Karen Blum

Borderline personality disorder and bipolar II disorder share some common features, but the illnesses can be distinguished by patients’ differences in emotion regulation strategies and perceptions of how their parents raised them, according to a report published online in the Journal of Affective Disorders.

Forty-eight psychiatric outpatients, half with borderline personality disorder and half with bipolar II, were recruited by Kathryn Fletcher of the University of New South Wales, Sydney, and the Black Dog Institute, Randwick, and her colleagues. The mean age of the outpatients was 33 years. Those with borderline reported a younger age of depression onset, and a higher proportion of patients in that group had more lifetime suicide and attempts at self-harm.

The participants completed the Cognitive Emotion Regulation Questionnaire and the Difficulties in Emotion Regulation Scale, both 36-item tests aimed at assessing strategies to regulate emotion. They also completed the Measure of Parental Style, a test that seeks to assess perceived parent abuse, indifference, and overcontrol.

Overall, the investigators found that the outpatients with borderline personality disorder scored "significantly higher than those with [bipolar II] on a number of maladaptive emotion regulation strategies, including difficulty controlling impulsive behaviors, having limited access to emotion regulation strategies, and a tendency to self-blame, catastrophize, and blame others," Ms. Fletcher and her colleagues wrote (J. Affect. Disord. 2014;157:52-9).

They found that the outpatients with borderline personality disorder were "significantly less likely than those with [bipolar II] to use adaptive cognitive emotion regulation strategies, including planning, positive reappraisal, and putting things into perspective."

Those with borderline also scored significantly higher on most perceived parental style subscales, "indicating a maternal relationship characterized by indifference, abuse, and overcontrol and a paternal relationship characterized by abuse and overcontrol."

Identifying "maladaptive strategies to regulate emotion highlights specific targets for psychological intervention," the authors said. "However, given that those with [borderline personality disorder] and [bipolar II] displayed differing patterns of emotion dysregulation, there may be a need to tailor intervention strategies," such as positive reappraisal and promotion of acceptance in borderline.

Psychological therapies focusing on lessening the impact of "toxic childhood experiences" might help patients with both disorders, they said.

Ms. Fletcher and her colleagues cited several limitations. Among them were a relatively small sample size and the absence of statistical control for numerous sociodemographic and clinical characteristics that differed between the groups.

This study was supported by the National Health and Medical Research Council, Australia’s main funding body for medical research. The authors reported no relevant financial conflicts of interest.

Borderline personality disorder and bipolar II disorder share some common features, but the illnesses can be distinguished by patients’ differences in emotion regulation strategies and perceptions of how their parents raised them, according to a report published online in the Journal of Affective Disorders.

Forty-eight psychiatric outpatients, half with borderline personality disorder and half with bipolar II, were recruited by Kathryn Fletcher of the University of New South Wales, Sydney, and the Black Dog Institute, Randwick, and her colleagues. The mean age of the outpatients was 33 years. Those with borderline reported a younger age of depression onset, and a higher proportion of patients in that group had more lifetime suicide and attempts at self-harm.

The participants completed the Cognitive Emotion Regulation Questionnaire and the Difficulties in Emotion Regulation Scale, both 36-item tests aimed at assessing strategies to regulate emotion. They also completed the Measure of Parental Style, a test that seeks to assess perceived parent abuse, indifference, and overcontrol.

Overall, the investigators found that the outpatients with borderline personality disorder scored "significantly higher than those with [bipolar II] on a number of maladaptive emotion regulation strategies, including difficulty controlling impulsive behaviors, having limited access to emotion regulation strategies, and a tendency to self-blame, catastrophize, and blame others," Ms. Fletcher and her colleagues wrote (J. Affect. Disord. 2014;157:52-9).

They found that the outpatients with borderline personality disorder were "significantly less likely than those with [bipolar II] to use adaptive cognitive emotion regulation strategies, including planning, positive reappraisal, and putting things into perspective."

Those with borderline also scored significantly higher on most perceived parental style subscales, "indicating a maternal relationship characterized by indifference, abuse, and overcontrol and a paternal relationship characterized by abuse and overcontrol."

Identifying "maladaptive strategies to regulate emotion highlights specific targets for psychological intervention," the authors said. "However, given that those with [borderline personality disorder] and [bipolar II] displayed differing patterns of emotion dysregulation, there may be a need to tailor intervention strategies," such as positive reappraisal and promotion of acceptance in borderline.

Psychological therapies focusing on lessening the impact of "toxic childhood experiences" might help patients with both disorders, they said.

Ms. Fletcher and her colleagues cited several limitations. Among them were a relatively small sample size and the absence of statistical control for numerous sociodemographic and clinical characteristics that differed between the groups.

This study was supported by the National Health and Medical Research Council, Australia’s main funding body for medical research. The authors reported no relevant financial conflicts of interest.

Borderline personality disorder and bipolar II disorder share some common features, but the illnesses can be distinguished by patients’ differences in emotion regulation strategies and perceptions of how their parents raised them, according to a report published online in the Journal of Affective Disorders.

Forty-eight psychiatric outpatients, half with borderline personality disorder and half with bipolar II, were recruited by Kathryn Fletcher of the University of New South Wales, Sydney, and the Black Dog Institute, Randwick, and her colleagues. The mean age of the outpatients was 33 years. Those with borderline reported a younger age of depression onset, and a higher proportion of patients in that group had more lifetime suicide and attempts at self-harm.

The participants completed the Cognitive Emotion Regulation Questionnaire and the Difficulties in Emotion Regulation Scale, both 36-item tests aimed at assessing strategies to regulate emotion. They also completed the Measure of Parental Style, a test that seeks to assess perceived parent abuse, indifference, and overcontrol.

Overall, the investigators found that the outpatients with borderline personality disorder scored "significantly higher than those with [bipolar II] on a number of maladaptive emotion regulation strategies, including difficulty controlling impulsive behaviors, having limited access to emotion regulation strategies, and a tendency to self-blame, catastrophize, and blame others," Ms. Fletcher and her colleagues wrote (J. Affect. Disord. 2014;157:52-9).

They found that the outpatients with borderline personality disorder were "significantly less likely than those with [bipolar II] to use adaptive cognitive emotion regulation strategies, including planning, positive reappraisal, and putting things into perspective."

Those with borderline also scored significantly higher on most perceived parental style subscales, "indicating a maternal relationship characterized by indifference, abuse, and overcontrol and a paternal relationship characterized by abuse and overcontrol."

Identifying "maladaptive strategies to regulate emotion highlights specific targets for psychological intervention," the authors said. "However, given that those with [borderline personality disorder] and [bipolar II] displayed differing patterns of emotion dysregulation, there may be a need to tailor intervention strategies," such as positive reappraisal and promotion of acceptance in borderline.

Psychological therapies focusing on lessening the impact of "toxic childhood experiences" might help patients with both disorders, they said.

Ms. Fletcher and her colleagues cited several limitations. Among them were a relatively small sample size and the absence of statistical control for numerous sociodemographic and clinical characteristics that differed between the groups.

This study was supported by the National Health and Medical Research Council, Australia’s main funding body for medical research. The authors reported no relevant financial conflicts of interest.

In areas where video electroencephalography is not available, clinicians can use a staged approach to diagnosing psychogenic nonepileptic seizures, incorporating medical histories, eyewitness accounts, and video recordings of seizure activity, an international study group has found.

Most patients with recurrent seizures are presumed to have epilepsy and are treated with antiepileptic drugs (AEDs), but AEDs do not treat psychogenic nonepileptic seizures (PNES) and could exacerbate them. Therefore, early and accurate recognition of PNES is "of paramount importance," according to an International League Against Epilepsy task force led by Dr. W. Curt LaFrance Jr. of Rhode Island Hospital and Brown University, Providence. It noted, however, that the matter is complicated by the fact that epilepsy is a recognized risk factor for the development of PNES.

The task force’s report aims "to provide greater clarity about the process and certainty of the diagnosis of PNES, with the intent to improve the care for people with epilepsy and nonepileptic seizures," the authors wrote. "The ability to diagnose PNES when vEEG is not available may open opportunities to lower and middle income countries where monitoring is not available."

The authors reviewed the medical literature to evaluate approaches to diagnosing PNES, including taking a history; electroencephalogram (EEG); ambulatory EEG; video EEG/monitoring; neurophysiologic, neurohumoral, neuroimaging, and neuropsychological testing; hypnosis; and conversation analysis (Epilepsia 2013 Sept. 20 [doi:10.1111/epi.12356]).

The combination of video EEG, along with history taken from patients and witnesses, offers the diagnostic standard, "however, vEEG is not available in some locations, and in some patients, events cannot be recorded," the authors said.

The group suggested four categories of certainty for PNES diagnosis, and what clinicians would need:

• Documented PNES relies on clinical history plus a vEEG recording of habitual events.

• Clinically established PNES is defined by a clinical history, clinician witness, plus ambulatory EEG recording of habitual event(s) without video. This would be appropriate if a clinician witness observed a seizure and documented the exam findings typically found in PNES, like resisted eye-opening, or if a clinician could review a non-EEG event by video or in person.

• Probable PNES is determined by a clinical history, a clinician review of video recording or live events, and a normal interictal EEG. This would be appropriate if a clinician could review a home or cell phone video recording of seizure activity or witness it live.

• Possible PNES relies on clinical history from the patient and/or witness and a normal interictal EEG. At minimum, a patient’s history and description of events and an eyewitness description could help identify possible PNES, but without the clinician "observing the ictus on video or in person, an alternative diagnosis of epilepsy would have to be considered very carefully."

The authors reported no conflicts of interest.

In areas where video electroencephalography is not available, clinicians can use a staged approach to diagnosing psychogenic nonepileptic seizures, incorporating medical histories, eyewitness accounts, and video recordings of seizure activity, an international study group has found.

Most patients with recurrent seizures are presumed to have epilepsy and are treated with antiepileptic drugs (AEDs), but AEDs do not treat psychogenic nonepileptic seizures (PNES) and could exacerbate them. Therefore, early and accurate recognition of PNES is "of paramount importance," according to an International League Against Epilepsy task force led by Dr. W. Curt LaFrance Jr. of Rhode Island Hospital and Brown University, Providence. It noted, however, that the matter is complicated by the fact that epilepsy is a recognized risk factor for the development of PNES.

The task force’s report aims "to provide greater clarity about the process and certainty of the diagnosis of PNES, with the intent to improve the care for people with epilepsy and nonepileptic seizures," the authors wrote. "The ability to diagnose PNES when vEEG is not available may open opportunities to lower and middle income countries where monitoring is not available."

The authors reviewed the medical literature to evaluate approaches to diagnosing PNES, including taking a history; electroencephalogram (EEG); ambulatory EEG; video EEG/monitoring; neurophysiologic, neurohumoral, neuroimaging, and neuropsychological testing; hypnosis; and conversation analysis (Epilepsia 2013 Sept. 20 [doi:10.1111/epi.12356]).

The combination of video EEG, along with history taken from patients and witnesses, offers the diagnostic standard, "however, vEEG is not available in some locations, and in some patients, events cannot be recorded," the authors said.

The group suggested four categories of certainty for PNES diagnosis, and what clinicians would need:

• Documented PNES relies on clinical history plus a vEEG recording of habitual events.

