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Strong need for eating disorder screening in patients with PTSD
WASHINGTON –
“Eating-related and body-image concerns may be more prevalent than we think, and if not considered, these concerns can make psychotherapy treatment less effective,” study author Nick Powers, a doctoral student in clinical psychology, La Salle University, Philadelphia, told this news organization.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Common bedfellows
Although many patients with PTSD also have an eating disorder, they are not always properly assessed for eating pathology and related functional impairment.
Some therapists don’t feel adequately equipped to target eating-related concerns in these patients and so may refer them to other providers. This, said Mr. Powers, can prolong symptoms and further distress patients.
Mr. Powers noted childhood physical or sexual abuse may affect eating patterns in patients with PTSD. “The evidence suggests these types of trauma exposure can be risk factors for the development of an eating disorder.”
Undiagnosed eating pathology may exacerbate functional impairment from PTSD and weaken the impact of evidence-based treatment.
Such patients are challenging to treat as they may not have the requisite skills to fully engage in exposure therapy, an evidence-based approach to treat PTSD, said Mr. Powers.
To determine whether PTSD would be significantly linked to greater eating disorder impairment (EDI) compared with other anxiety-related diagnoses and whether this would impair treatment, investigators studied 748 patients with an anxiety disorder who were attending a cognitive behavioral therapy (CBT) clinic. Anxiety disorders included PTSD, obsessive-compulsive disorder (OCD), social anxiety, and panic disorder.
Participants completed the 16-item Clinical Impairment Assessment (CIA) questionnaire, which includes questions about eating habits and feelings about food, body shape, and weight over the previous 4 weeks. Participants also reported anxiety symptom severity at the beginning, during, and end of treatment.
Need for better screening
Results showed that compared with those who had other anxiety disorders, patients with PTSD were three times more likely to have disordered eating (odds ratio [OR], 3.06; 95% confidence interval [CI], 1.47-6.37; P = .003).
In addition, higher baseline CIA scores predicted poorer PTSD treatment outcome (beta = –1.4; 95% CI, –1.67 to –1.10; P < .01).
“Having higher baseline CIA scores meant that patients’ PTSD symptoms did not remit as strongly compared to those with lower scores,” said Mr. Powers.
Patients with both PTSD and an eating disorder may have difficulty with regulating emotions and tolerating distress, he said.
“They may use binge eating, purging, or food restriction as strategies to regulate emotions. These behaviors may allow patients to become numb to or avoid heightened emotions that come from having PTSD and an eating disorder.”
Prior research linked perfectionism tendencies to poorer response to PTSD treatment. Those with an eating disorder may share similar tendencies, said Mr. Powers.
“If someone is consistently thinking negatively about their eating or body to the point where it interrupts their functioning, they may not be as likely to fully engage with PTSD treatment,” he said.
Ideally, clinicians would screen all patients with PTSD for an eating disorder, said Mr. Powers. “If screening instruments aren’t feasible or available, even just inquiring about body image or history of maladaptive eating behaviors can be helpful.”
He added this could open up a conversation about a traumatic event in the patient’s past.
Confirmatory research
Commenting on the study, Karen S. Mitchell, PhD, clinical research psychologist, National Center for PTSD, VA Boston Healthcare System, and associate professor in psychiatry, Boston University, said she was “excited” to see this research.
“Very few studies have examined the impact of baseline eating disorder symptoms on PTSD treatment outcomes or vice versa,” she said.
The study findings “add to the small but growing body of evidence suggesting that comorbid PTSD and eating disorder symptoms can impact recovery from each disorder,” she said.
She noted the importance of assessing comorbidity in patients presenting for treatment and of addressing comorbidity in both eating disorders and PTSD treatment. “But we need more research on how best to do this.”
Mr. Powers and Dr. Mitchell have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
WASHINGTON –
“Eating-related and body-image concerns may be more prevalent than we think, and if not considered, these concerns can make psychotherapy treatment less effective,” study author Nick Powers, a doctoral student in clinical psychology, La Salle University, Philadelphia, told this news organization.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Common bedfellows
Although many patients with PTSD also have an eating disorder, they are not always properly assessed for eating pathology and related functional impairment.
Some therapists don’t feel adequately equipped to target eating-related concerns in these patients and so may refer them to other providers. This, said Mr. Powers, can prolong symptoms and further distress patients.
Mr. Powers noted childhood physical or sexual abuse may affect eating patterns in patients with PTSD. “The evidence suggests these types of trauma exposure can be risk factors for the development of an eating disorder.”
Undiagnosed eating pathology may exacerbate functional impairment from PTSD and weaken the impact of evidence-based treatment.
Such patients are challenging to treat as they may not have the requisite skills to fully engage in exposure therapy, an evidence-based approach to treat PTSD, said Mr. Powers.
To determine whether PTSD would be significantly linked to greater eating disorder impairment (EDI) compared with other anxiety-related diagnoses and whether this would impair treatment, investigators studied 748 patients with an anxiety disorder who were attending a cognitive behavioral therapy (CBT) clinic. Anxiety disorders included PTSD, obsessive-compulsive disorder (OCD), social anxiety, and panic disorder.
Participants completed the 16-item Clinical Impairment Assessment (CIA) questionnaire, which includes questions about eating habits and feelings about food, body shape, and weight over the previous 4 weeks. Participants also reported anxiety symptom severity at the beginning, during, and end of treatment.
Need for better screening
Results showed that compared with those who had other anxiety disorders, patients with PTSD were three times more likely to have disordered eating (odds ratio [OR], 3.06; 95% confidence interval [CI], 1.47-6.37; P = .003).
In addition, higher baseline CIA scores predicted poorer PTSD treatment outcome (beta = –1.4; 95% CI, –1.67 to –1.10; P < .01).
“Having higher baseline CIA scores meant that patients’ PTSD symptoms did not remit as strongly compared to those with lower scores,” said Mr. Powers.
Patients with both PTSD and an eating disorder may have difficulty with regulating emotions and tolerating distress, he said.
“They may use binge eating, purging, or food restriction as strategies to regulate emotions. These behaviors may allow patients to become numb to or avoid heightened emotions that come from having PTSD and an eating disorder.”
Prior research linked perfectionism tendencies to poorer response to PTSD treatment. Those with an eating disorder may share similar tendencies, said Mr. Powers.
“If someone is consistently thinking negatively about their eating or body to the point where it interrupts their functioning, they may not be as likely to fully engage with PTSD treatment,” he said.
Ideally, clinicians would screen all patients with PTSD for an eating disorder, said Mr. Powers. “If screening instruments aren’t feasible or available, even just inquiring about body image or history of maladaptive eating behaviors can be helpful.”
He added this could open up a conversation about a traumatic event in the patient’s past.
Confirmatory research
Commenting on the study, Karen S. Mitchell, PhD, clinical research psychologist, National Center for PTSD, VA Boston Healthcare System, and associate professor in psychiatry, Boston University, said she was “excited” to see this research.
“Very few studies have examined the impact of baseline eating disorder symptoms on PTSD treatment outcomes or vice versa,” she said.
The study findings “add to the small but growing body of evidence suggesting that comorbid PTSD and eating disorder symptoms can impact recovery from each disorder,” she said.
She noted the importance of assessing comorbidity in patients presenting for treatment and of addressing comorbidity in both eating disorders and PTSD treatment. “But we need more research on how best to do this.”
Mr. Powers and Dr. Mitchell have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
WASHINGTON –
“Eating-related and body-image concerns may be more prevalent than we think, and if not considered, these concerns can make psychotherapy treatment less effective,” study author Nick Powers, a doctoral student in clinical psychology, La Salle University, Philadelphia, told this news organization.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Common bedfellows
Although many patients with PTSD also have an eating disorder, they are not always properly assessed for eating pathology and related functional impairment.
Some therapists don’t feel adequately equipped to target eating-related concerns in these patients and so may refer them to other providers. This, said Mr. Powers, can prolong symptoms and further distress patients.
Mr. Powers noted childhood physical or sexual abuse may affect eating patterns in patients with PTSD. “The evidence suggests these types of trauma exposure can be risk factors for the development of an eating disorder.”
Undiagnosed eating pathology may exacerbate functional impairment from PTSD and weaken the impact of evidence-based treatment.
Such patients are challenging to treat as they may not have the requisite skills to fully engage in exposure therapy, an evidence-based approach to treat PTSD, said Mr. Powers.
To determine whether PTSD would be significantly linked to greater eating disorder impairment (EDI) compared with other anxiety-related diagnoses and whether this would impair treatment, investigators studied 748 patients with an anxiety disorder who were attending a cognitive behavioral therapy (CBT) clinic. Anxiety disorders included PTSD, obsessive-compulsive disorder (OCD), social anxiety, and panic disorder.
Participants completed the 16-item Clinical Impairment Assessment (CIA) questionnaire, which includes questions about eating habits and feelings about food, body shape, and weight over the previous 4 weeks. Participants also reported anxiety symptom severity at the beginning, during, and end of treatment.
Need for better screening
Results showed that compared with those who had other anxiety disorders, patients with PTSD were three times more likely to have disordered eating (odds ratio [OR], 3.06; 95% confidence interval [CI], 1.47-6.37; P = .003).
In addition, higher baseline CIA scores predicted poorer PTSD treatment outcome (beta = –1.4; 95% CI, –1.67 to –1.10; P < .01).
“Having higher baseline CIA scores meant that patients’ PTSD symptoms did not remit as strongly compared to those with lower scores,” said Mr. Powers.
Patients with both PTSD and an eating disorder may have difficulty with regulating emotions and tolerating distress, he said.
“They may use binge eating, purging, or food restriction as strategies to regulate emotions. These behaviors may allow patients to become numb to or avoid heightened emotions that come from having PTSD and an eating disorder.”
Prior research linked perfectionism tendencies to poorer response to PTSD treatment. Those with an eating disorder may share similar tendencies, said Mr. Powers.
“If someone is consistently thinking negatively about their eating or body to the point where it interrupts their functioning, they may not be as likely to fully engage with PTSD treatment,” he said.
Ideally, clinicians would screen all patients with PTSD for an eating disorder, said Mr. Powers. “If screening instruments aren’t feasible or available, even just inquiring about body image or history of maladaptive eating behaviors can be helpful.”
He added this could open up a conversation about a traumatic event in the patient’s past.
Confirmatory research
Commenting on the study, Karen S. Mitchell, PhD, clinical research psychologist, National Center for PTSD, VA Boston Healthcare System, and associate professor in psychiatry, Boston University, said she was “excited” to see this research.
“Very few studies have examined the impact of baseline eating disorder symptoms on PTSD treatment outcomes or vice versa,” she said.
The study findings “add to the small but growing body of evidence suggesting that comorbid PTSD and eating disorder symptoms can impact recovery from each disorder,” she said.
She noted the importance of assessing comorbidity in patients presenting for treatment and of addressing comorbidity in both eating disorders and PTSD treatment. “But we need more research on how best to do this.”
Mr. Powers and Dr. Mitchell have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ADAA 2023
Psilocybin promising for body dysmorphic disorder
WASHINGTON – Psilocybin is safe and effective in patients with body dysmorphic disorder (BDD), preliminary findings of a small pilot study show.
“The results suggest that psilocybin appears to be relatively safe and potentially helpful for people with BDD, and that it has a broader scope than just depression,” study investigator Franklin Schneier, MD, codirector of the Anxiety Disorders Clinic, New York State Psychiatric Institute, and special lecturer in psychiatry at Columbia University Medical Center in New York City, told this news organization.
So far, psilocybin has mostly been examined in clinical trials among patients with major depression. Dr. Schneier said he is aware of only a single case in the literature of its use in BDD: a patient who self-treated with psilocybin and reported symptom improvement.
The current study was presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Few treatment options
Patients with BDD are preoccupied with a body part they perceive as ugly or defective, “and not just mildly so,” said Dr. Schneier. “It bothers them to the extreme such that they may obsess about it on and off all day long.”
Such patients may engage in compulsive behaviors like constantly checking themselves in the mirror, and going to great lengths to conceal the body part they feel is defective. “They often seek out cosmetic procedures that objectively aren’t warranted,” said Dr. Schneier.
BDD patients often have comorbid depression, and many attempt suicide. As with other anxiety and depressive disorders, BDD is twice as prevalent in women vs. men, said Dr. Schneier.
Selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy (CBT) are the only approved therapies for BDD.
The investigators thought there may be a good chance BDD patients could benefit from psilocybin. Psilocybin alters bodily self-awareness, which “might shake up people’s beliefs about their abnormal body perceptions,” said Dr. Schneier.
There’s also some suggestion that psilocybin relaxes inflexible thinking, he added. “People with BDD have very rigid beliefs about their body distortions that aren’t easily swayed by logic.”
The study included 12 adults (8 women, 4 men) with a mean age of 34 years and moderate to severe BDD who failed at least one SSRI course and had had BDD for an average of 21 years.
Participants had preliminary sessions with a therapist familiar with psilocybin who prepared them psychologically and discussed what to expect from the experience. On the day of the intervention, subjects took a single 25 mg oral dose of synthetic psilocybin in a comfortable setting.
Therapists were present for the next 8 hours to answer questions and support subjects through the experience.
High response rate
The primary efficacy outcome was change in the BDD Yale-Brown Obsessive Compulsive Disorder Scale Modified (BDD-YBOCS) total score.
The mean baseline BDD-YBOCS score was 29.17. Researchers regularly assessed this score in the following weeks.
At 12 weeks, BDD-YBOCS scores decreased significantly from baseline (P < .001) with a large effect size (partial eta squared = .54).
However, said Dr. Schneier, what really stood out was the proportion of responders. At week 12, seven (58%) of the 12 participants were responders, as defined by a 30% or greater decrease in the BDD-YBOCS score. Of these, three were “almost symptom-free,” he added.
A number of secondary outcomes, including conviction of belief, disability, and negative affect, also significantly improved.
It’s too early to determine if additional treatment is required. The investigators plan to follow-up with the cohort at 1 year.
Although exciting, these early results warrant caution, said Dr. Schneier. “On the one hand, this is a sample of people who have struggled for a long time and have failed previous therapies, so that’s good. But on the other hand, it’s an open trial with no placebo group, and everyone has high expectations, so we don’t know how much of a placebo effect there was.”
Most adverse events, including headaches and fatigue, were mild and resolved within the first week after dosing, and there were no serious adverse events.
Based on these findings, Dr. Schneier said controlled trials of psilocybin in BDD are warranted.
Need for scientific rigor
Commenting on the research, Charles B. Nemeroff, MD, PhD, professor and chair, department of psychiatry and behavioral sciences, University of Texas at Austin, said while promising, psilocybin is “not for everyone” and patients need to be closely screened.
“We want to know their medical history and if they have a family history of schizophrenia or bipolar disorder. We don’t know whether these [psychedelic] medicines might trigger an episode.”
Dr. Nemeroff also noted there’s a risk of “troubling” side effects from the drug.
“My view is psilocybin clearly has therapeutic effects and we need to apply scientific rigor as we would any medicine in order to determine the risk/benefit ratio,” said Dr. Nemeroff, who was not associated with this psilocybin trial.
In addition, psilocybin is being tested in conditions other than BDD and major depression, including anorexia nervosa, postpartum depression, and alcohol use disorder, he added.
The study received funding from COMPASS Pathways PLC.
Dr. Nemeroff reports he has received research support from the NIH and Stanley Medical Research Institute; served as a consultant for Bracket (Clintara), Fortress Biotech, Intra-Cellular Therapies, Janssen Research and Development, Magstim, Navitor Pharmaceuticals, Sunovion Pharmaceuticals, Taisho Pharmaceuticals, Takeda, TC MSO, and Xhale; served on scientific advisory boards for the American Foundation for Suicide Prevention, the Anxiety and Depression Association of America, Bracket (Clintara), Brain and Behavior Research Foundation, Laureate Institute for Brain Research, Skyland Trail, and Xhale; is a stockholder in AbbVie, Antares, BI Gen Holdings, Celgene, OPKO Health, Seattle Genetics, and Xhale; serves on the board of directors for the American Foundation for Suicide Prevention, Anxiety and Depression Association of America, and Gratitude America; has received income or equity of $10,000 or more from American Psychiatric Publishing, Bracket (Clintara), Magstim, CME Outfitters, and Intra-Cellular Therapies; and holds patents on a method and devices for transdermal delivery of lithium and a method of assessing antidepressant drug therapy via transport inhibition of monoamine neurotransmitters by ex vivo assay.
A version of this article first appeared on Medscape.com.
WASHINGTON – Psilocybin is safe and effective in patients with body dysmorphic disorder (BDD), preliminary findings of a small pilot study show.
“The results suggest that psilocybin appears to be relatively safe and potentially helpful for people with BDD, and that it has a broader scope than just depression,” study investigator Franklin Schneier, MD, codirector of the Anxiety Disorders Clinic, New York State Psychiatric Institute, and special lecturer in psychiatry at Columbia University Medical Center in New York City, told this news organization.
So far, psilocybin has mostly been examined in clinical trials among patients with major depression. Dr. Schneier said he is aware of only a single case in the literature of its use in BDD: a patient who self-treated with psilocybin and reported symptom improvement.
The current study was presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Few treatment options
Patients with BDD are preoccupied with a body part they perceive as ugly or defective, “and not just mildly so,” said Dr. Schneier. “It bothers them to the extreme such that they may obsess about it on and off all day long.”
Such patients may engage in compulsive behaviors like constantly checking themselves in the mirror, and going to great lengths to conceal the body part they feel is defective. “They often seek out cosmetic procedures that objectively aren’t warranted,” said Dr. Schneier.
BDD patients often have comorbid depression, and many attempt suicide. As with other anxiety and depressive disorders, BDD is twice as prevalent in women vs. men, said Dr. Schneier.
Selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy (CBT) are the only approved therapies for BDD.
The investigators thought there may be a good chance BDD patients could benefit from psilocybin. Psilocybin alters bodily self-awareness, which “might shake up people’s beliefs about their abnormal body perceptions,” said Dr. Schneier.
There’s also some suggestion that psilocybin relaxes inflexible thinking, he added. “People with BDD have very rigid beliefs about their body distortions that aren’t easily swayed by logic.”
The study included 12 adults (8 women, 4 men) with a mean age of 34 years and moderate to severe BDD who failed at least one SSRI course and had had BDD for an average of 21 years.
