Damian McNamara is a journalist for Medscape Medical News and MDedge. He worked full-time for MDedge as the Miami Bureau covering a dozen medical specialties during 2001-2012, then as a freelancer for Medscape and MDedge, before being hired on staff by Medscape in 2018. Now the two companies are one. He uses what he learned in school – Damian has a BS in chemistry and an MS in science, health and environmental reporting/journalism. He works out of a home office in Miami, with a 100-pound chocolate lab known to snore under his desk during work hours.

VIDEO: Could targeting gut dysbiosis in MS prevent disease?

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– Compelling findings in a genetically engineered mouse model of multiple sclerosis identify mechanisms of how adolescence and gut dysbiosis contribute to the risk of MS. In addition, disparities in gut microbiome species could explain why some people are at higher risk for developing multiple sclerosis, while others seem to enjoy a protective effect against development of this and other autoimmune diseases.

The hope is that these findings could pave the way for clinicians to potentially prevent development of multiple sclerosis in people at higher risk, perhaps through altering the gut flora and probiotic therapy, Suhayl Dhib-Jalbut, MD, said in a video interview at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Dr. Dhib-Jalbut and his team discovered these findings using humanized transgenic mice – in other words, mice containing risk genes for triggering disease transferred from a patient with multiple sclerosis. The mice were more likely to develop MS-like disease at certain ages and in the presence of an altered gut microbiome or gut dysbiosis (Proc Natl Acad Sci U S A. 2017 Oct 31;114[44]:E9318-27).


Dr. Dhib-Jalbut is past president of ACTRIMS and is professor and chairman of the departments of neurology at Rutgers–Robert Wood Johnson Medical School, New Brunswick, N.J., and New Jersey Medical School, Newark. He has received research grants from Biogen and Teva, and is a consultant for Genzyme, Teva, Celgene, and, Mallinckrodt.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– Compelling findings in a genetically engineered mouse model of multiple sclerosis identify mechanisms of how adolescence and gut dysbiosis contribute to the risk of MS. In addition, disparities in gut microbiome species could explain why some people are at higher risk for developing multiple sclerosis, while others seem to enjoy a protective effect against development of this and other autoimmune diseases.

The hope is that these findings could pave the way for clinicians to potentially prevent development of multiple sclerosis in people at higher risk, perhaps through altering the gut flora and probiotic therapy, Suhayl Dhib-Jalbut, MD, said in a video interview at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Dr. Dhib-Jalbut and his team discovered these findings using humanized transgenic mice – in other words, mice containing risk genes for triggering disease transferred from a patient with multiple sclerosis. The mice were more likely to develop MS-like disease at certain ages and in the presence of an altered gut microbiome or gut dysbiosis (Proc Natl Acad Sci U S A. 2017 Oct 31;114[44]:E9318-27).


Dr. Dhib-Jalbut is past president of ACTRIMS and is professor and chairman of the departments of neurology at Rutgers–Robert Wood Johnson Medical School, New Brunswick, N.J., and New Jersey Medical School, Newark. He has received research grants from Biogen and Teva, and is a consultant for Genzyme, Teva, Celgene, and, Mallinckrodt.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

– Compelling findings in a genetically engineered mouse model of multiple sclerosis identify mechanisms of how adolescence and gut dysbiosis contribute to the risk of MS. In addition, disparities in gut microbiome species could explain why some people are at higher risk for developing multiple sclerosis, while others seem to enjoy a protective effect against development of this and other autoimmune diseases.

The hope is that these findings could pave the way for clinicians to potentially prevent development of multiple sclerosis in people at higher risk, perhaps through altering the gut flora and probiotic therapy, Suhayl Dhib-Jalbut, MD, said in a video interview at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Dr. Dhib-Jalbut and his team discovered these findings using humanized transgenic mice – in other words, mice containing risk genes for triggering disease transferred from a patient with multiple sclerosis. The mice were more likely to develop MS-like disease at certain ages and in the presence of an altered gut microbiome or gut dysbiosis (Proc Natl Acad Sci U S A. 2017 Oct 31;114[44]:E9318-27).


Dr. Dhib-Jalbut is past president of ACTRIMS and is professor and chairman of the departments of neurology at Rutgers–Robert Wood Johnson Medical School, New Brunswick, N.J., and New Jersey Medical School, Newark. He has received research grants from Biogen and Teva, and is a consultant for Genzyme, Teva, Celgene, and, Mallinckrodt.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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Fingolimod cuts pediatric MS relapse rate more than interferon beta-1a

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Mon, 01/07/2019 - 13:05

 

Pediatric patients with relapsing remitting multiple sclerosis (MS) had fewer relapses after receiving the oral drug fingolimod when compared with patients who received intramuscular interferon beta-1a in the randomized, double-blind PARADIGMS study, suggesting that the sphingosine-1-phosphate receptor modulator could offer a new treatment option to patients younger than 18 years.

Dr. Tanuja Chitnis
“Adolescents are thought to present in the earliest relapsing phase of disease. Also the immune system is more active in younger patients, which could lead to higher relapse rates, compared to adults,” Tanuja Chitnis, MD, said in an interview in advance of her presentation of the PARADIGMS study results at ACTRIMS Forum 2018, a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, in San Diego. There is a true need to evaluate therapeutic options for younger patients because, she added, “there are currently no treatments prospectively tested in randomized trials in adolescents and thus no class I data to base treatment decisions on.”

The phase 3 PARADIGMS study is the first international controlled trial to evaluate the safety and efficacy of fingolimod in pediatric and adolescent patients. Dr. Chitnis and her colleagues randomized 215 participants aged 10-17 years to up to 0.5 mg/day of fingolimod based on body weight or to a once-a-week intramuscular injection of 30 mcg of interferon beta-1a. The trial lasted 2 years and was followed by an open-label extension for an additional 5 years.

The annualized relapse rate was the primary endpoint. The fingolimod group experienced 25 relapses in 180 patient-years, compared with 120 relapses in 163 patient-years in the interferon beta-1a group.

MRI findings and outcomes associated with relapse were secondary endpoints. The researchers found that, compared with the interferon beta-1a group, patients randomized to fingolimod had fewer lesions identified on MRI: There was a 53% annualized reduction in new or newly enlarged T2 lesions and 66% decrease in gadolinium-enhancing T1 lesions.

SOURCE: Chitnis T et al. ACTRIMS Forum 2018, Abstract P025.
 

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Pediatric patients with relapsing remitting multiple sclerosis (MS) had fewer relapses after receiving the oral drug fingolimod when compared with patients who received intramuscular interferon beta-1a in the randomized, double-blind PARADIGMS study, suggesting that the sphingosine-1-phosphate receptor modulator could offer a new treatment option to patients younger than 18 years.

Dr. Tanuja Chitnis
“Adolescents are thought to present in the earliest relapsing phase of disease. Also the immune system is more active in younger patients, which could lead to higher relapse rates, compared to adults,” Tanuja Chitnis, MD, said in an interview in advance of her presentation of the PARADIGMS study results at ACTRIMS Forum 2018, a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, in San Diego. There is a true need to evaluate therapeutic options for younger patients because, she added, “there are currently no treatments prospectively tested in randomized trials in adolescents and thus no class I data to base treatment decisions on.”

The phase 3 PARADIGMS study is the first international controlled trial to evaluate the safety and efficacy of fingolimod in pediatric and adolescent patients. Dr. Chitnis and her colleagues randomized 215 participants aged 10-17 years to up to 0.5 mg/day of fingolimod based on body weight or to a once-a-week intramuscular injection of 30 mcg of interferon beta-1a. The trial lasted 2 years and was followed by an open-label extension for an additional 5 years.

The annualized relapse rate was the primary endpoint. The fingolimod group experienced 25 relapses in 180 patient-years, compared with 120 relapses in 163 patient-years in the interferon beta-1a group.

MRI findings and outcomes associated with relapse were secondary endpoints. The researchers found that, compared with the interferon beta-1a group, patients randomized to fingolimod had fewer lesions identified on MRI: There was a 53% annualized reduction in new or newly enlarged T2 lesions and 66% decrease in gadolinium-enhancing T1 lesions.

SOURCE: Chitnis T et al. ACTRIMS Forum 2018, Abstract P025.
 

 

Pediatric patients with relapsing remitting multiple sclerosis (MS) had fewer relapses after receiving the oral drug fingolimod when compared with patients who received intramuscular interferon beta-1a in the randomized, double-blind PARADIGMS study, suggesting that the sphingosine-1-phosphate receptor modulator could offer a new treatment option to patients younger than 18 years.

Dr. Tanuja Chitnis
“Adolescents are thought to present in the earliest relapsing phase of disease. Also the immune system is more active in younger patients, which could lead to higher relapse rates, compared to adults,” Tanuja Chitnis, MD, said in an interview in advance of her presentation of the PARADIGMS study results at ACTRIMS Forum 2018, a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, in San Diego. There is a true need to evaluate therapeutic options for younger patients because, she added, “there are currently no treatments prospectively tested in randomized trials in adolescents and thus no class I data to base treatment decisions on.”

The phase 3 PARADIGMS study is the first international controlled trial to evaluate the safety and efficacy of fingolimod in pediatric and adolescent patients. Dr. Chitnis and her colleagues randomized 215 participants aged 10-17 years to up to 0.5 mg/day of fingolimod based on body weight or to a once-a-week intramuscular injection of 30 mcg of interferon beta-1a. The trial lasted 2 years and was followed by an open-label extension for an additional 5 years.

The annualized relapse rate was the primary endpoint. The fingolimod group experienced 25 relapses in 180 patient-years, compared with 120 relapses in 163 patient-years in the interferon beta-1a group.

MRI findings and outcomes associated with relapse were secondary endpoints. The researchers found that, compared with the interferon beta-1a group, patients randomized to fingolimod had fewer lesions identified on MRI: There was a 53% annualized reduction in new or newly enlarged T2 lesions and 66% decrease in gadolinium-enhancing T1 lesions.

SOURCE: Chitnis T et al. ACTRIMS Forum 2018, Abstract P025.
 

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Key clinical point: Fingolimod was associated with a lower relapse rate when compared with intramuscular interferon beta-1a in pediatric relapsing remitting MS patients.

Major finding: The fingolimod group experienced 25 relapses in 180 patient-years, compared with 120 relapses in 163 patient-years in the interferon beta-1a group.

Study details: International, randomized, double-blind, parallel-group study of 215 people aged 10-17 years.

Disclosures: The study was sponsored by Novartis, the maker of fingolimod. Dr. Chitnis and nearly all of her coauthors disclosed financial ties to Novartis. Three authors are employees of Novartis.

Source: Chitnis T et al. ACTRIMS Forum 2018, Abstract P025.

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Want to expand aesthetic dermatology business? Appeal to men

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Fri, 01/18/2019 - 17:21

 

– Bringing more men into an aesthetic dermatology practice can expand the patient population, increase business revenue, and pay long-term dividends in terms of patient loyalty and repeat business.

But men aren’t like women when it comes to aesthetic concerns, so the strategies used to market your aesthetic offerings to female patients might miss the mark with men, cautioned Terrence Keaney, MD.

James Dick
Dr. Terrence Keaney
Men are less cosmetically savvy and need more upfront education and counseling, Dr. Keaney said at the 2018 Orlando Dermatology Aesthetic and Clinical Conference.

“I spend more time explaining therapies and what might be best for them,” he noted. “I explain the scientific rationale and treatment mechanisms so they will be more comfortable.” Making sure they understand is important, because “men often nod and don’t ask questions.”

The extra effort up front can pay off.

“The beauty of men is when they get a great result and are happy with you, men are very physician loyal. Once they get a great result, they’re yours forever,” said Dr. Keaney, an assistant clinical professor of dermatology at George Washington University, Washington, and a private practice dermatologist in Arlington, Va.

Cost is the leading deterrent for men to embrace aesthetic procedures, a factor that also ranks first among women. Men are also concerned that results will not look natural and want information about safety and side effects, Dr. Keaney said. “These deterrents can be overcome with proper education and counseling.”

Marketing to men is different

Although growing a male anesthetic patient base is more difficult, Dr. Keaney recommends it, especially for dermatology practices in a competitive market.

This tactic of targeting untapped markets to grow a business, rather than competing on the same level as everyone else, is outlined in a book he recommends, “Blue Ocean Strategy,” by W. Chan Kim and Renée Mauborgne. “It’s about unlocking new demand, and I will argue that, in aesthetic medicine, it’s those male patients.”

“The male aesthetic market is truly untapped and shows tremendous growth potential,” Dr. Keaney said. “Particularly as millennials age, the demand for cosmetic procedures in men will only increase.”

A first step is to make male aesthetic patients feel welcome and comfortable. “Think about a reluctant male patient walking into your office; it can be intimidating if the staff and everyone in the waiting room is female,” Dr. Keaney said. “But you don’t need to put a keg in the corner, either.” He added more wood and changed the colors of his office, for example.

Don’t go overboard

Marketing aesthetic services to men is also different, a lesson Dr. Keaney learned from the outset.

“When I first started a practice, I wanted to attract more male cosmetic patients, and I decided to throw a male cosmetics seminar,” he recalled. “I thought it would be a great opportunity to educate them.”

He partnered with a plastic surgeon, rented a ballroom, sent out an e-blast, and mailed flyers. “We had zero RSVPs. We canceled it.”

He added, “Men are not sitting at the computer thinking, ‘I wish someone would throw a seminar on aesthetics.’”

A better strategy came the following year as a men’s health event with a broader scope. A urologist, internist, dermatologist, and plastic surgeon talked about a variety of health issues. “They were blown away by the options from the dermatologist and the plastic surgeon.”
 

A growing market

An American Society for Dermatologic Surgery annual survey reveals dermatologic surgeons performed nearly 10.5 million medically necessary and cosmetic procedures in 2016, the latest year for which results are available. The rate is up 5% from the year before, and up by more than 30%, compared with 2012.

“Within the growth of procedures performed, the male and millennial demographics’ interest in cosmetic treatments also continues to rise,” the survey authors noted. “In the last 5 years, men receiving wrinkle relaxers has increased 9%, and men using soft-tissue fillers grew from 2% to 9%.” The survey also reveals that patients younger than 30 years are seeking more cosmetic treatments. In fact, millennials’ use of wrinkle relaxers increased 20% from 2015, and 50% since 2012.

Address the top male aesthetic concerns

Men are interested in looking healthy, young, and staying fit, Dr. Keaney said, but there is often a disconnect in the male market. “I would argue the real rate limiter is education,” he explained, “and that both the industry and physicians are at fault.”

Most messages about aesthetic procedures have not been targeted toward men. For example, only 39% of 600 aesthetically inclined men knew about dermal fillers in a study Dr. Keaney co-authored (Dermatol Surg. 2016 Oct;42[10]:1155-63).

“I talk to men in my practice about dermal fillers, and most think they’re only for injection in the lips,” he said. The results of the online survey came from men “cosmetically on the cusp,” as he described them – men familiar with neuromodulators for facial rejuvenation, but who had never tried such a therapy.

Tear troughs, double chin, crow’s feet, and forehead lines were the most common concerns, in order, reported by study participants. Dr. Keaney said. “You’ll notice what is missing here: the cheeks, the nasolabial folds, and the lips. And what are those? The FDA-approved indications for dermal fillers.”

Even though it doesn’t top the list of men’s concerns in this study, overall, “if you’re looking to grow your male aesthetic patient population, the number one cosmetic concern among men remains hair loss,” noted Dr. Keaney. “You cannot ignore hair loss. It has a large psychosocial impact.”