• Clinically established PNES is defined by a clinical history, clinician witness, plus ambulatory EEG recording of habitual event(s) without video. This would be appropriate if a clinician witness observed a seizure and documented the exam findings typically found in PNES, like resisted eye-opening, or if a clinician could review a non-EEG event by video or in person.

• Probable PNES is determined by a clinical history, a clinician review of video recording or live events, and a normal interictal EEG. This would be appropriate if a clinician could review a home or cell phone video recording of seizure activity or witness it live.

• Possible PNES relies on clinical history from the patient and/or witness and a normal interictal EEG. At minimum, a patient’s history and description of events and an eyewitness description could help identify possible PNES, but without the clinician "observing the ictus on video or in person, an alternative diagnosis of epilepsy would have to be considered very carefully."

The authors reported no conflicts of interest.

In areas where video electroencephalography is not available, clinicians can use a staged approach to diagnosing psychogenic nonepileptic seizures, incorporating medical histories, eyewitness accounts, and video recordings of seizure activity, an international study group has found.

Most patients with recurrent seizures are presumed to have epilepsy and are treated with antiepileptic drugs (AEDs), but AEDs do not treat psychogenic nonepileptic seizures (PNES) and could exacerbate them. Therefore, early and accurate recognition of PNES is "of paramount importance," according to an International League Against Epilepsy task force led by Dr. W. Curt LaFrance Jr. of Rhode Island Hospital and Brown University, Providence. It noted, however, that the matter is complicated by the fact that epilepsy is a recognized risk factor for the development of PNES.

The task force’s report aims "to provide greater clarity about the process and certainty of the diagnosis of PNES, with the intent to improve the care for people with epilepsy and nonepileptic seizures," the authors wrote. "The ability to diagnose PNES when vEEG is not available may open opportunities to lower and middle income countries where monitoring is not available."

The authors reviewed the medical literature to evaluate approaches to diagnosing PNES, including taking a history; electroencephalogram (EEG); ambulatory EEG; video EEG/monitoring; neurophysiologic, neurohumoral, neuroimaging, and neuropsychological testing; hypnosis; and conversation analysis (Epilepsia 2013 Sept. 20 [doi:10.1111/epi.12356]).

The combination of video EEG, along with history taken from patients and witnesses, offers the diagnostic standard, "however, vEEG is not available in some locations, and in some patients, events cannot be recorded," the authors said.

The group suggested four categories of certainty for PNES diagnosis, and what clinicians would need:

• Documented PNES relies on clinical history plus a vEEG recording of habitual events.

• Clinically established PNES is defined by a clinical history, clinician witness, plus ambulatory EEG recording of habitual event(s) without video. This would be appropriate if a clinician witness observed a seizure and documented the exam findings typically found in PNES, like resisted eye-opening, or if a clinician could review a non-EEG event by video or in person.

• Probable PNES is determined by a clinical history, a clinician review of video recording or live events, and a normal interictal EEG. This would be appropriate if a clinician could review a home or cell phone video recording of seizure activity or witness it live.

• Possible PNES relies on clinical history from the patient and/or witness and a normal interictal EEG. At minimum, a patient’s history and description of events and an eyewitness description could help identify possible PNES, but without the clinician "observing the ictus on video or in person, an alternative diagnosis of epilepsy would have to be considered very carefully."

The authors reported no conflicts of interest.

Phenotypic and genetic data collected from patients with Lennox-Gastaut syndrome of unknown cause suggest that the condition has a broad range of epilepsy onset, predominantly affects males, and often is associated with normal development prior to the onset of seizures.

The study, conducted by Dr. Peter Widdess-Walsh of UPMC Beacon Hospital in Dublin, Ireland, and his colleagues, is the largest to date to describe the phenotype of patients with Lennox-Gastaut syndrome of unknown cause (LGS_u), which accounts for about 25% of cases. It is part of the Epilepsy

Phenome/Genome Project, a collaborative effort of 27 epilepsy centers in the United States, Australia, New Zealand, and Argentina to collect detailed phenotypic and genetic data on large numbers of patients with epilepsy. Dr. Widdess-Walsh was at St. Barnabas Medical Center in Livingston, N.J., when he conducted the analysis.

"Systematic definition of the clinical phenotype of LGS_u is critical to expand our knowledge of this distinctive subgroup of LGS and to correlate with genetic studies. ... By collecting comprehensive phenotypic data on these subjects, we will be well positioned to understand the consequences of the mutations identified in a future genomic analysis," many of which are suspected to occur de novo, the investigators wrote.

Dr. Widdess-Walsh and his associates reviewed medical history and records of 135 patients with LGS_u and their parents from 19 centers in the United States and Australia. These data included a representative EEG and brain MRI, and all patients and their parents contributed blood samples processed for DNA extraction and creation of immortalized cell lines. The investigators excluded patients with autism, moderate to severe developmental delay prior to the onset of seizures, a history of epilepsy in either parent, known genetic syndrome, TORCH (toxoplasmosis, rubella, cytomegalovirus, and herpes simplex virus) infection, metabolic disease, premature birth before 32 weeks, structural MRI lesion, hypoxic-ischemic encephalopathy, meningitis/encephalitis, stroke/intracerebral hemorrhage, microcephaly less than 2.5 standard deviations from normal, and significant head trauma (Epilepsia 2013 Oct. 7 [doi: 10.1111/epi.12395]).

The median age at enrollment was 14 years (range, 2-51 years), and 66% of patients were male. The 2:1 preponderance of males affected by the syndrome in this series "suggests that the vulnerability of the male brain extends to epilepsy in early life," possibly because of early exposure to pulses of testosterone or mutations involving genes on the X chromosome, according to the investigators.

Overall, 33 patients (24%) had mild developmental delay before onset of seizures, while 80 (59%) had normal development. Records did not clearly state whether the remaining 22 patients had developmental delay prior to their first seizure. Despite the invariable decline in development seen in patients with LGS_u, 21 of the 50 patients who were age 18 or older were secondary school graduates and 2 had completed some college. This group had no developmental delay prior to seizure onset, and no history of special education as reported by parents. Twenty patients did not complete high school; 13 of them had some mild developmental delay documented prior to seizure onset and had a history of special education. Information about schooling for the remaining seven patients was not known or not asked.

However, the schooling data were biased by the study’s exclusion of patients with moderate to severe developmental delay prior to the onset of seizures, the investigators said, and inclusive education programs to promote school completion may have contributed to their educational achievements. A bias toward enrolling patients with higher cognitive function also could have contributed to these findings.

The most common seizure types were absence (80%), atonic (65%), generalized tonic-clonic (60%), and tonic (55%). All patients had EEG recordings with generalized epileptiform abnormalities. Specific EEG phenotypic features could be assessed from digital EEG data of 71 patients, including generalized single spike and wave complexes seen in 39 (55%) with a frequency range of 1-5 Hz.Sixteen patients had West syndrome, which evolved to LGS by a median age of 2 years.

The median age at first seizure was 1 year, with a range of less than 1 year to age 13. Most patients (93%) were diagnosed with LGSwithin a year of seizure onset. Within 3 months of the first seizure, 17 patients (12%) had an abnormal neurologic exam. No abnormalities were detected in genetic studies of 32 patients and metabolic evaluations of 39 patients. Another 37 patients had normal chromosomes.

The parents of patients in the study had no higher rates of febrile seizure history or family history of epilepsy than did the general population, and their slightly higher age at the time of birth than that of the general population likely reflects their sociodemographic and educational background. "These findings are consistent with an effect of de novo mutations on risk for LGS_u, in patients selected on the basis of the absence of a parental history of epilepsy," the investigators wrote.

The Epilepsy Phenome/Genome Project is supported by the National Institute of Neurological Disorders and Stroke, the Finding a Cure for Epilepsy and Seizures (FACES) Foundation, and the Richard Thalheimer Philanthropic Fund. The authors had no conflicts of interest to disclose.

Phenotypic and genetic data collected from patients with Lennox-Gastaut syndrome of unknown cause suggest that the condition has a broad range of epilepsy onset, predominantly affects males, and often is associated with normal development prior to the onset of seizures.

The study, conducted by Dr. Peter Widdess-Walsh of UPMC Beacon Hospital in Dublin, Ireland, and his colleagues, is the largest to date to describe the phenotype of patients with Lennox-Gastaut syndrome of unknown cause (LGS_u), which accounts for about 25% of cases. It is part of the Epilepsy

Phenome/Genome Project, a collaborative effort of 27 epilepsy centers in the United States, Australia, New Zealand, and Argentina to collect detailed phenotypic and genetic data on large numbers of patients with epilepsy. Dr. Widdess-Walsh was at St. Barnabas Medical Center in Livingston, N.J., when he conducted the analysis.

"Systematic definition of the clinical phenotype of LGS_u is critical to expand our knowledge of this distinctive subgroup of LGS and to correlate with genetic studies. ... By collecting comprehensive phenotypic data on these subjects, we will be well positioned to understand the consequences of the mutations identified in a future genomic analysis," many of which are suspected to occur de novo, the investigators wrote.

Dr. Widdess-Walsh and his associates reviewed medical history and records of 135 patients with LGS_u and their parents from 19 centers in the United States and Australia. These data included a representative EEG and brain MRI, and all patients and their parents contributed blood samples processed for DNA extraction and creation of immortalized cell lines. The investigators excluded patients with autism, moderate to severe developmental delay prior to the onset of seizures, a history of epilepsy in either parent, known genetic syndrome, TORCH (toxoplasmosis, rubella, cytomegalovirus, and herpes simplex virus) infection, metabolic disease, premature birth before 32 weeks, structural MRI lesion, hypoxic-ischemic encephalopathy, meningitis/encephalitis, stroke/intracerebral hemorrhage, microcephaly less than 2.5 standard deviations from normal, and significant head trauma (Epilepsia 2013 Oct. 7 [doi: 10.1111/epi.12395]).

The median age at enrollment was 14 years (range, 2-51 years), and 66% of patients were male. The 2:1 preponderance of males affected by the syndrome in this series "suggests that the vulnerability of the male brain extends to epilepsy in early life," possibly because of early exposure to pulses of testosterone or mutations involving genes on the X chromosome, according to the investigators.

Overall, 33 patients (24%) had mild developmental delay before onset of seizures, while 80 (59%) had normal development. Records did not clearly state whether the remaining 22 patients had developmental delay prior to their first seizure. Despite the invariable decline in development seen in patients with LGS_u, 21 of the 50 patients who were age 18 or older were secondary school graduates and 2 had completed some college. This group had no developmental delay prior to seizure onset, and no history of special education as reported by parents. Twenty patients did not complete high school; 13 of them had some mild developmental delay documented prior to seizure onset and had a history of special education. Information about schooling for the remaining seven patients was not known or not asked.

However, the schooling data were biased by the study’s exclusion of patients with moderate to severe developmental delay prior to the onset of seizures, the investigators said, and inclusive education programs to promote school completion may have contributed to their educational achievements. A bias toward enrolling patients with higher cognitive function also could have contributed to these findings.

The most common seizure types were absence (80%), atonic (65%), generalized tonic-clonic (60%), and tonic (55%). All patients had EEG recordings with generalized epileptiform abnormalities. Specific EEG phenotypic features could be assessed from digital EEG data of 71 patients, including generalized single spike and wave complexes seen in 39 (55%) with a frequency range of 1-5 Hz.Sixteen patients had West syndrome, which evolved to LGS by a median age of 2 years.

