the study period, the researchers identified newborns of 327 women who tested positive for COVID-19 at any point during pregnancy and compared them to newborns of 2,125 unexposed women. Demographics were similar between the groups.

Overall, the total test positivity was 0.7% for exposed newborns; 1.0% tested positive on an initial test, and 0% were positive on retest. During the newborn hospital stay and a 2-week follow-up, 0% of all newborns showed clinical evidence of infection.

No significant differences were noted between exposed and unexposed newborns in clinical outcomes including gestational age, mode of delivery, 5-minute Apgar score, heart rate, respiratory rate, or temperature. Although more infants of COVID-19–exposed mothers compared with unexposed mothers had an emergency department visit within the first 14 days of life (6% vs. 3%, P = .002), none of the infants was diagnosed with COVID-19 during these visits. Cough, fever, congestion, or bilirubin were more frequent reasons for emergency department visits in the exposed infants compared with unexposed infants, but these differences were not significant.

The study findings were limited by several factors, including the retrospective design and the limited follow-up period to only the first 2 weeks of life, the researchers noted. In addition, perinatal transmission rates were available only for the 202 newborns who were followed up in the hospital system, they said. However, the results suggest that the risk of mother-to-newborn vertical transmission of COVID-19 remains low, even when mothers are breastfeeding and infants are rooming in, they concluded.
 

Study supports safety of rooming in

The study is important because of the value of mother and infant bonding, Karalyn Kinsella, MD, a pediatrician in Cheshire, Conn., said in an interview. “We know maternal and infant bonding and breastfeeding are extremely important in the first few days of life,” she said. “Initially, COVID-positive moms were separated from their babies during this important time.” Dr. Kinsella said she was not surprised by the study findings, as they reflect other research that newborns have not been getting infected with COVID-19 from their mothers.

Consequently, the take-home message is that newborns can room in with their mothers in the hospital setting, and they are at low risk for COVID-19 regardless of the mother’s exposure history, said Dr. Kinsella. Looking ahead, future areas of research could include examining SARS-CoV-2 antibodies in newborns, she noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Mothers with a history of COVID-19 exposure during pregnancy are not likely to transmit the infection to their newborns, based on data from more than 2,000 women.

“Uncertainty at the onset of the COVID-19 pandemic led to varying postnatal care recommendations for newborns exposed to SARS-CoV-2 in utero,” said Margaret H. Kyle, of Columbia University, New York, and colleagues.

The Columbia University Irving Medical Center, an early epicenter of the pandemic, allowed rooming-in and encouraged direct breastfeeding between infected mothers and their newborns while adopting extensive safety measures, the researchers said.

In a study presented at the virtual meeting of the Pediatric Academic Societies (Poster 141), the researchers conducted a retrospective chart review of all newborns born at the medical center from March 22, 2020, through August 7, 2020. The study was part of Columbia University’s ongoing COVID-19 Mother Baby Outcomes (COMBO) initiative to “describe the health and well-being of mother-infant dyads with and without prenatal SARS-CoV-2 infections,” according to the researchers.

During the study period, the researchers identified newborns of 327 women who tested positive for COVID-19 at any point during pregnancy and compared them to newborns of 2,125 unexposed women. Demographics were similar between the groups.

Overall, the total test positivity was 0.7% for exposed newborns; 1.0% tested positive on an initial test, and 0% were positive on retest. During the newborn hospital stay and a 2-week follow-up, 0% of all newborns showed clinical evidence of infection.

No significant differences were noted between exposed and unexposed newborns in clinical outcomes including gestational age, mode of delivery, 5-minute Apgar score, heart rate, respiratory rate, or temperature. Although more infants of COVID-19–exposed mothers compared with unexposed mothers had an emergency department visit within the first 14 days of life (6% vs. 3%, P = .002), none of the infants was diagnosed with COVID-19 during these visits. Cough, fever, congestion, or bilirubin were more frequent reasons for emergency department visits in the exposed infants compared with unexposed infants, but these differences were not significant.

The study findings were limited by several factors, including the retrospective design and the limited follow-up period to only the first 2 weeks of life, the researchers noted. In addition, perinatal transmission rates were available only for the 202 newborns who were followed up in the hospital system, they said. However, the results suggest that the risk of mother-to-newborn vertical transmission of COVID-19 remains low, even when mothers are breastfeeding and infants are rooming in, they concluded.
 

Study supports safety of rooming in

The study is important because of the value of mother and infant bonding, Karalyn Kinsella, MD, a pediatrician in Cheshire, Conn., said in an interview. “We know maternal and infant bonding and breastfeeding are extremely important in the first few days of life,” she said. “Initially, COVID-positive moms were separated from their babies during this important time.” Dr. Kinsella said she was not surprised by the study findings, as they reflect other research that newborns have not been getting infected with COVID-19 from their mothers.

Consequently, the take-home message is that newborns can room in with their mothers in the hospital setting, and they are at low risk for COVID-19 regardless of the mother’s exposure history, said Dr. Kinsella. Looking ahead, future areas of research could include examining SARS-CoV-2 antibodies in newborns, she noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Mothers with a history of COVID-19 exposure during pregnancy are not likely to transmit the infection to their newborns, based on data from more than 2,000 women.

“Uncertainty at the onset of the COVID-19 pandemic led to varying postnatal care recommendations for newborns exposed to SARS-CoV-2 in utero,” said Margaret H. Kyle, of Columbia University, New York, and colleagues.

The Columbia University Irving Medical Center, an early epicenter of the pandemic, allowed rooming-in and encouraged direct breastfeeding between infected mothers and their newborns while adopting extensive safety measures, the researchers said.

In a study presented at the virtual meeting of the Pediatric Academic Societies (Poster 141), the researchers conducted a retrospective chart review of all newborns born at the medical center from March 22, 2020, through August 7, 2020. The study was part of Columbia University’s ongoing COVID-19 Mother Baby Outcomes (COMBO) initiative to “describe the health and well-being of mother-infant dyads with and without prenatal SARS-CoV-2 infections,” according to the researchers.

During the study period, the researchers identified newborns of 327 women who tested positive for COVID-19 at any point during pregnancy and compared them to newborns of 2,125 unexposed women. Demographics were similar between the groups.

Overall, the total test positivity was 0.7% for exposed newborns; 1.0% tested positive on an initial test, and 0% were positive on retest. During the newborn hospital stay and a 2-week follow-up, 0% of all newborns showed clinical evidence of infection.

No significant differences were noted between exposed and unexposed newborns in clinical outcomes including gestational age, mode of delivery, 5-minute Apgar score, heart rate, respiratory rate, or temperature. Although more infants of COVID-19–exposed mothers compared with unexposed mothers had an emergency department visit within the first 14 days of life (6% vs. 3%, P = .002), none of the infants was diagnosed with COVID-19 during these visits. Cough, fever, congestion, or bilirubin were more frequent reasons for emergency department visits in the exposed infants compared with unexposed infants, but these differences were not significant.

The study findings were limited by several factors, including the retrospective design and the limited follow-up period to only the first 2 weeks of life, the researchers noted. In addition, perinatal transmission rates were available only for the 202 newborns who were followed up in the hospital system, they said. However, the results suggest that the risk of mother-to-newborn vertical transmission of COVID-19 remains low, even when mothers are breastfeeding and infants are rooming in, they concluded.
 

Study supports safety of rooming in

The study is important because of the value of mother and infant bonding, Karalyn Kinsella, MD, a pediatrician in Cheshire, Conn., said in an interview. “We know maternal and infant bonding and breastfeeding are extremely important in the first few days of life,” she said. “Initially, COVID-positive moms were separated from their babies during this important time.” Dr. Kinsella said she was not surprised by the study findings, as they reflect other research that newborns have not been getting infected with COVID-19 from their mothers.

Consequently, the take-home message is that newborns can room in with their mothers in the hospital setting, and they are at low risk for COVID-19 regardless of the mother’s exposure history, said Dr. Kinsella. Looking ahead, future areas of research could include examining SARS-CoV-2 antibodies in newborns, she noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

The prevalence of inflammatory bowel disease increased significantly among Americans aged 67 years and older from 2001 to 2018, based on data from more than 25 million Medicare beneficiaries.

FatCamera/Getty Images

The worldwide prevalence – or rate of existing cases – of inflammatory bowel disease (IBD) increased from 3.7 million in 1990 to 6.8 million in 2017, wrote Fang Xu, PhD, of the Centers for Disease Control and Prevention, and colleagues. “As the prevalence increases with age group, it is important to understand the disease epidemiology among the older population,” they said.

In a study published in the Morbidity and Mortality Weekly Report, the researchers reviewed 2018 Medicare data for 25.1 million beneficiaries aged 67 years and older to assess prevalence trends overall and by race and ethnicity. Over the study period, the study population ranged from 23.7 million persons in 2009 to 25.6 million persons in 2018. The incidence – or rate of new cases – of IBD peaks at 15-29 years of age, but approximately 10%-15% of new cases develop in adults aged 60 years and older, so the prevalence of IBD overall is expected to increase over time with the aging of the U.S. population, the researchers said.

In this population of beneficiaries, 0.40% overall had a Crohn’s disease diagnosis and 0.64% had an ulcerative colitis diagnosis. The prevalence for both diseases was consistently highest among non-Hispanic Whites, the researchers noted. In addition, the prevalence of Crohn’s disease was highest among younger beneficiaries, while the prevalence of ulcerative colitis was highest among those aged 75-84 years. Other factors associated with higher IBD prevalence were female gender and residence in large fringe metropolitan counties.

The overall age-adjusted prevalence of Crohn’s disease increased over time with an annual percentage change (APC) of 3.4%, and the overall age-adjusted prevalence of ulcerative colitis increased with an APC of 2.8%. When the researchers examined subgroups of race and ethnicity, the annual increases were higher for non-Hispanic Blacks for both Crohn’s disease and ulcerative colitis, with APCs of 5.0% and 3.5%, respectively. “The potential rapid increase of disease prevalence in certain racial and ethnic minority groups indicates the need for tailored disease management strategies in these populations,” the researchers noted.

The study findings were limited by several factors including the lack of socioeconomic data, the potential for coding errors related to Crohn’s disease or ulcerative colitis, and the lack of generalizability to all older adults in the United States, the researchers noted. However, “Medicare data are a useful resource to monitor prevalence of IBD over time, understand its prevalence among older adults, assess differences by demographic and geographic characteristics, and have rich information to study health care use,” they concluded.
 

Consider the younger population

The data from the study need to be considered in the context of an accumulation of patients with IBD, and the distinction between incidence and prevalence, Stephen B. Hanauer, MD, of Northwestern University, Chicago, said in an interview.

The overall incidence of IBD is much greater in younger individuals (approximately ages 15-29 years) compared with older adults, he said. Patients with IBD don’t die of it; they grow old with it. Consequently, the prevalence in the Medicare population increases over time, he explained.

The data may be of interest to the practicing clinician, but would be most useful to hospital and Medicare administrators in terms of planning for an increase in the number of older adults surviving into older adulthood with IBD who will require care, he noted.

The researchers and Dr. Hanauer had no financial conflicts to disclose.

The prevalence of inflammatory bowel disease increased significantly among Americans aged 67 years and older from 2001 to 2018, based on data from more than 25 million Medicare beneficiaries.

FatCamera/Getty Images

The worldwide prevalence – or rate of existing cases – of inflammatory bowel disease (IBD) increased from 3.7 million in 1990 to 6.8 million in 2017, wrote Fang Xu, PhD, of the Centers for Disease Control and Prevention, and colleagues. “As the prevalence increases with age group, it is important to understand the disease epidemiology among the older population,” they said.

In a study published in the Morbidity and Mortality Weekly Report, the researchers reviewed 2018 Medicare data for 25.1 million beneficiaries aged 67 years and older to assess prevalence trends overall and by race and ethnicity. Over the study period, the study population ranged from 23.7 million persons in 2009 to 25.6 million persons in 2018. The incidence – or rate of new cases – of IBD peaks at 15-29 years of age, but approximately 10%-15% of new cases develop in adults aged 60 years and older, so the prevalence of IBD overall is expected to increase over time with the aging of the U.S. population, the researchers said.

In this population of beneficiaries, 0.40% overall had a Crohn’s disease diagnosis and 0.64% had an ulcerative colitis diagnosis. The prevalence for both diseases was consistently highest among non-Hispanic Whites, the researchers noted. In addition, the prevalence of Crohn’s disease was highest among younger beneficiaries, while the prevalence of ulcerative colitis was highest among those aged 75-84 years. Other factors associated with higher IBD prevalence were female gender and residence in large fringe metropolitan counties.

The overall age-adjusted prevalence of Crohn’s disease increased over time with an annual percentage change (APC) of 3.4%, and the overall age-adjusted prevalence of ulcerative colitis increased with an APC of 2.8%. When the researchers examined subgroups of race and ethnicity, the annual increases were higher for non-Hispanic Blacks for both Crohn’s disease and ulcerative colitis, with APCs of 5.0% and 3.5%, respectively. “The potential rapid increase of disease prevalence in certain racial and ethnic minority groups indicates the need for tailored disease management strategies in these populations,” the researchers noted.

The study findings were limited by several factors including the lack of socioeconomic data, the potential for coding errors related to Crohn’s disease or ulcerative colitis, and the lack of generalizability to all older adults in the United States, the researchers noted. However, “Medicare data are a useful resource to monitor prevalence of IBD over time, understand its prevalence among older adults, assess differences by demographic and geographic characteristics, and have rich information to study health care use,” they concluded.
 

Consider the younger population

The data from the study need to be considered in the context of an accumulation of patients with IBD, and the distinction between incidence and prevalence, Stephen B. Hanauer, MD, of Northwestern University, Chicago, said in an interview.

