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Intervention urged for preschool children with selective eating habits
Primary care physicians should consider intervention for toddlers who exhibit even moderate signs of selective eating, as this could be a reliable early sign of avoidant/restrictive food intake disorder and increased predisposition to anxiety, depression, and attention-deficit/hyperactivity disorder, a study published online Aug. 3 says.
“There is a need to develop interventions or provide further guidance to caregivers about the management of [selective eating]. Despite data that some children will seemingly grow out of SE without intervention, the presence of concurrent impairment warrants the development of strategies to intervene in all cases,” says the study, led by Nancy Zucker, Ph.D., of the department of psychiatry and behavioral science at Duke University, Durham, N.C.
The Duke Preschool Anxiety Study enrolled 917 children, aged 24-71 months, through primary care clinics to determine “patterns of psychiatric comorbidity and environmental variables associated with preschool anxiety disorders,” wrote Dr. Zucker and her associates. From that group, 187 children completed baseline and follow-up assessment. Results found that children with moderate selective eating (SE) habits were almost twice as likely to exhibit symptoms of attention-deficit/hyperactivity disorder (ADHD) and separation anxiety, and those with severe SE were more likely to have a concurrent psychiatric diagnosis, such as depression or social anxiety (Pediatrics. 2015 Aug 3. doi:10.1542/peds.2014-2386).
Furthermore, both children with moderate and severe SE showed higher rates of symptoms related to generalized anxiety, social anxiety, and depressive symptoms than children who did not exhibit SE. Researchers also found ties between SE tendencies and parents; specifically, children with either moderate or severe SE were more likely to have mothers with elevated anxiety and to have family conflicts around food.
Dr. Zucker and her associates advise parents not to adopt a “wait and see” approach if they observe SE in their children, saying intervention is critical. “Intervention development should consider unique features of SE: sensory sensitivity and aversion/disgust,” the investigators wrote. They added that the study’s findings highlight not only the need for intervention, but also such interventions should include specifically tailored methods for dealing with each child.
The investigators said their findings should be considered in light of several limitations. For example, measurements of children’s eating were made based on parental report only. In addition, children with pervasive developmental disorders were excluded, which means that the current study’s findings might not be generalizable.
The Duke Preschool Anxiety Study was supported by grants from the National Institute of Mental Health. Dr. Zucker and her coauthors did not report any relevant financial disclosures.
Primary care physicians should consider intervention for toddlers who exhibit even moderate signs of selective eating, as this could be a reliable early sign of avoidant/restrictive food intake disorder and increased predisposition to anxiety, depression, and attention-deficit/hyperactivity disorder, a study published online Aug. 3 says.
“There is a need to develop interventions or provide further guidance to caregivers about the management of [selective eating]. Despite data that some children will seemingly grow out of SE without intervention, the presence of concurrent impairment warrants the development of strategies to intervene in all cases,” says the study, led by Nancy Zucker, Ph.D., of the department of psychiatry and behavioral science at Duke University, Durham, N.C.
The Duke Preschool Anxiety Study enrolled 917 children, aged 24-71 months, through primary care clinics to determine “patterns of psychiatric comorbidity and environmental variables associated with preschool anxiety disorders,” wrote Dr. Zucker and her associates. From that group, 187 children completed baseline and follow-up assessment. Results found that children with moderate selective eating (SE) habits were almost twice as likely to exhibit symptoms of attention-deficit/hyperactivity disorder (ADHD) and separation anxiety, and those with severe SE were more likely to have a concurrent psychiatric diagnosis, such as depression or social anxiety (Pediatrics. 2015 Aug 3. doi:10.1542/peds.2014-2386).
Furthermore, both children with moderate and severe SE showed higher rates of symptoms related to generalized anxiety, social anxiety, and depressive symptoms than children who did not exhibit SE. Researchers also found ties between SE tendencies and parents; specifically, children with either moderate or severe SE were more likely to have mothers with elevated anxiety and to have family conflicts around food.
Dr. Zucker and her associates advise parents not to adopt a “wait and see” approach if they observe SE in their children, saying intervention is critical. “Intervention development should consider unique features of SE: sensory sensitivity and aversion/disgust,” the investigators wrote. They added that the study’s findings highlight not only the need for intervention, but also such interventions should include specifically tailored methods for dealing with each child.
The investigators said their findings should be considered in light of several limitations. For example, measurements of children’s eating were made based on parental report only. In addition, children with pervasive developmental disorders were excluded, which means that the current study’s findings might not be generalizable.
The Duke Preschool Anxiety Study was supported by grants from the National Institute of Mental Health. Dr. Zucker and her coauthors did not report any relevant financial disclosures.
Primary care physicians should consider intervention for toddlers who exhibit even moderate signs of selective eating, as this could be a reliable early sign of avoidant/restrictive food intake disorder and increased predisposition to anxiety, depression, and attention-deficit/hyperactivity disorder, a study published online Aug. 3 says.
“There is a need to develop interventions or provide further guidance to caregivers about the management of [selective eating]. Despite data that some children will seemingly grow out of SE without intervention, the presence of concurrent impairment warrants the development of strategies to intervene in all cases,” says the study, led by Nancy Zucker, Ph.D., of the department of psychiatry and behavioral science at Duke University, Durham, N.C.
The Duke Preschool Anxiety Study enrolled 917 children, aged 24-71 months, through primary care clinics to determine “patterns of psychiatric comorbidity and environmental variables associated with preschool anxiety disorders,” wrote Dr. Zucker and her associates. From that group, 187 children completed baseline and follow-up assessment. Results found that children with moderate selective eating (SE) habits were almost twice as likely to exhibit symptoms of attention-deficit/hyperactivity disorder (ADHD) and separation anxiety, and those with severe SE were more likely to have a concurrent psychiatric diagnosis, such as depression or social anxiety (Pediatrics. 2015 Aug 3. doi:10.1542/peds.2014-2386).
Furthermore, both children with moderate and severe SE showed higher rates of symptoms related to generalized anxiety, social anxiety, and depressive symptoms than children who did not exhibit SE. Researchers also found ties between SE tendencies and parents; specifically, children with either moderate or severe SE were more likely to have mothers with elevated anxiety and to have family conflicts around food.
Dr. Zucker and her associates advise parents not to adopt a “wait and see” approach if they observe SE in their children, saying intervention is critical. “Intervention development should consider unique features of SE: sensory sensitivity and aversion/disgust,” the investigators wrote. They added that the study’s findings highlight not only the need for intervention, but also such interventions should include specifically tailored methods for dealing with each child.
The investigators said their findings should be considered in light of several limitations. For example, measurements of children’s eating were made based on parental report only. In addition, children with pervasive developmental disorders were excluded, which means that the current study’s findings might not be generalizable.
The Duke Preschool Anxiety Study was supported by grants from the National Institute of Mental Health. Dr. Zucker and her coauthors did not report any relevant financial disclosures.
FROM PEDIATRICS
Key clinical point: Preschool-age children who display moderate levels of selective eating should be considered children with avoidant/restrictive food intake disorder, and should undergo the necessary intervention and treatment.
Major finding: 20.3% of children reported selective eating, with 17.7% reporting “moderate,” and 3% reporting “severe” selective eating; children with moderate or severe SE were more likely to have elevated symptoms of anxiety, depression, and other conditions.
Data source: Population-based cohort study of 187 children, aged 24-71 months, from January 2007 to October 2010.
Disclosures: The Duke Preschool Anxiety Study was supported by grants from the National Institute of Mental Health. Dr. Zucker and her coauthors did not report any relevant financial disclosures.
Uncommon strain of enterovirus causes paralytic symptoms in children
The outbreak of acute flaccid myelitis last year was widely considered to be caused by the enterovirus D68 strain, but the condition might be caused by another, less common, enterovirus strain about which doctors should be aware.
Investigators at the University of Virginia Children’s Hospital, Charlottesville, discovered that the C105 strain of enterovirus might cause acute flaccid myelitis in pediatric patients, after a 6-year-old girl presented last October with symptoms of the condition during the outbreak, which affected more than 100 children across the United States.
“We followed Centers for Disease Control and Prevention protocols in evaluating her,” Dr. Ronald B. Turner, who treated the patient in October, said in an interview. However, blood tests yielded the C105 strain, not the more common D68 strain that Dr. Turner had expected. So far, it is still the only known case of acute flaccid myelitis caused by the C105 strain, but that doesn’t mean it will be the last.
When the patient presented at Children’s Hospital, she exhibited a dropping right shoulder and difficulty using her right hand, as well as a cough, headache, and fever of just above 100° F. However, there were no signs of speech, swallowing, or respiratory difficulties, and sensation was intact.
Dr. Turner and his colleagues performed an MRI on the patient, which showed “longitudinally extensive gray matter hyperintensity within the central cord [with] associated edema,” and an MR image of the brain proved “unremarkable.” The patient was put on a regimen of daily 2 g/kg intravenous immunoglobin for 5 days, but pain in her right arm, lower back pain (her back also exhibited a diffuse papular rash when first examined), and bilateral thigh pain when walking continued.
Despite being unresponsive to treatment, there was no further degradation in pain or mobility, and the patient was discharged. However, the patient’s pain resolved itself “spontaneously,” according Dr. Turner and his colleagues, with her right arm strength and movement almost fully healed after nearly 8 months.
Now, Dr. Turner and his colleagues are urging doctors nationwide to keep in mind that enterovirus D68 is not solely responsible for acute flaccid myelitis. “We’re not saying that [enterovirus C105] is the cause of all cases, but D68 is not the final answer on this,” said Dr. Turner, adding that physicians should keep an open mind as to the causes of this condition and make sure to look at all possible causes.
To that end, the investigators at the University of Virginia have published a case study in the CDC’s Emerging Infectious Diseases (2015 Oct. [doi:10.3201/eid2110.150759], detailing the case that brought about the discovery of enterovirus C105’s connection to acute flaccid myelitis. Because the discovery of enterovirus C105 is relatively recent – it was first detected in Peru and the Republic of Congo in 2010 – the need for awareness, particularly among American physicians, is critical.
Why did the C105 strain cause the acute flaccid myelitis, and what explains the patient’s quick recovery? Dr. Turner advises waiting “until the CDC has finished its examination; [the agency has] specimens from over 100 kids with [acute flaccid myelitis]. But in the end, I don’t think we’ll end up with a satisfactory or unifying answer to this,” he said.
The outbreak of acute flaccid myelitis last year was widely considered to be caused by the enterovirus D68 strain, but the condition might be caused by another, less common, enterovirus strain about which doctors should be aware.
Investigators at the University of Virginia Children’s Hospital, Charlottesville, discovered that the C105 strain of enterovirus might cause acute flaccid myelitis in pediatric patients, after a 6-year-old girl presented last October with symptoms of the condition during the outbreak, which affected more than 100 children across the United States.
“We followed Centers for Disease Control and Prevention protocols in evaluating her,” Dr. Ronald B. Turner, who treated the patient in October, said in an interview. However, blood tests yielded the C105 strain, not the more common D68 strain that Dr. Turner had expected. So far, it is still the only known case of acute flaccid myelitis caused by the C105 strain, but that doesn’t mean it will be the last.
When the patient presented at Children’s Hospital, she exhibited a dropping right shoulder and difficulty using her right hand, as well as a cough, headache, and fever of just above 100° F. However, there were no signs of speech, swallowing, or respiratory difficulties, and sensation was intact.
Dr. Turner and his colleagues performed an MRI on the patient, which showed “longitudinally extensive gray matter hyperintensity within the central cord [with] associated edema,” and an MR image of the brain proved “unremarkable.” The patient was put on a regimen of daily 2 g/kg intravenous immunoglobin for 5 days, but pain in her right arm, lower back pain (her back also exhibited a diffuse papular rash when first examined), and bilateral thigh pain when walking continued.