During a full-body exam, Dr. Keaney recommends using a scalp exam as an opportunity to ask about any hair-loss concerns.

Encouraging signs from other industries

Other industries are showing a rise in the appearance-conscious male consumer, Dr. Keaney said. Men’s skin care, grooming, and luxury fashion industries are all growing, for example.

Worldwide, the personal care market for men is forecast to grow to $166 billion globally by 2022, according to a report from Allied Market Research. The compound average growth rate is expected to grow more than 5% each year between now and then.

“Men are spending money on their hair and skin,” Dr. Keaney said. “The question is, Why aren’t they spending money on their face? It’s how we interact with the world.”

Dr. Keaney has served on the advisory board of, consulted for, and was a speaker for Allergan. He was also a speaker for Eclipse, Sciton, and Syneron Candela, and served on the advisory boards for Aclaris and Merz.

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– Bringing more men into an aesthetic dermatology practice can expand the patient population, increase business revenue, and pay long-term dividends in terms of patient loyalty and repeat business.

But men aren’t like women when it comes to aesthetic concerns, so the strategies used to market your aesthetic offerings to female patients might miss the mark with men, cautioned Terrence Keaney, MD.

James Dick
Dr. Terrence Keaney
Men are less cosmetically savvy and need more upfront education and counseling, Dr. Keaney said at the 2018 Orlando Dermatology Aesthetic and Clinical Conference.

“I spend more time explaining therapies and what might be best for them,” he noted. “I explain the scientific rationale and treatment mechanisms so they will be more comfortable.” Making sure they understand is important, because “men often nod and don’t ask questions.”

The extra effort up front can pay off.

“The beauty of men is when they get a great result and are happy with you, men are very physician loyal. Once they get a great result, they’re yours forever,” said Dr. Keaney, an assistant clinical professor of dermatology at George Washington University, Washington, and a private practice dermatologist in Arlington, Va.

Cost is the leading deterrent for men to embrace aesthetic procedures, a factor that also ranks first among women. Men are also concerned that results will not look natural and want information about safety and side effects, Dr. Keaney said. “These deterrents can be overcome with proper education and counseling.”

Marketing to men is different

Although growing a male anesthetic patient base is more difficult, Dr. Keaney recommends it, especially for dermatology practices in a competitive market.

This tactic of targeting untapped markets to grow a business, rather than competing on the same level as everyone else, is outlined in a book he recommends, “Blue Ocean Strategy,” by W. Chan Kim and Renée Mauborgne. “It’s about unlocking new demand, and I will argue that, in aesthetic medicine, it’s those male patients.”

“The male aesthetic market is truly untapped and shows tremendous growth potential,” Dr. Keaney said. “Particularly as millennials age, the demand for cosmetic procedures in men will only increase.”

A first step is to make male aesthetic patients feel welcome and comfortable. “Think about a reluctant male patient walking into your office; it can be intimidating if the staff and everyone in the waiting room is female,” Dr. Keaney said. “But you don’t need to put a keg in the corner, either.” He added more wood and changed the colors of his office, for example.

Don’t go overboard

Marketing aesthetic services to men is also different, a lesson Dr. Keaney learned from the outset.

“When I first started a practice, I wanted to attract more male cosmetic patients, and I decided to throw a male cosmetics seminar,” he recalled. “I thought it would be a great opportunity to educate them.”

He partnered with a plastic surgeon, rented a ballroom, sent out an e-blast, and mailed flyers. “We had zero RSVPs. We canceled it.”

He added, “Men are not sitting at the computer thinking, ‘I wish someone would throw a seminar on aesthetics.’”

A better strategy came the following year as a men’s health event with a broader scope. A urologist, internist, dermatologist, and plastic surgeon talked about a variety of health issues. “They were blown away by the options from the dermatologist and the plastic surgeon.”
 

A growing market

An American Society for Dermatologic Surgery annual survey reveals dermatologic surgeons performed nearly 10.5 million medically necessary and cosmetic procedures in 2016, the latest year for which results are available. The rate is up 5% from the year before, and up by more than 30%, compared with 2012.

“Within the growth of procedures performed, the male and millennial demographics’ interest in cosmetic treatments also continues to rise,” the survey authors noted. “In the last 5 years, men receiving wrinkle relaxers has increased 9%, and men using soft-tissue fillers grew from 2% to 9%.” The survey also reveals that patients younger than 30 years are seeking more cosmetic treatments. In fact, millennials’ use of wrinkle relaxers increased 20% from 2015, and 50% since 2012.

Address the top male aesthetic concerns

Men are interested in looking healthy, young, and staying fit, Dr. Keaney said, but there is often a disconnect in the male market. “I would argue the real rate limiter is education,” he explained, “and that both the industry and physicians are at fault.”

Most messages about aesthetic procedures have not been targeted toward men. For example, only 39% of 600 aesthetically inclined men knew about dermal fillers in a study Dr. Keaney co-authored (Dermatol Surg. 2016 Oct;42[10]:1155-63).

“I talk to men in my practice about dermal fillers, and most think they’re only for injection in the lips,” he said. The results of the online survey came from men “cosmetically on the cusp,” as he described them – men familiar with neuromodulators for facial rejuvenation, but who had never tried such a therapy.

Tear troughs, double chin, crow’s feet, and forehead lines were the most common concerns, in order, reported by study participants. Dr. Keaney said. “You’ll notice what is missing here: the cheeks, the nasolabial folds, and the lips. And what are those? The FDA-approved indications for dermal fillers.”

Even though it doesn’t top the list of men’s concerns in this study, overall, “if you’re looking to grow your male aesthetic patient population, the number one cosmetic concern among men remains hair loss,” noted Dr. Keaney. “You cannot ignore hair loss. It has a large psychosocial impact.”

During a full-body exam, Dr. Keaney recommends using a scalp exam as an opportunity to ask about any hair-loss concerns.

Encouraging signs from other industries

Other industries are showing a rise in the appearance-conscious male consumer, Dr. Keaney said. Men’s skin care, grooming, and luxury fashion industries are all growing, for example.

Worldwide, the personal care market for men is forecast to grow to $166 billion globally by 2022, according to a report from Allied Market Research. The compound average growth rate is expected to grow more than 5% each year between now and then.

“Men are spending money on their hair and skin,” Dr. Keaney said. “The question is, Why aren’t they spending money on their face? It’s how we interact with the world.”

Dr. Keaney has served on the advisory board of, consulted for, and was a speaker for Allergan. He was also a speaker for Eclipse, Sciton, and Syneron Candela, and served on the advisory boards for Aclaris and Merz.

 

– Bringing more men into an aesthetic dermatology practice can expand the patient population, increase business revenue, and pay long-term dividends in terms of patient loyalty and repeat business.

But men aren’t like women when it comes to aesthetic concerns, so the strategies used to market your aesthetic offerings to female patients might miss the mark with men, cautioned Terrence Keaney, MD.

James Dick
Dr. Terrence Keaney
Men are less cosmetically savvy and need more upfront education and counseling, Dr. Keaney said at the 2018 Orlando Dermatology Aesthetic and Clinical Conference.

“I spend more time explaining therapies and what might be best for them,” he noted. “I explain the scientific rationale and treatment mechanisms so they will be more comfortable.” Making sure they understand is important, because “men often nod and don’t ask questions.”

The extra effort up front can pay off.

“The beauty of men is when they get a great result and are happy with you, men are very physician loyal. Once they get a great result, they’re yours forever,” said Dr. Keaney, an assistant clinical professor of dermatology at George Washington University, Washington, and a private practice dermatologist in Arlington, Va.

Cost is the leading deterrent for men to embrace aesthetic procedures, a factor that also ranks first among women. Men are also concerned that results will not look natural and want information about safety and side effects, Dr. Keaney said. “These deterrents can be overcome with proper education and counseling.”

Marketing to men is different

Although growing a male anesthetic patient base is more difficult, Dr. Keaney recommends it, especially for dermatology practices in a competitive market.

This tactic of targeting untapped markets to grow a business, rather than competing on the same level as everyone else, is outlined in a book he recommends, “Blue Ocean Strategy,” by W. Chan Kim and Renée Mauborgne. “It’s about unlocking new demand, and I will argue that, in aesthetic medicine, it’s those male patients.”

“The male aesthetic market is truly untapped and shows tremendous growth potential,” Dr. Keaney said. “Particularly as millennials age, the demand for cosmetic procedures in men will only increase.”

A first step is to make male aesthetic patients feel welcome and comfortable. “Think about a reluctant male patient walking into your office; it can be intimidating if the staff and everyone in the waiting room is female,” Dr. Keaney said. “But you don’t need to put a keg in the corner, either.” He added more wood and changed the colors of his office, for example.

Don’t go overboard

Marketing aesthetic services to men is also different, a lesson Dr. Keaney learned from the outset.

“When I first started a practice, I wanted to attract more male cosmetic patients, and I decided to throw a male cosmetics seminar,” he recalled. “I thought it would be a great opportunity to educate them.”

He partnered with a plastic surgeon, rented a ballroom, sent out an e-blast, and mailed flyers. “We had zero RSVPs. We canceled it.”

He added, “Men are not sitting at the computer thinking, ‘I wish someone would throw a seminar on aesthetics.’”

A better strategy came the following year as a men’s health event with a broader scope. A urologist, internist, dermatologist, and plastic surgeon talked about a variety of health issues. “They were blown away by the options from the dermatologist and the plastic surgeon.”
 

A growing market

An American Society for Dermatologic Surgery annual survey reveals dermatologic surgeons performed nearly 10.5 million medically necessary and cosmetic procedures in 2016, the latest year for which results are available. The rate is up 5% from the year before, and up by more than 30%, compared with 2012.

“Within the growth of procedures performed, the male and millennial demographics’ interest in cosmetic treatments also continues to rise,” the survey authors noted. “In the last 5 years, men receiving wrinkle relaxers has increased 9%, and men using soft-tissue fillers grew from 2% to 9%.” The survey also reveals that patients younger than 30 years are seeking more cosmetic treatments. In fact, millennials’ use of wrinkle relaxers increased 20% from 2015, and 50% since 2012.

Address the top male aesthetic concerns

Men are interested in looking healthy, young, and staying fit, Dr. Keaney said, but there is often a disconnect in the male market. “I would argue the real rate limiter is education,” he explained, “and that both the industry and physicians are at fault.”

Most messages about aesthetic procedures have not been targeted toward men. For example, only 39% of 600 aesthetically inclined men knew about dermal fillers in a study Dr. Keaney co-authored (Dermatol Surg. 2016 Oct;42[10]:1155-63).

“I talk to men in my practice about dermal fillers, and most think they’re only for injection in the lips,” he said. The results of the online survey came from men “cosmetically on the cusp,” as he described them – men familiar with neuromodulators for facial rejuvenation, but who had never tried such a therapy.

Tear troughs, double chin, crow’s feet, and forehead lines were the most common concerns, in order, reported by study participants. Dr. Keaney said. “You’ll notice what is missing here: the cheeks, the nasolabial folds, and the lips. And what are those? The FDA-approved indications for dermal fillers.”

Even though it doesn’t top the list of men’s concerns in this study, overall, “if you’re looking to grow your male aesthetic patient population, the number one cosmetic concern among men remains hair loss,” noted Dr. Keaney. “You cannot ignore hair loss. It has a large psychosocial impact.”

During a full-body exam, Dr. Keaney recommends using a scalp exam as an opportunity to ask about any hair-loss concerns.

Encouraging signs from other industries

Other industries are showing a rise in the appearance-conscious male consumer, Dr. Keaney said. Men’s skin care, grooming, and luxury fashion industries are all growing, for example.

Worldwide, the personal care market for men is forecast to grow to $166 billion globally by 2022, according to a report from Allied Market Research. The compound average growth rate is expected to grow more than 5% each year between now and then.

“Men are spending money on their hair and skin,” Dr. Keaney said. “The question is, Why aren’t they spending money on their face? It’s how we interact with the world.”

Dr. Keaney has served on the advisory board of, consulted for, and was a speaker for Allergan. He was also a speaker for Eclipse, Sciton, and Syneron Candela, and served on the advisory boards for Aclaris and Merz.

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Best practices address latest trends in PDT, skin cancer treatment

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Mon, 01/14/2019 - 10:15

 

– Pearls for providers of photodynamic therapy (PDT) include tips on skin preparation, eye protection, and use of three new codes to maximize reimbursement. Also trending in medical dermatology are best practices for intralesional injections of 5-FU to treat the often challenging isomorphic squamous cell carcinomas (SCCs) or keratoacanthomas on the lower leg, as well as use of neoadjuvant hedgehog inhibitors to shrink large skin cancer lesions, according to Glenn David Goldman, MD.

“This talk is about what you can do medically as a dermatologic surgeon,” Dr. Goldman said at the Orlando Dermatology Aesthetic and Clinical Conference.
 

Use new billing codes for photodynamic therapy

There are now three new PDT billing codes. “Make sure your coders are using these properly. They are active now, and if you don’t use them, you won’t get paid properly,” said Dr. Goldman, professor and medical director of dermatology at the University of Vermont, Burlington. Specifically, 96567 is for standard PDT applied by staff; 96573 is for PDT applied by a physician; and 96574 is for PDT and curettage performed by a physician.

“Be involved, don’t delegate,” Dr. Goldman added. “If you do, you will get paid half as much as you used to, which means you will lose money on every single patient you treat.”

What type of PDT physicians choose to use in their practice remains controversial. “Do you do short-contact PDT, do you do daylight PDT? We’ve gone back and forth in our practice,” Dr. Goldman said. “I’m not impressed with daylight PDT. I know this is at odds with some of the people here, but at least in Vermont, it doesn’t work very well.”

The way PDT was described in the original trials (a photosensitizer applied in the office followed by PDT) “works the best, with one caveat,” Dr. Goldman said. The caveat is that dermatologists should aim for a PDT clearance that approaches the efficacy of 5-fluorouracil (5-FU). “If you can get to that – which is difficult by the way – I think your patients will really appreciate this.”

An additional PDT pearl Dr. Goldman shared involves skin preparation: the use of acetone to defat the skin, even in patients with very thick lesions. Apply acetone with gauze to the site for 5 minutes and “all of that hyperkeratosis just wipes away,” curette off any residual hyperkeratosis – and consider a ring anesthetic block to control pain for the patient with severe disease, he advised.

Another tip is to forgo the goggles that come with most PDT kits. Instead, purchase smaller, disposable laser eye shields for PDT patients, Dr. Goldman said. “They work better. You can get closer to the eye … and they are more comfortable for the patient.”

Dr. Goldman’s practice is providing more PDT and much less 5-FU for patient convenience. “I believe if someone is willing to go through 3 weeks of 5-FU or 12-16 weeks of imiquimod, they get the best results. However, most people don’t want to do that if they can sit in front of a light for 15 minutes.”
 

Consider intralesional injections for SCCs and KAs on the legs

An ongoing challenge in medical dermatology is preventing rapid recurrence of SCCs and/or keratoacanthomas (KAs) near sites of previous excision on the legs. “We all see this quite a bit. Often you get lesions on the leg, you cut them out, and they come right back” close to the excision site, Dr. Goldman said.

He does not recommend methotrexate injections for these lesions. “Methotrexate does not work. It doesn’t hurt, but I’ve injected methotrexate into squamous cell carcinomas many times and they’ve never gone away.” In contrast, 5-FU “works incredibly well. They go away, I’ve had tremendous success. This has changed the way we treat these lesions.” 5-FU is inexpensive and can be obtained from oncology pharmacies. One caveat is 5-FU injections can be painful and patients require anesthesia prior to injection.