The overall incidence of IBD is much greater in younger individuals (approximately ages 15-29 years) compared with older adults, he said. Patients with IBD don’t die of it; they grow old with it. Consequently, the prevalence in the Medicare population increases over time, he explained.

The data may be of interest to the practicing clinician, but would be most useful to hospital and Medicare administrators in terms of planning for an increase in the number of older adults surviving into older adulthood with IBD who will require care, he noted.

The researchers and Dr. Hanauer had no financial conflicts to disclose.

The prevalence of inflammatory bowel disease increased significantly among Americans aged 67 years and older from 2001 to 2018, based on data from more than 25 million Medicare beneficiaries.

FatCamera/Getty Images

The worldwide prevalence – or rate of existing cases – of inflammatory bowel disease (IBD) increased from 3.7 million in 1990 to 6.8 million in 2017, wrote Fang Xu, PhD, of the Centers for Disease Control and Prevention, and colleagues. “As the prevalence increases with age group, it is important to understand the disease epidemiology among the older population,” they said.

In a study published in the Morbidity and Mortality Weekly Report, the researchers reviewed 2018 Medicare data for 25.1 million beneficiaries aged 67 years and older to assess prevalence trends overall and by race and ethnicity. Over the study period, the study population ranged from 23.7 million persons in 2009 to 25.6 million persons in 2018. The incidence – or rate of new cases – of IBD peaks at 15-29 years of age, but approximately 10%-15% of new cases develop in adults aged 60 years and older, so the prevalence of IBD overall is expected to increase over time with the aging of the U.S. population, the researchers said.

In this population of beneficiaries, 0.40% overall had a Crohn’s disease diagnosis and 0.64% had an ulcerative colitis diagnosis. The prevalence for both diseases was consistently highest among non-Hispanic Whites, the researchers noted. In addition, the prevalence of Crohn’s disease was highest among younger beneficiaries, while the prevalence of ulcerative colitis was highest among those aged 75-84 years. Other factors associated with higher IBD prevalence were female gender and residence in large fringe metropolitan counties.

The overall age-adjusted prevalence of Crohn’s disease increased over time with an annual percentage change (APC) of 3.4%, and the overall age-adjusted prevalence of ulcerative colitis increased with an APC of 2.8%. When the researchers examined subgroups of race and ethnicity, the annual increases were higher for non-Hispanic Blacks for both Crohn’s disease and ulcerative colitis, with APCs of 5.0% and 3.5%, respectively. “The potential rapid increase of disease prevalence in certain racial and ethnic minority groups indicates the need for tailored disease management strategies in these populations,” the researchers noted.

The study findings were limited by several factors including the lack of socioeconomic data, the potential for coding errors related to Crohn’s disease or ulcerative colitis, and the lack of generalizability to all older adults in the United States, the researchers noted. However, “Medicare data are a useful resource to monitor prevalence of IBD over time, understand its prevalence among older adults, assess differences by demographic and geographic characteristics, and have rich information to study health care use,” they concluded.
 

Consider the younger population

The data from the study need to be considered in the context of an accumulation of patients with IBD, and the distinction between incidence and prevalence, Stephen B. Hanauer, MD, of Northwestern University, Chicago, said in an interview.

The overall incidence of IBD is much greater in younger individuals (approximately ages 15-29 years) compared with older adults, he said. Patients with IBD don’t die of it; they grow old with it. Consequently, the prevalence in the Medicare population increases over time, he explained.

The data may be of interest to the practicing clinician, but would be most useful to hospital and Medicare administrators in terms of planning for an increase in the number of older adults surviving into older adulthood with IBD who will require care, he noted.

The researchers and Dr. Hanauer had no financial conflicts to disclose.

Sigmund Freud said, “Out of your vulnerabilities will come greatest strength.” What exactly did Dr. Freud mean by this?

Many aspects of mental health treatment include cognitive restructuring, behavioral changes, emotion processing, and setting boundaries. These are all critical aspects of treatment, but what about kindness and compassion?

We often forget that kindness requires us to be vulnerable and take a risk at times. Being kind to others is not always easy, and it is not always an automatic reaction. Vulnerability often involves risk, but the outcomes often outweigh fear.

Dr. Freud was highlighting that being kind, open, and honest will often result in strong character and resilience. In turn, it will help others. Psychology and psychiatry have proved time and time again that empathy, compassion, and kindness have numerous benefits for mental and physical health for both the giver and the receiver.

From a biological perspective, we know that acts of kindness signal the brain to release serotonin and dopamine, known as “feel good transmitters,” and endorphins, which in turn lessen pain, depression, and anxiety. According to Waguih W. Ishak, MD, a psychiatrist affiliated with Cedars-Sinai in Los Angeles,¹ in addition to boosting oxytocin and dopamine, being kind can increase serotonin, a neurotransmitter that helps regulate mood. Kindness and compassion have been shown to release oxytocin, known as the “love hormone,” which increases self-esteem, trust, connection, and optimism. Oxytocin also reduces blood pressure and has been dubbed the “cardioprotective” hormone. According to Kelli Harding, MD, MPH, a psychiatrist affiliated with Columbia University in New York,² kindness can extend the lifespan. Research from Emory University in Atlanta has shown that, when an individual is kind to another, the brain’s reward centers light up – resulting in a “helper’s high.” Thus, kindness is self-reinforcing.³

Kindness leads to a greater sense of connection to others and a lessening in feelings of isolation. Small acts of kindness build up compassion in oneself. Research indicates that kindness doesn’t just positively affect the giver and receiver but can also benefit onlookers. An article in Psychology Today,⁴ suggests that those who witness acts of kindness are also more likely to “pay it forward,” resulting in a domino effect. Along these same lines, altruistic people, specifically those who engage in charitable donations, expressed higher levels of overall happiness according to a 2010 Harvard Business School survey.⁵

“You can’t pour from an empty cup” is a trendy quote making its way around social media. Before we can be kind and compassionate to others, we must first be kind and compassionate to ourselves. In today’s world, productivity and pressure-filled environments consume us daily. We often find ourselves skipping meals, forgetting to connect with loved ones, missing breaks, and even neglecting our sleep. It is virtually impossible to care for others when we are depleted ourselves. Sometimes not prioritizing ourselves can result in collateral damage. We may become short-tempered, irritable, moody, and overwhelmed. At this point kindness, compassion, and empathy toward others are likely to be absent. Once we replenish ourselves, by taking time off, indulging in a nice meal, exercising, we are more likely to respond as opposed to react, ask others about themselves, and engage in overall positive interactions throughout our day. Kindness is best fostered by being kind to ourselves to sustain our own well-being and by being kind to others in order to maintain the cycle. For clinicians who have been pushed to respond to various aspects of the COVID-19 pandemic, self-care has never been more important.

COVID-19 has been difficult for everyone, particularly the elderly and vulnerable populations. However, kindness has proved to be an overwhelming response as many businesses and individuals have taken to volunteering time and resources for those in need. Even big corporations have chipped in. For example, Lyft and Uber – in a partnership with the White House – are now offering free rides to vaccine sites, and several local businesses have donated personal protective equipment to hospitals and assisted living facilities.

Kindness and empathy are ever present in the field of mental health, medicine, and substance use treatment. The very act of caring for another involves kindness. In medicine, empathy has been defined as “an emotional experience between an observer and a subject in which the observer, based on visual and auditory cues, identifies and transiently experiences the subject’s emotional state.”⁶

As mental health professionals, we receive empathy training early on in our schooling – increasingly so over the last decade. Research has indicated that trusting relationships between clinicians and patients result in optimal care. Evidence-based communication styles are being widely implemented. This entails using nonjudgmental language, open-ended questions, and active listening skills, for example. In addition, the mental health professionals have our conscious and unconscious judgments. If empathy training is provided, we can learn to acknowledge our biases and mitigate them. Lastly, empathy training has been proven to assist with destigmatization, increase in treatment seeking, and overall better outcomes.

Substance use treatment, which often focuses on cognition and behavior changing, boundaries, and family dynamics, also requires support and kindness. Although it is not an empirically based “treatment,” Alcoholics Anonymous (AA) has used kindness for decades.

Step 12 of AA’s 12-step program, which was developed by two people with alcohol use disorder in 1935 in Akron, Ohio, is as follows: “Having had a spiritual awakening as the result of these steps, we tried to carry this message to alcoholics, and to practice these principles in all our affairs.”

Once AA members are on solid ground with their sobriety, they are urged to help others in their recovery. This process provides many benefits. When individuals are concerned about someone else, they are less focused on themselves. This helps the individuals in recovery to decrease their rumination and “get out of themselves.” It also allows for the AA member to be kind and helpful to an individual who is suffering, thereby expressing kindness, compassion, and empathy. This act of “paying it forward” produces a domino effect that has withstood the test of time as evidenced by the ever-growing fellowship of Alcoholics Anonymous.

Several small acts of kindness can help us as clinicians and our patients:

1. Practice self-care.

2. Take a half day off from your practice.

3. Give staff a half day off.

4. Call a family member or friend and ask them how they are doing. Then engage in active listening and refrain from giving advice.

5. Donate to a homeless shelter or volunteer your time at a charity.

6. Give a stranger a compliment.

7. Surprise someone with a small gift.

8. Send a loved one a letter instead of a text.

9. Pick up litter.

10. Acknowledge family and friends who gave you extra support during the pandemic.

11. Take baked goods to your office.

12. Help a neighbor with groceries.

13. Leave a generous tip.

14. Play soft music in your office.

In conclusion, kindness, empathy, and compassion are vital concepts that are not just fluffy theories. They have vast mental, physical, and social benefits for us and our patients.
 

References

1. Cedars-Sinai staff. The Science of Kindness. 2019 Feb 13. Cedars-Sinai blog.

2. Harding K. The Rabbit Effect: Live Longer, Happier, and Healthier with the Groundbreaking Science of Kindness. Atria Books, 2019.

3. Ritvo E. BeKindr. Momosa Publishing, 2017.

4. Svoboda E. “Pay it Forward.” Psychology Today. Last reviewed 2016 Jun 9.

5. Aknin LB et al. “Prosocial spending and well-being: Cross-Cultural Evidence for a Psychological Universal.” Harvard Business School. Working Paper 11-038. 2010.

6. Hirsch EM. AMA J Ethics. Virtual Mentor. 2007;9(6):423-7.

Dr. Haji is a licensed clinical psychologist specializing in psychodiagnostic assessment, forensic assessment, dual diagnosis, serious and persistent mental illness, depression, anxiety, personality disorders, and substance abuse treatment. She practices in Miami and has no conflicts of interest.

Sigmund Freud said, “Out of your vulnerabilities will come greatest strength.” What exactly did Dr. Freud mean by this?

Many aspects of mental health treatment include cognitive restructuring, behavioral changes, emotion processing, and setting boundaries. These are all critical aspects of treatment, but what about kindness and compassion?

We often forget that kindness requires us to be vulnerable and take a risk at times. Being kind to others is not always easy, and it is not always an automatic reaction. Vulnerability often involves risk, but the outcomes often outweigh fear.

Dr. Freud was highlighting that being kind, open, and honest will often result in strong character and resilience. In turn, it will help others. Psychology and psychiatry have proved time and time again that empathy, compassion, and kindness have numerous benefits for mental and physical health for both the giver and the receiver.

From a biological perspective, we know that acts of kindness signal the brain to release serotonin and dopamine, known as “feel good transmitters,” and endorphins, which in turn lessen pain, depression, and anxiety. According to Waguih W. Ishak, MD, a psychiatrist affiliated with Cedars-Sinai in Los Angeles,¹ in addition to boosting oxytocin and dopamine, being kind can increase serotonin, a neurotransmitter that helps regulate mood. Kindness and compassion have been shown to release oxytocin, known as the “love hormone,” which increases self-esteem, trust, connection, and optimism. Oxytocin also reduces blood pressure and has been dubbed the “cardioprotective” hormone. According to Kelli Harding, MD, MPH, a psychiatrist affiliated with Columbia University in New York,² kindness can extend the lifespan. Research from Emory University in Atlanta has shown that, when an individual is kind to another, the brain’s reward centers light up – resulting in a “helper’s high.” Thus, kindness is self-reinforcing.³

Kindness leads to a greater sense of connection to others and a lessening in feelings of isolation. Small acts of kindness build up compassion in oneself. Research indicates that kindness doesn’t just positively affect the giver and receiver but can also benefit onlookers. An article in Psychology Today,⁴ suggests that those who witness acts of kindness are also more likely to “pay it forward,” resulting in a domino effect. Along these same lines, altruistic people, specifically those who engage in charitable donations, expressed higher levels of overall happiness according to a 2010 Harvard Business School survey.⁵

“You can’t pour from an empty cup” is a trendy quote making its way around social media. Before we can be kind and compassionate to others, we must first be kind and compassionate to ourselves. In today’s world, productivity and pressure-filled environments consume us daily. We often find ourselves skipping meals, forgetting to connect with loved ones, missing breaks, and even neglecting our sleep. It is virtually impossible to care for others when we are depleted ourselves. Sometimes not prioritizing ourselves can result in collateral damage. We may become short-tempered, irritable, moody, and overwhelmed. At this point kindness, compassion, and empathy toward others are likely to be absent. Once we replenish ourselves, by taking time off, indulging in a nice meal, exercising, we are more likely to respond as opposed to react, ask others about themselves, and engage in overall positive interactions throughout our day. Kindness is best fostered by being kind to ourselves to sustain our own well-being and by being kind to others in order to maintain the cycle. For clinicians who have been pushed to respond to various aspects of the COVID-19 pandemic, self-care has never been more important.

COVID-19 has been difficult for everyone, particularly the elderly and vulnerable populations. However, kindness has proved to be an overwhelming response as many businesses and individuals have taken to volunteering time and resources for those in need. Even big corporations have chipped in. For example, Lyft and Uber – in a partnership with the White House – are now offering free rides to vaccine sites, and several local businesses have donated personal protective equipment to hospitals and assisted living facilities.