The median age at first seizure was 1 year, with a range of less than 1 year to age 13. Most patients (93%) were diagnosed with LGSwithin a year of seizure onset. Within 3 months of the first seizure, 17 patients (12%) had an abnormal neurologic exam. No abnormalities were detected in genetic studies of 32 patients and metabolic evaluations of 39 patients. Another 37 patients had normal chromosomes.

The parents of patients in the study had no higher rates of febrile seizure history or family history of epilepsy than did the general population, and their slightly higher age at the time of birth than that of the general population likely reflects their sociodemographic and educational background. "These findings are consistent with an effect of de novo mutations on risk for LGS_u, in patients selected on the basis of the absence of a parental history of epilepsy," the investigators wrote.

The Epilepsy Phenome/Genome Project is supported by the National Institute of Neurological Disorders and Stroke, the Finding a Cure for Epilepsy and Seizures (FACES) Foundation, and the Richard Thalheimer Philanthropic Fund. The authors had no conflicts of interest to disclose.

Phenotypic and genetic data collected from patients with Lennox-Gastaut syndrome of unknown cause suggest that the condition has a broad range of epilepsy onset, predominantly affects males, and often is associated with normal development prior to the onset of seizures.

The study, conducted by Dr. Peter Widdess-Walsh of UPMC Beacon Hospital in Dublin, Ireland, and his colleagues, is the largest to date to describe the phenotype of patients with Lennox-Gastaut syndrome of unknown cause (LGS_u), which accounts for about 25% of cases. It is part of the Epilepsy

Phenome/Genome Project, a collaborative effort of 27 epilepsy centers in the United States, Australia, New Zealand, and Argentina to collect detailed phenotypic and genetic data on large numbers of patients with epilepsy. Dr. Widdess-Walsh was at St. Barnabas Medical Center in Livingston, N.J., when he conducted the analysis.

"Systematic definition of the clinical phenotype of LGS_u is critical to expand our knowledge of this distinctive subgroup of LGS and to correlate with genetic studies. ... By collecting comprehensive phenotypic data on these subjects, we will be well positioned to understand the consequences of the mutations identified in a future genomic analysis," many of which are suspected to occur de novo, the investigators wrote.

Dr. Widdess-Walsh and his associates reviewed medical history and records of 135 patients with LGS_u and their parents from 19 centers in the United States and Australia. These data included a representative EEG and brain MRI, and all patients and their parents contributed blood samples processed for DNA extraction and creation of immortalized cell lines. The investigators excluded patients with autism, moderate to severe developmental delay prior to the onset of seizures, a history of epilepsy in either parent, known genetic syndrome, TORCH (toxoplasmosis, rubella, cytomegalovirus, and herpes simplex virus) infection, metabolic disease, premature birth before 32 weeks, structural MRI lesion, hypoxic-ischemic encephalopathy, meningitis/encephalitis, stroke/intracerebral hemorrhage, microcephaly less than 2.5 standard deviations from normal, and significant head trauma (Epilepsia 2013 Oct. 7 [doi: 10.1111/epi.12395]).

The median age at enrollment was 14 years (range, 2-51 years), and 66% of patients were male. The 2:1 preponderance of males affected by the syndrome in this series "suggests that the vulnerability of the male brain extends to epilepsy in early life," possibly because of early exposure to pulses of testosterone or mutations involving genes on the X chromosome, according to the investigators.

Overall, 33 patients (24%) had mild developmental delay before onset of seizures, while 80 (59%) had normal development. Records did not clearly state whether the remaining 22 patients had developmental delay prior to their first seizure. Despite the invariable decline in development seen in patients with LGS_u, 21 of the 50 patients who were age 18 or older were secondary school graduates and 2 had completed some college. This group had no developmental delay prior to seizure onset, and no history of special education as reported by parents. Twenty patients did not complete high school; 13 of them had some mild developmental delay documented prior to seizure onset and had a history of special education. Information about schooling for the remaining seven patients was not known or not asked.

However, the schooling data were biased by the study’s exclusion of patients with moderate to severe developmental delay prior to the onset of seizures, the investigators said, and inclusive education programs to promote school completion may have contributed to their educational achievements. A bias toward enrolling patients with higher cognitive function also could have contributed to these findings.

The most common seizure types were absence (80%), atonic (65%), generalized tonic-clonic (60%), and tonic (55%). All patients had EEG recordings with generalized epileptiform abnormalities. Specific EEG phenotypic features could be assessed from digital EEG data of 71 patients, including generalized single spike and wave complexes seen in 39 (55%) with a frequency range of 1-5 Hz.Sixteen patients had West syndrome, which evolved to LGS by a median age of 2 years.

The median age at first seizure was 1 year, with a range of less than 1 year to age 13. Most patients (93%) were diagnosed with LGSwithin a year of seizure onset. Within 3 months of the first seizure, 17 patients (12%) had an abnormal neurologic exam. No abnormalities were detected in genetic studies of 32 patients and metabolic evaluations of 39 patients. Another 37 patients had normal chromosomes.

The parents of patients in the study had no higher rates of febrile seizure history or family history of epilepsy than did the general population, and their slightly higher age at the time of birth than that of the general population likely reflects their sociodemographic and educational background. "These findings are consistent with an effect of de novo mutations on risk for LGS_u, in patients selected on the basis of the absence of a parental history of epilepsy," the investigators wrote.

The Epilepsy Phenome/Genome Project is supported by the National Institute of Neurological Disorders and Stroke, the Finding a Cure for Epilepsy and Seizures (FACES) Foundation, and the Richard Thalheimer Philanthropic Fund. The authors had no conflicts of interest to disclose.

Treating conditions such as anxiety, depression, and sleeping disorders might help opioid-maintained patients reduce their use of benzodiazepines, a study of 193 patients suggests.

The study, conducted to assess the motives and patterns of benzodiazepine (BZD) use and psychiatric comorbidity among patients on injectable heroin or oral opioids, found that nearly half of patients reported prolonged use of benzodiazepines in the past 5 years. Led by Dr. Marc Vogel, the investigators also found that the patients reported prolonged use most often to reduce anxiety, forget problems, feel relaxed, and feel secure (Addict. Behav. 2013;38:2477-84). Prolonged use also was associated with negative affect regulation and "somato-medical" motives.

Dr. Vogel, of the Psychiatric Hospital of the University of Basel in Switzerland, surveyed patients in two of the hospital’s outpatient clinics about their psychiatric family history and patterns of benzodiazepine use; the clinics specialized in either oral opioid agonist treatment or heroin-assisted treatment. Sixty-six percent of participants were male; the mean age was 42.

Patterns of benzodiazepine use were collected only among participants who reported "prolonged use of BZD," defined as regular benzodiazepine use several times per week for longer than 2 months. Patients underwent urinalysis on the same day to confirm their self-reported data, Dr. Vogel and his colleagues reported.

Most patients were maintained on a single agonist, but many of the 80 patients maintained on diacetylmorphine received additional opioids for issues such as avoiding night-time withdrawal. The average daily agonist dose was 111 mg methadone-equivalent; the daily methadone-equivalent dose was 60 mg or higher in 163 patients (84%). Overall, 164 (85%) participants reported lifetime use of benzodiazepines, 108 (56%) reported use in the past 30 days, and 107 (56%) had positive urinalysis. The investigators classified the 117 (62%) subjects with either positive urinalysis or self-reported use in the past 30 days as current users. There were 52 (31%) former users; only 24 participants (12%) did not fulfill the criteria for lifetime use.

"Patients need to be informed about the risks, particularly in light of our finding that many users ingest their daily dose in one portion, regardless of prescription."

Both opioid agonist treatment and diacetylmorphine patients reported similar proportions of lifetime use – about 85% – but diacetylmorphine patients had lower proportions of prolonged benzodiazepine use (37% vs. 54%) and current use (51% vs. 67%), and higher proportions of former use (40% vs. 25%). Diacetylmorphine patients also were less likely to test positive for benzodiazepine use in urinalysis. All of these findings were significant (P less than .05).

Ninety participants (47%) reported prolonged benzodiazepine use in the past 5 years. Diazepam was used most commonly, followed by flunitrazepam and midazolam – all agents with a rapid onset of action. Twenty percent of patients reported using combinations of different benzodiazepines, and 76% combined benzodiazepines with other drugs. Nineteen percent used parenteral routes of administration, and almost half acquired benzodiazepines on the black market. The most common reasons for initially using benzodiazepines included searching for a high (19%), out of curiosity (16%), or because of sleeping problems (13%).

The study "shows that high-risk behaviors associated with BZD use are common, such as parenteral use, purchasing on the black market, or [using them in] combination with other respiratory depressant substances like other BZDs, heroin, or methadone," the authors said.

The investigators cited several limitations of the study, including its cross-sectional design and the use of self-report. "Use of structured clinical interviews for diagnostic purposes would be desirable for future studies," they said.

Because benzodiazepines often are involved in overdose-related deaths, "patients need to be informed about the risks, particularly in light of our finding that many users ingest their daily dose in one portion, regardless of prescription," Dr. Vogel and his colleagues wrote.

The authors reported no conflicts of interest.

Treating conditions such as anxiety, depression, and sleeping disorders might help opioid-maintained patients reduce their use of benzodiazepines, a study of 193 patients suggests.

The study, conducted to assess the motives and patterns of benzodiazepine (BZD) use and psychiatric comorbidity among patients on injectable heroin or oral opioids, found that nearly half of patients reported prolonged use of benzodiazepines in the past 5 years. Led by Dr. Marc Vogel, the investigators also found that the patients reported prolonged use most often to reduce anxiety, forget problems, feel relaxed, and feel secure (Addict. Behav. 2013;38:2477-84). Prolonged use also was associated with negative affect regulation and "somato-medical" motives.

Dr. Vogel, of the Psychiatric Hospital of the University of Basel in Switzerland, surveyed patients in two of the hospital’s outpatient clinics about their psychiatric family history and patterns of benzodiazepine use; the clinics specialized in either oral opioid agonist treatment or heroin-assisted treatment. Sixty-six percent of participants were male; the mean age was 42.

Patterns of benzodiazepine use were collected only among participants who reported "prolonged use of BZD," defined as regular benzodiazepine use several times per week for longer than 2 months. Patients underwent urinalysis on the same day to confirm their self-reported data, Dr. Vogel and his colleagues reported.

Most patients were maintained on a single agonist, but many of the 80 patients maintained on diacetylmorphine received additional opioids for issues such as avoiding night-time withdrawal. The average daily agonist dose was 111 mg methadone-equivalent; the daily methadone-equivalent dose was 60 mg or higher in 163 patients (84%). Overall, 164 (85%) participants reported lifetime use of benzodiazepines, 108 (56%) reported use in the past 30 days, and 107 (56%) had positive urinalysis. The investigators classified the 117 (62%) subjects with either positive urinalysis or self-reported use in the past 30 days as current users. There were 52 (31%) former users; only 24 participants (12%) did not fulfill the criteria for lifetime use.

"Patients need to be informed about the risks, particularly in light of our finding that many users ingest their daily dose in one portion, regardless of prescription."