Using a 25-gauge or 27-gauge needle, Dr. Goldman injects 5-FU “exactly as I would a hypertrophic scar. I inject a squamous cell carcinoma carefully and ‘expand’ the tumor.” He typically injects a lesion every 2 weeks until it resolves completely, which typically takes two or three sessions.

“I want to emphasize that that’s really true about intralesional 5-FU for those KAs and scars on the legs,” said session moderator James Spencer, MD, a dermatologist in private practice in St. Petersburg, Florida. “Otherwise, you’re just chasing your tail trying to cut them out. You’ll do much better with the intralesional 5-FU; it’s easy to get, it’s affordable, it comes as 50 mg/mL … just keep it in the office.”
 

 

 

A recommended role for hedgehog inhibitors

Hedgehog inhibitors work best as neoadjuvant therapy to shrink large skin cancer tumors prior to excision, Dr. Goldman said. “Hedgehog inhibitors don’t cure anything … except for rare cases of small basal cell carcinomas.” For most lesions, however, the strategy is not curative.

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– Pearls for providers of photodynamic therapy (PDT) include tips on skin preparation, eye protection, and use of three new codes to maximize reimbursement. Also trending in medical dermatology are best practices for intralesional injections of 5-FU to treat the often challenging isomorphic squamous cell carcinomas (SCCs) or keratoacanthomas on the lower leg, as well as use of neoadjuvant hedgehog inhibitors to shrink large skin cancer lesions, according to Glenn David Goldman, MD.

“This talk is about what you can do medically as a dermatologic surgeon,” Dr. Goldman said at the Orlando Dermatology Aesthetic and Clinical Conference.
 

Use new billing codes for photodynamic therapy

There are now three new PDT billing codes. “Make sure your coders are using these properly. They are active now, and if you don’t use them, you won’t get paid properly,” said Dr. Goldman, professor and medical director of dermatology at the University of Vermont, Burlington. Specifically, 96567 is for standard PDT applied by staff; 96573 is for PDT applied by a physician; and 96574 is for PDT and curettage performed by a physician.

“Be involved, don’t delegate,” Dr. Goldman added. “If you do, you will get paid half as much as you used to, which means you will lose money on every single patient you treat.”

What type of PDT physicians choose to use in their practice remains controversial. “Do you do short-contact PDT, do you do daylight PDT? We’ve gone back and forth in our practice,” Dr. Goldman said. “I’m not impressed with daylight PDT. I know this is at odds with some of the people here, but at least in Vermont, it doesn’t work very well.”

The way PDT was described in the original trials (a photosensitizer applied in the office followed by PDT) “works the best, with one caveat,” Dr. Goldman said. The caveat is that dermatologists should aim for a PDT clearance that approaches the efficacy of 5-fluorouracil (5-FU). “If you can get to that – which is difficult by the way – I think your patients will really appreciate this.”

An additional PDT pearl Dr. Goldman shared involves skin preparation: the use of acetone to defat the skin, even in patients with very thick lesions. Apply acetone with gauze to the site for 5 minutes and “all of that hyperkeratosis just wipes away,” curette off any residual hyperkeratosis – and consider a ring anesthetic block to control pain for the patient with severe disease, he advised.

Another tip is to forgo the goggles that come with most PDT kits. Instead, purchase smaller, disposable laser eye shields for PDT patients, Dr. Goldman said. “They work better. You can get closer to the eye … and they are more comfortable for the patient.”

Dr. Goldman’s practice is providing more PDT and much less 5-FU for patient convenience. “I believe if someone is willing to go through 3 weeks of 5-FU or 12-16 weeks of imiquimod, they get the best results. However, most people don’t want to do that if they can sit in front of a light for 15 minutes.”
 

Consider intralesional injections for SCCs and KAs on the legs

An ongoing challenge in medical dermatology is preventing rapid recurrence of SCCs and/or keratoacanthomas (KAs) near sites of previous excision on the legs. “We all see this quite a bit. Often you get lesions on the leg, you cut them out, and they come right back” close to the excision site, Dr. Goldman said.

He does not recommend methotrexate injections for these lesions. “Methotrexate does not work. It doesn’t hurt, but I’ve injected methotrexate into squamous cell carcinomas many times and they’ve never gone away.” In contrast, 5-FU “works incredibly well. They go away, I’ve had tremendous success. This has changed the way we treat these lesions.” 5-FU is inexpensive and can be obtained from oncology pharmacies. One caveat is 5-FU injections can be painful and patients require anesthesia prior to injection.

Using a 25-gauge or 27-gauge needle, Dr. Goldman injects 5-FU “exactly as I would a hypertrophic scar. I inject a squamous cell carcinoma carefully and ‘expand’ the tumor.” He typically injects a lesion every 2 weeks until it resolves completely, which typically takes two or three sessions.

“I want to emphasize that that’s really true about intralesional 5-FU for those KAs and scars on the legs,” said session moderator James Spencer, MD, a dermatologist in private practice in St. Petersburg, Florida. “Otherwise, you’re just chasing your tail trying to cut them out. You’ll do much better with the intralesional 5-FU; it’s easy to get, it’s affordable, it comes as 50 mg/mL … just keep it in the office.”
 

 

 

A recommended role for hedgehog inhibitors

Hedgehog inhibitors work best as neoadjuvant therapy to shrink large skin cancer tumors prior to excision, Dr. Goldman said. “Hedgehog inhibitors don’t cure anything … except for rare cases of small basal cell carcinomas.” For most lesions, however, the strategy is not curative.

 

– Pearls for providers of photodynamic therapy (PDT) include tips on skin preparation, eye protection, and use of three new codes to maximize reimbursement. Also trending in medical dermatology are best practices for intralesional injections of 5-FU to treat the often challenging isomorphic squamous cell carcinomas (SCCs) or keratoacanthomas on the lower leg, as well as use of neoadjuvant hedgehog inhibitors to shrink large skin cancer lesions, according to Glenn David Goldman, MD.

“This talk is about what you can do medically as a dermatologic surgeon,” Dr. Goldman said at the Orlando Dermatology Aesthetic and Clinical Conference.
 

Use new billing codes for photodynamic therapy

There are now three new PDT billing codes. “Make sure your coders are using these properly. They are active now, and if you don’t use them, you won’t get paid properly,” said Dr. Goldman, professor and medical director of dermatology at the University of Vermont, Burlington. Specifically, 96567 is for standard PDT applied by staff; 96573 is for PDT applied by a physician; and 96574 is for PDT and curettage performed by a physician.

“Be involved, don’t delegate,” Dr. Goldman added. “If you do, you will get paid half as much as you used to, which means you will lose money on every single patient you treat.”

What type of PDT physicians choose to use in their practice remains controversial. “Do you do short-contact PDT, do you do daylight PDT? We’ve gone back and forth in our practice,” Dr. Goldman said. “I’m not impressed with daylight PDT. I know this is at odds with some of the people here, but at least in Vermont, it doesn’t work very well.”

The way PDT was described in the original trials (a photosensitizer applied in the office followed by PDT) “works the best, with one caveat,” Dr. Goldman said. The caveat is that dermatologists should aim for a PDT clearance that approaches the efficacy of 5-fluorouracil (5-FU). “If you can get to that – which is difficult by the way – I think your patients will really appreciate this.”

An additional PDT pearl Dr. Goldman shared involves skin preparation: the use of acetone to defat the skin, even in patients with very thick lesions. Apply acetone with gauze to the site for 5 minutes and “all of that hyperkeratosis just wipes away,” curette off any residual hyperkeratosis – and consider a ring anesthetic block to control pain for the patient with severe disease, he advised.

Another tip is to forgo the goggles that come with most PDT kits. Instead, purchase smaller, disposable laser eye shields for PDT patients, Dr. Goldman said. “They work better. You can get closer to the eye … and they are more comfortable for the patient.”

Dr. Goldman’s practice is providing more PDT and much less 5-FU for patient convenience. “I believe if someone is willing to go through 3 weeks of 5-FU or 12-16 weeks of imiquimod, they get the best results. However, most people don’t want to do that if they can sit in front of a light for 15 minutes.”
 

Consider intralesional injections for SCCs and KAs on the legs

An ongoing challenge in medical dermatology is preventing rapid recurrence of SCCs and/or keratoacanthomas (KAs) near sites of previous excision on the legs. “We all see this quite a bit. Often you get lesions on the leg, you cut them out, and they come right back” close to the excision site, Dr. Goldman said.

He does not recommend methotrexate injections for these lesions. “Methotrexate does not work. It doesn’t hurt, but I’ve injected methotrexate into squamous cell carcinomas many times and they’ve never gone away.” In contrast, 5-FU “works incredibly well. They go away, I’ve had tremendous success. This has changed the way we treat these lesions.” 5-FU is inexpensive and can be obtained from oncology pharmacies. One caveat is 5-FU injections can be painful and patients require anesthesia prior to injection.

Using a 25-gauge or 27-gauge needle, Dr. Goldman injects 5-FU “exactly as I would a hypertrophic scar. I inject a squamous cell carcinoma carefully and ‘expand’ the tumor.” He typically injects a lesion every 2 weeks until it resolves completely, which typically takes two or three sessions.

“I want to emphasize that that’s really true about intralesional 5-FU for those KAs and scars on the legs,” said session moderator James Spencer, MD, a dermatologist in private practice in St. Petersburg, Florida. “Otherwise, you’re just chasing your tail trying to cut them out. You’ll do much better with the intralesional 5-FU; it’s easy to get, it’s affordable, it comes as 50 mg/mL … just keep it in the office.”
 

 

 

A recommended role for hedgehog inhibitors

Hedgehog inhibitors work best as neoadjuvant therapy to shrink large skin cancer tumors prior to excision, Dr. Goldman said. “Hedgehog inhibitors don’t cure anything … except for rare cases of small basal cell carcinomas.” For most lesions, however, the strategy is not curative.

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Five pearls target wound healing

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Mon, 01/14/2019 - 10:15

 

MIAMI – Another reason not to prescribe opioids for postoperative pain – besides potentially adding to the epidemic the nation – comes from evidence showing these agents can impair wound healing.

In addition, epidermal sutures to close dermatologic surgery sites may be unnecessary if deep suturing is done proficiently. These and other pearls to optimize wound closure were suggested by Robert S. Kirsner, MD, PhD, professor and chair of the department of dermatology and cutaneous surgery at the University of Miami.
 

Avoid opioids for postoperative pain

“We know the opioid epidemic is a big problem. An estimated 5-8 million Americans use them for chronic pain,” Dr. Kirsner said at the Orlando Dermatology Aesthetic and Clinical Conference. “And there has been a steady increase in the use of illicit and prescription opioids.”

Dr. Robert S. Kirsner
Emerging evidence suggests opioids also impair wound healing (J Invest Dermatol. 2017;137:2646-9). This study of 715 patients with leg ulcers, for example, showed use of opioids the most strongly associated with nonhealing at 12 weeks. “We found if you took an opioid you were less likely to heal,” Dr. Kirsner said. They found opioids significantly impaired healing, even when the investigators controlled for ulcer area, duration, and patient gender.

“The take-home message is that for the first time we have patient-oriented data that suggests that opioids impair healing,” Dr. Kirsner said. “So avoid opioids if at all possible.”

The precise mechanism remains unknown. The most likely explanation, he said, is that opioids inhibit substance P, a peptide that promotes healing in animal models. Interestingly, he added, adding the opioid antagonist naltrexone in animal studies improves healing.
 

Consider skipping epidermal sutures in some cases

Dermatologists who place really good deep sutures when closing a wound might be able to forgo traditional epidural suturing, Dr. Kirsner said. “If you believe the literature, you can actually forget epidermal sutures. That’s hard for us. We’re trained to put epidermal sutures in, and changing habits can be difficult.”

A prospective, randomized study demonstrated no difference in cosmesis at 6 months, for example, in a split scar study where half of each wound was closed with epidural suturing and half was not (Dermatol. Surg. 2015;41:1257-63). In another randomized study, researchers found something similar when comparing buried interrupted subcuticular suturing of wounds with and without adhesive strips to close the epidermis (JAMA Dermatol. 2015;15:862-7). “When they looked at the scars, complications, and cosmesis at 6 months, there was no difference,” Dr. Kirsner said.

“Forget epidermal sutures if you’re brave enough,” he said.

Dr. Kirsner acknowledged that some dermatologists might point out a requirement to evert wound edges with epidermal stitches. “It turns out you don’t need to, again, if you believe the literature.” He cited a randomized, controlled, split scar trial that revealed no difference in cosmetic outcomes according to blinded physician ratings or patient reports at 3 months (J Am Acad Dermatol. 2015;72;668-73). “So maybe the concept of wound eversion is not as important as we were originally taught.”

And speaking of wound edges …
 

When debriding a nonhealing wound ...

There may be something highly abnormal about a nonhealing wound edge, Dr. Kirsner said. In fact, they can be phenotypically and genotypically different from surrounding tissue, including characteristic overexpression of c-Myc and beta catenin. These two factors in higher amounts can inhibit the migration of keratinocytes into a wound to promote healing.

“Sometimes we debride the wound because it’s necrotic,” Dr. Kirsner said. But in the case of a nonhealing wound, it can be more effective to debride the edges to remove the abnormal tissue. “You can change the fortune of a wound by debriding the edge. You want to remove all the abnormal tissue, and give it a chance to heal.” Pathology supports the elevated presence of the c-Myc and beta catenin factors in the “healing incompetent” tissue around the edges of nonhealing wounds, he added.
 

If a patient is unusually anxious or stressed

Stress can impair wound healing by 40%, Dr. Kirsner said (Psychosom Med. 1998;60:362-5). Some anxiety before a dermatologic surgery procedure is normal for many patients, but there also are unusual circumstances. For example, “if a patient comes for cyst excision but learns while in the waiting room that his dog just died,” he said. It’s often better to reschedule the procedure than to proceed.

“What you can do on a daily basis is create a stress-free environment” as well, Dr. Kirsner said.

“From a practical standpoint, things that can impair healing include patient depression, negativism, isolation, and postoperative pain,” he added. The mechanism between elevated stress and impaired wound healing includes release of catecholamines that induce the action of endogenous steroids. This, in turn, can cause a cascade of events that reduce inflammatory cells and their pro-healing cytokines, thereby leading to poor healing.

“All of this is mediated through the love hormone, oxytocin. Maybe someday we will be able to give oxytocin to speed healing.”
 

 

 

Two technologies still look good for scarless donor sites

Epidermal grafting and technology based on fractional laser treatments continue to show promise for achieving a scarless donor site for patients who need grafting to promote wound healing, Dr. Kirsner said.

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MIAMI – Another reason not to prescribe opioids for postoperative pain – besides potentially adding to the epidemic the nation – comes from evidence showing these agents can impair wound healing.

In addition, epidermal sutures to close dermatologic surgery sites may be unnecessary if deep suturing is done proficiently. These and other pearls to optimize wound closure were suggested by Robert S. Kirsner, MD, PhD, professor and chair of the department of dermatology and cutaneous surgery at the University of Miami.
 

Avoid opioids for postoperative pain

“We know the opioid epidemic is a big problem. An estimated 5-8 million Americans use them for chronic pain,” Dr. Kirsner said at the Orlando Dermatology Aesthetic and Clinical Conference. “And there has been a steady increase in the use of illicit and prescription opioids.”