Kindness and empathy are ever present in the field of mental health, medicine, and substance use treatment. The very act of caring for another involves kindness. In medicine, empathy has been defined as “an emotional experience between an observer and a subject in which the observer, based on visual and auditory cues, identifies and transiently experiences the subject’s emotional state.”⁶

As mental health professionals, we receive empathy training early on in our schooling – increasingly so over the last decade. Research has indicated that trusting relationships between clinicians and patients result in optimal care. Evidence-based communication styles are being widely implemented. This entails using nonjudgmental language, open-ended questions, and active listening skills, for example. In addition, the mental health professionals have our conscious and unconscious judgments. If empathy training is provided, we can learn to acknowledge our biases and mitigate them. Lastly, empathy training has been proven to assist with destigmatization, increase in treatment seeking, and overall better outcomes.

Substance use treatment, which often focuses on cognition and behavior changing, boundaries, and family dynamics, also requires support and kindness. Although it is not an empirically based “treatment,” Alcoholics Anonymous (AA) has used kindness for decades.

Step 12 of AA’s 12-step program, which was developed by two people with alcohol use disorder in 1935 in Akron, Ohio, is as follows: “Having had a spiritual awakening as the result of these steps, we tried to carry this message to alcoholics, and to practice these principles in all our affairs.”

Once AA members are on solid ground with their sobriety, they are urged to help others in their recovery. This process provides many benefits. When individuals are concerned about someone else, they are less focused on themselves. This helps the individuals in recovery to decrease their rumination and “get out of themselves.” It also allows for the AA member to be kind and helpful to an individual who is suffering, thereby expressing kindness, compassion, and empathy. This act of “paying it forward” produces a domino effect that has withstood the test of time as evidenced by the ever-growing fellowship of Alcoholics Anonymous.

Several small acts of kindness can help us as clinicians and our patients:

1. Practice self-care.

2. Take a half day off from your practice.

3. Give staff a half day off.

4. Call a family member or friend and ask them how they are doing. Then engage in active listening and refrain from giving advice.

5. Donate to a homeless shelter or volunteer your time at a charity.

6. Give a stranger a compliment.

7. Surprise someone with a small gift.

8. Send a loved one a letter instead of a text.

9. Pick up litter.

10. Acknowledge family and friends who gave you extra support during the pandemic.

11. Take baked goods to your office.

12. Help a neighbor with groceries.

13. Leave a generous tip.

14. Play soft music in your office.

In conclusion, kindness, empathy, and compassion are vital concepts that are not just fluffy theories. They have vast mental, physical, and social benefits for us and our patients.
 

References

1. Cedars-Sinai staff. The Science of Kindness. 2019 Feb 13. Cedars-Sinai blog.

2. Harding K. The Rabbit Effect: Live Longer, Happier, and Healthier with the Groundbreaking Science of Kindness. Atria Books, 2019.

3. Ritvo E. BeKindr. Momosa Publishing, 2017.

4. Svoboda E. “Pay it Forward.” Psychology Today. Last reviewed 2016 Jun 9.

5. Aknin LB et al. “Prosocial spending and well-being: Cross-Cultural Evidence for a Psychological Universal.” Harvard Business School. Working Paper 11-038. 2010.

6. Hirsch EM. AMA J Ethics. Virtual Mentor. 2007;9(6):423-7.

Dr. Haji is a licensed clinical psychologist specializing in psychodiagnostic assessment, forensic assessment, dual diagnosis, serious and persistent mental illness, depression, anxiety, personality disorders, and substance abuse treatment. She practices in Miami and has no conflicts of interest.

Sigmund Freud said, “Out of your vulnerabilities will come greatest strength.” What exactly did Dr. Freud mean by this?

Many aspects of mental health treatment include cognitive restructuring, behavioral changes, emotion processing, and setting boundaries. These are all critical aspects of treatment, but what about kindness and compassion?

We often forget that kindness requires us to be vulnerable and take a risk at times. Being kind to others is not always easy, and it is not always an automatic reaction. Vulnerability often involves risk, but the outcomes often outweigh fear.

Dr. Freud was highlighting that being kind, open, and honest will often result in strong character and resilience. In turn, it will help others. Psychology and psychiatry have proved time and time again that empathy, compassion, and kindness have numerous benefits for mental and physical health for both the giver and the receiver.

From a biological perspective, we know that acts of kindness signal the brain to release serotonin and dopamine, known as “feel good transmitters,” and endorphins, which in turn lessen pain, depression, and anxiety. According to Waguih W. Ishak, MD, a psychiatrist affiliated with Cedars-Sinai in Los Angeles,¹ in addition to boosting oxytocin and dopamine, being kind can increase serotonin, a neurotransmitter that helps regulate mood. Kindness and compassion have been shown to release oxytocin, known as the “love hormone,” which increases self-esteem, trust, connection, and optimism. Oxytocin also reduces blood pressure and has been dubbed the “cardioprotective” hormone. According to Kelli Harding, MD, MPH, a psychiatrist affiliated with Columbia University in New York,² kindness can extend the lifespan. Research from Emory University in Atlanta has shown that, when an individual is kind to another, the brain’s reward centers light up – resulting in a “helper’s high.” Thus, kindness is self-reinforcing.³

Kindness leads to a greater sense of connection to others and a lessening in feelings of isolation. Small acts of kindness build up compassion in oneself. Research indicates that kindness doesn’t just positively affect the giver and receiver but can also benefit onlookers. An article in Psychology Today,⁴ suggests that those who witness acts of kindness are also more likely to “pay it forward,” resulting in a domino effect. Along these same lines, altruistic people, specifically those who engage in charitable donations, expressed higher levels of overall happiness according to a 2010 Harvard Business School survey.⁵

“You can’t pour from an empty cup” is a trendy quote making its way around social media. Before we can be kind and compassionate to others, we must first be kind and compassionate to ourselves. In today’s world, productivity and pressure-filled environments consume us daily. We often find ourselves skipping meals, forgetting to connect with loved ones, missing breaks, and even neglecting our sleep. It is virtually impossible to care for others when we are depleted ourselves. Sometimes not prioritizing ourselves can result in collateral damage. We may become short-tempered, irritable, moody, and overwhelmed. At this point kindness, compassion, and empathy toward others are likely to be absent. Once we replenish ourselves, by taking time off, indulging in a nice meal, exercising, we are more likely to respond as opposed to react, ask others about themselves, and engage in overall positive interactions throughout our day. Kindness is best fostered by being kind to ourselves to sustain our own well-being and by being kind to others in order to maintain the cycle. For clinicians who have been pushed to respond to various aspects of the COVID-19 pandemic, self-care has never been more important.

COVID-19 has been difficult for everyone, particularly the elderly and vulnerable populations. However, kindness has proved to be an overwhelming response as many businesses and individuals have taken to volunteering time and resources for those in need. Even big corporations have chipped in. For example, Lyft and Uber – in a partnership with the White House – are now offering free rides to vaccine sites, and several local businesses have donated personal protective equipment to hospitals and assisted living facilities.

Kindness and empathy are ever present in the field of mental health, medicine, and substance use treatment. The very act of caring for another involves kindness. In medicine, empathy has been defined as “an emotional experience between an observer and a subject in which the observer, based on visual and auditory cues, identifies and transiently experiences the subject’s emotional state.”⁶

As mental health professionals, we receive empathy training early on in our schooling – increasingly so over the last decade. Research has indicated that trusting relationships between clinicians and patients result in optimal care. Evidence-based communication styles are being widely implemented. This entails using nonjudgmental language, open-ended questions, and active listening skills, for example. In addition, the mental health professionals have our conscious and unconscious judgments. If empathy training is provided, we can learn to acknowledge our biases and mitigate them. Lastly, empathy training has been proven to assist with destigmatization, increase in treatment seeking, and overall better outcomes.

Substance use treatment, which often focuses on cognition and behavior changing, boundaries, and family dynamics, also requires support and kindness. Although it is not an empirically based “treatment,” Alcoholics Anonymous (AA) has used kindness for decades.

Step 12 of AA’s 12-step program, which was developed by two people with alcohol use disorder in 1935 in Akron, Ohio, is as follows: “Having had a spiritual awakening as the result of these steps, we tried to carry this message to alcoholics, and to practice these principles in all our affairs.”

Once AA members are on solid ground with their sobriety, they are urged to help others in their recovery. This process provides many benefits. When individuals are concerned about someone else, they are less focused on themselves. This helps the individuals in recovery to decrease their rumination and “get out of themselves.” It also allows for the AA member to be kind and helpful to an individual who is suffering, thereby expressing kindness, compassion, and empathy. This act of “paying it forward” produces a domino effect that has withstood the test of time as evidenced by the ever-growing fellowship of Alcoholics Anonymous.

Several small acts of kindness can help us as clinicians and our patients:

1. Practice self-care.

2. Take a half day off from your practice.

3. Give staff a half day off.

4. Call a family member or friend and ask them how they are doing. Then engage in active listening and refrain from giving advice.

5. Donate to a homeless shelter or volunteer your time at a charity.

6. Give a stranger a compliment.

7. Surprise someone with a small gift.

8. Send a loved one a letter instead of a text.

9. Pick up litter.

10. Acknowledge family and friends who gave you extra support during the pandemic.

11. Take baked goods to your office.

12. Help a neighbor with groceries.

13. Leave a generous tip.

14. Play soft music in your office.

In conclusion, kindness, empathy, and compassion are vital concepts that are not just fluffy theories. They have vast mental, physical, and social benefits for us and our patients.
 

References

1. Cedars-Sinai staff. The Science of Kindness. 2019 Feb 13. Cedars-Sinai blog.

2. Harding K. The Rabbit Effect: Live Longer, Happier, and Healthier with the Groundbreaking Science of Kindness. Atria Books, 2019.

3. Ritvo E. BeKindr. Momosa Publishing, 2017.

4. Svoboda E. “Pay it Forward.” Psychology Today. Last reviewed 2016 Jun 9.

5. Aknin LB et al. “Prosocial spending and well-being: Cross-Cultural Evidence for a Psychological Universal.” Harvard Business School. Working Paper 11-038. 2010.

6. Hirsch EM. AMA J Ethics. Virtual Mentor. 2007;9(6):423-7.

Dr. Haji is a licensed clinical psychologist specializing in psychodiagnostic assessment, forensic assessment, dual diagnosis, serious and persistent mental illness, depression, anxiety, personality disorders, and substance abuse treatment. She practices in Miami and has no conflicts of interest.

A 75-year-old man with Parkinson’s disease has had three falls over the past 4 weeks. He has been compliant with his Parkinson’s treatment. Which of the following options would most help decrease his fall risk?

A. Vitamin D supplementation

B. Vitamin B₁₂ supplementation

C. Calcium supplementation

D. Tai chi

Falls are a catastrophic problem in our elderly population, and are especially common in patients with Parkinson’s disease.

There has been recent evidence that vitamin D supplementation is not helpful in preventing falls in most community-dwelling older adults. Bolland and colleagues performed a meta-analysis of 81 randomized, controlled trials and found that vitamin D supplementation does not prevent fractures or falls.¹ They found no difference or benefit in high-dose versus low-dose vitamin D supplementation.

The U.S. Preventive Services Task Force recommends against vitamin D supplementation for the purpose of preventing falls in community-dwelling adults over the age of 65.² The same USPSTF report recommends exercise intervention, as having the strongest evidence for fall prevention in community-dwelling adults age 65 or older who are at risk for falls.
 

The benefits of tai chi

Tai chi with it’s emphasis on balance, strength training as well as stress reduction is an excellent option for older adults.

Lui and colleagues performed a meta-analyses of five randomized, controlled trials (355 patients) of tai chi in patients with Parkinson disease.³ Tai chi significantly decreased fall rates (odds ratio, 0.47; 95% confidence interval, 0.30-0.74; P = .001) and significantly improved balance and functional mobility (P < .001) in people with Parkinson disease, compared with no training.

Tai chi can also help prevent falls in a more general population of elderly patients. Lomas-Vega and colleagues performed a meta-analysis of 10 high-quality studies that met inclusion criteria evaluating tai chi for fall prevention.⁴ Fall risk was reduced over short-term follow-up (incident rate ratio, 0.57; 95% CI, 0.46-0.70) and a small protective effect was seen over long-term follow-up (IRR, 0.87; 95% CI, 0.77-0.98).

Pearl: Consider tai chi in your elderly patients with fall risk to increase their balance and reduce risks of falls.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Bolland MJ et al. Lancet Diabetes Endocrinol. 2018;6(11):847.

2. U.S. Preventive Services Task Force. JAMA. 2018;319(16):1696.

3. Liu HH et al. Parkinsons Dis. 2019 Feb 21;2019:9626934

4. Lomas-Vega R et al. J Am Geriatr Soc. 2017;65(9):2037.

A 75-year-old man with Parkinson’s disease has had three falls over the past 4 weeks. He has been compliant with his Parkinson’s treatment. Which of the following options would most help decrease his fall risk?

A. Vitamin D supplementation

B. Vitamin B₁₂ supplementation

C. Calcium supplementation

D. Tai chi

Falls are a catastrophic problem in our elderly population, and are especially common in patients with Parkinson’s disease.

There has been recent evidence that vitamin D supplementation is not helpful in preventing falls in most community-dwelling older adults. Bolland and colleagues performed a meta-analysis of 81 randomized, controlled trials and found that vitamin D supplementation does not prevent fractures or falls.¹ They found no difference or benefit in high-dose versus low-dose vitamin D supplementation.

The U.S. Preventive Services Task Force recommends against vitamin D supplementation for the purpose of preventing falls in community-dwelling adults over the age of 65.² The same USPSTF report recommends exercise intervention, as having the strongest evidence for fall prevention in community-dwelling adults age 65 or older who are at risk for falls.
 