Both opioid agonist treatment and diacetylmorphine patients reported similar proportions of lifetime use – about 85% – but diacetylmorphine patients had lower proportions of prolonged benzodiazepine use (37% vs. 54%) and current use (51% vs. 67%), and higher proportions of former use (40% vs. 25%). Diacetylmorphine patients also were less likely to test positive for benzodiazepine use in urinalysis. All of these findings were significant (P less than .05).

Ninety participants (47%) reported prolonged benzodiazepine use in the past 5 years. Diazepam was used most commonly, followed by flunitrazepam and midazolam – all agents with a rapid onset of action. Twenty percent of patients reported using combinations of different benzodiazepines, and 76% combined benzodiazepines with other drugs. Nineteen percent used parenteral routes of administration, and almost half acquired benzodiazepines on the black market. The most common reasons for initially using benzodiazepines included searching for a high (19%), out of curiosity (16%), or because of sleeping problems (13%).

The study "shows that high-risk behaviors associated with BZD use are common, such as parenteral use, purchasing on the black market, or [using them in] combination with other respiratory depressant substances like other BZDs, heroin, or methadone," the authors said.

The investigators cited several limitations of the study, including its cross-sectional design and the use of self-report. "Use of structured clinical interviews for diagnostic purposes would be desirable for future studies," they said.

Because benzodiazepines often are involved in overdose-related deaths, "patients need to be informed about the risks, particularly in light of our finding that many users ingest their daily dose in one portion, regardless of prescription," Dr. Vogel and his colleagues wrote.

The authors reported no conflicts of interest.

Treating conditions such as anxiety, depression, and sleeping disorders might help opioid-maintained patients reduce their use of benzodiazepines, a study of 193 patients suggests.

The study, conducted to assess the motives and patterns of benzodiazepine (BZD) use and psychiatric comorbidity among patients on injectable heroin or oral opioids, found that nearly half of patients reported prolonged use of benzodiazepines in the past 5 years. Led by Dr. Marc Vogel, the investigators also found that the patients reported prolonged use most often to reduce anxiety, forget problems, feel relaxed, and feel secure (Addict. Behav. 2013;38:2477-84). Prolonged use also was associated with negative affect regulation and "somato-medical" motives.

Dr. Vogel, of the Psychiatric Hospital of the University of Basel in Switzerland, surveyed patients in two of the hospital’s outpatient clinics about their psychiatric family history and patterns of benzodiazepine use; the clinics specialized in either oral opioid agonist treatment or heroin-assisted treatment. Sixty-six percent of participants were male; the mean age was 42.

Patterns of benzodiazepine use were collected only among participants who reported "prolonged use of BZD," defined as regular benzodiazepine use several times per week for longer than 2 months. Patients underwent urinalysis on the same day to confirm their self-reported data, Dr. Vogel and his colleagues reported.

Most patients were maintained on a single agonist, but many of the 80 patients maintained on diacetylmorphine received additional opioids for issues such as avoiding night-time withdrawal. The average daily agonist dose was 111 mg methadone-equivalent; the daily methadone-equivalent dose was 60 mg or higher in 163 patients (84%). Overall, 164 (85%) participants reported lifetime use of benzodiazepines, 108 (56%) reported use in the past 30 days, and 107 (56%) had positive urinalysis. The investigators classified the 117 (62%) subjects with either positive urinalysis or self-reported use in the past 30 days as current users. There were 52 (31%) former users; only 24 participants (12%) did not fulfill the criteria for lifetime use.

"Patients need to be informed about the risks, particularly in light of our finding that many users ingest their daily dose in one portion, regardless of prescription."

Both opioid agonist treatment and diacetylmorphine patients reported similar proportions of lifetime use – about 85% – but diacetylmorphine patients had lower proportions of prolonged benzodiazepine use (37% vs. 54%) and current use (51% vs. 67%), and higher proportions of former use (40% vs. 25%). Diacetylmorphine patients also were less likely to test positive for benzodiazepine use in urinalysis. All of these findings were significant (P less than .05).

Ninety participants (47%) reported prolonged benzodiazepine use in the past 5 years. Diazepam was used most commonly, followed by flunitrazepam and midazolam – all agents with a rapid onset of action. Twenty percent of patients reported using combinations of different benzodiazepines, and 76% combined benzodiazepines with other drugs. Nineteen percent used parenteral routes of administration, and almost half acquired benzodiazepines on the black market. The most common reasons for initially using benzodiazepines included searching for a high (19%), out of curiosity (16%), or because of sleeping problems (13%).

The study "shows that high-risk behaviors associated with BZD use are common, such as parenteral use, purchasing on the black market, or [using them in] combination with other respiratory depressant substances like other BZDs, heroin, or methadone," the authors said.

The investigators cited several limitations of the study, including its cross-sectional design and the use of self-report. "Use of structured clinical interviews for diagnostic purposes would be desirable for future studies," they said.

Because benzodiazepines often are involved in overdose-related deaths, "patients need to be informed about the risks, particularly in light of our finding that many users ingest their daily dose in one portion, regardless of prescription," Dr. Vogel and his colleagues wrote.

The authors reported no conflicts of interest.

Interventions that relieve both depression and pain best improve daily functioning and quality of life among patients with major depressive disorder, Taiwanese researchers have found.

Dr. Ching-Hua Lin and colleagues enrolled 131 new inpatients with major depressive disorder from Kai-Syuan Psychiatric Hospital in Kaohsiung, Taiwan, in their study. The patients ranged in age from 18 to 70 years, were physically healthy, and had received a major depressive disorder diagnosis using the Structured Clinical Interview for DSM-IV. After a washout period of 72 hours, the patients were given 20 mg/day of fluoxetine for 6 weeks, reported Dr. Lin of the hospital (Prog. Neuropsychopharmacol. Biol. Psychiatry 2013;47:93-8)

Researchers assessed depression severity, pain severity, daily functioning and quality of life (QOL) at baseline and at week 6 using the Hamilton Depression Rating Scale (HAMD-17), the Short Form 36 Body Pain Index (BPI), and the Work and Social Adjustment Scale (WSAS). They assessed health-related quality of life using three areas of the SF-36, including social functioning, vitality and general health perceptions.

They also proposed five models to explain the relationships among depression relief, pain relief, daily functioning improvement, and QOL improvement of depressed patients after treatment. In model 1, depression relief alone improved daily functioning and QOL; in 2, pain relief alone improved daily functioning and QOL; in 3, depression relief, mediated by pain relief, improved daily functioning and QOL; in 4, pain relief, mediated by depression relief, improved daily functioning and QOL; and in 5, both depression relief and pain relief improved daily functioning and QOL. The investigators used structural equation modeling to validate the models.

A total of 112 patients (85.5%) completed the fluoxetine trial, of whom 106 completed all assessments. Most of the patients (78%) were female; the mean age was 46 years. All assessments and measures changed significantly after the 6-week treatment. HAMD-17 scores improved from a mean 31.4 at baseline to a mean 13.7 (P less than .001) after fluoxetine treatment; BPI scores improved from a mean 45.3 to a mean 50.9 (P = .018); and WSAS scores improved from a mean 30.4 to a mean 22 (P less than 0.001). In health-related QOL measures, social function scores improved from a mean 34.1 to a mean 43.1 (P = .001); vitality improved from a mean 24.6 to a mean 33.7 (P less than .001) and general health perceptions improved from a mean 28 to a mean 35.9 (P = .001).

The researchers’ fifth hypothetical model, where both depression relief and pain relief that were interrelated affected improvement in daily functioning and QOL, was found to be the most accurate, explaining 57% of improvement variance. "The greater the depression symptoms and pain relief, the greater the improvement in daily functioning and QOL," the authors said. The investigators cited several limitations. For example, the sample size was relatively small, which made it possible to examine only limited variables. Also, they acknowledged that using different scales to measure depression, pain, daily functioning, and QOL might have yielded different results. They also pointed out that it is difficult to know whether the findings are generalizable, because the study focused in patients who were hospitalized because of severe depression.

Still, they said the study advanced the importance of understanding the relationship between depression and pain relief, and "their synergistic impact on daily functioning and QOL." "This study reinforced the need to effectively treat both depression and pain to achieve optimal outcomes," the authors wrote.

The study was funded by the hospital and the National Science Council of Taiwan. The authors reported no conflicts of interest.

Interventions that relieve both depression and pain best improve daily functioning and quality of life among patients with major depressive disorder, Taiwanese researchers have found.

Dr. Ching-Hua Lin and colleagues enrolled 131 new inpatients with major depressive disorder from Kai-Syuan Psychiatric Hospital in Kaohsiung, Taiwan, in their study. The patients ranged in age from 18 to 70 years, were physically healthy, and had received a major depressive disorder diagnosis using the Structured Clinical Interview for DSM-IV. After a washout period of 72 hours, the patients were given 20 mg/day of fluoxetine for 6 weeks, reported Dr. Lin of the hospital (Prog. Neuropsychopharmacol. Biol. Psychiatry 2013;47:93-8)

Researchers assessed depression severity, pain severity, daily functioning and quality of life (QOL) at baseline and at week 6 using the Hamilton Depression Rating Scale (HAMD-17), the Short Form 36 Body Pain Index (BPI), and the Work and Social Adjustment Scale (WSAS). They assessed health-related quality of life using three areas of the SF-36, including social functioning, vitality and general health perceptions.

They also proposed five models to explain the relationships among depression relief, pain relief, daily functioning improvement, and QOL improvement of depressed patients after treatment. In model 1, depression relief alone improved daily functioning and QOL; in 2, pain relief alone improved daily functioning and QOL; in 3, depression relief, mediated by pain relief, improved daily functioning and QOL; in 4, pain relief, mediated by depression relief, improved daily functioning and QOL; and in 5, both depression relief and pain relief improved daily functioning and QOL. The investigators used structural equation modeling to validate the models.

A total of 112 patients (85.5%) completed the fluoxetine trial, of whom 106 completed all assessments. Most of the patients (78%) were female; the mean age was 46 years. All assessments and measures changed significantly after the 6-week treatment. HAMD-17 scores improved from a mean 31.4 at baseline to a mean 13.7 (P less than .001) after fluoxetine treatment; BPI scores improved from a mean 45.3 to a mean 50.9 (P = .018); and WSAS scores improved from a mean 30.4 to a mean 22 (P less than 0.001). In health-related QOL measures, social function scores improved from a mean 34.1 to a mean 43.1 (P = .001); vitality improved from a mean 24.6 to a mean 33.7 (P less than .001) and general health perceptions improved from a mean 28 to a mean 35.9 (P = .001).

The researchers’ fifth hypothetical model, where both depression relief and pain relief that were interrelated affected improvement in daily functioning and QOL, was found to be the most accurate, explaining 57% of improvement variance. "The greater the depression symptoms and pain relief, the greater the improvement in daily functioning and QOL," the authors said. The investigators cited several limitations. For example, the sample size was relatively small, which made it possible to examine only limited variables. Also, they acknowledged that using different scales to measure depression, pain, daily functioning, and QOL might have yielded different results. They also pointed out that it is difficult to know whether the findings are generalizable, because the study focused in patients who were hospitalized because of severe depression.

Still, they said the study advanced the importance of understanding the relationship between depression and pain relief, and "their synergistic impact on daily functioning and QOL." "This study reinforced the need to effectively treat both depression and pain to achieve optimal outcomes," the authors wrote.

The study was funded by the hospital and the National Science Council of Taiwan. The authors reported no conflicts of interest.