Dr. Robert S. Kirsner
Emerging evidence suggests opioids also impair wound healing (J Invest Dermatol. 2017;137:2646-9). This study of 715 patients with leg ulcers, for example, showed use of opioids the most strongly associated with nonhealing at 12 weeks. “We found if you took an opioid you were less likely to heal,” Dr. Kirsner said. They found opioids significantly impaired healing, even when the investigators controlled for ulcer area, duration, and patient gender.

“The take-home message is that for the first time we have patient-oriented data that suggests that opioids impair healing,” Dr. Kirsner said. “So avoid opioids if at all possible.”

The precise mechanism remains unknown. The most likely explanation, he said, is that opioids inhibit substance P, a peptide that promotes healing in animal models. Interestingly, he added, adding the opioid antagonist naltrexone in animal studies improves healing.
 

Consider skipping epidermal sutures in some cases

Dermatologists who place really good deep sutures when closing a wound might be able to forgo traditional epidural suturing, Dr. Kirsner said. “If you believe the literature, you can actually forget epidermal sutures. That’s hard for us. We’re trained to put epidermal sutures in, and changing habits can be difficult.”

A prospective, randomized study demonstrated no difference in cosmesis at 6 months, for example, in a split scar study where half of each wound was closed with epidural suturing and half was not (Dermatol. Surg. 2015;41:1257-63). In another randomized study, researchers found something similar when comparing buried interrupted subcuticular suturing of wounds with and without adhesive strips to close the epidermis (JAMA Dermatol. 2015;15:862-7). “When they looked at the scars, complications, and cosmesis at 6 months, there was no difference,” Dr. Kirsner said.

“Forget epidermal sutures if you’re brave enough,” he said.

Dr. Kirsner acknowledged that some dermatologists might point out a requirement to evert wound edges with epidermal stitches. “It turns out you don’t need to, again, if you believe the literature.” He cited a randomized, controlled, split scar trial that revealed no difference in cosmetic outcomes according to blinded physician ratings or patient reports at 3 months (J Am Acad Dermatol. 2015;72;668-73). “So maybe the concept of wound eversion is not as important as we were originally taught.”

And speaking of wound edges …
 

When debriding a nonhealing wound ...

There may be something highly abnormal about a nonhealing wound edge, Dr. Kirsner said. In fact, they can be phenotypically and genotypically different from surrounding tissue, including characteristic overexpression of c-Myc and beta catenin. These two factors in higher amounts can inhibit the migration of keratinocytes into a wound to promote healing.

“Sometimes we debride the wound because it’s necrotic,” Dr. Kirsner said. But in the case of a nonhealing wound, it can be more effective to debride the edges to remove the abnormal tissue. “You can change the fortune of a wound by debriding the edge. You want to remove all the abnormal tissue, and give it a chance to heal.” Pathology supports the elevated presence of the c-Myc and beta catenin factors in the “healing incompetent” tissue around the edges of nonhealing wounds, he added.
 

If a patient is unusually anxious or stressed

Stress can impair wound healing by 40%, Dr. Kirsner said (Psychosom Med. 1998;60:362-5). Some anxiety before a dermatologic surgery procedure is normal for many patients, but there also are unusual circumstances. For example, “if a patient comes for cyst excision but learns while in the waiting room that his dog just died,” he said. It’s often better to reschedule the procedure than to proceed.

“What you can do on a daily basis is create a stress-free environment” as well, Dr. Kirsner said.

“From a practical standpoint, things that can impair healing include patient depression, negativism, isolation, and postoperative pain,” he added. The mechanism between elevated stress and impaired wound healing includes release of catecholamines that induce the action of endogenous steroids. This, in turn, can cause a cascade of events that reduce inflammatory cells and their pro-healing cytokines, thereby leading to poor healing.

“All of this is mediated through the love hormone, oxytocin. Maybe someday we will be able to give oxytocin to speed healing.”
 

 

 

Two technologies still look good for scarless donor sites

Epidermal grafting and technology based on fractional laser treatments continue to show promise for achieving a scarless donor site for patients who need grafting to promote wound healing, Dr. Kirsner said.

 

MIAMI – Another reason not to prescribe opioids for postoperative pain – besides potentially adding to the epidemic the nation – comes from evidence showing these agents can impair wound healing.

In addition, epidermal sutures to close dermatologic surgery sites may be unnecessary if deep suturing is done proficiently. These and other pearls to optimize wound closure were suggested by Robert S. Kirsner, MD, PhD, professor and chair of the department of dermatology and cutaneous surgery at the University of Miami.
 

Avoid opioids for postoperative pain

“We know the opioid epidemic is a big problem. An estimated 5-8 million Americans use them for chronic pain,” Dr. Kirsner said at the Orlando Dermatology Aesthetic and Clinical Conference. “And there has been a steady increase in the use of illicit and prescription opioids.”

Dr. Robert S. Kirsner
Emerging evidence suggests opioids also impair wound healing (J Invest Dermatol. 2017;137:2646-9). This study of 715 patients with leg ulcers, for example, showed use of opioids the most strongly associated with nonhealing at 12 weeks. “We found if you took an opioid you were less likely to heal,” Dr. Kirsner said. They found opioids significantly impaired healing, even when the investigators controlled for ulcer area, duration, and patient gender.

“The take-home message is that for the first time we have patient-oriented data that suggests that opioids impair healing,” Dr. Kirsner said. “So avoid opioids if at all possible.”

The precise mechanism remains unknown. The most likely explanation, he said, is that opioids inhibit substance P, a peptide that promotes healing in animal models. Interestingly, he added, adding the opioid antagonist naltrexone in animal studies improves healing.
 

Consider skipping epidermal sutures in some cases

Dermatologists who place really good deep sutures when closing a wound might be able to forgo traditional epidural suturing, Dr. Kirsner said. “If you believe the literature, you can actually forget epidermal sutures. That’s hard for us. We’re trained to put epidermal sutures in, and changing habits can be difficult.”

A prospective, randomized study demonstrated no difference in cosmesis at 6 months, for example, in a split scar study where half of each wound was closed with epidural suturing and half was not (Dermatol. Surg. 2015;41:1257-63). In another randomized study, researchers found something similar when comparing buried interrupted subcuticular suturing of wounds with and without adhesive strips to close the epidermis (JAMA Dermatol. 2015;15:862-7). “When they looked at the scars, complications, and cosmesis at 6 months, there was no difference,” Dr. Kirsner said.

“Forget epidermal sutures if you’re brave enough,” he said.

Dr. Kirsner acknowledged that some dermatologists might point out a requirement to evert wound edges with epidermal stitches. “It turns out you don’t need to, again, if you believe the literature.” He cited a randomized, controlled, split scar trial that revealed no difference in cosmetic outcomes according to blinded physician ratings or patient reports at 3 months (J Am Acad Dermatol. 2015;72;668-73). “So maybe the concept of wound eversion is not as important as we were originally taught.”

And speaking of wound edges …
 

When debriding a nonhealing wound ...

There may be something highly abnormal about a nonhealing wound edge, Dr. Kirsner said. In fact, they can be phenotypically and genotypically different from surrounding tissue, including characteristic overexpression of c-Myc and beta catenin. These two factors in higher amounts can inhibit the migration of keratinocytes into a wound to promote healing.

“Sometimes we debride the wound because it’s necrotic,” Dr. Kirsner said. But in the case of a nonhealing wound, it can be more effective to debride the edges to remove the abnormal tissue. “You can change the fortune of a wound by debriding the edge. You want to remove all the abnormal tissue, and give it a chance to heal.” Pathology supports the elevated presence of the c-Myc and beta catenin factors in the “healing incompetent” tissue around the edges of nonhealing wounds, he added.
 

If a patient is unusually anxious or stressed

Stress can impair wound healing by 40%, Dr. Kirsner said (Psychosom Med. 1998;60:362-5). Some anxiety before a dermatologic surgery procedure is normal for many patients, but there also are unusual circumstances. For example, “if a patient comes for cyst excision but learns while in the waiting room that his dog just died,” he said. It’s often better to reschedule the procedure than to proceed.

“What you can do on a daily basis is create a stress-free environment” as well, Dr. Kirsner said.

“From a practical standpoint, things that can impair healing include patient depression, negativism, isolation, and postoperative pain,” he added. The mechanism between elevated stress and impaired wound healing includes release of catecholamines that induce the action of endogenous steroids. This, in turn, can cause a cascade of events that reduce inflammatory cells and their pro-healing cytokines, thereby leading to poor healing.

“All of this is mediated through the love hormone, oxytocin. Maybe someday we will be able to give oxytocin to speed healing.”
 

 

 

Two technologies still look good for scarless donor sites

Epidermal grafting and technology based on fractional laser treatments continue to show promise for achieving a scarless donor site for patients who need grafting to promote wound healing, Dr. Kirsner said.

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Award program to drive more community-based rheumatology research

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Thu, 12/06/2018 - 11:45

 

Practice makes perfect. It also makes the perfect setting for real-world research in rheumatology. Traditionally, however, rheumatologists in day-to-day private practice settings have been hampered by limited opportunities, time constraints, and competition from larger academic medical centers to conduct cutting edge research.

That could soon change. The Norman B. Gaylis, MD, Research Award for Rheumatologists in Community Practice is being relaunched to offer rheumatologists research grants from $50,000-$200,000 per year, for up to 2 years, to drive the field forward. The program stems from a generous $1 million commitment from Dr. Gaylis, a rheumatologist in private practice in Aventura, Fla., in partnership with the Rheumatology Research Foundation.

Courtesy Dr. Norman Gaylis
Dr. Norman Gaylis
Although the award program was first met with high levels of enthusiasm when announced 2 years ago, it soon became clear that the application process was too complicated and it dissuaded many from pursuing the award. Now, however, based on what was learned along the way, now the process will be simpler and geared more toward practicing rheumatologists.

“Clinicians are very busy with their day-to-day practices,” Dr. Gaylis said. “I really want to support this kind of research for clinicians with ideas but who didn’t have the resources or the time to develop their ideas.” During his nearly 4 decades in rheumatology practice, Dr. Gaylis has performed “a lot of clinical research, including research being driven purely by my own ideas.” This award program is his way of paying it forward.
 

Investigator-driven initiatives

In addition to financial support, the program will help community rheumatologists with viable ideas, including clinicians with less research experience, to refine their hypothesis and methodology as appropriate. “For example, if someone submits a proposal to study the effect of diet on gout, we, as part of the application process, will help them develop the application so it meets the quality expectations of the review committee,” Dr. Gaylis said. “We want it to be their idea, uniquely, the idea of the application. We can guide them so it will be a quality application,” Dr. Gaylis said. “Then it’s up to them.”

Support from the Foundation will remain available and periodic reports will be required to ensure the research is progressing on schedule. “We don’t expect them to get this turned around in 6 months,” Dr. Gaylis said. “It could be a 2-year study ... or even longer.”

“Understanding their priorities and research interests are very different from their colleagues in academia, the Foundation wants to encourage rheumatologists in a clinical setting to explore their own, independent research ideas,” said Shelley A. Malcolm, director of marketing and communication at the Rheumatology Research Foundation.

“The application process and award terms are tailored for rheumatology health professionals who may not have experience in writing grant proposals, or have time to draft applications similar to those required for NIH funding, because their priority lies in patient care and practice management,” Ms. Malcolm said. The Foundation will begin accepting proposals in March 2018 and up until the July 1, 2018 deadline.
 

Smart but not academic

Dr. Gaylis and the Rheumatology Research Foundation worked together to streamline the process with busy clinicians in mind.

This award is really for the rheumatologist in practice … who is not affiliated with academic institutions. They can be attached as a clinical professor, but they’re not really supported by an institution,” Dr. Gaylis said. “Effectively, this should really allow them to have the flexibility to do the research they feel needs to be done without having to go through the whole administrative process you would normally find in an academic institution.”

Recipients will not be competing with academic medical centers that have “the reputation, the manpower, and the capabilities that in general can swallow up all the research awards available.” This recognizes what the practicing clinician brings to the table without making them feel like they’re wasting their time by applying, Dr. Gaylis added.

“This is not saying that academia doesn’t have its role.” But the award program “levels the playing field.”
 

Keeping it real

Clinical practice “is really a real-world environment. Whether one is trying to understand the possibilities in using treatments differently, approaching patients differently, or seeing outcomes you’re seeing that are different from the standard, controlled, double-blind placebo study that is the norm in academic research,” Dr. Gaylis said.

“This is much more focused on the patient who walks into your office,” he continued. “I believe there are many, many more rheumatologists like me who could embrace this opportunity.” He added, “If I was allowed to, I would apply for it myself.”

The research award program can serve as a platform not only for making new discoveries but also taking drugs that are on the marketplace and using them in different forms or fashions in a successful way, Dr. Gaylis said. “And it doesn’t just have to be medications; it could be behavior mechanisms – understanding which patients might be more responsive to therapies, for example.”

The purpose is to initiate research, including but not limited to, health services research or outcome studies, practice supply and demand, and/or patient communications, Ms. Malcolm said. “The goal of the award is to provide independent investigators with the funding they need to pursue ideas that could lead to important breakthroughs in discovering new treatments and, one day, a cure.”

“Clinical practice is an incredible petri dish for research,” Dr. Gaylis said. “We end up losing a lot of opportunities by pigeonholing most research in academic centers. So if we can show the value and validity and identify clinicians who have the aptitude for this kind of clinical research, I think not only will this award program become more exciting, it will become more valuable.”
 

Maintain career-long clinical curiosity

Clinical practice is a very important point in the journey of being a rheumatologist, Dr. Gaylis said, but research shouldn’t end when you complete your fellowship. “It should continue for your whole career. One should be putting into effect the principles of investigation, the principles of observation, and the principle of generating ideas that are instilled in everyone during their education, but they get diluted as time goes on. We’re trying to prevent that.”

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Practice makes perfect. It also makes the perfect setting for real-world research in rheumatology. Traditionally, however, rheumatologists in day-to-day private practice settings have been hampered by limited opportunities, time constraints, and competition from larger academic medical centers to conduct cutting edge research.

That could soon change. The Norman B. Gaylis, MD, Research Award for Rheumatologists in Community Practice is being relaunched to offer rheumatologists research grants from $50,000-$200,000 per year, for up to 2 years, to drive the field forward. The program stems from a generous $1 million commitment from Dr. Gaylis, a rheumatologist in private practice in Aventura, Fla., in partnership with the Rheumatology Research Foundation.

Courtesy Dr. Norman Gaylis
Dr. Norman Gaylis
Although the award program was first met with high levels of enthusiasm when announced 2 years ago, it soon became clear that the application process was too complicated and it dissuaded many from pursuing the award. Now, however, based on what was learned along the way, now the process will be simpler and geared more toward practicing rheumatologists.

“Clinicians are very busy with their day-to-day practices,” Dr. Gaylis said. “I really want to support this kind of research for clinicians with ideas but who didn’t have the resources or the time to develop their ideas.” During his nearly 4 decades in rheumatology practice, Dr. Gaylis has performed “a lot of clinical research, including research being driven purely by my own ideas.” This award program is his way of paying it forward.
 

Investigator-driven initiatives

In addition to financial support, the program will help community rheumatologists with viable ideas, including clinicians with less research experience, to refine their hypothesis and methodology as appropriate. “For example, if someone submits a proposal to study the effect of diet on gout, we, as part of the application process, will help them develop the application so it meets the quality expectations of the review committee,” Dr. Gaylis said. “We want it to be their idea, uniquely, the idea of the application. We can guide them so it will be a quality application,” Dr. Gaylis said. “Then it’s up to them.”