Participants had preliminary sessions with a therapist familiar with psilocybin who prepared them psychologically and discussed what to expect from the experience. On the day of the intervention, subjects took a single 25 mg oral dose of synthetic psilocybin in a comfortable setting.
Therapists were present for the next 8 hours to answer questions and support subjects through the experience.
High response rate
The primary efficacy outcome was change in the BDD Yale-Brown Obsessive Compulsive Disorder Scale Modified (BDD-YBOCS) total score.
The mean baseline BDD-YBOCS score was 29.17. Researchers regularly assessed this score in the following weeks.
At 12 weeks, BDD-YBOCS scores decreased significantly from baseline (P < .001) with a large effect size (partial eta squared = .54).
However, said Dr. Schneier, what really stood out was the proportion of responders. At week 12, seven (58%) of the 12 participants were responders, as defined by a 30% or greater decrease in the BDD-YBOCS score. Of these, three were “almost symptom-free,” he added.
A number of secondary outcomes, including conviction of belief, disability, and negative affect, also significantly improved.
It’s too early to determine if additional treatment is required. The investigators plan to follow-up with the cohort at 1 year.
Although exciting, these early results warrant caution, said Dr. Schneier. “On the one hand, this is a sample of people who have struggled for a long time and have failed previous therapies, so that’s good. But on the other hand, it’s an open trial with no placebo group, and everyone has high expectations, so we don’t know how much of a placebo effect there was.”
Most adverse events, including headaches and fatigue, were mild and resolved within the first week after dosing, and there were no serious adverse events.
Based on these findings, Dr. Schneier said controlled trials of psilocybin in BDD are warranted.
Need for scientific rigor
Commenting on the research, Charles B. Nemeroff, MD, PhD, professor and chair, department of psychiatry and behavioral sciences, University of Texas at Austin, said while promising, psilocybin is “not for everyone” and patients need to be closely screened.
“We want to know their medical history and if they have a family history of schizophrenia or bipolar disorder. We don’t know whether these [psychedelic] medicines might trigger an episode.”
Dr. Nemeroff also noted there’s a risk of “troubling” side effects from the drug.
“My view is psilocybin clearly has therapeutic effects and we need to apply scientific rigor as we would any medicine in order to determine the risk/benefit ratio,” said Dr. Nemeroff, who was not associated with this psilocybin trial.
In addition, psilocybin is being tested in conditions other than BDD and major depression, including anorexia nervosa, postpartum depression, and alcohol use disorder, he added.
The study received funding from COMPASS Pathways PLC.
Dr. Nemeroff reports he has received research support from the NIH and Stanley Medical Research Institute; served as a consultant for Bracket (Clintara), Fortress Biotech, Intra-Cellular Therapies, Janssen Research and Development, Magstim, Navitor Pharmaceuticals, Sunovion Pharmaceuticals, Taisho Pharmaceuticals, Takeda, TC MSO, and Xhale; served on scientific advisory boards for the American Foundation for Suicide Prevention, the Anxiety and Depression Association of America, Bracket (Clintara), Brain and Behavior Research Foundation, Laureate Institute for Brain Research, Skyland Trail, and Xhale; is a stockholder in AbbVie, Antares, BI Gen Holdings, Celgene, OPKO Health, Seattle Genetics, and Xhale; serves on the board of directors for the American Foundation for Suicide Prevention, Anxiety and Depression Association of America, and Gratitude America; has received income or equity of $10,000 or more from American Psychiatric Publishing, Bracket (Clintara), Magstim, CME Outfitters, and Intra-Cellular Therapies; and holds patents on a method and devices for transdermal delivery of lithium and a method of assessing antidepressant drug therapy via transport inhibition of monoamine neurotransmitters by ex vivo assay.
A version of this article first appeared on Medscape.com.
WASHINGTON – Psilocybin is safe and effective in patients with body dysmorphic disorder (BDD), preliminary findings of a small pilot study show.
“The results suggest that psilocybin appears to be relatively safe and potentially helpful for people with BDD, and that it has a broader scope than just depression,” study investigator Franklin Schneier, MD, codirector of the Anxiety Disorders Clinic, New York State Psychiatric Institute, and special lecturer in psychiatry at Columbia University Medical Center in New York City, told this news organization.
So far, psilocybin has mostly been examined in clinical trials among patients with major depression. Dr. Schneier said he is aware of only a single case in the literature of its use in BDD: a patient who self-treated with psilocybin and reported symptom improvement.
The current study was presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Few treatment options
Patients with BDD are preoccupied with a body part they perceive as ugly or defective, “and not just mildly so,” said Dr. Schneier. “It bothers them to the extreme such that they may obsess about it on and off all day long.”
Such patients may engage in compulsive behaviors like constantly checking themselves in the mirror, and going to great lengths to conceal the body part they feel is defective. “They often seek out cosmetic procedures that objectively aren’t warranted,” said Dr. Schneier.
BDD patients often have comorbid depression, and many attempt suicide. As with other anxiety and depressive disorders, BDD is twice as prevalent in women vs. men, said Dr. Schneier.
Selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy (CBT) are the only approved therapies for BDD.
The investigators thought there may be a good chance BDD patients could benefit from psilocybin. Psilocybin alters bodily self-awareness, which “might shake up people’s beliefs about their abnormal body perceptions,” said Dr. Schneier.
There’s also some suggestion that psilocybin relaxes inflexible thinking, he added. “People with BDD have very rigid beliefs about their body distortions that aren’t easily swayed by logic.”
The study included 12 adults (8 women, 4 men) with a mean age of 34 years and moderate to severe BDD who failed at least one SSRI course and had had BDD for an average of 21 years.
Participants had preliminary sessions with a therapist familiar with psilocybin who prepared them psychologically and discussed what to expect from the experience. On the day of the intervention, subjects took a single 25 mg oral dose of synthetic psilocybin in a comfortable setting.
Therapists were present for the next 8 hours to answer questions and support subjects through the experience.
High response rate
The primary efficacy outcome was change in the BDD Yale-Brown Obsessive Compulsive Disorder Scale Modified (BDD-YBOCS) total score.
The mean baseline BDD-YBOCS score was 29.17. Researchers regularly assessed this score in the following weeks.
At 12 weeks, BDD-YBOCS scores decreased significantly from baseline (P < .001) with a large effect size (partial eta squared = .54).
However, said Dr. Schneier, what really stood out was the proportion of responders. At week 12, seven (58%) of the 12 participants were responders, as defined by a 30% or greater decrease in the BDD-YBOCS score. Of these, three were “almost symptom-free,” he added.
A number of secondary outcomes, including conviction of belief, disability, and negative affect, also significantly improved.
It’s too early to determine if additional treatment is required. The investigators plan to follow-up with the cohort at 1 year.
Although exciting, these early results warrant caution, said Dr. Schneier. “On the one hand, this is a sample of people who have struggled for a long time and have failed previous therapies, so that’s good. But on the other hand, it’s an open trial with no placebo group, and everyone has high expectations, so we don’t know how much of a placebo effect there was.”
Most adverse events, including headaches and fatigue, were mild and resolved within the first week after dosing, and there were no serious adverse events.
Based on these findings, Dr. Schneier said controlled trials of psilocybin in BDD are warranted.
Need for scientific rigor
Commenting on the research, Charles B. Nemeroff, MD, PhD, professor and chair, department of psychiatry and behavioral sciences, University of Texas at Austin, said while promising, psilocybin is “not for everyone” and patients need to be closely screened.
“We want to know their medical history and if they have a family history of schizophrenia or bipolar disorder. We don’t know whether these [psychedelic] medicines might trigger an episode.”
Dr. Nemeroff also noted there’s a risk of “troubling” side effects from the drug.
“My view is psilocybin clearly has therapeutic effects and we need to apply scientific rigor as we would any medicine in order to determine the risk/benefit ratio,” said Dr. Nemeroff, who was not associated with this psilocybin trial.
In addition, psilocybin is being tested in conditions other than BDD and major depression, including anorexia nervosa, postpartum depression, and alcohol use disorder, he added.
The study received funding from COMPASS Pathways PLC.
Dr. Nemeroff reports he has received research support from the NIH and Stanley Medical Research Institute; served as a consultant for Bracket (Clintara), Fortress Biotech, Intra-Cellular Therapies, Janssen Research and Development, Magstim, Navitor Pharmaceuticals, Sunovion Pharmaceuticals, Taisho Pharmaceuticals, Takeda, TC MSO, and Xhale; served on scientific advisory boards for the American Foundation for Suicide Prevention, the Anxiety and Depression Association of America, Bracket (Clintara), Brain and Behavior Research Foundation, Laureate Institute for Brain Research, Skyland Trail, and Xhale; is a stockholder in AbbVie, Antares, BI Gen Holdings, Celgene, OPKO Health, Seattle Genetics, and Xhale; serves on the board of directors for the American Foundation for Suicide Prevention, Anxiety and Depression Association of America, and Gratitude America; has received income or equity of $10,000 or more from American Psychiatric Publishing, Bracket (Clintara), Magstim, CME Outfitters, and Intra-Cellular Therapies; and holds patents on a method and devices for transdermal delivery of lithium and a method of assessing antidepressant drug therapy via transport inhibition of monoamine neurotransmitters by ex vivo assay.
A version of this article first appeared on Medscape.com.
AT ADAA 2023
Telehealth suicide prevention program safe, acceptable
WASHINGTON –
Skeptics had worried that participating in the program through telehealth would exacerbate safety and other issues veterans had about discussing suicide in a group setting, study investigator Sarah Sullivan, PhD student, Health Psychology & Clinical Science, City University of New York, told this news organization.
“But that for us was not really true. People opened up about their suicidal thoughts and triggers even on this telehealth format, and that’s really important for providers to know,” she said.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Trial run
Suicide is a major public health issue, particularly for veterans. Recent data from the Veterans Administration show 17 veterans die by suicide every day.
The current study included 15 male and 2 female veterans (29.4% White, 70.6% Hispanic) from New York City and Philadelphia. Participants had an average age of 50 and all were either deemed by a clinician to be at extremely high risk for suicide or were hospitalized for this reason.
The individuals completed an online version of the Project Life Force (PLF) program, which uses dialectical behavioral therapy and psychoeducational approaches. The program includes the brief Safety Planning intervention (SPI), aimed at reducing short-term suicide risk.
Considered a best practice, the SPI includes a written list of personal suicide warning signs or triggers, internal coping strategies, social contacts who offer support and distraction from suicidal thoughts, contact information for professionals, a suicide crisis hotline, and nearby emergency services.
In addition to these steps, the PLF program focuses on sleep, exercise, and making the safety plan accessible.
The telehealth platform for the program was WebEx software. Participants were offered a “trial run” to orient them to the technology, said Ms. Sullivan.
Group sessions were held once weekly for 10 weeks, with optional “booster” sessions if needed. Each session included about five participants.
To ensure privacy, participants were provided with headphones and laptops. This was especially important for those sharing a living space, including spouses and children, said Ms. Sullivan.
High ratings
Participants completed the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Each of these yields scores from four items rated on a Likert scale of 1-5, for a total score ranging from 5 to 20, with higher scores indicating higher ratings.
Veterans rated PLF-T as highly acceptable (mean AIM, 17.50), appropriate (mean IAM, 17.25), and feasible (mean FIM, 18).
Study participants reported the program was convenient and noted that it decreased the burden of traveling to sessions, especially during the COVID-19 pandemic.
They also reported the program was less likely to compete with other demands such as childcare and other appointments, said Ms. Sullivan.
In addition, it helped those with comorbidities such as posttraumatic stress disorder, she added. She noted veterans with PTSD may be triggered on subways or buses when traveling to in-person treatment sessions.
“That can take away from addressing the suicidal triggers,” said Ms. Sullivan. “So, this program allows them to fully concentrate on the safety plan.”
Results showed that study participants “enjoyed the group and would recommend it to others,” said Ms. Sullivan. “I think that signifies the group was effective in its goal of mitigating loneliness, which was exacerbated during the COVID-19 pandemic, and creating a socially supportive environment, especially for the vets living alone.”
Veterans also reported that the program helped them understand the connection between depression or PTSD and suicidal thoughts, urges, and plans. In addition, they appreciated the group dynamics, where they felt connected to other veterans experiencing similar challenges.
Hopeful results
Commenting on the study, Paul E. Holtzheimer, MD, deputy director for research at the National Center for PTSD, praised the study for focusing on a very high-risk group.
“This gets you closer to the population you’re probably going to have an impact on in terms of preventing suicide,” said Dr. Holtzheimer, a professor of psychiatry and surgery at Dartmouth College’s Geisel School of Medicine, Hanover, N.H.
The fact that many of the participants had attempted suicide in the last year underlines that this was a very high-risk population, said Dr. Holtzheimer. “Not only are they thinking about suicide, but almost two-thirds had actually attempted or tried something.”
This kind of program “would be great for rural environments where people may be living like four hours away from the VA or a clinic,” said Dr. Holtzheimer, noting that many veterans are often quite isolated.
“One of the very positive outcomes of the COVID-19 pandemic was helping us strengthen our ability to do telehealth,” he said.
However, Dr. Holtzheimer noted the study was small and qualitative. “The next step ideally would be a controlled trial looking at not just ideation but at risky behavior or clear suicide attempts or preparation, like buying a gun or hoarding medication, to help determine efficacy.”
The researchers and Dr. Holtzheimer report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
WASHINGTON –
Skeptics had worried that participating in the program through telehealth would exacerbate safety and other issues veterans had about discussing suicide in a group setting, study investigator Sarah Sullivan, PhD student, Health Psychology & Clinical Science, City University of New York, told this news organization.
“But that for us was not really true. People opened up about their suicidal thoughts and triggers even on this telehealth format, and that’s really important for providers to know,” she said.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Trial run
Suicide is a major public health issue, particularly for veterans. Recent data from the Veterans Administration show 17 veterans die by suicide every day.
The current study included 15 male and 2 female veterans (29.4% White, 70.6% Hispanic) from New York City and Philadelphia. Participants had an average age of 50 and all were either deemed by a clinician to be at extremely high risk for suicide or were hospitalized for this reason.
The individuals completed an online version of the Project Life Force (PLF) program, which uses dialectical behavioral therapy and psychoeducational approaches. The program includes the brief Safety Planning intervention (SPI), aimed at reducing short-term suicide risk.
Considered a best practice, the SPI includes a written list of personal suicide warning signs or triggers, internal coping strategies, social contacts who offer support and distraction from suicidal thoughts, contact information for professionals, a suicide crisis hotline, and nearby emergency services.
In addition to these steps, the PLF program focuses on sleep, exercise, and making the safety plan accessible.
The telehealth platform for the program was WebEx software. Participants were offered a “trial run” to orient them to the technology, said Ms. Sullivan.
Group sessions were held once weekly for 10 weeks, with optional “booster” sessions if needed. Each session included about five participants.
To ensure privacy, participants were provided with headphones and laptops. This was especially important for those sharing a living space, including spouses and children, said Ms. Sullivan.
High ratings
Participants completed the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Each of these yields scores from four items rated on a Likert scale of 1-5, for a total score ranging from 5 to 20, with higher scores indicating higher ratings.
Veterans rated PLF-T as highly acceptable (mean AIM, 17.50), appropriate (mean IAM, 17.25), and feasible (mean FIM, 18).
Study participants reported the program was convenient and noted that it decreased the burden of traveling to sessions, especially during the COVID-19 pandemic.
They also reported the program was less likely to compete with other demands such as childcare and other appointments, said Ms. Sullivan.
In addition, it helped those with comorbidities such as posttraumatic stress disorder, she added. She noted veterans with PTSD may be triggered on subways or buses when traveling to in-person treatment sessions.
“That can take away from addressing the suicidal triggers,” said Ms. Sullivan. “So, this program allows them to fully concentrate on the safety plan.”
Results showed that study participants “enjoyed the group and would recommend it to others,” said Ms. Sullivan. “I think that signifies the group was effective in its goal of mitigating loneliness, which was exacerbated during the COVID-19 pandemic, and creating a socially supportive environment, especially for the vets living alone.”
Veterans also reported that the program helped them understand the connection between depression or PTSD and suicidal thoughts, urges, and plans. In addition, they appreciated the group dynamics, where they felt connected to other veterans experiencing similar challenges.
Hopeful results
Commenting on the study, Paul E. Holtzheimer, MD, deputy director for research at the National Center for PTSD, praised the study for focusing on a very high-risk group.
“This gets you closer to the population you’re probably going to have an impact on in terms of preventing suicide,” said Dr. Holtzheimer, a professor of psychiatry and surgery at Dartmouth College’s Geisel School of Medicine, Hanover, N.H.
The fact that many of the participants had attempted suicide in the last year underlines that this was a very high-risk population, said Dr. Holtzheimer. “Not only are they thinking about suicide, but almost two-thirds had actually attempted or tried something.”
This kind of program “would be great for rural environments where people may be living like four hours away from the VA or a clinic,” said Dr. Holtzheimer, noting that many veterans are often quite isolated.
“One of the very positive outcomes of the COVID-19 pandemic was helping us strengthen our ability to do telehealth,” he said.
However, Dr. Holtzheimer noted the study was small and qualitative. “The next step ideally would be a controlled trial looking at not just ideation but at risky behavior or clear suicide attempts or preparation, like buying a gun or hoarding medication, to help determine efficacy.”
The researchers and Dr. Holtzheimer report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
WASHINGTON –
Skeptics had worried that participating in the program through telehealth would exacerbate safety and other issues veterans had about discussing suicide in a group setting, study investigator Sarah Sullivan, PhD student, Health Psychology & Clinical Science, City University of New York, told this news organization.
“But that for us was not really true. People opened up about their suicidal thoughts and triggers even on this telehealth format, and that’s really important for providers to know,” she said.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Trial run
Suicide is a major public health issue, particularly for veterans. Recent data from the Veterans Administration show 17 veterans die by suicide every day.
The current study included 15 male and 2 female veterans (29.4% White, 70.6% Hispanic) from New York City and Philadelphia. Participants had an average age of 50 and all were either deemed by a clinician to be at extremely high risk for suicide or were hospitalized for this reason.
The individuals completed an online version of the Project Life Force (PLF) program, which uses dialectical behavioral therapy and psychoeducational approaches. The program includes the brief Safety Planning intervention (SPI), aimed at reducing short-term suicide risk.
