TORONTO – Researchers have described a behavioral syndrome that they say can be a forerunner of Alzheimer’s disease and other neurodegenerative diseases and released a tool for diagnosing it.

Mild behavioral impairment (MBI) defines a syndrome of new-onset neuropsychiatric symptoms that appear in nondemented people older than 50, and are sustained for at least 6 months. Symptoms can occur in any of five domains: apathy/drive/motivation; mood/affect/anxiety; impulse control/agitation/reward; social appropriateness; and thoughts/perception.

Zahinoor Ismail, MD, described the concept of MBI for the first time at the Alzheimer’s Association International Conference 2016, and unveiled the MBI Checklist (MBI-C), a two-page screen that identifies and scores these symptoms. The MBI-C is a project of the Alzheimer’s Association International Society to Advance Alzheimer’s Research and Treatment (ISTAART), and is still being validated, although is available for clinical use now, said Dr. Ismail of the University of Calgary (Alta.).

Changes in personality are often the earliest signs of an emerging neurocognitive disorder, appearing well before any problems with memory or cognition. The MBI-C will allow clinicians to identify and track these changes in patients.

“We can now describe this preclinical dementia phenotype and use this tool to diagnose it and to capture change over time,” Dr. Ismail said.

In addition to being clinically useful, he said the checklist will wield great power in research: It could target a population at the greatest risk for neurocognitive decline, at a time where any future disease-modifying drugs could be most beneficial.

“We all know that dementia is much more than memory or cognitive impairment alone. The neuropsychiatric symptoms of dementia are associated with functional impairment, caregiver burden, institutionalization, accelerated rates of progression, and a greater burden of plaques and tangles. There is a great need to identify people early on, people in whom we might be able to change the course of illness. These patients, who present with early neuropsychiatric symptoms, may be a population we can examine to see if that is possible.”

A large body of research has already linked new-onset neuropsychiatric symptoms with neurocognitive disease, particularly frontotemporal dementia, Dr. Ismail said. One of the most compelling studies comprised about 500 subjects enrolled in the ongoing Mayo Clinic Study of Aging, who were followed for 5 years (Am J Psychiatry. 2014;171[5];572-81). This study found that the emergence of neuropsychiatric symptoms in cognitively normal older adults was associated with significant increases in the risk of developing mild cognitive impairment. Agitation conferred the highest risk (hazard ratio, 3.06), followed by apathy (HR, 2.6), anxiety (HR, 1.87), irritability (HR, 1.84), and depression (HR, 1.63).

Dr. Ismail said new-onset neuropsychiatric symptoms are already quite common by the time patients enter care for memory concerns. At the meeting, he presented data on a group of about 300 patients with mild cognitive impairment who attended a memory clinic. A total of 82% endorsed at least one neuropsychiatric symptom. When sorted into the five MBI-C domains, 78% of patients expressed mood symptoms; 64% impulse control symptoms; 52% apathy symptoms; 28% social appropriateness symptoms; and 9% psychotic symptoms.

“Our study suggests that this concept of mild behavioral impairment may be a common and clinically relevant syndrome, particularly given that neuropsychiatric symptoms are associated with greater caregiver burden,” Dr. Ismail said.

Dr. Ismail did not address how the screen should be scored or interpreted. It is composed of five overall domains, each asking about the emergence of a new, persistent symptom. Patients rate the presences and severity of those symptoms on a 3-point scale. The researchers who developed it chose age 50 as the cutoff point because symptoms that emerge at that age can herald the onset of frontotemporal dementia in relatively young patients.

“This idea of symptoms persisting for at least 6 months is important,” Dr. Ismail said. “What we’re talking about is a sustained change from baseline personality. But these are still nondemented patients. Function is maintained. Independent activities of daily living are intact.”

The most comprehensive domain is impulse control, agitation, and reward. “This captures a lot of function with regard to agitation in dementia, new-onset substance abuse, irritability, new-onset road rage … things we might not otherwise capture.”

The social appropriateness domain examines symptoms like a loss of the ability to share appropriately, acting out sexually, and loss of social judgment. The psychosis domain inquires about feelings of aggrandizement, persecution, and suspicion, as well as auditory and visual hallucinations.

The mood domain asks about new-onset anxiety, panic, and depression. The motivation domain asks about the development of apathy or disinterest in family, friends, and activities.

 

Validation studies in large cohorts are ongoing, as well as studies that Dr. Ismail hopes will link these early behavioral changes to well-established Alzheimer’s biomarkers.

The MBI-C website is not yet complete, but the checklist is available for free by emailing [email protected].

Dr. Ismail had no financial disclosures.

TORONTO – Researchers have described a behavioral syndrome that they say can be a forerunner of Alzheimer’s disease and other neurodegenerative diseases and released a tool for diagnosing it.

Mild behavioral impairment (MBI) defines a syndrome of new-onset neuropsychiatric symptoms that appear in nondemented people older than 50, and are sustained for at least 6 months. Symptoms can occur in any of five domains: apathy/drive/motivation; mood/affect/anxiety; impulse control/agitation/reward; social appropriateness; and thoughts/perception.

Zahinoor Ismail, MD, described the concept of MBI for the first time at the Alzheimer’s Association International Conference 2016, and unveiled the MBI Checklist (MBI-C), a two-page screen that identifies and scores these symptoms. The MBI-C is a project of the Alzheimer’s Association International Society to Advance Alzheimer’s Research and Treatment (ISTAART), and is still being validated, although is available for clinical use now, said Dr. Ismail of the University of Calgary (Alta.).

Changes in personality are often the earliest signs of an emerging neurocognitive disorder, appearing well before any problems with memory or cognition. The MBI-C will allow clinicians to identify and track these changes in patients.

“We can now describe this preclinical dementia phenotype and use this tool to diagnose it and to capture change over time,” Dr. Ismail said.

In addition to being clinically useful, he said the checklist will wield great power in research: It could target a population at the greatest risk for neurocognitive decline, at a time where any future disease-modifying drugs could be most beneficial.

“We all know that dementia is much more than memory or cognitive impairment alone. The neuropsychiatric symptoms of dementia are associated with functional impairment, caregiver burden, institutionalization, accelerated rates of progression, and a greater burden of plaques and tangles. There is a great need to identify people early on, people in whom we might be able to change the course of illness. These patients, who present with early neuropsychiatric symptoms, may be a population we can examine to see if that is possible.”

A large body of research has already linked new-onset neuropsychiatric symptoms with neurocognitive disease, particularly frontotemporal dementia, Dr. Ismail said. One of the most compelling studies comprised about 500 subjects enrolled in the ongoing Mayo Clinic Study of Aging, who were followed for 5 years (Am J Psychiatry. 2014;171[5];572-81). This study found that the emergence of neuropsychiatric symptoms in cognitively normal older adults was associated with significant increases in the risk of developing mild cognitive impairment. Agitation conferred the highest risk (hazard ratio, 3.06), followed by apathy (HR, 2.6), anxiety (HR, 1.87), irritability (HR, 1.84), and depression (HR, 1.63).

Dr. Ismail said new-onset neuropsychiatric symptoms are already quite common by the time patients enter care for memory concerns. At the meeting, he presented data on a group of about 300 patients with mild cognitive impairment who attended a memory clinic. A total of 82% endorsed at least one neuropsychiatric symptom. When sorted into the five MBI-C domains, 78% of patients expressed mood symptoms; 64% impulse control symptoms; 52% apathy symptoms; 28% social appropriateness symptoms; and 9% psychotic symptoms.

“Our study suggests that this concept of mild behavioral impairment may be a common and clinically relevant syndrome, particularly given that neuropsychiatric symptoms are associated with greater caregiver burden,” Dr. Ismail said.

Dr. Ismail did not address how the screen should be scored or interpreted. It is composed of five overall domains, each asking about the emergence of a new, persistent symptom. Patients rate the presences and severity of those symptoms on a 3-point scale. The researchers who developed it chose age 50 as the cutoff point because symptoms that emerge at that age can herald the onset of frontotemporal dementia in relatively young patients.

“This idea of symptoms persisting for at least 6 months is important,” Dr. Ismail said. “What we’re talking about is a sustained change from baseline personality. But these are still nondemented patients. Function is maintained. Independent activities of daily living are intact.”

The most comprehensive domain is impulse control, agitation, and reward. “This captures a lot of function with regard to agitation in dementia, new-onset substance abuse, irritability, new-onset road rage … things we might not otherwise capture.”

The social appropriateness domain examines symptoms like a loss of the ability to share appropriately, acting out sexually, and loss of social judgment. The psychosis domain inquires about feelings of aggrandizement, persecution, and suspicion, as well as auditory and visual hallucinations.

The mood domain asks about new-onset anxiety, panic, and depression. The motivation domain asks about the development of apathy or disinterest in family, friends, and activities.

 

Validation studies in large cohorts are ongoing, as well as studies that Dr. Ismail hopes will link these early behavioral changes to well-established Alzheimer’s biomarkers.

The MBI-C website is not yet complete, but the checklist is available for free by emailing [email protected].

Dr. Ismail had no financial disclosures.

TORONTO – Researchers have described a behavioral syndrome that they say can be a forerunner of Alzheimer’s disease and other neurodegenerative diseases and released a tool for diagnosing it.

Mild behavioral impairment (MBI) defines a syndrome of new-onset neuropsychiatric symptoms that appear in nondemented people older than 50, and are sustained for at least 6 months. Symptoms can occur in any of five domains: apathy/drive/motivation; mood/affect/anxiety; impulse control/agitation/reward; social appropriateness; and thoughts/perception.

Zahinoor Ismail, MD, described the concept of MBI for the first time at the Alzheimer’s Association International Conference 2016, and unveiled the MBI Checklist (MBI-C), a two-page screen that identifies and scores these symptoms. The MBI-C is a project of the Alzheimer’s Association International Society to Advance Alzheimer’s Research and Treatment (ISTAART), and is still being validated, although is available for clinical use now, said Dr. Ismail of the University of Calgary (Alta.).

Changes in personality are often the earliest signs of an emerging neurocognitive disorder, appearing well before any problems with memory or cognition. The MBI-C will allow clinicians to identify and track these changes in patients.

“We can now describe this preclinical dementia phenotype and use this tool to diagnose it and to capture change over time,” Dr. Ismail said.

In addition to being clinically useful, he said the checklist will wield great power in research: It could target a population at the greatest risk for neurocognitive decline, at a time where any future disease-modifying drugs could be most beneficial.

“We all know that dementia is much more than memory or cognitive impairment alone. The neuropsychiatric symptoms of dementia are associated with functional impairment, caregiver burden, institutionalization, accelerated rates of progression, and a greater burden of plaques and tangles. There is a great need to identify people early on, people in whom we might be able to change the course of illness. These patients, who present with early neuropsychiatric symptoms, may be a population we can examine to see if that is possible.”

A large body of research has already linked new-onset neuropsychiatric symptoms with neurocognitive disease, particularly frontotemporal dementia, Dr. Ismail said. One of the most compelling studies comprised about 500 subjects enrolled in the ongoing Mayo Clinic Study of Aging, who were followed for 5 years (Am J Psychiatry. 2014;171[5];572-81). This study found that the emergence of neuropsychiatric symptoms in cognitively normal older adults was associated with significant increases in the risk of developing mild cognitive impairment. Agitation conferred the highest risk (hazard ratio, 3.06), followed by apathy (HR, 2.6), anxiety (HR, 1.87), irritability (HR, 1.84), and depression (HR, 1.63).

Dr. Ismail said new-onset neuropsychiatric symptoms are already quite common by the time patients enter care for memory concerns. At the meeting, he presented data on a group of about 300 patients with mild cognitive impairment who attended a memory clinic. A total of 82% endorsed at least one neuropsychiatric symptom. When sorted into the five MBI-C domains, 78% of patients expressed mood symptoms; 64% impulse control symptoms; 52% apathy symptoms; 28% social appropriateness symptoms; and 9% psychotic symptoms.

“Our study suggests that this concept of mild behavioral impairment may be a common and clinically relevant syndrome, particularly given that neuropsychiatric symptoms are associated with greater caregiver burden,” Dr. Ismail said.

Dr. Ismail did not address how the screen should be scored or interpreted. It is composed of five overall domains, each asking about the emergence of a new, persistent symptom. Patients rate the presences and severity of those symptoms on a 3-point scale. The researchers who developed it chose age 50 as the cutoff point because symptoms that emerge at that age can herald the onset of frontotemporal dementia in relatively young patients.

“This idea of symptoms persisting for at least 6 months is important,” Dr. Ismail said. “What we’re talking about is a sustained change from baseline personality. But these are still nondemented patients. Function is maintained. Independent activities of daily living are intact.”

The most comprehensive domain is impulse control, agitation, and reward. “This captures a lot of function with regard to agitation in dementia, new-onset substance abuse, irritability, new-onset road rage … things we might not otherwise capture.”

The social appropriateness domain examines symptoms like a loss of the ability to share appropriately, acting out sexually, and loss of social judgment. The psychosis domain inquires about feelings of aggrandizement, persecution, and suspicion, as well as auditory and visual hallucinations.

The mood domain asks about new-onset anxiety, panic, and depression. The motivation domain asks about the development of apathy or disinterest in family, friends, and activities.