Despite being unresponsive to treatment, there was no further degradation in pain or mobility, and the patient was discharged. However, the patient’s pain resolved itself “spontaneously,” according Dr. Turner and his colleagues, with her right arm strength and movement almost fully healed after nearly 8 months.
Now, Dr. Turner and his colleagues are urging doctors nationwide to keep in mind that enterovirus D68 is not solely responsible for acute flaccid myelitis. “We’re not saying that [enterovirus C105] is the cause of all cases, but D68 is not the final answer on this,” said Dr. Turner, adding that physicians should keep an open mind as to the causes of this condition and make sure to look at all possible causes.
To that end, the investigators at the University of Virginia have published a case study in the CDC’s Emerging Infectious Diseases (2015 Oct. [doi:10.3201/eid2110.150759], detailing the case that brought about the discovery of enterovirus C105’s connection to acute flaccid myelitis. Because the discovery of enterovirus C105 is relatively recent – it was first detected in Peru and the Republic of Congo in 2010 – the need for awareness, particularly among American physicians, is critical.
Why did the C105 strain cause the acute flaccid myelitis, and what explains the patient’s quick recovery? Dr. Turner advises waiting “until the CDC has finished its examination; [the agency has] specimens from over 100 kids with [acute flaccid myelitis]. But in the end, I don’t think we’ll end up with a satisfactory or unifying answer to this,” he said.
The outbreak of acute flaccid myelitis last year was widely considered to be caused by the enterovirus D68 strain, but the condition might be caused by another, less common, enterovirus strain about which doctors should be aware.
Investigators at the University of Virginia Children’s Hospital, Charlottesville, discovered that the C105 strain of enterovirus might cause acute flaccid myelitis in pediatric patients, after a 6-year-old girl presented last October with symptoms of the condition during the outbreak, which affected more than 100 children across the United States.
“We followed Centers for Disease Control and Prevention protocols in evaluating her,” Dr. Ronald B. Turner, who treated the patient in October, said in an interview. However, blood tests yielded the C105 strain, not the more common D68 strain that Dr. Turner had expected. So far, it is still the only known case of acute flaccid myelitis caused by the C105 strain, but that doesn’t mean it will be the last.
When the patient presented at Children’s Hospital, she exhibited a dropping right shoulder and difficulty using her right hand, as well as a cough, headache, and fever of just above 100° F. However, there were no signs of speech, swallowing, or respiratory difficulties, and sensation was intact.
Dr. Turner and his colleagues performed an MRI on the patient, which showed “longitudinally extensive gray matter hyperintensity within the central cord [with] associated edema,” and an MR image of the brain proved “unremarkable.” The patient was put on a regimen of daily 2 g/kg intravenous immunoglobin for 5 days, but pain in her right arm, lower back pain (her back also exhibited a diffuse papular rash when first examined), and bilateral thigh pain when walking continued.
Despite being unresponsive to treatment, there was no further degradation in pain or mobility, and the patient was discharged. However, the patient’s pain resolved itself “spontaneously,” according Dr. Turner and his colleagues, with her right arm strength and movement almost fully healed after nearly 8 months.
Now, Dr. Turner and his colleagues are urging doctors nationwide to keep in mind that enterovirus D68 is not solely responsible for acute flaccid myelitis. “We’re not saying that [enterovirus C105] is the cause of all cases, but D68 is not the final answer on this,” said Dr. Turner, adding that physicians should keep an open mind as to the causes of this condition and make sure to look at all possible causes.
To that end, the investigators at the University of Virginia have published a case study in the CDC’s Emerging Infectious Diseases (2015 Oct. [doi:10.3201/eid2110.150759], detailing the case that brought about the discovery of enterovirus C105’s connection to acute flaccid myelitis. Because the discovery of enterovirus C105 is relatively recent – it was first detected in Peru and the Republic of Congo in 2010 – the need for awareness, particularly among American physicians, is critical.
Why did the C105 strain cause the acute flaccid myelitis, and what explains the patient’s quick recovery? Dr. Turner advises waiting “until the CDC has finished its examination; [the agency has] specimens from over 100 kids with [acute flaccid myelitis]. But in the end, I don’t think we’ll end up with a satisfactory or unifying answer to this,” he said.
Chemo lessens quality of life for end-stage patients with good performance status
Palliative chemotherapy for patients with end-stage cancer who exhibit promising performance scores should be discouraged, as it does not improve the quality of life for these patients and may actively detract from it, according to a study published in JAMA Oncology.
“Despite the lack of evidence to support the practice, chemotherapy is widely used in cancer patients with poor performance status and progression following an initial course of palliative chemotherapy,” wrote Holly G. Prigerson, Ph.D., of Weill Cornell Medical College, New York. “The goal of palliative chemotherapy for patients with incurable cancer is to prolong survival and promote [quality of life] [but] chemotherapy use among patients with metastatic cancer whose cancer has progressed while receiving prior chemotherapy was not significantly related to longer survival [and] was associated with more aggressive medical care in the patient’s final week and heightened risk of dying in an intensive care unit.”
Dr. Prigerson and her coinvestigators looked at 312 end-stage metastatic cancer patients between September 2002 and February 2008, all of whom were on at least one chemotherapy regimen at one of six outpatient oncology clinics in the United States. They were followed prospectively until death to determine quality of life near death (QOD) as measured by Eastern Cooperative Oncology Group (ECOG) Performance Status scores of 0 (“fully active, able to carry on all predisease performance without restriction”) through 5 (“dead”).
At enrollment, 158 subjects were on chemotherapy and 154 were not. Of the nine subjects with baseline ECOG score of 0, all of whom continued with chemotherapy, six (66.7%) reported lower QOD following treatment. Of 122 subjects with ECOG score 1, 71 of whom continued with chemotherapy, 40 (56.3%) reported lower QOD compared with 35 of the 51 subjects (68.6%) who reported higher QOD after not undergoing chemotherapy. However, as ECOG scores got higher, chemotherapy did appear to be of some benefit to patients.
ECOG score of 2 was found in 116 patients at baseline, of which 55 did chemotherapy and 67 did not; 28 chemotherapy subjects (50.9%) reported lower QOD than at baseline, and 32 (52.5%) of those without chemotherapy also reported lower QOD. For the 58 subjects with ECOG scores of 3, 12 of the 22 who did chemotherapy (54.5%) reported higher QOD after chemotherapy, compared with 19 of the 36 who did not do chemotherapy (52.8%) reporting lower QOD. Finally, seven subjects had ECOG scores of 4 at baseline, of which one did chemotherapy and reported a higher QOD after treatment; of the six who did not, it was a 50/50 split between those with higher and lower QOD.
“Patients receiving palliative chemotherapy with an ECOG performance status of 0 or 1 had significantly worse QOD than did those who avoided chemotherapy [and] no difference in QOD scores was observed by chemotherapy use among those with ECOG performance status of 2 or 3,” the researchers wrote. “Given no observed survival benefit in the studied patients [and] the observed significant association between chemotherapy use and worse QOL in the final week of life among those with a baseline ECOG score of 1, these results highlight the potential harm of chemotherapy in patients with metastatic cancer toward the end of life, even in patients with good performance status,” the investigators said (JAMA Oncol. 2015 July 23 [doi:10.1001/jamaoncol.2015.2378]).
The study had limitations; specifically, Dr. Prigerson and colleagues did not have complete information about the dose and duration of the chemotherapy used for each patient, as well as detailed information on prior chemotherapy use and the exact specifications of chemotherapy treatments given between baseline assessment and death for each patient.
This study was supported by the National Institute of Mental Health, National Cancer Institute, National Institute of Minority Heath and Health Disparities, Weill Cornell Medical College, and the Health Services Research and Development Service Career Development Award from the Department of Veterans Affairs. Dr. Prigerson did not report any relevant financial disclosures, but two coinvestigators reported associations with pharmaceutical companies.
These data from Prigerson and associates suggest that equating treatment with hope is inappropriate. Even when oncologists communicate clearly about prognosis and are honest about the limitations of treatment, many patients feel immense pressure to continue treatment. Patients with end-stage cancer are encouraged by friends and family to keep fighting, but the battle analogy itself can portray the dying patient as a loser and should be discouraged.
Costs aside, we feel the last 6 months of life are not best spent in an oncology treatment unit or at home suffering the toxic effects of largely ineffectual therapies for the majority of patients. At this time, it would not be fitting to suggest guidelines must be changed to prohibit chemotherapy for all patients near death without irrefutable data defining who might actually benefit, but if an oncologist suspects the death of a patient in the next 6 months, the default should be no active treatment. Oncologists with a compelling reason to offer chemotherapy in that setting should only do so after documenting a conversation discussing prognosis, goals, fears, and acceptable trade-offs with the patient and family. Let us help patients with metastatic cancer make good decisions at this sad, but often inevitable, stage. Let us not contribute to the suffering that cancer, and often associated therapy, brings, particularly at the end.
Dr. Charles D. Blanke and Dr. Erik K. Fromme are in the division of hematology and medical oncology, Knight Cancer Institute and Oregon Health and Science University, Portland. Neither reported any relevant disclosures. These comments were excerpted from an editorial (JAMA Oncol. 2015 July 23 [doi:10.1001/jamaoncol.2015.2379]).
These data from Prigerson and associates suggest that equating treatment with hope is inappropriate. Even when oncologists communicate clearly about prognosis and are honest about the limitations of treatment, many patients feel immense pressure to continue treatment. Patients with end-stage cancer are encouraged by friends and family to keep fighting, but the battle analogy itself can portray the dying patient as a loser and should be discouraged.
Costs aside, we feel the last 6 months of life are not best spent in an oncology treatment unit or at home suffering the toxic effects of largely ineffectual therapies for the majority of patients. At this time, it would not be fitting to suggest guidelines must be changed to prohibit chemotherapy for all patients near death without irrefutable data defining who might actually benefit, but if an oncologist suspects the death of a patient in the next 6 months, the default should be no active treatment. Oncologists with a compelling reason to offer chemotherapy in that setting should only do so after documenting a conversation discussing prognosis, goals, fears, and acceptable trade-offs with the patient and family. Let us help patients with metastatic cancer make good decisions at this sad, but often inevitable, stage. Let us not contribute to the suffering that cancer, and often associated therapy, brings, particularly at the end.
Dr. Charles D. Blanke and Dr. Erik K. Fromme are in the division of hematology and medical oncology, Knight Cancer Institute and Oregon Health and Science University, Portland. Neither reported any relevant disclosures. These comments were excerpted from an editorial (JAMA Oncol. 2015 July 23 [doi:10.1001/jamaoncol.2015.2379]).
These data from Prigerson and associates suggest that equating treatment with hope is inappropriate. Even when oncologists communicate clearly about prognosis and are honest about the limitations of treatment, many patients feel immense pressure to continue treatment. Patients with end-stage cancer are encouraged by friends and family to keep fighting, but the battle analogy itself can portray the dying patient as a loser and should be discouraged.
Costs aside, we feel the last 6 months of life are not best spent in an oncology treatment unit or at home suffering the toxic effects of largely ineffectual therapies for the majority of patients. At this time, it would not be fitting to suggest guidelines must be changed to prohibit chemotherapy for all patients near death without irrefutable data defining who might actually benefit, but if an oncologist suspects the death of a patient in the next 6 months, the default should be no active treatment. Oncologists with a compelling reason to offer chemotherapy in that setting should only do so after documenting a conversation discussing prognosis, goals, fears, and acceptable trade-offs with the patient and family. Let us help patients with metastatic cancer make good decisions at this sad, but often inevitable, stage. Let us not contribute to the suffering that cancer, and often associated therapy, brings, particularly at the end.