The benefits of tai chi

Tai chi with it’s emphasis on balance, strength training as well as stress reduction is an excellent option for older adults.

Lui and colleagues performed a meta-analyses of five randomized, controlled trials (355 patients) of tai chi in patients with Parkinson disease.³ Tai chi significantly decreased fall rates (odds ratio, 0.47; 95% confidence interval, 0.30-0.74; P = .001) and significantly improved balance and functional mobility (P < .001) in people with Parkinson disease, compared with no training.

Tai chi can also help prevent falls in a more general population of elderly patients. Lomas-Vega and colleagues performed a meta-analysis of 10 high-quality studies that met inclusion criteria evaluating tai chi for fall prevention.⁴ Fall risk was reduced over short-term follow-up (incident rate ratio, 0.57; 95% CI, 0.46-0.70) and a small protective effect was seen over long-term follow-up (IRR, 0.87; 95% CI, 0.77-0.98).

Pearl: Consider tai chi in your elderly patients with fall risk to increase their balance and reduce risks of falls.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Bolland MJ et al. Lancet Diabetes Endocrinol. 2018;6(11):847.

2. U.S. Preventive Services Task Force. JAMA. 2018;319(16):1696.

3. Liu HH et al. Parkinsons Dis. 2019 Feb 21;2019:9626934

4. Lomas-Vega R et al. J Am Geriatr Soc. 2017;65(9):2037.

A 75-year-old man with Parkinson’s disease has had three falls over the past 4 weeks. He has been compliant with his Parkinson’s treatment. Which of the following options would most help decrease his fall risk?

A. Vitamin D supplementation

B. Vitamin B₁₂ supplementation

C. Calcium supplementation

D. Tai chi

Falls are a catastrophic problem in our elderly population, and are especially common in patients with Parkinson’s disease.

There has been recent evidence that vitamin D supplementation is not helpful in preventing falls in most community-dwelling older adults. Bolland and colleagues performed a meta-analysis of 81 randomized, controlled trials and found that vitamin D supplementation does not prevent fractures or falls.¹ They found no difference or benefit in high-dose versus low-dose vitamin D supplementation.

The U.S. Preventive Services Task Force recommends against vitamin D supplementation for the purpose of preventing falls in community-dwelling adults over the age of 65.² The same USPSTF report recommends exercise intervention, as having the strongest evidence for fall prevention in community-dwelling adults age 65 or older who are at risk for falls.
 

The benefits of tai chi

Tai chi with it’s emphasis on balance, strength training as well as stress reduction is an excellent option for older adults.

Lui and colleagues performed a meta-analyses of five randomized, controlled trials (355 patients) of tai chi in patients with Parkinson disease.³ Tai chi significantly decreased fall rates (odds ratio, 0.47; 95% confidence interval, 0.30-0.74; P = .001) and significantly improved balance and functional mobility (P < .001) in people with Parkinson disease, compared with no training.

Tai chi can also help prevent falls in a more general population of elderly patients. Lomas-Vega and colleagues performed a meta-analysis of 10 high-quality studies that met inclusion criteria evaluating tai chi for fall prevention.⁴ Fall risk was reduced over short-term follow-up (incident rate ratio, 0.57; 95% CI, 0.46-0.70) and a small protective effect was seen over long-term follow-up (IRR, 0.87; 95% CI, 0.77-0.98).

Pearl: Consider tai chi in your elderly patients with fall risk to increase their balance and reduce risks of falls.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Bolland MJ et al. Lancet Diabetes Endocrinol. 2018;6(11):847.

2. U.S. Preventive Services Task Force. JAMA. 2018;319(16):1696.

3. Liu HH et al. Parkinsons Dis. 2019 Feb 21;2019:9626934

4. Lomas-Vega R et al. J Am Geriatr Soc. 2017;65(9):2037.

As the number of patients struggling with lingering effects of COVID-19 grows, much of the diagnosis and symptom management will fall on primary care, experts say.

“It could be as many as 5% to 10% who are still having symptoms at 12 weeks. Those numbers are higher if you’re talking about patients who had been hospitalized with COVID-19,” Russ Phillips, MD, director of the Center for Primary Care at Harvard Medical School, Boston, said in an interview.

A recent study from the Centers for Disease Control and Prevention and Kaiser Permanente Georgia found that among 3,171 nonhospitalized adult patients with COVID-19, 69% had one or more outpatient visits 28 to 180 days after the diagnosis. Two-thirds had a visit for a new primary diagnosis, and about one-third had a new specialist visit. Symptom diagnoses included cough, shortness of breath, chest or throat pain, and fatigue.

These visits have come while cases of acute COVID continue to occur, and there has been an increase in patients returning to primary care after avoiding it while the pandemic surged. For these patients, delay in seeking care has often led a worsening of chronic conditions.

Dr. Phillips pointed to a shortcoming in primary care that will need to be addressed with regard to long-COVID: “We don’t have good systems to follow patients and their symptoms over time.”

Long-COVID will require that kind of care, but current payment systems don’t support proactively reaching out to patients to track them over time, he noted.

“We do a good job of identifying these issues for patients who come in, but it’s the patients who don’t that we worry about the most,” he said.

Dr. Phillips provided examples of the kind of management plans needed to improve outcomes for patients with long-COVID. In anticoagulation clinics, patients who receive blood thinners are monitored closely, and in mental health care, patients with depression are linked with social workers and are monitored regularly.

“Around COVID, those management plans are in their infancy,” he said.

John Brooks, MD, chief medical officer for the CDC’s COVID-19 response, testified in a congressional hearing at the end of April that interim guidance concerning protocols for long-COVID in primary care are forthcoming. He also noted that the CDC is working closely with the Centers for Medicare & Medicaid Services to develop medical coding for long-COVID.

In the meantime, Dr. Phillips said, one strategy is to have patients self-monitor their condition and relay results to primary care physicians electronically.

As an example, Dr. Phillips described a patient with long-COVID who was receiving supplemental oxygen and who wanted to resume her exercise regimen.

She checked her own oxygen saturation levels before and during exercise and reported the levels every few days through their patient portal.

“Very slowly we were able to cut down on her oxygen and increase her exercise capacity until she no longer needed oxygen and could go back to her usual activities of daily living,” he said.

Nurse practitioners, social workers, and other nonphysician care team members may be increasingly relied upon to provide care for long-COVID patients as well, he said.

Additionally, telehealth, which is currently reimbursed the same way as in-person visits are, enables easier access for checking in with patients, he said.
 

Empathy and listening needed

Sabrina Assoumou, MD, MPH, assistant professor of medicine at Boston University, told this news organization that it will be crucial to address health care disparities as long-COVID cases mount.

COVID disproportionately affects communities of color, and it stands to reason that this will be the case for long-COVID as well, she said. Diversifying the workforce will be vital, inasmuch as diagnosis may depend on how well a physician listens to patients as they describe their symptoms, continued Dr. Assoumou, whose primary care practice centers on HIV patients.

The symptoms of long-COVID are vague, she explained, and include brain fog, fatigue, and shortness of breath, and it takes longer to diagnose than many conditions.

Dr. Assoumou said some people were never tested for COVID and never received a diagnosis, yet they are now experiencing the extended effects.

“Long-COVID will force us to go back to the basics – like really listening to our patients,” she said. “We’re definitely going to need to be more empathetic.”
 

No large influx yet

Charles Vega, MD, health sciences clinical professor of family medicine at the University of California, Irvine, said he is skeptical that the primary care system will be overwhelmed with long-COVID cases.

Dr. Vega is a family physician working in the largest safety net clinic in Orange County, California. About 90% of his patients are LatinX, a population disproportionately burdened by COVID, yet he hasn’t seen a surge in long-COVID cases.

He said that may be because patients know there isn’t a treatment for long-COVID. They are well connected through online forums such as Body Politic COVID-19 Support Group and may not feel they need to see a doctor.

“It wasn’t scientists finding [long-COVID], it was patients who developed this disease model themselves,” he said. “That’s where most of the data sharing is.”

Yet, for long-COVID patients who do need care, primary care is the best home for them, Dr. Vega said.

He said the most common symptoms he sees are fatigue and poor activity tolerance. “They get winded going to the bathroom,” he said.

The most difficult symptom is dyspnea, he said. Patients describe being breathless, but it’s not bad enough to qualify for supplemental oxygen.

“Being breathless is a pretty desperate thing and hurts quality of life,” he said.

Most patients describe general malaise.

Care for long-COVID will require medical care and mental health care, Dr. Vega notes. Primary care is already set up to screen and to coordinate care with the appropriate provider.

“I think there’s a role for specialists, but primary care has to be involved,” he said.

Dr. Phillips, Dr. Assoumou, and Dr. Vega report no relevant financial relationships.

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

As the number of patients struggling with lingering effects of COVID-19 grows, much of the diagnosis and symptom management will fall on primary care, experts say.

“It could be as many as 5% to 10% who are still having symptoms at 12 weeks. Those numbers are higher if you’re talking about patients who had been hospitalized with COVID-19,” Russ Phillips, MD, director of the Center for Primary Care at Harvard Medical School, Boston, said in an interview.

A recent study from the Centers for Disease Control and Prevention and Kaiser Permanente Georgia found that among 3,171 nonhospitalized adult patients with COVID-19, 69% had one or more outpatient visits 28 to 180 days after the diagnosis. Two-thirds had a visit for a new primary diagnosis, and about one-third had a new specialist visit. Symptom diagnoses included cough, shortness of breath, chest or throat pain, and fatigue.

These visits have come while cases of acute COVID continue to occur, and there has been an increase in patients returning to primary care after avoiding it while the pandemic surged. For these patients, delay in seeking care has often led a worsening of chronic conditions.

Dr. Phillips pointed to a shortcoming in primary care that will need to be addressed with regard to long-COVID: “We don’t have good systems to follow patients and their symptoms over time.”

Long-COVID will require that kind of care, but current payment systems don’t support proactively reaching out to patients to track them over time, he noted.

“We do a good job of identifying these issues for patients who come in, but it’s the patients who don’t that we worry about the most,” he said.

Dr. Phillips provided examples of the kind of management plans needed to improve outcomes for patients with long-COVID. In anticoagulation clinics, patients who receive blood thinners are monitored closely, and in mental health care, patients with depression are linked with social workers and are monitored regularly.

“Around COVID, those management plans are in their infancy,” he said.

John Brooks, MD, chief medical officer for the CDC’s COVID-19 response, testified in a congressional hearing at the end of April that interim guidance concerning protocols for long-COVID in primary care are forthcoming. He also noted that the CDC is working closely with the Centers for Medicare & Medicaid Services to develop medical coding for long-COVID.

In the meantime, Dr. Phillips said, one strategy is to have patients self-monitor their condition and relay results to primary care physicians electronically.

As an example, Dr. Phillips described a patient with long-COVID who was receiving supplemental oxygen and who wanted to resume her exercise regimen.

She checked her own oxygen saturation levels before and during exercise and reported the levels every few days through their patient portal.

“Very slowly we were able to cut down on her oxygen and increase her exercise capacity until she no longer needed oxygen and could go back to her usual activities of daily living,” he said.

Nurse practitioners, social workers, and other nonphysician care team members may be increasingly relied upon to provide care for long-COVID patients as well, he said.

Additionally, telehealth, which is currently reimbursed the same way as in-person visits are, enables easier access for checking in with patients, he said.
 

Empathy and listening needed

Sabrina Assoumou, MD, MPH, assistant professor of medicine at Boston University, told this news organization that it will be crucial to address health care disparities as long-COVID cases mount.

COVID disproportionately affects communities of color, and it stands to reason that this will be the case for long-COVID as well, she said. Diversifying the workforce will be vital, inasmuch as diagnosis may depend on how well a physician listens to patients as they describe their symptoms, continued Dr. Assoumou, whose primary care practice centers on HIV patients.

The symptoms of long-COVID are vague, she explained, and include brain fog, fatigue, and shortness of breath, and it takes longer to diagnose than many conditions.

Dr. Assoumou said some people were never tested for COVID and never received a diagnosis, yet they are now experiencing the extended effects.

“Long-COVID will force us to go back to the basics – like really listening to our patients,” she said. “We’re definitely going to need to be more empathetic.”
 

No large influx yet

Charles Vega, MD, health sciences clinical professor of family medicine at the University of California, Irvine, said he is skeptical that the primary care system will be overwhelmed with long-COVID cases.

Dr. Vega is a family physician working in the largest safety net clinic in Orange County, California. About 90% of his patients are LatinX, a population disproportionately burdened by COVID, yet he hasn’t seen a surge in long-COVID cases.

He said that may be because patients know there isn’t a treatment for long-COVID. They are well connected through online forums such as Body Politic COVID-19 Support Group and may not feel they need to see a doctor.

“It wasn’t scientists finding [long-COVID], it was patients who developed this disease model themselves,” he said. “That’s where most of the data sharing is.”

Yet, for long-COVID patients who do need care, primary care is the best home for them, Dr. Vega said.

He said the most common symptoms he sees are fatigue and poor activity tolerance. “They get winded going to the bathroom,” he said.

The most difficult symptom is dyspnea, he said. Patients describe being breathless, but it’s not bad enough to qualify for supplemental oxygen.

“Being breathless is a pretty desperate thing and hurts quality of life,” he said.

Most patients describe general malaise.

Care for long-COVID will require medical care and mental health care, Dr. Vega notes. Primary care is already set up to screen and to coordinate care with the appropriate provider.

“I think there’s a role for specialists, but primary care has to be involved,” he said.

Dr. Phillips, Dr. Assoumou, and Dr. Vega report no relevant financial relationships.

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

As the number of patients struggling with lingering effects of COVID-19 grows, much of the diagnosis and symptom management will fall on primary care, experts say.