Considered a best practice, the SPI includes a written list of personal suicide warning signs or triggers, internal coping strategies, social contacts who offer support and distraction from suicidal thoughts, contact information for professionals, a suicide crisis hotline, and nearby emergency services.
In addition to these steps, the PLF program focuses on sleep, exercise, and making the safety plan accessible.
The telehealth platform for the program was WebEx software. Participants were offered a “trial run” to orient them to the technology, said Ms. Sullivan.
Group sessions were held once weekly for 10 weeks, with optional “booster” sessions if needed. Each session included about five participants.
To ensure privacy, participants were provided with headphones and laptops. This was especially important for those sharing a living space, including spouses and children, said Ms. Sullivan.
High ratings
Participants completed the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Each of these yields scores from four items rated on a Likert scale of 1-5, for a total score ranging from 5 to 20, with higher scores indicating higher ratings.
Veterans rated PLF-T as highly acceptable (mean AIM, 17.50), appropriate (mean IAM, 17.25), and feasible (mean FIM, 18).
Study participants reported the program was convenient and noted that it decreased the burden of traveling to sessions, especially during the COVID-19 pandemic.
They also reported the program was less likely to compete with other demands such as childcare and other appointments, said Ms. Sullivan.
In addition, it helped those with comorbidities such as posttraumatic stress disorder, she added. She noted veterans with PTSD may be triggered on subways or buses when traveling to in-person treatment sessions.
“That can take away from addressing the suicidal triggers,” said Ms. Sullivan. “So, this program allows them to fully concentrate on the safety plan.”
Results showed that study participants “enjoyed the group and would recommend it to others,” said Ms. Sullivan. “I think that signifies the group was effective in its goal of mitigating loneliness, which was exacerbated during the COVID-19 pandemic, and creating a socially supportive environment, especially for the vets living alone.”
Veterans also reported that the program helped them understand the connection between depression or PTSD and suicidal thoughts, urges, and plans. In addition, they appreciated the group dynamics, where they felt connected to other veterans experiencing similar challenges.
Hopeful results
Commenting on the study, Paul E. Holtzheimer, MD, deputy director for research at the National Center for PTSD, praised the study for focusing on a very high-risk group.
“This gets you closer to the population you’re probably going to have an impact on in terms of preventing suicide,” said Dr. Holtzheimer, a professor of psychiatry and surgery at Dartmouth College’s Geisel School of Medicine, Hanover, N.H.
The fact that many of the participants had attempted suicide in the last year underlines that this was a very high-risk population, said Dr. Holtzheimer. “Not only are they thinking about suicide, but almost two-thirds had actually attempted or tried something.”
This kind of program “would be great for rural environments where people may be living like four hours away from the VA or a clinic,” said Dr. Holtzheimer, noting that many veterans are often quite isolated.
“One of the very positive outcomes of the COVID-19 pandemic was helping us strengthen our ability to do telehealth,” he said.
However, Dr. Holtzheimer noted the study was small and qualitative. “The next step ideally would be a controlled trial looking at not just ideation but at risky behavior or clear suicide attempts or preparation, like buying a gun or hoarding medication, to help determine efficacy.”
The researchers and Dr. Holtzheimer report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ADAA 2023
Melatonin: A new way to reduce self-harm?
. However, at least one expert has some concerns about the strength of the evidence.
The results suggest improving sleep hygiene in this population may reduce self-injury, study investigator Sarah E. Bergen, PhD, associate professor, department of medical epidemiology and biostatistics, Karolinska Institute, Stockholm, said in an interview.
In addition, she noted, for “pediatric patients who are experiencing sleep problems, melatonin is a safe and effective way to help them.”
Dr. Bergen believes clinicians should recommend melatonin to all teens because “there’s little harm that could come from it and possibly a lot of benefit.”
The findings were published online in the Journal of Child Psychology and Psychiatry.
Few treatments available
Research shows sleep disorders like insomnia are common in youth, particularly among those with psychiatric disorders. Sleep disorders can significantly affect daytime functioning, cognition, emotional regulation, and behavior, and can be a risk factor for unintentional injuries such as falls and vehicular accidents, as well as for intentional self-harm.
The lifetime prevalence of self-harm in youth is estimated to be 17%, but this varies across study designs. There are few treatments for self-harm in youth, although psychosocial treatments appear promising.
Melatonin is a naturally occurring hormone secreted primarily by the pineal gland in response to darkness. It helps promote and maintain the normal sleep-wake cycle and is involved in other biological functions.
In Sweden, melatonin is the most commonly prescribed drug for sleep disturbances in children and adolescents. Prior to 2020, during the course of the study, it was only available by prescription.
The study, which used linked national databases, included 25,575 children and adolescents, 58.2% of them male, who initiated a melatonin treatment between the ages of 6 and 18 years.
Researchers estimated the risks of self-harm, including poisoning (57%) and cutting (34%). The fact that poisoning was more common than cutting was somewhat surprising, said Dr. Bergen. “I would have thought the opposite would be true; that cutting was more prevalent.”
The study examined the risk of self-harm in individual participants by comparing the last unmedicated month with the 12 months after initiating melatonin treatment. In this way, they accounted for potential confounders such as genetics, sleep disorder severity, and psychiatric disorders.
The median age at first melatonin prescription was 13 years for males and 15 years for females.
While there were no statistically significant changes in relative risk for body injuries, falls, and transport accidents, the relative risk for self-injury was statistically significantly lower during the months following melatonin treatment initiation.
The incidence rate ratio in the month following treatment was 0.58 (95% confidence interval, 0.46-0.73) for self-harm and 0.59 (95% CI, 0.45-0.78) for poisoning.
Higher risks in females
The relative risk of self-harm was higher in females than males. This, said Dr. Bergen, is possibly because self-harm is more common in adolescence than in childhood. Female study participants were older than their male counterparts.
Melatonin may help male teens, too, she said. “It’s just that the problem is not that great in males to begin with, so a decrease is not very dramatic after melatonin initiation.”
About 87.2% of participants treated with melatonin were diagnosed with at least one psychiatric disorder. Attention-deficit hyperactivity disorder, the most common comorbidity, was diagnosed in more than 50% of new melatonin users. This isn’t surprising, because sleep disturbances are associated with this psychiatric condition and are frequent side effects of ADHD medications.
After ADHD, anxiety and depression were the next most common psychiatric disorders among study subjects. The analysis found risks for self-harm and poisoning were largely driven by patients suffering from one or both of these disorders, particularly among females.
The IRR in the month following melatonin treatment initiation was 0.46 (95% CI, 0.27-0.76] among adolescent females with psychiatric disorders, after excluding antidepressant users.
Melatonin may reduce the risk of self-harm by treating sleep problems related to psychiatric comorbidities, especially anxiety and depression. It could also decrease pain sensitivity experienced by adolescents who self-harm.
Other factors could play a role in treating sleep problems and/or preventing self-harm in these patients. For example, increased clinician awareness and monitoring, behavioral interventions, a placebo effect, and concurrent use of other medications.
When researchers ran an analysis that excluded individuals taking an antidepressant, “surprisingly, there wasn’t much difference,” said Dr. Bergen. “We thought antidepressants might be causing some of the effect we observed, but when we removed antidepressant users, we saw a very similar pattern of intentional self-harm rates following melatonin use, which suggests melatonin is causal, but we can’t prove that.”
Other sleep medications such as sedatives could also affect self-harm rates by improving sleep. However, these are not typically prescribed to children because of their side effects and overdose potential, said Dr. Bergen.
“Melatonin is extremely safe and side effects are rare; it’s impossible to overdose, and people really can’t hurt themselves with it.”
More research needed
Adrian Jacques Ambrose, MD, medical director, Columbia University Irving Medical Center, and assistant professor of psychiatry, Columbia University, New York, pointed out some evidence in the study is relatively weak.
“When the authors separated out the on- and off-melatonin groups, it looks like there wasn’t a statistically significant difference [in IRRs] between the two groups – for example, in any injury, self-harm, or poisoning – and this weakens their argument that melatonin is associated with self-harm and poisoning.”
Given the current youth mental health crisis, more research “would absolutely be indicated” to better explore possible additional variables, said Dr. Ambrose.
“For example, some additional follow-up studies may add on covariates in conjunction with melatonin usage, such as the number of medical appointments, the presence of psychotherapeutic interventions, dosage of melatonin, or even the sleepiness scale, to evaluate whether the symptoms of sleep disturbances are more directly correlated with the self-harm behaviors.”
The study was supported by the European Union’s Horizon 2020 Research and Innovation Programme. Dr. Bergen and Dr. Ambrose report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
. However, at least one expert has some concerns about the strength of the evidence.
The results suggest improving sleep hygiene in this population may reduce self-injury, study investigator Sarah E. Bergen, PhD, associate professor, department of medical epidemiology and biostatistics, Karolinska Institute, Stockholm, said in an interview.
In addition, she noted, for “pediatric patients who are experiencing sleep problems, melatonin is a safe and effective way to help them.”
Dr. Bergen believes clinicians should recommend melatonin to all teens because “there’s little harm that could come from it and possibly a lot of benefit.”
The findings were published online in the Journal of Child Psychology and Psychiatry.
Few treatments available
Research shows sleep disorders like insomnia are common in youth, particularly among those with psychiatric disorders. Sleep disorders can significantly affect daytime functioning, cognition, emotional regulation, and behavior, and can be a risk factor for unintentional injuries such as falls and vehicular accidents, as well as for intentional self-harm.
The lifetime prevalence of self-harm in youth is estimated to be 17%, but this varies across study designs. There are few treatments for self-harm in youth, although psychosocial treatments appear promising.
Melatonin is a naturally occurring hormone secreted primarily by the pineal gland in response to darkness. It helps promote and maintain the normal sleep-wake cycle and is involved in other biological functions.
In Sweden, melatonin is the most commonly prescribed drug for sleep disturbances in children and adolescents. Prior to 2020, during the course of the study, it was only available by prescription.
The study, which used linked national databases, included 25,575 children and adolescents, 58.2% of them male, who initiated a melatonin treatment between the ages of 6 and 18 years.
Researchers estimated the risks of self-harm, including poisoning (57%) and cutting (34%). The fact that poisoning was more common than cutting was somewhat surprising, said Dr. Bergen. “I would have thought the opposite would be true; that cutting was more prevalent.”
The study examined the risk of self-harm in individual participants by comparing the last unmedicated month with the 12 months after initiating melatonin treatment. In this way, they accounted for potential confounders such as genetics, sleep disorder severity, and psychiatric disorders.
The median age at first melatonin prescription was 13 years for males and 15 years for females.
While there were no statistically significant changes in relative risk for body injuries, falls, and transport accidents, the relative risk for self-injury was statistically significantly lower during the months following melatonin treatment initiation.
The incidence rate ratio in the month following treatment was 0.58 (95% confidence interval, 0.46-0.73) for self-harm and 0.59 (95% CI, 0.45-0.78) for poisoning.
Higher risks in females
The relative risk of self-harm was higher in females than males. This, said Dr. Bergen, is possibly because self-harm is more common in adolescence than in childhood. Female study participants were older than their male counterparts.
Melatonin may help male teens, too, she said. “It’s just that the problem is not that great in males to begin with, so a decrease is not very dramatic after melatonin initiation.”
About 87.2% of participants treated with melatonin were diagnosed with at least one psychiatric disorder. Attention-deficit hyperactivity disorder, the most common comorbidity, was diagnosed in more than 50% of new melatonin users. This isn’t surprising, because sleep disturbances are associated with this psychiatric condition and are frequent side effects of ADHD medications.
After ADHD, anxiety and depression were the next most common psychiatric disorders among study subjects. The analysis found risks for self-harm and poisoning were largely driven by patients suffering from one or both of these disorders, particularly among females.
The IRR in the month following melatonin treatment initiation was 0.46 (95% CI, 0.27-0.76] among adolescent females with psychiatric disorders, after excluding antidepressant users.
Melatonin may reduce the risk of self-harm by treating sleep problems related to psychiatric comorbidities, especially anxiety and depression. It could also decrease pain sensitivity experienced by adolescents who self-harm.
Other factors could play a role in treating sleep problems and/or preventing self-harm in these patients. For example, increased clinician awareness and monitoring, behavioral interventions, a placebo effect, and concurrent use of other medications.
When researchers ran an analysis that excluded individuals taking an antidepressant, “surprisingly, there wasn’t much difference,” said Dr. Bergen. “We thought antidepressants might be causing some of the effect we observed, but when we removed antidepressant users, we saw a very similar pattern of intentional self-harm rates following melatonin use, which suggests melatonin is causal, but we can’t prove that.”
Other sleep medications such as sedatives could also affect self-harm rates by improving sleep. However, these are not typically prescribed to children because of their side effects and overdose potential, said Dr. Bergen.
“Melatonin is extremely safe and side effects are rare; it’s impossible to overdose, and people really can’t hurt themselves with it.”
More research needed
Adrian Jacques Ambrose, MD, medical director, Columbia University Irving Medical Center, and assistant professor of psychiatry, Columbia University, New York, pointed out some evidence in the study is relatively weak.
“When the authors separated out the on- and off-melatonin groups, it looks like there wasn’t a statistically significant difference [in IRRs] between the two groups – for example, in any injury, self-harm, or poisoning – and this weakens their argument that melatonin is associated with self-harm and poisoning.”
Given the current youth mental health crisis, more research “would absolutely be indicated” to better explore possible additional variables, said Dr. Ambrose.
“For example, some additional follow-up studies may add on covariates in conjunction with melatonin usage, such as the number of medical appointments, the presence of psychotherapeutic interventions, dosage of melatonin, or even the sleepiness scale, to evaluate whether the symptoms of sleep disturbances are more directly correlated with the self-harm behaviors.”
The study was supported by the European Union’s Horizon 2020 Research and Innovation Programme. Dr. Bergen and Dr. Ambrose report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
. However, at least one expert has some concerns about the strength of the evidence.
The results suggest improving sleep hygiene in this population may reduce self-injury, study investigator Sarah E. Bergen, PhD, associate professor, department of medical epidemiology and biostatistics, Karolinska Institute, Stockholm, said in an interview.
In addition, she noted, for “pediatric patients who are experiencing sleep problems, melatonin is a safe and effective way to help them.”
Dr. Bergen believes clinicians should recommend melatonin to all teens because “there’s little harm that could come from it and possibly a lot of benefit.”
The findings were published online in the Journal of Child Psychology and Psychiatry.
Few treatments available
Research shows sleep disorders like insomnia are common in youth, particularly among those with psychiatric disorders. Sleep disorders can significantly affect daytime functioning, cognition, emotional regulation, and behavior, and can be a risk factor for unintentional injuries such as falls and vehicular accidents, as well as for intentional self-harm.
The lifetime prevalence of self-harm in youth is estimated to be 17%, but this varies across study designs. There are few treatments for self-harm in youth, although psychosocial treatments appear promising.
Melatonin is a naturally occurring hormone secreted primarily by the pineal gland in response to darkness. It helps promote and maintain the normal sleep-wake cycle and is involved in other biological functions.
In Sweden, melatonin is the most commonly prescribed drug for sleep disturbances in children and adolescents. Prior to 2020, during the course of the study, it was only available by prescription.
The study, which used linked national databases, included 25,575 children and adolescents, 58.2% of them male, who initiated a melatonin treatment between the ages of 6 and 18 years.
Researchers estimated the risks of self-harm, including poisoning (57%) and cutting (34%). The fact that poisoning was more common than cutting was somewhat surprising, said Dr. Bergen. “I would have thought the opposite would be true; that cutting was more prevalent.”
The study examined the risk of self-harm in individual participants by comparing the last unmedicated month with the 12 months after initiating melatonin treatment. In this way, they accounted for potential confounders such as genetics, sleep disorder severity, and psychiatric disorders.
The median age at first melatonin prescription was 13 years for males and 15 years for females.
While there were no statistically significant changes in relative risk for body injuries, falls, and transport accidents, the relative risk for self-injury was statistically significantly lower during the months following melatonin treatment initiation.
The incidence rate ratio in the month following treatment was 0.58 (95% confidence interval, 0.46-0.73) for self-harm and 0.59 (95% CI, 0.45-0.78) for poisoning.
Higher risks in females
The relative risk of self-harm was higher in females than males. This, said Dr. Bergen, is possibly because self-harm is more common in adolescence than in childhood. Female study participants were older than their male counterparts.
Melatonin may help male teens, too, she said. “It’s just that the problem is not that great in males to begin with, so a decrease is not very dramatic after melatonin initiation.”
About 87.2% of participants treated with melatonin were diagnosed with at least one psychiatric disorder. Attention-deficit hyperactivity disorder, the most common comorbidity, was diagnosed in more than 50% of new melatonin users. This isn’t surprising, because sleep disturbances are associated with this psychiatric condition and are frequent side effects of ADHD medications.
After ADHD, anxiety and depression were the next most common psychiatric disorders among study subjects. The analysis found risks for self-harm and poisoning were largely driven by patients suffering from one or both of these disorders, particularly among females.
The IRR in the month following melatonin treatment initiation was 0.46 (95% CI, 0.27-0.76] among adolescent females with psychiatric disorders, after excluding antidepressant users.
Melatonin may reduce the risk of self-harm by treating sleep problems related to psychiatric comorbidities, especially anxiety and depression. It could also decrease pain sensitivity experienced by adolescents who self-harm.
Other factors could play a role in treating sleep problems and/or preventing self-harm in these patients. For example, increased clinician awareness and monitoring, behavioral interventions, a placebo effect, and concurrent use of other medications.
When researchers ran an analysis that excluded individuals taking an antidepressant, “surprisingly, there wasn’t much difference,” said Dr. Bergen. “We thought antidepressants might be causing some of the effect we observed, but when we removed antidepressant users, we saw a very similar pattern of intentional self-harm rates following melatonin use, which suggests melatonin is causal, but we can’t prove that.”
Other sleep medications such as sedatives could also affect self-harm rates by improving sleep. However, these are not typically prescribed to children because of their side effects and overdose potential, said Dr. Bergen.
“Melatonin is extremely safe and side effects are rare; it’s impossible to overdose, and people really can’t hurt themselves with it.”