 

Validation studies in large cohorts are ongoing, as well as studies that Dr. Ismail hopes will link these early behavioral changes to well-established Alzheimer’s biomarkers.

The MBI-C website is not yet complete, but the checklist is available for free by emailing [email protected].

Dr. Ismail had no financial disclosures.

TORONTO – Researchers have described a behavioral syndrome that they say can be a forerunner of Alzheimer’s disease and other neurodegenerative diseases and released a tool for diagnosing it.

Mild behavioral impairment (MBI) defines a syndrome of new-onset neuropsychiatric symptoms that appear in nondemented people older than 50, and are sustained for at least 6 months. Symptoms can occur in any of five domains: apathy/drive/motivation; mood/affect/anxiety; impulse control/agitation/reward; social appropriateness; and thoughts/perception.

Zahinoor Ismail, MD, described the concept of MBI for the first time at the Alzheimer’s Association International Conference 2016, and unveiled the MBI Checklist (MBI-C), a two-page screen that identifies and scores these symptoms. The MBI-C is a project of the Alzheimer’s Association International Society to Advance Alzheimer’s Research and Treatment (ISTAART), and is still being validated, although is available for clinical use now, said Dr. Ismail of the University of Calgary (Alta.).

Changes in personality are often the earliest signs of an emerging neurocognitive disorder, appearing well before any problems with memory or cognition. The MBI-C will allow clinicians to identify and track these changes in patients.

“We can now describe this preclinical dementia phenotype and use this tool to diagnose it and to capture change over time,” Dr. Ismail said.

In addition to being clinically useful, he said the checklist will wield great power in research: It could target a population at the greatest risk for neurocognitive decline, at a time where any future disease-modifying drugs could be most beneficial.

“We all know that dementia is much more than memory or cognitive impairment alone. The neuropsychiatric symptoms of dementia are associated with functional impairment, caregiver burden, institutionalization, accelerated rates of progression, and a greater burden of plaques and tangles. There is a great need to identify people early on, people in whom we might be able to change the course of illness. These patients, who present with early neuropsychiatric symptoms, may be a population we can examine to see if that is possible.”

A large body of research has already linked new-onset neuropsychiatric symptoms with neurocognitive disease, particularly frontotemporal dementia, Dr. Ismail said. One of the most compelling studies comprised about 500 subjects enrolled in the ongoing Mayo Clinic Study of Aging, who were followed for 5 years (Am J Psychiatry. 2014;171[5];572-81). This study found that the emergence of neuropsychiatric symptoms in cognitively normal older adults was associated with significant increases in the risk of developing mild cognitive impairment. Agitation conferred the highest risk (hazard ratio, 3.06), followed by apathy (HR, 2.6), anxiety (HR, 1.87), irritability (HR, 1.84), and depression (HR, 1.63).

Dr. Ismail said new-onset neuropsychiatric symptoms are already quite common by the time patients enter care for memory concerns. At the meeting, he presented data on a group of about 300 patients with mild cognitive impairment who attended a memory clinic. A total of 82% endorsed at least one neuropsychiatric symptom. When sorted into the five MBI-C domains, 78% of patients expressed mood symptoms; 64% impulse control symptoms; 52% apathy symptoms; 28% social appropriateness symptoms; and 9% psychotic symptoms.

“Our study suggests that this concept of mild behavioral impairment may be a common and clinically relevant syndrome, particularly given that neuropsychiatric symptoms are associated with greater caregiver burden,” Dr. Ismail said.

Dr. Ismail did not address how the screen should be scored or interpreted. It is composed of five overall domains, each asking about the emergence of a new, persistent symptom. Patients rate the presences and severity of those symptoms on a 3-point scale. The researchers who developed it chose age 50 as the cutoff point because symptoms that emerge at that age can herald the onset of frontotemporal dementia in relatively young patients.

“This idea of symptoms persisting for at least 6 months is important,” Dr. Ismail said. “What we’re talking about is a sustained change from baseline personality. But these are still nondemented patients. Function is maintained. Independent activities of daily living are intact.”

The most comprehensive domain is impulse control, agitation, and reward. “This captures a lot of function with regard to agitation in dementia, new-onset substance abuse, irritability, new-onset road rage … things we might not otherwise capture.”

The social appropriateness domain examines symptoms like a loss of the ability to share appropriately, acting out sexually, and loss of social judgment. The psychosis domain inquires about feelings of aggrandizement, persecution, and suspicion, as well as auditory and visual hallucinations.

The mood domain asks about new-onset anxiety, panic, and depression. The motivation domain asks about the development of apathy or disinterest in family, friends, and activities.

 

Validation studies in large cohorts are ongoing, as well as studies that Dr. Ismail hopes will link these early behavioral changes to well-established Alzheimer’s biomarkers.

The MBI-C website is not yet complete, but the checklist is available for free by emailing [email protected].

Dr. Ismail had no financial disclosures.

[email protected]

On Twitter @alz_gal

TORONTO – Researchers have described a behavioral syndrome that they say can be a forerunner of Alzheimer’s disease and other neurodegenerative diseases and released a tool for diagnosing it.

Mild behavioral impairment (MBI) defines a syndrome of new-onset neuropsychiatric symptoms that appear in nondemented people older than 50, and are sustained for at least 6 months. Symptoms can occur in any of five domains: apathy/drive/motivation; mood/affect/anxiety; impulse control/agitation/reward; social appropriateness; and thoughts/perception.

Zahinoor Ismail, MD, described the concept of MBI for the first time at the Alzheimer’s Association International Conference 2016, and unveiled the MBI Checklist (MBI-C), a two-page screen that identifies and scores these symptoms. The MBI-C is a project of the Alzheimer’s Association International Society to Advance Alzheimer’s Research and Treatment (ISTAART), and is still being validated, although is available for clinical use now, said Dr. Ismail of the University of Calgary (Alta.).

Changes in personality are often the earliest signs of an emerging neurocognitive disorder, appearing well before any problems with memory or cognition. The MBI-C will allow clinicians to identify and track these changes in patients.

“We can now describe this preclinical dementia phenotype and use this tool to diagnose it and to capture change over time,” Dr. Ismail said.

In addition to being clinically useful, he said the checklist will wield great power in research: It could target a population at the greatest risk for neurocognitive decline, at a time where any future disease-modifying drugs could be most beneficial.

“We all know that dementia is much more than memory or cognitive impairment alone. The neuropsychiatric symptoms of dementia are associated with functional impairment, caregiver burden, institutionalization, accelerated rates of progression, and a greater burden of plaques and tangles. There is a great need to identify people early on, people in whom we might be able to change the course of illness. These patients, who present with early neuropsychiatric symptoms, may be a population we can examine to see if that is possible.”

A large body of research has already linked new-onset neuropsychiatric symptoms with neurocognitive disease, particularly frontotemporal dementia, Dr. Ismail said. One of the most compelling studies comprised about 500 subjects enrolled in the ongoing Mayo Clinic Study of Aging, who were followed for 5 years (Am J Psychiatry. 2014;171[5];572-81). This study found that the emergence of neuropsychiatric symptoms in cognitively normal older adults was associated with significant increases in the risk of developing mild cognitive impairment. Agitation conferred the highest risk (hazard ratio, 3.06), followed by apathy (HR, 2.6), anxiety (HR, 1.87), irritability (HR, 1.84), and depression (HR, 1.63).

Dr. Ismail said new-onset neuropsychiatric symptoms are already quite common by the time patients enter care for memory concerns. At the meeting, he presented data on a group of about 300 patients with mild cognitive impairment who attended a memory clinic. A total of 82% endorsed at least one neuropsychiatric symptom. When sorted into the five MBI-C domains, 78% of patients expressed mood symptoms; 64% impulse control symptoms; 52% apathy symptoms; 28% social appropriateness symptoms; and 9% psychotic symptoms.

“Our study suggests that this concept of mild behavioral impairment may be a common and clinically relevant syndrome, particularly given that neuropsychiatric symptoms are associated with greater caregiver burden,” Dr. Ismail said.

Dr. Ismail did not address how the screen should be scored or interpreted. It is composed of five overall domains, each asking about the emergence of a new, persistent symptom. Patients rate the presences and severity of those symptoms on a 3-point scale. The researchers who developed it chose age 50 as the cutoff point because symptoms that emerge at that age can herald the onset of frontotemporal dementia in relatively young patients.

“This idea of symptoms persisting for at least 6 months is important,” Dr. Ismail said. “What we’re talking about is a sustained change from baseline personality. But these are still nondemented patients. Function is maintained. Independent activities of daily living are intact.”

The most comprehensive domain is impulse control, agitation, and reward. “This captures a lot of function with regard to agitation in dementia, new-onset substance abuse, irritability, new-onset road rage … things we might not otherwise capture.”

The social appropriateness domain examines symptoms like a loss of the ability to share appropriately, acting out sexually, and loss of social judgment. The psychosis domain inquires about feelings of aggrandizement, persecution, and suspicion, as well as auditory and visual hallucinations.

The mood domain asks about new-onset anxiety, panic, and depression. The motivation domain asks about the development of apathy or disinterest in family, friends, and activities.

 

Validation studies in large cohorts are ongoing, as well as studies that Dr. Ismail hopes will link these early behavioral changes to well-established Alzheimer’s biomarkers.

The MBI-C website is not yet complete, but the checklist is available for free by emailing [email protected].

Dr. Ismail had no financial disclosures.

[email protected]

On Twitter @alz_gal

TORONTO – Researchers have described a behavioral syndrome that they say can be a forerunner of Alzheimer’s disease and other neurodegenerative diseases and released a tool for diagnosing it.

Mild behavioral impairment (MBI) defines a syndrome of new-onset neuropsychiatric symptoms that appear in nondemented people older than 50, and are sustained for at least 6 months. Symptoms can occur in any of five domains: apathy/drive/motivation; mood/affect/anxiety; impulse control/agitation/reward; social appropriateness; and thoughts/perception.

Zahinoor Ismail, MD, described the concept of MBI for the first time at the Alzheimer’s Association International Conference 2016, and unveiled the MBI Checklist (MBI-C), a two-page screen that identifies and scores these symptoms. The MBI-C is a project of the Alzheimer’s Association International Society to Advance Alzheimer’s Research and Treatment (ISTAART), and is still being validated, although is available for clinical use now, said Dr. Ismail of the University of Calgary (Alta.).

Changes in personality are often the earliest signs of an emerging neurocognitive disorder, appearing well before any problems with memory or cognition. The MBI-C will allow clinicians to identify and track these changes in patients.

“We can now describe this preclinical dementia phenotype and use this tool to diagnose it and to capture change over time,” Dr. Ismail said.

In addition to being clinically useful, he said the checklist will wield great power in research: It could target a population at the greatest risk for neurocognitive decline, at a time where any future disease-modifying drugs could be most beneficial.

“We all know that dementia is much more than memory or cognitive impairment alone. The neuropsychiatric symptoms of dementia are associated with functional impairment, caregiver burden, institutionalization, accelerated rates of progression, and a greater burden of plaques and tangles. There is a great need to identify people early on, people in whom we might be able to change the course of illness. These patients, who present with early neuropsychiatric symptoms, may be a population we can examine to see if that is possible.”

A large body of research has already linked new-onset neuropsychiatric symptoms with neurocognitive disease, particularly frontotemporal dementia, Dr. Ismail said. One of the most compelling studies comprised about 500 subjects enrolled in the ongoing Mayo Clinic Study of Aging, who were followed for 5 years (Am J Psychiatry. 2014;171[5];572-81). This study found that the emergence of neuropsychiatric symptoms in cognitively normal older adults was associated with significant increases in the risk of developing mild cognitive impairment. Agitation conferred the highest risk (hazard ratio, 3.06), followed by apathy (HR, 2.6), anxiety (HR, 1.87), irritability (HR, 1.84), and depression (HR, 1.63).

Dr. Ismail said new-onset neuropsychiatric symptoms are already quite common by the time patients enter care for memory concerns. At the meeting, he presented data on a group of about 300 patients with mild cognitive impairment who attended a memory clinic. A total of 82% endorsed at least one neuropsychiatric symptom. When sorted into the five MBI-C domains, 78% of patients expressed mood symptoms; 64% impulse control symptoms; 52% apathy symptoms; 28% social appropriateness symptoms; and 9% psychotic symptoms.

“Our study suggests that this concept of mild behavioral impairment may be a common and clinically relevant syndrome, particularly given that neuropsychiatric symptoms are associated with greater caregiver burden,” Dr. Ismail said.

Dr. Ismail did not address how the screen should be scored or interpreted. It is composed of five overall domains, each asking about the emergence of a new, persistent symptom. Patients rate the presences and severity of those symptoms on a 3-point scale. The researchers who developed it chose age 50 as the cutoff point because symptoms that emerge at that age can herald the onset of frontotemporal dementia in relatively young patients.

“This idea of symptoms persisting for at least 6 months is important,” Dr. Ismail said. “What we’re talking about is a sustained change from baseline personality. But these are still nondemented patients. Function is maintained. Independent activities of daily living are intact.”