Interventions that relieve both depression and pain best improve daily functioning and quality of life among patients with major depressive disorder, Taiwanese researchers have found.

Dr. Ching-Hua Lin and colleagues enrolled 131 new inpatients with major depressive disorder from Kai-Syuan Psychiatric Hospital in Kaohsiung, Taiwan, in their study. The patients ranged in age from 18 to 70 years, were physically healthy, and had received a major depressive disorder diagnosis using the Structured Clinical Interview for DSM-IV. After a washout period of 72 hours, the patients were given 20 mg/day of fluoxetine for 6 weeks, reported Dr. Lin of the hospital (Prog. Neuropsychopharmacol. Biol. Psychiatry 2013;47:93-8)

Researchers assessed depression severity, pain severity, daily functioning and quality of life (QOL) at baseline and at week 6 using the Hamilton Depression Rating Scale (HAMD-17), the Short Form 36 Body Pain Index (BPI), and the Work and Social Adjustment Scale (WSAS). They assessed health-related quality of life using three areas of the SF-36, including social functioning, vitality and general health perceptions.

They also proposed five models to explain the relationships among depression relief, pain relief, daily functioning improvement, and QOL improvement of depressed patients after treatment. In model 1, depression relief alone improved daily functioning and QOL; in 2, pain relief alone improved daily functioning and QOL; in 3, depression relief, mediated by pain relief, improved daily functioning and QOL; in 4, pain relief, mediated by depression relief, improved daily functioning and QOL; and in 5, both depression relief and pain relief improved daily functioning and QOL. The investigators used structural equation modeling to validate the models.

A total of 112 patients (85.5%) completed the fluoxetine trial, of whom 106 completed all assessments. Most of the patients (78%) were female; the mean age was 46 years. All assessments and measures changed significantly after the 6-week treatment. HAMD-17 scores improved from a mean 31.4 at baseline to a mean 13.7 (P less than .001) after fluoxetine treatment; BPI scores improved from a mean 45.3 to a mean 50.9 (P = .018); and WSAS scores improved from a mean 30.4 to a mean 22 (P less than 0.001). In health-related QOL measures, social function scores improved from a mean 34.1 to a mean 43.1 (P = .001); vitality improved from a mean 24.6 to a mean 33.7 (P less than .001) and general health perceptions improved from a mean 28 to a mean 35.9 (P = .001).

The researchers’ fifth hypothetical model, where both depression relief and pain relief that were interrelated affected improvement in daily functioning and QOL, was found to be the most accurate, explaining 57% of improvement variance. "The greater the depression symptoms and pain relief, the greater the improvement in daily functioning and QOL," the authors said. The investigators cited several limitations. For example, the sample size was relatively small, which made it possible to examine only limited variables. Also, they acknowledged that using different scales to measure depression, pain, daily functioning, and QOL might have yielded different results. They also pointed out that it is difficult to know whether the findings are generalizable, because the study focused in patients who were hospitalized because of severe depression.

Still, they said the study advanced the importance of understanding the relationship between depression and pain relief, and "their synergistic impact on daily functioning and QOL." "This study reinforced the need to effectively treat both depression and pain to achieve optimal outcomes," the authors wrote.

The study was funded by the hospital and the National Science Council of Taiwan. The authors reported no conflicts of interest.

Statin therapy does not decrease mortality among intensive care unit patients with ventilator-associated pneumonia, according to a clinical trial by French researchers.

Investigators stopped the randomized study for futility after analyzing 28-day mortality results in the first 300 of a projected 1,002 patients, and finding higher rates among patients randomized to take daily simvastatin (21.2%) compared with placebo (15.2%). The study, published online Oct. 8 in JAMA, was released this week at the European Society of Intensive Care Medicine’s annual congress.

"These findings do not support the use of statins with the goal of improving VAP outcomes," wrote the study authors, led by Dr. Laurent Papazian of Hôpital Nord in Marseille, France.

For the trial, conducted in 26 French intensive care units (ICUs) between January 2010 and March 2013, patients who had received mechanical ventilation for at least 2 days were eligible for participation if they had suspected ventilator-associated pneumonia (VAP), defined as a modified Clinical Pulmonary Infection Score of at least 5, and if they had quantitative bacteriological cultures of bronchoalveolar lavage fluid, a protected telescopic catheter, or an endotracheal aspirate.

In a double-blind study, participants were randomized to receive a daily 60-mg dose of simvastatin or placebo given orally or via a nasogastric tube from study inclusion until ICU discharge, death, or day 28, whichever occurred first. Simvastatin or placebo was started on the same day as antibiotic therapy for suspected VAP (JAMA 2013 Oct. 9 [doi: 10.1001/jama.2013.280031]).

A total of 153 patients received simvastatin, and 147 received placebo; all patients received at least one dose. The only clinically significant baseline difference between groups was a higher proportion of patients receiving antibiotics in the simvastatin group. No patients had definite bacterial VAP. Probable VAP was diagnosed in 106 patients (73%) in the simvastatin group and 105 (76%) in the placebo group.

Analyzing 28-day mortality, the investigators found that restricting the analysis to patients with probable VAP did not change the overall results: Day 28 mortality was 22.6% with simvastatin versus 14.3% with placebo.

There were no significant between-group differences in day 14, ICU, or hospital mortality rates; mechanical ventilation duration; number of ventilator-free days by day 28; coronary events; or acute respiratory distress syndrome (ARDS) within 28 days after enrollment. The groups also did not differ regarding the course of organ dysfunctions or the development of kidney dysfunction.

Simvastatin was "well tolerated, with no increases in rates of elevated creatine kinase, ALT or AST levels," the authors noted, and no between-group differences in creatinine levels at days 3, 7, 14, or 21. The study treatment was interrupted for at least 24 hours because of an adverse event in 55 patients (19%) in the simvastatin group and 24 (17%) in the placebo group.

"Our results do not support the use of adjunctive statin therapy in ICU patients with VAP, and this conclusion probably deserves to be extended to ICU patients with any type of nosocomial infection," the authors wrote.

The study was supported by the French Ministry of Health. Four of the 21 authors disclosed receiving travel expenses, payment for lectures, or payment for providing expert testimony from industry sources, including Fresenius Kabi and MSD. No other authors reported disclosures.

Statin therapy does not decrease mortality among intensive care unit patients with ventilator-associated pneumonia, according to a clinical trial by French researchers.

Investigators stopped the randomized study for futility after analyzing 28-day mortality results in the first 300 of a projected 1,002 patients, and finding higher rates among patients randomized to take daily simvastatin (21.2%) compared with placebo (15.2%). The study, published online Oct. 8 in JAMA, was released this week at the European Society of Intensive Care Medicine’s annual congress.

"These findings do not support the use of statins with the goal of improving VAP outcomes," wrote the study authors, led by Dr. Laurent Papazian of Hôpital Nord in Marseille, France.

For the trial, conducted in 26 French intensive care units (ICUs) between January 2010 and March 2013, patients who had received mechanical ventilation for at least 2 days were eligible for participation if they had suspected ventilator-associated pneumonia (VAP), defined as a modified Clinical Pulmonary Infection Score of at least 5, and if they had quantitative bacteriological cultures of bronchoalveolar lavage fluid, a protected telescopic catheter, or an endotracheal aspirate.

In a double-blind study, participants were randomized to receive a daily 60-mg dose of simvastatin or placebo given orally or via a nasogastric tube from study inclusion until ICU discharge, death, or day 28, whichever occurred first. Simvastatin or placebo was started on the same day as antibiotic therapy for suspected VAP (JAMA 2013 Oct. 9 [doi: 10.1001/jama.2013.280031]).

A total of 153 patients received simvastatin, and 147 received placebo; all patients received at least one dose. The only clinically significant baseline difference between groups was a higher proportion of patients receiving antibiotics in the simvastatin group. No patients had definite bacterial VAP. Probable VAP was diagnosed in 106 patients (73%) in the simvastatin group and 105 (76%) in the placebo group.

Analyzing 28-day mortality, the investigators found that restricting the analysis to patients with probable VAP did not change the overall results: Day 28 mortality was 22.6% with simvastatin versus 14.3% with placebo.

There were no significant between-group differences in day 14, ICU, or hospital mortality rates; mechanical ventilation duration; number of ventilator-free days by day 28; coronary events; or acute respiratory distress syndrome (ARDS) within 28 days after enrollment. The groups also did not differ regarding the course of organ dysfunctions or the development of kidney dysfunction.

Simvastatin was "well tolerated, with no increases in rates of elevated creatine kinase, ALT or AST levels," the authors noted, and no between-group differences in creatinine levels at days 3, 7, 14, or 21. The study treatment was interrupted for at least 24 hours because of an adverse event in 55 patients (19%) in the simvastatin group and 24 (17%) in the placebo group.

"Our results do not support the use of adjunctive statin therapy in ICU patients with VAP, and this conclusion probably deserves to be extended to ICU patients with any type of nosocomial infection," the authors wrote.

The study was supported by the French Ministry of Health. Four of the 21 authors disclosed receiving travel expenses, payment for lectures, or payment for providing expert testimony from industry sources, including Fresenius Kabi and MSD. No other authors reported disclosures.

Statin therapy does not decrease mortality among intensive care unit patients with ventilator-associated pneumonia, according to a clinical trial by French researchers.

Investigators stopped the randomized study for futility after analyzing 28-day mortality results in the first 300 of a projected 1,002 patients, and finding higher rates among patients randomized to take daily simvastatin (21.2%) compared with placebo (15.2%). The study, published online Oct. 8 in JAMA, was released this week at the European Society of Intensive Care Medicine’s annual congress.

"These findings do not support the use of statins with the goal of improving VAP outcomes," wrote the study authors, led by Dr. Laurent Papazian of Hôpital Nord in Marseille, France.

For the trial, conducted in 26 French intensive care units (ICUs) between January 2010 and March 2013, patients who had received mechanical ventilation for at least 2 days were eligible for participation if they had suspected ventilator-associated pneumonia (VAP), defined as a modified Clinical Pulmonary Infection Score of at least 5, and if they had quantitative bacteriological cultures of bronchoalveolar lavage fluid, a protected telescopic catheter, or an endotracheal aspirate.

In a double-blind study, participants were randomized to receive a daily 60-mg dose of simvastatin or placebo given orally or via a nasogastric tube from study inclusion until ICU discharge, death, or day 28, whichever occurred first. Simvastatin or placebo was started on the same day as antibiotic therapy for suspected VAP (JAMA 2013 Oct. 9 [doi: 10.1001/jama.2013.280031]).

A total of 153 patients received simvastatin, and 147 received placebo; all patients received at least one dose. The only clinically significant baseline difference between groups was a higher proportion of patients receiving antibiotics in the simvastatin group. No patients had definite bacterial VAP. Probable VAP was diagnosed in 106 patients (73%) in the simvastatin group and 105 (76%) in the placebo group.

Analyzing 28-day mortality, the investigators found that restricting the analysis to patients with probable VAP did not change the overall results: Day 28 mortality was 22.6% with simvastatin versus 14.3% with placebo.

There were no significant between-group differences in day 14, ICU, or hospital mortality rates; mechanical ventilation duration; number of ventilator-free days by day 28; coronary events; or acute respiratory distress syndrome (ARDS) within 28 days after enrollment. The groups also did not differ regarding the course of organ dysfunctions or the development of kidney dysfunction.