More research needed
Adrian Jacques Ambrose, MD, medical director, Columbia University Irving Medical Center, and assistant professor of psychiatry, Columbia University, New York, pointed out some evidence in the study is relatively weak.
“When the authors separated out the on- and off-melatonin groups, it looks like there wasn’t a statistically significant difference [in IRRs] between the two groups – for example, in any injury, self-harm, or poisoning – and this weakens their argument that melatonin is associated with self-harm and poisoning.”
Given the current youth mental health crisis, more research “would absolutely be indicated” to better explore possible additional variables, said Dr. Ambrose.
“For example, some additional follow-up studies may add on covariates in conjunction with melatonin usage, such as the number of medical appointments, the presence of psychotherapeutic interventions, dosage of melatonin, or even the sleepiness scale, to evaluate whether the symptoms of sleep disturbances are more directly correlated with the self-harm behaviors.”
The study was supported by the European Union’s Horizon 2020 Research and Innovation Programme. Dr. Bergen and Dr. Ambrose report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF CHILD PSYCHOLOGY AND PSYCHIATRY
Safety, efficacy of analgesics for low back pain ‘uncertain’
Higher-quality randomized controlled trials of head-to-head comparisons are needed, study investigator Michael A. Wewege, PhD candidate, research fellow, University of New South Wales and Neuroscience Research Australia, Sydney, said in an interview.
“Until then, doctors should use caution when prescribing analgesic medicines for adults with nonspecific acute low back pain. They should use this new evidence in line with their own expertise and the patient sitting in front of them when making any decision about a medication,” he added.
The findings were published online in the BMJ.
Poor quality evidence
Analgesics such as ibuprofen, acetaminophen, and codeine are widely used to treat nonspecific low-back pain, which is defined as pain lasting less than 6 weeks, but evidence for the comparative efficacy of these agents is limited.
To fill this knowledge gap, the researchers conducted a systematic review and analysis of controlled trials comparing analgesics with another analgesic, placebo, or no treatment in patients with acute, nonspecific low back pain.
The review involved 98 randomized controlled trials that included 15,134 adults (49% women) aged 30-60 years with pain duration ranging from 24 hours to 21 days. The median baseline pain intensity was 65 on a pain scale of 0-100.
Of the included trials, 39% were placebo controlled, 67% masked both participants and clinicians, and 41% reported industry sponsorship.
The studies compared an analgesic medicine with another analgesic, placebo, or no treatment comprised of usual care or being placed on a wait list.
Study medications, which had to be approved in the United States, Europe, or Australia, included nonsteroidal anti-inflammatory drugs, paracetamol, opioids, anticonvulsants, antidepressants, muscle relaxants, and corticosteroids.
These drugs were administered systemically as a single drug or in combination formulations, at any dose.
Researchers used a network meta-analysis, which combines direct and indirect information across a network of randomized clinical trials to estimate the comparative effectiveness of multiple treatments.
The primary outcomes were reductions in low back pain intensity (measured with a visual analogue scale), numerical rating scale or another ordinal scale, and safety as indicated by the number of participants who had any adverse event.
Investigators found several medications were associated with large reductions in pain intensity, compared with placebo, though with low or very low confidence.
Low or very low confidence was found for reduced pain intensity after treatment with tolperisone (mean difference, −26.1; 95% confidence interval, −34.0 to −18.2), aceclofenac plus tizanidine (mean difference, −26.1; 95% CI, −38.5 to −13.6), pregabalin (mean difference, −24.7; 95% CI, −34.6 to −14.7), and 14 other medicines, compared with placebo, the researchers report.
In addition, they found low or very low confidence for no difference between the effects of several of these medications.
Increased adverse events had moderate to very low confidence with tramadol (risk ratio, 2.6; 95% CI, 1.5-4.5), paracetamol plus sustained release tramadol (RR, 2.4; 95% CI, 1.5-3.8), baclofen (RR, 2.3; 95% CI, 1.5-3.4), and paracetamol plus tramadol (RR, 2.1; 95% CI, 1.3-3.4), compared with placebo, the investigators add.
“These medicines could increase the risk of adverse events, compared with other medicines with moderate to low confidence. Moderate to low confidence was also noted for secondary outcomes and secondary analysis of medicine classes,” the researchers note.
The review suggested 14 additional comparisons favored the treatment over placebo, all with very low confidence except for one with low confidence.
In the 68 trials that included the number of participants reporting an adverse event, there was moderate confidence for increased adverse events with the opioid tramadol (RR, 2.6; 95% CI, 1.5-4.5), paracetamol plus sustained release tramadol (RR, 2.4; 95% CI, 1.5-3.8), paracetamol plus tramadol (RR, 2.1; 95% CI, 1.3-3.4), and low confidence for baclofen (RR, 2.3; 1.5-3.4), compared with placebo.
The review also uncovered moderate to low confidence for secondary outcomes, which included low back-specific function, serious adverse events, and acceptability (number of participants who dropped out).
Unexpected findings
The new results were somewhat unexpected, said Mr. Wewege.
“When we set out to do this review, we envisioned the evidence would be a lot more comprehensive. We didn’t think it would be so disconnected and there would be so few trials looking at the different comparisons that would lead us to have low confidence in most of the findings.”
Various factors contributed to this low confidence, he said. One was the risk of bias – about 90% of trials had some concerns or high risk of bias. Another factor was the heterogeneity in effect estimates.
Most of the evidence is based on studies comparing different analgesics to placebo, Mr. Wewege noted. The lack of head-to-head drug comparisons is because “the easiest way to get a drug approved is just to demonstrate it’s better than placebo,” he said.
In addition to these new findings, clinicians should consider a medication’s availability, their own expertise, and patient preferences when selecting an analgesic, said Mr. Wewege. He noted most patients with acute low back pain get better within a few weeks without any intervention.
“Patients should be reassured that things will heal naturally and that they are not going to be in pain forever,” he said.
Determining optimal treatment is key
Chris Gilligan, MD, associate chief medical officer, Brigham and Women’s Hospital, and associate professor of anesthesia, Harvard Medical School, both in Boston, said determining which medications are optimal is “key,” as acute low back pain is very common and analgesics are used frequently.
The new review does provide information on which medications have the strongest evidence for pain reduction, said Dr. Gilligan. “On the one hand, it directionally points you towards certain medications, and even certain classes of medication, for comparative effectiveness.”
However, he said, the confidence for this effectiveness is low or very low, “so I wouldn’t overweight it.”
The data on adverse effects, where the confidence is mostly moderate to low, might have more of an influence on prescribing, he said.
“For example, there’s some indication tramadol may be more closely associated with adverse events in patients with acute low back pain and that would add to our caution about using tramadol; it’s not that we would never use it, but [we]would take that into account.”
Dr. Gilligan agrees clinicians should be cautious about prescribing analgesics for low back pain. One reason for being conservative in terms of treatments, he noted, is that “acute low back pain has a very favorable natural history.”
While clinical practice guidelines recommend nonpharmacologic therapies as first- and second-line treatment for acute, nonspecific low back pain, Dr. Gilligan noted that as with drugs, evidence for nondrug therapies also has low or very low confidence.
The study received funding from a 2020 Exercise Physiology Research (Consumables) Grant from the University of New South Wales, which was used to obtain translations of studies published in languages other than English.
Mr. Wewege was supported by a Postgraduate Scholarship from the National Health and Medical Research Council of Australia, a School of Medical Sciences Top-Up Scholarship from the University of New South Wales, and a PhD Supplementary Scholarship from Neuroscience Research Australia. Dr. Gilligan reports that he conducts clinical trials with companies and groups, including the National Institutes of Health related to medications, devices, and procedures for pain.
A version of this article first appeared on Medscape.com.
Higher-quality randomized controlled trials of head-to-head comparisons are needed, study investigator Michael A. Wewege, PhD candidate, research fellow, University of New South Wales and Neuroscience Research Australia, Sydney, said in an interview.
“Until then, doctors should use caution when prescribing analgesic medicines for adults with nonspecific acute low back pain. They should use this new evidence in line with their own expertise and the patient sitting in front of them when making any decision about a medication,” he added.
The findings were published online in the BMJ.
Poor quality evidence
Analgesics such as ibuprofen, acetaminophen, and codeine are widely used to treat nonspecific low-back pain, which is defined as pain lasting less than 6 weeks, but evidence for the comparative efficacy of these agents is limited.
To fill this knowledge gap, the researchers conducted a systematic review and analysis of controlled trials comparing analgesics with another analgesic, placebo, or no treatment in patients with acute, nonspecific low back pain.
The review involved 98 randomized controlled trials that included 15,134 adults (49% women) aged 30-60 years with pain duration ranging from 24 hours to 21 days. The median baseline pain intensity was 65 on a pain scale of 0-100.
Of the included trials, 39% were placebo controlled, 67% masked both participants and clinicians, and 41% reported industry sponsorship.
The studies compared an analgesic medicine with another analgesic, placebo, or no treatment comprised of usual care or being placed on a wait list.
Study medications, which had to be approved in the United States, Europe, or Australia, included nonsteroidal anti-inflammatory drugs, paracetamol, opioids, anticonvulsants, antidepressants, muscle relaxants, and corticosteroids.
These drugs were administered systemically as a single drug or in combination formulations, at any dose.
Researchers used a network meta-analysis, which combines direct and indirect information across a network of randomized clinical trials to estimate the comparative effectiveness of multiple treatments.
The primary outcomes were reductions in low back pain intensity (measured with a visual analogue scale), numerical rating scale or another ordinal scale, and safety as indicated by the number of participants who had any adverse event.
Investigators found several medications were associated with large reductions in pain intensity, compared with placebo, though with low or very low confidence.
Low or very low confidence was found for reduced pain intensity after treatment with tolperisone (mean difference, −26.1; 95% confidence interval, −34.0 to −18.2), aceclofenac plus tizanidine (mean difference, −26.1; 95% CI, −38.5 to −13.6), pregabalin (mean difference, −24.7; 95% CI, −34.6 to −14.7), and 14 other medicines, compared with placebo, the researchers report.
In addition, they found low or very low confidence for no difference between the effects of several of these medications.
Increased adverse events had moderate to very low confidence with tramadol (risk ratio, 2.6; 95% CI, 1.5-4.5), paracetamol plus sustained release tramadol (RR, 2.4; 95% CI, 1.5-3.8), baclofen (RR, 2.3; 95% CI, 1.5-3.4), and paracetamol plus tramadol (RR, 2.1; 95% CI, 1.3-3.4), compared with placebo, the investigators add.
“These medicines could increase the risk of adverse events, compared with other medicines with moderate to low confidence. Moderate to low confidence was also noted for secondary outcomes and secondary analysis of medicine classes,” the researchers note.
The review suggested 14 additional comparisons favored the treatment over placebo, all with very low confidence except for one with low confidence.
In the 68 trials that included the number of participants reporting an adverse event, there was moderate confidence for increased adverse events with the opioid tramadol (RR, 2.6; 95% CI, 1.5-4.5), paracetamol plus sustained release tramadol (RR, 2.4; 95% CI, 1.5-3.8), paracetamol plus tramadol (RR, 2.1; 95% CI, 1.3-3.4), and low confidence for baclofen (RR, 2.3; 1.5-3.4), compared with placebo.
The review also uncovered moderate to low confidence for secondary outcomes, which included low back-specific function, serious adverse events, and acceptability (number of participants who dropped out).
Unexpected findings
The new results were somewhat unexpected, said Mr. Wewege.
“When we set out to do this review, we envisioned the evidence would be a lot more comprehensive. We didn’t think it would be so disconnected and there would be so few trials looking at the different comparisons that would lead us to have low confidence in most of the findings.”
Various factors contributed to this low confidence, he said. One was the risk of bias – about 90% of trials had some concerns or high risk of bias. Another factor was the heterogeneity in effect estimates.
Most of the evidence is based on studies comparing different analgesics to placebo, Mr. Wewege noted. The lack of head-to-head drug comparisons is because “the easiest way to get a drug approved is just to demonstrate it’s better than placebo,” he said.
In addition to these new findings, clinicians should consider a medication’s availability, their own expertise, and patient preferences when selecting an analgesic, said Mr. Wewege. He noted most patients with acute low back pain get better within a few weeks without any intervention.
“Patients should be reassured that things will heal naturally and that they are not going to be in pain forever,” he said.
Determining optimal treatment is key
Chris Gilligan, MD, associate chief medical officer, Brigham and Women’s Hospital, and associate professor of anesthesia, Harvard Medical School, both in Boston, said determining which medications are optimal is “key,” as acute low back pain is very common and analgesics are used frequently.
The new review does provide information on which medications have the strongest evidence for pain reduction, said Dr. Gilligan. “On the one hand, it directionally points you towards certain medications, and even certain classes of medication, for comparative effectiveness.”
However, he said, the confidence for this effectiveness is low or very low, “so I wouldn’t overweight it.”
The data on adverse effects, where the confidence is mostly moderate to low, might have more of an influence on prescribing, he said.
“For example, there’s some indication tramadol may be more closely associated with adverse events in patients with acute low back pain and that would add to our caution about using tramadol; it’s not that we would never use it, but [we]would take that into account.”
Dr. Gilligan agrees clinicians should be cautious about prescribing analgesics for low back pain. One reason for being conservative in terms of treatments, he noted, is that “acute low back pain has a very favorable natural history.”
While clinical practice guidelines recommend nonpharmacologic therapies as first- and second-line treatment for acute, nonspecific low back pain, Dr. Gilligan noted that as with drugs, evidence for nondrug therapies also has low or very low confidence.
The study received funding from a 2020 Exercise Physiology Research (Consumables) Grant from the University of New South Wales, which was used to obtain translations of studies published in languages other than English.
Mr. Wewege was supported by a Postgraduate Scholarship from the National Health and Medical Research Council of Australia, a School of Medical Sciences Top-Up Scholarship from the University of New South Wales, and a PhD Supplementary Scholarship from Neuroscience Research Australia. Dr. Gilligan reports that he conducts clinical trials with companies and groups, including the National Institutes of Health related to medications, devices, and procedures for pain.
A version of this article first appeared on Medscape.com.
Higher-quality randomized controlled trials of head-to-head comparisons are needed, study investigator Michael A. Wewege, PhD candidate, research fellow, University of New South Wales and Neuroscience Research Australia, Sydney, said in an interview.
“Until then, doctors should use caution when prescribing analgesic medicines for adults with nonspecific acute low back pain. They should use this new evidence in line with their own expertise and the patient sitting in front of them when making any decision about a medication,” he added.
The findings were published online in the BMJ.
Poor quality evidence
Analgesics such as ibuprofen, acetaminophen, and codeine are widely used to treat nonspecific low-back pain, which is defined as pain lasting less than 6 weeks, but evidence for the comparative efficacy of these agents is limited.
To fill this knowledge gap, the researchers conducted a systematic review and analysis of controlled trials comparing analgesics with another analgesic, placebo, or no treatment in patients with acute, nonspecific low back pain.
The review involved 98 randomized controlled trials that included 15,134 adults (49% women) aged 30-60 years with pain duration ranging from 24 hours to 21 days. The median baseline pain intensity was 65 on a pain scale of 0-100.
Of the included trials, 39% were placebo controlled, 67% masked both participants and clinicians, and 41% reported industry sponsorship.
The studies compared an analgesic medicine with another analgesic, placebo, or no treatment comprised of usual care or being placed on a wait list.
Study medications, which had to be approved in the United States, Europe, or Australia, included nonsteroidal anti-inflammatory drugs, paracetamol, opioids, anticonvulsants, antidepressants, muscle relaxants, and corticosteroids.
These drugs were administered systemically as a single drug or in combination formulations, at any dose.
Researchers used a network meta-analysis, which combines direct and indirect information across a network of randomized clinical trials to estimate the comparative effectiveness of multiple treatments.
The primary outcomes were reductions in low back pain intensity (measured with a visual analogue scale), numerical rating scale or another ordinal scale, and safety as indicated by the number of participants who had any adverse event.
Investigators found several medications were associated with large reductions in pain intensity, compared with placebo, though with low or very low confidence.
Low or very low confidence was found for reduced pain intensity after treatment with tolperisone (mean difference, −26.1; 95% confidence interval, −34.0 to −18.2), aceclofenac plus tizanidine (mean difference, −26.1; 95% CI, −38.5 to −13.6), pregabalin (mean difference, −24.7; 95% CI, −34.6 to −14.7), and 14 other medicines, compared with placebo, the researchers report.
In addition, they found low or very low confidence for no difference between the effects of several of these medications.
Increased adverse events had moderate to very low confidence with tramadol (risk ratio, 2.6; 95% CI, 1.5-4.5), paracetamol plus sustained release tramadol (RR, 2.4; 95% CI, 1.5-3.8), baclofen (RR, 2.3; 95% CI, 1.5-3.4), and paracetamol plus tramadol (RR, 2.1; 95% CI, 1.3-3.4), compared with placebo, the investigators add.
“These medicines could increase the risk of adverse events, compared with other medicines with moderate to low confidence. Moderate to low confidence was also noted for secondary outcomes and secondary analysis of medicine classes,” the researchers note.
The review suggested 14 additional comparisons favored the treatment over placebo, all with very low confidence except for one with low confidence.
In the 68 trials that included the number of participants reporting an adverse event, there was moderate confidence for increased adverse events with the opioid tramadol (RR, 2.6; 95% CI, 1.5-4.5), paracetamol plus sustained release tramadol (RR, 2.4; 95% CI, 1.5-3.8), paracetamol plus tramadol (RR, 2.1; 95% CI, 1.3-3.4), and low confidence for baclofen (RR, 2.3; 1.5-3.4), compared with placebo.
The review also uncovered moderate to low confidence for secondary outcomes, which included low back-specific function, serious adverse events, and acceptability (number of participants who dropped out).
Unexpected findings
The new results were somewhat unexpected, said Mr. Wewege.
“When we set out to do this review, we envisioned the evidence would be a lot more comprehensive. We didn’t think it would be so disconnected and there would be so few trials looking at the different comparisons that would lead us to have low confidence in most of the findings.”
Various factors contributed to this low confidence, he said. One was the risk of bias – about 90% of trials had some concerns or high risk of bias. Another factor was the heterogeneity in effect estimates.
Most of the evidence is based on studies comparing different analgesics to placebo, Mr. Wewege noted. The lack of head-to-head drug comparisons is because “the easiest way to get a drug approved is just to demonstrate it’s better than placebo,” he said.