The most comprehensive domain is impulse control, agitation, and reward. “This captures a lot of function with regard to agitation in dementia, new-onset substance abuse, irritability, new-onset road rage … things we might not otherwise capture.”

The social appropriateness domain examines symptoms like a loss of the ability to share appropriately, acting out sexually, and loss of social judgment. The psychosis domain inquires about feelings of aggrandizement, persecution, and suspicion, as well as auditory and visual hallucinations.

The mood domain asks about new-onset anxiety, panic, and depression. The motivation domain asks about the development of apathy or disinterest in family, friends, and activities.

 

Validation studies in large cohorts are ongoing, as well as studies that Dr. Ismail hopes will link these early behavioral changes to well-established Alzheimer’s biomarkers.

The MBI-C website is not yet complete, but the checklist is available for free by emailing [email protected].

Dr. Ismail had no financial disclosures.

[email protected]

On Twitter @alz_gal

MINNEAPOLIS – When it comes to allergic contact dermatitis in children, the answer is sometimes hiding in plain sight. Cleansers, moisturizers, shampoos, detergents – all can contain ingredients that provoke significant reactions, yet many of these ingredients are not on the most common testing panels.

Erin Warshaw, MD, professor of dermatology at the University of Minnesota, reviewed common but often unsuspected causes of allergic dermatitis in the pediatric population at the annual meeting of the Society for Pediatric Dermatology.

Even some hypoallergenic and frequently recommended products can contain preservatives and other ingredients that provoke allergic reactions, according to Dr. Warshaw. A chief culprit is methylisothiazolinone (MI), a preservative that came into common use as formaldehyde has been gradually phased out.

“If there’s anything I could emphasize from this talk, it’s MI, MI, MI. This is the major epidemic of our time in the contact dermatitis world,” Dr. Warshaw said. Upcoming publications, she added, will place MI in the top five most common contact allergens. “MI is in everything, including things you would think would be hypoallergenic,” she said. She recommended looking at ingredient labels with a keen eye when making testing decisions.

Despite MI’s status as a frequent culprit, it’s not an allergen that appears on common test kits, Dr. Warshaw pointed out. For example, it’s absent from one of the most commonly used test kits, the Thin-Layer Rapid Use Epicutaneous Patch (T.R.U.E. test).

The T.R.U.E. test, said Dr. Warshaw, has reasonable sensitivity – it can detect 71% of relevant positive patch tests (RPPTs) in children. However, she added, a recent study showed that about 23% of children reacted to a supplemental allergen. “That’s significant. One quarter of these individuals only reacted to a preservative … or a sunscreen, or an acrylate. These aren’t on the T.R.U.E. test.”

Decyl glucoside is another frequent culprit that is not included in commercial patch test kits. “It’s really an important emerging allergen,” said Dr. Warshaw, noting that it commonly cross-reacts with coco and lauryl glucoside, frequently found in fragrance-free products. “It’s always humbling when we find the allergen in the product we’ve recommended to our patients.”

Other important allergens not on the T.R.U.E. test include propolis, tocopherol, oxybenzone, and many surfactants and botanicals.

In order to avoid a confounding reaction to aluminum, Dr. Warshaw recommends testing using plastic-backed test chambers, such as IQ chambers, rather than Finn chambers, which are aluminum backed.

When working with families to track down allergens in the pediatric population, Dr. Warshaw adjusts her approach from what she would use for adults.

“What do I do differently in kids? First of all, I set expectations for children and parents,” she said. Some of the most frequent parental questions deal with food allergies, so she allots time to explain the rationale for not testing for food allergens when allergic contact dermatitis is suspected.

For many patients, “I try and frame that there is probably baseline eczema, and our goal is to try to figure out if there is an allergy in addition to that that is contributing to the flares,” she said. She makes sure to convey that “all it takes is one exposure every 3 weeks; that will keep this reaction going.”

However, she’s judicious in interpreting equivocal results. “I feel a responsibility not to label children with an allergy” if results are unclear. Finally, providing enough time is key, said Dr. Warshaw, who allots an hour for reviewing final testing results.

The take-home points? It’s worthwhile to patch test children, since over half of children will have at least one RPPT. Also, contact dermatitis can be an overlay on preexisting allergic dermatitis, so patch testing can still be helpful for these children. Supplemental allergens are important in patch testing, “especially in children with a negative test to a screening series,” Dr. Warshaw said.

She recommended accessing the Contact Allergen Management Program (CAMP) database, found on the American Contact Dermatitis Society website. The list is a searchable database that generates a list of “safe” products that don’t contain a given allergen. This resource is available for society members, but a member’s access code can be shared among faculty members at academic institutions, she said. Patients can also be given unique codes that will give them access for life, so they can use the CAMP database on a computer or via a smartphone app.

Dr. Warshaw reported no relevant financial disclosures.

MINNEAPOLIS – When it comes to allergic contact dermatitis in children, the answer is sometimes hiding in plain sight. Cleansers, moisturizers, shampoos, detergents – all can contain ingredients that provoke significant reactions, yet many of these ingredients are not on the most common testing panels.

Erin Warshaw, MD, professor of dermatology at the University of Minnesota, reviewed common but often unsuspected causes of allergic dermatitis in the pediatric population at the annual meeting of the Society for Pediatric Dermatology.

Even some hypoallergenic and frequently recommended products can contain preservatives and other ingredients that provoke allergic reactions, according to Dr. Warshaw. A chief culprit is methylisothiazolinone (MI), a preservative that came into common use as formaldehyde has been gradually phased out.

“If there’s anything I could emphasize from this talk, it’s MI, MI, MI. This is the major epidemic of our time in the contact dermatitis world,” Dr. Warshaw said. Upcoming publications, she added, will place MI in the top five most common contact allergens. “MI is in everything, including things you would think would be hypoallergenic,” she said. She recommended looking at ingredient labels with a keen eye when making testing decisions.

Despite MI’s status as a frequent culprit, it’s not an allergen that appears on common test kits, Dr. Warshaw pointed out. For example, it’s absent from one of the most commonly used test kits, the Thin-Layer Rapid Use Epicutaneous Patch (T.R.U.E. test).

The T.R.U.E. test, said Dr. Warshaw, has reasonable sensitivity – it can detect 71% of relevant positive patch tests (RPPTs) in children. However, she added, a recent study showed that about 23% of children reacted to a supplemental allergen. “That’s significant. One quarter of these individuals only reacted to a preservative … or a sunscreen, or an acrylate. These aren’t on the T.R.U.E. test.”

Decyl glucoside is another frequent culprit that is not included in commercial patch test kits. “It’s really an important emerging allergen,” said Dr. Warshaw, noting that it commonly cross-reacts with coco and lauryl glucoside, frequently found in fragrance-free products. “It’s always humbling when we find the allergen in the product we’ve recommended to our patients.”

Other important allergens not on the T.R.U.E. test include propolis, tocopherol, oxybenzone, and many surfactants and botanicals.

In order to avoid a confounding reaction to aluminum, Dr. Warshaw recommends testing using plastic-backed test chambers, such as IQ chambers, rather than Finn chambers, which are aluminum backed.

When working with families to track down allergens in the pediatric population, Dr. Warshaw adjusts her approach from what she would use for adults.

“What do I do differently in kids? First of all, I set expectations for children and parents,” she said. Some of the most frequent parental questions deal with food allergies, so she allots time to explain the rationale for not testing for food allergens when allergic contact dermatitis is suspected.

For many patients, “I try and frame that there is probably baseline eczema, and our goal is to try to figure out if there is an allergy in addition to that that is contributing to the flares,” she said. She makes sure to convey that “all it takes is one exposure every 3 weeks; that will keep this reaction going.”

However, she’s judicious in interpreting equivocal results. “I feel a responsibility not to label children with an allergy” if results are unclear. Finally, providing enough time is key, said Dr. Warshaw, who allots an hour for reviewing final testing results.

The take-home points? It’s worthwhile to patch test children, since over half of children will have at least one RPPT. Also, contact dermatitis can be an overlay on preexisting allergic dermatitis, so patch testing can still be helpful for these children. Supplemental allergens are important in patch testing, “especially in children with a negative test to a screening series,” Dr. Warshaw said.

She recommended accessing the Contact Allergen Management Program (CAMP) database, found on the American Contact Dermatitis Society website. The list is a searchable database that generates a list of “safe” products that don’t contain a given allergen. This resource is available for society members, but a member’s access code can be shared among faculty members at academic institutions, she said. Patients can also be given unique codes that will give them access for life, so they can use the CAMP database on a computer or via a smartphone app.

Dr. Warshaw reported no relevant financial disclosures.

MINNEAPOLIS – When it comes to allergic contact dermatitis in children, the answer is sometimes hiding in plain sight. Cleansers, moisturizers, shampoos, detergents – all can contain ingredients that provoke significant reactions, yet many of these ingredients are not on the most common testing panels.

Erin Warshaw, MD, professor of dermatology at the University of Minnesota, reviewed common but often unsuspected causes of allergic dermatitis in the pediatric population at the annual meeting of the Society for Pediatric Dermatology.

Even some hypoallergenic and frequently recommended products can contain preservatives and other ingredients that provoke allergic reactions, according to Dr. Warshaw. A chief culprit is methylisothiazolinone (MI), a preservative that came into common use as formaldehyde has been gradually phased out.

“If there’s anything I could emphasize from this talk, it’s MI, MI, MI. This is the major epidemic of our time in the contact dermatitis world,” Dr. Warshaw said. Upcoming publications, she added, will place MI in the top five most common contact allergens. “MI is in everything, including things you would think would be hypoallergenic,” she said. She recommended looking at ingredient labels with a keen eye when making testing decisions.

Despite MI’s status as a frequent culprit, it’s not an allergen that appears on common test kits, Dr. Warshaw pointed out. For example, it’s absent from one of the most commonly used test kits, the Thin-Layer Rapid Use Epicutaneous Patch (T.R.U.E. test).

The T.R.U.E. test, said Dr. Warshaw, has reasonable sensitivity – it can detect 71% of relevant positive patch tests (RPPTs) in children. However, she added, a recent study showed that about 23% of children reacted to a supplemental allergen. “That’s significant. One quarter of these individuals only reacted to a preservative … or a sunscreen, or an acrylate. These aren’t on the T.R.U.E. test.”

Decyl glucoside is another frequent culprit that is not included in commercial patch test kits. “It’s really an important emerging allergen,” said Dr. Warshaw, noting that it commonly cross-reacts with coco and lauryl glucoside, frequently found in fragrance-free products. “It’s always humbling when we find the allergen in the product we’ve recommended to our patients.”

Other important allergens not on the T.R.U.E. test include propolis, tocopherol, oxybenzone, and many surfactants and botanicals.

In order to avoid a confounding reaction to aluminum, Dr. Warshaw recommends testing using plastic-backed test chambers, such as IQ chambers, rather than Finn chambers, which are aluminum backed.

When working with families to track down allergens in the pediatric population, Dr. Warshaw adjusts her approach from what she would use for adults.

“What do I do differently in kids? First of all, I set expectations for children and parents,” she said. Some of the most frequent parental questions deal with food allergies, so she allots time to explain the rationale for not testing for food allergens when allergic contact dermatitis is suspected.

For many patients, “I try and frame that there is probably baseline eczema, and our goal is to try to figure out if there is an allergy in addition to that that is contributing to the flares,” she said. She makes sure to convey that “all it takes is one exposure every 3 weeks; that will keep this reaction going.”

However, she’s judicious in interpreting equivocal results. “I feel a responsibility not to label children with an allergy” if results are unclear. Finally, providing enough time is key, said Dr. Warshaw, who allots an hour for reviewing final testing results.

The take-home points? It’s worthwhile to patch test children, since over half of children will have at least one RPPT. Also, contact dermatitis can be an overlay on preexisting allergic dermatitis, so patch testing can still be helpful for these children. Supplemental allergens are important in patch testing, “especially in children with a negative test to a screening series,” Dr. Warshaw said.

She recommended accessing the Contact Allergen Management Program (CAMP) database, found on the American Contact Dermatitis Society website. The list is a searchable database that generates a list of “safe” products that don’t contain a given allergen. This resource is available for society members, but a member’s access code can be shared among faculty members at academic institutions, she said. Patients can also be given unique codes that will give them access for life, so they can use the CAMP database on a computer or via a smartphone app.

Dr. Warshaw reported no relevant financial disclosures.

MINNEAPOLIS – When it comes to allergic contact dermatitis in children, the answer is sometimes hiding in plain sight. Cleansers, moisturizers, shampoos, detergents – all can contain ingredients that provoke significant reactions, yet many of these ingredients are not on the most common testing panels.

Erin Warshaw, MD, professor of dermatology at the University of Minnesota, reviewed common but often unsuspected causes of allergic dermatitis in the pediatric population at the annual meeting of the Society for Pediatric Dermatology.

Even some hypoallergenic and frequently recommended products can contain preservatives and other ingredients that provoke allergic reactions, according to Dr. Warshaw. A chief culprit is methylisothiazolinone (MI), a preservative that came into common use as formaldehyde has been gradually phased out.