Dr. Charles D. Blanke and Dr. Erik K. Fromme are in the division of hematology and medical oncology, Knight Cancer Institute and Oregon Health and Science University, Portland. Neither reported any relevant disclosures. These comments were excerpted from an editorial (JAMA Oncol. 2015 July 23 [doi:10.1001/jamaoncol.2015.2379]).
Palliative chemotherapy for patients with end-stage cancer who exhibit promising performance scores should be discouraged, as it does not improve the quality of life for these patients and may actively detract from it, according to a study published in JAMA Oncology.
“Despite the lack of evidence to support the practice, chemotherapy is widely used in cancer patients with poor performance status and progression following an initial course of palliative chemotherapy,” wrote Holly G. Prigerson, Ph.D., of Weill Cornell Medical College, New York. “The goal of palliative chemotherapy for patients with incurable cancer is to prolong survival and promote [quality of life] [but] chemotherapy use among patients with metastatic cancer whose cancer has progressed while receiving prior chemotherapy was not significantly related to longer survival [and] was associated with more aggressive medical care in the patient’s final week and heightened risk of dying in an intensive care unit.”
Dr. Prigerson and her coinvestigators looked at 312 end-stage metastatic cancer patients between September 2002 and February 2008, all of whom were on at least one chemotherapy regimen at one of six outpatient oncology clinics in the United States. They were followed prospectively until death to determine quality of life near death (QOD) as measured by Eastern Cooperative Oncology Group (ECOG) Performance Status scores of 0 (“fully active, able to carry on all predisease performance without restriction”) through 5 (“dead”).
At enrollment, 158 subjects were on chemotherapy and 154 were not. Of the nine subjects with baseline ECOG score of 0, all of whom continued with chemotherapy, six (66.7%) reported lower QOD following treatment. Of 122 subjects with ECOG score 1, 71 of whom continued with chemotherapy, 40 (56.3%) reported lower QOD compared with 35 of the 51 subjects (68.6%) who reported higher QOD after not undergoing chemotherapy. However, as ECOG scores got higher, chemotherapy did appear to be of some benefit to patients.
ECOG score of 2 was found in 116 patients at baseline, of which 55 did chemotherapy and 67 did not; 28 chemotherapy subjects (50.9%) reported lower QOD than at baseline, and 32 (52.5%) of those without chemotherapy also reported lower QOD. For the 58 subjects with ECOG scores of 3, 12 of the 22 who did chemotherapy (54.5%) reported higher QOD after chemotherapy, compared with 19 of the 36 who did not do chemotherapy (52.8%) reporting lower QOD. Finally, seven subjects had ECOG scores of 4 at baseline, of which one did chemotherapy and reported a higher QOD after treatment; of the six who did not, it was a 50/50 split between those with higher and lower QOD.
“Patients receiving palliative chemotherapy with an ECOG performance status of 0 or 1 had significantly worse QOD than did those who avoided chemotherapy [and] no difference in QOD scores was observed by chemotherapy use among those with ECOG performance status of 2 or 3,” the researchers wrote. “Given no observed survival benefit in the studied patients [and] the observed significant association between chemotherapy use and worse QOL in the final week of life among those with a baseline ECOG score of 1, these results highlight the potential harm of chemotherapy in patients with metastatic cancer toward the end of life, even in patients with good performance status,” the investigators said (JAMA Oncol. 2015 July 23 [doi:10.1001/jamaoncol.2015.2378]).
The study had limitations; specifically, Dr. Prigerson and colleagues did not have complete information about the dose and duration of the chemotherapy used for each patient, as well as detailed information on prior chemotherapy use and the exact specifications of chemotherapy treatments given between baseline assessment and death for each patient.
This study was supported by the National Institute of Mental Health, National Cancer Institute, National Institute of Minority Heath and Health Disparities, Weill Cornell Medical College, and the Health Services Research and Development Service Career Development Award from the Department of Veterans Affairs. Dr. Prigerson did not report any relevant financial disclosures, but two coinvestigators reported associations with pharmaceutical companies.
Palliative chemotherapy for patients with end-stage cancer who exhibit promising performance scores should be discouraged, as it does not improve the quality of life for these patients and may actively detract from it, according to a study published in JAMA Oncology.
“Despite the lack of evidence to support the practice, chemotherapy is widely used in cancer patients with poor performance status and progression following an initial course of palliative chemotherapy,” wrote Holly G. Prigerson, Ph.D., of Weill Cornell Medical College, New York. “The goal of palliative chemotherapy for patients with incurable cancer is to prolong survival and promote [quality of life] [but] chemotherapy use among patients with metastatic cancer whose cancer has progressed while receiving prior chemotherapy was not significantly related to longer survival [and] was associated with more aggressive medical care in the patient’s final week and heightened risk of dying in an intensive care unit.”
Dr. Prigerson and her coinvestigators looked at 312 end-stage metastatic cancer patients between September 2002 and February 2008, all of whom were on at least one chemotherapy regimen at one of six outpatient oncology clinics in the United States. They were followed prospectively until death to determine quality of life near death (QOD) as measured by Eastern Cooperative Oncology Group (ECOG) Performance Status scores of 0 (“fully active, able to carry on all predisease performance without restriction”) through 5 (“dead”).
At enrollment, 158 subjects were on chemotherapy and 154 were not. Of the nine subjects with baseline ECOG score of 0, all of whom continued with chemotherapy, six (66.7%) reported lower QOD following treatment. Of 122 subjects with ECOG score 1, 71 of whom continued with chemotherapy, 40 (56.3%) reported lower QOD compared with 35 of the 51 subjects (68.6%) who reported higher QOD after not undergoing chemotherapy. However, as ECOG scores got higher, chemotherapy did appear to be of some benefit to patients.
ECOG score of 2 was found in 116 patients at baseline, of which 55 did chemotherapy and 67 did not; 28 chemotherapy subjects (50.9%) reported lower QOD than at baseline, and 32 (52.5%) of those without chemotherapy also reported lower QOD. For the 58 subjects with ECOG scores of 3, 12 of the 22 who did chemotherapy (54.5%) reported higher QOD after chemotherapy, compared with 19 of the 36 who did not do chemotherapy (52.8%) reporting lower QOD. Finally, seven subjects had ECOG scores of 4 at baseline, of which one did chemotherapy and reported a higher QOD after treatment; of the six who did not, it was a 50/50 split between those with higher and lower QOD.
“Patients receiving palliative chemotherapy with an ECOG performance status of 0 or 1 had significantly worse QOD than did those who avoided chemotherapy [and] no difference in QOD scores was observed by chemotherapy use among those with ECOG performance status of 2 or 3,” the researchers wrote. “Given no observed survival benefit in the studied patients [and] the observed significant association between chemotherapy use and worse QOL in the final week of life among those with a baseline ECOG score of 1, these results highlight the potential harm of chemotherapy in patients with metastatic cancer toward the end of life, even in patients with good performance status,” the investigators said (JAMA Oncol. 2015 July 23 [doi:10.1001/jamaoncol.2015.2378]).
The study had limitations; specifically, Dr. Prigerson and colleagues did not have complete information about the dose and duration of the chemotherapy used for each patient, as well as detailed information on prior chemotherapy use and the exact specifications of chemotherapy treatments given between baseline assessment and death for each patient.
This study was supported by the National Institute of Mental Health, National Cancer Institute, National Institute of Minority Heath and Health Disparities, Weill Cornell Medical College, and the Health Services Research and Development Service Career Development Award from the Department of Veterans Affairs. Dr. Prigerson did not report any relevant financial disclosures, but two coinvestigators reported associations with pharmaceutical companies.
FROM JAMA ONCOLOGY
Key clinical point: End-stage cancer patients should not receive chemotherapy because it does not improve quality of life and, in some cases, can harm it.
Major finding: Among patients with good baseline performance chemotherapy status (ECOG score = 1), patients with chemotherapy use versus those without chemotherapy had worse quality of life near death (QOD) (P = .01).
Data source: A multi-institutional, longitudinal cohort study of 312 patients with progressive metastatic cancer, conducted between September 2002 and February 2008.
Disclosures: Study was supported by the National Institute of Mental Health, National Cancer Institute, National Institute of Minority Heath and Health Disparities, Weill Cornell Medical College, and the Health Services Research and Development Service Career Development Award from the Department of Veterans Affairs. Dr. Prigerson did not report any relevant financial disclosures.
Vietnam veterans still struggling with PTSD, VA study says
Thousands of veterans of the Vietnam War continue to experience posttraumatic stress disorder tied to war zone experiences that occurred 40 years ago, a new study published in JAMA Psychiatry shows.
“An important minority of Vietnam veterans are symptomatic after 4 decades, with more than twice as many deteriorating as improving,” reported Dr. Charles R. Marmar and his coinvestigators in the National Vietnam Veterans Longitudinal Study (NVVLS) (JAMA Psychiatry 2015 July 22 [(doi:10.1001/jamapsychiatry.015.0803]).
The NVVLS, a follow-up of the original the National Vietnam Veterans Readjustment Study (NVVRS), found that about 271,000 living Vietnam veterans who were deployed into active war zones currently experience PTSD. Furthermore, 36.7% of veterans with current war zone PTSD also suffer from major depressive disorder, reported Dr. Marmar, the Lucius N. Littauer Professor of Psychiatry at of the NYU Langone Medical Center.
A total of 1,839 veterans from NVVRS were alive when NVVLS was undertaken, of which 1,450 (78.8%) participated in at least one phase of the latter study. Dr. Marmar and his coinvestigators estimated that 4.5% (95% confidence interval, 1.7%-7.3%) of male and 6.1% (95% CI, 1.8%-10.3%) of female war zone veterans from the Vietnam War currently have PTSD, based on Clinician-Administered PTSD Scale for DSM-5 PTSD criteria. The prevalence of current PTSD from any cause related to service in Vietnam was estimated at 12.2% for males and 8.5% for females, said Dr. Marmar, also director of PTSD research program and chairman of the department of psychiatry at the NYU School of Medicine.
Meanwhile, Dr. Marmar and his associates found that the prevalence of alcohol and other drug abuse was low in both PTSD and subthreshold PTSD.
“Policy implications include the need for greater access to evidence-based mental health services; the importance of integrating mental health treatment into primary care in light of the nearly 20% mortality; attention to the stresses of aging, including retirement, chronic illness, declining social support, and cognitive changes that create difficulties with the management of unwanted memories; and anticipating challenges that lie ahead for Iraq and Afghanistan veterans,” the authors concluded.
The NVVLS was funded by the Department of Veterans Affairs. The authors did not report any financial disclosures.
“The most important [National Vietnam Veterans Longitudinal Study] finding is confirmation of the chronic and debilitating course of war-related PTSD,” Dr. Charles W. Hoge wrote. Using the Clinician-Administered PTSD Scale for DSM-5, or CAPS-5, Dr. Marmar and his colleagues found lifetime and current war-zone PTSD prevalences of 17.0% and 4.5%, respectively, in male veterans (15.2% and 6.1%, respectively, in female veterans).” These estimates are lower than those found by Bruce P. Dohrenwend, Ph.D., and his colleagues (Science 2006;313:979-82) and probably do not reflect the “full disease burden owing to potential psychometric concerns with the CAPS-5.” Also, almost a quarter of the cohort died in the interim between the National Vietnam Veterans Readjustment Study (NVVRS) and the NVVLS, the National Vietnam Veterans Longitudinal Study.
“In summary, the NVVLS is a historic achievement confirming the long-term impact of Vietnam service across evolving (or devolving) diagnostic classifications,” Dr. Hoge wrote. In addition, the study “underscores medical service needs for PTSD and related comorbidities extending decades after service and highlights a need to reconsider changes to the PTSD definition.”