In addition to these new findings, clinicians should consider a medication’s availability, their own expertise, and patient preferences when selecting an analgesic, said Mr. Wewege. He noted most patients with acute low back pain get better within a few weeks without any intervention.
“Patients should be reassured that things will heal naturally and that they are not going to be in pain forever,” he said.
Determining optimal treatment is key
Chris Gilligan, MD, associate chief medical officer, Brigham and Women’s Hospital, and associate professor of anesthesia, Harvard Medical School, both in Boston, said determining which medications are optimal is “key,” as acute low back pain is very common and analgesics are used frequently.
The new review does provide information on which medications have the strongest evidence for pain reduction, said Dr. Gilligan. “On the one hand, it directionally points you towards certain medications, and even certain classes of medication, for comparative effectiveness.”
However, he said, the confidence for this effectiveness is low or very low, “so I wouldn’t overweight it.”
The data on adverse effects, where the confidence is mostly moderate to low, might have more of an influence on prescribing, he said.
“For example, there’s some indication tramadol may be more closely associated with adverse events in patients with acute low back pain and that would add to our caution about using tramadol; it’s not that we would never use it, but [we]would take that into account.”
Dr. Gilligan agrees clinicians should be cautious about prescribing analgesics for low back pain. One reason for being conservative in terms of treatments, he noted, is that “acute low back pain has a very favorable natural history.”
While clinical practice guidelines recommend nonpharmacologic therapies as first- and second-line treatment for acute, nonspecific low back pain, Dr. Gilligan noted that as with drugs, evidence for nondrug therapies also has low or very low confidence.
The study received funding from a 2020 Exercise Physiology Research (Consumables) Grant from the University of New South Wales, which was used to obtain translations of studies published in languages other than English.
Mr. Wewege was supported by a Postgraduate Scholarship from the National Health and Medical Research Council of Australia, a School of Medical Sciences Top-Up Scholarship from the University of New South Wales, and a PhD Supplementary Scholarship from Neuroscience Research Australia. Dr. Gilligan reports that he conducts clinical trials with companies and groups, including the National Institutes of Health related to medications, devices, and procedures for pain.
A version of this article first appeared on Medscape.com.
FROM BMJ
Physical activity is a growing priority for patients with MS
SAN DIEGO – As , researchers have developed a mobile app to encourage young patients with the disease to become more active. The smartphone-based app provides tailored physical activity information, coaching advice, and tools to increase social connectedness.
A pilot study examining whether the intervention changes activity, depression, and fatigue levels should be wrapped up later this year, but it looks as though the app is succeeding.
“The feedback we’ve gotten so far from our coaches is that the kids seem highly motivated,” said one of the creators, E. Ann Yeh, MD, professor in the faculty of medicine at the University of Toronto and director of the pediatric MS and neuroinflammatory disorders program at the Hospital for Sick Children.
Preliminary work showed that use of the app was associated with a 31% increase in physical activity.
They discussed this and other studies of the role of exercise in MS at the annual meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis.
Higher levels of depression and fatigue
Studies show that youths with MS who are less physically active are more likely to experience higher levels of fatigue and depression. Evidence suggests just 15-30 more minutes of moderate to vigorous physical activity (MVPA) makes a clinical difference in terms of improved depression and fatigue scores, said Dr. Yeh.
With moderate physical activity (for example, a brisk walk or raking the yard), the maximal heart rate (HRmax) reaches 64%-76%, while with vigorous physical activity (which includes jogging/running or participating in a strenuous fitness class), the HRmax reaches 77%-93%.
Dr. Yeh described vigorous physical activity as “the stuff that makes you sweat, makes your heart rate go up, and makes you not be able to talk when you’re moving.”
As it stands, kids get very little MVPA – 9.5 min/day, which is well below the recommended 60 min/day. Adults do a bit better – 18.7 min/day of MVPA – but this is still below the recommended 30 min/day.
Being physically active improves fatigue for adults as well as kids, said Dr. Yeh. She referred to a network meta-analysis of 27 studies involving 1,470 participants that evaluated 10 types of exercise interventions, including yoga, resistance training, dance, and aquatic activities. It found that exercise “does move the needle,” she said. “Regardless of the kind of activity that was studied, fatigue seemed to improve.”
The authors of that study ranked aquatic exercise as the most effective intervention. “It’s possible that aquatics worked better because people who can’t move well feel more comfortable in the water,” Dr. Yeh said.
But she cautioned that the one study in the meta-analysis that found a “quite strong” effect of aquatic exercise was “very small.”
With regard to depression, which affects about 30% of people with MS, Dr. Yeh told meeting attendees, “unfortunately, the data are less clear” when it comes to physical activity for adults. One meta-analysis of 15 randomized controlled trials involving 331 exercising participants and 260 control persons found that only a few studies showed positive effects of exercise on depressive symptoms.
However, Dr. Yeh noted that in this review, the baseline depressive symptoms of participants were “above the cutoff level,” which makes it more difficult to demonstrate change in depression levels.
Clear structural effects
Researchers have also described clear brain structural and functional effects from being physically active. For example, MVPA has been shown to affect brain volume, and it has been associated with better optical coherence tomography (OCT) metrics, which measures retinal thinning.
As for the impact of exercise on memory deficits, which is of interest, given the current focus on Alzheimer’s disease, “the jury is still out,” said Dr. Yeh. One 24-week randomized controlled trial found no difference in results on the Brief Repeatable Battery of Neuropsychological tests between participants who engaged in progressive aerobic exercise and control persons.
However, said Dr. Yeh, “the problem may not be with the intervention but with the outcome measures” and potentially with the populations studied.
It might be a different story for high-intensity exercise, though. A study by Danish researchers assessed the effects of a 24-week high-intensity intervention among 84 adult patients with mild-severe impairment.
The primary outcome of that study, which was the percentage of brain volume change, was not met, possibly because the study was too short. There were significant results for some secondary endpoints, including improved cardiorespiratory fitness and lower relapse rate.
“Even though on the face of it, it sounds like a negative study, there were important outcomes,” said Dr. Yeh.
Research into the possible mechanisms behind positive effects of physical activity is limited with regard to patients with MS, said Dr. Yeh. Some studies have implicated certain circulating factors, such as the cytokine irisin and brain-derived neurotrophic factor, but more work is needed, she said.
“There is need for further mechanistic knowledge related to exercise in MS, and this must be accomplished through prospective, randomized studies.”
While exercise likely makes some difference for MS patients, the problem is in getting them to be more active. “You can’t just write a prescription,” said Dr. Yeh.
“Patients should be doing whatever they can, but gradually, and should not go crazy at the beginning because they’ll just burn out,” she said.
She stressed that patients need to find what works for them personally. It’s also important for them to find ways to be active with a friend who can be “a motivator” to help sustain physical activity goals, said Dr. Yeh.
Patients can also look online for remote physical activity programs geared to people with MS, which popped up during the pandemic.
Improved mood, cognition, pain, sleep
In a comment, Marwa Kaisey, MD, assistant professor of neurology at Cedars-Sinai Medical Center, in Los Angeles, who cochaired the session highlighting the presentation, praised Dr. Yeh’s “excellent talk,” which highlighted the “strong benefit” of exercise for patients with MS.
“As a clinician, I often talk to my patients about the importance of physical exercise and have heard countless anecdotes of how their workout programs helped improve mood, cognition, pain, or sleep.”
However, she agreed there are several areas “where we need more data-driven solutions and a mechanistic understanding of the benefits of physical exercise.”
The pilot study was funded by the Consortium of Multiple Sclerosis Centers. The MS Society of Canada funded early work on the app, and the National MS Society is funding the trial of the app. Dr. Yeh receives support from the MS Society of Canada. Dr. Kaisey reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN DIEGO – As , researchers have developed a mobile app to encourage young patients with the disease to become more active. The smartphone-based app provides tailored physical activity information, coaching advice, and tools to increase social connectedness.
A pilot study examining whether the intervention changes activity, depression, and fatigue levels should be wrapped up later this year, but it looks as though the app is succeeding.
“The feedback we’ve gotten so far from our coaches is that the kids seem highly motivated,” said one of the creators, E. Ann Yeh, MD, professor in the faculty of medicine at the University of Toronto and director of the pediatric MS and neuroinflammatory disorders program at the Hospital for Sick Children.
Preliminary work showed that use of the app was associated with a 31% increase in physical activity.
They discussed this and other studies of the role of exercise in MS at the annual meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis.
Higher levels of depression and fatigue
Studies show that youths with MS who are less physically active are more likely to experience higher levels of fatigue and depression. Evidence suggests just 15-30 more minutes of moderate to vigorous physical activity (MVPA) makes a clinical difference in terms of improved depression and fatigue scores, said Dr. Yeh.
With moderate physical activity (for example, a brisk walk or raking the yard), the maximal heart rate (HRmax) reaches 64%-76%, while with vigorous physical activity (which includes jogging/running or participating in a strenuous fitness class), the HRmax reaches 77%-93%.
Dr. Yeh described vigorous physical activity as “the stuff that makes you sweat, makes your heart rate go up, and makes you not be able to talk when you’re moving.”
As it stands, kids get very little MVPA – 9.5 min/day, which is well below the recommended 60 min/day. Adults do a bit better – 18.7 min/day of MVPA – but this is still below the recommended 30 min/day.
Being physically active improves fatigue for adults as well as kids, said Dr. Yeh. She referred to a network meta-analysis of 27 studies involving 1,470 participants that evaluated 10 types of exercise interventions, including yoga, resistance training, dance, and aquatic activities. It found that exercise “does move the needle,” she said. “Regardless of the kind of activity that was studied, fatigue seemed to improve.”
The authors of that study ranked aquatic exercise as the most effective intervention. “It’s possible that aquatics worked better because people who can’t move well feel more comfortable in the water,” Dr. Yeh said.
But she cautioned that the one study in the meta-analysis that found a “quite strong” effect of aquatic exercise was “very small.”
With regard to depression, which affects about 30% of people with MS, Dr. Yeh told meeting attendees, “unfortunately, the data are less clear” when it comes to physical activity for adults. One meta-analysis of 15 randomized controlled trials involving 331 exercising participants and 260 control persons found that only a few studies showed positive effects of exercise on depressive symptoms.
However, Dr. Yeh noted that in this review, the baseline depressive symptoms of participants were “above the cutoff level,” which makes it more difficult to demonstrate change in depression levels.
Clear structural effects
Researchers have also described clear brain structural and functional effects from being physically active. For example, MVPA has been shown to affect brain volume, and it has been associated with better optical coherence tomography (OCT) metrics, which measures retinal thinning.
As for the impact of exercise on memory deficits, which is of interest, given the current focus on Alzheimer’s disease, “the jury is still out,” said Dr. Yeh. One 24-week randomized controlled trial found no difference in results on the Brief Repeatable Battery of Neuropsychological tests between participants who engaged in progressive aerobic exercise and control persons.
However, said Dr. Yeh, “the problem may not be with the intervention but with the outcome measures” and potentially with the populations studied.
It might be a different story for high-intensity exercise, though. A study by Danish researchers assessed the effects of a 24-week high-intensity intervention among 84 adult patients with mild-severe impairment.
The primary outcome of that study, which was the percentage of brain volume change, was not met, possibly because the study was too short. There were significant results for some secondary endpoints, including improved cardiorespiratory fitness and lower relapse rate.
“Even though on the face of it, it sounds like a negative study, there were important outcomes,” said Dr. Yeh.
Research into the possible mechanisms behind positive effects of physical activity is limited with regard to patients with MS, said Dr. Yeh. Some studies have implicated certain circulating factors, such as the cytokine irisin and brain-derived neurotrophic factor, but more work is needed, she said.
“There is need for further mechanistic knowledge related to exercise in MS, and this must be accomplished through prospective, randomized studies.”
While exercise likely makes some difference for MS patients, the problem is in getting them to be more active. “You can’t just write a prescription,” said Dr. Yeh.
“Patients should be doing whatever they can, but gradually, and should not go crazy at the beginning because they’ll just burn out,” she said.
She stressed that patients need to find what works for them personally. It’s also important for them to find ways to be active with a friend who can be “a motivator” to help sustain physical activity goals, said Dr. Yeh.
Patients can also look online for remote physical activity programs geared to people with MS, which popped up during the pandemic.
Improved mood, cognition, pain, sleep
In a comment, Marwa Kaisey, MD, assistant professor of neurology at Cedars-Sinai Medical Center, in Los Angeles, who cochaired the session highlighting the presentation, praised Dr. Yeh’s “excellent talk,” which highlighted the “strong benefit” of exercise for patients with MS.
“As a clinician, I often talk to my patients about the importance of physical exercise and have heard countless anecdotes of how their workout programs helped improve mood, cognition, pain, or sleep.”
However, she agreed there are several areas “where we need more data-driven solutions and a mechanistic understanding of the benefits of physical exercise.”
The pilot study was funded by the Consortium of Multiple Sclerosis Centers. The MS Society of Canada funded early work on the app, and the National MS Society is funding the trial of the app. Dr. Yeh receives support from the MS Society of Canada. Dr. Kaisey reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN DIEGO – As , researchers have developed a mobile app to encourage young patients with the disease to become more active. The smartphone-based app provides tailored physical activity information, coaching advice, and tools to increase social connectedness.
A pilot study examining whether the intervention changes activity, depression, and fatigue levels should be wrapped up later this year, but it looks as though the app is succeeding.
“The feedback we’ve gotten so far from our coaches is that the kids seem highly motivated,” said one of the creators, E. Ann Yeh, MD, professor in the faculty of medicine at the University of Toronto and director of the pediatric MS and neuroinflammatory disorders program at the Hospital for Sick Children.
Preliminary work showed that use of the app was associated with a 31% increase in physical activity.
They discussed this and other studies of the role of exercise in MS at the annual meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis.
Higher levels of depression and fatigue
Studies show that youths with MS who are less physically active are more likely to experience higher levels of fatigue and depression. Evidence suggests just 15-30 more minutes of moderate to vigorous physical activity (MVPA) makes a clinical difference in terms of improved depression and fatigue scores, said Dr. Yeh.
With moderate physical activity (for example, a brisk walk or raking the yard), the maximal heart rate (HRmax) reaches 64%-76%, while with vigorous physical activity (which includes jogging/running or participating in a strenuous fitness class), the HRmax reaches 77%-93%.
Dr. Yeh described vigorous physical activity as “the stuff that makes you sweat, makes your heart rate go up, and makes you not be able to talk when you’re moving.”
As it stands, kids get very little MVPA – 9.5 min/day, which is well below the recommended 60 min/day. Adults do a bit better – 18.7 min/day of MVPA – but this is still below the recommended 30 min/day.
Being physically active improves fatigue for adults as well as kids, said Dr. Yeh. She referred to a network meta-analysis of 27 studies involving 1,470 participants that evaluated 10 types of exercise interventions, including yoga, resistance training, dance, and aquatic activities. It found that exercise “does move the needle,” she said. “Regardless of the kind of activity that was studied, fatigue seemed to improve.”
The authors of that study ranked aquatic exercise as the most effective intervention. “It’s possible that aquatics worked better because people who can’t move well feel more comfortable in the water,” Dr. Yeh said.
But she cautioned that the one study in the meta-analysis that found a “quite strong” effect of aquatic exercise was “very small.”
With regard to depression, which affects about 30% of people with MS, Dr. Yeh told meeting attendees, “unfortunately, the data are less clear” when it comes to physical activity for adults. One meta-analysis of 15 randomized controlled trials involving 331 exercising participants and 260 control persons found that only a few studies showed positive effects of exercise on depressive symptoms.
However, Dr. Yeh noted that in this review, the baseline depressive symptoms of participants were “above the cutoff level,” which makes it more difficult to demonstrate change in depression levels.
Clear structural effects
Researchers have also described clear brain structural and functional effects from being physically active. For example, MVPA has been shown to affect brain volume, and it has been associated with better optical coherence tomography (OCT) metrics, which measures retinal thinning.
As for the impact of exercise on memory deficits, which is of interest, given the current focus on Alzheimer’s disease, “the jury is still out,” said Dr. Yeh. One 24-week randomized controlled trial found no difference in results on the Brief Repeatable Battery of Neuropsychological tests between participants who engaged in progressive aerobic exercise and control persons.
However, said Dr. Yeh, “the problem may not be with the intervention but with the outcome measures” and potentially with the populations studied.
It might be a different story for high-intensity exercise, though. A study by Danish researchers assessed the effects of a 24-week high-intensity intervention among 84 adult patients with mild-severe impairment.
The primary outcome of that study, which was the percentage of brain volume change, was not met, possibly because the study was too short. There were significant results for some secondary endpoints, including improved cardiorespiratory fitness and lower relapse rate.
“Even though on the face of it, it sounds like a negative study, there were important outcomes,” said Dr. Yeh.
Research into the possible mechanisms behind positive effects of physical activity is limited with regard to patients with MS, said Dr. Yeh. Some studies have implicated certain circulating factors, such as the cytokine irisin and brain-derived neurotrophic factor, but more work is needed, she said.
“There is need for further mechanistic knowledge related to exercise in MS, and this must be accomplished through prospective, randomized studies.”
While exercise likely makes some difference for MS patients, the problem is in getting them to be more active. “You can’t just write a prescription,” said Dr. Yeh.
“Patients should be doing whatever they can, but gradually, and should not go crazy at the beginning because they’ll just burn out,” she said.
She stressed that patients need to find what works for them personally. It’s also important for them to find ways to be active with a friend who can be “a motivator” to help sustain physical activity goals, said Dr. Yeh.
Patients can also look online for remote physical activity programs geared to people with MS, which popped up during the pandemic.
Improved mood, cognition, pain, sleep
In a comment, Marwa Kaisey, MD, assistant professor of neurology at Cedars-Sinai Medical Center, in Los Angeles, who cochaired the session highlighting the presentation, praised Dr. Yeh’s “excellent talk,” which highlighted the “strong benefit” of exercise for patients with MS.
“As a clinician, I often talk to my patients about the importance of physical exercise and have heard countless anecdotes of how their workout programs helped improve mood, cognition, pain, or sleep.”
However, she agreed there are several areas “where we need more data-driven solutions and a mechanistic understanding of the benefits of physical exercise.”