“It could be as many as 5% to 10% who are still having symptoms at 12 weeks. Those numbers are higher if you’re talking about patients who had been hospitalized with COVID-19,” Russ Phillips, MD, director of the Center for Primary Care at Harvard Medical School, Boston, said in an interview.

A recent study from the Centers for Disease Control and Prevention and Kaiser Permanente Georgia found that among 3,171 nonhospitalized adult patients with COVID-19, 69% had one or more outpatient visits 28 to 180 days after the diagnosis. Two-thirds had a visit for a new primary diagnosis, and about one-third had a new specialist visit. Symptom diagnoses included cough, shortness of breath, chest or throat pain, and fatigue.

These visits have come while cases of acute COVID continue to occur, and there has been an increase in patients returning to primary care after avoiding it while the pandemic surged. For these patients, delay in seeking care has often led a worsening of chronic conditions.

Dr. Phillips pointed to a shortcoming in primary care that will need to be addressed with regard to long-COVID: “We don’t have good systems to follow patients and their symptoms over time.”

Long-COVID will require that kind of care, but current payment systems don’t support proactively reaching out to patients to track them over time, he noted.

“We do a good job of identifying these issues for patients who come in, but it’s the patients who don’t that we worry about the most,” he said.

Dr. Phillips provided examples of the kind of management plans needed to improve outcomes for patients with long-COVID. In anticoagulation clinics, patients who receive blood thinners are monitored closely, and in mental health care, patients with depression are linked with social workers and are monitored regularly.

“Around COVID, those management plans are in their infancy,” he said.

John Brooks, MD, chief medical officer for the CDC’s COVID-19 response, testified in a congressional hearing at the end of April that interim guidance concerning protocols for long-COVID in primary care are forthcoming. He also noted that the CDC is working closely with the Centers for Medicare & Medicaid Services to develop medical coding for long-COVID.

In the meantime, Dr. Phillips said, one strategy is to have patients self-monitor their condition and relay results to primary care physicians electronically.

As an example, Dr. Phillips described a patient with long-COVID who was receiving supplemental oxygen and who wanted to resume her exercise regimen.

She checked her own oxygen saturation levels before and during exercise and reported the levels every few days through their patient portal.

“Very slowly we were able to cut down on her oxygen and increase her exercise capacity until she no longer needed oxygen and could go back to her usual activities of daily living,” he said.

Nurse practitioners, social workers, and other nonphysician care team members may be increasingly relied upon to provide care for long-COVID patients as well, he said.

Additionally, telehealth, which is currently reimbursed the same way as in-person visits are, enables easier access for checking in with patients, he said.
 

Empathy and listening needed

Sabrina Assoumou, MD, MPH, assistant professor of medicine at Boston University, told this news organization that it will be crucial to address health care disparities as long-COVID cases mount.

COVID disproportionately affects communities of color, and it stands to reason that this will be the case for long-COVID as well, she said. Diversifying the workforce will be vital, inasmuch as diagnosis may depend on how well a physician listens to patients as they describe their symptoms, continued Dr. Assoumou, whose primary care practice centers on HIV patients.

The symptoms of long-COVID are vague, she explained, and include brain fog, fatigue, and shortness of breath, and it takes longer to diagnose than many conditions.

Dr. Assoumou said some people were never tested for COVID and never received a diagnosis, yet they are now experiencing the extended effects.

“Long-COVID will force us to go back to the basics – like really listening to our patients,” she said. “We’re definitely going to need to be more empathetic.”
 

No large influx yet

Charles Vega, MD, health sciences clinical professor of family medicine at the University of California, Irvine, said he is skeptical that the primary care system will be overwhelmed with long-COVID cases.

Dr. Vega is a family physician working in the largest safety net clinic in Orange County, California. About 90% of his patients are LatinX, a population disproportionately burdened by COVID, yet he hasn’t seen a surge in long-COVID cases.

He said that may be because patients know there isn’t a treatment for long-COVID. They are well connected through online forums such as Body Politic COVID-19 Support Group and may not feel they need to see a doctor.

“It wasn’t scientists finding [long-COVID], it was patients who developed this disease model themselves,” he said. “That’s where most of the data sharing is.”

Yet, for long-COVID patients who do need care, primary care is the best home for them, Dr. Vega said.

He said the most common symptoms he sees are fatigue and poor activity tolerance. “They get winded going to the bathroom,” he said.

The most difficult symptom is dyspnea, he said. Patients describe being breathless, but it’s not bad enough to qualify for supplemental oxygen.

“Being breathless is a pretty desperate thing and hurts quality of life,” he said.

Most patients describe general malaise.

Care for long-COVID will require medical care and mental health care, Dr. Vega notes. Primary care is already set up to screen and to coordinate care with the appropriate provider.

“I think there’s a role for specialists, but primary care has to be involved,” he said.

Dr. Phillips, Dr. Assoumou, and Dr. Vega report no relevant financial relationships.

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

Although use of some herbal and dietary supplements show statistically greater weight loss compared with placebo, it is not sufficient to benefit health, according to the joint findings of two systematic reviews, which are the first to comprehensively include all available herbal and dietary supplements for weight loss for over 15 years.

Sally Kubetin/MDedge News

“There is currently insufficient evidence to recommend any of the supplements we included in our reviews for weight loss,” stressed lead author Erica Bessell, a PhD candidate from the University of Sydney.

She added that some products with promising results warrant further investigation in well-conducted randomized controlled trials (RCTs) to determine their efficacy and safety.

But, overall, she would like to see a reduction in the number of products on the market without evidence to support their efficacy, “because, as we found, many of the products currently marketed for weight loss just do not work.

“Herbal and dietary supplements might seem like a quick-fix solution to weight problems, but people need to be aware of how little we actually know about them,” she said in an interview. “We would recommend that people trying to lose weight should save their money and seek out evidence-based care instead,” she emphasized.

The research was presented as two posters at this year’s online European Congress on Obesity (ECO). The meeting was presented by the European Association for the Study of Obesity.
 

Herbal and dietary supplement industry booming

Supplements for weight loss are growing in popularity, sustaining a rapidly expanding business sector globally. In the United States, the herbal and dietary supplements industry was estimated to be worth USD $41 billion in 2020, with 15% of Americans having tried a weight loss supplement in their efforts to shed pounds.

In light of this, Ms. Bessell said it is increasingly important to ensure supplements are efficacious and safe: “The popularity of these products underscores the urgency of conducting larger, more rigorous studies to have reasonable assurance of their safety and effectiveness for weight loss.”

Commenting on the study and the wider issues related to the surge in uptake of herbal and dietary supplements, Susan Arentz, PhD, said the evidence is similar to that for other complex interventions that people attempt for weight loss, including for example exercise, in that it is heterogeneous and low quality.

“One outstanding limitation for herbal medicine was the failure of trialists to validate the contents of interventions. Given the chemical variability of plants grown and harvested in different conditions, and the presence of pharmaceuticals and heavy metals found in some supplements ... future investigations of standardized herbal supplements and RCTs of higher methodological quality are needed,” remarked Dr. Arentz, a board member of the Australasian Integrative Medicine Association and researcher at Western Sydney University.

“Also, further RCTs are warranted due to the consumer preferences for natural treatments, especially in health settings with predominant use of traditional medicines and practices,” said Dr. Arentz.   
 

One review for herbal supplements, one for organic compounds

To accommodate the large number of trials investigating supplements for weight loss, the researchers conducted two systematic reviews, together representing 121 randomized placebo-controlled trials. One of the reviews investigated herbal supplements, and the other examined supplements with isolated organic compounds for example, specific fibers or lipids.  

Many of the included trials had been published in the last decade and had not been previously included in an up-to-date systematic review.

Ms. Bessell added that many studies often had a small sample size or were poorly designed, with insufficient information on the composition of supplements, and often featured little data on long-term effectiveness.

The two reviews primarily analyzed efficacy, not safety, because many of the studies did not report adverse effects.

The first review, published last year in Diabetes, Obesity and Metabolism, looked at 54 placebo-controlled randomized trials up to August 2018 on the effect of herbal supplements on weight loss . The study included 4,331 individuals aged 16 years or older who were overweight or obese. To be clinically meaningful, a weight loss of at least 2.5 kg was required over a period of, most often, 12 weeks or less.

Herbal supplements included in the analysis included green tea, Garcinia cambogia and mangosteen (tropical fruits), white kidney bean, ephedra (a stimulant that increases metabolism), African mango, yerba mate (herbal tea made from the leaves and twigs of the Ilex paraguariensis plant), veld grape (commonly used in Indian traditional medicine), licorice root, and East Indian Globe Thistle (used in Ayurvedic medicine).

The second review analyzed 67 randomized trials up to December 2019 that compared the effect of dietary supplements containing naturally occurring isolated organic compounds to placebo for weight loss in 5,194 individuals aged 16 years or older who were overweight or obese.

Meta-analyses were conducted for chitosan, glucomannan, conjugated linoleic acid, and fructans comparing the mean weight difference post intervention between participants receiving the dietary supplement and those on placebo.
 

No clinically significant results

Commenting on the overall results, Ms. Bessell said: “Though most supplements were safe for use in the short term, very few were found to produce clinically meaningful weight loss. Those that were found to result in clinically meaningful weight loss had only been investigated in one or two trials, so we need more research.”

The first review on herbal supplements found that only Phaseolus vulgaris (white kidney bean) resulted in significant weight loss compared with placebo, with an average weight difference of 1.61 kg (3.5 pounds). The result was not clinically meaningful, however.

For isolated organic compounds, significant weight differences compared with placebo were seen for chitosan, with a mean difference of 1.84 kg (4 pounds), glucomannan at 1.27 kg (2.8 pounds), and conjugated linoleic acid at 1.08 kg (2.4 pounds).

Again, none of these findings met the criteria for clinical significance (weight loss of 2.5 kg [5.5 pounds] or more).

In addition, some combination preparations containing African mango, veld grape, East Indian Globe Thistle, and mangosteen showed promising results with a mean weight difference of 1.85 kg (4 pounds), but were investigated in three or fewer trials, often with poor research methodology or reporting, and the findings should be interpreted with caution, the researchers noted.

Other dietary supplements, including modified cellulose – a plant fiber that expands in the stomach to induce a feeling of fullness – and blood orange juice extract, also showed encouraging results but were investigated in one trial and need more evidence before they can be recommended for weight loss, Ms. Bessell added.

She pointed out that some supplements are banned in some countries, such as ephedra (an extract from the plant Ephedra sinica). “This supplement is already banned in many countries because of the risk of serious adverse effects. The possibility of drug interactions may also be present with some other supplements, so health professionals and consumers should be aware of this.”

The isolated organic compounds supplements review was published in the International Journal of Obesity to coincide with the ECO 2021 conference.

Ms. Bessell has declared no relevant conflicts of interests. Dr. Arentz reviewed the systematic review of RCTs of herbal medicine supplements for weight loss published in Diabetes, Obesity and Metabolism.
 

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

Although use of some herbal and dietary supplements show statistically greater weight loss compared with placebo, it is not sufficient to benefit health, according to the joint findings of two systematic reviews, which are the first to comprehensively include all available herbal and dietary supplements for weight loss for over 15 years.

Sally Kubetin/MDedge News

“There is currently insufficient evidence to recommend any of the supplements we included in our reviews for weight loss,” stressed lead author Erica Bessell, a PhD candidate from the University of Sydney.

She added that some products with promising results warrant further investigation in well-conducted randomized controlled trials (RCTs) to determine their efficacy and safety.

But, overall, she would like to see a reduction in the number of products on the market without evidence to support their efficacy, “because, as we found, many of the products currently marketed for weight loss just do not work.

“Herbal and dietary supplements might seem like a quick-fix solution to weight problems, but people need to be aware of how little we actually know about them,” she said in an interview. “We would recommend that people trying to lose weight should save their money and seek out evidence-based care instead,” she emphasized.

The research was presented as two posters at this year’s online European Congress on Obesity (ECO). The meeting was presented by the European Association for the Study of Obesity.
 

Herbal and dietary supplement industry booming

Supplements for weight loss are growing in popularity, sustaining a rapidly expanding business sector globally. In the United States, the herbal and dietary supplements industry was estimated to be worth USD $41 billion in 2020, with 15% of Americans having tried a weight loss supplement in their efforts to shed pounds.

In light of this, Ms. Bessell said it is increasingly important to ensure supplements are efficacious and safe: “The popularity of these products underscores the urgency of conducting larger, more rigorous studies to have reasonable assurance of their safety and effectiveness for weight loss.”

Commenting on the study and the wider issues related to the surge in uptake of herbal and dietary supplements, Susan Arentz, PhD, said the evidence is similar to that for other complex interventions that people attempt for weight loss, including for example exercise, in that it is heterogeneous and low quality.

“One outstanding limitation for herbal medicine was the failure of trialists to validate the contents of interventions. Given the chemical variability of plants grown and harvested in different conditions, and the presence of pharmaceuticals and heavy metals found in some supplements ... future investigations of standardized herbal supplements and RCTs of higher methodological quality are needed,” remarked Dr. Arentz, a board member of the Australasian Integrative Medicine Association and researcher at Western Sydney University.

“Also, further RCTs are warranted due to the consumer preferences for natural treatments, especially in health settings with predominant use of traditional medicines and practices,” said Dr. Arentz.   
 

One review for herbal supplements, one for organic compounds

To accommodate the large number of trials investigating supplements for weight loss, the researchers conducted two systematic reviews, together representing 121 randomized placebo-controlled trials. One of the reviews investigated herbal supplements, and the other examined supplements with isolated organic compounds for example, specific fibers or lipids.  

Many of the included trials had been published in the last decade and had not been previously included in an up-to-date systematic review.

Ms. Bessell added that many studies often had a small sample size or were poorly designed, with insufficient information on the composition of supplements, and often featured little data on long-term effectiveness.

The two reviews primarily analyzed efficacy, not safety, because many of the studies did not report adverse effects.