“If there’s anything I could emphasize from this talk, it’s MI, MI, MI. This is the major epidemic of our time in the contact dermatitis world,” Dr. Warshaw said. Upcoming publications, she added, will place MI in the top five most common contact allergens. “MI is in everything, including things you would think would be hypoallergenic,” she said. She recommended looking at ingredient labels with a keen eye when making testing decisions.

Despite MI’s status as a frequent culprit, it’s not an allergen that appears on common test kits, Dr. Warshaw pointed out. For example, it’s absent from one of the most commonly used test kits, the Thin-Layer Rapid Use Epicutaneous Patch (T.R.U.E. test).

The T.R.U.E. test, said Dr. Warshaw, has reasonable sensitivity – it can detect 71% of relevant positive patch tests (RPPTs) in children. However, she added, a recent study showed that about 23% of children reacted to a supplemental allergen. “That’s significant. One quarter of these individuals only reacted to a preservative … or a sunscreen, or an acrylate. These aren’t on the T.R.U.E. test.”

Decyl glucoside is another frequent culprit that is not included in commercial patch test kits. “It’s really an important emerging allergen,” said Dr. Warshaw, noting that it commonly cross-reacts with coco and lauryl glucoside, frequently found in fragrance-free products. “It’s always humbling when we find the allergen in the product we’ve recommended to our patients.”

Other important allergens not on the T.R.U.E. test include propolis, tocopherol, oxybenzone, and many surfactants and botanicals.

In order to avoid a confounding reaction to aluminum, Dr. Warshaw recommends testing using plastic-backed test chambers, such as IQ chambers, rather than Finn chambers, which are aluminum backed.

When working with families to track down allergens in the pediatric population, Dr. Warshaw adjusts her approach from what she would use for adults.

“What do I do differently in kids? First of all, I set expectations for children and parents,” she said. Some of the most frequent parental questions deal with food allergies, so she allots time to explain the rationale for not testing for food allergens when allergic contact dermatitis is suspected.

For many patients, “I try and frame that there is probably baseline eczema, and our goal is to try to figure out if there is an allergy in addition to that that is contributing to the flares,” she said. She makes sure to convey that “all it takes is one exposure every 3 weeks; that will keep this reaction going.”

However, she’s judicious in interpreting equivocal results. “I feel a responsibility not to label children with an allergy” if results are unclear. Finally, providing enough time is key, said Dr. Warshaw, who allots an hour for reviewing final testing results.

The take-home points? It’s worthwhile to patch test children, since over half of children will have at least one RPPT. Also, contact dermatitis can be an overlay on preexisting allergic dermatitis, so patch testing can still be helpful for these children. Supplemental allergens are important in patch testing, “especially in children with a negative test to a screening series,” Dr. Warshaw said.

She recommended accessing the Contact Allergen Management Program (CAMP) database, found on the American Contact Dermatitis Society website. The list is a searchable database that generates a list of “safe” products that don’t contain a given allergen. This resource is available for society members, but a member’s access code can be shared among faculty members at academic institutions, she said. Patients can also be given unique codes that will give them access for life, so they can use the CAMP database on a computer or via a smartphone app.

Dr. Warshaw reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

MINNEAPOLIS – When it comes to allergic contact dermatitis in children, the answer is sometimes hiding in plain sight. Cleansers, moisturizers, shampoos, detergents – all can contain ingredients that provoke significant reactions, yet many of these ingredients are not on the most common testing panels.

Erin Warshaw, MD, professor of dermatology at the University of Minnesota, reviewed common but often unsuspected causes of allergic dermatitis in the pediatric population at the annual meeting of the Society for Pediatric Dermatology.

Even some hypoallergenic and frequently recommended products can contain preservatives and other ingredients that provoke allergic reactions, according to Dr. Warshaw. A chief culprit is methylisothiazolinone (MI), a preservative that came into common use as formaldehyde has been gradually phased out.

“If there’s anything I could emphasize from this talk, it’s MI, MI, MI. This is the major epidemic of our time in the contact dermatitis world,” Dr. Warshaw said. Upcoming publications, she added, will place MI in the top five most common contact allergens. “MI is in everything, including things you would think would be hypoallergenic,” she said. She recommended looking at ingredient labels with a keen eye when making testing decisions.

Despite MI’s status as a frequent culprit, it’s not an allergen that appears on common test kits, Dr. Warshaw pointed out. For example, it’s absent from one of the most commonly used test kits, the Thin-Layer Rapid Use Epicutaneous Patch (T.R.U.E. test).

The T.R.U.E. test, said Dr. Warshaw, has reasonable sensitivity – it can detect 71% of relevant positive patch tests (RPPTs) in children. However, she added, a recent study showed that about 23% of children reacted to a supplemental allergen. “That’s significant. One quarter of these individuals only reacted to a preservative … or a sunscreen, or an acrylate. These aren’t on the T.R.U.E. test.”

Decyl glucoside is another frequent culprit that is not included in commercial patch test kits. “It’s really an important emerging allergen,” said Dr. Warshaw, noting that it commonly cross-reacts with coco and lauryl glucoside, frequently found in fragrance-free products. “It’s always humbling when we find the allergen in the product we’ve recommended to our patients.”

Other important allergens not on the T.R.U.E. test include propolis, tocopherol, oxybenzone, and many surfactants and botanicals.

In order to avoid a confounding reaction to aluminum, Dr. Warshaw recommends testing using plastic-backed test chambers, such as IQ chambers, rather than Finn chambers, which are aluminum backed.

When working with families to track down allergens in the pediatric population, Dr. Warshaw adjusts her approach from what she would use for adults.

“What do I do differently in kids? First of all, I set expectations for children and parents,” she said. Some of the most frequent parental questions deal with food allergies, so she allots time to explain the rationale for not testing for food allergens when allergic contact dermatitis is suspected.

For many patients, “I try and frame that there is probably baseline eczema, and our goal is to try to figure out if there is an allergy in addition to that that is contributing to the flares,” she said. She makes sure to convey that “all it takes is one exposure every 3 weeks; that will keep this reaction going.”

However, she’s judicious in interpreting equivocal results. “I feel a responsibility not to label children with an allergy” if results are unclear. Finally, providing enough time is key, said Dr. Warshaw, who allots an hour for reviewing final testing results.

The take-home points? It’s worthwhile to patch test children, since over half of children will have at least one RPPT. Also, contact dermatitis can be an overlay on preexisting allergic dermatitis, so patch testing can still be helpful for these children. Supplemental allergens are important in patch testing, “especially in children with a negative test to a screening series,” Dr. Warshaw said.

She recommended accessing the Contact Allergen Management Program (CAMP) database, found on the American Contact Dermatitis Society website. The list is a searchable database that generates a list of “safe” products that don’t contain a given allergen. This resource is available for society members, but a member’s access code can be shared among faculty members at academic institutions, she said. Patients can also be given unique codes that will give them access for life, so they can use the CAMP database on a computer or via a smartphone app.

Dr. Warshaw reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

MINNEAPOLIS – When it comes to allergic contact dermatitis in children, the answer is sometimes hiding in plain sight. Cleansers, moisturizers, shampoos, detergents – all can contain ingredients that provoke significant reactions, yet many of these ingredients are not on the most common testing panels.

Erin Warshaw, MD, professor of dermatology at the University of Minnesota, reviewed common but often unsuspected causes of allergic dermatitis in the pediatric population at the annual meeting of the Society for Pediatric Dermatology.

Even some hypoallergenic and frequently recommended products can contain preservatives and other ingredients that provoke allergic reactions, according to Dr. Warshaw. A chief culprit is methylisothiazolinone (MI), a preservative that came into common use as formaldehyde has been gradually phased out.

“If there’s anything I could emphasize from this talk, it’s MI, MI, MI. This is the major epidemic of our time in the contact dermatitis world,” Dr. Warshaw said. Upcoming publications, she added, will place MI in the top five most common contact allergens. “MI is in everything, including things you would think would be hypoallergenic,” she said. She recommended looking at ingredient labels with a keen eye when making testing decisions.

Despite MI’s status as a frequent culprit, it’s not an allergen that appears on common test kits, Dr. Warshaw pointed out. For example, it’s absent from one of the most commonly used test kits, the Thin-Layer Rapid Use Epicutaneous Patch (T.R.U.E. test).

The T.R.U.E. test, said Dr. Warshaw, has reasonable sensitivity – it can detect 71% of relevant positive patch tests (RPPTs) in children. However, she added, a recent study showed that about 23% of children reacted to a supplemental allergen. “That’s significant. One quarter of these individuals only reacted to a preservative … or a sunscreen, or an acrylate. These aren’t on the T.R.U.E. test.”

Decyl glucoside is another frequent culprit that is not included in commercial patch test kits. “It’s really an important emerging allergen,” said Dr. Warshaw, noting that it commonly cross-reacts with coco and lauryl glucoside, frequently found in fragrance-free products. “It’s always humbling when we find the allergen in the product we’ve recommended to our patients.”

Other important allergens not on the T.R.U.E. test include propolis, tocopherol, oxybenzone, and many surfactants and botanicals.

In order to avoid a confounding reaction to aluminum, Dr. Warshaw recommends testing using plastic-backed test chambers, such as IQ chambers, rather than Finn chambers, which are aluminum backed.

When working with families to track down allergens in the pediatric population, Dr. Warshaw adjusts her approach from what she would use for adults.

“What do I do differently in kids? First of all, I set expectations for children and parents,” she said. Some of the most frequent parental questions deal with food allergies, so she allots time to explain the rationale for not testing for food allergens when allergic contact dermatitis is suspected.

For many patients, “I try and frame that there is probably baseline eczema, and our goal is to try to figure out if there is an allergy in addition to that that is contributing to the flares,” she said. She makes sure to convey that “all it takes is one exposure every 3 weeks; that will keep this reaction going.”

However, she’s judicious in interpreting equivocal results. “I feel a responsibility not to label children with an allergy” if results are unclear. Finally, providing enough time is key, said Dr. Warshaw, who allots an hour for reviewing final testing results.

The take-home points? It’s worthwhile to patch test children, since over half of children will have at least one RPPT. Also, contact dermatitis can be an overlay on preexisting allergic dermatitis, so patch testing can still be helpful for these children. Supplemental allergens are important in patch testing, “especially in children with a negative test to a screening series,” Dr. Warshaw said.

She recommended accessing the Contact Allergen Management Program (CAMP) database, found on the American Contact Dermatitis Society website. The list is a searchable database that generates a list of “safe” products that don’t contain a given allergen. This resource is available for society members, but a member’s access code can be shared among faculty members at academic institutions, she said. Patients can also be given unique codes that will give them access for life, so they can use the CAMP database on a computer or via a smartphone app.

Dr. Warshaw reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

The European League Against Rheumatism’s updated recommendations on gout generally resemble those from the American College of Rheumatology, but with several important caveats, two prominent U.S. rheumatologists said in interviews.

First came the praise. “Both ACR and EULAR are sending a consistent message that gout needs more attention and improvement in the quality of care that’s being provided,” said John FitzGerald, MD, PhD, who coauthored the 2012 ACR guidelines and is a professor of medicine and rheumatology at the University of California, Los Angeles.

EULAR also strengthened its advice to start urate-lowering therapy (ULT) early (Ann Rheum Dis. 2016 Jul 25. doi: 10.1136/annrheumdis-2016-209707). This choice reflects “the opinion of many gout experts, that delaying treatment only allows for further accumulation of monosodium urate deposition around the body, which promotes inflammation and tissue destruction and makes it harder to achieve clinical and biologic remission,” said N. Lawrence Edwards, MD, who also helped write the ACR guidelines and is a vice chairman of the department of medicine at the University of Florida, Gainesville.

Finally, EULAR again emphasized treating to a target serum urate level of less than 6.0 mg/dL. “That is definitely consistent with the current recommendations from ACR, and with the way most rheumatologists think,” Dr. FitzGerald said. “The recommendations for future research are also very good and should be commended.”

But several other points depart from the ACR guidance and have prompted critiques.

Allopurinol

Perhaps most strikingly, EULAR now recommends adjusting maximum allopurinol dose based on creatinine clearance if patients have renal impairment. “This modification is very surprising, since [it has] never been shown to affect the incidence of severe allopurinol hypersensitivity reactions,” Dr. Edwards said. “Instead, these antiquated treatment schedules have only added to the epidemic of underdosing of allopurinol by both general practitioners and rheumatologists alike.”

Indeed, requiring clinicians to consider creatinine clearance when using allopurinol in many of their gout patients might push them toward other drugs and their accompanying side effects, “without first trying a slow, safe titration” of allopurinol, Dr. FitzGerald said.

Instead, both he and Dr. Edwards recommended following the gradual allopurinol dose escalation detailed in the 2012 ACR recommendations. “The biggest risk of adverse effects with allopurinol is during the initial treatment period, whereas there is little data about maximum dose,” Dr. FitzGerald emphasized. “I think the starting dose should be 50 mg every day, or even 50 mg every other day – the latter if patients have stage 4 chronic kidney disease.”