The pilot study was funded by the Consortium of Multiple Sclerosis Centers. The MS Society of Canada funded early work on the app, and the National MS Society is funding the trial of the app. Dr. Yeh receives support from the MS Society of Canada. Dr. Kaisey reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ACTRIMS FORUM 2023
New digital tools hold promise for patients with MS
SAN DIEGO – A new wearable device detects, with a high degree of precision, various types of visual dysfunction, which eventually affects most patients with multiple sclerosis (MS). The device uses advanced digital technology to stimulate the retina and the occipital cortex while also stimulating the eye tracking system, and reports out this data, one of its developers, Jennifer Graves, MD, PhD, director of neuroimmunology research, University of California, San Diego, said in an interview.
“In one paradigm of testing, we can get both sets of information,” which eliminates the complicated equipment set-up used by neuro-ophthalmologists, and makes eye assessments more readily available, she said.
“We can make this accessible for more clinicians and more patients, even eventually having it in an emergency setting or an outpatient clinic setting.”
Dr. Graves discussed this and other next-generation digital tools at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Currently, patients with MS can use accelerometers that determine overall activity level and devices that detect heart rate variability. They can also access mobile apps that track symptoms and medication adherence.
Limited sensitivity of current tools
However, current tools used to determine disability in MS are limited. The classification of MS subtypes is largely retrospective, and the preferred Expanded Disability Status Scale (EDSS) is problematic, said Dr. Graves.
For example, she said, the EDSS lacks sensitivity to short-term changes, depends on ambulation, and only poorly captures upper-extremity disability. “We know our patients are experiencing change and we know the tools we have now aren’t capturing that.”
She used the example of a pianist who can no longer play well with her right hand, but this can’t be detected with current tools. A device that uses technology from the gaming and computer control industry “can quantify that” change, said Dr. Graves.
She added that . “Rather than having descriptive terms, these digital tools will help us quantitate change so we can take action.”
The new sensing devices use multiple sensors, including accelerometers, gyroscopes, and surface electrical signals in muscles to capture very precise temporal and textural information related to movement. Their development uses traditional signal processing as well as artificial intelligence approaches.
Dr. Graves’s device, the MSight, captures afferent and efferent visual function with a single mobile brain-computer interface.
At least 80% of patients with MS have some measurable dysfunction in the afferent system that oversees how light from the environment is turned into images in the brain, explained Dr. Graves. The efferent visual system that controls eye movements is also “profoundly impacted by MS” with, again, up to 80% of patients with MS experiencing related dysfunction, she said.
Her new visual system correlates with burden of MS disease, said Dr. Graves. “Having efferent and eye tracking problems correlates with overall disability and walking function.”
The information collected by this new device “tends to be really helpful even in people who don’t appear to be disabled with MS because it’s literally a window into the brain to let us see what’s happening,” said Dr. Graves.
She and her colleagues are testing the MSight device in clinical trials and have a provisional patent for it.
Finger and foot taps
Another device her team is developing detects minute changes over several months in finger and toe tap movements that are very difficult for the human eye to capture.
Dr. Graves reported on a cross sectional validation study of 17 patients with MS showing the foot and finger tap measures strongly correlated with the EDSS and patient-reported outcomes (P < .0001). A longitudinal analysis of 68 patients with MS found information on finger and foot taps distinguished those with progressive from those with relapsing MS.
“We found that in patients with progressive MS, the information in the signal we were capturing was changing, whereas someone with relapsing MS had a little bit of that but much less,” said Dr. Graves.
These and other novel, self-contained devices “will provide a set of neurological vital signs that we can put in the hands of clinicians and patients” with MS, as is currently being done in other specialties – for example, cardiology, said Dr. Graves.
Intriguing, exciting
In a comment, David Gosselin, PhD, associate professor, department of molecular medicine, Laval University, Quebec City, who cochaired the session featuring next-generation digital tools, said more sensitive monitoring technologies coming down the pipeline are “intriguing and exciting.”
While the devices are still in early development, “the eventual integration of such noninvasive technology that measures subtle limb muscle function has the potential to redefine clinical practice,” said Dr. Gosselin.
“The idea of sampling a patient’s ability to move about on a frequent basis, perhaps even daily, and to generate data profiles over time, certainly hold promise with respect to tracking disease evolution and responses to treatments on a scale not accessible before.”
A more immediate and comprehensive overview of a patient’s response to a treatment “could yield more rapid insights into the effectiveness of novel therapies tested in clinical trials,” said Dr. Gosselin. “This could have profound implications.”
Future digital devices may facilitate monitoring of patients in more remote communities, too, said Dr. Gosselin.
However, before these technologies can be introduced on a broad level, several outstanding issues will have to be addressed, the most important being the streams of data they generate, said Dr. Gosselin.
“This clearly has the potential to overwhelm neurologists in the assessment of their patients’ conditions,” he said. “Which information, and in which analyzed forms, truly provides meaningful insights into patients’ conditions will need to be identified, and this will take time.”
Privacy may be an issue, too, said Dr. Gosselin. Some patients may be less inclined to comply with a procedure “that can capture and record their life so extensively.”
And how health care insurance providers can interface with these comprehensive profiles of patients’ lives will also have to be considered, he said.
Dr. Graves has a provisional patent on the MSight device; has received research support from MMSS, Octave, Biogen EMD Serono, Novartis, ATARA Biotherapeutics, and ABM; has served on advisory boards for Bayer, Genentech, and TG therapeutic and a pediatric clinical trial steering committee for Novartis; and has consulted for Google. Dr. Gosselin reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN DIEGO – A new wearable device detects, with a high degree of precision, various types of visual dysfunction, which eventually affects most patients with multiple sclerosis (MS). The device uses advanced digital technology to stimulate the retina and the occipital cortex while also stimulating the eye tracking system, and reports out this data, one of its developers, Jennifer Graves, MD, PhD, director of neuroimmunology research, University of California, San Diego, said in an interview.
“In one paradigm of testing, we can get both sets of information,” which eliminates the complicated equipment set-up used by neuro-ophthalmologists, and makes eye assessments more readily available, she said.
“We can make this accessible for more clinicians and more patients, even eventually having it in an emergency setting or an outpatient clinic setting.”
Dr. Graves discussed this and other next-generation digital tools at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Currently, patients with MS can use accelerometers that determine overall activity level and devices that detect heart rate variability. They can also access mobile apps that track symptoms and medication adherence.
Limited sensitivity of current tools
However, current tools used to determine disability in MS are limited. The classification of MS subtypes is largely retrospective, and the preferred Expanded Disability Status Scale (EDSS) is problematic, said Dr. Graves.
For example, she said, the EDSS lacks sensitivity to short-term changes, depends on ambulation, and only poorly captures upper-extremity disability. “We know our patients are experiencing change and we know the tools we have now aren’t capturing that.”
She used the example of a pianist who can no longer play well with her right hand, but this can’t be detected with current tools. A device that uses technology from the gaming and computer control industry “can quantify that” change, said Dr. Graves.
She added that . “Rather than having descriptive terms, these digital tools will help us quantitate change so we can take action.”
The new sensing devices use multiple sensors, including accelerometers, gyroscopes, and surface electrical signals in muscles to capture very precise temporal and textural information related to movement. Their development uses traditional signal processing as well as artificial intelligence approaches.
Dr. Graves’s device, the MSight, captures afferent and efferent visual function with a single mobile brain-computer interface.
At least 80% of patients with MS have some measurable dysfunction in the afferent system that oversees how light from the environment is turned into images in the brain, explained Dr. Graves. The efferent visual system that controls eye movements is also “profoundly impacted by MS” with, again, up to 80% of patients with MS experiencing related dysfunction, she said.
Her new visual system correlates with burden of MS disease, said Dr. Graves. “Having efferent and eye tracking problems correlates with overall disability and walking function.”
The information collected by this new device “tends to be really helpful even in people who don’t appear to be disabled with MS because it’s literally a window into the brain to let us see what’s happening,” said Dr. Graves.
She and her colleagues are testing the MSight device in clinical trials and have a provisional patent for it.
Finger and foot taps
Another device her team is developing detects minute changes over several months in finger and toe tap movements that are very difficult for the human eye to capture.
Dr. Graves reported on a cross sectional validation study of 17 patients with MS showing the foot and finger tap measures strongly correlated with the EDSS and patient-reported outcomes (P < .0001). A longitudinal analysis of 68 patients with MS found information on finger and foot taps distinguished those with progressive from those with relapsing MS.
“We found that in patients with progressive MS, the information in the signal we were capturing was changing, whereas someone with relapsing MS had a little bit of that but much less,” said Dr. Graves.
These and other novel, self-contained devices “will provide a set of neurological vital signs that we can put in the hands of clinicians and patients” with MS, as is currently being done in other specialties – for example, cardiology, said Dr. Graves.
Intriguing, exciting
In a comment, David Gosselin, PhD, associate professor, department of molecular medicine, Laval University, Quebec City, who cochaired the session featuring next-generation digital tools, said more sensitive monitoring technologies coming down the pipeline are “intriguing and exciting.”
While the devices are still in early development, “the eventual integration of such noninvasive technology that measures subtle limb muscle function has the potential to redefine clinical practice,” said Dr. Gosselin.
“The idea of sampling a patient’s ability to move about on a frequent basis, perhaps even daily, and to generate data profiles over time, certainly hold promise with respect to tracking disease evolution and responses to treatments on a scale not accessible before.”
A more immediate and comprehensive overview of a patient’s response to a treatment “could yield more rapid insights into the effectiveness of novel therapies tested in clinical trials,” said Dr. Gosselin. “This could have profound implications.”
Future digital devices may facilitate monitoring of patients in more remote communities, too, said Dr. Gosselin.
However, before these technologies can be introduced on a broad level, several outstanding issues will have to be addressed, the most important being the streams of data they generate, said Dr. Gosselin.
“This clearly has the potential to overwhelm neurologists in the assessment of their patients’ conditions,” he said. “Which information, and in which analyzed forms, truly provides meaningful insights into patients’ conditions will need to be identified, and this will take time.”
Privacy may be an issue, too, said Dr. Gosselin. Some patients may be less inclined to comply with a procedure “that can capture and record their life so extensively.”
And how health care insurance providers can interface with these comprehensive profiles of patients’ lives will also have to be considered, he said.
Dr. Graves has a provisional patent on the MSight device; has received research support from MMSS, Octave, Biogen EMD Serono, Novartis, ATARA Biotherapeutics, and ABM; has served on advisory boards for Bayer, Genentech, and TG therapeutic and a pediatric clinical trial steering committee for Novartis; and has consulted for Google. Dr. Gosselin reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN DIEGO – A new wearable device detects, with a high degree of precision, various types of visual dysfunction, which eventually affects most patients with multiple sclerosis (MS). The device uses advanced digital technology to stimulate the retina and the occipital cortex while also stimulating the eye tracking system, and reports out this data, one of its developers, Jennifer Graves, MD, PhD, director of neuroimmunology research, University of California, San Diego, said in an interview.
“In one paradigm of testing, we can get both sets of information,” which eliminates the complicated equipment set-up used by neuro-ophthalmologists, and makes eye assessments more readily available, she said.
“We can make this accessible for more clinicians and more patients, even eventually having it in an emergency setting or an outpatient clinic setting.”
Dr. Graves discussed this and other next-generation digital tools at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Currently, patients with MS can use accelerometers that determine overall activity level and devices that detect heart rate variability. They can also access mobile apps that track symptoms and medication adherence.
Limited sensitivity of current tools
However, current tools used to determine disability in MS are limited. The classification of MS subtypes is largely retrospective, and the preferred Expanded Disability Status Scale (EDSS) is problematic, said Dr. Graves.
For example, she said, the EDSS lacks sensitivity to short-term changes, depends on ambulation, and only poorly captures upper-extremity disability. “We know our patients are experiencing change and we know the tools we have now aren’t capturing that.”
She used the example of a pianist who can no longer play well with her right hand, but this can’t be detected with current tools. A device that uses technology from the gaming and computer control industry “can quantify that” change, said Dr. Graves.
She added that . “Rather than having descriptive terms, these digital tools will help us quantitate change so we can take action.”
The new sensing devices use multiple sensors, including accelerometers, gyroscopes, and surface electrical signals in muscles to capture very precise temporal and textural information related to movement. Their development uses traditional signal processing as well as artificial intelligence approaches.
Dr. Graves’s device, the MSight, captures afferent and efferent visual function with a single mobile brain-computer interface.
At least 80% of patients with MS have some measurable dysfunction in the afferent system that oversees how light from the environment is turned into images in the brain, explained Dr. Graves. The efferent visual system that controls eye movements is also “profoundly impacted by MS” with, again, up to 80% of patients with MS experiencing related dysfunction, she said.
Her new visual system correlates with burden of MS disease, said Dr. Graves. “Having efferent and eye tracking problems correlates with overall disability and walking function.”
The information collected by this new device “tends to be really helpful even in people who don’t appear to be disabled with MS because it’s literally a window into the brain to let us see what’s happening,” said Dr. Graves.
She and her colleagues are testing the MSight device in clinical trials and have a provisional patent for it.
Finger and foot taps
Another device her team is developing detects minute changes over several months in finger and toe tap movements that are very difficult for the human eye to capture.
Dr. Graves reported on a cross sectional validation study of 17 patients with MS showing the foot and finger tap measures strongly correlated with the EDSS and patient-reported outcomes (P < .0001). A longitudinal analysis of 68 patients with MS found information on finger and foot taps distinguished those with progressive from those with relapsing MS.
“We found that in patients with progressive MS, the information in the signal we were capturing was changing, whereas someone with relapsing MS had a little bit of that but much less,” said Dr. Graves.
These and other novel, self-contained devices “will provide a set of neurological vital signs that we can put in the hands of clinicians and patients” with MS, as is currently being done in other specialties – for example, cardiology, said Dr. Graves.
Intriguing, exciting
In a comment, David Gosselin, PhD, associate professor, department of molecular medicine, Laval University, Quebec City, who cochaired the session featuring next-generation digital tools, said more sensitive monitoring technologies coming down the pipeline are “intriguing and exciting.”
While the devices are still in early development, “the eventual integration of such noninvasive technology that measures subtle limb muscle function has the potential to redefine clinical practice,” said Dr. Gosselin.
“The idea of sampling a patient’s ability to move about on a frequent basis, perhaps even daily, and to generate data profiles over time, certainly hold promise with respect to tracking disease evolution and responses to treatments on a scale not accessible before.”
A more immediate and comprehensive overview of a patient’s response to a treatment “could yield more rapid insights into the effectiveness of novel therapies tested in clinical trials,” said Dr. Gosselin. “This could have profound implications.”
Future digital devices may facilitate monitoring of patients in more remote communities, too, said Dr. Gosselin.
However, before these technologies can be introduced on a broad level, several outstanding issues will have to be addressed, the most important being the streams of data they generate, said Dr. Gosselin.
“This clearly has the potential to overwhelm neurologists in the assessment of their patients’ conditions,” he said. “Which information, and in which analyzed forms, truly provides meaningful insights into patients’ conditions will need to be identified, and this will take time.”
Privacy may be an issue, too, said Dr. Gosselin. Some patients may be less inclined to comply with a procedure “that can capture and record their life so extensively.”
And how health care insurance providers can interface with these comprehensive profiles of patients’ lives will also have to be considered, he said.
Dr. Graves has a provisional patent on the MSight device; has received research support from MMSS, Octave, Biogen EMD Serono, Novartis, ATARA Biotherapeutics, and ABM; has served on advisory boards for Bayer, Genentech, and TG therapeutic and a pediatric clinical trial steering committee for Novartis; and has consulted for Google. Dr. Gosselin reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ACTRIMS FORUM 2023
Cutting calories may benefit cognition in MS
SAN DIEGO – , new research suggests.
Although this was just one small 12-week trial, “we were still able to see an amelioration in certain measures, for example, measures of fatigue as well as measures of cognitive function” in participants following the diet, said study investigator Laura Piccio, MD, PhD, associate professor, Washington University, St. Louis, and the University of Sydney.
Overall, the results underscore the importance of patients with MS maintaining an ideal body weight, Dr. Piccio said.
The findings were presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
High adherence rate
Obesity, which is associated with increased inflammation, has previously been linked to the development of MS. Release of adipokines from adipose tissue “shifts the balance” toward a proinflammatory milieu; and a chronic low-grade inflammatory state may promote autoimmunity, Dr. Piccio noted.
The current study included 42 adult patients (85.7% women; mean age, 48.2 years) with relapsing-remitting MS. Their mean baseline body mass index was 28.7, indicating being overweight, and the mean weight was 80.7 kg. The median Expanded Disability Status Scale (EDSS) score was 2.0.
Researchers randomly assigned participants to an intermittent calorie restriction (iCR) group or to a control group. For 2 days per week, the diet group ate 25% of what they normally would. For example, they might consume 500 calories from salads and non-starchy vegetables with a light dressing, Dr. Piccio said. The control group was not restricted in their eating.
In addition to the baseline assessment, the patients had study visits at weeks 6 and 12. Researchers adjusted for age, sex, and use of MS disease-modifying therapy.
Calorie reduction turned out to be a feasible intervention. “We had a pretty high adherence to the diet,” with 17 members of each group completing the study, Dr. Piccio reported. “So it shows this diet is possible,” she added.
Participants in the iCR group demonstrated a significant decrease in weight, BMI, and waist circumference at weeks 6 and 12 compared with baseline. They lost an average of 2.2 kg (about 5 pounds) over the course of the trial.
Serum leptin levels were also significantly decreased in the iCR group – and several lipids affected by the diet were positively correlated with adiponectin. Calorie restriction also affected T-cell subtypes.
“We definitely had an impact on body weight and also changes in certain inflammatory markers,” said Dr. Piccio.
Maintain healthy weight
The diet affected clinical measures, too. The score on the Symbol Digit Modalities Test (SDMT) increased significantly with iCR at 6 weeks (mean increase, 3.5; 95% confidence interval [CI], 0.6-6.3; P = .01) and 12 weeks (mean increase, 6.2; 95% CI, 3.4–9.5; P = .00004) compared with baseline.
There were no significant differences on the SDMT in the control group over time. In addition, the mean score on this test at 12 weeks was significantly higher in the iCR group compared with the control group.
Researchers also noted benefits of the diet on some patient-reported outcomes, such as certain subscales of the Modified Fatigue Impact Scale.