Dr. Charles W. Hoge is a retired U.S. Army colonel, is affiliated with the Walter Reed Army Institute of Research in Silver Spring, Md., and is an expert on PTSD and traumatic brain injury. These comments are excerpted from his accompanying editorial (JAMA Psychiatry 2015 July 22 [(doi:10.1001/jamapsychiatry.2015.1066]). He reported no conflicts of interest.
“The most important [National Vietnam Veterans Longitudinal Study] finding is confirmation of the chronic and debilitating course of war-related PTSD,” Dr. Charles W. Hoge wrote. Using the Clinician-Administered PTSD Scale for DSM-5, or CAPS-5, Dr. Marmar and his colleagues found lifetime and current war-zone PTSD prevalences of 17.0% and 4.5%, respectively, in male veterans (15.2% and 6.1%, respectively, in female veterans).” These estimates are lower than those found by Bruce P. Dohrenwend, Ph.D., and his colleagues (Science 2006;313:979-82) and probably do not reflect the “full disease burden owing to potential psychometric concerns with the CAPS-5.” Also, almost a quarter of the cohort died in the interim between the National Vietnam Veterans Readjustment Study (NVVRS) and the NVVLS, the National Vietnam Veterans Longitudinal Study.
“In summary, the NVVLS is a historic achievement confirming the long-term impact of Vietnam service across evolving (or devolving) diagnostic classifications,” Dr. Hoge wrote. In addition, the study “underscores medical service needs for PTSD and related comorbidities extending decades after service and highlights a need to reconsider changes to the PTSD definition.”
Dr. Charles W. Hoge is a retired U.S. Army colonel, is affiliated with the Walter Reed Army Institute of Research in Silver Spring, Md., and is an expert on PTSD and traumatic brain injury. These comments are excerpted from his accompanying editorial (JAMA Psychiatry 2015 July 22 [(doi:10.1001/jamapsychiatry.2015.1066]). He reported no conflicts of interest.
“The most important [National Vietnam Veterans Longitudinal Study] finding is confirmation of the chronic and debilitating course of war-related PTSD,” Dr. Charles W. Hoge wrote. Using the Clinician-Administered PTSD Scale for DSM-5, or CAPS-5, Dr. Marmar and his colleagues found lifetime and current war-zone PTSD prevalences of 17.0% and 4.5%, respectively, in male veterans (15.2% and 6.1%, respectively, in female veterans).” These estimates are lower than those found by Bruce P. Dohrenwend, Ph.D., and his colleagues (Science 2006;313:979-82) and probably do not reflect the “full disease burden owing to potential psychometric concerns with the CAPS-5.” Also, almost a quarter of the cohort died in the interim between the National Vietnam Veterans Readjustment Study (NVVRS) and the NVVLS, the National Vietnam Veterans Longitudinal Study.
“In summary, the NVVLS is a historic achievement confirming the long-term impact of Vietnam service across evolving (or devolving) diagnostic classifications,” Dr. Hoge wrote. In addition, the study “underscores medical service needs for PTSD and related comorbidities extending decades after service and highlights a need to reconsider changes to the PTSD definition.”
Dr. Charles W. Hoge is a retired U.S. Army colonel, is affiliated with the Walter Reed Army Institute of Research in Silver Spring, Md., and is an expert on PTSD and traumatic brain injury. These comments are excerpted from his accompanying editorial (JAMA Psychiatry 2015 July 22 [(doi:10.1001/jamapsychiatry.2015.1066]). He reported no conflicts of interest.
Thousands of veterans of the Vietnam War continue to experience posttraumatic stress disorder tied to war zone experiences that occurred 40 years ago, a new study published in JAMA Psychiatry shows.
“An important minority of Vietnam veterans are symptomatic after 4 decades, with more than twice as many deteriorating as improving,” reported Dr. Charles R. Marmar and his coinvestigators in the National Vietnam Veterans Longitudinal Study (NVVLS) (JAMA Psychiatry 2015 July 22 [(doi:10.1001/jamapsychiatry.015.0803]).
The NVVLS, a follow-up of the original the National Vietnam Veterans Readjustment Study (NVVRS), found that about 271,000 living Vietnam veterans who were deployed into active war zones currently experience PTSD. Furthermore, 36.7% of veterans with current war zone PTSD also suffer from major depressive disorder, reported Dr. Marmar, the Lucius N. Littauer Professor of Psychiatry at of the NYU Langone Medical Center.
A total of 1,839 veterans from NVVRS were alive when NVVLS was undertaken, of which 1,450 (78.8%) participated in at least one phase of the latter study. Dr. Marmar and his coinvestigators estimated that 4.5% (95% confidence interval, 1.7%-7.3%) of male and 6.1% (95% CI, 1.8%-10.3%) of female war zone veterans from the Vietnam War currently have PTSD, based on Clinician-Administered PTSD Scale for DSM-5 PTSD criteria. The prevalence of current PTSD from any cause related to service in Vietnam was estimated at 12.2% for males and 8.5% for females, said Dr. Marmar, also director of PTSD research program and chairman of the department of psychiatry at the NYU School of Medicine.
Meanwhile, Dr. Marmar and his associates found that the prevalence of alcohol and other drug abuse was low in both PTSD and subthreshold PTSD.
“Policy implications include the need for greater access to evidence-based mental health services; the importance of integrating mental health treatment into primary care in light of the nearly 20% mortality; attention to the stresses of aging, including retirement, chronic illness, declining social support, and cognitive changes that create difficulties with the management of unwanted memories; and anticipating challenges that lie ahead for Iraq and Afghanistan veterans,” the authors concluded.
The NVVLS was funded by the Department of Veterans Affairs. The authors did not report any financial disclosures.
Thousands of veterans of the Vietnam War continue to experience posttraumatic stress disorder tied to war zone experiences that occurred 40 years ago, a new study published in JAMA Psychiatry shows.
“An important minority of Vietnam veterans are symptomatic after 4 decades, with more than twice as many deteriorating as improving,” reported Dr. Charles R. Marmar and his coinvestigators in the National Vietnam Veterans Longitudinal Study (NVVLS) (JAMA Psychiatry 2015 July 22 [(doi:10.1001/jamapsychiatry.015.0803]).
The NVVLS, a follow-up of the original the National Vietnam Veterans Readjustment Study (NVVRS), found that about 271,000 living Vietnam veterans who were deployed into active war zones currently experience PTSD. Furthermore, 36.7% of veterans with current war zone PTSD also suffer from major depressive disorder, reported Dr. Marmar, the Lucius N. Littauer Professor of Psychiatry at of the NYU Langone Medical Center.
A total of 1,839 veterans from NVVRS were alive when NVVLS was undertaken, of which 1,450 (78.8%) participated in at least one phase of the latter study. Dr. Marmar and his coinvestigators estimated that 4.5% (95% confidence interval, 1.7%-7.3%) of male and 6.1% (95% CI, 1.8%-10.3%) of female war zone veterans from the Vietnam War currently have PTSD, based on Clinician-Administered PTSD Scale for DSM-5 PTSD criteria. The prevalence of current PTSD from any cause related to service in Vietnam was estimated at 12.2% for males and 8.5% for females, said Dr. Marmar, also director of PTSD research program and chairman of the department of psychiatry at the NYU School of Medicine.
Meanwhile, Dr. Marmar and his associates found that the prevalence of alcohol and other drug abuse was low in both PTSD and subthreshold PTSD.
“Policy implications include the need for greater access to evidence-based mental health services; the importance of integrating mental health treatment into primary care in light of the nearly 20% mortality; attention to the stresses of aging, including retirement, chronic illness, declining social support, and cognitive changes that create difficulties with the management of unwanted memories; and anticipating challenges that lie ahead for Iraq and Afghanistan veterans,” the authors concluded.
The NVVLS was funded by the Department of Veterans Affairs. The authors did not report any financial disclosures.
FROM JAMA PSYCHIATRY
Key clinical point: Nearly 271,000 war zone veterans of the Vietnam War currently have full, symptomatic posttraumatic stress disorder.
Major finding: The estimated prevalence of current war zone–related PTSD in male war zone veterans is 4.5% and 6.1% in female war zone veterans.
Data source: The National Vietnam Veterans Longitudinal Study (NVVLS), a congressionally mandated study of 1,839 Vietnam War veterans who also were assessed as part of the National Vietnam Veterans Readjustment Study.
Disclosures: The NVVLS was funded by the Department of Veterans Affairs, and the authors reported no financial disclosures.
Elective colectomy topped medical therapy for advanced ulcerative colitis
For adults with advanced ulcerative colitis (UC) older than 50 years of age, elective colectomy offered a significantly higher survival rate than did medical therapy, according to a retrospective study of 8,371 patients.
Dr. Meenakshi Bewtra of the University of Pennsylvania, Philadelphia, and her coinvestigators matched 830 UC patients seeking elective colectomy for treatment with 7,541 UC patients opting for more traditional medical therapy, all recruited using data from Medicaid and Medicare from 2000 to 2011 (Ann. Intern. Med. July 14, 2015 [doi:10.7326/M14-0960]).
In total, 63 patients who received elective colectomy died, compared with 783 patients in the medical therapy cohort. Mortality rates per cohort were 34 and 54 per 1,000 person-years, respectively. Furthermore, patients were more likely to respond more favorably to elective colectomy than to medical therapy, with an adjusted hazard ratio of 0.67. Additional post hoc analysis revealed higher survival odds with colectomy for patients age 50 years or older (HR, 0.60; P = .032). “These findings warrant discussion with patients when one is weighing the risks and benefits of different medical therapies and total colectomy,” the investigators said.
The authors noted that the study had several limitations, such as potential residual confounding and the possibility of reduced statistical power in subsequent analyses because several databases were used to cull data.
The study was funded by grants from the National Institutes of Health and the Agency for Healthcare Research and Quality. Dr. Bewtra disclosed receiving a grant from NIH and accepting speaking engagements for Imedex and the Crohn’s & Colitis Foundation of America/Robert Michael Educational Institute outside the submitted work.
For adults with advanced ulcerative colitis (UC) older than 50 years of age, elective colectomy offered a significantly higher survival rate than did medical therapy, according to a retrospective study of 8,371 patients.
Dr. Meenakshi Bewtra of the University of Pennsylvania, Philadelphia, and her coinvestigators matched 830 UC patients seeking elective colectomy for treatment with 7,541 UC patients opting for more traditional medical therapy, all recruited using data from Medicaid and Medicare from 2000 to 2011 (Ann. Intern. Med. July 14, 2015 [doi:10.7326/M14-0960]).
In total, 63 patients who received elective colectomy died, compared with 783 patients in the medical therapy cohort. Mortality rates per cohort were 34 and 54 per 1,000 person-years, respectively. Furthermore, patients were more likely to respond more favorably to elective colectomy than to medical therapy, with an adjusted hazard ratio of 0.67. Additional post hoc analysis revealed higher survival odds with colectomy for patients age 50 years or older (HR, 0.60; P = .032). “These findings warrant discussion with patients when one is weighing the risks and benefits of different medical therapies and total colectomy,” the investigators said.
The authors noted that the study had several limitations, such as potential residual confounding and the possibility of reduced statistical power in subsequent analyses because several databases were used to cull data.
The study was funded by grants from the National Institutes of Health and the Agency for Healthcare Research and Quality. Dr. Bewtra disclosed receiving a grant from NIH and accepting speaking engagements for Imedex and the Crohn’s & Colitis Foundation of America/Robert Michael Educational Institute outside the submitted work.
For adults with advanced ulcerative colitis (UC) older than 50 years of age, elective colectomy offered a significantly higher survival rate than did medical therapy, according to a retrospective study of 8,371 patients.