The first review, published last year in Diabetes, Obesity and Metabolism, looked at 54 placebo-controlled randomized trials up to August 2018 on the effect of herbal supplements on weight loss . The study included 4,331 individuals aged 16 years or older who were overweight or obese. To be clinically meaningful, a weight loss of at least 2.5 kg was required over a period of, most often, 12 weeks or less.

Herbal supplements included in the analysis included green tea, Garcinia cambogia and mangosteen (tropical fruits), white kidney bean, ephedra (a stimulant that increases metabolism), African mango, yerba mate (herbal tea made from the leaves and twigs of the Ilex paraguariensis plant), veld grape (commonly used in Indian traditional medicine), licorice root, and East Indian Globe Thistle (used in Ayurvedic medicine).

The second review analyzed 67 randomized trials up to December 2019 that compared the effect of dietary supplements containing naturally occurring isolated organic compounds to placebo for weight loss in 5,194 individuals aged 16 years or older who were overweight or obese.

Meta-analyses were conducted for chitosan, glucomannan, conjugated linoleic acid, and fructans comparing the mean weight difference post intervention between participants receiving the dietary supplement and those on placebo.
 

No clinically significant results

Commenting on the overall results, Ms. Bessell said: “Though most supplements were safe for use in the short term, very few were found to produce clinically meaningful weight loss. Those that were found to result in clinically meaningful weight loss had only been investigated in one or two trials, so we need more research.”

The first review on herbal supplements found that only Phaseolus vulgaris (white kidney bean) resulted in significant weight loss compared with placebo, with an average weight difference of 1.61 kg (3.5 pounds). The result was not clinically meaningful, however.

For isolated organic compounds, significant weight differences compared with placebo were seen for chitosan, with a mean difference of 1.84 kg (4 pounds), glucomannan at 1.27 kg (2.8 pounds), and conjugated linoleic acid at 1.08 kg (2.4 pounds).

Again, none of these findings met the criteria for clinical significance (weight loss of 2.5 kg [5.5 pounds] or more).

In addition, some combination preparations containing African mango, veld grape, East Indian Globe Thistle, and mangosteen showed promising results with a mean weight difference of 1.85 kg (4 pounds), but were investigated in three or fewer trials, often with poor research methodology or reporting, and the findings should be interpreted with caution, the researchers noted.

Other dietary supplements, including modified cellulose – a plant fiber that expands in the stomach to induce a feeling of fullness – and blood orange juice extract, also showed encouraging results but were investigated in one trial and need more evidence before they can be recommended for weight loss, Ms. Bessell added.

She pointed out that some supplements are banned in some countries, such as ephedra (an extract from the plant Ephedra sinica). “This supplement is already banned in many countries because of the risk of serious adverse effects. The possibility of drug interactions may also be present with some other supplements, so health professionals and consumers should be aware of this.”

The isolated organic compounds supplements review was published in the International Journal of Obesity to coincide with the ECO 2021 conference.

Ms. Bessell has declared no relevant conflicts of interests. Dr. Arentz reviewed the systematic review of RCTs of herbal medicine supplements for weight loss published in Diabetes, Obesity and Metabolism.
 

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

Although use of some herbal and dietary supplements show statistically greater weight loss compared with placebo, it is not sufficient to benefit health, according to the joint findings of two systematic reviews, which are the first to comprehensively include all available herbal and dietary supplements for weight loss for over 15 years.

Sally Kubetin/MDedge News

“There is currently insufficient evidence to recommend any of the supplements we included in our reviews for weight loss,” stressed lead author Erica Bessell, a PhD candidate from the University of Sydney.

She added that some products with promising results warrant further investigation in well-conducted randomized controlled trials (RCTs) to determine their efficacy and safety.

But, overall, she would like to see a reduction in the number of products on the market without evidence to support their efficacy, “because, as we found, many of the products currently marketed for weight loss just do not work.

“Herbal and dietary supplements might seem like a quick-fix solution to weight problems, but people need to be aware of how little we actually know about them,” she said in an interview. “We would recommend that people trying to lose weight should save their money and seek out evidence-based care instead,” she emphasized.

The research was presented as two posters at this year’s online European Congress on Obesity (ECO). The meeting was presented by the European Association for the Study of Obesity.
 

Herbal and dietary supplement industry booming

Supplements for weight loss are growing in popularity, sustaining a rapidly expanding business sector globally. In the United States, the herbal and dietary supplements industry was estimated to be worth USD $41 billion in 2020, with 15% of Americans having tried a weight loss supplement in their efforts to shed pounds.

In light of this, Ms. Bessell said it is increasingly important to ensure supplements are efficacious and safe: “The popularity of these products underscores the urgency of conducting larger, more rigorous studies to have reasonable assurance of their safety and effectiveness for weight loss.”

Commenting on the study and the wider issues related to the surge in uptake of herbal and dietary supplements, Susan Arentz, PhD, said the evidence is similar to that for other complex interventions that people attempt for weight loss, including for example exercise, in that it is heterogeneous and low quality.

“One outstanding limitation for herbal medicine was the failure of trialists to validate the contents of interventions. Given the chemical variability of plants grown and harvested in different conditions, and the presence of pharmaceuticals and heavy metals found in some supplements ... future investigations of standardized herbal supplements and RCTs of higher methodological quality are needed,” remarked Dr. Arentz, a board member of the Australasian Integrative Medicine Association and researcher at Western Sydney University.

“Also, further RCTs are warranted due to the consumer preferences for natural treatments, especially in health settings with predominant use of traditional medicines and practices,” said Dr. Arentz.   
 

One review for herbal supplements, one for organic compounds

To accommodate the large number of trials investigating supplements for weight loss, the researchers conducted two systematic reviews, together representing 121 randomized placebo-controlled trials. One of the reviews investigated herbal supplements, and the other examined supplements with isolated organic compounds for example, specific fibers or lipids.  

Many of the included trials had been published in the last decade and had not been previously included in an up-to-date systematic review.

Ms. Bessell added that many studies often had a small sample size or were poorly designed, with insufficient information on the composition of supplements, and often featured little data on long-term effectiveness.

The two reviews primarily analyzed efficacy, not safety, because many of the studies did not report adverse effects.

The first review, published last year in Diabetes, Obesity and Metabolism, looked at 54 placebo-controlled randomized trials up to August 2018 on the effect of herbal supplements on weight loss . The study included 4,331 individuals aged 16 years or older who were overweight or obese. To be clinically meaningful, a weight loss of at least 2.5 kg was required over a period of, most often, 12 weeks or less.

Herbal supplements included in the analysis included green tea, Garcinia cambogia and mangosteen (tropical fruits), white kidney bean, ephedra (a stimulant that increases metabolism), African mango, yerba mate (herbal tea made from the leaves and twigs of the Ilex paraguariensis plant), veld grape (commonly used in Indian traditional medicine), licorice root, and East Indian Globe Thistle (used in Ayurvedic medicine).

The second review analyzed 67 randomized trials up to December 2019 that compared the effect of dietary supplements containing naturally occurring isolated organic compounds to placebo for weight loss in 5,194 individuals aged 16 years or older who were overweight or obese.

Meta-analyses were conducted for chitosan, glucomannan, conjugated linoleic acid, and fructans comparing the mean weight difference post intervention between participants receiving the dietary supplement and those on placebo.
 

No clinically significant results

Commenting on the overall results, Ms. Bessell said: “Though most supplements were safe for use in the short term, very few were found to produce clinically meaningful weight loss. Those that were found to result in clinically meaningful weight loss had only been investigated in one or two trials, so we need more research.”

The first review on herbal supplements found that only Phaseolus vulgaris (white kidney bean) resulted in significant weight loss compared with placebo, with an average weight difference of 1.61 kg (3.5 pounds). The result was not clinically meaningful, however.

For isolated organic compounds, significant weight differences compared with placebo were seen for chitosan, with a mean difference of 1.84 kg (4 pounds), glucomannan at 1.27 kg (2.8 pounds), and conjugated linoleic acid at 1.08 kg (2.4 pounds).

Again, none of these findings met the criteria for clinical significance (weight loss of 2.5 kg [5.5 pounds] or more).

In addition, some combination preparations containing African mango, veld grape, East Indian Globe Thistle, and mangosteen showed promising results with a mean weight difference of 1.85 kg (4 pounds), but were investigated in three or fewer trials, often with poor research methodology or reporting, and the findings should be interpreted with caution, the researchers noted.

Other dietary supplements, including modified cellulose – a plant fiber that expands in the stomach to induce a feeling of fullness – and blood orange juice extract, also showed encouraging results but were investigated in one trial and need more evidence before they can be recommended for weight loss, Ms. Bessell added.

She pointed out that some supplements are banned in some countries, such as ephedra (an extract from the plant Ephedra sinica). “This supplement is already banned in many countries because of the risk of serious adverse effects. The possibility of drug interactions may also be present with some other supplements, so health professionals and consumers should be aware of this.”

The isolated organic compounds supplements review was published in the International Journal of Obesity to coincide with the ECO 2021 conference.

Ms. Bessell has declared no relevant conflicts of interests. Dr. Arentz reviewed the systematic review of RCTs of herbal medicine supplements for weight loss published in Diabetes, Obesity and Metabolism.
 

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

Those of us treating nonalcoholic fatty liver disease (NAFLD) often find ourselves having similar conversations with our patients. After diagnosis, our next step is usually describing to them how they can improve their outcomes through a healthy diet and exercise.

Westend61/Getty Images

We can point to the latest data espousing the benefits of moderate weight reduction. The recently released American Gastroenterological Association (AGA) Clinical Practice Update gives us compelling evidence of what can be achieved with specific thresholds of total body weight loss: >5% can decrease hepatic steatosis, >7% potentially leads to resolution of nonalcoholic steatohepatitis, and >10% possibly allows for regression or stability of fibrosis.

More often than not, our patients then ask us, “What diet do you recommend?”

The AGA’s Clinical Practice Update recommends that people with NAFLD follow the Mediterranean diet, minimize saturated fatty acid intake (specifically red and processed meat), and limit or eliminate consumption of commercially produced fructose.

It’s a tried-and-true, evidence-based recommendation. Yet, recent data suggest that modifying the Mediterranean diet so that it’s further enriched with specific green polyphenols may yield even more benefits to at-risk patients.
 

The upside of a greener Mediterranean diet

In a recently published study, investigators behind the DIRECT-PLUS clinical trial randomly assigned 294 participants with abdominal obesity/dyslipidemia into three diet groups (all accompanied by physical activity): standard healthy dietary guidelines (HDG), standard Mediterranean, and the so-called green Mediterranean diet.

Both Mediterranean diet groups were calorie restricted and called for 28 g/day of walnuts (+440 mg/day polyphenols provided). However, the green Mediterranean diet was further supplemented with 3-4 cups/day of green tea and 100 g/day of Mankai (a Wolffia globosa aquatic plant strain) in the form of frozen cubes turned into a green shake that replaced dinner (+1,240 mg/day total polyphenols provided). The percent change in intrahepatic fat content was quantified continuously by proton magnetic resonance spectroscopy. NAFLD was defined as an intrahepatic fat content of >5%.

After 18 months, the prevalence of NAFLD declined to 54.8% in the HDG group, 47.9% in the standard Mediterranean group, and 31.5% in the green Mediterranean group. Both Mediterranean groups achieved similar moderate weight loss and had significantly higher total plasma polyphenol levels versus the HDG group. However, the green Mediterranean group achieved significantly greater proportional intrahepatic fat content loss (-38.9%) than both the standard Mediterranean (-19.6; P = .023) and HDG (-12.2%; P < .001) groups.

In isolating the individual components of the diets, researchers determined that the degree of intrahepatic fat content loss was significantly associated with increased Mankai and walnut intake, decreased red/processed meat consumption, improved serum folate and adipokines/lipids biomarkers, and changes in microbiome composition and specific bacteria.

The authors suggest that the mechanisms by which polyphenols reduced steatosis and prevented liver injury may include reduced de novo lipogenesis, increased fatty acid oxidation, and reduced oxidative stress.

In an additional analysis, DIRECT-PLUS investigators also revealed the beneficial effects of the green Mediterranean diet on cardiometabolic health. Although both Mediterranean diets achieved similar weight loss (-6.2 kg for green Mediterranean and -5.4 kg for standard Mediterranean), which was superior to that observed in the HDG group (-1.5 kg; P < .001), the green Mediterranean group had a greater reduction in waist circumference than the standard Mediterranean group (-8.6 vs. -6.8 cm, respectively; P = .033). Within 6 months, the green Mediterranean group also achieved a greater decrease in low-density lipoprotein cholesterol levels, diastolic blood pressure, and insulin resistance.
 

A new dietary tool for combating obesity

The rising global incidence of NAFLD has made it even more urgent to identify new and improved ways of preventing the onset of obesity-related complications. To aid those efforts, we’ve been equipped with useful tools for educating our patients and their families, such as the 2020-2025 Dietary Guidelines for Americans from the U.S. Department of Agriculture (USDA), which makes a clear case for the disease-combating effects of healthy eating patterns.

This message does not appear to be making the impact it should, however, particularly among teens and young adults. It was recently reported that in 2017, only 7% of U.S. high school students consumed recommended amounts of fruits and only 2% consumed enough vegetables to meet USDA recommendations.

Novel approaches, including enhanced school and community programs, will be required to address this issue, but so will presenting patients with satisfactory dietary alternatives. Compellingly, DIRECT-PLUS investigators reported an 89.8% retention rate at 18 months among volunteers, who were able to comply with the dietary regimen with no significant complaints regarding taste. This signals that even though the “green” modification is more stringent than the typical Mediterranean regimen, it is one to which participants can adhere.

Although the real-world applicability of this diet remains to be seen, DIRECT-PLUS gives us encouraging evidence that a Mediterranean diet amplified with green plant-based proteins/polyphenols can lead to twice the intrahepatic fat loss, as compared to other nutritional strategies, and reduce the rate of NAFLD.