However, Dr. Piccio stressed that these results should be viewed with caution. “There could be many other factors driving this change in a small study like this,” she said. For example, just being on a diet might make individuals feel and function better. Dr. Piccio added that it is not clear what happens when participants return to their normal diet and their original body weight.
She noted that it is probably important to “get to a healthy body weight and to maintain it” – and it may not matter whether that’s through intermittent fasting or changing diet in other ways. “Anything you can do in order to keep your body weight within a normal range is important,” Dr. Piccio said.
Superb study
Commenting on the study findings, ACTRIMS program committee chair Catherine Larochelle, MD, PhD, clinician-scientist at Centre Hospitalier de l’Université de Montréal, said results from this “superb” study suggest that cognition can be positively influenced by healthy dietary habits.
“This is very promising and exciting,” Dr. Larochelle said. However, she cautioned that the data need to be reproduced and confirmed in other cohorts.
Overall, Dr. Larochelle noted that diet is becoming a “hot topic” in the field of MS. “This effervescent field of research should lead to new nonpharmacological therapeutic approaches to complement existing disease-modifying therapies and improve meaningful outcomes for people with MS,” she said.
The study was funded by the National MS Society in the United States. Dr. Piccio and Dr. Larochelle have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SAN DIEGO – , new research suggests.
Although this was just one small 12-week trial, “we were still able to see an amelioration in certain measures, for example, measures of fatigue as well as measures of cognitive function” in participants following the diet, said study investigator Laura Piccio, MD, PhD, associate professor, Washington University, St. Louis, and the University of Sydney.
Overall, the results underscore the importance of patients with MS maintaining an ideal body weight, Dr. Piccio said.
The findings were presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
High adherence rate
Obesity, which is associated with increased inflammation, has previously been linked to the development of MS. Release of adipokines from adipose tissue “shifts the balance” toward a proinflammatory milieu; and a chronic low-grade inflammatory state may promote autoimmunity, Dr. Piccio noted.
The current study included 42 adult patients (85.7% women; mean age, 48.2 years) with relapsing-remitting MS. Their mean baseline body mass index was 28.7, indicating being overweight, and the mean weight was 80.7 kg. The median Expanded Disability Status Scale (EDSS) score was 2.0.
Researchers randomly assigned participants to an intermittent calorie restriction (iCR) group or to a control group. For 2 days per week, the diet group ate 25% of what they normally would. For example, they might consume 500 calories from salads and non-starchy vegetables with a light dressing, Dr. Piccio said. The control group was not restricted in their eating.
In addition to the baseline assessment, the patients had study visits at weeks 6 and 12. Researchers adjusted for age, sex, and use of MS disease-modifying therapy.
Calorie reduction turned out to be a feasible intervention. “We had a pretty high adherence to the diet,” with 17 members of each group completing the study, Dr. Piccio reported. “So it shows this diet is possible,” she added.
Participants in the iCR group demonstrated a significant decrease in weight, BMI, and waist circumference at weeks 6 and 12 compared with baseline. They lost an average of 2.2 kg (about 5 pounds) over the course of the trial.
Serum leptin levels were also significantly decreased in the iCR group – and several lipids affected by the diet were positively correlated with adiponectin. Calorie restriction also affected T-cell subtypes.
“We definitely had an impact on body weight and also changes in certain inflammatory markers,” said Dr. Piccio.
Maintain healthy weight
The diet affected clinical measures, too. The score on the Symbol Digit Modalities Test (SDMT) increased significantly with iCR at 6 weeks (mean increase, 3.5; 95% confidence interval [CI], 0.6-6.3; P = .01) and 12 weeks (mean increase, 6.2; 95% CI, 3.4–9.5; P = .00004) compared with baseline.
There were no significant differences on the SDMT in the control group over time. In addition, the mean score on this test at 12 weeks was significantly higher in the iCR group compared with the control group.
Researchers also noted benefits of the diet on some patient-reported outcomes, such as certain subscales of the Modified Fatigue Impact Scale.
However, Dr. Piccio stressed that these results should be viewed with caution. “There could be many other factors driving this change in a small study like this,” she said. For example, just being on a diet might make individuals feel and function better. Dr. Piccio added that it is not clear what happens when participants return to their normal diet and their original body weight.
She noted that it is probably important to “get to a healthy body weight and to maintain it” – and it may not matter whether that’s through intermittent fasting or changing diet in other ways. “Anything you can do in order to keep your body weight within a normal range is important,” Dr. Piccio said.
Superb study
Commenting on the study findings, ACTRIMS program committee chair Catherine Larochelle, MD, PhD, clinician-scientist at Centre Hospitalier de l’Université de Montréal, said results from this “superb” study suggest that cognition can be positively influenced by healthy dietary habits.
“This is very promising and exciting,” Dr. Larochelle said. However, she cautioned that the data need to be reproduced and confirmed in other cohorts.
Overall, Dr. Larochelle noted that diet is becoming a “hot topic” in the field of MS. “This effervescent field of research should lead to new nonpharmacological therapeutic approaches to complement existing disease-modifying therapies and improve meaningful outcomes for people with MS,” she said.
The study was funded by the National MS Society in the United States. Dr. Piccio and Dr. Larochelle have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SAN DIEGO – , new research suggests.
Although this was just one small 12-week trial, “we were still able to see an amelioration in certain measures, for example, measures of fatigue as well as measures of cognitive function” in participants following the diet, said study investigator Laura Piccio, MD, PhD, associate professor, Washington University, St. Louis, and the University of Sydney.
Overall, the results underscore the importance of patients with MS maintaining an ideal body weight, Dr. Piccio said.
The findings were presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
High adherence rate
Obesity, which is associated with increased inflammation, has previously been linked to the development of MS. Release of adipokines from adipose tissue “shifts the balance” toward a proinflammatory milieu; and a chronic low-grade inflammatory state may promote autoimmunity, Dr. Piccio noted.
The current study included 42 adult patients (85.7% women; mean age, 48.2 years) with relapsing-remitting MS. Their mean baseline body mass index was 28.7, indicating being overweight, and the mean weight was 80.7 kg. The median Expanded Disability Status Scale (EDSS) score was 2.0.
Researchers randomly assigned participants to an intermittent calorie restriction (iCR) group or to a control group. For 2 days per week, the diet group ate 25% of what they normally would. For example, they might consume 500 calories from salads and non-starchy vegetables with a light dressing, Dr. Piccio said. The control group was not restricted in their eating.
In addition to the baseline assessment, the patients had study visits at weeks 6 and 12. Researchers adjusted for age, sex, and use of MS disease-modifying therapy.
Calorie reduction turned out to be a feasible intervention. “We had a pretty high adherence to the diet,” with 17 members of each group completing the study, Dr. Piccio reported. “So it shows this diet is possible,” she added.
Participants in the iCR group demonstrated a significant decrease in weight, BMI, and waist circumference at weeks 6 and 12 compared with baseline. They lost an average of 2.2 kg (about 5 pounds) over the course of the trial.
Serum leptin levels were also significantly decreased in the iCR group – and several lipids affected by the diet were positively correlated with adiponectin. Calorie restriction also affected T-cell subtypes.
“We definitely had an impact on body weight and also changes in certain inflammatory markers,” said Dr. Piccio.
Maintain healthy weight
The diet affected clinical measures, too. The score on the Symbol Digit Modalities Test (SDMT) increased significantly with iCR at 6 weeks (mean increase, 3.5; 95% confidence interval [CI], 0.6-6.3; P = .01) and 12 weeks (mean increase, 6.2; 95% CI, 3.4–9.5; P = .00004) compared with baseline.
There were no significant differences on the SDMT in the control group over time. In addition, the mean score on this test at 12 weeks was significantly higher in the iCR group compared with the control group.
Researchers also noted benefits of the diet on some patient-reported outcomes, such as certain subscales of the Modified Fatigue Impact Scale.
However, Dr. Piccio stressed that these results should be viewed with caution. “There could be many other factors driving this change in a small study like this,” she said. For example, just being on a diet might make individuals feel and function better. Dr. Piccio added that it is not clear what happens when participants return to their normal diet and their original body weight.
She noted that it is probably important to “get to a healthy body weight and to maintain it” – and it may not matter whether that’s through intermittent fasting or changing diet in other ways. “Anything you can do in order to keep your body weight within a normal range is important,” Dr. Piccio said.
Superb study
Commenting on the study findings, ACTRIMS program committee chair Catherine Larochelle, MD, PhD, clinician-scientist at Centre Hospitalier de l’Université de Montréal, said results from this “superb” study suggest that cognition can be positively influenced by healthy dietary habits.
“This is very promising and exciting,” Dr. Larochelle said. However, she cautioned that the data need to be reproduced and confirmed in other cohorts.
Overall, Dr. Larochelle noted that diet is becoming a “hot topic” in the field of MS. “This effervescent field of research should lead to new nonpharmacological therapeutic approaches to complement existing disease-modifying therapies and improve meaningful outcomes for people with MS,” she said.
The study was funded by the National MS Society in the United States. Dr. Piccio and Dr. Larochelle have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT ACTRIMS FORUM 2023
High level of psychiatric morbidity in prodromal MS
SAN DIEGO – new research reveals. Results of a population-based study show the relative risk of psychiatric morbidity, including depression and anxiety, was up to 88% higher in patients with MS, compared with their counterparts without the disease.
These results are an incentive to “keep exploring” to get a “clearer picture” of the MS prodrome, said study investigator Anibal Chertcoff, MD, who is trained both as a neurologist and psychiatrist and is a postdoctoral fellow at the University of British Columbia, Vancouver.
With a better understanding of this phase, it might be possible to “push the limits to get an earlier diagnosis of MS,” said Dr. Chertcoff.
The findings were presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
Psychiatric morbidity during the prodromal phase of MS
Psychiatric comorbidities are common in MS. Emerging research suggests psychiatric disorders may be present before disease onset.
Using administrative and clinical data, the investigators collected information on MS cases and healthy matched controls who had no demyelinating disease claims. They used a clinical cohort of patients attending an MS clinic and a much larger administrative cohort that used an algorithm to detect MS cases using diagnostic codes and prescription data for disease modifying therapies.
The administrative cohort consisted of 6,863 MS cases and 31,865 controls while the clinical cohort had 966 cases and 4,534 controls. The majority (73%) of cases and controls were female. The mean age at the first demyelinating claim was 44 years.
The study’s primary outcome was prevalence of psychiatric morbidity using diagnostic codes for depression, anxiety, bipolar disorder, and schizophrenia. In the 5 years pre-MS onset, 28% of MS cases and 14.9% of controls had psychiatric morbidity.
The researchers plotted psychiatric morbidity in both MS cases and controls over time on a graph. “In terms of the prevalence of psychiatric morbidity, in each year the difference between the groups, at least visually, seems to increase with time as it gets closer to MS onset,” said Dr. Chertcoff.
The analysis showed the relative risk of psychiatric morbidity over the 5 years before MS onset was 1.88 (95% confidence interval, 1.80-1.97) in the administrative cohort, and 1.57 (95% CI, 1.36-1.80) in the clinical cohort.
Secondary analyses showed individuals with MS had more yearly physician visits, visits to psychiatrists, psychiatric hospital admissions, and prescription fills for psychiatric medication, compared with controls. This, said Dr. Chertcoff, illustrates the burden psychiatric morbidity during the prodromal phase of MS places on health care resources.
It’s possible that low-grade inflammation, which is linked to MS, is also pushing these psychiatric phenomena, said Dr. Chertcoff. He noted that the prevalence of depression is significantly higher not only in MS, but in a wide range of other inflammatory conditions.
In addition to psychiatric complaints, MS patients experience other symptoms, including pain, sleep disturbances, fatigue, and gastrointestinal issues during the MS prodrome, said Dr. Chertcoff.
Patients with MS are often seeing other physicians – including psychiatrists during the prodromal phase of the disease. Neurologists, Dr. Chertcoff said, could perhaps “raise awareness” among these other specialists about the prevalence of psychiatric morbidities during this phase.
He hopes experts in the field will consider developing research criteria for the MS prodrome similar to what has been done in Parkinson’s disease.
When does MS start?
Commenting on the research findings, Mark Freedman, MD, professor of medicine (Neurology), University of Ottawa, and director of the multiple sclerosis research unit, Ottawa Hospital-General Campus, said the study illustrates the increased research attention the interplay between MS and psychiatric disorders is getting.
He recalled “one of the most compelling” recent studies that looked at a large group of children with MS and showed their grades started falling more than 5 years before developing MS symptoms. “You could see their grades going down year by year by year, so an indicator that a young brain, which should be like a sponge and improving, was actually faltering well before the symptoms.”
Results from this new study continue to beg the question of when MS actually starts, said Dr. Freedman.
The study received funding from the U.S. National MS Society, the MS Society of Canada, and the Michael Smith Foundation. Dr. Chertcoff and Dr. Freedman reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SAN DIEGO – new research reveals. Results of a population-based study show the relative risk of psychiatric morbidity, including depression and anxiety, was up to 88% higher in patients with MS, compared with their counterparts without the disease.
These results are an incentive to “keep exploring” to get a “clearer picture” of the MS prodrome, said study investigator Anibal Chertcoff, MD, who is trained both as a neurologist and psychiatrist and is a postdoctoral fellow at the University of British Columbia, Vancouver.
With a better understanding of this phase, it might be possible to “push the limits to get an earlier diagnosis of MS,” said Dr. Chertcoff.
The findings were presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
Psychiatric morbidity during the prodromal phase of MS
Psychiatric comorbidities are common in MS. Emerging research suggests psychiatric disorders may be present before disease onset.
Using administrative and clinical data, the investigators collected information on MS cases and healthy matched controls who had no demyelinating disease claims. They used a clinical cohort of patients attending an MS clinic and a much larger administrative cohort that used an algorithm to detect MS cases using diagnostic codes and prescription data for disease modifying therapies.
The administrative cohort consisted of 6,863 MS cases and 31,865 controls while the clinical cohort had 966 cases and 4,534 controls. The majority (73%) of cases and controls were female. The mean age at the first demyelinating claim was 44 years.
The study’s primary outcome was prevalence of psychiatric morbidity using diagnostic codes for depression, anxiety, bipolar disorder, and schizophrenia. In the 5 years pre-MS onset, 28% of MS cases and 14.9% of controls had psychiatric morbidity.
The researchers plotted psychiatric morbidity in both MS cases and controls over time on a graph. “In terms of the prevalence of psychiatric morbidity, in each year the difference between the groups, at least visually, seems to increase with time as it gets closer to MS onset,” said Dr. Chertcoff.
The analysis showed the relative risk of psychiatric morbidity over the 5 years before MS onset was 1.88 (95% confidence interval, 1.80-1.97) in the administrative cohort, and 1.57 (95% CI, 1.36-1.80) in the clinical cohort.
Secondary analyses showed individuals with MS had more yearly physician visits, visits to psychiatrists, psychiatric hospital admissions, and prescription fills for psychiatric medication, compared with controls. This, said Dr. Chertcoff, illustrates the burden psychiatric morbidity during the prodromal phase of MS places on health care resources.
It’s possible that low-grade inflammation, which is linked to MS, is also pushing these psychiatric phenomena, said Dr. Chertcoff. He noted that the prevalence of depression is significantly higher not only in MS, but in a wide range of other inflammatory conditions.
In addition to psychiatric complaints, MS patients experience other symptoms, including pain, sleep disturbances, fatigue, and gastrointestinal issues during the MS prodrome, said Dr. Chertcoff.
Patients with MS are often seeing other physicians – including psychiatrists during the prodromal phase of the disease. Neurologists, Dr. Chertcoff said, could perhaps “raise awareness” among these other specialists about the prevalence of psychiatric morbidities during this phase.
He hopes experts in the field will consider developing research criteria for the MS prodrome similar to what has been done in Parkinson’s disease.
When does MS start?
Commenting on the research findings, Mark Freedman, MD, professor of medicine (Neurology), University of Ottawa, and director of the multiple sclerosis research unit, Ottawa Hospital-General Campus, said the study illustrates the increased research attention the interplay between MS and psychiatric disorders is getting.
He recalled “one of the most compelling” recent studies that looked at a large group of children with MS and showed their grades started falling more than 5 years before developing MS symptoms. “You could see their grades going down year by year by year, so an indicator that a young brain, which should be like a sponge and improving, was actually faltering well before the symptoms.”
Results from this new study continue to beg the question of when MS actually starts, said Dr. Freedman.
The study received funding from the U.S. National MS Society, the MS Society of Canada, and the Michael Smith Foundation. Dr. Chertcoff and Dr. Freedman reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SAN DIEGO – new research reveals. Results of a population-based study show the relative risk of psychiatric morbidity, including depression and anxiety, was up to 88% higher in patients with MS, compared with their counterparts without the disease.
These results are an incentive to “keep exploring” to get a “clearer picture” of the MS prodrome, said study investigator Anibal Chertcoff, MD, who is trained both as a neurologist and psychiatrist and is a postdoctoral fellow at the University of British Columbia, Vancouver.
With a better understanding of this phase, it might be possible to “push the limits to get an earlier diagnosis of MS,” said Dr. Chertcoff.
The findings were presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
Psychiatric morbidity during the prodromal phase of MS
Psychiatric comorbidities are common in MS. Emerging research suggests psychiatric disorders may be present before disease onset.
Using administrative and clinical data, the investigators collected information on MS cases and healthy matched controls who had no demyelinating disease claims. They used a clinical cohort of patients attending an MS clinic and a much larger administrative cohort that used an algorithm to detect MS cases using diagnostic codes and prescription data for disease modifying therapies.
The administrative cohort consisted of 6,863 MS cases and 31,865 controls while the clinical cohort had 966 cases and 4,534 controls. The majority (73%) of cases and controls were female. The mean age at the first demyelinating claim was 44 years.
The study’s primary outcome was prevalence of psychiatric morbidity using diagnostic codes for depression, anxiety, bipolar disorder, and schizophrenia. In the 5 years pre-MS onset, 28% of MS cases and 14.9% of controls had psychiatric morbidity.
The researchers plotted psychiatric morbidity in both MS cases and controls over time on a graph. “In terms of the prevalence of psychiatric morbidity, in each year the difference between the groups, at least visually, seems to increase with time as it gets closer to MS onset,” said Dr. Chertcoff.