Dr. Meenakshi Bewtra of the University of Pennsylvania, Philadelphia, and her coinvestigators matched 830 UC patients seeking elective colectomy for treatment with 7,541 UC patients opting for more traditional medical therapy, all recruited using data from Medicaid and Medicare from 2000 to 2011 (Ann. Intern. Med. July 14, 2015 [doi:10.7326/M14-0960]).
In total, 63 patients who received elective colectomy died, compared with 783 patients in the medical therapy cohort. Mortality rates per cohort were 34 and 54 per 1,000 person-years, respectively. Furthermore, patients were more likely to respond more favorably to elective colectomy than to medical therapy, with an adjusted hazard ratio of 0.67. Additional post hoc analysis revealed higher survival odds with colectomy for patients age 50 years or older (HR, 0.60; P = .032). “These findings warrant discussion with patients when one is weighing the risks and benefits of different medical therapies and total colectomy,” the investigators said.
The authors noted that the study had several limitations, such as potential residual confounding and the possibility of reduced statistical power in subsequent analyses because several databases were used to cull data.
The study was funded by grants from the National Institutes of Health and the Agency for Healthcare Research and Quality. Dr. Bewtra disclosed receiving a grant from NIH and accepting speaking engagements for Imedex and the Crohn’s & Colitis Foundation of America/Robert Michael Educational Institute outside the submitted work.
FROM THE ANNALS OF INTERNAL MEDICINE
Diet, exercise programs increasingly effective at reducing type 2 diabetes risk
Programs designed to promote diet and physical activity, specifically geared toward individuals at high risk for developing type 2 diabetes, can be effective at reducing the number of new-onset diabetes cases, according to a recommendation from the Community Preventive Services Task Force.
The recommendation was derived from a review of 53 studies examining 66 programs already in place across the nation, which presented a consensus that promoting dietary changes and increased physical activity in either a clinical or community engagement setting can significantly decrease the risk of at-risk individuals to develop type 2 diabetes (Ann. Intern. Med. 2015 July 13 [doi:10.7326/M15-1029]).
These programs vary in several ways – length, method of delivery, and individual versus group-based activities – but all share the common goal of education and awareness of diabetes and measures to prevent it.
“Programs commonly include a weight-loss goal, individual or group sessions (or both) about diet and exercise, meetings with a trained diet or exercise counselor (or both), and individually tailored diet or exercise plans (or both),” wrote Dr. Nicolaas P. Pronk and Dr. Patrick L. Remington. “Higher-intensity programs lead to greater weight loss and reduction in new-onset diabetes.”
From a search of MEDLINE, the Cochrane Central Register of Controlled Trials, CAB Abstracts, Global Health, and Ovid HealthSTAR from 1991 through 2015, investigators with the Community Preventive Services Task Force included randomized, controlled trials and prospective nonrandomized comparative studies of at least 30 participants. All programs examined by the included studies ran from 3 months to 6 years in length, with all but 5 programs being longer than 6 months. Programs mostly used in-person exercises, either individually or in a group setting, focusing on diet improvement or exercise.
Programs were typically led by nutritionists or physical trainers, but several were also led by physicians, psychologists, nurses, or a “trained layperson.” The recommendations highlight that while some programs had participants outline specific goals and all programs varied in the intensity and style of their counseling, they all led to either reduced risk of diabetes, weight loss, or both.
“In 17 studies that reported blood pressure outcomes and 14 that reported lipid outcomes, programs reduced systolic and diastolic blood pressures and improved lipid levels, including total, low-density lipoprotein, and high-density lipoprotein cholesterol levels and triglyceride levels,” the recommendations state, adding that no long-term ramifications were reported relating to any of the programs.
Economic review of 28 programs indicated that median program cost per participant was $653, although this cost was substantially lower for programs in either community or primary care-based settings (median cost of $424) and group-based programs (median cost of $417). While these costs can be prohibitively high for many Americans, the recommendations advise that many employers list health programs as a covered benefit, and urges private and public health insurers to join in covering participation costs. Most programs also offer free information online.
The Community Preventive Services Task Force is an independent, unpaid, nonfederal body. Dr. Pronk and Dr. Remington did not report any relevant financial disclosures.
What is the Community Preventive Services Task Force?
The U.S. Community Preventive Services Task Force was created in 1996 by the U.S. Department of Health and Human Services with the goal of making recommendations and identifying evidence gaps in existing knowledge and research to “help inform the decision making of federal, state, and local health departments, other government agencies, communities, healthcare providers, employers, schools and research organizations.”
These findings are released as The Community Guide, which collects information on studies of relevant public health topics, assesses the strengths and weaknesses of these studies and their findings, and summarizes the evidence in a way that presents whether or not intervention is necessary, how to make an intervention the most effective it can be, what costs would be associated with such an intervention, and what gaps in our existing knowledge or research exist that should be rectified.
As of passage of the Patient Protection and Affordable Care Act in 2010, the task force’s findings are collected in an annual report presented to Congress, which has mandated the Centers for Disease Control and Prevention to support the work of the task force even though the task force is considered an independent, nonfederal, unpaid body. However, according to a disclaimer from the task force’s most recent clinical guideline, “recommendations made by the Task Force are independent of the U.S. government and should not be construed as an official position of the Centers for Disease Control and Prevention or the U.S. Department of Health and Human Services.
The 14 current members of the task force come from across the country, and from both the private and public spheres. The task force is chaired by Dr. Jonathan E. Fielding, director of and a health officer in the Los Angeles County Department of Health.
Combined diet and physical activity promotion programs are an effective prescription for diabetes prevention – they have a preferred [U.S. Diabetes Prevention Program (DPP)] formulation, a minimum dose, and must be taken continuously. This treatment has become increasingly available, but most people remain unaware of their need for a prescription or where to fill it. Health care providers should assume a greater role in performing recommended screening and linking high-risk patients with combined diet and physical activity promotion programs; the National DPP registry and the YMCA of the USA’s program database should be used as tools. Health payers should recognize that these programs meet Affordable Care Act–directed coverage requirements for recent [U.S. Preventive Services Task Force (USPSTF)] recommendations. As a society, we should no longer hold the potential to reduce the burden of diabetes for ransom by continuing to await further evidence that interventions will be cost-saving or prevent myocardial infarctions or deaths. It is imperative that we promote a known cost-effective intervention that improves health, reduces the need for medication, and has the potential to enable millions of Americans to evade a remaining lifetime burdened by the daily management of diabetes.
Dr. Ronald T. Ackerman is professor of medicine and director of the Center for Community Health at Northwestern University’s Feinberg School of Medicine in Chicago. He did not report any disclosures. (Ann Intern Med. doi:10.7326/M15-1563).
Combined diet and physical activity promotion programs are an effective prescription for diabetes prevention – they have a preferred [U.S. Diabetes Prevention Program (DPP)] formulation, a minimum dose, and must be taken continuously. This treatment has become increasingly available, but most people remain unaware of their need for a prescription or where to fill it. Health care providers should assume a greater role in performing recommended screening and linking high-risk patients with combined diet and physical activity promotion programs; the National DPP registry and the YMCA of the USA’s program database should be used as tools. Health payers should recognize that these programs meet Affordable Care Act–directed coverage requirements for recent [U.S. Preventive Services Task Force (USPSTF)] recommendations. As a society, we should no longer hold the potential to reduce the burden of diabetes for ransom by continuing to await further evidence that interventions will be cost-saving or prevent myocardial infarctions or deaths. It is imperative that we promote a known cost-effective intervention that improves health, reduces the need for medication, and has the potential to enable millions of Americans to evade a remaining lifetime burdened by the daily management of diabetes.
Dr. Ronald T. Ackerman is professor of medicine and director of the Center for Community Health at Northwestern University’s Feinberg School of Medicine in Chicago. He did not report any disclosures. (Ann Intern Med. doi:10.7326/M15-1563).
Combined diet and physical activity promotion programs are an effective prescription for diabetes prevention – they have a preferred [U.S. Diabetes Prevention Program (DPP)] formulation, a minimum dose, and must be taken continuously. This treatment has become increasingly available, but most people remain unaware of their need for a prescription or where to fill it. Health care providers should assume a greater role in performing recommended screening and linking high-risk patients with combined diet and physical activity promotion programs; the National DPP registry and the YMCA of the USA’s program database should be used as tools. Health payers should recognize that these programs meet Affordable Care Act–directed coverage requirements for recent [U.S. Preventive Services Task Force (USPSTF)] recommendations. As a society, we should no longer hold the potential to reduce the burden of diabetes for ransom by continuing to await further evidence that interventions will be cost-saving or prevent myocardial infarctions or deaths. It is imperative that we promote a known cost-effective intervention that improves health, reduces the need for medication, and has the potential to enable millions of Americans to evade a remaining lifetime burdened by the daily management of diabetes.
Dr. Ronald T. Ackerman is professor of medicine and director of the Center for Community Health at Northwestern University’s Feinberg School of Medicine in Chicago. He did not report any disclosures. (Ann Intern Med. doi:10.7326/M15-1563).
Programs designed to promote diet and physical activity, specifically geared toward individuals at high risk for developing type 2 diabetes, can be effective at reducing the number of new-onset diabetes cases, according to a recommendation from the Community Preventive Services Task Force.
The recommendation was derived from a review of 53 studies examining 66 programs already in place across the nation, which presented a consensus that promoting dietary changes and increased physical activity in either a clinical or community engagement setting can significantly decrease the risk of at-risk individuals to develop type 2 diabetes (Ann. Intern. Med. 2015 July 13 [doi:10.7326/M15-1029]).
These programs vary in several ways – length, method of delivery, and individual versus group-based activities – but all share the common goal of education and awareness of diabetes and measures to prevent it.
“Programs commonly include a weight-loss goal, individual or group sessions (or both) about diet and exercise, meetings with a trained diet or exercise counselor (or both), and individually tailored diet or exercise plans (or both),” wrote Dr. Nicolaas P. Pronk and Dr. Patrick L. Remington. “Higher-intensity programs lead to greater weight loss and reduction in new-onset diabetes.”
From a search of MEDLINE, the Cochrane Central Register of Controlled Trials, CAB Abstracts, Global Health, and Ovid HealthSTAR from 1991 through 2015, investigators with the Community Preventive Services Task Force included randomized, controlled trials and prospective nonrandomized comparative studies of at least 30 participants. All programs examined by the included studies ran from 3 months to 6 years in length, with all but 5 programs being longer than 6 months. Programs mostly used in-person exercises, either individually or in a group setting, focusing on diet improvement or exercise.
Programs were typically led by nutritionists or physical trainers, but several were also led by physicians, psychologists, nurses, or a “trained layperson.” The recommendations highlight that while some programs had participants outline specific goals and all programs varied in the intensity and style of their counseling, they all led to either reduced risk of diabetes, weight loss, or both.
“In 17 studies that reported blood pressure outcomes and 14 that reported lipid outcomes, programs reduced systolic and diastolic blood pressures and improved lipid levels, including total, low-density lipoprotein, and high-density lipoprotein cholesterol levels and triglyceride levels,” the recommendations state, adding that no long-term ramifications were reported relating to any of the programs.
Economic review of 28 programs indicated that median program cost per participant was $653, although this cost was substantially lower for programs in either community or primary care-based settings (median cost of $424) and group-based programs (median cost of $417). While these costs can be prohibitively high for many Americans, the recommendations advise that many employers list health programs as a covered benefit, and urges private and public health insurers to join in covering participation costs. Most programs also offer free information online.
The Community Preventive Services Task Force is an independent, unpaid, nonfederal body. Dr. Pronk and Dr. Remington did not report any relevant financial disclosures.
What is the Community Preventive Services Task Force?
The U.S. Community Preventive Services Task Force was created in 1996 by the U.S. Department of Health and Human Services with the goal of making recommendations and identifying evidence gaps in existing knowledge and research to “help inform the decision making of federal, state, and local health departments, other government agencies, communities, healthcare providers, employers, schools and research organizations.”