And as we know, having another dietary option to offer our patients is always a welcome addition to the menu.

Dr. Balistreri is with the department of hepatology & nutrition at Cincinnati Children’s Hospital Medical Center. He has disclosed no relevant financial relationships.

Iris Shai, PhD, one of the authors of the study, “Effect of green-Mediterranean diet on intrahepatic fat: the DIRECT PLUS randomised controlled trial,” is an adviser to Hinoman, which markets Mankai. Ilan Youngster, MD, another author of that study, is medical adviser for MyBiotics.

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

This article was updated May 21, 2021.

Those of us treating nonalcoholic fatty liver disease (NAFLD) often find ourselves having similar conversations with our patients. After diagnosis, our next step is usually describing to them how they can improve their outcomes through a healthy diet and exercise.

Westend61/Getty Images

We can point to the latest data espousing the benefits of moderate weight reduction. The recently released American Gastroenterological Association (AGA) Clinical Practice Update gives us compelling evidence of what can be achieved with specific thresholds of total body weight loss: >5% can decrease hepatic steatosis, >7% potentially leads to resolution of nonalcoholic steatohepatitis, and >10% possibly allows for regression or stability of fibrosis.

More often than not, our patients then ask us, “What diet do you recommend?”

The AGA’s Clinical Practice Update recommends that people with NAFLD follow the Mediterranean diet, minimize saturated fatty acid intake (specifically red and processed meat), and limit or eliminate consumption of commercially produced fructose.

It’s a tried-and-true, evidence-based recommendation. Yet, recent data suggest that modifying the Mediterranean diet so that it’s further enriched with specific green polyphenols may yield even more benefits to at-risk patients.
 

The upside of a greener Mediterranean diet

In a recently published study, investigators behind the DIRECT-PLUS clinical trial randomly assigned 294 participants with abdominal obesity/dyslipidemia into three diet groups (all accompanied by physical activity): standard healthy dietary guidelines (HDG), standard Mediterranean, and the so-called green Mediterranean diet.

Both Mediterranean diet groups were calorie restricted and called for 28 g/day of walnuts (+440 mg/day polyphenols provided). However, the green Mediterranean diet was further supplemented with 3-4 cups/day of green tea and 100 g/day of Mankai (a Wolffia globosa aquatic plant strain) in the form of frozen cubes turned into a green shake that replaced dinner (+1,240 mg/day total polyphenols provided). The percent change in intrahepatic fat content was quantified continuously by proton magnetic resonance spectroscopy. NAFLD was defined as an intrahepatic fat content of >5%.

After 18 months, the prevalence of NAFLD declined to 54.8% in the HDG group, 47.9% in the standard Mediterranean group, and 31.5% in the green Mediterranean group. Both Mediterranean groups achieved similar moderate weight loss and had significantly higher total plasma polyphenol levels versus the HDG group. However, the green Mediterranean group achieved significantly greater proportional intrahepatic fat content loss (-38.9%) than both the standard Mediterranean (-19.6; P = .023) and HDG (-12.2%; P < .001) groups.

In isolating the individual components of the diets, researchers determined that the degree of intrahepatic fat content loss was significantly associated with increased Mankai and walnut intake, decreased red/processed meat consumption, improved serum folate and adipokines/lipids biomarkers, and changes in microbiome composition and specific bacteria.

The authors suggest that the mechanisms by which polyphenols reduced steatosis and prevented liver injury may include reduced de novo lipogenesis, increased fatty acid oxidation, and reduced oxidative stress.

In an additional analysis, DIRECT-PLUS investigators also revealed the beneficial effects of the green Mediterranean diet on cardiometabolic health. Although both Mediterranean diets achieved similar weight loss (-6.2 kg for green Mediterranean and -5.4 kg for standard Mediterranean), which was superior to that observed in the HDG group (-1.5 kg; P < .001), the green Mediterranean group had a greater reduction in waist circumference than the standard Mediterranean group (-8.6 vs. -6.8 cm, respectively; P = .033). Within 6 months, the green Mediterranean group also achieved a greater decrease in low-density lipoprotein cholesterol levels, diastolic blood pressure, and insulin resistance.
 

A new dietary tool for combating obesity

The rising global incidence of NAFLD has made it even more urgent to identify new and improved ways of preventing the onset of obesity-related complications. To aid those efforts, we’ve been equipped with useful tools for educating our patients and their families, such as the 2020-2025 Dietary Guidelines for Americans from the U.S. Department of Agriculture (USDA), which makes a clear case for the disease-combating effects of healthy eating patterns.

This message does not appear to be making the impact it should, however, particularly among teens and young adults. It was recently reported that in 2017, only 7% of U.S. high school students consumed recommended amounts of fruits and only 2% consumed enough vegetables to meet USDA recommendations.

Novel approaches, including enhanced school and community programs, will be required to address this issue, but so will presenting patients with satisfactory dietary alternatives. Compellingly, DIRECT-PLUS investigators reported an 89.8% retention rate at 18 months among volunteers, who were able to comply with the dietary regimen with no significant complaints regarding taste. This signals that even though the “green” modification is more stringent than the typical Mediterranean regimen, it is one to which participants can adhere.

Although the real-world applicability of this diet remains to be seen, DIRECT-PLUS gives us encouraging evidence that a Mediterranean diet amplified with green plant-based proteins/polyphenols can lead to twice the intrahepatic fat loss, as compared to other nutritional strategies, and reduce the rate of NAFLD.

And as we know, having another dietary option to offer our patients is always a welcome addition to the menu.

Dr. Balistreri is with the department of hepatology & nutrition at Cincinnati Children’s Hospital Medical Center. He has disclosed no relevant financial relationships.

Iris Shai, PhD, one of the authors of the study, “Effect of green-Mediterranean diet on intrahepatic fat: the DIRECT PLUS randomised controlled trial,” is an adviser to Hinoman, which markets Mankai. Ilan Youngster, MD, another author of that study, is medical adviser for MyBiotics.

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

This article was updated May 21, 2021.

Those of us treating nonalcoholic fatty liver disease (NAFLD) often find ourselves having similar conversations with our patients. After diagnosis, our next step is usually describing to them how they can improve their outcomes through a healthy diet and exercise.

Westend61/Getty Images

We can point to the latest data espousing the benefits of moderate weight reduction. The recently released American Gastroenterological Association (AGA) Clinical Practice Update gives us compelling evidence of what can be achieved with specific thresholds of total body weight loss: >5% can decrease hepatic steatosis, >7% potentially leads to resolution of nonalcoholic steatohepatitis, and >10% possibly allows for regression or stability of fibrosis.

More often than not, our patients then ask us, “What diet do you recommend?”

The AGA’s Clinical Practice Update recommends that people with NAFLD follow the Mediterranean diet, minimize saturated fatty acid intake (specifically red and processed meat), and limit or eliminate consumption of commercially produced fructose.

It’s a tried-and-true, evidence-based recommendation. Yet, recent data suggest that modifying the Mediterranean diet so that it’s further enriched with specific green polyphenols may yield even more benefits to at-risk patients.
 

The upside of a greener Mediterranean diet

In a recently published study, investigators behind the DIRECT-PLUS clinical trial randomly assigned 294 participants with abdominal obesity/dyslipidemia into three diet groups (all accompanied by physical activity): standard healthy dietary guidelines (HDG), standard Mediterranean, and the so-called green Mediterranean diet.

Both Mediterranean diet groups were calorie restricted and called for 28 g/day of walnuts (+440 mg/day polyphenols provided). However, the green Mediterranean diet was further supplemented with 3-4 cups/day of green tea and 100 g/day of Mankai (a Wolffia globosa aquatic plant strain) in the form of frozen cubes turned into a green shake that replaced dinner (+1,240 mg/day total polyphenols provided). The percent change in intrahepatic fat content was quantified continuously by proton magnetic resonance spectroscopy. NAFLD was defined as an intrahepatic fat content of >5%.

After 18 months, the prevalence of NAFLD declined to 54.8% in the HDG group, 47.9% in the standard Mediterranean group, and 31.5% in the green Mediterranean group. Both Mediterranean groups achieved similar moderate weight loss and had significantly higher total plasma polyphenol levels versus the HDG group. However, the green Mediterranean group achieved significantly greater proportional intrahepatic fat content loss (-38.9%) than both the standard Mediterranean (-19.6; P = .023) and HDG (-12.2%; P < .001) groups.

In isolating the individual components of the diets, researchers determined that the degree of intrahepatic fat content loss was significantly associated with increased Mankai and walnut intake, decreased red/processed meat consumption, improved serum folate and adipokines/lipids biomarkers, and changes in microbiome composition and specific bacteria.

The authors suggest that the mechanisms by which polyphenols reduced steatosis and prevented liver injury may include reduced de novo lipogenesis, increased fatty acid oxidation, and reduced oxidative stress.

In an additional analysis, DIRECT-PLUS investigators also revealed the beneficial effects of the green Mediterranean diet on cardiometabolic health. Although both Mediterranean diets achieved similar weight loss (-6.2 kg for green Mediterranean and -5.4 kg for standard Mediterranean), which was superior to that observed in the HDG group (-1.5 kg; P < .001), the green Mediterranean group had a greater reduction in waist circumference than the standard Mediterranean group (-8.6 vs. -6.8 cm, respectively; P = .033). Within 6 months, the green Mediterranean group also achieved a greater decrease in low-density lipoprotein cholesterol levels, diastolic blood pressure, and insulin resistance.
 

A new dietary tool for combating obesity

The rising global incidence of NAFLD has made it even more urgent to identify new and improved ways of preventing the onset of obesity-related complications. To aid those efforts, we’ve been equipped with useful tools for educating our patients and their families, such as the 2020-2025 Dietary Guidelines for Americans from the U.S. Department of Agriculture (USDA), which makes a clear case for the disease-combating effects of healthy eating patterns.

This message does not appear to be making the impact it should, however, particularly among teens and young adults. It was recently reported that in 2017, only 7% of U.S. high school students consumed recommended amounts of fruits and only 2% consumed enough vegetables to meet USDA recommendations.

Novel approaches, including enhanced school and community programs, will be required to address this issue, but so will presenting patients with satisfactory dietary alternatives. Compellingly, DIRECT-PLUS investigators reported an 89.8% retention rate at 18 months among volunteers, who were able to comply with the dietary regimen with no significant complaints regarding taste. This signals that even though the “green” modification is more stringent than the typical Mediterranean regimen, it is one to which participants can adhere.

Although the real-world applicability of this diet remains to be seen, DIRECT-PLUS gives us encouraging evidence that a Mediterranean diet amplified with green plant-based proteins/polyphenols can lead to twice the intrahepatic fat loss, as compared to other nutritional strategies, and reduce the rate of NAFLD.

And as we know, having another dietary option to offer our patients is always a welcome addition to the menu.

Dr. Balistreri is with the department of hepatology & nutrition at Cincinnati Children’s Hospital Medical Center. He has disclosed no relevant financial relationships.

Iris Shai, PhD, one of the authors of the study, “Effect of green-Mediterranean diet on intrahepatic fat: the DIRECT PLUS randomised controlled trial,” is an adviser to Hinoman, which markets Mankai. Ilan Youngster, MD, another author of that study, is medical adviser for MyBiotics.

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

This article was updated May 21, 2021.

Botulinum toxin’s possible effect on improving depression has been discussed for some time. But confounding factors, such as medications, injection/acupuncture effect, physician interaction or touch, or other life scenarios, have made it difficult to discern botulinum toxin type A’s true effect on mood or psychiatric diagnosis. Now a systematic review and meta-analysis of randomized controlled trials examining botulinum toxin versus placebo provides evidence that botulinum toxin type A (BTX-A) injections are associated with statistically significant improvement in depressive symptoms.

Qian et al. analyzed all randomized controlled trials that investigated the efficacy and safety of facial BTX-A injections on patients with a diagnosis of major depressive disorder in PubMed and Web of Science from inception to June 17, 2020. A meta-analysis of the changes in depressive symptoms 6 weeks after BTX-A injections compared with placebo were the primary outcome of the report, while the safety of injections were also assessed.

A total of 417 patients from five randomized controlled trials (189 patients who received BTX-A injections and 228 in the placebo group) were deemed eligible. There was a statistically significant improvement in depressive symptoms in the BTX-A injections compared with placebo (Hedges’ g, –0.82; 95% confidence interval, –1.38 to 0.27). BTX-A injections were well tolerated with mild and temporary adverse events (headache, eyelid ptosis, and upper respiratory tract infection) reported in three of the five studies.

Limitations to the analysis include publication bias due to the limited number of studies in the analysis, the difficulty of being able to reliably blind participants because of potential noticeable cosmetic effects of BTX-A treatment, and the heterogeneity of symptom severity associated with major depressive disorder.

The authors referred to the Global Burden of Disease Study, which estimated that approximately 216 million people experienced major depressive disorder in 2015, the latest data available. MDD symptoms of sadness, fatigue, and loss of interest or pleasure, “incur a tremendous burden on health and finances,” they wrote. According to the Department of Health and Human Services, it is estimated that about 60% of people who commit suicide have had a mood disorder (major depression, bipolar disorder, dysthymia). The high rate of suicide associated with severe depression is also a serious public health concern. While further analysis is clearly warranted, cosmetic BTX-A injections may provide an alternative option in the treatment of depression.
 

Dr. Wesley and Dr. Lily Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. Write to them at [email protected]. They had no relevant disclosures.

Botulinum toxin’s possible effect on improving depression has been discussed for some time. But confounding factors, such as medications, injection/acupuncture effect, physician interaction or touch, or other life scenarios, have made it difficult to discern botulinum toxin type A’s true effect on mood or psychiatric diagnosis. Now a systematic review and meta-analysis of randomized controlled trials examining botulinum toxin versus placebo provides evidence that botulinum toxin type A (BTX-A) injections are associated with statistically significant improvement in depressive symptoms.