Support from the Foundation will remain available and periodic reports will be required to ensure the research is progressing on schedule. “We don’t expect them to get this turned around in 6 months,” Dr. Gaylis said. “It could be a 2-year study ... or even longer.”

“Understanding their priorities and research interests are very different from their colleagues in academia, the Foundation wants to encourage rheumatologists in a clinical setting to explore their own, independent research ideas,” said Shelley A. Malcolm, director of marketing and communication at the Rheumatology Research Foundation.

“The application process and award terms are tailored for rheumatology health professionals who may not have experience in writing grant proposals, or have time to draft applications similar to those required for NIH funding, because their priority lies in patient care and practice management,” Ms. Malcolm said. The Foundation will begin accepting proposals in March 2018 and up until the July 1, 2018 deadline.
 

Smart but not academic

Dr. Gaylis and the Rheumatology Research Foundation worked together to streamline the process with busy clinicians in mind.

This award is really for the rheumatologist in practice … who is not affiliated with academic institutions. They can be attached as a clinical professor, but they’re not really supported by an institution,” Dr. Gaylis said. “Effectively, this should really allow them to have the flexibility to do the research they feel needs to be done without having to go through the whole administrative process you would normally find in an academic institution.”

Recipients will not be competing with academic medical centers that have “the reputation, the manpower, and the capabilities that in general can swallow up all the research awards available.” This recognizes what the practicing clinician brings to the table without making them feel like they’re wasting their time by applying, Dr. Gaylis added.

“This is not saying that academia doesn’t have its role.” But the award program “levels the playing field.”
 

Keeping it real

Clinical practice “is really a real-world environment. Whether one is trying to understand the possibilities in using treatments differently, approaching patients differently, or seeing outcomes you’re seeing that are different from the standard, controlled, double-blind placebo study that is the norm in academic research,” Dr. Gaylis said.

“This is much more focused on the patient who walks into your office,” he continued. “I believe there are many, many more rheumatologists like me who could embrace this opportunity.” He added, “If I was allowed to, I would apply for it myself.”

The research award program can serve as a platform not only for making new discoveries but also taking drugs that are on the marketplace and using them in different forms or fashions in a successful way, Dr. Gaylis said. “And it doesn’t just have to be medications; it could be behavior mechanisms – understanding which patients might be more responsive to therapies, for example.”

The purpose is to initiate research, including but not limited to, health services research or outcome studies, practice supply and demand, and/or patient communications, Ms. Malcolm said. “The goal of the award is to provide independent investigators with the funding they need to pursue ideas that could lead to important breakthroughs in discovering new treatments and, one day, a cure.”

“Clinical practice is an incredible petri dish for research,” Dr. Gaylis said. “We end up losing a lot of opportunities by pigeonholing most research in academic centers. So if we can show the value and validity and identify clinicians who have the aptitude for this kind of clinical research, I think not only will this award program become more exciting, it will become more valuable.”
 

Maintain career-long clinical curiosity

Clinical practice is a very important point in the journey of being a rheumatologist, Dr. Gaylis said, but research shouldn’t end when you complete your fellowship. “It should continue for your whole career. One should be putting into effect the principles of investigation, the principles of observation, and the principle of generating ideas that are instilled in everyone during their education, but they get diluted as time goes on. We’re trying to prevent that.”

 

Practice makes perfect. It also makes the perfect setting for real-world research in rheumatology. Traditionally, however, rheumatologists in day-to-day private practice settings have been hampered by limited opportunities, time constraints, and competition from larger academic medical centers to conduct cutting edge research.

That could soon change. The Norman B. Gaylis, MD, Research Award for Rheumatologists in Community Practice is being relaunched to offer rheumatologists research grants from $50,000-$200,000 per year, for up to 2 years, to drive the field forward. The program stems from a generous $1 million commitment from Dr. Gaylis, a rheumatologist in private practice in Aventura, Fla., in partnership with the Rheumatology Research Foundation.

Courtesy Dr. Norman Gaylis
Dr. Norman Gaylis
Although the award program was first met with high levels of enthusiasm when announced 2 years ago, it soon became clear that the application process was too complicated and it dissuaded many from pursuing the award. Now, however, based on what was learned along the way, now the process will be simpler and geared more toward practicing rheumatologists.

“Clinicians are very busy with their day-to-day practices,” Dr. Gaylis said. “I really want to support this kind of research for clinicians with ideas but who didn’t have the resources or the time to develop their ideas.” During his nearly 4 decades in rheumatology practice, Dr. Gaylis has performed “a lot of clinical research, including research being driven purely by my own ideas.” This award program is his way of paying it forward.
 

Investigator-driven initiatives

In addition to financial support, the program will help community rheumatologists with viable ideas, including clinicians with less research experience, to refine their hypothesis and methodology as appropriate. “For example, if someone submits a proposal to study the effect of diet on gout, we, as part of the application process, will help them develop the application so it meets the quality expectations of the review committee,” Dr. Gaylis said. “We want it to be their idea, uniquely, the idea of the application. We can guide them so it will be a quality application,” Dr. Gaylis said. “Then it’s up to them.”

Support from the Foundation will remain available and periodic reports will be required to ensure the research is progressing on schedule. “We don’t expect them to get this turned around in 6 months,” Dr. Gaylis said. “It could be a 2-year study ... or even longer.”

“Understanding their priorities and research interests are very different from their colleagues in academia, the Foundation wants to encourage rheumatologists in a clinical setting to explore their own, independent research ideas,” said Shelley A. Malcolm, director of marketing and communication at the Rheumatology Research Foundation.

“The application process and award terms are tailored for rheumatology health professionals who may not have experience in writing grant proposals, or have time to draft applications similar to those required for NIH funding, because their priority lies in patient care and practice management,” Ms. Malcolm said. The Foundation will begin accepting proposals in March 2018 and up until the July 1, 2018 deadline.
 

Smart but not academic

Dr. Gaylis and the Rheumatology Research Foundation worked together to streamline the process with busy clinicians in mind.

This award is really for the rheumatologist in practice … who is not affiliated with academic institutions. They can be attached as a clinical professor, but they’re not really supported by an institution,” Dr. Gaylis said. “Effectively, this should really allow them to have the flexibility to do the research they feel needs to be done without having to go through the whole administrative process you would normally find in an academic institution.”

Recipients will not be competing with academic medical centers that have “the reputation, the manpower, and the capabilities that in general can swallow up all the research awards available.” This recognizes what the practicing clinician brings to the table without making them feel like they’re wasting their time by applying, Dr. Gaylis added.

“This is not saying that academia doesn’t have its role.” But the award program “levels the playing field.”
 

Keeping it real

Clinical practice “is really a real-world environment. Whether one is trying to understand the possibilities in using treatments differently, approaching patients differently, or seeing outcomes you’re seeing that are different from the standard, controlled, double-blind placebo study that is the norm in academic research,” Dr. Gaylis said.

“This is much more focused on the patient who walks into your office,” he continued. “I believe there are many, many more rheumatologists like me who could embrace this opportunity.” He added, “If I was allowed to, I would apply for it myself.”

The research award program can serve as a platform not only for making new discoveries but also taking drugs that are on the marketplace and using them in different forms or fashions in a successful way, Dr. Gaylis said. “And it doesn’t just have to be medications; it could be behavior mechanisms – understanding which patients might be more responsive to therapies, for example.”

The purpose is to initiate research, including but not limited to, health services research or outcome studies, practice supply and demand, and/or patient communications, Ms. Malcolm said. “The goal of the award is to provide independent investigators with the funding they need to pursue ideas that could lead to important breakthroughs in discovering new treatments and, one day, a cure.”

“Clinical practice is an incredible petri dish for research,” Dr. Gaylis said. “We end up losing a lot of opportunities by pigeonholing most research in academic centers. So if we can show the value and validity and identify clinicians who have the aptitude for this kind of clinical research, I think not only will this award program become more exciting, it will become more valuable.”
 

Maintain career-long clinical curiosity

Clinical practice is a very important point in the journey of being a rheumatologist, Dr. Gaylis said, but research shouldn’t end when you complete your fellowship. “It should continue for your whole career. One should be putting into effect the principles of investigation, the principles of observation, and the principle of generating ideas that are instilled in everyone during their education, but they get diluted as time goes on. We’re trying to prevent that.”

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Evidence-backed questions can guide a GERD vs. NERD differential diagnosis

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CHICAGO – “All that vomits is not necessarily GERD,” so distinguishing gastroesophageal reflux disease (GERD) from nonerosive reflux disease (NERD) remains essential when doing a differential diagnosis. Fortunately, five questions backed by increasing evidence can help you make the call.

“Everyone in the room knows babies puke, and babies can puke a lot,” Barry K. Wershil, MD, said at the annual meeting of the American Academy of Pediatrics. The approach to diagnosing GERD is age specific. “Kids who puke tend to outgrow it over time. With development, 95% or more are no longer refluxing at 18 months of age.”

captain_galaxy/Thinkstock
In infants and toddlers, there is no symptom or group of symptoms to reliably diagnose GERD or predict treatment response – that’s key take-home point No. 1, said Dr. Wershil, the head of the division of gastroenterology, hepatology and nutrition at the Ann & Robert H. Lurie Children’s Hospital of Chicago, as well as a professor of pediatrics at Northwestern University, also in Chicago. In older children and adults, a history and/or physical exam are generally sufficient to diagnose GERD reliably and to start treatment.

“So generally there is no reason to initially refer older children and teenagers to a gastroenterologist,” Dr. Wershil said. “One of the essential things [you] do is consider all the causes of vomiting that are not GERD. If your first go-to is GERD, you’re going to miss other issues.”

Dr. Wershil reviewed the definitions: Gastroesophageal reflux is passage of gastric contents into the esophagus. GERD, on the other hand, is defined by the troublesome symptoms or complications associated with reflux of gastric material into the esophagus. In contrast, NERD is the presence of reflux symptoms with no evidence of mucosal erosion or mucosal breaks.
 

Considerations backed by evidence

Unfortunately, symptoms alone do not always differentiate erosive versus nonerosive esophagitis, Dr. Wershil said, although recurrent vomiting, poor weight gain, anemia, feeding problems, and respiratory problems can be signs of complicated GERD.

He recommended the following five considerations to distinguish GERD from NERD:

  • Is the patient exhibiting normal weight gain? If not, ask questions about how the child is being fed. Have the parents started diluting the formula because they think that will take care of the vomiting? Have they begun limiting the amount of formula after observing that the child throws up at 4 ounces but not at 2 ounces?
  • Is the patient bleeding or anemic? Hematemesis is rarely the presentation of infants with GERD, but anemia may be.
  • Does the patient have respiratory problems (for example, a history of aspiration, recurring wheezing, or cough)?
  • Is the patient neurologically normal? If so, that can present a special class of patients in which vomiting may not be just normal infant vomiting.
  • Is the patient older than 2 years? We expect 95% of children to outgrow reflux by 18 months, and most children who have physiological reflux will outgrow it by 2 years.

“Those five questions in 1983 had little evidence, but in 2017 there is more evidence that these are the questions to focus on,” Dr. Wershil said.
 

The role of diagnostic testing

Diagnostic testing, such as pH monitoring, impedance testing, and endoscopy, can be useful in specific situations but carry limitations for widespread use, Dr. Wershil said. “Each test has reasons and limitations.”

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CHICAGO – “All that vomits is not necessarily GERD,” so distinguishing gastroesophageal reflux disease (GERD) from nonerosive reflux disease (NERD) remains essential when doing a differential diagnosis. Fortunately, five questions backed by increasing evidence can help you make the call.

“Everyone in the room knows babies puke, and babies can puke a lot,” Barry K. Wershil, MD, said at the annual meeting of the American Academy of Pediatrics. The approach to diagnosing GERD is age specific. “Kids who puke tend to outgrow it over time. With development, 95% or more are no longer refluxing at 18 months of age.”

captain_galaxy/Thinkstock
In infants and toddlers, there is no symptom or group of symptoms to reliably diagnose GERD or predict treatment response – that’s key take-home point No. 1, said Dr. Wershil, the head of the division of gastroenterology, hepatology and nutrition at the Ann & Robert H. Lurie Children’s Hospital of Chicago, as well as a professor of pediatrics at Northwestern University, also in Chicago. In older children and adults, a history and/or physical exam are generally sufficient to diagnose GERD reliably and to start treatment.

“So generally there is no reason to initially refer older children and teenagers to a gastroenterologist,” Dr. Wershil said. “One of the essential things [you] do is consider all the causes of vomiting that are not GERD. If your first go-to is GERD, you’re going to miss other issues.”

Dr. Wershil reviewed the definitions: Gastroesophageal reflux is passage of gastric contents into the esophagus. GERD, on the other hand, is defined by the troublesome symptoms or complications associated with reflux of gastric material into the esophagus. In contrast, NERD is the presence of reflux symptoms with no evidence of mucosal erosion or mucosal breaks.
 

Considerations backed by evidence

Unfortunately, symptoms alone do not always differentiate erosive versus nonerosive esophagitis, Dr. Wershil said, although recurrent vomiting, poor weight gain, anemia, feeding problems, and respiratory problems can be signs of complicated GERD.

He recommended the following five considerations to distinguish GERD from NERD:

  • Is the patient exhibiting normal weight gain? If not, ask questions about how the child is being fed. Have the parents started diluting the formula because they think that will take care of the vomiting? Have they begun limiting the amount of formula after observing that the child throws up at 4 ounces but not at 2 ounces?
  • Is the patient bleeding or anemic? Hematemesis is rarely the presentation of infants with GERD, but anemia may be.
  • Does the patient have respiratory problems (for example, a history of aspiration, recurring wheezing, or cough)?
  • Is the patient neurologically normal? If so, that can present a special class of patients in which vomiting may not be just normal infant vomiting.
  • Is the patient older than 2 years? We expect 95% of children to outgrow reflux by 18 months, and most children who have physiological reflux will outgrow it by 2 years.

“Those five questions in 1983 had little evidence, but in 2017 there is more evidence that these are the questions to focus on,” Dr. Wershil said.
 

The role of diagnostic testing

Diagnostic testing, such as pH monitoring, impedance testing, and endoscopy, can be useful in specific situations but carry limitations for widespread use, Dr. Wershil said. “Each test has reasons and limitations.”

 

CHICAGO – “All that vomits is not necessarily GERD,” so distinguishing gastroesophageal reflux disease (GERD) from nonerosive reflux disease (NERD) remains essential when doing a differential diagnosis. Fortunately, five questions backed by increasing evidence can help you make the call.

“Everyone in the room knows babies puke, and babies can puke a lot,” Barry K. Wershil, MD, said at the annual meeting of the American Academy of Pediatrics. The approach to diagnosing GERD is age specific. “Kids who puke tend to outgrow it over time. With development, 95% or more are no longer refluxing at 18 months of age.”

captain_galaxy/Thinkstock
In infants and toddlers, there is no symptom or group of symptoms to reliably diagnose GERD or predict treatment response – that’s key take-home point No. 1, said Dr. Wershil, the head of the division of gastroenterology, hepatology and nutrition at the Ann & Robert H. Lurie Children’s Hospital of Chicago, as well as a professor of pediatrics at Northwestern University, also in Chicago. In older children and adults, a history and/or physical exam are generally sufficient to diagnose GERD reliably and to start treatment.

“So generally there is no reason to initially refer older children and teenagers to a gastroenterologist,” Dr. Wershil said. “One of the essential things [you] do is consider all the causes of vomiting that are not GERD. If your first go-to is GERD, you’re going to miss other issues.”