These findings are released as The Community Guide, which collects information on studies of relevant public health topics, assesses the strengths and weaknesses of these studies and their findings, and summarizes the evidence in a way that presents whether or not intervention is necessary, how to make an intervention the most effective it can be, what costs would be associated with such an intervention, and what gaps in our existing knowledge or research exist that should be rectified.
As of passage of the Patient Protection and Affordable Care Act in 2010, the task force’s findings are collected in an annual report presented to Congress, which has mandated the Centers for Disease Control and Prevention to support the work of the task force even though the task force is considered an independent, nonfederal, unpaid body. However, according to a disclaimer from the task force’s most recent clinical guideline, “recommendations made by the Task Force are independent of the U.S. government and should not be construed as an official position of the Centers for Disease Control and Prevention or the U.S. Department of Health and Human Services.
The 14 current members of the task force come from across the country, and from both the private and public spheres. The task force is chaired by Dr. Jonathan E. Fielding, director of and a health officer in the Los Angeles County Department of Health.
Programs designed to promote diet and physical activity, specifically geared toward individuals at high risk for developing type 2 diabetes, can be effective at reducing the number of new-onset diabetes cases, according to a recommendation from the Community Preventive Services Task Force.
The recommendation was derived from a review of 53 studies examining 66 programs already in place across the nation, which presented a consensus that promoting dietary changes and increased physical activity in either a clinical or community engagement setting can significantly decrease the risk of at-risk individuals to develop type 2 diabetes (Ann. Intern. Med. 2015 July 13 [doi:10.7326/M15-1029]).
These programs vary in several ways – length, method of delivery, and individual versus group-based activities – but all share the common goal of education and awareness of diabetes and measures to prevent it.
“Programs commonly include a weight-loss goal, individual or group sessions (or both) about diet and exercise, meetings with a trained diet or exercise counselor (or both), and individually tailored diet or exercise plans (or both),” wrote Dr. Nicolaas P. Pronk and Dr. Patrick L. Remington. “Higher-intensity programs lead to greater weight loss and reduction in new-onset diabetes.”
From a search of MEDLINE, the Cochrane Central Register of Controlled Trials, CAB Abstracts, Global Health, and Ovid HealthSTAR from 1991 through 2015, investigators with the Community Preventive Services Task Force included randomized, controlled trials and prospective nonrandomized comparative studies of at least 30 participants. All programs examined by the included studies ran from 3 months to 6 years in length, with all but 5 programs being longer than 6 months. Programs mostly used in-person exercises, either individually or in a group setting, focusing on diet improvement or exercise.
Programs were typically led by nutritionists or physical trainers, but several were also led by physicians, psychologists, nurses, or a “trained layperson.” The recommendations highlight that while some programs had participants outline specific goals and all programs varied in the intensity and style of their counseling, they all led to either reduced risk of diabetes, weight loss, or both.
“In 17 studies that reported blood pressure outcomes and 14 that reported lipid outcomes, programs reduced systolic and diastolic blood pressures and improved lipid levels, including total, low-density lipoprotein, and high-density lipoprotein cholesterol levels and triglyceride levels,” the recommendations state, adding that no long-term ramifications were reported relating to any of the programs.
Economic review of 28 programs indicated that median program cost per participant was $653, although this cost was substantially lower for programs in either community or primary care-based settings (median cost of $424) and group-based programs (median cost of $417). While these costs can be prohibitively high for many Americans, the recommendations advise that many employers list health programs as a covered benefit, and urges private and public health insurers to join in covering participation costs. Most programs also offer free information online.
The Community Preventive Services Task Force is an independent, unpaid, nonfederal body. Dr. Pronk and Dr. Remington did not report any relevant financial disclosures.
What is the Community Preventive Services Task Force?
The U.S. Community Preventive Services Task Force was created in 1996 by the U.S. Department of Health and Human Services with the goal of making recommendations and identifying evidence gaps in existing knowledge and research to “help inform the decision making of federal, state, and local health departments, other government agencies, communities, healthcare providers, employers, schools and research organizations.”
These findings are released as The Community Guide, which collects information on studies of relevant public health topics, assesses the strengths and weaknesses of these studies and their findings, and summarizes the evidence in a way that presents whether or not intervention is necessary, how to make an intervention the most effective it can be, what costs would be associated with such an intervention, and what gaps in our existing knowledge or research exist that should be rectified.
As of passage of the Patient Protection and Affordable Care Act in 2010, the task force’s findings are collected in an annual report presented to Congress, which has mandated the Centers for Disease Control and Prevention to support the work of the task force even though the task force is considered an independent, nonfederal, unpaid body. However, according to a disclaimer from the task force’s most recent clinical guideline, “recommendations made by the Task Force are independent of the U.S. government and should not be construed as an official position of the Centers for Disease Control and Prevention or the U.S. Department of Health and Human Services.
The 14 current members of the task force come from across the country, and from both the private and public spheres. The task force is chaired by Dr. Jonathan E. Fielding, director of and a health officer in the Los Angeles County Department of Health.
FROM ANNALS OF INTERNAL MEDICINE
AHS: Noncephalic pain sites shed light on progression from episodic to chronic migraine
WASHINGTON – Noncephalic pain is associated with higher likelihood of progression from episodic migraine to chronic migraine, and pain comorbidities at noncephalic locations are common with migraine regardless of headache frequency, according to findings from the CaMEO study.
The study was presented during the poster session of the American Headache Society’s annual meeting by Dr. Ann I. Scher, deputy director and professor at the Uniformed Services University of the Health Science, Bethesda, Md.
The CaMEO (Chronic Migraine Epidemiology and Outcomes) study was initiated in the fall of 2012 as a prospective, web-based study that surveyed individuals with migraine and chronic migraine using “cross-sectional modules embedded in a longitudinal design.”
The investigators used the survey’s Comorbidity/Endophenotype module to study 12,810 individuals with migraine, of whom 8,908 were randomized and completed the second assessment snapshot module 3 months after baseline.
Overall, 8,139 (91.4%) had episodic migraine and 769 (8.6%) had chronic migraine. At baseline, subjects were asked to identify noncephalic pain sites by location (head, face, neck/shoulders, back, arms/hands, legs/feet, chest, abdomen/pelvis, or other), frequency of pain (0-4 scale ranging from “never” to “always” experiencing pain), and intensity of pain (0-10 scale of “no pain” to “worst pain imaginable”).
At 3 months, the investigators followed up with patients to determine if they still had either chronic or episode migraine, and performed multivariate binary regression analysis to determine if the noncephalic pain sites were an indicator of progression from episodic to chronic migraine, based on the aforementioned factors as well as sociodemographic ones.
Subjects with episodic migraine at baseline tended to stay that way, with 278 (3.4%) progressing to chronic after 3 months. However, 385 (50.1%) of those with chronic migraine at baseline were still classified as such after 3 months, meaning nearly half went from chronic to episodic. Regression models indicated that while noncephalic pain is common for both episodic and chronic migraine, after adjustment for pain site scores and sociodemographic factors, the odds of progressing from episodic to chronic migraine increases by about 30% for each noncephalic pain site (odds ratio, 1.30; 95% confidence interval, 1.21-1.40). For those already experiencing chronic migraine, the odds of remaining that way after 3 months increase by about 6% with each noncephalic pain site (OR, 1.06, 95% CI, 0.97-1.16).
In the CaMEO study, the mean age of subjects with episodic migraine was 40.6 years versus 41.0 years for those with chronic migraine. Both cohorts were mostly female, too: 73.8% for episodic and 81.1% for chronic. Both cohorts were mostly white – 83.3% and 87.5%, respectively – while 45.9% of those with episodic and 34.9% of those with chronic migraine had at least a bachelor’s degree–level education. Sixty-six percent of those with episodic and 56.4% of those with chronic migraine held full-time employment at baseline.
The CaMEO study was sponsored by Allergan. Lead author Dr. Scher has received honoraria from Allergan and grant support from Congressionally Directed Medical Research Programs and the Center for Neuroscience and Regenerative Medicine, and is on the editorial boards of Cephalagia and Pain Medicine.
WASHINGTON – Noncephalic pain is associated with higher likelihood of progression from episodic migraine to chronic migraine, and pain comorbidities at noncephalic locations are common with migraine regardless of headache frequency, according to findings from the CaMEO study.
The study was presented during the poster session of the American Headache Society’s annual meeting by Dr. Ann I. Scher, deputy director and professor at the Uniformed Services University of the Health Science, Bethesda, Md.
The CaMEO (Chronic Migraine Epidemiology and Outcomes) study was initiated in the fall of 2012 as a prospective, web-based study that surveyed individuals with migraine and chronic migraine using “cross-sectional modules embedded in a longitudinal design.”
The investigators used the survey’s Comorbidity/Endophenotype module to study 12,810 individuals with migraine, of whom 8,908 were randomized and completed the second assessment snapshot module 3 months after baseline.
Overall, 8,139 (91.4%) had episodic migraine and 769 (8.6%) had chronic migraine. At baseline, subjects were asked to identify noncephalic pain sites by location (head, face, neck/shoulders, back, arms/hands, legs/feet, chest, abdomen/pelvis, or other), frequency of pain (0-4 scale ranging from “never” to “always” experiencing pain), and intensity of pain (0-10 scale of “no pain” to “worst pain imaginable”).
At 3 months, the investigators followed up with patients to determine if they still had either chronic or episode migraine, and performed multivariate binary regression analysis to determine if the noncephalic pain sites were an indicator of progression from episodic to chronic migraine, based on the aforementioned factors as well as sociodemographic ones.
Subjects with episodic migraine at baseline tended to stay that way, with 278 (3.4%) progressing to chronic after 3 months. However, 385 (50.1%) of those with chronic migraine at baseline were still classified as such after 3 months, meaning nearly half went from chronic to episodic. Regression models indicated that while noncephalic pain is common for both episodic and chronic migraine, after adjustment for pain site scores and sociodemographic factors, the odds of progressing from episodic to chronic migraine increases by about 30% for each noncephalic pain site (odds ratio, 1.30; 95% confidence interval, 1.21-1.40). For those already experiencing chronic migraine, the odds of remaining that way after 3 months increase by about 6% with each noncephalic pain site (OR, 1.06, 95% CI, 0.97-1.16).
In the CaMEO study, the mean age of subjects with episodic migraine was 40.6 years versus 41.0 years for those with chronic migraine. Both cohorts were mostly female, too: 73.8% for episodic and 81.1% for chronic. Both cohorts were mostly white – 83.3% and 87.5%, respectively – while 45.9% of those with episodic and 34.9% of those with chronic migraine had at least a bachelor’s degree–level education. Sixty-six percent of those with episodic and 56.4% of those with chronic migraine held full-time employment at baseline.
The CaMEO study was sponsored by Allergan. Lead author Dr. Scher has received honoraria from Allergan and grant support from Congressionally Directed Medical Research Programs and the Center for Neuroscience and Regenerative Medicine, and is on the editorial boards of Cephalagia and Pain Medicine.
WASHINGTON – Noncephalic pain is associated with higher likelihood of progression from episodic migraine to chronic migraine, and pain comorbidities at noncephalic locations are common with migraine regardless of headache frequency, according to findings from the CaMEO study.
The study was presented during the poster session of the American Headache Society’s annual meeting by Dr. Ann I. Scher, deputy director and professor at the Uniformed Services University of the Health Science, Bethesda, Md.
The CaMEO (Chronic Migraine Epidemiology and Outcomes) study was initiated in the fall of 2012 as a prospective, web-based study that surveyed individuals with migraine and chronic migraine using “cross-sectional modules embedded in a longitudinal design.”