Simvastatin was "well tolerated, with no increases in rates of elevated creatine kinase, ALT or AST levels," the authors noted, and no between-group differences in creatinine levels at days 3, 7, 14, or 21. The study treatment was interrupted for at least 24 hours because of an adverse event in 55 patients (19%) in the simvastatin group and 24 (17%) in the placebo group.

"Our results do not support the use of adjunctive statin therapy in ICU patients with VAP, and this conclusion probably deserves to be extended to ICU patients with any type of nosocomial infection," the authors wrote.

The study was supported by the French Ministry of Health. Four of the 21 authors disclosed receiving travel expenses, payment for lectures, or payment for providing expert testimony from industry sources, including Fresenius Kabi and MSD. No other authors reported disclosures.

Inducing hypothermia in patients with severe bacterial meningitis offers no clinical benefit and might, in fact, be harmful, according to a clinical trial conducted in France.

Investigators had planned to enroll up to 318 patients in a randomized trial comparing hypothermia treatment to standard care, conducted at 49 intensive care units in France between February 2009 and November 2011. They halted the trial, however, after enrolling the first 98 patients because of concerns by the data and safety monitoring board about excess mortality among those randomized to receive hypothermia treatment, which consisted of a loading dose of 4°C/39°F cold saline and cooling the patient to 32°C/90°F to 34°C/93°F for 48 hours, then passive warming. The trial was led by Dr. Bruno Mourvillier of the Groupe Hospitalier Bichat-Claude Bernard in Paris.

Twenty-five of 49 patients (51%) in the hypothermia group died, compared with 15 of 49 patients (31%) receiving standard care (relative risk, 1.99). Pneumococcal meningitis was diagnosed in 77% of patients. At 3 months, 42 of 49 patients (86%) in the hypothermia group and 36 of 49 patients (74%) in the control group had an unfavorable outcome (RR, 2.17), as gauged by the Glasgow Outcome Scale.

After adjustment for age, scores on the Glasgow Coma Scale at the point of study inclusion, and the presence of septic shock at study inclusion, mortality remained higher in the hypothermia group, but not significantly (hazard ratio, 1.76). However, a post hoc analysis showed a low probability to reach statistical significance in favor of hypothermia by the end of the three original planned stages of the trial.

The study, published online (JAMA 2013 Oct. 8 [doi:10.1001/jama.2013.280506]), was released at the European Society of Intensive Care Medicine’s annual congress in Paris.

Potential mechanisms behind the mortality difference "remain unclear," the authors wrote, noting that they found no difference in nosocomial infections, hemorrhage, cardiovascular effects, or hyperglycemia between the treatment groups. In addition, no significant differences were found in baseline characteristics. All patients received mechanical ventilation and were severely ill, with an average Glasgow Coma Scale rating of 7.

In animal model studies of meningitis, moderate hypothermia has shown favorable effects, such as lowering intracranial pressure and reducing cerebral injury, Dr. Mourvillier and associates noted. They hypothesized that hypothermia would improve functional outcome at 3 months.

"Our trial does not support the use of hypothermia in adults with severe meningitis," they concluded. "Moderate hypothermia did not improve outcome in patients with severe bacterial meningitis and may even be harmful. Our results may have important implications for future trials on hypothermia in patients presenting with septic shock or stroke."

Careful evaluation of safety issues in ongoing trials is needed, they said.

The study was supported by the French Ministry of Health, IST Cardiology, and Covidien. The authors reported no conflicts of interest.

Inducing hypothermia in patients with severe bacterial meningitis offers no clinical benefit and might, in fact, be harmful, according to a clinical trial conducted in France.

Investigators had planned to enroll up to 318 patients in a randomized trial comparing hypothermia treatment to standard care, conducted at 49 intensive care units in France between February 2009 and November 2011. They halted the trial, however, after enrolling the first 98 patients because of concerns by the data and safety monitoring board about excess mortality among those randomized to receive hypothermia treatment, which consisted of a loading dose of 4°C/39°F cold saline and cooling the patient to 32°C/90°F to 34°C/93°F for 48 hours, then passive warming. The trial was led by Dr. Bruno Mourvillier of the Groupe Hospitalier Bichat-Claude Bernard in Paris.

Twenty-five of 49 patients (51%) in the hypothermia group died, compared with 15 of 49 patients (31%) receiving standard care (relative risk, 1.99). Pneumococcal meningitis was diagnosed in 77% of patients. At 3 months, 42 of 49 patients (86%) in the hypothermia group and 36 of 49 patients (74%) in the control group had an unfavorable outcome (RR, 2.17), as gauged by the Glasgow Outcome Scale.

After adjustment for age, scores on the Glasgow Coma Scale at the point of study inclusion, and the presence of septic shock at study inclusion, mortality remained higher in the hypothermia group, but not significantly (hazard ratio, 1.76). However, a post hoc analysis showed a low probability to reach statistical significance in favor of hypothermia by the end of the three original planned stages of the trial.

The study, published online (JAMA 2013 Oct. 8 [doi:10.1001/jama.2013.280506]), was released at the European Society of Intensive Care Medicine’s annual congress in Paris.

Potential mechanisms behind the mortality difference "remain unclear," the authors wrote, noting that they found no difference in nosocomial infections, hemorrhage, cardiovascular effects, or hyperglycemia between the treatment groups. In addition, no significant differences were found in baseline characteristics. All patients received mechanical ventilation and were severely ill, with an average Glasgow Coma Scale rating of 7.

In animal model studies of meningitis, moderate hypothermia has shown favorable effects, such as lowering intracranial pressure and reducing cerebral injury, Dr. Mourvillier and associates noted. They hypothesized that hypothermia would improve functional outcome at 3 months.

"Our trial does not support the use of hypothermia in adults with severe meningitis," they concluded. "Moderate hypothermia did not improve outcome in patients with severe bacterial meningitis and may even be harmful. Our results may have important implications for future trials on hypothermia in patients presenting with septic shock or stroke."

Careful evaluation of safety issues in ongoing trials is needed, they said.

The study was supported by the French Ministry of Health, IST Cardiology, and Covidien. The authors reported no conflicts of interest.

Inducing hypothermia in patients with severe bacterial meningitis offers no clinical benefit and might, in fact, be harmful, according to a clinical trial conducted in France.

Investigators had planned to enroll up to 318 patients in a randomized trial comparing hypothermia treatment to standard care, conducted at 49 intensive care units in France between February 2009 and November 2011. They halted the trial, however, after enrolling the first 98 patients because of concerns by the data and safety monitoring board about excess mortality among those randomized to receive hypothermia treatment, which consisted of a loading dose of 4°C/39°F cold saline and cooling the patient to 32°C/90°F to 34°C/93°F for 48 hours, then passive warming. The trial was led by Dr. Bruno Mourvillier of the Groupe Hospitalier Bichat-Claude Bernard in Paris.

Twenty-five of 49 patients (51%) in the hypothermia group died, compared with 15 of 49 patients (31%) receiving standard care (relative risk, 1.99). Pneumococcal meningitis was diagnosed in 77% of patients. At 3 months, 42 of 49 patients (86%) in the hypothermia group and 36 of 49 patients (74%) in the control group had an unfavorable outcome (RR, 2.17), as gauged by the Glasgow Outcome Scale.

After adjustment for age, scores on the Glasgow Coma Scale at the point of study inclusion, and the presence of septic shock at study inclusion, mortality remained higher in the hypothermia group, but not significantly (hazard ratio, 1.76). However, a post hoc analysis showed a low probability to reach statistical significance in favor of hypothermia by the end of the three original planned stages of the trial.

The study, published online (JAMA 2013 Oct. 8 [doi:10.1001/jama.2013.280506]), was released at the European Society of Intensive Care Medicine’s annual congress in Paris.

Potential mechanisms behind the mortality difference "remain unclear," the authors wrote, noting that they found no difference in nosocomial infections, hemorrhage, cardiovascular effects, or hyperglycemia between the treatment groups. In addition, no significant differences were found in baseline characteristics. All patients received mechanical ventilation and were severely ill, with an average Glasgow Coma Scale rating of 7.

In animal model studies of meningitis, moderate hypothermia has shown favorable effects, such as lowering intracranial pressure and reducing cerebral injury, Dr. Mourvillier and associates noted. They hypothesized that hypothermia would improve functional outcome at 3 months.

"Our trial does not support the use of hypothermia in adults with severe meningitis," they concluded. "Moderate hypothermia did not improve outcome in patients with severe bacterial meningitis and may even be harmful. Our results may have important implications for future trials on hypothermia in patients presenting with septic shock or stroke."

Careful evaluation of safety issues in ongoing trials is needed, they said.

The study was supported by the French Ministry of Health, IST Cardiology, and Covidien. The authors reported no conflicts of interest.

Inducing hypothermia in patients with severe bacterial meningitis offers no clinical benefit and might, in fact, be harmful, according to a clinical trial conducted in France.

Investigators had planned to enroll up to 318 patients in a randomized trial comparing hypothermia treatment to standard care, conducted at 49 intensive care units in France between February 2009 and November 2011. They halted the trial, however, after enrolling the first 98 patients because of concerns by the data and safety monitoring board about excess mortality among those randomized to receive hypothermia treatment, which consisted of a loading dose of 4°C/39°F cold saline and cooling the patient to 32°C/90°F to 34°C/93°F for 48 hours, then passive warming. The trial was led by Dr. Bruno Mourvillier of the Groupe Hospitalier Bichat-Claude Bernard in Paris.

Twenty-five of 49 patients (51%) in the hypothermia group died, compared with 15 of 49 patients (31%) receiving standard care (relative risk, 1.99). Pneumococcal meningitis was diagnosed in 77% of patients. At 3 months, 42 of 49 patients (86%) in the hypothermia group and 36 of 49 patients (74%) in the control group had an unfavorable outcome (RR, 2.17), as gauged by the Glasgow Outcome Scale.

After adjustment for age, scores on the Glasgow Coma Scale at the point of study inclusion, and the presence of septic shock at study inclusion, mortality remained higher in the hypothermia group, but not significantly (hazard ratio, 1.76). However, a post hoc analysis showed a low probability to reach statistical significance in favor of hypothermia by the end of the three original planned stages of the trial.

The study, published online (JAMA 2013 Oct. 8 [doi:10.1001/jama.2013.280506]), was released at the European Society of Intensive Care Medicine’s annual congress in Paris.

Potential mechanisms behind the mortality difference "remain unclear," the authors wrote, noting that they found no difference in nosocomial infections, hemorrhage, cardiovascular effects, or hyperglycemia between the treatment groups. In addition, no significant differences were found in baseline characteristics. All patients received mechanical ventilation and were severely ill, with an average Glasgow Coma Scale rating of 7.

In animal model studies of meningitis, moderate hypothermia has shown favorable effects, such as lowering intracranial pressure and reducing cerebral injury, Dr. Mourvillier and associates noted. They hypothesized that hypothermia would improve functional outcome at 3 months.

"Our trial does not support the use of hypothermia in adults with severe meningitis," they concluded. "Moderate hypothermia did not improve outcome in patients with severe bacterial meningitis and may even be harmful. Our results may have important implications for future trials on hypothermia in patients presenting with septic shock or stroke."