Dr. Wershil reviewed the definitions: Gastroesophageal reflux is passage of gastric contents into the esophagus. GERD, on the other hand, is defined by the troublesome symptoms or complications associated with reflux of gastric material into the esophagus. In contrast, NERD is the presence of reflux symptoms with no evidence of mucosal erosion or mucosal breaks.
 

Considerations backed by evidence

Unfortunately, symptoms alone do not always differentiate erosive versus nonerosive esophagitis, Dr. Wershil said, although recurrent vomiting, poor weight gain, anemia, feeding problems, and respiratory problems can be signs of complicated GERD.

He recommended the following five considerations to distinguish GERD from NERD:

  • Is the patient exhibiting normal weight gain? If not, ask questions about how the child is being fed. Have the parents started diluting the formula because they think that will take care of the vomiting? Have they begun limiting the amount of formula after observing that the child throws up at 4 ounces but not at 2 ounces?
  • Is the patient bleeding or anemic? Hematemesis is rarely the presentation of infants with GERD, but anemia may be.
  • Does the patient have respiratory problems (for example, a history of aspiration, recurring wheezing, or cough)?
  • Is the patient neurologically normal? If so, that can present a special class of patients in which vomiting may not be just normal infant vomiting.
  • Is the patient older than 2 years? We expect 95% of children to outgrow reflux by 18 months, and most children who have physiological reflux will outgrow it by 2 years.

“Those five questions in 1983 had little evidence, but in 2017 there is more evidence that these are the questions to focus on,” Dr. Wershil said.
 

The role of diagnostic testing

Diagnostic testing, such as pH monitoring, impedance testing, and endoscopy, can be useful in specific situations but carry limitations for widespread use, Dr. Wershil said. “Each test has reasons and limitations.”

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Sorting out syncope signs and symptoms in kids remains essential

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Interpreting new 2017 syncope guideline

CHICAGO – Syncope often is misdiagnosed in pediatric patients complaining of chest pain, and a new guideline released in 2017 could guide clinicians toward a more accurate differential diagnosis and help them know when immediate referral to cardiology or the emergency department is warranted.

“There are recent guidelines published this year which are helpful,” said Dr. Barbara Deal, the Getz Professor of Cardiology at Northwestern University in Chicago. “I’d like you to pay attention to the fact that the [guideline states] that a 12-lead ECG should be performed in all pediatric patients presenting with syncope,” which is defined as transient loss of consciousness.

hepatus/iStockphoto
The ECG is indicated because “sometimes it’s hard to know if something was vasovagal or not. Even for me, I still sometimes get it wrong.” The 12-lead ECG is recommended for the first but not every episode, according to the 2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society. Although this guideline was developed by groups that typically focus more on adults, the Pediatric and Congenital Electrophysiology Society endorsed the guideline.

“Once you establish it is a simple vasovagal [cause], you need to educate patients on conditions that would promote this and the need to be anticipatory,” Dr. Deal said at the annual meeting of the American Academy of Pediatrics. “Further testing with an echo[cardiogram] should be done if you suspect heart disease or a rhythm disorder.”

Chest pain and syncope are common complaints that can lead to significant anxiety for patients, parents, and pediatric providers. The greatest cause of this anxiety is the prospect of a fatal or near-fatal event. An abnormal cardiac examination, any associated palpitations, and a history of urinary incontinence or traumatic injury are reasons to worry, she said. “Any of these should prompt an urgent consult to cardiology or the emergency department.”

Cardiac causes of chest pain include reflex or vasovagal syncope or even a more serious cardiac cause, such as arrhythmic or structural issues, Dr. Deal said. Symptoms that appear with exertion or stress also are very worrisome. “You would know if they have a heart murmur or stenosis – it’s these other things that don’t present with a cardiac abnormality: hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy,” she said. “If they have symptoms on exertion, pay attention. This is not good.”

Syncope often is misdiagnosed, Dr. Deal said. Approximately 35%-48% of patients classified as having syncope do not have actual syncope;rather they experience dizziness rather than a loss of consciousness. In a study of 194 children, for example, the leading etiologies diagnosed after evaluation for syncope included simple fainting in 49%, a vasopressor/vasovagal response in 14%, and possible seizure in 14% (J Am Coll Cardiol. 1997;29[6]:1039-45). Seven percent were diagnosed with syncope not otherwise specified in this series. Some other causes included psychogenic or orthostatic ones, hyperventilation, dysmenorrhea, vertigo, dehydration, trauma, stress, exhaustion, or an infectious condition.*

“When should you be thinking life-threatening syncope?” Dr. Deal asked. Arrhythmic disorders that are heritable, such as an ion channelopathy, are an example. “They don’t always feel the racing heartbeat, but they feel something is not right; they feel a sense of impending doom. Some families report signs during exercise like swimming, seizures, gargling noises, or unusual symptoms on awakening.”

Dr. Deal noted that ages 3-24 years are “the problem territory for cardiac arrest.” In this age group, 43%-55% of cardiac arrests are associated with hypertrophic cardiomyopathy or arrhythmias; about one in three will have prior syncope. “These causes are not detectable on physical examination and often are not detectable with ECG only,” adding to the differential diagnosis challenges.*
 

Refer to a pediatric cardiologist

For this reason and others, referral to a pediatric cardiologist is indicated instead of a consult with an adult cardiologist, Dr. Deal said. “You know how your kids will start with ‘no offense.’ Like, ‘no offense, Mom, but your hair looks awful.’ With moderate offense intended, having an adult cardiologist read a pediatric ECG and clear them is not adequate. They will be looking for ischemia or A-fib [atrial fibrillation]; they’re not looking for long QT syndrome, arrhythmogenic cardiomyopathy, or abnormal T waves.”

Early detection of long QT syndrome is optimal, Dr. Deal said, because symptom onset often is between infancy and age 7 years. In addition, mortality is highest in the first 2 decades of life. “I think this could be why adult cardiologists are not as concerned as we are,” Dr. Deal said. “The bad ones die before they reach adulthood.”
 

 

 

Ruling out a cardiac cause

The 2017 joint guideline defined syncope as a transient loss of consciousness. “By definition, you pass out, you’re not aware of where you are, and you cannot hear,” Dr. Deal said. If a patient reports they could hear people talking, they may have lost postural tone, but they did not have syncope, she added.

“Sometimes, we see teenagers who are said to pass out and are unresponsive for 5 minutes, 10 minutes, or 20 minutes. I’m usually relieved to hear that because that gets cardiac off the hook,” Dr. Deal said. “There is nothing cardiac that makes you pass out for 20 minutes, unless people are resuscitating you.” She added, “I’m not suggesting it’s not a significant problem that you need to get to the bottom of.”

Noncardiac etiologies can be neurologic, metabolic, drug-induced, or psychogenic. “This is where the detective work comes in.”

Keep clinical suspicion high for psychogenic syncope, Dr. Deal said. Psychogenic episodes stem from significant psychological stress, often something so profoundly bothersome that they cannot cope, such as sexual abuse.

A helpful tip for diagnosing the less worrisome vasovagal syncope is asking whether a patient was sitting to standing or standing a long time before an episode, Dr. Deal said. “A common complaint is that the family went to airport, got up early, didn’t eat, and ended up standing for a long time. Kids will say they don’t feel well, they fall down, and all hell breaks loose.” Other causes of vasovagal syncope include stress, pain, or a situational trigger, for example, when a person faints during a blood draw or immunization.

The 2017 guideline also set forth the evidence behind various medications used to lower the risk of syncope. However, Dr. Deal said, “If syncope only happens every 3 years when you go to an airport, it’s probably not worth daily therapy to prevent that.”

‘The world’s most boring test’

For the most part, lifestyle measures should work to address vasovagal syncope. A tilt table test can be useful to aid the differential diagnosis, but it’s recommended only when the etiology is unclear, Dr. Deal said. On the plus side, the tilt table test allows clinicians to reproduce symptoms in a controlled environment. On the downside, she added, “It’s the world’s most boring test. It’s a challenge for the cardiologist to stay awake. It’s very boring, until all hell breaks loose.”

“I find this helpful in the setting of kids with seizures and for kids with this atypical syncope where you just cannot convince the family that these 20-minute episodes of loss of consciousness are not near-death episodes.”

Dr. Deal had no relevant financial disclosures.

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Interpreting new 2017 syncope guideline
Interpreting new 2017 syncope guideline

CHICAGO – Syncope often is misdiagnosed in pediatric patients complaining of chest pain, and a new guideline released in 2017 could guide clinicians toward a more accurate differential diagnosis and help them know when immediate referral to cardiology or the emergency department is warranted.

“There are recent guidelines published this year which are helpful,” said Dr. Barbara Deal, the Getz Professor of Cardiology at Northwestern University in Chicago. “I’d like you to pay attention to the fact that the [guideline states] that a 12-lead ECG should be performed in all pediatric patients presenting with syncope,” which is defined as transient loss of consciousness.

hepatus/iStockphoto
The ECG is indicated because “sometimes it’s hard to know if something was vasovagal or not. Even for me, I still sometimes get it wrong.” The 12-lead ECG is recommended for the first but not every episode, according to the 2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society. Although this guideline was developed by groups that typically focus more on adults, the Pediatric and Congenital Electrophysiology Society endorsed the guideline.

“Once you establish it is a simple vasovagal [cause], you need to educate patients on conditions that would promote this and the need to be anticipatory,” Dr. Deal said at the annual meeting of the American Academy of Pediatrics. “Further testing with an echo[cardiogram] should be done if you suspect heart disease or a rhythm disorder.”

Chest pain and syncope are common complaints that can lead to significant anxiety for patients, parents, and pediatric providers. The greatest cause of this anxiety is the prospect of a fatal or near-fatal event. An abnormal cardiac examination, any associated palpitations, and a history of urinary incontinence or traumatic injury are reasons to worry, she said. “Any of these should prompt an urgent consult to cardiology or the emergency department.”

Cardiac causes of chest pain include reflex or vasovagal syncope or even a more serious cardiac cause, such as arrhythmic or structural issues, Dr. Deal said. Symptoms that appear with exertion or stress also are very worrisome. “You would know if they have a heart murmur or stenosis – it’s these other things that don’t present with a cardiac abnormality: hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy,” she said. “If they have symptoms on exertion, pay attention. This is not good.”

Syncope often is misdiagnosed, Dr. Deal said. Approximately 35%-48% of patients classified as having syncope do not have actual syncope;rather they experience dizziness rather than a loss of consciousness. In a study of 194 children, for example, the leading etiologies diagnosed after evaluation for syncope included simple fainting in 49%, a vasopressor/vasovagal response in 14%, and possible seizure in 14% (J Am Coll Cardiol. 1997;29[6]:1039-45). Seven percent were diagnosed with syncope not otherwise specified in this series. Some other causes included psychogenic or orthostatic ones, hyperventilation, dysmenorrhea, vertigo, dehydration, trauma, stress, exhaustion, or an infectious condition.*

“When should you be thinking life-threatening syncope?” Dr. Deal asked. Arrhythmic disorders that are heritable, such as an ion channelopathy, are an example. “They don’t always feel the racing heartbeat, but they feel something is not right; they feel a sense of impending doom. Some families report signs during exercise like swimming, seizures, gargling noises, or unusual symptoms on awakening.”

Dr. Deal noted that ages 3-24 years are “the problem territory for cardiac arrest.” In this age group, 43%-55% of cardiac arrests are associated with hypertrophic cardiomyopathy or arrhythmias; about one in three will have prior syncope. “These causes are not detectable on physical examination and often are not detectable with ECG only,” adding to the differential diagnosis challenges.*
 

Refer to a pediatric cardiologist

For this reason and others, referral to a pediatric cardiologist is indicated instead of a consult with an adult cardiologist, Dr. Deal said. “You know how your kids will start with ‘no offense.’ Like, ‘no offense, Mom, but your hair looks awful.’ With moderate offense intended, having an adult cardiologist read a pediatric ECG and clear them is not adequate. They will be looking for ischemia or A-fib [atrial fibrillation]; they’re not looking for long QT syndrome, arrhythmogenic cardiomyopathy, or abnormal T waves.”

Early detection of long QT syndrome is optimal, Dr. Deal said, because symptom onset often is between infancy and age 7 years. In addition, mortality is highest in the first 2 decades of life. “I think this could be why adult cardiologists are not as concerned as we are,” Dr. Deal said. “The bad ones die before they reach adulthood.”
 

 

 

Ruling out a cardiac cause

The 2017 joint guideline defined syncope as a transient loss of consciousness. “By definition, you pass out, you’re not aware of where you are, and you cannot hear,” Dr. Deal said. If a patient reports they could hear people talking, they may have lost postural tone, but they did not have syncope, she added.

“Sometimes, we see teenagers who are said to pass out and are unresponsive for 5 minutes, 10 minutes, or 20 minutes. I’m usually relieved to hear that because that gets cardiac off the hook,” Dr. Deal said. “There is nothing cardiac that makes you pass out for 20 minutes, unless people are resuscitating you.” She added, “I’m not suggesting it’s not a significant problem that you need to get to the bottom of.”

Noncardiac etiologies can be neurologic, metabolic, drug-induced, or psychogenic. “This is where the detective work comes in.”

Keep clinical suspicion high for psychogenic syncope, Dr. Deal said. Psychogenic episodes stem from significant psychological stress, often something so profoundly bothersome that they cannot cope, such as sexual abuse.

A helpful tip for diagnosing the less worrisome vasovagal syncope is asking whether a patient was sitting to standing or standing a long time before an episode, Dr. Deal said. “A common complaint is that the family went to airport, got up early, didn’t eat, and ended up standing for a long time. Kids will say they don’t feel well, they fall down, and all hell breaks loose.” Other causes of vasovagal syncope include stress, pain, or a situational trigger, for example, when a person faints during a blood draw or immunization.

The 2017 guideline also set forth the evidence behind various medications used to lower the risk of syncope. However, Dr. Deal said, “If syncope only happens every 3 years when you go to an airport, it’s probably not worth daily therapy to prevent that.”

‘The world’s most boring test’

For the most part, lifestyle measures should work to address vasovagal syncope. A tilt table test can be useful to aid the differential diagnosis, but it’s recommended only when the etiology is unclear, Dr. Deal said. On the plus side, the tilt table test allows clinicians to reproduce symptoms in a controlled environment. On the downside, she added, “It’s the world’s most boring test. It’s a challenge for the cardiologist to stay awake. It’s very boring, until all hell breaks loose.”

“I find this helpful in the setting of kids with seizures and for kids with this atypical syncope where you just cannot convince the family that these 20-minute episodes of loss of consciousness are not near-death episodes.”

Dr. Deal had no relevant financial disclosures.

CHICAGO – Syncope often is misdiagnosed in pediatric patients complaining of chest pain, and a new guideline released in 2017 could guide clinicians toward a more accurate differential diagnosis and help them know when immediate referral to cardiology or the emergency department is warranted.

“There are recent guidelines published this year which are helpful,” said Dr. Barbara Deal, the Getz Professor of Cardiology at Northwestern University in Chicago. “I’d like you to pay attention to the fact that the [guideline states] that a 12-lead ECG should be performed in all pediatric patients presenting with syncope,” which is defined as transient loss of consciousness.

hepatus/iStockphoto
The ECG is indicated because “sometimes it’s hard to know if something was vasovagal or not. Even for me, I still sometimes get it wrong.” The 12-lead ECG is recommended for the first but not every episode, according to the 2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society. Although this guideline was developed by groups that typically focus more on adults, the Pediatric and Congenital Electrophysiology Society endorsed the guideline.