The investigators used the survey’s Comorbidity/Endophenotype module to study 12,810 individuals with migraine, of whom 8,908 were randomized and completed the second assessment snapshot module 3 months after baseline.
Overall, 8,139 (91.4%) had episodic migraine and 769 (8.6%) had chronic migraine. At baseline, subjects were asked to identify noncephalic pain sites by location (head, face, neck/shoulders, back, arms/hands, legs/feet, chest, abdomen/pelvis, or other), frequency of pain (0-4 scale ranging from “never” to “always” experiencing pain), and intensity of pain (0-10 scale of “no pain” to “worst pain imaginable”).
At 3 months, the investigators followed up with patients to determine if they still had either chronic or episode migraine, and performed multivariate binary regression analysis to determine if the noncephalic pain sites were an indicator of progression from episodic to chronic migraine, based on the aforementioned factors as well as sociodemographic ones.
Subjects with episodic migraine at baseline tended to stay that way, with 278 (3.4%) progressing to chronic after 3 months. However, 385 (50.1%) of those with chronic migraine at baseline were still classified as such after 3 months, meaning nearly half went from chronic to episodic. Regression models indicated that while noncephalic pain is common for both episodic and chronic migraine, after adjustment for pain site scores and sociodemographic factors, the odds of progressing from episodic to chronic migraine increases by about 30% for each noncephalic pain site (odds ratio, 1.30; 95% confidence interval, 1.21-1.40). For those already experiencing chronic migraine, the odds of remaining that way after 3 months increase by about 6% with each noncephalic pain site (OR, 1.06, 95% CI, 0.97-1.16).
In the CaMEO study, the mean age of subjects with episodic migraine was 40.6 years versus 41.0 years for those with chronic migraine. Both cohorts were mostly female, too: 73.8% for episodic and 81.1% for chronic. Both cohorts were mostly white – 83.3% and 87.5%, respectively – while 45.9% of those with episodic and 34.9% of those with chronic migraine had at least a bachelor’s degree–level education. Sixty-six percent of those with episodic and 56.4% of those with chronic migraine held full-time employment at baseline.
The CaMEO study was sponsored by Allergan. Lead author Dr. Scher has received honoraria from Allergan and grant support from Congressionally Directed Medical Research Programs and the Center for Neuroscience and Regenerative Medicine, and is on the editorial boards of Cephalagia and Pain Medicine.
AT THE AHS ANNUAL MEETING
Key clinical point: Noncephalic pain is a key indicator of how likely a patient is of progressing from episodic to chronic migraine.
Major finding: For patients with episodic migraine, the odds of developing chronic migraine increased by 42% with each additional noncephalic pain site.
Data source: The CaMEO study – a prospective, web-based study with several modules; specifically, the “Comorbidity/Endophenotype” module, which examined 8,908 chronic and episodic migraine sufferers over a 3-month period.
Disclosures: Dr. Scher has received honoraria from Allergan and grant support from Congressionally Directed Medical Research Programs and the Center for Neuroscience and Regenerative Medicine, and is on the editorial boards of Cephalagia and Pain Medicine.
Lithium, caffeine effective for hypnic headache treatment
WASHINGTON – Lithium is the best treatment option for patients with hypnic headaches, according to a retrospective, cross-sectional study presented by Dr. Nauman Tariq of the Cleveland Clinic at the annual meeting of the American Headache Society.
The study, which looked at a series of 40 patients, is the largest to date from a single institution and examined treatment of hypnic headache, defined as a primary headache disorder characterized by onset during sleep that causes waking.
Seven patients were excluded for having active chronic migraine, and one who was taking lithium was excluded after developing renal side effects. Dr. Tariq and his associates studied the efficacy of 13 different treatments on the 32 remaining patients, between October 2008 and September 2014 using ICD-9 codes and the International Classification of Headache Disorders II and III–beta criteria for diagnosis.
Lithium had the highest positive response rate of all treatments, with 70% of study subjects experiencing complete response and 20% experiencing moderate response, defined as more than a 50% improvement in the frequency and intensity of hypnic headache episodes.
The researchers reported that the second-best treatment option was caffeine taken before bedtime, which induced complete response in 29% of subjects and moderate response in 33% of subjects. Dr. Tariq also stated that consuming caffeine upon awakening can also help alleviate symptoms. One patient on the lithium regimen was removed from the study after experiencing renal side effects.
Of the 32 patients included in the study, 86% were women, with a mean headache onset age of 62 years and a range of 44 to 83 years of age. More than half (59%) of subjects had a previous history of migraine prior to the study, and 90% experienced hypnic headaches between 1:00 a.m. and 5:00 a.m. Mean duration of these episodes was 193 minutes – with a range of 45-720 minutes. The mean number of days per month subjects were awakened due to hypnic headache was 21 days, with 20% of subjects experiencing headaches lasting longer than 4 hours.
Dr. Tariq did not report any relevant financial disclosures.
WASHINGTON – Lithium is the best treatment option for patients with hypnic headaches, according to a retrospective, cross-sectional study presented by Dr. Nauman Tariq of the Cleveland Clinic at the annual meeting of the American Headache Society.
The study, which looked at a series of 40 patients, is the largest to date from a single institution and examined treatment of hypnic headache, defined as a primary headache disorder characterized by onset during sleep that causes waking.
Seven patients were excluded for having active chronic migraine, and one who was taking lithium was excluded after developing renal side effects. Dr. Tariq and his associates studied the efficacy of 13 different treatments on the 32 remaining patients, between October 2008 and September 2014 using ICD-9 codes and the International Classification of Headache Disorders II and III–beta criteria for diagnosis.
Lithium had the highest positive response rate of all treatments, with 70% of study subjects experiencing complete response and 20% experiencing moderate response, defined as more than a 50% improvement in the frequency and intensity of hypnic headache episodes.
The researchers reported that the second-best treatment option was caffeine taken before bedtime, which induced complete response in 29% of subjects and moderate response in 33% of subjects. Dr. Tariq also stated that consuming caffeine upon awakening can also help alleviate symptoms. One patient on the lithium regimen was removed from the study after experiencing renal side effects.
Of the 32 patients included in the study, 86% were women, with a mean headache onset age of 62 years and a range of 44 to 83 years of age. More than half (59%) of subjects had a previous history of migraine prior to the study, and 90% experienced hypnic headaches between 1:00 a.m. and 5:00 a.m. Mean duration of these episodes was 193 minutes – with a range of 45-720 minutes. The mean number of days per month subjects were awakened due to hypnic headache was 21 days, with 20% of subjects experiencing headaches lasting longer than 4 hours.
Dr. Tariq did not report any relevant financial disclosures.
WASHINGTON – Lithium is the best treatment option for patients with hypnic headaches, according to a retrospective, cross-sectional study presented by Dr. Nauman Tariq of the Cleveland Clinic at the annual meeting of the American Headache Society.
The study, which looked at a series of 40 patients, is the largest to date from a single institution and examined treatment of hypnic headache, defined as a primary headache disorder characterized by onset during sleep that causes waking.
Seven patients were excluded for having active chronic migraine, and one who was taking lithium was excluded after developing renal side effects. Dr. Tariq and his associates studied the efficacy of 13 different treatments on the 32 remaining patients, between October 2008 and September 2014 using ICD-9 codes and the International Classification of Headache Disorders II and III–beta criteria for diagnosis.
Lithium had the highest positive response rate of all treatments, with 70% of study subjects experiencing complete response and 20% experiencing moderate response, defined as more than a 50% improvement in the frequency and intensity of hypnic headache episodes.
The researchers reported that the second-best treatment option was caffeine taken before bedtime, which induced complete response in 29% of subjects and moderate response in 33% of subjects. Dr. Tariq also stated that consuming caffeine upon awakening can also help alleviate symptoms. One patient on the lithium regimen was removed from the study after experiencing renal side effects.
Of the 32 patients included in the study, 86% were women, with a mean headache onset age of 62 years and a range of 44 to 83 years of age. More than half (59%) of subjects had a previous history of migraine prior to the study, and 90% experienced hypnic headaches between 1:00 a.m. and 5:00 a.m. Mean duration of these episodes was 193 minutes – with a range of 45-720 minutes. The mean number of days per month subjects were awakened due to hypnic headache was 21 days, with 20% of subjects experiencing headaches lasting longer than 4 hours.
Dr. Tariq did not report any relevant financial disclosures.
AT THE AHS ANNUAL MEETING
Key clinical point: Lithium is the most effective treatment option followed by caffeine at bedtime in patients with hypnic headaches; caffeine consumption after awakening is also effective.
Major finding: Among 13 different medications, the best response was seen with lithium (7 of 10 [70%] complete response and 2 of 10 [20%] moderate response). With caffeine, there was a complete response in 5 of 17 (29%) and moderate response in 6 of 18 (33%) subjects.
Data source: Retrospective, cross-sectional study of 32 hypnic headache patients.
Disclosures: Dr. Tariq did not report any relevant financial conflicts.
Investigative agent effective against episodic migraine
WASHINGTON – AMG 334, a fully human monoclonal antibody that blocks the calcitonin gene-related peptide (CGRP) receptor, is an effective treatment for episodic migraine when administered in 70-mg doses, Dr. Robert Lenz of Amgen said at the annual meeting of the American Headache Society.
The researchers randomized 483 patients with episodic migraine – characterized as experiencing at least 4 and no more than 14 migraines per month – into cohorts receiving a 70-mg dose (107 subjects), a 21-mg dose (108 patients), a 7-mg dose (108 patients), or a placebo (160 subjects). The primary endpoint measure was a reduction in the number of migraine episodes from baseline to 12 weeks. Secondary endpoints were overall reduction in migraine episodes per month, the number of patients who experienced an episode reduction of at least 50%, and safety/tolerability factors. Women comprised 81% of the study population, and mean age was 41 years.
Patients on the 70-mg dosage of AMG 334 had a mean reduction of 3.40 migraine days per month, versus the 2.28 mean migraine-days reduction observed in the placebo cohort (P = .021). In secondary outcomes, 46.5% of patients taking 70 mg of AMG 334 experienced an episode reduction per month of at least 50%, compared with only 29.9% in the placebo cohort (P = .011); reductions were also seen in monthly headache days (3.54 in 70-mg cohort vs. 2.39 in placebo cohort, P = .022) and monthly migraine specific–medication use days (1.64 in 70-mg cohort vs. 0.69 in placebo cohort, P = .004).
There were no significant differences in the safety and tolerability data between the AMG 334 70-mg patients and those taking the placebo. Subjects in the cohorts receiving 7-mg and 21-mg doses of AMG 334 did not experience a statistically significant reduction in mean migraine days.
Dr. Lenz is employed by Amgen and receives a salary, stock options, and ownership interests.
WASHINGTON – AMG 334, a fully human monoclonal antibody that blocks the calcitonin gene-related peptide (CGRP) receptor, is an effective treatment for episodic migraine when administered in 70-mg doses, Dr. Robert Lenz of Amgen said at the annual meeting of the American Headache Society.
The researchers randomized 483 patients with episodic migraine – characterized as experiencing at least 4 and no more than 14 migraines per month – into cohorts receiving a 70-mg dose (107 subjects), a 21-mg dose (108 patients), a 7-mg dose (108 patients), or a placebo (160 subjects). The primary endpoint measure was a reduction in the number of migraine episodes from baseline to 12 weeks. Secondary endpoints were overall reduction in migraine episodes per month, the number of patients who experienced an episode reduction of at least 50%, and safety/tolerability factors. Women comprised 81% of the study population, and mean age was 41 years.