Careful evaluation of safety issues in ongoing trials is needed, they said.

The study was supported by the French Ministry of Health, IST Cardiology, and Covidien. The authors reported no conflicts of interest.

Inducing hypothermia in patients with severe bacterial meningitis offers no clinical benefit and might, in fact, be harmful, according to a clinical trial conducted in France.

Investigators had planned to enroll up to 318 patients in a randomized trial comparing hypothermia treatment to standard care, conducted at 49 intensive care units in France between February 2009 and November 2011. They halted the trial, however, after enrolling the first 98 patients because of concerns by the data and safety monitoring board about excess mortality among those randomized to receive hypothermia treatment, which consisted of a loading dose of 4°C/39°F cold saline and cooling the patient to 32°C/90°F to 34°C/93°F for 48 hours, then passive warming. The trial was led by Dr. Bruno Mourvillier of the Groupe Hospitalier Bichat-Claude Bernard in Paris.

Twenty-five of 49 patients (51%) in the hypothermia group died, compared with 15 of 49 patients (31%) receiving standard care (relative risk, 1.99). Pneumococcal meningitis was diagnosed in 77% of patients. At 3 months, 42 of 49 patients (86%) in the hypothermia group and 36 of 49 patients (74%) in the control group had an unfavorable outcome (RR, 2.17), as gauged by the Glasgow Outcome Scale.

After adjustment for age, scores on the Glasgow Coma Scale at the point of study inclusion, and the presence of septic shock at study inclusion, mortality remained higher in the hypothermia group, but not significantly (hazard ratio, 1.76). However, a post hoc analysis showed a low probability to reach statistical significance in favor of hypothermia by the end of the three original planned stages of the trial.

The study, published online (JAMA 2013 Oct. 8 [doi:10.1001/jama.2013.280506]), was released at the European Society of Intensive Care Medicine’s annual congress in Paris.

Potential mechanisms behind the mortality difference "remain unclear," the authors wrote, noting that they found no difference in nosocomial infections, hemorrhage, cardiovascular effects, or hyperglycemia between the treatment groups. In addition, no significant differences were found in baseline characteristics. All patients received mechanical ventilation and were severely ill, with an average Glasgow Coma Scale rating of 7.

In animal model studies of meningitis, moderate hypothermia has shown favorable effects, such as lowering intracranial pressure and reducing cerebral injury, Dr. Mourvillier and associates noted. They hypothesized that hypothermia would improve functional outcome at 3 months.

"Our trial does not support the use of hypothermia in adults with severe meningitis," they concluded. "Moderate hypothermia did not improve outcome in patients with severe bacterial meningitis and may even be harmful. Our results may have important implications for future trials on hypothermia in patients presenting with septic shock or stroke."

Careful evaluation of safety issues in ongoing trials is needed, they said.

The study was supported by the French Ministry of Health, IST Cardiology, and Covidien. The authors reported no conflicts of interest.

Inducing hypothermia in patients with severe bacterial meningitis offers no clinical benefit and might, in fact, be harmful, according to a clinical trial conducted in France.

Investigators had planned to enroll up to 318 patients in a randomized trial comparing hypothermia treatment to standard care, conducted at 49 intensive care units in France between February 2009 and November 2011. They halted the trial, however, after enrolling the first 98 patients because of concerns by the data and safety monitoring board about excess mortality among those randomized to receive hypothermia treatment, which consisted of a loading dose of 4°C/39°F cold saline and cooling the patient to 32°C/90°F to 34°C/93°F for 48 hours, then passive warming. The trial was led by Dr. Bruno Mourvillier of the Groupe Hospitalier Bichat-Claude Bernard in Paris.

Twenty-five of 49 patients (51%) in the hypothermia group died, compared with 15 of 49 patients (31%) receiving standard care (relative risk, 1.99). Pneumococcal meningitis was diagnosed in 77% of patients. At 3 months, 42 of 49 patients (86%) in the hypothermia group and 36 of 49 patients (74%) in the control group had an unfavorable outcome (RR, 2.17), as gauged by the Glasgow Outcome Scale.

After adjustment for age, scores on the Glasgow Coma Scale at the point of study inclusion, and the presence of septic shock at study inclusion, mortality remained higher in the hypothermia group, but not significantly (hazard ratio, 1.76). However, a post hoc analysis showed a low probability to reach statistical significance in favor of hypothermia by the end of the three original planned stages of the trial.

The study, published online (JAMA 2013 Oct. 8 [doi:10.1001/jama.2013.280506]), was released at the European Society of Intensive Care Medicine’s annual congress in Paris.

Potential mechanisms behind the mortality difference "remain unclear," the authors wrote, noting that they found no difference in nosocomial infections, hemorrhage, cardiovascular effects, or hyperglycemia between the treatment groups. In addition, no significant differences were found in baseline characteristics. All patients received mechanical ventilation and were severely ill, with an average Glasgow Coma Scale rating of 7.

In animal model studies of meningitis, moderate hypothermia has shown favorable effects, such as lowering intracranial pressure and reducing cerebral injury, Dr. Mourvillier and associates noted. They hypothesized that hypothermia would improve functional outcome at 3 months.

"Our trial does not support the use of hypothermia in adults with severe meningitis," they concluded. "Moderate hypothermia did not improve outcome in patients with severe bacterial meningitis and may even be harmful. Our results may have important implications for future trials on hypothermia in patients presenting with septic shock or stroke."

Careful evaluation of safety issues in ongoing trials is needed, they said.

The study was supported by the French Ministry of Health, IST Cardiology, and Covidien. The authors reported no conflicts of interest.

BALTIMORE – A treatment regimen combining nasal expiratory positive airway pressure with sleeping on one’s side can help manage obstructive sleep apnea, even in patients with cardiovascular comorbidities who have failed prior therapies, according to Cleveland researchers.

In a small study of 42 adults who tried this dual therapy for 1 month, 81% achieved good to optimal control of obstructive sleep apnea (OSA) and 92% reported tolerability and compliance with the Provent expiratory positive airway pressure (EPAP) device.

"Generally, continuous positive airway pressure [CPAP] is prescribed as first-line therapy because of its proven effectiveness, however adherence remains low with CPAP, with anywhere from 46% to 83% of patients still nonadherent," said Dr. Mita Deoras of University Hospitals Case Medical Center. Because of this, physicians continue to search for alternate therapies, she said at the annual meeting of the Associated Professional Sleep Societies.

Dr. Deoras and her colleagues have recruited 42 adults with OSA from an independent sleep center starting in 2010. Twenty-five (60%) of the participants were men. The average age was 61 years and the average BMI was 30.9. The majority (76%) had known cardiovascular comorbidities, including diabetes, hypertension, hyperlipidemia, and/or coronary artery disease. Ninety percent (38) had had previous treatment for their OSA, mostly with CPAP but a few with oral appliances, uvulopalatopharyngoplasty, or some combination. Fifteen percent had mild OSA, 42.5% had moderate OSA, 37.5% had severe OSA, and 5% had primary snoring.

"This study has the ability to offer an effective therapeutic option for this very common patient population."

Researchers obtained a baseline apnea-hypopnea index (AHI) from patients’ medical records. After an initial visit, participants were told about EPAP and shown how to use it, then asked to use it for 1 month. They also were asked to sleep in positions other than their backs. After the month, if patients were compliant, they came for a validation polysomnogram in which they stayed overnight at the sleep center while wearing the EPAP device and a cannula to measure nasal flow, and were encouraged to sleep in positions other than their backs.

The majority of patients had an improvement in AHI, with a mean reduction of 22.4. No statistically significant differences in improvement were seen between genders or among varying BMI levels. Sixty percent met the study condition for optimal control of OSA, defined as an AHI less than 5, and 20% met the definition of good control of OSA, defined as an AHI of 10 or less. Patients also reported a reduction in daytime sleepiness; the average Epworth Sleepiness Scale rating declined from 9.8 at baseline to 7.6.

"While we know that nasal EPAP is FDA approved for the treatment of OSA, clinicians are still often cautious against using it in patients with severe OSA or significant comorbidities," she said. And while sleep repositioning "can be as effective as CPAP in patients with position-dependent OSA, it isn’t often recommended as a first-line therapy.... This study has the ability to offer an effective therapeutic option for this very common patient population."

Study contributors were from MetroHealth Medical Center, the Cleveland Clinic Foundation, and Northcoast Clinical Trials Sleep Center. The study was funded by University Hospitals Case Medical Center. The researchers reported having no financial conflicts.

BALTIMORE – A treatment regimen combining nasal expiratory positive airway pressure with sleeping on one’s side can help manage obstructive sleep apnea, even in patients with cardiovascular comorbidities who have failed prior therapies, according to Cleveland researchers.

In a small study of 42 adults who tried this dual therapy for 1 month, 81% achieved good to optimal control of obstructive sleep apnea (OSA) and 92% reported tolerability and compliance with the Provent expiratory positive airway pressure (EPAP) device.

"Generally, continuous positive airway pressure [CPAP] is prescribed as first-line therapy because of its proven effectiveness, however adherence remains low with CPAP, with anywhere from 46% to 83% of patients still nonadherent," said Dr. Mita Deoras of University Hospitals Case Medical Center. Because of this, physicians continue to search for alternate therapies, she said at the annual meeting of the Associated Professional Sleep Societies.

Dr. Deoras and her colleagues have recruited 42 adults with OSA from an independent sleep center starting in 2010. Twenty-five (60%) of the participants were men. The average age was 61 years and the average BMI was 30.9. The majority (76%) had known cardiovascular comorbidities, including diabetes, hypertension, hyperlipidemia, and/or coronary artery disease. Ninety percent (38) had had previous treatment for their OSA, mostly with CPAP but a few with oral appliances, uvulopalatopharyngoplasty, or some combination. Fifteen percent had mild OSA, 42.5% had moderate OSA, 37.5% had severe OSA, and 5% had primary snoring.

"This study has the ability to offer an effective therapeutic option for this very common patient population."

Researchers obtained a baseline apnea-hypopnea index (AHI) from patients’ medical records. After an initial visit, participants were told about EPAP and shown how to use it, then asked to use it for 1 month. They also were asked to sleep in positions other than their backs. After the month, if patients were compliant, they came for a validation polysomnogram in which they stayed overnight at the sleep center while wearing the EPAP device and a cannula to measure nasal flow, and were encouraged to sleep in positions other than their backs.

The majority of patients had an improvement in AHI, with a mean reduction of 22.4. No statistically significant differences in improvement were seen between genders or among varying BMI levels. Sixty percent met the study condition for optimal control of OSA, defined as an AHI less than 5, and 20% met the definition of good control of OSA, defined as an AHI of 10 or less. Patients also reported a reduction in daytime sleepiness; the average Epworth Sleepiness Scale rating declined from 9.8 at baseline to 7.6.

"While we know that nasal EPAP is FDA approved for the treatment of OSA, clinicians are still often cautious against using it in patients with severe OSA or significant comorbidities," she said. And while sleep repositioning "can be as effective as CPAP in patients with position-dependent OSA, it isn’t often recommended as a first-line therapy.... This study has the ability to offer an effective therapeutic option for this very common patient population."

Study contributors were from MetroHealth Medical Center, the Cleveland Clinic Foundation, and Northcoast Clinical Trials Sleep Center. The study was funded by University Hospitals Case Medical Center. The researchers reported having no financial conflicts.

