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CBT may improve comorbid posttraumatic headache, PTSD
Results from a randomized clinical trial of almost 200 military veterans showed that, compared with usual care, CBT for headache led to significant improvement in both headache disability and PTSD symptoms. Cognitive-processing therapy (CPT) also led to significant improvement in PTSD symptoms, but it did not improve headache disability.
Lead author Donald McGeary, PhD, department of rehabilitation medicine, the University of Texas Health Science Center,San Antonio, noted the improvements shown in headache disability after CBT were likely caused by its building of patients’ confidence that they could control or manage their headaches themselves.
That sense of control was key to helping patients “get their lives back. If you can improve a person’s belief that they can control their headache, they function better,” Dr. McGeary said in a news release.
The findings were published online in JAMA Neurology.
Signature wounds
Both mild traumatic brain injury (TBI) and PTSD are signature wounds of post-9/11 military conflicts. The two conditions commonly occur together and can harm quality of life and functioning, the investigators noted. Following mild TBI, many veterans experience persistent posttraumatic headache, which often co-occurs with PTSD.
To gauge the impact of CBTs for this patient population, researchers recruited 193 post-9/11 combat veterans (mean age, 39.7 years) with clinically significant PTSD symptoms and posttraumatic headache that had persisted more than 3 months after TBI. Of these, 167 were men.
All participants were receiving care at the Polytrauma Rehabilitation Center of the South Texas Veterans Health Care System in Houston.
They were randomly allocated to undergo 8 sessions of manualized CBT for headache, 12 sessions of manualized CPT for PTSD, or usual headache treatment.
CBT for headache uses CBT concepts to reduce headache disability and improve mood – and includes key components, such as relaxation, setting goals for activities patients want to resume, and planning for those situations.
CPT is a leading psychotherapy for PTSD. It teaches patients how to evaluate and change upsetting and maladaptive thoughts related to their trauma. The idea is that, by changing thoughts, patients can change the way they feel.
Treatment as usual was consistent with multidisciplinary treatment in a large Veterans Affairs multiple-trauma center and could include pharmacotherapies, physical and occupational therapies, pain medications, acupuncture, and massage.
The coprimary outcomes were headache-related disability on the six-item Headache Impact Test (HIT-6) and PTSD symptom severity on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5), assessed from end of treatment to 6 months post treatment.
At baseline, all participants reported severe headache-related disability (mean HIT-6 score, 65.8 points) and severe PTSD symptoms (mean PCL-5 score, 48.4 points).
Significant improvement
Compared with usual care, CBT for headache led to significant improvement in headache disability (posttreatment mean change in HIT-6 score, –3.4 points; P < .01) and PTSD symptoms (posttreatment change in PCL-5, –6.5 points; P = .04).
CPT also led to significant improvement in PTSD symptoms (8.9 points lower on the PCL-5 after treatment; P = .01), but it had only a modest effect on headache disability (1.4 points lower after treatment; P = .21).
“This was a surprise,” Dr. McGeary said. “If theories about PTSD driving posttraumatic headache are correct, you’d expect CPT to help both PTSD and headache. Our findings call that into question.”
Despite improvements in headache disability, CBT for headache did not significantly reduce headache frequency or intensity.
The researchers are now hoping to replicate their findings in a larger trial at multiple military and VA sites around the United States.
“We need more women, more racial and ethnic diversity, veterans as well as active military of different branches with varying comorbidities in different geographic regions attached to different hospitals and medical systems, because we’re comparing to usual care,” Dr. McGeary said.
A step forward
Commenting on the study, retired Col. Elspeth Cameron Ritchie, MD, chair of psychiatry, MedStar Washington Hospital Center, Washington, said she was “pleased” to see that this study was conducted and that she was pleased with the results.
“It’s been 20 years since 9/11, and wars are pretty much forgotten, but people are still suffering from the effects of traumatic brain injury and posttraumatic stress disorder. These are not conditions that go away quickly or lightly. They do take work,” said Dr. Ritchie, who was not involved with the research.
Finding therapies besides medication that are helpful is “good and is a step forward. The more alternatives we have, the better,” she concluded.