Serum urate

EULAR also advises against letting serum urate fall below 3.0 mg/dL “in the long term” – that is, over several years. This guidance stems from reports that hyperuricemia could help prevent neurodegenerative diseases, Dr. Edwards said. But studies have never clearly linked serum urate to neurologic processes, nor have they shown that low serum urate triggers or worsens disease, he added. “The harm of this EULAR recommendation comes from the chilling effect it might have on getting internists and general practitioners to more fully engage in urate lowering in subjects with gout. They could view a therapeutic serum urate window of 3.0 mg/dL to 6.0 mg/dL as too narrow and requiring too much oversight – leading once again to undertreatment.”

Comorbidities

ACR already had recommended ULT for gout patients with chronic kidney disease or urate renoliths, but EULAR expanded this list to include not only renal impairment, but also hypertension, ischemic heart disease, and heart failure, Dr. FitzGerald pointed out. “The recommendation for hypertension was based on a systematic literature review, but hypertension is so prevalent that this additional recommendation really expands the number of patients that would be treated with ULT,” he added. “If it is a patient’s first attack of gout, I think a lot of primary care providers would be uncomfortable starting patients on ULT.”

EULAR and ACR have always diverged in their recommendations about who should receive ULT, and widening these criteria further without direct supporting evidence from a clinical trial will provoke concerns, according to Dr. FitzGerald. “The EULAR authors lay out the logic for it, but without direct evidence it will be controversial, and the risk-benefit ratio of treating this expanded list of patients is unclear.”

Febuxostat

Dr. FitzGerald also recommended starting the xanthine oxidase inhibitor febuxostat (Uloric) at 40 mg, rather than 80 mg as recommended by EULAR. “This is based on a similar logic, that starting lower and titrating up has less risks than starting at a higher dose.”

Dr. Pascal Richette, first author of the updated EULAR recommendations, disclosed fees from Ipsen Pharma/Menarini, AstraZeneca, and Savient. Dr. FitzGerald and Dr. Edwards were coauthors of the 2012 ACR guidelines on gout, part 1 and part 2.

The European League Against Rheumatism’s updated recommendations on gout generally resemble those from the American College of Rheumatology, but with several important caveats, two prominent U.S. rheumatologists said in interviews.

First came the praise. “Both ACR and EULAR are sending a consistent message that gout needs more attention and improvement in the quality of care that’s being provided,” said John FitzGerald, MD, PhD, who coauthored the 2012 ACR guidelines and is a professor of medicine and rheumatology at the University of California, Los Angeles.

EULAR also strengthened its advice to start urate-lowering therapy (ULT) early (Ann Rheum Dis. 2016 Jul 25. doi: 10.1136/annrheumdis-2016-209707). This choice reflects “the opinion of many gout experts, that delaying treatment only allows for further accumulation of monosodium urate deposition around the body, which promotes inflammation and tissue destruction and makes it harder to achieve clinical and biologic remission,” said N. Lawrence Edwards, MD, who also helped write the ACR guidelines and is a vice chairman of the department of medicine at the University of Florida, Gainesville.

Finally, EULAR again emphasized treating to a target serum urate level of less than 6.0 mg/dL. “That is definitely consistent with the current recommendations from ACR, and with the way most rheumatologists think,” Dr. FitzGerald said. “The recommendations for future research are also very good and should be commended.”

But several other points depart from the ACR guidance and have prompted critiques.

Allopurinol

Perhaps most strikingly, EULAR now recommends adjusting maximum allopurinol dose based on creatinine clearance if patients have renal impairment. “This modification is very surprising, since [it has] never been shown to affect the incidence of severe allopurinol hypersensitivity reactions,” Dr. Edwards said. “Instead, these antiquated treatment schedules have only added to the epidemic of underdosing of allopurinol by both general practitioners and rheumatologists alike.”

Indeed, requiring clinicians to consider creatinine clearance when using allopurinol in many of their gout patients might push them toward other drugs and their accompanying side effects, “without first trying a slow, safe titration” of allopurinol, Dr. FitzGerald said.

Instead, both he and Dr. Edwards recommended following the gradual allopurinol dose escalation detailed in the 2012 ACR recommendations. “The biggest risk of adverse effects with allopurinol is during the initial treatment period, whereas there is little data about maximum dose,” Dr. FitzGerald emphasized. “I think the starting dose should be 50 mg every day, or even 50 mg every other day – the latter if patients have stage 4 chronic kidney disease.”

Serum urate

EULAR also advises against letting serum urate fall below 3.0 mg/dL “in the long term” – that is, over several years. This guidance stems from reports that hyperuricemia could help prevent neurodegenerative diseases, Dr. Edwards said. But studies have never clearly linked serum urate to neurologic processes, nor have they shown that low serum urate triggers or worsens disease, he added. “The harm of this EULAR recommendation comes from the chilling effect it might have on getting internists and general practitioners to more fully engage in urate lowering in subjects with gout. They could view a therapeutic serum urate window of 3.0 mg/dL to 6.0 mg/dL as too narrow and requiring too much oversight – leading once again to undertreatment.”

Comorbidities

ACR already had recommended ULT for gout patients with chronic kidney disease or urate renoliths, but EULAR expanded this list to include not only renal impairment, but also hypertension, ischemic heart disease, and heart failure, Dr. FitzGerald pointed out. “The recommendation for hypertension was based on a systematic literature review, but hypertension is so prevalent that this additional recommendation really expands the number of patients that would be treated with ULT,” he added. “If it is a patient’s first attack of gout, I think a lot of primary care providers would be uncomfortable starting patients on ULT.”

EULAR and ACR have always diverged in their recommendations about who should receive ULT, and widening these criteria further without direct supporting evidence from a clinical trial will provoke concerns, according to Dr. FitzGerald. “The EULAR authors lay out the logic for it, but without direct evidence it will be controversial, and the risk-benefit ratio of treating this expanded list of patients is unclear.”

Febuxostat

Dr. FitzGerald also recommended starting the xanthine oxidase inhibitor febuxostat (Uloric) at 40 mg, rather than 80 mg as recommended by EULAR. “This is based on a similar logic, that starting lower and titrating up has less risks than starting at a higher dose.”

Dr. Pascal Richette, first author of the updated EULAR recommendations, disclosed fees from Ipsen Pharma/Menarini, AstraZeneca, and Savient. Dr. FitzGerald and Dr. Edwards were coauthors of the 2012 ACR guidelines on gout, part 1 and part 2.

The European League Against Rheumatism’s updated recommendations on gout generally resemble those from the American College of Rheumatology, but with several important caveats, two prominent U.S. rheumatologists said in interviews.

First came the praise. “Both ACR and EULAR are sending a consistent message that gout needs more attention and improvement in the quality of care that’s being provided,” said John FitzGerald, MD, PhD, who coauthored the 2012 ACR guidelines and is a professor of medicine and rheumatology at the University of California, Los Angeles.

EULAR also strengthened its advice to start urate-lowering therapy (ULT) early (Ann Rheum Dis. 2016 Jul 25. doi: 10.1136/annrheumdis-2016-209707). This choice reflects “the opinion of many gout experts, that delaying treatment only allows for further accumulation of monosodium urate deposition around the body, which promotes inflammation and tissue destruction and makes it harder to achieve clinical and biologic remission,” said N. Lawrence Edwards, MD, who also helped write the ACR guidelines and is a vice chairman of the department of medicine at the University of Florida, Gainesville.

Finally, EULAR again emphasized treating to a target serum urate level of less than 6.0 mg/dL. “That is definitely consistent with the current recommendations from ACR, and with the way most rheumatologists think,” Dr. FitzGerald said. “The recommendations for future research are also very good and should be commended.”

But several other points depart from the ACR guidance and have prompted critiques.

Allopurinol

Perhaps most strikingly, EULAR now recommends adjusting maximum allopurinol dose based on creatinine clearance if patients have renal impairment. “This modification is very surprising, since [it has] never been shown to affect the incidence of severe allopurinol hypersensitivity reactions,” Dr. Edwards said. “Instead, these antiquated treatment schedules have only added to the epidemic of underdosing of allopurinol by both general practitioners and rheumatologists alike.”

Indeed, requiring clinicians to consider creatinine clearance when using allopurinol in many of their gout patients might push them toward other drugs and their accompanying side effects, “without first trying a slow, safe titration” of allopurinol, Dr. FitzGerald said.

Instead, both he and Dr. Edwards recommended following the gradual allopurinol dose escalation detailed in the 2012 ACR recommendations. “The biggest risk of adverse effects with allopurinol is during the initial treatment period, whereas there is little data about maximum dose,” Dr. FitzGerald emphasized. “I think the starting dose should be 50 mg every day, or even 50 mg every other day – the latter if patients have stage 4 chronic kidney disease.”

Serum urate

EULAR also advises against letting serum urate fall below 3.0 mg/dL “in the long term” – that is, over several years. This guidance stems from reports that hyperuricemia could help prevent neurodegenerative diseases, Dr. Edwards said. But studies have never clearly linked serum urate to neurologic processes, nor have they shown that low serum urate triggers or worsens disease, he added. “The harm of this EULAR recommendation comes from the chilling effect it might have on getting internists and general practitioners to more fully engage in urate lowering in subjects with gout. They could view a therapeutic serum urate window of 3.0 mg/dL to 6.0 mg/dL as too narrow and requiring too much oversight – leading once again to undertreatment.”

Comorbidities

ACR already had recommended ULT for gout patients with chronic kidney disease or urate renoliths, but EULAR expanded this list to include not only renal impairment, but also hypertension, ischemic heart disease, and heart failure, Dr. FitzGerald pointed out. “The recommendation for hypertension was based on a systematic literature review, but hypertension is so prevalent that this additional recommendation really expands the number of patients that would be treated with ULT,” he added. “If it is a patient’s first attack of gout, I think a lot of primary care providers would be uncomfortable starting patients on ULT.”

EULAR and ACR have always diverged in their recommendations about who should receive ULT, and widening these criteria further without direct supporting evidence from a clinical trial will provoke concerns, according to Dr. FitzGerald. “The EULAR authors lay out the logic for it, but without direct evidence it will be controversial, and the risk-benefit ratio of treating this expanded list of patients is unclear.”

Febuxostat

Dr. FitzGerald also recommended starting the xanthine oxidase inhibitor febuxostat (Uloric) at 40 mg, rather than 80 mg as recommended by EULAR. “This is based on a similar logic, that starting lower and titrating up has less risks than starting at a higher dose.”

Dr. Pascal Richette, first author of the updated EULAR recommendations, disclosed fees from Ipsen Pharma/Menarini, AstraZeneca, and Savient. Dr. FitzGerald and Dr. Edwards were coauthors of the 2012 ACR guidelines on gout, part 1 and part 2.

Speaker: Lisa Zaoutis, MD, Pediatric Residency Program Director at the Children’s Hospital of Philadelphia.

Amid the skyscrapers of the Windy City, Pediatric Hospital Medicine (PHM) 2016 swept into town, bringing with it the denizens of pediatric hospitalist programs across the country. Some 1,150 attendees, comprised of hospitalists, PHM program leaders, and advanced care practitioners, gathered to educate and inspire one another in the the care of hospitalized children.

Dr. Lisa Zaoutis, director of the pediatric residency program at Children’s Hospital of Philadelphia, kicked off the conference with the opening plenary. Initially titled “North Star and Space,” she quickly changed the title to, “Changing Our Minds.” Touching on the disconnect between positive experiences that bring physicians into PHM and negative experiences that often drive behavior, she started with the beginning, the evolution of our brains.

“We are wired toward the negative,” stated Dr. Zaoutis. “We are Teflon for positive experiences and Velcro for negative experiences.” In addition, negative experiences are more likely to be stored in our memories. “It’s easy to park negative experiences.”

Delving deeper into neuroanatomy, Dr. Zaoutis spoke of “amygdala hijack,” where chronic stress inherent to the professional lives of pediatric hospitalists lead to anxiety responses that are faster, more robust, and triggered more easily.

But all is not lost, asserted Dr. Zaoutis, as our brains are more plastic than previously known. The “neural Darwinism,” of our brains, as Dr. Zaoutis states, leads to epigenetic intracellular changes, more sensitive synapses, improved blood flow, and even new cells as a result of experience dependent neuroplasticity. For example, stated Dr. Zaoutis, London taxi drivers have thicker white matter in their hippocampus as a result of the effect of learning London city streets, and mindfulness meditators have thicker gray matter in regions that control attention and self-insight.

Key Takeaways:

The lesson for pediatric hospitalists, stated Dr. Zaoutis, is that you can shape your brain for greater joy. “Consciously choose activities,” said Dr. Zaoutis, that counter our evolutionary negativity bias. How is this done?

1. Have a positive experience (you can create one or retrieve a prior one);

2. Enrich it and install it by dwelling on it for at least 15-30 seconds; and

3. Absorb it into your body, which my require somatisizing it – Dr. Zaoutis presses her hand into her chest to aid in this.

Further, spread this to your group by the old medical training technique of “see one, do one, teach one.” See if you can start your signout with the best thing that happened to you in the week. Most importantly, start with observing yourself.

---

Dr. Chang is pediatric editor of The Hospitalist. He is associate clinical professor of medicine and pediatrics at the University of California at San Diego (UCSD) School of Medicine, and a hospitalist at both UCSD Medical Center and Rady Children’s Hospital. Send comments and questions to [email protected].