BALTIMORE – A treatment regimen combining nasal expiratory positive airway pressure with sleeping on one’s side can help manage obstructive sleep apnea, even in patients with cardiovascular comorbidities who have failed prior therapies, according to Cleveland researchers.

In a small study of 42 adults who tried this dual therapy for 1 month, 81% achieved good to optimal control of obstructive sleep apnea (OSA) and 92% reported tolerability and compliance with the Provent expiratory positive airway pressure (EPAP) device.

"Generally, continuous positive airway pressure [CPAP] is prescribed as first-line therapy because of its proven effectiveness, however adherence remains low with CPAP, with anywhere from 46% to 83% of patients still nonadherent," said Dr. Mita Deoras of University Hospitals Case Medical Center. Because of this, physicians continue to search for alternate therapies, she said at the annual meeting of the Associated Professional Sleep Societies.

Dr. Deoras and her colleagues have recruited 42 adults with OSA from an independent sleep center starting in 2010. Twenty-five (60%) of the participants were men. The average age was 61 years and the average BMI was 30.9. The majority (76%) had known cardiovascular comorbidities, including diabetes, hypertension, hyperlipidemia, and/or coronary artery disease. Ninety percent (38) had had previous treatment for their OSA, mostly with CPAP but a few with oral appliances, uvulopalatopharyngoplasty, or some combination. Fifteen percent had mild OSA, 42.5% had moderate OSA, 37.5% had severe OSA, and 5% had primary snoring.

"This study has the ability to offer an effective therapeutic option for this very common patient population."

Researchers obtained a baseline apnea-hypopnea index (AHI) from patients’ medical records. After an initial visit, participants were told about EPAP and shown how to use it, then asked to use it for 1 month. They also were asked to sleep in positions other than their backs. After the month, if patients were compliant, they came for a validation polysomnogram in which they stayed overnight at the sleep center while wearing the EPAP device and a cannula to measure nasal flow, and were encouraged to sleep in positions other than their backs.

The majority of patients had an improvement in AHI, with a mean reduction of 22.4. No statistically significant differences in improvement were seen between genders or among varying BMI levels. Sixty percent met the study condition for optimal control of OSA, defined as an AHI less than 5, and 20% met the definition of good control of OSA, defined as an AHI of 10 or less. Patients also reported a reduction in daytime sleepiness; the average Epworth Sleepiness Scale rating declined from 9.8 at baseline to 7.6.

"While we know that nasal EPAP is FDA approved for the treatment of OSA, clinicians are still often cautious against using it in patients with severe OSA or significant comorbidities," she said. And while sleep repositioning "can be as effective as CPAP in patients with position-dependent OSA, it isn’t often recommended as a first-line therapy.... This study has the ability to offer an effective therapeutic option for this very common patient population."

Study contributors were from MetroHealth Medical Center, the Cleveland Clinic Foundation, and Northcoast Clinical Trials Sleep Center. The study was funded by University Hospitals Case Medical Center. The researchers reported having no financial conflicts.

BALTIMORE – A single session of cognitive-behavioral therapy for insomnia, given in a large group format, may effectively improve sleep conditions for many healthy adults, California researchers have found.

Nearly 90% of 363 insomnia patients who attended the session reported improvements in their sleep patterns, of whom nearly a third said their insomnia had resolved, said Dr. Dennis Hwang, director of the Sleep Disorders Center at Kaiser Permanente Fontana (Calif.) Medical Center. He reported results of a retrospective analysis from his center at the annual meeting of the Associated Professional Sleep Societies.

To offer cognitive-behavioral therapy (CBT) efficiently, Dr. Hwang and his colleagues created a 2.5-hour CBT session, taught by a physician assistant (PA) to groups of 20 patients at a time. The first 2 hours of the class discuss proper sleep hygiene, sleep beliefs, relaxation techniques, and sleep restriction, and offer patients a chance to create an individual plan of action and sleep diary. The next 15 minutes of the class, taught by a PA or pharmacist, goes over basic insomnia medication education, including how to wean off insomnia medications, and the last 15-minute section of the class, taught by a PA or physical therapist, demonstrates optimal sleep positions.

"We teach patients how to sleep better by positioning pillows in certain areas and really try to get them into a neutral spine position," Dr. Hwang said. Many patients report that doing that alone helps their insomnia, he said.

Individual telephone follow-up calls are scheduled between the PA and the participants as needed, until there is an improvement in sleep patterns or the patient declines further participation.

Dr. Hwang’s group reviewed responses from patients participating between December 2010 and December 2011. There were 230 women and 133 men with an average age of 56 years. Among them, 117 had obstructive sleep apnea, 20 had restless legs syndrome, and 20 were night-shift workers; 134 took medications for insomnia and 102 took medications for depression or anxiety.

After completing the program, 321 (88%) patients said they had at least some improvement in their insomnia, and 110 (30%) said their insomnia had resolved. Twenty-five patients said they had no improvement.

Statistically significant improvements were seen in the following sleep parameters before and after the program: sleep latency (57 vs. 26 minutes); awakenings (3 vs. 1.4); and total sleep time (5 hours vs. 6.5 hours). The patients taking sleep medications decreased their use from 6.1 to 3.9 nights/week). And there was a decrease in primary care office visits in the year following the program, compared with the year before the program, from 4.3 to 3.5, an adjusted average of 1 full visit.

Most patients completed the program within 2.5 months, needing only one follow-up telephone call, Dr. Hwang said, indicating that "the class itself is effective even without follow-up." He cautioned that he could not find a good control group to match to those in the CBT program and that the office had a 30%-40% no-show rate for sessions.

An online program and weekly/biweekly interactive voice response questionnaire have been added to the therapy program since the study was completed, he said, allowing providers to single out those in need of additional follow-up.

The study was funded by his Kaiser Permanente.

BALTIMORE – A single session of cognitive-behavioral therapy for insomnia, given in a large group format, may effectively improve sleep conditions for many healthy adults, California researchers have found.

Nearly 90% of 363 insomnia patients who attended the session reported improvements in their sleep patterns, of whom nearly a third said their insomnia had resolved, said Dr. Dennis Hwang, director of the Sleep Disorders Center at Kaiser Permanente Fontana (Calif.) Medical Center. He reported results of a retrospective analysis from his center at the annual meeting of the Associated Professional Sleep Societies.

To offer cognitive-behavioral therapy (CBT) efficiently, Dr. Hwang and his colleagues created a 2.5-hour CBT session, taught by a physician assistant (PA) to groups of 20 patients at a time. The first 2 hours of the class discuss proper sleep hygiene, sleep beliefs, relaxation techniques, and sleep restriction, and offer patients a chance to create an individual plan of action and sleep diary. The next 15 minutes of the class, taught by a PA or pharmacist, goes over basic insomnia medication education, including how to wean off insomnia medications, and the last 15-minute section of the class, taught by a PA or physical therapist, demonstrates optimal sleep positions.

"We teach patients how to sleep better by positioning pillows in certain areas and really try to get them into a neutral spine position," Dr. Hwang said. Many patients report that doing that alone helps their insomnia, he said.

Individual telephone follow-up calls are scheduled between the PA and the participants as needed, until there is an improvement in sleep patterns or the patient declines further participation.

Dr. Hwang’s group reviewed responses from patients participating between December 2010 and December 2011. There were 230 women and 133 men with an average age of 56 years. Among them, 117 had obstructive sleep apnea, 20 had restless legs syndrome, and 20 were night-shift workers; 134 took medications for insomnia and 102 took medications for depression or anxiety.

After completing the program, 321 (88%) patients said they had at least some improvement in their insomnia, and 110 (30%) said their insomnia had resolved. Twenty-five patients said they had no improvement.

Statistically significant improvements were seen in the following sleep parameters before and after the program: sleep latency (57 vs. 26 minutes); awakenings (3 vs. 1.4); and total sleep time (5 hours vs. 6.5 hours). The patients taking sleep medications decreased their use from 6.1 to 3.9 nights/week). And there was a decrease in primary care office visits in the year following the program, compared with the year before the program, from 4.3 to 3.5, an adjusted average of 1 full visit.

Most patients completed the program within 2.5 months, needing only one follow-up telephone call, Dr. Hwang said, indicating that "the class itself is effective even without follow-up." He cautioned that he could not find a good control group to match to those in the CBT program and that the office had a 30%-40% no-show rate for sessions.

An online program and weekly/biweekly interactive voice response questionnaire have been added to the therapy program since the study was completed, he said, allowing providers to single out those in need of additional follow-up.

The study was funded by his Kaiser Permanente.

BALTIMORE – A single session of cognitive-behavioral therapy for insomnia, given in a large group format, may effectively improve sleep conditions for many healthy adults, California researchers have found.

Nearly 90% of 363 insomnia patients who attended the session reported improvements in their sleep patterns, of whom nearly a third said their insomnia had resolved, said Dr. Dennis Hwang, director of the Sleep Disorders Center at Kaiser Permanente Fontana (Calif.) Medical Center. He reported results of a retrospective analysis from his center at the annual meeting of the Associated Professional Sleep Societies.

To offer cognitive-behavioral therapy (CBT) efficiently, Dr. Hwang and his colleagues created a 2.5-hour CBT session, taught by a physician assistant (PA) to groups of 20 patients at a time. The first 2 hours of the class discuss proper sleep hygiene, sleep beliefs, relaxation techniques, and sleep restriction, and offer patients a chance to create an individual plan of action and sleep diary. The next 15 minutes of the class, taught by a PA or pharmacist, goes over basic insomnia medication education, including how to wean off insomnia medications, and the last 15-minute section of the class, taught by a PA or physical therapist, demonstrates optimal sleep positions.

"We teach patients how to sleep better by positioning pillows in certain areas and really try to get them into a neutral spine position," Dr. Hwang said. Many patients report that doing that alone helps their insomnia, he said.

Individual telephone follow-up calls are scheduled between the PA and the participants as needed, until there is an improvement in sleep patterns or the patient declines further participation.

Dr. Hwang’s group reviewed responses from patients participating between December 2010 and December 2011. There were 230 women and 133 men with an average age of 56 years. Among them, 117 had obstructive sleep apnea, 20 had restless legs syndrome, and 20 were night-shift workers; 134 took medications for insomnia and 102 took medications for depression or anxiety.

After completing the program, 321 (88%) patients said they had at least some improvement in their insomnia, and 110 (30%) said their insomnia had resolved. Twenty-five patients said they had no improvement.

Statistically significant improvements were seen in the following sleep parameters before and after the program: sleep latency (57 vs. 26 minutes); awakenings (3 vs. 1.4); and total sleep time (5 hours vs. 6.5 hours). The patients taking sleep medications decreased their use from 6.1 to 3.9 nights/week). And there was a decrease in primary care office visits in the year following the program, compared with the year before the program, from 4.3 to 3.5, an adjusted average of 1 full visit.

Most patients completed the program within 2.5 months, needing only one follow-up telephone call, Dr. Hwang said, indicating that "the class itself is effective even without follow-up." He cautioned that he could not find a good control group to match to those in the CBT program and that the office had a 30%-40% no-show rate for sessions.

An online program and weekly/biweekly interactive voice response questionnaire have been added to the therapy program since the study was completed, he said, allowing providers to single out those in need of additional follow-up.

The study was funded by his Kaiser Permanente.