The study was supported in part by the Department of Defense and the Department of Veterans Affairs. Dr. McGeary and Dr. Ritchie have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Results from a randomized clinical trial of almost 200 military veterans showed that, compared with usual care, CBT for headache led to significant improvement in both headache disability and PTSD symptoms. Cognitive-processing therapy (CPT) also led to significant improvement in PTSD symptoms, but it did not improve headache disability.
Lead author Donald McGeary, PhD, department of rehabilitation medicine, the University of Texas Health Science Center,San Antonio, noted the improvements shown in headache disability after CBT were likely caused by its building of patients’ confidence that they could control or manage their headaches themselves.
That sense of control was key to helping patients “get their lives back. If you can improve a person’s belief that they can control their headache, they function better,” Dr. McGeary said in a news release.
The findings were published online in JAMA Neurology.
Signature wounds
Both mild traumatic brain injury (TBI) and PTSD are signature wounds of post-9/11 military conflicts. The two conditions commonly occur together and can harm quality of life and functioning, the investigators noted. Following mild TBI, many veterans experience persistent posttraumatic headache, which often co-occurs with PTSD.
To gauge the impact of CBTs for this patient population, researchers recruited 193 post-9/11 combat veterans (mean age, 39.7 years) with clinically significant PTSD symptoms and posttraumatic headache that had persisted more than 3 months after TBI. Of these, 167 were men.
All participants were receiving care at the Polytrauma Rehabilitation Center of the South Texas Veterans Health Care System in Houston.
They were randomly allocated to undergo 8 sessions of manualized CBT for headache, 12 sessions of manualized CPT for PTSD, or usual headache treatment.
CBT for headache uses CBT concepts to reduce headache disability and improve mood – and includes key components, such as relaxation, setting goals for activities patients want to resume, and planning for those situations.
CPT is a leading psychotherapy for PTSD. It teaches patients how to evaluate and change upsetting and maladaptive thoughts related to their trauma. The idea is that, by changing thoughts, patients can change the way they feel.
Treatment as usual was consistent with multidisciplinary treatment in a large Veterans Affairs multiple-trauma center and could include pharmacotherapies, physical and occupational therapies, pain medications, acupuncture, and massage.
The coprimary outcomes were headache-related disability on the six-item Headache Impact Test (HIT-6) and PTSD symptom severity on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5), assessed from end of treatment to 6 months post treatment.
At baseline, all participants reported severe headache-related disability (mean HIT-6 score, 65.8 points) and severe PTSD symptoms (mean PCL-5 score, 48.4 points).
Significant improvement
Compared with usual care, CBT for headache led to significant improvement in headache disability (posttreatment mean change in HIT-6 score, –3.4 points; P < .01) and PTSD symptoms (posttreatment change in PCL-5, –6.5 points; P = .04).
CPT also led to significant improvement in PTSD symptoms (8.9 points lower on the PCL-5 after treatment; P = .01), but it had only a modest effect on headache disability (1.4 points lower after treatment; P = .21).
“This was a surprise,” Dr. McGeary said. “If theories about PTSD driving posttraumatic headache are correct, you’d expect CPT to help both PTSD and headache. Our findings call that into question.”
Despite improvements in headache disability, CBT for headache did not significantly reduce headache frequency or intensity.
The researchers are now hoping to replicate their findings in a larger trial at multiple military and VA sites around the United States.
“We need more women, more racial and ethnic diversity, veterans as well as active military of different branches with varying comorbidities in different geographic regions attached to different hospitals and medical systems, because we’re comparing to usual care,” Dr. McGeary said.
A step forward
Commenting on the study, retired Col. Elspeth Cameron Ritchie, MD, chair of psychiatry, MedStar Washington Hospital Center, Washington, said she was “pleased” to see that this study was conducted and that she was pleased with the results.
“It’s been 20 years since 9/11, and wars are pretty much forgotten, but people are still suffering from the effects of traumatic brain injury and posttraumatic stress disorder. These are not conditions that go away quickly or lightly. They do take work,” said Dr. Ritchie, who was not involved with the research.
Finding therapies besides medication that are helpful is “good and is a step forward. The more alternatives we have, the better,” she concluded.
The study was supported in part by the Department of Defense and the Department of Veterans Affairs. Dr. McGeary and Dr. Ritchie have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Results from a randomized clinical trial of almost 200 military veterans showed that, compared with usual care, CBT for headache led to significant improvement in both headache disability and PTSD symptoms. Cognitive-processing therapy (CPT) also led to significant improvement in PTSD symptoms, but it did not improve headache disability.