Speaker: Lisa Zaoutis, MD, Pediatric Residency Program Director at the Children’s Hospital of Philadelphia.

Amid the skyscrapers of the Windy City, Pediatric Hospital Medicine (PHM) 2016 swept into town, bringing with it the denizens of pediatric hospitalist programs across the country. Some 1,150 attendees, comprised of hospitalists, PHM program leaders, and advanced care practitioners, gathered to educate and inspire one another in the the care of hospitalized children.

Dr. Lisa Zaoutis, director of the pediatric residency program at Children’s Hospital of Philadelphia, kicked off the conference with the opening plenary. Initially titled “North Star and Space,” she quickly changed the title to, “Changing Our Minds.” Touching on the disconnect between positive experiences that bring physicians into PHM and negative experiences that often drive behavior, she started with the beginning, the evolution of our brains.

“We are wired toward the negative,” stated Dr. Zaoutis. “We are Teflon for positive experiences and Velcro for negative experiences.” In addition, negative experiences are more likely to be stored in our memories. “It’s easy to park negative experiences.”

Delving deeper into neuroanatomy, Dr. Zaoutis spoke of “amygdala hijack,” where chronic stress inherent to the professional lives of pediatric hospitalists lead to anxiety responses that are faster, more robust, and triggered more easily.

But all is not lost, asserted Dr. Zaoutis, as our brains are more plastic than previously known. The “neural Darwinism,” of our brains, as Dr. Zaoutis states, leads to epigenetic intracellular changes, more sensitive synapses, improved blood flow, and even new cells as a result of experience dependent neuroplasticity. For example, stated Dr. Zaoutis, London taxi drivers have thicker white matter in their hippocampus as a result of the effect of learning London city streets, and mindfulness meditators have thicker gray matter in regions that control attention and self-insight.

Key Takeaways:

The lesson for pediatric hospitalists, stated Dr. Zaoutis, is that you can shape your brain for greater joy. “Consciously choose activities,” said Dr. Zaoutis, that counter our evolutionary negativity bias. How is this done?

1. Have a positive experience (you can create one or retrieve a prior one);

2. Enrich it and install it by dwelling on it for at least 15-30 seconds; and

3. Absorb it into your body, which my require somatisizing it – Dr. Zaoutis presses her hand into her chest to aid in this.

Further, spread this to your group by the old medical training technique of “see one, do one, teach one.” See if you can start your signout with the best thing that happened to you in the week. Most importantly, start with observing yourself.

---

Dr. Chang is pediatric editor of The Hospitalist. He is associate clinical professor of medicine and pediatrics at the University of California at San Diego (UCSD) School of Medicine, and a hospitalist at both UCSD Medical Center and Rady Children’s Hospital. Send comments and questions to [email protected].

Speaker: Lisa Zaoutis, MD, Pediatric Residency Program Director at the Children’s Hospital of Philadelphia.

Amid the skyscrapers of the Windy City, Pediatric Hospital Medicine (PHM) 2016 swept into town, bringing with it the denizens of pediatric hospitalist programs across the country. Some 1,150 attendees, comprised of hospitalists, PHM program leaders, and advanced care practitioners, gathered to educate and inspire one another in the the care of hospitalized children.

Dr. Lisa Zaoutis, director of the pediatric residency program at Children’s Hospital of Philadelphia, kicked off the conference with the opening plenary. Initially titled “North Star and Space,” she quickly changed the title to, “Changing Our Minds.” Touching on the disconnect between positive experiences that bring physicians into PHM and negative experiences that often drive behavior, she started with the beginning, the evolution of our brains.

“We are wired toward the negative,” stated Dr. Zaoutis. “We are Teflon for positive experiences and Velcro for negative experiences.” In addition, negative experiences are more likely to be stored in our memories. “It’s easy to park negative experiences.”

Delving deeper into neuroanatomy, Dr. Zaoutis spoke of “amygdala hijack,” where chronic stress inherent to the professional lives of pediatric hospitalists lead to anxiety responses that are faster, more robust, and triggered more easily.

But all is not lost, asserted Dr. Zaoutis, as our brains are more plastic than previously known. The “neural Darwinism,” of our brains, as Dr. Zaoutis states, leads to epigenetic intracellular changes, more sensitive synapses, improved blood flow, and even new cells as a result of experience dependent neuroplasticity. For example, stated Dr. Zaoutis, London taxi drivers have thicker white matter in their hippocampus as a result of the effect of learning London city streets, and mindfulness meditators have thicker gray matter in regions that control attention and self-insight.

Key Takeaways:

The lesson for pediatric hospitalists, stated Dr. Zaoutis, is that you can shape your brain for greater joy. “Consciously choose activities,” said Dr. Zaoutis, that counter our evolutionary negativity bias. How is this done?

1. Have a positive experience (you can create one or retrieve a prior one);

2. Enrich it and install it by dwelling on it for at least 15-30 seconds; and

3. Absorb it into your body, which my require somatisizing it – Dr. Zaoutis presses her hand into her chest to aid in this.

Further, spread this to your group by the old medical training technique of “see one, do one, teach one.” See if you can start your signout with the best thing that happened to you in the week. Most importantly, start with observing yourself.

---

Dr. Chang is pediatric editor of The Hospitalist. He is associate clinical professor of medicine and pediatrics at the University of California at San Diego (UCSD) School of Medicine, and a hospitalist at both UCSD Medical Center and Rady Children’s Hospital. Send comments and questions to [email protected].

MINNEAPOLIS – A small study of cloth diaper–wearing toddlers with unusual vesiculobullous and erosive lesions found that the rashes fully resolved with aggressive barrier cream application and a switch to disposable diapers.

The four patients had previously received aggressive work-ups, including biopsy in some cases; all had received systemic antibiotics. Katya L. Harfmann, MD, a pediatric dermatologist at Nationwide Children’s Hospital in Columbus, Ohio, was the lead author in a poster presentation at the annual meeting of the Society for Pediatric Dermatology.

The toddlers, aged 17 months to 2 years, had diaper dermatitis of several weeks’ to several months’ duration, with a presentation of vesicles, bullae, and erosions. All of the children had been placed in cloth diapers since birth. The patients, three of them male, had undergone work-ups that included bacterial culture for three patients, herpes simplex virus (HSV) polymerase chain reaction (PCR) testing for three patients, and blood work for two patients. HSV cultures and viral cultures were each performed on one patient. With the exception of one bacterial culture returning methicillin-sensitive Staphylococcus aureus (MSSA), all results were negative.

Two patients underwent biopsies. One biopsy was reported as “spongiform dermatitis,” while the other was read as a “nonspecific ulcer.”

A variety of treatments had been tried for the children. All of the children had received systemic antibiotics; two received systemic antivirals as well. Two patients each received topical steroids and topical antibacterials, and one patient also received topical dapsone. Many treatments were given “in repetitive courses, without improvement in the lesions,” wrote Dr. Harfmann and her coauthor.

The families were advised to switch to exclusive use of disposable diapers and to begin frequent use of a zinc oxide–based thick diaper paste. For all patients, the diaper dermatitis completely resolved within as little as 2 weeks.

The medical literature documents an increased risk of diaper dermatitis with cloth diaper use. “Despite this knowledge in the medical community, nearly half of cloth diaper–using parents select cloth diapers with the assumption that diaper rash is less frequent with their usage,” the researchers noted.

They pointed out that bullae in the diaper region are often thought to be associated with such infectious conditions as impetigo and herpes simplex infection, and can also be associated with immunobullous disorders. Diaper changes are less frequent in older children, though, giving the opportunity for prolonged contact with the irritating chemicals in feces and urine. This prolonged contact, exacerbated by the moister environment of a cloth diaper, may account for the unusual, severe presentation seen in these cases.

Also, the three boys had vesicular lesions on their testicles and penis. “It is possible that the thinner skin in these areas has a lower irritation threshold or that the redundancy of skin often seen on the penile shaft leads to trapping of irritants with extended diaper use,” they wrote.

“An empiric trial of disposable diapers exclusively with aggressive barrier cream application for several weeks may eliminate the need for more invasive procedures and laboratory tests,” wrote Dr. Harfmann and her coauthor.

They reported no conflicts of interest.

MINNEAPOLIS – A small study of cloth diaper–wearing toddlers with unusual vesiculobullous and erosive lesions found that the rashes fully resolved with aggressive barrier cream application and a switch to disposable diapers.

The four patients had previously received aggressive work-ups, including biopsy in some cases; all had received systemic antibiotics. Katya L. Harfmann, MD, a pediatric dermatologist at Nationwide Children’s Hospital in Columbus, Ohio, was the lead author in a poster presentation at the annual meeting of the Society for Pediatric Dermatology.

The toddlers, aged 17 months to 2 years, had diaper dermatitis of several weeks’ to several months’ duration, with a presentation of vesicles, bullae, and erosions. All of the children had been placed in cloth diapers since birth. The patients, three of them male, had undergone work-ups that included bacterial culture for three patients, herpes simplex virus (HSV) polymerase chain reaction (PCR) testing for three patients, and blood work for two patients. HSV cultures and viral cultures were each performed on one patient. With the exception of one bacterial culture returning methicillin-sensitive Staphylococcus aureus (MSSA), all results were negative.

Two patients underwent biopsies. One biopsy was reported as “spongiform dermatitis,” while the other was read as a “nonspecific ulcer.”

A variety of treatments had been tried for the children. All of the children had received systemic antibiotics; two received systemic antivirals as well. Two patients each received topical steroids and topical antibacterials, and one patient also received topical dapsone. Many treatments were given “in repetitive courses, without improvement in the lesions,” wrote Dr. Harfmann and her coauthor.

The families were advised to switch to exclusive use of disposable diapers and to begin frequent use of a zinc oxide–based thick diaper paste. For all patients, the diaper dermatitis completely resolved within as little as 2 weeks.

The medical literature documents an increased risk of diaper dermatitis with cloth diaper use. “Despite this knowledge in the medical community, nearly half of cloth diaper–using parents select cloth diapers with the assumption that diaper rash is less frequent with their usage,” the researchers noted.

They pointed out that bullae in the diaper region are often thought to be associated with such infectious conditions as impetigo and herpes simplex infection, and can also be associated with immunobullous disorders. Diaper changes are less frequent in older children, though, giving the opportunity for prolonged contact with the irritating chemicals in feces and urine. This prolonged contact, exacerbated by the moister environment of a cloth diaper, may account for the unusual, severe presentation seen in these cases.

Also, the three boys had vesicular lesions on their testicles and penis. “It is possible that the thinner skin in these areas has a lower irritation threshold or that the redundancy of skin often seen on the penile shaft leads to trapping of irritants with extended diaper use,” they wrote.

“An empiric trial of disposable diapers exclusively with aggressive barrier cream application for several weeks may eliminate the need for more invasive procedures and laboratory tests,” wrote Dr. Harfmann and her coauthor.

They reported no conflicts of interest.

MINNEAPOLIS – A small study of cloth diaper–wearing toddlers with unusual vesiculobullous and erosive lesions found that the rashes fully resolved with aggressive barrier cream application and a switch to disposable diapers.

The four patients had previously received aggressive work-ups, including biopsy in some cases; all had received systemic antibiotics. Katya L. Harfmann, MD, a pediatric dermatologist at Nationwide Children’s Hospital in Columbus, Ohio, was the lead author in a poster presentation at the annual meeting of the Society for Pediatric Dermatology.

The toddlers, aged 17 months to 2 years, had diaper dermatitis of several weeks’ to several months’ duration, with a presentation of vesicles, bullae, and erosions. All of the children had been placed in cloth diapers since birth. The patients, three of them male, had undergone work-ups that included bacterial culture for three patients, herpes simplex virus (HSV) polymerase chain reaction (PCR) testing for three patients, and blood work for two patients. HSV cultures and viral cultures were each performed on one patient. With the exception of one bacterial culture returning methicillin-sensitive Staphylococcus aureus (MSSA), all results were negative.

Two patients underwent biopsies. One biopsy was reported as “spongiform dermatitis,” while the other was read as a “nonspecific ulcer.”

A variety of treatments had been tried for the children. All of the children had received systemic antibiotics; two received systemic antivirals as well. Two patients each received topical steroids and topical antibacterials, and one patient also received topical dapsone. Many treatments were given “in repetitive courses, without improvement in the lesions,” wrote Dr. Harfmann and her coauthor.

The families were advised to switch to exclusive use of disposable diapers and to begin frequent use of a zinc oxide–based thick diaper paste. For all patients, the diaper dermatitis completely resolved within as little as 2 weeks.

The medical literature documents an increased risk of diaper dermatitis with cloth diaper use. “Despite this knowledge in the medical community, nearly half of cloth diaper–using parents select cloth diapers with the assumption that diaper rash is less frequent with their usage,” the researchers noted.

They pointed out that bullae in the diaper region are often thought to be associated with such infectious conditions as impetigo and herpes simplex infection, and can also be associated with immunobullous disorders. Diaper changes are less frequent in older children, though, giving the opportunity for prolonged contact with the irritating chemicals in feces and urine. This prolonged contact, exacerbated by the moister environment of a cloth diaper, may account for the unusual, severe presentation seen in these cases.