Patients on the 70-mg dosage of AMG 334 had a mean reduction of 3.40 migraine days per month, versus the 2.28 mean migraine-days reduction observed in the placebo cohort (P = .021). In secondary outcomes, 46.5% of patients taking 70 mg of AMG 334 experienced an episode reduction per month of at least 50%, compared with only 29.9% in the placebo cohort (P = .011); reductions were also seen in monthly headache days (3.54 in 70-mg cohort vs. 2.39 in placebo cohort, P = .022) and monthly migraine specific–medication use days (1.64 in 70-mg cohort vs. 0.69 in placebo cohort, P = .004).
There were no significant differences in the safety and tolerability data between the AMG 334 70-mg patients and those taking the placebo. Subjects in the cohorts receiving 7-mg and 21-mg doses of AMG 334 did not experience a statistically significant reduction in mean migraine days.
Dr. Lenz is employed by Amgen and receives a salary, stock options, and ownership interests.
WASHINGTON – AMG 334, a fully human monoclonal antibody that blocks the calcitonin gene-related peptide (CGRP) receptor, is an effective treatment for episodic migraine when administered in 70-mg doses, Dr. Robert Lenz of Amgen said at the annual meeting of the American Headache Society.
The researchers randomized 483 patients with episodic migraine – characterized as experiencing at least 4 and no more than 14 migraines per month – into cohorts receiving a 70-mg dose (107 subjects), a 21-mg dose (108 patients), a 7-mg dose (108 patients), or a placebo (160 subjects). The primary endpoint measure was a reduction in the number of migraine episodes from baseline to 12 weeks. Secondary endpoints were overall reduction in migraine episodes per month, the number of patients who experienced an episode reduction of at least 50%, and safety/tolerability factors. Women comprised 81% of the study population, and mean age was 41 years.
Patients on the 70-mg dosage of AMG 334 had a mean reduction of 3.40 migraine days per month, versus the 2.28 mean migraine-days reduction observed in the placebo cohort (P = .021). In secondary outcomes, 46.5% of patients taking 70 mg of AMG 334 experienced an episode reduction per month of at least 50%, compared with only 29.9% in the placebo cohort (P = .011); reductions were also seen in monthly headache days (3.54 in 70-mg cohort vs. 2.39 in placebo cohort, P = .022) and monthly migraine specific–medication use days (1.64 in 70-mg cohort vs. 0.69 in placebo cohort, P = .004).
There were no significant differences in the safety and tolerability data between the AMG 334 70-mg patients and those taking the placebo. Subjects in the cohorts receiving 7-mg and 21-mg doses of AMG 334 did not experience a statistically significant reduction in mean migraine days.
Dr. Lenz is employed by Amgen and receives a salary, stock options, and ownership interests.
AT THE AHS ANNUAL MEETING
Key clinical point:The AMG 334 antibody, in 70-mg doses, is an effective treatment option against episodic migraine.
Major finding: Subjects on 70 mg AMG 334 experienced a mean migraine-days per month reduction of 3.40 versus 2.28 for subjects on placebo (P = .021).
Data source: Phase II, double-blind, placebo-controlled study of 483 patients.
Disclosures: Dr. Lenz is employed by Amgen and receives a salary, stock options, and ownership interests.
AHS: Intravenous diphenhydramine does not improve acute migraine outcomes
WASHINGTON – Intravenous diphenhydramine is not an effective adjuvant therapy for the treatment of acute migraine, according to a study presented by Dr. Ben Friedman at the annual meeting of the American Headache Society.
Dr. Friedman of the department of emergency medicine at Albert Einstein College of Medicine in New York explained that no high-quality evidence exists to support or refute the role of antihistamines in the treatment of acute migraine. Therefore, the purpose of Dr. Friedman’s investigation was to confirm that acute migraine, of either moderate or severe intensity, can be effectively treated by a combination of diphenhydramine 50 mg IV plus metoclopramide 10 mg IV, rather than a placebo and metoclopramide 10 mg IV.
All subjects were no older than 65 years and presented to an emergency department with acute or severe migraine, or had probable migraine without aura – International Classification of Headache Disorders, 2nd edition, diagnoses 1.1 and 1.6.1, respectively – in the previous year. Patients were excluded if they had a history of allergy, a contraindication, intolerance of medications in the trial, or suspicion of secondary headache.
In total, 420 patients were deemed eligible for inclusion and 208 ultimately consented; they were randomized into either the placebo or diphenhydramine arm, and followed for 21 months starting in April 2013. The primary outcome was defined as achieving a mild headache, or no headache at all, within 2 hours of receiving medication and maintaining that level for at least 48 hours. The secondary outcome was an average improvement in the 0-10 numerical migraine rating scale within 1 hour of taking medication.
The results between the two cohorts, however, were not significantly different, and the study was halted for futility by a data safety monitoring committee at a planned interim analysis because of the lack of effect of diphenhydramine. Of patients randomized to diphenhydramine, 40% reported sustained relief, compared with 37% of patients randomized to placebo. One hour after medication administration, those randomized to diphenhydramine improved by a mean of 5.1 on a 0-10 scale, versus 4.8 for those randomized to placebo. Overall, 85% of the patients in the diphenhydramine arm reported they would want the same medication combination during a subsequent ED visit, as did 76% of those who received placebo. The length of stay in emergency departments – 122 minutes for patients who took diphenhydramine versus 131 minutes for those who took placebo – and the rates of side effects were also not significantly different between the two cohorts.
Eighty-five percent of the diphenhydramine group (88/104) were females, while 89% (92/104) were female in the placebo group. The average age was 34 years versus 36 years, while 64% (66 of 104) and 65% (67 of 104) were taking some form of medication before coming to the emergency department, respectively. Both cohorts reported a mean of 3 headache days per subject at baseline.
Although the study was conducted at just a single center (Montefiore Medical Center) within an underserved population, the results of the study clearly show that “there is no reason to administer [intravenous] diphenhydramine routinely for patients who present with acute or severe migraine,” Dr. Friedman said.
He did not report any relevant financial disclosures.
WASHINGTON – Intravenous diphenhydramine is not an effective adjuvant therapy for the treatment of acute migraine, according to a study presented by Dr. Ben Friedman at the annual meeting of the American Headache Society.
Dr. Friedman of the department of emergency medicine at Albert Einstein College of Medicine in New York explained that no high-quality evidence exists to support or refute the role of antihistamines in the treatment of acute migraine. Therefore, the purpose of Dr. Friedman’s investigation was to confirm that acute migraine, of either moderate or severe intensity, can be effectively treated by a combination of diphenhydramine 50 mg IV plus metoclopramide 10 mg IV, rather than a placebo and metoclopramide 10 mg IV.
All subjects were no older than 65 years and presented to an emergency department with acute or severe migraine, or had probable migraine without aura – International Classification of Headache Disorders, 2nd edition, diagnoses 1.1 and 1.6.1, respectively – in the previous year. Patients were excluded if they had a history of allergy, a contraindication, intolerance of medications in the trial, or suspicion of secondary headache.
In total, 420 patients were deemed eligible for inclusion and 208 ultimately consented; they were randomized into either the placebo or diphenhydramine arm, and followed for 21 months starting in April 2013. The primary outcome was defined as achieving a mild headache, or no headache at all, within 2 hours of receiving medication and maintaining that level for at least 48 hours. The secondary outcome was an average improvement in the 0-10 numerical migraine rating scale within 1 hour of taking medication.
The results between the two cohorts, however, were not significantly different, and the study was halted for futility by a data safety monitoring committee at a planned interim analysis because of the lack of effect of diphenhydramine. Of patients randomized to diphenhydramine, 40% reported sustained relief, compared with 37% of patients randomized to placebo. One hour after medication administration, those randomized to diphenhydramine improved by a mean of 5.1 on a 0-10 scale, versus 4.8 for those randomized to placebo. Overall, 85% of the patients in the diphenhydramine arm reported they would want the same medication combination during a subsequent ED visit, as did 76% of those who received placebo. The length of stay in emergency departments – 122 minutes for patients who took diphenhydramine versus 131 minutes for those who took placebo – and the rates of side effects were also not significantly different between the two cohorts.
Eighty-five percent of the diphenhydramine group (88/104) were females, while 89% (92/104) were female in the placebo group. The average age was 34 years versus 36 years, while 64% (66 of 104) and 65% (67 of 104) were taking some form of medication before coming to the emergency department, respectively. Both cohorts reported a mean of 3 headache days per subject at baseline.
Although the study was conducted at just a single center (Montefiore Medical Center) within an underserved population, the results of the study clearly show that “there is no reason to administer [intravenous] diphenhydramine routinely for patients who present with acute or severe migraine,” Dr. Friedman said.
He did not report any relevant financial disclosures.
WASHINGTON – Intravenous diphenhydramine is not an effective adjuvant therapy for the treatment of acute migraine, according to a study presented by Dr. Ben Friedman at the annual meeting of the American Headache Society.
Dr. Friedman of the department of emergency medicine at Albert Einstein College of Medicine in New York explained that no high-quality evidence exists to support or refute the role of antihistamines in the treatment of acute migraine. Therefore, the purpose of Dr. Friedman’s investigation was to confirm that acute migraine, of either moderate or severe intensity, can be effectively treated by a combination of diphenhydramine 50 mg IV plus metoclopramide 10 mg IV, rather than a placebo and metoclopramide 10 mg IV.
All subjects were no older than 65 years and presented to an emergency department with acute or severe migraine, or had probable migraine without aura – International Classification of Headache Disorders, 2nd edition, diagnoses 1.1 and 1.6.1, respectively – in the previous year. Patients were excluded if they had a history of allergy, a contraindication, intolerance of medications in the trial, or suspicion of secondary headache.
In total, 420 patients were deemed eligible for inclusion and 208 ultimately consented; they were randomized into either the placebo or diphenhydramine arm, and followed for 21 months starting in April 2013. The primary outcome was defined as achieving a mild headache, or no headache at all, within 2 hours of receiving medication and maintaining that level for at least 48 hours. The secondary outcome was an average improvement in the 0-10 numerical migraine rating scale within 1 hour of taking medication.
The results between the two cohorts, however, were not significantly different, and the study was halted for futility by a data safety monitoring committee at a planned interim analysis because of the lack of effect of diphenhydramine. Of patients randomized to diphenhydramine, 40% reported sustained relief, compared with 37% of patients randomized to placebo. One hour after medication administration, those randomized to diphenhydramine improved by a mean of 5.1 on a 0-10 scale, versus 4.8 for those randomized to placebo. Overall, 85% of the patients in the diphenhydramine arm reported they would want the same medication combination during a subsequent ED visit, as did 76% of those who received placebo. The length of stay in emergency departments – 122 minutes for patients who took diphenhydramine versus 131 minutes for those who took placebo – and the rates of side effects were also not significantly different between the two cohorts.
Eighty-five percent of the diphenhydramine group (88/104) were females, while 89% (92/104) were female in the placebo group. The average age was 34 years versus 36 years, while 64% (66 of 104) and 65% (67 of 104) were taking some form of medication before coming to the emergency department, respectively. Both cohorts reported a mean of 3 headache days per subject at baseline.
Although the study was conducted at just a single center (Montefiore Medical Center) within an underserved population, the results of the study clearly show that “there is no reason to administer [intravenous] diphenhydramine routinely for patients who present with acute or severe migraine,” Dr. Friedman said.
He did not report any relevant financial disclosures.
AT THE AHS ANNUAL MEETING
Key clinical point: Intravenous diphenhydramine, when administered as adjuvant therapy, does not improve migraine outcomes.
Major finding: Overall, 40% of patients who took diphenhydramine plus metoclopramide reported sustained relief, compared with 37% of patients randomized to placebo.
Data source: A randomized, double-blind placebo-controlled trial of 208 patients over a 21-month period starting in April 2013.
Disclosures: Dr. Friedman did not report any relevant financial disclosures.