“Once you establish it is a simple vasovagal [cause], you need to educate patients on conditions that would promote this and the need to be anticipatory,” Dr. Deal said at the annual meeting of the American Academy of Pediatrics. “Further testing with an echo[cardiogram] should be done if you suspect heart disease or a rhythm disorder.”

Chest pain and syncope are common complaints that can lead to significant anxiety for patients, parents, and pediatric providers. The greatest cause of this anxiety is the prospect of a fatal or near-fatal event. An abnormal cardiac examination, any associated palpitations, and a history of urinary incontinence or traumatic injury are reasons to worry, she said. “Any of these should prompt an urgent consult to cardiology or the emergency department.”

Cardiac causes of chest pain include reflex or vasovagal syncope or even a more serious cardiac cause, such as arrhythmic or structural issues, Dr. Deal said. Symptoms that appear with exertion or stress also are very worrisome. “You would know if they have a heart murmur or stenosis – it’s these other things that don’t present with a cardiac abnormality: hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy,” she said. “If they have symptoms on exertion, pay attention. This is not good.”

Syncope often is misdiagnosed, Dr. Deal said. Approximately 35%-48% of patients classified as having syncope do not have actual syncope;rather they experience dizziness rather than a loss of consciousness. In a study of 194 children, for example, the leading etiologies diagnosed after evaluation for syncope included simple fainting in 49%, a vasopressor/vasovagal response in 14%, and possible seizure in 14% (J Am Coll Cardiol. 1997;29[6]:1039-45). Seven percent were diagnosed with syncope not otherwise specified in this series. Some other causes included psychogenic or orthostatic ones, hyperventilation, dysmenorrhea, vertigo, dehydration, trauma, stress, exhaustion, or an infectious condition.*

“When should you be thinking life-threatening syncope?” Dr. Deal asked. Arrhythmic disorders that are heritable, such as an ion channelopathy, are an example. “They don’t always feel the racing heartbeat, but they feel something is not right; they feel a sense of impending doom. Some families report signs during exercise like swimming, seizures, gargling noises, or unusual symptoms on awakening.”

Dr. Deal noted that ages 3-24 years are “the problem territory for cardiac arrest.” In this age group, 43%-55% of cardiac arrests are associated with hypertrophic cardiomyopathy or arrhythmias; about one in three will have prior syncope. “These causes are not detectable on physical examination and often are not detectable with ECG only,” adding to the differential diagnosis challenges.*
 

Refer to a pediatric cardiologist

For this reason and others, referral to a pediatric cardiologist is indicated instead of a consult with an adult cardiologist, Dr. Deal said. “You know how your kids will start with ‘no offense.’ Like, ‘no offense, Mom, but your hair looks awful.’ With moderate offense intended, having an adult cardiologist read a pediatric ECG and clear them is not adequate. They will be looking for ischemia or A-fib [atrial fibrillation]; they’re not looking for long QT syndrome, arrhythmogenic cardiomyopathy, or abnormal T waves.”

Early detection of long QT syndrome is optimal, Dr. Deal said, because symptom onset often is between infancy and age 7 years. In addition, mortality is highest in the first 2 decades of life. “I think this could be why adult cardiologists are not as concerned as we are,” Dr. Deal said. “The bad ones die before they reach adulthood.”
 

 

 

Ruling out a cardiac cause

The 2017 joint guideline defined syncope as a transient loss of consciousness. “By definition, you pass out, you’re not aware of where you are, and you cannot hear,” Dr. Deal said. If a patient reports they could hear people talking, they may have lost postural tone, but they did not have syncope, she added.

“Sometimes, we see teenagers who are said to pass out and are unresponsive for 5 minutes, 10 minutes, or 20 minutes. I’m usually relieved to hear that because that gets cardiac off the hook,” Dr. Deal said. “There is nothing cardiac that makes you pass out for 20 minutes, unless people are resuscitating you.” She added, “I’m not suggesting it’s not a significant problem that you need to get to the bottom of.”

Noncardiac etiologies can be neurologic, metabolic, drug-induced, or psychogenic. “This is where the detective work comes in.”

Keep clinical suspicion high for psychogenic syncope, Dr. Deal said. Psychogenic episodes stem from significant psychological stress, often something so profoundly bothersome that they cannot cope, such as sexual abuse.

A helpful tip for diagnosing the less worrisome vasovagal syncope is asking whether a patient was sitting to standing or standing a long time before an episode, Dr. Deal said. “A common complaint is that the family went to airport, got up early, didn’t eat, and ended up standing for a long time. Kids will say they don’t feel well, they fall down, and all hell breaks loose.” Other causes of vasovagal syncope include stress, pain, or a situational trigger, for example, when a person faints during a blood draw or immunization.

The 2017 guideline also set forth the evidence behind various medications used to lower the risk of syncope. However, Dr. Deal said, “If syncope only happens every 3 years when you go to an airport, it’s probably not worth daily therapy to prevent that.”

‘The world’s most boring test’

For the most part, lifestyle measures should work to address vasovagal syncope. A tilt table test can be useful to aid the differential diagnosis, but it’s recommended only when the etiology is unclear, Dr. Deal said. On the plus side, the tilt table test allows clinicians to reproduce symptoms in a controlled environment. On the downside, she added, “It’s the world’s most boring test. It’s a challenge for the cardiologist to stay awake. It’s very boring, until all hell breaks loose.”

“I find this helpful in the setting of kids with seizures and for kids with this atypical syncope where you just cannot convince the family that these 20-minute episodes of loss of consciousness are not near-death episodes.”

Dr. Deal had no relevant financial disclosures.

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Evidence is mixed on probiotics in pediatric patients

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When prescribing probiotics in a primary care setting, evidence in the literature supports the efficacy of specific probiotic strains for specific indications. Outside of that, things are less clear.

“In terms of diarrhea, the evidence is positive, but probiotics only provide about 25 hours of benefit. And treatment of antibiotic-associated diarrhea is really dependent on patient adherence,” said Michael D. Cabana, MD. When it comes to treating colic, there is a particular probiotic that looks promising, he added, but the research so far demonstrating effectiveness is limited to breastfed babies. Also, the probiotic therapy appears to work best when started relatively early.

CharlieAJA/Thinkstock
In contrast, when families ask about eczema, inform them that studies in the literature generally do not support treatment with probiotics. “In terms of prevention, the results are mixed. But once a child has eczema, it generally doesn’t help,” Dr. Cabana said at the annual meeting of the American Academy of Pediatrics.

You are very likely to be asked your take on probiotics for a wide range of conditions, Dr. Cabana said, Overall, however, skepticism is warranted. Advise patients and families to be aware of advertising that promotes many different products as “probiotic,” especially around claims of improved “gut health” or “balanced microbiota.” He emphasized: “Make sure what your patients are using has some evidence behind it.”

Knowing the particular probiotic strain is essential to researching the evidence around its use, said Dr. Cabana, professor of pediatrics at the University of California, San Francisco. “I used the Canis familiaris example. All dogs are C. familiaris. But there are different breeds. You want to make sure you match the right breed to the task. If you were in an avalanche in the Swiss Alps, you would want a St. Bernard to rescue you, not a Chihuahua,” he said. “Similarly, when you are using probiotics you want to make sure you have the right strain, not just the genus and species.” For example, if a product label states it contains Bifidobacterium breve C50, the “C50” is the strain.

Another tip is to look for labeling that lists probiotic concentrations in colony-forming units or CFUs, Dr. Cabana said. He’s seen concentrations listed in mg, a red flag that a product is not legitimate.

Families also might ask if it’s better to take a probiotic supplement or choose food that contains probiotics. “Food products offer additional nutritional benefits, but you can give a relatively higher dose with supplements with a much lower volume ingested,” Dr. Cabana said. “And supplements theoretically provide a more consistent dose.” Speaking of dose, it’s difficult to counsel patients on dosing and frequency in general because probiotics really vary by the indication and formulation.

“As a pediatrician, I also get this question: Should kids get a lower dose of probiotic?” Dr. Cabana said. There are no known reports of toxicity associated with probiotic use in either adults or children, he said. “Unless a dose modification has been documented in a clinical trial, it is not clear that this is necessary. You’re just giving less of the probiotic.”
 

Treating diarrhea and antibiotic-associated diarrhea

When it comes to probiotics for treating acute diarrhea in children, “the literature is actually fairly good here,” Dr. Cabana said. More than 60 studies with an excess of 8,000 participants, the majority with rotavirus infection, suggests probiotics are not associated with any adverse effects and generally shorten duration of diarrhea.

In fact, Dr. Cabana added, multiple meta-analyses support a shorter course of diarrhea. He added, “Look at the units here – it’s hours, not days. You can treat, but on average it’s only 25 hours.” He added that a day less of diarrhea can be significant for patients and parents, however.

In another meta-analysis probiotics, particularly Lactobacillus strains, were analyzed for prevention of antibiotic-associated diarrhea (JAMA. 2012 May 9;307[18]:1959-69). Researchers assessed 63 randomized controlled trials with nearly 12,000 participants. The pooled results showed a statistically significant positive reduction in antibiotic-associated diarrhea (relative risk, 0.58; P less than .001). “Note the number needed to treat to see the effect is 13, so it won’t work in every patient,” Dr. Cabana said.

“So prevention of antibiotic-associated diarrhea is well documented. However, it’s also highly dependent on patent adherence,” he emphasized.
 

The clinical evidence on colic

For treating babies with colic, the best evidence is behind use of Lactobacilus reuteri DSM 17938, Dr. Cabana said. It tends to work best in breastfed infants, babies not on any gastrointestinal meds, and babies that start therapy early in the course of symptoms. “Use in formula-fed infants is unknown, because there are not enough data so far,” he said.

 

 

In some cases, during a prenatal visit, soon-to-be-parents will ask if they should start a probiotic to prevent colic. Dr. Cabana has seen only one prophylaxis study for this indication (JAMA Pediatr. 2014 Mar;168[3]:228-33). In the study, 589 infants were randomly allocated to take L. reuteri DSM 17938 or placebo daily for 90 days. At 3 months of age, the researchers discovered a significantly shorter mean duration of daily crying in the probiotic group (38 vs. 71 minutes; P less than .01).
 

What’s known about efficacy for eczema

The evidence for treating a child who presents with eczema with probiotics does not support efficacy in general, Dr. Cabana said. And the evidence on prevention of atopic eczema is mixed.

For example, in a randomized, controlled study from Finland, investigators randomized mothers to receive Lactobacillus GG or placebo during the prenatal period (Lancet. 2001;357:1076-9). Of 132 of the children, 35% were later diagnosed with atopic eczema, and the rate in the probiotic group, 23%, was half the 46% rate in the placebo group.

In contrast, researchers found no benefit regarding prevention of atopic dermatitis when 105 pregnant women were randomized to Lactobacillus GG or placebo. At the age of 2 years, atopic dermatitis was diagnosed in 28% of the 50 children in the probiotic group and 27.3% of the 44 in the placebo group (Pediatrics. 2008;121:e850-6).

The region of Germany where the study was conducted was rural/agricultural, so the diet could be different, Dr. Cabana said. Also, the median duration of breastfeeding differed between the Finnish and German study population, 6.8 months versus 9.2 months, respectively. “So that could potentially explain it, or there are just differences that cannot be explained.”

For more information, Dr. Cabana recommended information provided by the International Scientific Association of Prebiotics & Probiotics (https://isappscience.org/infographics/). The association’s website has easy to understand infographics including: What are probiotics and what can they do for you?; What’s so special about fermented foods?; and How do you read a probiotic label?

Dr. Cabana reported he receives research support from the National Institutes of Health, Wyeth Nutrition, and Nestle; is on the speakers bureau for Merck; owns stocks or bonds in Abbot and AbbVie; and is a consultant for Mead Johnson, Abbott, Genentech, Biogaia, General Mills, and Nestle.

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When prescribing probiotics in a primary care setting, evidence in the literature supports the efficacy of specific probiotic strains for specific indications. Outside of that, things are less clear.

“In terms of diarrhea, the evidence is positive, but probiotics only provide about 25 hours of benefit. And treatment of antibiotic-associated diarrhea is really dependent on patient adherence,” said Michael D. Cabana, MD. When it comes to treating colic, there is a particular probiotic that looks promising, he added, but the research so far demonstrating effectiveness is limited to breastfed babies. Also, the probiotic therapy appears to work best when started relatively early.

CharlieAJA/Thinkstock
In contrast, when families ask about eczema, inform them that studies in the literature generally do not support treatment with probiotics. “In terms of prevention, the results are mixed. But once a child has eczema, it generally doesn’t help,” Dr. Cabana said at the annual meeting of the American Academy of Pediatrics.

You are very likely to be asked your take on probiotics for a wide range of conditions, Dr. Cabana said, Overall, however, skepticism is warranted. Advise patients and families to be aware of advertising that promotes many different products as “probiotic,” especially around claims of improved “gut health” or “balanced microbiota.” He emphasized: “Make sure what your patients are using has some evidence behind it.”

Knowing the particular probiotic strain is essential to researching the evidence around its use, said Dr. Cabana, professor of pediatrics at the University of California, San Francisco. “I used the Canis familiaris example. All dogs are C. familiaris. But there are different breeds. You want to make sure you match the right breed to the task. If you were in an avalanche in the Swiss Alps, you would want a St. Bernard to rescue you, not a Chihuahua,” he said. “Similarly, when you are using probiotics you want to make sure you have the right strain, not just the genus and species.” For example, if a product label states it contains Bifidobacterium breve C50, the “C50” is the strain.

Another tip is to look for labeling that lists probiotic concentrations in colony-forming units or CFUs, Dr. Cabana said. He’s seen concentrations listed in mg, a red flag that a product is not legitimate.

Families also might ask if it’s better to take a probiotic supplement or choose food that contains probiotics. “Food products offer additional nutritional benefits, but you can give a relatively higher dose with supplements with a much lower volume ingested,” Dr. Cabana said. “And supplements theoretically provide a more consistent dose.” Speaking of dose, it’s difficult to counsel patients on dosing and frequency in general because probiotics really vary by the indication and formulation.

“As a pediatrician, I also get this question: Should kids get a lower dose of probiotic?” Dr. Cabana said. There are no known reports of toxicity associated with probiotic use in either adults or children, he said. “Unless a dose modification has been documented in a clinical trial, it is not clear that this is necessary. You’re just giving less of the probiotic.”
 

Treating diarrhea and antibiotic-associated diarrhea

When it comes to probiotics for treating acute diarrhea in children, “the literature is actually fairly good here,” Dr. Cabana said. More than 60 studies with an excess of 8,000 participants, the majority with rotavirus infection, suggests probiotics are not associated with any adverse effects and generally shorten duration of diarrhea.

In fact, Dr. Cabana added, multiple meta-analyses support a shorter course of diarrhea. He added, “Look at the units here – it’s hours, not days. You can treat, but on average it’s only 25 hours.” He added that a day less of diarrhea can be significant for patients and parents, however.

In another meta-analysis probiotics, particularly Lactobacillus strains, were analyzed for prevention of antibiotic-associated diarrhea (JAMA. 2012 May 9;307[18]:1959-69). Researchers assessed 63 randomized controlled trials with nearly 12,000 participants. The pooled results showed a statistically significant positive reduction in antibiotic-associated diarrhea (relative risk, 0.58; P less than .001). “Note the number needed to treat to see the effect is 13, so it won’t work in every patient,” Dr. Cabana said.