Qian et al. analyzed all randomized controlled trials that investigated the efficacy and safety of facial BTX-A injections on patients with a diagnosis of major depressive disorder in PubMed and Web of Science from inception to June 17, 2020. A meta-analysis of the changes in depressive symptoms 6 weeks after BTX-A injections compared with placebo were the primary outcome of the report, while the safety of injections were also assessed.

A total of 417 patients from five randomized controlled trials (189 patients who received BTX-A injections and 228 in the placebo group) were deemed eligible. There was a statistically significant improvement in depressive symptoms in the BTX-A injections compared with placebo (Hedges’ g, –0.82; 95% confidence interval, –1.38 to 0.27). BTX-A injections were well tolerated with mild and temporary adverse events (headache, eyelid ptosis, and upper respiratory tract infection) reported in three of the five studies.

Limitations to the analysis include publication bias due to the limited number of studies in the analysis, the difficulty of being able to reliably blind participants because of potential noticeable cosmetic effects of BTX-A treatment, and the heterogeneity of symptom severity associated with major depressive disorder.

The authors referred to the Global Burden of Disease Study, which estimated that approximately 216 million people experienced major depressive disorder in 2015, the latest data available. MDD symptoms of sadness, fatigue, and loss of interest or pleasure, “incur a tremendous burden on health and finances,” they wrote. According to the Department of Health and Human Services, it is estimated that about 60% of people who commit suicide have had a mood disorder (major depression, bipolar disorder, dysthymia). The high rate of suicide associated with severe depression is also a serious public health concern. While further analysis is clearly warranted, cosmetic BTX-A injections may provide an alternative option in the treatment of depression.
 

Dr. Wesley and Dr. Lily Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. Write to them at [email protected]. They had no relevant disclosures.

Botulinum toxin’s possible effect on improving depression has been discussed for some time. But confounding factors, such as medications, injection/acupuncture effect, physician interaction or touch, or other life scenarios, have made it difficult to discern botulinum toxin type A’s true effect on mood or psychiatric diagnosis. Now a systematic review and meta-analysis of randomized controlled trials examining botulinum toxin versus placebo provides evidence that botulinum toxin type A (BTX-A) injections are associated with statistically significant improvement in depressive symptoms.

Qian et al. analyzed all randomized controlled trials that investigated the efficacy and safety of facial BTX-A injections on patients with a diagnosis of major depressive disorder in PubMed and Web of Science from inception to June 17, 2020. A meta-analysis of the changes in depressive symptoms 6 weeks after BTX-A injections compared with placebo were the primary outcome of the report, while the safety of injections were also assessed.

A total of 417 patients from five randomized controlled trials (189 patients who received BTX-A injections and 228 in the placebo group) were deemed eligible. There was a statistically significant improvement in depressive symptoms in the BTX-A injections compared with placebo (Hedges’ g, –0.82; 95% confidence interval, –1.38 to 0.27). BTX-A injections were well tolerated with mild and temporary adverse events (headache, eyelid ptosis, and upper respiratory tract infection) reported in three of the five studies.

Limitations to the analysis include publication bias due to the limited number of studies in the analysis, the difficulty of being able to reliably blind participants because of potential noticeable cosmetic effects of BTX-A treatment, and the heterogeneity of symptom severity associated with major depressive disorder.

The authors referred to the Global Burden of Disease Study, which estimated that approximately 216 million people experienced major depressive disorder in 2015, the latest data available. MDD symptoms of sadness, fatigue, and loss of interest or pleasure, “incur a tremendous burden on health and finances,” they wrote. According to the Department of Health and Human Services, it is estimated that about 60% of people who commit suicide have had a mood disorder (major depression, bipolar disorder, dysthymia). The high rate of suicide associated with severe depression is also a serious public health concern. While further analysis is clearly warranted, cosmetic BTX-A injections may provide an alternative option in the treatment of depression.
 

Dr. Wesley and Dr. Lily Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. Write to them at [email protected]. They had no relevant disclosures.

Adults in treatment for opioid dependence report high satisfaction with buprenorphine injections, in new findings that researchers say could help improve treatment and management of patients with opioid dependence.

In the DEBUT trial, patients who received weekly or monthly depot buprenorphine had significantly higher overall treatment satisfaction, reduced treatment burden, and higher quality-of-life ratings than peers who received daily treatment with sublingual buprenorphine.

“The study’s focus on patient-reported outcomes (PROs) can help to better inform patients and clinicians when selecting treatment options than the clinical traditional outcomes of opioid dependence treatment studies,” lead investigator Fredrik Tiberg, PhD, president and CEO of Camurus, a pharmaceutical company in Lund, Sweden, said in an interview.

“The positive patient experiences with the depot buprenorphine injection reported in the DEBUT study indicate that long-acting treatments could contribute to advancing the quality of care and access to treatment for patients with opioid dependence/use disorder,” said Dr. Tiberg.

The study was published online May 10 in JAMA Network Open.
 

Novel study

The study was an open-label, parallel-group randomized controlled trial that included 119 patients from six outpatient clinics in Australia; 60 received weekly or monthly depot buprenorphine and 59 received sublingual buprenorphine for 24 weeks.

The primary outcome was global treatment satisfaction, as measured by the 14-question Treatment Satisfaction Questionnaire for Medication (TSQM) at the end of the study at week 24.

The study met its primary endpoint with a significantly higher TSQM global satisfaction score among adults who received depot injections, compared with those who received sublingual buprenorphine (mean score 82.5 vs. 74.3; difference, 8.2; 95% confidence interval, 1.7-14.6; P = .01).

Improvement was also observed for several secondary outcomes, including decreased treatment burden and higher quality of life.

The safety profile was consistent with the known safety profile of buprenorphine, aside from transient, mild-to-moderate injection site reactions.

“To our knowledge, this is the first randomized study that has used a range of PROs to compare outcomes between a long-acting injection and daily dosing of buprenorphine in the treatment of opioid dependence,” the investigators note.

“The study highlights the application of PROs as alternate endpoints to traditional markers of substance use in addiction treatment outcome studies,” they conclude.
 

Giving patients a voice

In an invited commentary, Nora D. Volkow, MD, director of the National Institute on Drug Abuse, and Wilson M. Compton, MD, deputy director of NIDA, note that the “voice of the patient” has been missing from most of the work in medication development, including for opioid use disorder.

The current study addresses this very issue in a “well designed and executed” fashion and the results “consistently demonstrated” the superiority of injectable buprenorphine across many outcomes.

The study highlights the importance of considering PRO measures in clinical trials, Dr. Volkow and Dr. Compton say.

“Even if efficacy is no different for various formulations, PROs may provide an important reason to select a new formulation. Patient preferences and apparently improved function may prove to be useful secondary outcomes in medication trials, and the measures used in this new study deserve consideration,” they write.

In addition, the greater treatment satisfaction by patients receiving extended-release buprenorphine suggests that these formulations “might help to improve long-term retention and, as such, be a valuable tool to help combat the current opioid epidemic and reduce its associated mortality,” they conclude.

This study was supported by Camurus AB. Dr. Tiberg is president and CEO of Camurus AB. A complete list of author disclosures is with the original article. Dr. Volkow and Dr. Compton have disclosed no relevant financial relationships.

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

Adults in treatment for opioid dependence report high satisfaction with buprenorphine injections, in new findings that researchers say could help improve treatment and management of patients with opioid dependence.

In the DEBUT trial, patients who received weekly or monthly depot buprenorphine had significantly higher overall treatment satisfaction, reduced treatment burden, and higher quality-of-life ratings than peers who received daily treatment with sublingual buprenorphine.

“The study’s focus on patient-reported outcomes (PROs) can help to better inform patients and clinicians when selecting treatment options than the clinical traditional outcomes of opioid dependence treatment studies,” lead investigator Fredrik Tiberg, PhD, president and CEO of Camurus, a pharmaceutical company in Lund, Sweden, said in an interview.

“The positive patient experiences with the depot buprenorphine injection reported in the DEBUT study indicate that long-acting treatments could contribute to advancing the quality of care and access to treatment for patients with opioid dependence/use disorder,” said Dr. Tiberg.

The study was published online May 10 in JAMA Network Open.
 

Novel study

The study was an open-label, parallel-group randomized controlled trial that included 119 patients from six outpatient clinics in Australia; 60 received weekly or monthly depot buprenorphine and 59 received sublingual buprenorphine for 24 weeks.

The primary outcome was global treatment satisfaction, as measured by the 14-question Treatment Satisfaction Questionnaire for Medication (TSQM) at the end of the study at week 24.

The study met its primary endpoint with a significantly higher TSQM global satisfaction score among adults who received depot injections, compared with those who received sublingual buprenorphine (mean score 82.5 vs. 74.3; difference, 8.2; 95% confidence interval, 1.7-14.6; P = .01).

Improvement was also observed for several secondary outcomes, including decreased treatment burden and higher quality of life.

The safety profile was consistent with the known safety profile of buprenorphine, aside from transient, mild-to-moderate injection site reactions.

“To our knowledge, this is the first randomized study that has used a range of PROs to compare outcomes between a long-acting injection and daily dosing of buprenorphine in the treatment of opioid dependence,” the investigators note.

“The study highlights the application of PROs as alternate endpoints to traditional markers of substance use in addiction treatment outcome studies,” they conclude.
 

Giving patients a voice

In an invited commentary, Nora D. Volkow, MD, director of the National Institute on Drug Abuse, and Wilson M. Compton, MD, deputy director of NIDA, note that the “voice of the patient” has been missing from most of the work in medication development, including for opioid use disorder.

The current study addresses this very issue in a “well designed and executed” fashion and the results “consistently demonstrated” the superiority of injectable buprenorphine across many outcomes.

The study highlights the importance of considering PRO measures in clinical trials, Dr. Volkow and Dr. Compton say.

“Even if efficacy is no different for various formulations, PROs may provide an important reason to select a new formulation. Patient preferences and apparently improved function may prove to be useful secondary outcomes in medication trials, and the measures used in this new study deserve consideration,” they write.

In addition, the greater treatment satisfaction by patients receiving extended-release buprenorphine suggests that these formulations “might help to improve long-term retention and, as such, be a valuable tool to help combat the current opioid epidemic and reduce its associated mortality,” they conclude.

This study was supported by Camurus AB. Dr. Tiberg is president and CEO of Camurus AB. A complete list of author disclosures is with the original article. Dr. Volkow and Dr. Compton have disclosed no relevant financial relationships.

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

Adults in treatment for opioid dependence report high satisfaction with buprenorphine injections, in new findings that researchers say could help improve treatment and management of patients with opioid dependence.

In the DEBUT trial, patients who received weekly or monthly depot buprenorphine had significantly higher overall treatment satisfaction, reduced treatment burden, and higher quality-of-life ratings than peers who received daily treatment with sublingual buprenorphine.

“The study’s focus on patient-reported outcomes (PROs) can help to better inform patients and clinicians when selecting treatment options than the clinical traditional outcomes of opioid dependence treatment studies,” lead investigator Fredrik Tiberg, PhD, president and CEO of Camurus, a pharmaceutical company in Lund, Sweden, said in an interview.

“The positive patient experiences with the depot buprenorphine injection reported in the DEBUT study indicate that long-acting treatments could contribute to advancing the quality of care and access to treatment for patients with opioid dependence/use disorder,” said Dr. Tiberg.

The study was published online May 10 in JAMA Network Open.
 

Novel study

The study was an open-label, parallel-group randomized controlled trial that included 119 patients from six outpatient clinics in Australia; 60 received weekly or monthly depot buprenorphine and 59 received sublingual buprenorphine for 24 weeks.

The primary outcome was global treatment satisfaction, as measured by the 14-question Treatment Satisfaction Questionnaire for Medication (TSQM) at the end of the study at week 24.

The study met its primary endpoint with a significantly higher TSQM global satisfaction score among adults who received depot injections, compared with those who received sublingual buprenorphine (mean score 82.5 vs. 74.3; difference, 8.2; 95% confidence interval, 1.7-14.6; P = .01).

Improvement was also observed for several secondary outcomes, including decreased treatment burden and higher quality of life.

The safety profile was consistent with the known safety profile of buprenorphine, aside from transient, mild-to-moderate injection site reactions.

“To our knowledge, this is the first randomized study that has used a range of PROs to compare outcomes between a long-acting injection and daily dosing of buprenorphine in the treatment of opioid dependence,” the investigators note.

“The study highlights the application of PROs as alternate endpoints to traditional markers of substance use in addiction treatment outcome studies,” they conclude.
 

Giving patients a voice

In an invited commentary, Nora D. Volkow, MD, director of the National Institute on Drug Abuse, and Wilson M. Compton, MD, deputy director of NIDA, note that the “voice of the patient” has been missing from most of the work in medication development, including for opioid use disorder.

The current study addresses this very issue in a “well designed and executed” fashion and the results “consistently demonstrated” the superiority of injectable buprenorphine across many outcomes.

The study highlights the importance of considering PRO measures in clinical trials, Dr. Volkow and Dr. Compton say.

“Even if efficacy is no different for various formulations, PROs may provide an important reason to select a new formulation. Patient preferences and apparently improved function may prove to be useful secondary outcomes in medication trials, and the measures used in this new study deserve consideration,” they write.

In addition, the greater treatment satisfaction by patients receiving extended-release buprenorphine suggests that these formulations “might help to improve long-term retention and, as such, be a valuable tool to help combat the current opioid epidemic and reduce its associated mortality,” they conclude.

This study was supported by Camurus AB. Dr. Tiberg is president and CEO of Camurus AB. A complete list of author disclosures is with the original article. Dr. Volkow and Dr. Compton have disclosed no relevant financial relationships.

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