Also, the three boys had vesicular lesions on their testicles and penis. “It is possible that the thinner skin in these areas has a lower irritation threshold or that the redundancy of skin often seen on the penile shaft leads to trapping of irritants with extended diaper use,” they wrote.

“An empiric trial of disposable diapers exclusively with aggressive barrier cream application for several weeks may eliminate the need for more invasive procedures and laboratory tests,” wrote Dr. Harfmann and her coauthor.

They reported no conflicts of interest.

MINNEAPOLIS – A small study of cloth diaper–wearing toddlers with unusual vesiculobullous and erosive lesions found that the rashes fully resolved with aggressive barrier cream application and a switch to disposable diapers.

The four patients had previously received aggressive work-ups, including biopsy in some cases; all had received systemic antibiotics. Katya L. Harfmann, MD, a pediatric dermatologist at Nationwide Children’s Hospital in Columbus, Ohio, was the lead author in a poster presentation at the annual meeting of the Society for Pediatric Dermatology.

The toddlers, aged 17 months to 2 years, had diaper dermatitis of several weeks’ to several months’ duration, with a presentation of vesicles, bullae, and erosions. All of the children had been placed in cloth diapers since birth. The patients, three of them male, had undergone work-ups that included bacterial culture for three patients, herpes simplex virus (HSV) polymerase chain reaction (PCR) testing for three patients, and blood work for two patients. HSV cultures and viral cultures were each performed on one patient. With the exception of one bacterial culture returning methicillin-sensitive Staphylococcus aureus (MSSA), all results were negative.

Two patients underwent biopsies. One biopsy was reported as “spongiform dermatitis,” while the other was read as a “nonspecific ulcer.”

A variety of treatments had been tried for the children. All of the children had received systemic antibiotics; two received systemic antivirals as well. Two patients each received topical steroids and topical antibacterials, and one patient also received topical dapsone. Many treatments were given “in repetitive courses, without improvement in the lesions,” wrote Dr. Harfmann and her coauthor.

The families were advised to switch to exclusive use of disposable diapers and to begin frequent use of a zinc oxide–based thick diaper paste. For all patients, the diaper dermatitis completely resolved within as little as 2 weeks.

The medical literature documents an increased risk of diaper dermatitis with cloth diaper use. “Despite this knowledge in the medical community, nearly half of cloth diaper–using parents select cloth diapers with the assumption that diaper rash is less frequent with their usage,” the researchers noted.

They pointed out that bullae in the diaper region are often thought to be associated with such infectious conditions as impetigo and herpes simplex infection, and can also be associated with immunobullous disorders. Diaper changes are less frequent in older children, though, giving the opportunity for prolonged contact with the irritating chemicals in feces and urine. This prolonged contact, exacerbated by the moister environment of a cloth diaper, may account for the unusual, severe presentation seen in these cases.

Also, the three boys had vesicular lesions on their testicles and penis. “It is possible that the thinner skin in these areas has a lower irritation threshold or that the redundancy of skin often seen on the penile shaft leads to trapping of irritants with extended diaper use,” they wrote.

“An empiric trial of disposable diapers exclusively with aggressive barrier cream application for several weeks may eliminate the need for more invasive procedures and laboratory tests,” wrote Dr. Harfmann and her coauthor.

They reported no conflicts of interest.

[email protected]

On Twitter @karioakes

MINNEAPOLIS – A small study of cloth diaper–wearing toddlers with unusual vesiculobullous and erosive lesions found that the rashes fully resolved with aggressive barrier cream application and a switch to disposable diapers.

The four patients had previously received aggressive work-ups, including biopsy in some cases; all had received systemic antibiotics. Katya L. Harfmann, MD, a pediatric dermatologist at Nationwide Children’s Hospital in Columbus, Ohio, was the lead author in a poster presentation at the annual meeting of the Society for Pediatric Dermatology.

The toddlers, aged 17 months to 2 years, had diaper dermatitis of several weeks’ to several months’ duration, with a presentation of vesicles, bullae, and erosions. All of the children had been placed in cloth diapers since birth. The patients, three of them male, had undergone work-ups that included bacterial culture for three patients, herpes simplex virus (HSV) polymerase chain reaction (PCR) testing for three patients, and blood work for two patients. HSV cultures and viral cultures were each performed on one patient. With the exception of one bacterial culture returning methicillin-sensitive Staphylococcus aureus (MSSA), all results were negative.

Two patients underwent biopsies. One biopsy was reported as “spongiform dermatitis,” while the other was read as a “nonspecific ulcer.”

A variety of treatments had been tried for the children. All of the children had received systemic antibiotics; two received systemic antivirals as well. Two patients each received topical steroids and topical antibacterials, and one patient also received topical dapsone. Many treatments were given “in repetitive courses, without improvement in the lesions,” wrote Dr. Harfmann and her coauthor.

The families were advised to switch to exclusive use of disposable diapers and to begin frequent use of a zinc oxide–based thick diaper paste. For all patients, the diaper dermatitis completely resolved within as little as 2 weeks.

The medical literature documents an increased risk of diaper dermatitis with cloth diaper use. “Despite this knowledge in the medical community, nearly half of cloth diaper–using parents select cloth diapers with the assumption that diaper rash is less frequent with their usage,” the researchers noted.

They pointed out that bullae in the diaper region are often thought to be associated with such infectious conditions as impetigo and herpes simplex infection, and can also be associated with immunobullous disorders. Diaper changes are less frequent in older children, though, giving the opportunity for prolonged contact with the irritating chemicals in feces and urine. This prolonged contact, exacerbated by the moister environment of a cloth diaper, may account for the unusual, severe presentation seen in these cases.

Also, the three boys had vesicular lesions on their testicles and penis. “It is possible that the thinner skin in these areas has a lower irritation threshold or that the redundancy of skin often seen on the penile shaft leads to trapping of irritants with extended diaper use,” they wrote.

“An empiric trial of disposable diapers exclusively with aggressive barrier cream application for several weeks may eliminate the need for more invasive procedures and laboratory tests,” wrote Dr. Harfmann and her coauthor.

They reported no conflicts of interest.

[email protected]

On Twitter @karioakes

MINNEAPOLIS – A small study of cloth diaper–wearing toddlers with unusual vesiculobullous and erosive lesions found that the rashes fully resolved with aggressive barrier cream application and a switch to disposable diapers.

The four patients had previously received aggressive work-ups, including biopsy in some cases; all had received systemic antibiotics. Katya L. Harfmann, MD, a pediatric dermatologist at Nationwide Children’s Hospital in Columbus, Ohio, was the lead author in a poster presentation at the annual meeting of the Society for Pediatric Dermatology.

The toddlers, aged 17 months to 2 years, had diaper dermatitis of several weeks’ to several months’ duration, with a presentation of vesicles, bullae, and erosions. All of the children had been placed in cloth diapers since birth. The patients, three of them male, had undergone work-ups that included bacterial culture for three patients, herpes simplex virus (HSV) polymerase chain reaction (PCR) testing for three patients, and blood work for two patients. HSV cultures and viral cultures were each performed on one patient. With the exception of one bacterial culture returning methicillin-sensitive Staphylococcus aureus (MSSA), all results were negative.

Two patients underwent biopsies. One biopsy was reported as “spongiform dermatitis,” while the other was read as a “nonspecific ulcer.”

A variety of treatments had been tried for the children. All of the children had received systemic antibiotics; two received systemic antivirals as well. Two patients each received topical steroids and topical antibacterials, and one patient also received topical dapsone. Many treatments were given “in repetitive courses, without improvement in the lesions,” wrote Dr. Harfmann and her coauthor.

The families were advised to switch to exclusive use of disposable diapers and to begin frequent use of a zinc oxide–based thick diaper paste. For all patients, the diaper dermatitis completely resolved within as little as 2 weeks.

The medical literature documents an increased risk of diaper dermatitis with cloth diaper use. “Despite this knowledge in the medical community, nearly half of cloth diaper–using parents select cloth diapers with the assumption that diaper rash is less frequent with their usage,” the researchers noted.

They pointed out that bullae in the diaper region are often thought to be associated with such infectious conditions as impetigo and herpes simplex infection, and can also be associated with immunobullous disorders. Diaper changes are less frequent in older children, though, giving the opportunity for prolonged contact with the irritating chemicals in feces and urine. This prolonged contact, exacerbated by the moister environment of a cloth diaper, may account for the unusual, severe presentation seen in these cases.

Also, the three boys had vesicular lesions on their testicles and penis. “It is possible that the thinner skin in these areas has a lower irritation threshold or that the redundancy of skin often seen on the penile shaft leads to trapping of irritants with extended diaper use,” they wrote.

“An empiric trial of disposable diapers exclusively with aggressive barrier cream application for several weeks may eliminate the need for more invasive procedures and laboratory tests,” wrote Dr. Harfmann and her coauthor.

They reported no conflicts of interest.

[email protected]

On Twitter @karioakes

Combination therapy involving chondroitin sulfate and glucosamine sulfate proved no better than placebo for the management of pain and functional impairment brought on by knee osteoarthritis, in a double-blind, randomized trial.

“This is the first RCT sponsored by a pharmaceutical company to evaluate the efficacy of a combination of CS [chondroitin sulfate] plus GS [glucosamine sulfate] and including a [Data and Safety Monitoring Board] composed of independent experts charged with ensuring participant safety and accurate, bias-free data,” wrote the authors, led by Jorge A. Roman-Blas, MD, of Fundación Jiménez Díaz in Madrid (Arthritis Rheumatol. 2016 Jul 31. doi: 10.1002/art.39819).

©KatarzynaBialasiewicz/ Thinkstock.com

Dr. Roman-Blas and his coinvestigators recruited patients with Kellgren-Lawrence stages II-III knee osteoarthritis from one orthopedic surgery and nine rheumatology centers across Spain. The study was split into two parts; the first part would have half of the patients complete the study in 6 months, followed by an interim analysis and evaluation of the data. If deemed okay by the Data and Safety Monitoring Board, the second part of the study would proceed, in which half of the patients would again complete the study in 6 months.

Ultimately, the study comprised 164 patients. They were randomized in a 1:1 ratio into cohorts receiving either a placebo or a regimen of 1,200 mg CS derived from bovine tracheal cartilage plus 1,500 mg of crystalline GS derived from crustaceans. The primary endpoint was reduction in pain from baseline evaluation, which was based on the visual analog scale (VAS) of 1-100 mm.

Patients in the combination therapy cohort had a lower average reduction in pain at 6 months than did those taking the placebo. In the modified intention-to-treat population, those taking CS+GS therapy had an average reduction of 11.8 ± 2.4 mm, or 19%, compared with baseline. On the other hand, those in the placebo cohort recorded a 20.5 ± 2.4 mm, or 33%, reduction in pain (P = .029). Based on this analysis, the trial was stopped early at 6 months to prevent “overexposure of additional patients to placebo treatment,” the investigators said.

However, pain measured by VAS did not differ between the groups in a per-protocol analysis. Furthermore, when taking Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores into account, there was no significant difference in improvement between CS+GS therapy and placebo in pain and function, for both intention-to-treat and per-protocol subjects.

Although placebo was more effective in pain reduction in the modified intent-to-treat analysis than was CS plus GS combination treatment, the effect size of placebo was small and the effect size of CS plus GS in this study was smaller than in previous studies, the investigators noted. “These findings may be related to the fact that GS may interfere with the absorption of CS and therefore reduce its local effect. Eventually, our patients may have had less severe pain than those in other studies, which would justify a lesser effect after the pharmacological intervention,” the authors wrote. “Furthermore, when the main outcome studied is particularly subjective, the placebo effect can overcome the effect of the active drug.”

Tedec Meiji Farma SA of Madrid funded the study. Dr. Roman-Blas and his coauthors did not report any relevant financial disclosures.

Combination therapy involving chondroitin sulfate and glucosamine sulfate proved no better than placebo for the management of pain and functional impairment brought on by knee osteoarthritis, in a double-blind, randomized trial.

“This is the first RCT sponsored by a pharmaceutical company to evaluate the efficacy of a combination of CS [chondroitin sulfate] plus GS [glucosamine sulfate] and including a [Data and Safety Monitoring Board] composed of independent experts charged with ensuring participant safety and accurate, bias-free data,” wrote the authors, led by Jorge A. Roman-Blas, MD, of Fundación Jiménez Díaz in Madrid (Arthritis Rheumatol. 2016 Jul 31. doi: 10.1002/art.39819).

©KatarzynaBialasiewicz/ Thinkstock.com

Dr. Roman-Blas and his coinvestigators recruited patients with Kellgren-Lawrence stages II-III knee osteoarthritis from one orthopedic surgery and nine rheumatology centers across Spain. The study was split into two parts; the first part would have half of the patients complete the study in 6 months, followed by an interim analysis and evaluation of the data. If deemed okay by the Data and Safety Monitoring Board, the second part of the study would proceed, in which half of the patients would again complete the study in 6 months.

Ultimately, the study comprised 164 patients. They were randomized in a 1:1 ratio into cohorts receiving either a placebo or a regimen of 1,200 mg CS derived from bovine tracheal cartilage plus 1,500 mg of crystalline GS derived from crustaceans. The primary endpoint was reduction in pain from baseline evaluation, which was based on the visual analog scale (VAS) of 1-100 mm.