“So prevention of antibiotic-associated diarrhea is well documented. However, it’s also highly dependent on patent adherence,” he emphasized.
 

The clinical evidence on colic

For treating babies with colic, the best evidence is behind use of Lactobacilus reuteri DSM 17938, Dr. Cabana said. It tends to work best in breastfed infants, babies not on any gastrointestinal meds, and babies that start therapy early in the course of symptoms. “Use in formula-fed infants is unknown, because there are not enough data so far,” he said.

 

 

In some cases, during a prenatal visit, soon-to-be-parents will ask if they should start a probiotic to prevent colic. Dr. Cabana has seen only one prophylaxis study for this indication (JAMA Pediatr. 2014 Mar;168[3]:228-33). In the study, 589 infants were randomly allocated to take L. reuteri DSM 17938 or placebo daily for 90 days. At 3 months of age, the researchers discovered a significantly shorter mean duration of daily crying in the probiotic group (38 vs. 71 minutes; P less than .01).
 

What’s known about efficacy for eczema

The evidence for treating a child who presents with eczema with probiotics does not support efficacy in general, Dr. Cabana said. And the evidence on prevention of atopic eczema is mixed.

For example, in a randomized, controlled study from Finland, investigators randomized mothers to receive Lactobacillus GG or placebo during the prenatal period (Lancet. 2001;357:1076-9). Of 132 of the children, 35% were later diagnosed with atopic eczema, and the rate in the probiotic group, 23%, was half the 46% rate in the placebo group.

In contrast, researchers found no benefit regarding prevention of atopic dermatitis when 105 pregnant women were randomized to Lactobacillus GG or placebo. At the age of 2 years, atopic dermatitis was diagnosed in 28% of the 50 children in the probiotic group and 27.3% of the 44 in the placebo group (Pediatrics. 2008;121:e850-6).

The region of Germany where the study was conducted was rural/agricultural, so the diet could be different, Dr. Cabana said. Also, the median duration of breastfeeding differed between the Finnish and German study population, 6.8 months versus 9.2 months, respectively. “So that could potentially explain it, or there are just differences that cannot be explained.”

For more information, Dr. Cabana recommended information provided by the International Scientific Association of Prebiotics & Probiotics (https://isappscience.org/infographics/). The association’s website has easy to understand infographics including: What are probiotics and what can they do for you?; What’s so special about fermented foods?; and How do you read a probiotic label?

Dr. Cabana reported he receives research support from the National Institutes of Health, Wyeth Nutrition, and Nestle; is on the speakers bureau for Merck; owns stocks or bonds in Abbot and AbbVie; and is a consultant for Mead Johnson, Abbott, Genentech, Biogaia, General Mills, and Nestle.

 

When prescribing probiotics in a primary care setting, evidence in the literature supports the efficacy of specific probiotic strains for specific indications. Outside of that, things are less clear.

“In terms of diarrhea, the evidence is positive, but probiotics only provide about 25 hours of benefit. And treatment of antibiotic-associated diarrhea is really dependent on patient adherence,” said Michael D. Cabana, MD. When it comes to treating colic, there is a particular probiotic that looks promising, he added, but the research so far demonstrating effectiveness is limited to breastfed babies. Also, the probiotic therapy appears to work best when started relatively early.

CharlieAJA/Thinkstock
In contrast, when families ask about eczema, inform them that studies in the literature generally do not support treatment with probiotics. “In terms of prevention, the results are mixed. But once a child has eczema, it generally doesn’t help,” Dr. Cabana said at the annual meeting of the American Academy of Pediatrics.

You are very likely to be asked your take on probiotics for a wide range of conditions, Dr. Cabana said, Overall, however, skepticism is warranted. Advise patients and families to be aware of advertising that promotes many different products as “probiotic,” especially around claims of improved “gut health” or “balanced microbiota.” He emphasized: “Make sure what your patients are using has some evidence behind it.”

Knowing the particular probiotic strain is essential to researching the evidence around its use, said Dr. Cabana, professor of pediatrics at the University of California, San Francisco. “I used the Canis familiaris example. All dogs are C. familiaris. But there are different breeds. You want to make sure you match the right breed to the task. If you were in an avalanche in the Swiss Alps, you would want a St. Bernard to rescue you, not a Chihuahua,” he said. “Similarly, when you are using probiotics you want to make sure you have the right strain, not just the genus and species.” For example, if a product label states it contains Bifidobacterium breve C50, the “C50” is the strain.

Another tip is to look for labeling that lists probiotic concentrations in colony-forming units or CFUs, Dr. Cabana said. He’s seen concentrations listed in mg, a red flag that a product is not legitimate.

Families also might ask if it’s better to take a probiotic supplement or choose food that contains probiotics. “Food products offer additional nutritional benefits, but you can give a relatively higher dose with supplements with a much lower volume ingested,” Dr. Cabana said. “And supplements theoretically provide a more consistent dose.” Speaking of dose, it’s difficult to counsel patients on dosing and frequency in general because probiotics really vary by the indication and formulation.

“As a pediatrician, I also get this question: Should kids get a lower dose of probiotic?” Dr. Cabana said. There are no known reports of toxicity associated with probiotic use in either adults or children, he said. “Unless a dose modification has been documented in a clinical trial, it is not clear that this is necessary. You’re just giving less of the probiotic.”
 

Treating diarrhea and antibiotic-associated diarrhea

When it comes to probiotics for treating acute diarrhea in children, “the literature is actually fairly good here,” Dr. Cabana said. More than 60 studies with an excess of 8,000 participants, the majority with rotavirus infection, suggests probiotics are not associated with any adverse effects and generally shorten duration of diarrhea.

In fact, Dr. Cabana added, multiple meta-analyses support a shorter course of diarrhea. He added, “Look at the units here – it’s hours, not days. You can treat, but on average it’s only 25 hours.” He added that a day less of diarrhea can be significant for patients and parents, however.

In another meta-analysis probiotics, particularly Lactobacillus strains, were analyzed for prevention of antibiotic-associated diarrhea (JAMA. 2012 May 9;307[18]:1959-69). Researchers assessed 63 randomized controlled trials with nearly 12,000 participants. The pooled results showed a statistically significant positive reduction in antibiotic-associated diarrhea (relative risk, 0.58; P less than .001). “Note the number needed to treat to see the effect is 13, so it won’t work in every patient,” Dr. Cabana said.

“So prevention of antibiotic-associated diarrhea is well documented. However, it’s also highly dependent on patent adherence,” he emphasized.
 

The clinical evidence on colic

For treating babies with colic, the best evidence is behind use of Lactobacilus reuteri DSM 17938, Dr. Cabana said. It tends to work best in breastfed infants, babies not on any gastrointestinal meds, and babies that start therapy early in the course of symptoms. “Use in formula-fed infants is unknown, because there are not enough data so far,” he said.

 

 

In some cases, during a prenatal visit, soon-to-be-parents will ask if they should start a probiotic to prevent colic. Dr. Cabana has seen only one prophylaxis study for this indication (JAMA Pediatr. 2014 Mar;168[3]:228-33). In the study, 589 infants were randomly allocated to take L. reuteri DSM 17938 or placebo daily for 90 days. At 3 months of age, the researchers discovered a significantly shorter mean duration of daily crying in the probiotic group (38 vs. 71 minutes; P less than .01).
 

What’s known about efficacy for eczema

The evidence for treating a child who presents with eczema with probiotics does not support efficacy in general, Dr. Cabana said. And the evidence on prevention of atopic eczema is mixed.

For example, in a randomized, controlled study from Finland, investigators randomized mothers to receive Lactobacillus GG or placebo during the prenatal period (Lancet. 2001;357:1076-9). Of 132 of the children, 35% were later diagnosed with atopic eczema, and the rate in the probiotic group, 23%, was half the 46% rate in the placebo group.

In contrast, researchers found no benefit regarding prevention of atopic dermatitis when 105 pregnant women were randomized to Lactobacillus GG or placebo. At the age of 2 years, atopic dermatitis was diagnosed in 28% of the 50 children in the probiotic group and 27.3% of the 44 in the placebo group (Pediatrics. 2008;121:e850-6).

The region of Germany where the study was conducted was rural/agricultural, so the diet could be different, Dr. Cabana said. Also, the median duration of breastfeeding differed between the Finnish and German study population, 6.8 months versus 9.2 months, respectively. “So that could potentially explain it, or there are just differences that cannot be explained.”

For more information, Dr. Cabana recommended information provided by the International Scientific Association of Prebiotics & Probiotics (https://isappscience.org/infographics/). The association’s website has easy to understand infographics including: What are probiotics and what can they do for you?; What’s so special about fermented foods?; and How do you read a probiotic label?

Dr. Cabana reported he receives research support from the National Institutes of Health, Wyeth Nutrition, and Nestle; is on the speakers bureau for Merck; owns stocks or bonds in Abbot and AbbVie; and is a consultant for Mead Johnson, Abbott, Genentech, Biogaia, General Mills, and Nestle.

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Treatment of hemangioma with brand-name propranolol tied to fewer dosing errors

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– Among physicians using generic propranolol to treat infantile hemangioma, 30% reported at least one patient experienced a miscalculation dosing error, a new survey showed. Among respondents who prescribed Hemangeol (Pierre Fabre Pharmaceuticals), 10% reported a similar error. The errors were made by either a provider or caregiver.

Confusion may have contributed to a second source of errors, said Elaine Siegfried, MD, professor of pediatrics and dermatology at St. Louis University in Missouri. Generic propranolol is supplied as a 20-mg/5-mL oral solution and a 40-mg/5-mL oral solution. “Any time you have more than one formulation, it’s a nidus for dispensing error by the pharmacy.”

Dr. Elaine Siegfried
“That’s what I noticed. I make people bring in their medicines to check that, because I know dispensing errors are common,” Dr. Siegfried said in an interview following a presentation at the annual meeting of the American Academy of Pediatrics.

“So if a doctor prescribes [the lower dose], which is what we always do for safety, and they get 40 [mg], the [patient] can become hypoglycemic, hypotensive, or bradycardic,” Dr. Siegfried said. “That’s not good.”

Dr. Siegfried and colleagues assessed survey responses from 223 physicians. The majority, 90%, reported prescribing generic propranolol to treat infantile hemangioma in the past. Sixty-percent reported also prescribing the brand name formulation approved by the Food and Drug Administration in 2014. Most of those who completed the survey, 70%, were pediatric dermatologists; general dermatologists, pediatric otolaryngologists, and other specialists also participated.

A total of 18% of physicians surveyed reported a dispensing error associated with use of generic propranolol. Dr. Siegfried said such errors are not possible with the branded formulation because it is available only in a single concentration, a 4.28 mg/mL oral solution. She added that one central specialty pharmacy dispenses Hemangeol, further reducing the likelihood of errors.
Wikimedia Commons/Zeimusu/Public Domain

 

Addressing cost concerns

“When this [branded] drug became available, I wondered why everyone was not prescribing it,” Dr. Siegfried said.

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– Among physicians using generic propranolol to treat infantile hemangioma, 30% reported at least one patient experienced a miscalculation dosing error, a new survey showed. Among respondents who prescribed Hemangeol (Pierre Fabre Pharmaceuticals), 10% reported a similar error. The errors were made by either a provider or caregiver.

Confusion may have contributed to a second source of errors, said Elaine Siegfried, MD, professor of pediatrics and dermatology at St. Louis University in Missouri. Generic propranolol is supplied as a 20-mg/5-mL oral solution and a 40-mg/5-mL oral solution. “Any time you have more than one formulation, it’s a nidus for dispensing error by the pharmacy.”

Dr. Elaine Siegfried
“That’s what I noticed. I make people bring in their medicines to check that, because I know dispensing errors are common,” Dr. Siegfried said in an interview following a presentation at the annual meeting of the American Academy of Pediatrics.

“So if a doctor prescribes [the lower dose], which is what we always do for safety, and they get 40 [mg], the [patient] can become hypoglycemic, hypotensive, or bradycardic,” Dr. Siegfried said. “That’s not good.”

Dr. Siegfried and colleagues assessed survey responses from 223 physicians. The majority, 90%, reported prescribing generic propranolol to treat infantile hemangioma in the past. Sixty-percent reported also prescribing the brand name formulation approved by the Food and Drug Administration in 2014. Most of those who completed the survey, 70%, were pediatric dermatologists; general dermatologists, pediatric otolaryngologists, and other specialists also participated.

A total of 18% of physicians surveyed reported a dispensing error associated with use of generic propranolol. Dr. Siegfried said such errors are not possible with the branded formulation because it is available only in a single concentration, a 4.28 mg/mL oral solution. She added that one central specialty pharmacy dispenses Hemangeol, further reducing the likelihood of errors.
Wikimedia Commons/Zeimusu/Public Domain

 

Addressing cost concerns

“When this [branded] drug became available, I wondered why everyone was not prescribing it,” Dr. Siegfried said.

 

– Among physicians using generic propranolol to treat infantile hemangioma, 30% reported at least one patient experienced a miscalculation dosing error, a new survey showed. Among respondents who prescribed Hemangeol (Pierre Fabre Pharmaceuticals), 10% reported a similar error. The errors were made by either a provider or caregiver.

Confusion may have contributed to a second source of errors, said Elaine Siegfried, MD, professor of pediatrics and dermatology at St. Louis University in Missouri. Generic propranolol is supplied as a 20-mg/5-mL oral solution and a 40-mg/5-mL oral solution. “Any time you have more than one formulation, it’s a nidus for dispensing error by the pharmacy.”

Dr. Elaine Siegfried
“That’s what I noticed. I make people bring in their medicines to check that, because I know dispensing errors are common,” Dr. Siegfried said in an interview following a presentation at the annual meeting of the American Academy of Pediatrics.

“So if a doctor prescribes [the lower dose], which is what we always do for safety, and they get 40 [mg], the [patient] can become hypoglycemic, hypotensive, or bradycardic,” Dr. Siegfried said. “That’s not good.”

Dr. Siegfried and colleagues assessed survey responses from 223 physicians. The majority, 90%, reported prescribing generic propranolol to treat infantile hemangioma in the past. Sixty-percent reported also prescribing the brand name formulation approved by the Food and Drug Administration in 2014. Most of those who completed the survey, 70%, were pediatric dermatologists; general dermatologists, pediatric otolaryngologists, and other specialists also participated.

A total of 18% of physicians surveyed reported a dispensing error associated with use of generic propranolol. Dr. Siegfried said such errors are not possible with the branded formulation because it is available only in a single concentration, a 4.28 mg/mL oral solution. She added that one central specialty pharmacy dispenses Hemangeol, further reducing the likelihood of errors.
Wikimedia Commons/Zeimusu/Public Domain

 

Addressing cost concerns

“When this [branded] drug became available, I wondered why everyone was not prescribing it,” Dr. Siegfried said.

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Key clinical point: Although more costly than generics, Hemangeol (Pierre Fabre) could reduce safety concerns for treating infantile hemangioma.

Major finding: Physicians prescribing generic propranolol had a higher rate of miscalculated dosing errors, 30%, compared with 10% prescribing the brand-name formulation.

Data source: Based on survey responses from 223 physicians, 70% of whom were pediatric dermatologists.

Disclosures: Dr. Siegfried is a consultant for Pierre Fabre and served as a principle investigator on phase 3 research. The company did not sponsor the current study, but a coauthor and employee of Pierre Fabre assisted with the logistics of the survey.

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