The analysis showed the relative risk of psychiatric morbidity over the 5 years before MS onset was 1.88 (95% confidence interval, 1.80-1.97) in the administrative cohort, and 1.57 (95% CI, 1.36-1.80) in the clinical cohort.
Secondary analyses showed individuals with MS had more yearly physician visits, visits to psychiatrists, psychiatric hospital admissions, and prescription fills for psychiatric medication, compared with controls. This, said Dr. Chertcoff, illustrates the burden psychiatric morbidity during the prodromal phase of MS places on health care resources.
It’s possible that low-grade inflammation, which is linked to MS, is also pushing these psychiatric phenomena, said Dr. Chertcoff. He noted that the prevalence of depression is significantly higher not only in MS, but in a wide range of other inflammatory conditions.
In addition to psychiatric complaints, MS patients experience other symptoms, including pain, sleep disturbances, fatigue, and gastrointestinal issues during the MS prodrome, said Dr. Chertcoff.
Patients with MS are often seeing other physicians – including psychiatrists during the prodromal phase of the disease. Neurologists, Dr. Chertcoff said, could perhaps “raise awareness” among these other specialists about the prevalence of psychiatric morbidities during this phase.
He hopes experts in the field will consider developing research criteria for the MS prodrome similar to what has been done in Parkinson’s disease.
When does MS start?
Commenting on the research findings, Mark Freedman, MD, professor of medicine (Neurology), University of Ottawa, and director of the multiple sclerosis research unit, Ottawa Hospital-General Campus, said the study illustrates the increased research attention the interplay between MS and psychiatric disorders is getting.
He recalled “one of the most compelling” recent studies that looked at a large group of children with MS and showed their grades started falling more than 5 years before developing MS symptoms. “You could see their grades going down year by year by year, so an indicator that a young brain, which should be like a sponge and improving, was actually faltering well before the symptoms.”
Results from this new study continue to beg the question of when MS actually starts, said Dr. Freedman.
The study received funding from the U.S. National MS Society, the MS Society of Canada, and the Michael Smith Foundation. Dr. Chertcoff and Dr. Freedman reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT ACTRIMS FORUM 2023
CBT alone and with meds may decrease MS fatigue
SAN DIEGO – , new research shows.
As well, study results suggest that individuals with poorer sleep hygiene may benefit more from CBT, researchers noted.
“Clinicians should consider clinical characteristics and overall treatment goals when selecting fatigue interventions, to offer a more personalized approach for MS fatigue,” said study investigator Tiffany Braley, MD, associate professor of neurology, University of Michigan, Ann Arbor.
The findings were presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Incapacitating symptom
Dr. Braley noted that fatigue affects up to 90% of patients with MS and is the most incapacitating symptom for more than 40% of these patients. In addition, fatigue is a strong predictor of reduced work productivity, unemployment, reduced social participation, and reduced quality of life.
“Given the impact that fatigue has on the health and well-being of people with MS, it is essential to find ways to optimize the current treatments that we have at hand for fatigue in MS in the most patient-centered way possible,” Dr. Braley said.
CBT, which teaches strategies to target maladaptive thoughts and beliefs, is one of the most promising behavioral strategies, the investigators noted. It has been shown to be effective for multiple conditions including depression, posttraumatic stress disorder, insomnia, and pain.
For MS fatigue, CBT is considered a second-line treatment. Moderate and sustained efficacy have been shown across trials but access remains limited, Dr. Braley reported.
Modafinil, which is approved by the U.S. Food and Drug Administration to treat sleepiness secondary to obstructive sleep apnea and narcolepsy, is commonly used off-label to treat MS-related fatigue. However, prior trials have yielded mixed results regarding the efficacy of the drug for MS fatigue, said Dr. Braley.
Also, different behavioral and pharmacologic therapies have never been combined to determine if there might be a synergistic benefit, she added.
The new 12-week parallel-arm, analyst-blinded COMBO-MS trial included 336 participants (76.2% women; mean age, 48.8 years). Most of the patients (85.1%) were White and most (71.1%) had relapsing remitting MS (RRMS).
Participants were randomly assigned to receive 8 weekly and then two “booster” sessions of telephone-delivered one-on-one CBT, or modafinil with the dose generally ranging from 100 to 200 mg per day, or a combination of the two therapies.
The primary outcome measure was change in fatigue on the self-report Modified Fatigue Impact Scale (MFIS), using online surveys. The mean baseline MFIS was 52.7.
Study participants also completed questionnaires on disability, sleep disorders, sleep hygiene, and sleepiness (Epworth sleepiness scale).
Covariates included demographics, anxiety based on the Generalized Anxiety Disorder-7, pain score on the Brief Pain Inventory, baseline fatigue score, and physical activity.
Clinically, statistically significant
The overall treatment effect on the total MFIS score at 12 weeks was positive for each group. “Each treatment arm was associated with a clinically significant and a statistically significant within-group reduction in MSIF score from 15 to 17 points,” Dr. Braley reported.
“But even though the combination therapy ended up having the highest absolute reduction, it ultimately was not statistically significant,” she added.
Responder analyses showed almost two-thirds of each treatment group experienced at least a 10-point reduction in MSIF, which is considered clinically significant. In addition, more than 50% experienced at least 25% reduction in MSIF. “Again, although the combination therapy seemed to have a higher proportion of responders, this was not statistically significant,” said Dr. Braley.
A secondary outcome was the self-reported Patient Global Impression of Change, which rates overall symptoms and quality of life. More participants in all groups said their symptoms and quality of life at study’s end were somewhat better, moderately better, a definite improvement, or a great deal better.
But here the combination therapy was significantly better than the other interventions. “This suggests there may be more subjective benefits of combination therapy that we’re not capturing” with other measures, Dr. Braley noted.
Sleep hygiene significantly moderated the treatment effect (P = .03). As sleep hygiene worsened, the effect of modafinil monotherapy relative to CBT monotherapy appeared to diminish, and behavior therapy started to have more benefit relative to modafinil therapy, the investigators noted.
“Our results suggest that people with MS who have problems maintaining healthy sleep behaviors could potentially see more benefit from behaviorally based treatments that target sleep habits as part of the fatigue management plan, as opposed to a stimulant medication that could make sleep more difficult to maintain,” Dr. Braley said.
“On the other hand, people with good sleep hygiene may sufficiently respond to modafinil. For those who believe their mood, activity limitations, and quality of life are closely linked to their fatigue, combination therapy may offer more global benefits,” she added.
Sleepiness, as assessed with the Epworth sleepiness scale, had a direct effect on treatment response (P = .0087) that did not vary by intervention. Those who were sleepier had greater reductions on MSIF scores.
Dr. Braley noted that there was an excellent adherence rate, with only 26 participants discontinuing the study. Of these, 20 were from the modafinil group and discontinued because of side effects, and 6 were from the CBT group and discontinued because of time constraints. There were no serious adverse events reported.
Important lifestyle factor
Session cochair Deepak Kaushik, PhD, of the department of biomedical sciences, Memorial University, St John’s, Nfld., said the benefit of CBT for MS fatigue “definitely needs to be looked into further.”
Sleep deprivation, along with ensuing fatigue, is among the lifestyle factors that play a vital role in MS, said Dr. Kaushik, who was not involved with the research.
The effect of CBT on fatigue is likely through stress reduction, he said, adding that the immune system is significantly affected by stress. “We know the immune system has a direct linkage to the way you feel [and] your stress response to situations,” so it makes sense that CBT lowers fatigue because it reduces stress, Dr. Kaushik said.
The study received funding from the Patient-Centered Outcomes Research Institute. Dr. Braley and Dr. Kaushik have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN DIEGO – , new research shows.
As well, study results suggest that individuals with poorer sleep hygiene may benefit more from CBT, researchers noted.
“Clinicians should consider clinical characteristics and overall treatment goals when selecting fatigue interventions, to offer a more personalized approach for MS fatigue,” said study investigator Tiffany Braley, MD, associate professor of neurology, University of Michigan, Ann Arbor.
The findings were presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Incapacitating symptom
Dr. Braley noted that fatigue affects up to 90% of patients with MS and is the most incapacitating symptom for more than 40% of these patients. In addition, fatigue is a strong predictor of reduced work productivity, unemployment, reduced social participation, and reduced quality of life.
“Given the impact that fatigue has on the health and well-being of people with MS, it is essential to find ways to optimize the current treatments that we have at hand for fatigue in MS in the most patient-centered way possible,” Dr. Braley said.
CBT, which teaches strategies to target maladaptive thoughts and beliefs, is one of the most promising behavioral strategies, the investigators noted. It has been shown to be effective for multiple conditions including depression, posttraumatic stress disorder, insomnia, and pain.
For MS fatigue, CBT is considered a second-line treatment. Moderate and sustained efficacy have been shown across trials but access remains limited, Dr. Braley reported.
Modafinil, which is approved by the U.S. Food and Drug Administration to treat sleepiness secondary to obstructive sleep apnea and narcolepsy, is commonly used off-label to treat MS-related fatigue. However, prior trials have yielded mixed results regarding the efficacy of the drug for MS fatigue, said Dr. Braley.
Also, different behavioral and pharmacologic therapies have never been combined to determine if there might be a synergistic benefit, she added.
The new 12-week parallel-arm, analyst-blinded COMBO-MS trial included 336 participants (76.2% women; mean age, 48.8 years). Most of the patients (85.1%) were White and most (71.1%) had relapsing remitting MS (RRMS).
Participants were randomly assigned to receive 8 weekly and then two “booster” sessions of telephone-delivered one-on-one CBT, or modafinil with the dose generally ranging from 100 to 200 mg per day, or a combination of the two therapies.
The primary outcome measure was change in fatigue on the self-report Modified Fatigue Impact Scale (MFIS), using online surveys. The mean baseline MFIS was 52.7.
Study participants also completed questionnaires on disability, sleep disorders, sleep hygiene, and sleepiness (Epworth sleepiness scale).
Covariates included demographics, anxiety based on the Generalized Anxiety Disorder-7, pain score on the Brief Pain Inventory, baseline fatigue score, and physical activity.
Clinically, statistically significant
The overall treatment effect on the total MFIS score at 12 weeks was positive for each group. “Each treatment arm was associated with a clinically significant and a statistically significant within-group reduction in MSIF score from 15 to 17 points,” Dr. Braley reported.
“But even though the combination therapy ended up having the highest absolute reduction, it ultimately was not statistically significant,” she added.
Responder analyses showed almost two-thirds of each treatment group experienced at least a 10-point reduction in MSIF, which is considered clinically significant. In addition, more than 50% experienced at least 25% reduction in MSIF. “Again, although the combination therapy seemed to have a higher proportion of responders, this was not statistically significant,” said Dr. Braley.
A secondary outcome was the self-reported Patient Global Impression of Change, which rates overall symptoms and quality of life. More participants in all groups said their symptoms and quality of life at study’s end were somewhat better, moderately better, a definite improvement, or a great deal better.
But here the combination therapy was significantly better than the other interventions. “This suggests there may be more subjective benefits of combination therapy that we’re not capturing” with other measures, Dr. Braley noted.
Sleep hygiene significantly moderated the treatment effect (P = .03). As sleep hygiene worsened, the effect of modafinil monotherapy relative to CBT monotherapy appeared to diminish, and behavior therapy started to have more benefit relative to modafinil therapy, the investigators noted.
“Our results suggest that people with MS who have problems maintaining healthy sleep behaviors could potentially see more benefit from behaviorally based treatments that target sleep habits as part of the fatigue management plan, as opposed to a stimulant medication that could make sleep more difficult to maintain,” Dr. Braley said.
“On the other hand, people with good sleep hygiene may sufficiently respond to modafinil. For those who believe their mood, activity limitations, and quality of life are closely linked to their fatigue, combination therapy may offer more global benefits,” she added.
Sleepiness, as assessed with the Epworth sleepiness scale, had a direct effect on treatment response (P = .0087) that did not vary by intervention. Those who were sleepier had greater reductions on MSIF scores.
Dr. Braley noted that there was an excellent adherence rate, with only 26 participants discontinuing the study. Of these, 20 were from the modafinil group and discontinued because of side effects, and 6 were from the CBT group and discontinued because of time constraints. There were no serious adverse events reported.
Important lifestyle factor
Session cochair Deepak Kaushik, PhD, of the department of biomedical sciences, Memorial University, St John’s, Nfld., said the benefit of CBT for MS fatigue “definitely needs to be looked into further.”
Sleep deprivation, along with ensuing fatigue, is among the lifestyle factors that play a vital role in MS, said Dr. Kaushik, who was not involved with the research.
The effect of CBT on fatigue is likely through stress reduction, he said, adding that the immune system is significantly affected by stress. “We know the immune system has a direct linkage to the way you feel [and] your stress response to situations,” so it makes sense that CBT lowers fatigue because it reduces stress, Dr. Kaushik said.
The study received funding from the Patient-Centered Outcomes Research Institute. Dr. Braley and Dr. Kaushik have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN DIEGO – , new research shows.
As well, study results suggest that individuals with poorer sleep hygiene may benefit more from CBT, researchers noted.
“Clinicians should consider clinical characteristics and overall treatment goals when selecting fatigue interventions, to offer a more personalized approach for MS fatigue,” said study investigator Tiffany Braley, MD, associate professor of neurology, University of Michigan, Ann Arbor.
The findings were presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Incapacitating symptom
Dr. Braley noted that fatigue affects up to 90% of patients with MS and is the most incapacitating symptom for more than 40% of these patients. In addition, fatigue is a strong predictor of reduced work productivity, unemployment, reduced social participation, and reduced quality of life.
“Given the impact that fatigue has on the health and well-being of people with MS, it is essential to find ways to optimize the current treatments that we have at hand for fatigue in MS in the most patient-centered way possible,” Dr. Braley said.
CBT, which teaches strategies to target maladaptive thoughts and beliefs, is one of the most promising behavioral strategies, the investigators noted. It has been shown to be effective for multiple conditions including depression, posttraumatic stress disorder, insomnia, and pain.
For MS fatigue, CBT is considered a second-line treatment. Moderate and sustained efficacy have been shown across trials but access remains limited, Dr. Braley reported.
Modafinil, which is approved by the U.S. Food and Drug Administration to treat sleepiness secondary to obstructive sleep apnea and narcolepsy, is commonly used off-label to treat MS-related fatigue. However, prior trials have yielded mixed results regarding the efficacy of the drug for MS fatigue, said Dr. Braley.
Also, different behavioral and pharmacologic therapies have never been combined to determine if there might be a synergistic benefit, she added.
The new 12-week parallel-arm, analyst-blinded COMBO-MS trial included 336 participants (76.2% women; mean age, 48.8 years). Most of the patients (85.1%) were White and most (71.1%) had relapsing remitting MS (RRMS).
Participants were randomly assigned to receive 8 weekly and then two “booster” sessions of telephone-delivered one-on-one CBT, or modafinil with the dose generally ranging from 100 to 200 mg per day, or a combination of the two therapies.
The primary outcome measure was change in fatigue on the self-report Modified Fatigue Impact Scale (MFIS), using online surveys. The mean baseline MFIS was 52.7.
Study participants also completed questionnaires on disability, sleep disorders, sleep hygiene, and sleepiness (Epworth sleepiness scale).
Covariates included demographics, anxiety based on the Generalized Anxiety Disorder-7, pain score on the Brief Pain Inventory, baseline fatigue score, and physical activity.
Clinically, statistically significant
The overall treatment effect on the total MFIS score at 12 weeks was positive for each group. “Each treatment arm was associated with a clinically significant and a statistically significant within-group reduction in MSIF score from 15 to 17 points,” Dr. Braley reported.
“But even though the combination therapy ended up having the highest absolute reduction, it ultimately was not statistically significant,” she added.
Responder analyses showed almost two-thirds of each treatment group experienced at least a 10-point reduction in MSIF, which is considered clinically significant. In addition, more than 50% experienced at least 25% reduction in MSIF. “Again, although the combination therapy seemed to have a higher proportion of responders, this was not statistically significant,” said Dr. Braley.
A secondary outcome was the self-reported Patient Global Impression of Change, which rates overall symptoms and quality of life. More participants in all groups said their symptoms and quality of life at study’s end were somewhat better, moderately better, a definite improvement, or a great deal better.
But here the combination therapy was significantly better than the other interventions. “This suggests there may be more subjective benefits of combination therapy that we’re not capturing” with other measures, Dr. Braley noted.
Sleep hygiene significantly moderated the treatment effect (P = .03). As sleep hygiene worsened, the effect of modafinil monotherapy relative to CBT monotherapy appeared to diminish, and behavior therapy started to have more benefit relative to modafinil therapy, the investigators noted.
“Our results suggest that people with MS who have problems maintaining healthy sleep behaviors could potentially see more benefit from behaviorally based treatments that target sleep habits as part of the fatigue management plan, as opposed to a stimulant medication that could make sleep more difficult to maintain,” Dr. Braley said.
“On the other hand, people with good sleep hygiene may sufficiently respond to modafinil. For those who believe their mood, activity limitations, and quality of life are closely linked to their fatigue, combination therapy may offer more global benefits,” she added.
Sleepiness, as assessed with the Epworth sleepiness scale, had a direct effect on treatment response (P = .0087) that did not vary by intervention. Those who were sleepier had greater reductions on MSIF scores.
Dr. Braley noted that there was an excellent adherence rate, with only 26 participants discontinuing the study. Of these, 20 were from the modafinil group and discontinued because of side effects, and 6 were from the CBT group and discontinued because of time constraints. There were no serious adverse events reported.
Important lifestyle factor
Session cochair Deepak Kaushik, PhD, of the department of biomedical sciences, Memorial University, St John’s, Nfld., said the benefit of CBT for MS fatigue “definitely needs to be looked into further.”
Sleep deprivation, along with ensuing fatigue, is among the lifestyle factors that play a vital role in MS, said Dr. Kaushik, who was not involved with the research.
The effect of CBT on fatigue is likely through stress reduction, he said, adding that the immune system is significantly affected by stress. “We know the immune system has a direct linkage to the way you feel [and] your stress response to situations,” so it makes sense that CBT lowers fatigue because it reduces stress, Dr. Kaushik said.
The study received funding from the Patient-Centered Outcomes Research Institute. Dr. Braley and Dr. Kaushik have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ACTRIMS FORUM 2023