Patients in the combination therapy cohort had a lower average reduction in pain at 6 months than did those taking the placebo. In the modified intention-to-treat population, those taking CS+GS therapy had an average reduction of 11.8 ± 2.4 mm, or 19%, compared with baseline. On the other hand, those in the placebo cohort recorded a 20.5 ± 2.4 mm, or 33%, reduction in pain (P = .029). Based on this analysis, the trial was stopped early at 6 months to prevent “overexposure of additional patients to placebo treatment,” the investigators said.

However, pain measured by VAS did not differ between the groups in a per-protocol analysis. Furthermore, when taking Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores into account, there was no significant difference in improvement between CS+GS therapy and placebo in pain and function, for both intention-to-treat and per-protocol subjects.

Although placebo was more effective in pain reduction in the modified intent-to-treat analysis than was CS plus GS combination treatment, the effect size of placebo was small and the effect size of CS plus GS in this study was smaller than in previous studies, the investigators noted. “These findings may be related to the fact that GS may interfere with the absorption of CS and therefore reduce its local effect. Eventually, our patients may have had less severe pain than those in other studies, which would justify a lesser effect after the pharmacological intervention,” the authors wrote. “Furthermore, when the main outcome studied is particularly subjective, the placebo effect can overcome the effect of the active drug.”

Tedec Meiji Farma SA of Madrid funded the study. Dr. Roman-Blas and his coauthors did not report any relevant financial disclosures.

Combination therapy involving chondroitin sulfate and glucosamine sulfate proved no better than placebo for the management of pain and functional impairment brought on by knee osteoarthritis, in a double-blind, randomized trial.

“This is the first RCT sponsored by a pharmaceutical company to evaluate the efficacy of a combination of CS [chondroitin sulfate] plus GS [glucosamine sulfate] and including a [Data and Safety Monitoring Board] composed of independent experts charged with ensuring participant safety and accurate, bias-free data,” wrote the authors, led by Jorge A. Roman-Blas, MD, of Fundación Jiménez Díaz in Madrid (Arthritis Rheumatol. 2016 Jul 31. doi: 10.1002/art.39819).

©KatarzynaBialasiewicz/ Thinkstock.com

Dr. Roman-Blas and his coinvestigators recruited patients with Kellgren-Lawrence stages II-III knee osteoarthritis from one orthopedic surgery and nine rheumatology centers across Spain. The study was split into two parts; the first part would have half of the patients complete the study in 6 months, followed by an interim analysis and evaluation of the data. If deemed okay by the Data and Safety Monitoring Board, the second part of the study would proceed, in which half of the patients would again complete the study in 6 months.

Ultimately, the study comprised 164 patients. They were randomized in a 1:1 ratio into cohorts receiving either a placebo or a regimen of 1,200 mg CS derived from bovine tracheal cartilage plus 1,500 mg of crystalline GS derived from crustaceans. The primary endpoint was reduction in pain from baseline evaluation, which was based on the visual analog scale (VAS) of 1-100 mm.

Patients in the combination therapy cohort had a lower average reduction in pain at 6 months than did those taking the placebo. In the modified intention-to-treat population, those taking CS+GS therapy had an average reduction of 11.8 ± 2.4 mm, or 19%, compared with baseline. On the other hand, those in the placebo cohort recorded a 20.5 ± 2.4 mm, or 33%, reduction in pain (P = .029). Based on this analysis, the trial was stopped early at 6 months to prevent “overexposure of additional patients to placebo treatment,” the investigators said.

However, pain measured by VAS did not differ between the groups in a per-protocol analysis. Furthermore, when taking Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores into account, there was no significant difference in improvement between CS+GS therapy and placebo in pain and function, for both intention-to-treat and per-protocol subjects.

Although placebo was more effective in pain reduction in the modified intent-to-treat analysis than was CS plus GS combination treatment, the effect size of placebo was small and the effect size of CS plus GS in this study was smaller than in previous studies, the investigators noted. “These findings may be related to the fact that GS may interfere with the absorption of CS and therefore reduce its local effect. Eventually, our patients may have had less severe pain than those in other studies, which would justify a lesser effect after the pharmacological intervention,” the authors wrote. “Furthermore, when the main outcome studied is particularly subjective, the placebo effect can overcome the effect of the active drug.”

Tedec Meiji Farma SA of Madrid funded the study. Dr. Roman-Blas and his coauthors did not report any relevant financial disclosures.

Combination therapy involving chondroitin sulfate and glucosamine sulfate proved no better than placebo for the management of pain and functional impairment brought on by knee osteoarthritis, in a double-blind, randomized trial.

“This is the first RCT sponsored by a pharmaceutical company to evaluate the efficacy of a combination of CS [chondroitin sulfate] plus GS [glucosamine sulfate] and including a [Data and Safety Monitoring Board] composed of independent experts charged with ensuring participant safety and accurate, bias-free data,” wrote the authors, led by Jorge A. Roman-Blas, MD, of Fundación Jiménez Díaz in Madrid (Arthritis Rheumatol. 2016 Jul 31. doi: 10.1002/art.39819).

©KatarzynaBialasiewicz/ Thinkstock.com

Dr. Roman-Blas and his coinvestigators recruited patients with Kellgren-Lawrence stages II-III knee osteoarthritis from one orthopedic surgery and nine rheumatology centers across Spain. The study was split into two parts; the first part would have half of the patients complete the study in 6 months, followed by an interim analysis and evaluation of the data. If deemed okay by the Data and Safety Monitoring Board, the second part of the study would proceed, in which half of the patients would again complete the study in 6 months.

Ultimately, the study comprised 164 patients. They were randomized in a 1:1 ratio into cohorts receiving either a placebo or a regimen of 1,200 mg CS derived from bovine tracheal cartilage plus 1,500 mg of crystalline GS derived from crustaceans. The primary endpoint was reduction in pain from baseline evaluation, which was based on the visual analog scale (VAS) of 1-100 mm.

Patients in the combination therapy cohort had a lower average reduction in pain at 6 months than did those taking the placebo. In the modified intention-to-treat population, those taking CS+GS therapy had an average reduction of 11.8 ± 2.4 mm, or 19%, compared with baseline. On the other hand, those in the placebo cohort recorded a 20.5 ± 2.4 mm, or 33%, reduction in pain (P = .029). Based on this analysis, the trial was stopped early at 6 months to prevent “overexposure of additional patients to placebo treatment,” the investigators said.

However, pain measured by VAS did not differ between the groups in a per-protocol analysis. Furthermore, when taking Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores into account, there was no significant difference in improvement between CS+GS therapy and placebo in pain and function, for both intention-to-treat and per-protocol subjects.

Although placebo was more effective in pain reduction in the modified intent-to-treat analysis than was CS plus GS combination treatment, the effect size of placebo was small and the effect size of CS plus GS in this study was smaller than in previous studies, the investigators noted. “These findings may be related to the fact that GS may interfere with the absorption of CS and therefore reduce its local effect. Eventually, our patients may have had less severe pain than those in other studies, which would justify a lesser effect after the pharmacological intervention,” the authors wrote. “Furthermore, when the main outcome studied is particularly subjective, the placebo effect can overcome the effect of the active drug.”

Tedec Meiji Farma SA of Madrid funded the study. Dr. Roman-Blas and his coauthors did not report any relevant financial disclosures.

[email protected]

Combination therapy involving chondroitin sulfate and glucosamine sulfate proved no better than placebo for the management of pain and functional impairment brought on by knee osteoarthritis, in a double-blind, randomized trial.

“This is the first RCT sponsored by a pharmaceutical company to evaluate the efficacy of a combination of CS [chondroitin sulfate] plus GS [glucosamine sulfate] and including a [Data and Safety Monitoring Board] composed of independent experts charged with ensuring participant safety and accurate, bias-free data,” wrote the authors, led by Jorge A. Roman-Blas, MD, of Fundación Jiménez Díaz in Madrid (Arthritis Rheumatol. 2016 Jul 31. doi: 10.1002/art.39819).

©KatarzynaBialasiewicz/ Thinkstock.com

Dr. Roman-Blas and his coinvestigators recruited patients with Kellgren-Lawrence stages II-III knee osteoarthritis from one orthopedic surgery and nine rheumatology centers across Spain. The study was split into two parts; the first part would have half of the patients complete the study in 6 months, followed by an interim analysis and evaluation of the data. If deemed okay by the Data and Safety Monitoring Board, the second part of the study would proceed, in which half of the patients would again complete the study in 6 months.

Ultimately, the study comprised 164 patients. They were randomized in a 1:1 ratio into cohorts receiving either a placebo or a regimen of 1,200 mg CS derived from bovine tracheal cartilage plus 1,500 mg of crystalline GS derived from crustaceans. The primary endpoint was reduction in pain from baseline evaluation, which was based on the visual analog scale (VAS) of 1-100 mm.

Patients in the combination therapy cohort had a lower average reduction in pain at 6 months than did those taking the placebo. In the modified intention-to-treat population, those taking CS+GS therapy had an average reduction of 11.8 ± 2.4 mm, or 19%, compared with baseline. On the other hand, those in the placebo cohort recorded a 20.5 ± 2.4 mm, or 33%, reduction in pain (P = .029). Based on this analysis, the trial was stopped early at 6 months to prevent “overexposure of additional patients to placebo treatment,” the investigators said.

However, pain measured by VAS did not differ between the groups in a per-protocol analysis. Furthermore, when taking Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores into account, there was no significant difference in improvement between CS+GS therapy and placebo in pain and function, for both intention-to-treat and per-protocol subjects.

Although placebo was more effective in pain reduction in the modified intent-to-treat analysis than was CS plus GS combination treatment, the effect size of placebo was small and the effect size of CS plus GS in this study was smaller than in previous studies, the investigators noted. “These findings may be related to the fact that GS may interfere with the absorption of CS and therefore reduce its local effect. Eventually, our patients may have had less severe pain than those in other studies, which would justify a lesser effect after the pharmacological intervention,” the authors wrote. “Furthermore, when the main outcome studied is particularly subjective, the placebo effect can overcome the effect of the active drug.”

Tedec Meiji Farma SA of Madrid funded the study. Dr. Roman-Blas and his coauthors did not report any relevant financial disclosures.

[email protected]

Combination therapy involving chondroitin sulfate and glucosamine sulfate proved no better than placebo for the management of pain and functional impairment brought on by knee osteoarthritis, in a double-blind, randomized trial.

“This is the first RCT sponsored by a pharmaceutical company to evaluate the efficacy of a combination of CS [chondroitin sulfate] plus GS [glucosamine sulfate] and including a [Data and Safety Monitoring Board] composed of independent experts charged with ensuring participant safety and accurate, bias-free data,” wrote the authors, led by Jorge A. Roman-Blas, MD, of Fundación Jiménez Díaz in Madrid (Arthritis Rheumatol. 2016 Jul 31. doi: 10.1002/art.39819).

©KatarzynaBialasiewicz/ Thinkstock.com

Dr. Roman-Blas and his coinvestigators recruited patients with Kellgren-Lawrence stages II-III knee osteoarthritis from one orthopedic surgery and nine rheumatology centers across Spain. The study was split into two parts; the first part would have half of the patients complete the study in 6 months, followed by an interim analysis and evaluation of the data. If deemed okay by the Data and Safety Monitoring Board, the second part of the study would proceed, in which half of the patients would again complete the study in 6 months.

Ultimately, the study comprised 164 patients. They were randomized in a 1:1 ratio into cohorts receiving either a placebo or a regimen of 1,200 mg CS derived from bovine tracheal cartilage plus 1,500 mg of crystalline GS derived from crustaceans. The primary endpoint was reduction in pain from baseline evaluation, which was based on the visual analog scale (VAS) of 1-100 mm.

Patients in the combination therapy cohort had a lower average reduction in pain at 6 months than did those taking the placebo. In the modified intention-to-treat population, those taking CS+GS therapy had an average reduction of 11.8 ± 2.4 mm, or 19%, compared with baseline. On the other hand, those in the placebo cohort recorded a 20.5 ± 2.4 mm, or 33%, reduction in pain (P = .029). Based on this analysis, the trial was stopped early at 6 months to prevent “overexposure of additional patients to placebo treatment,” the investigators said.

However, pain measured by VAS did not differ between the groups in a per-protocol analysis. Furthermore, when taking Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores into account, there was no significant difference in improvement between CS+GS therapy and placebo in pain and function, for both intention-to-treat and per-protocol subjects.

Although placebo was more effective in pain reduction in the modified intent-to-treat analysis than was CS plus GS combination treatment, the effect size of placebo was small and the effect size of CS plus GS in this study was smaller than in previous studies, the investigators noted. “These findings may be related to the fact that GS may interfere with the absorption of CS and therefore reduce its local effect. Eventually, our patients may have had less severe pain than those in other studies, which would justify a lesser effect after the pharmacological intervention,” the authors wrote. “Furthermore, when the main outcome studied is particularly subjective, the placebo effect can overcome the effect of the active drug.”

Tedec Meiji Farma SA of Madrid funded the study. Dr. Roman-Blas and his coauthors did not report any relevant financial disclosures.

[email protected]