Lead author Donald McGeary, PhD, department of rehabilitation medicine, the University of Texas Health Science Center,San Antonio, noted the improvements shown in headache disability after CBT were likely caused by its building of patients’ confidence that they could control or manage their headaches themselves.
That sense of control was key to helping patients “get their lives back. If you can improve a person’s belief that they can control their headache, they function better,” Dr. McGeary said in a news release.
The findings were published online in JAMA Neurology.
Signature wounds
Both mild traumatic brain injury (TBI) and PTSD are signature wounds of post-9/11 military conflicts. The two conditions commonly occur together and can harm quality of life and functioning, the investigators noted. Following mild TBI, many veterans experience persistent posttraumatic headache, which often co-occurs with PTSD.
To gauge the impact of CBTs for this patient population, researchers recruited 193 post-9/11 combat veterans (mean age, 39.7 years) with clinically significant PTSD symptoms and posttraumatic headache that had persisted more than 3 months after TBI. Of these, 167 were men.
All participants were receiving care at the Polytrauma Rehabilitation Center of the South Texas Veterans Health Care System in Houston.
They were randomly allocated to undergo 8 sessions of manualized CBT for headache, 12 sessions of manualized CPT for PTSD, or usual headache treatment.
CBT for headache uses CBT concepts to reduce headache disability and improve mood – and includes key components, such as relaxation, setting goals for activities patients want to resume, and planning for those situations.
CPT is a leading psychotherapy for PTSD. It teaches patients how to evaluate and change upsetting and maladaptive thoughts related to their trauma. The idea is that, by changing thoughts, patients can change the way they feel.
Treatment as usual was consistent with multidisciplinary treatment in a large Veterans Affairs multiple-trauma center and could include pharmacotherapies, physical and occupational therapies, pain medications, acupuncture, and massage.
The coprimary outcomes were headache-related disability on the six-item Headache Impact Test (HIT-6) and PTSD symptom severity on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5), assessed from end of treatment to 6 months post treatment.
At baseline, all participants reported severe headache-related disability (mean HIT-6 score, 65.8 points) and severe PTSD symptoms (mean PCL-5 score, 48.4 points).
Significant improvement
Compared with usual care, CBT for headache led to significant improvement in headache disability (posttreatment mean change in HIT-6 score, –3.4 points; P < .01) and PTSD symptoms (posttreatment change in PCL-5, –6.5 points; P = .04).
CPT also led to significant improvement in PTSD symptoms (8.9 points lower on the PCL-5 after treatment; P = .01), but it had only a modest effect on headache disability (1.4 points lower after treatment; P = .21).
“This was a surprise,” Dr. McGeary said. “If theories about PTSD driving posttraumatic headache are correct, you’d expect CPT to help both PTSD and headache. Our findings call that into question.”
Despite improvements in headache disability, CBT for headache did not significantly reduce headache frequency or intensity.
The researchers are now hoping to replicate their findings in a larger trial at multiple military and VA sites around the United States.
“We need more women, more racial and ethnic diversity, veterans as well as active military of different branches with varying comorbidities in different geographic regions attached to different hospitals and medical systems, because we’re comparing to usual care,” Dr. McGeary said.
A step forward
Commenting on the study, retired Col. Elspeth Cameron Ritchie, MD, chair of psychiatry, MedStar Washington Hospital Center, Washington, said she was “pleased” to see that this study was conducted and that she was pleased with the results.
“It’s been 20 years since 9/11, and wars are pretty much forgotten, but people are still suffering from the effects of traumatic brain injury and posttraumatic stress disorder. These are not conditions that go away quickly or lightly. They do take work,” said Dr. Ritchie, who was not involved with the research.
Finding therapies besides medication that are helpful is “good and is a step forward. The more alternatives we have, the better,” she concluded.
The study was supported in part by the Department of Defense and the Department of Veterans Affairs. Dr. McGeary and Dr. Ritchie have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NEUROLOGY
Impact of eliminating cost-sharing on follow-up colonoscopy mixed
Oregon and Kentucky recently enacted policies to eliminate financial disincentives that may have deterred people from undergoing a follow-up colonoscopy after a positive result on a noninvasive screening test for colorectal cancer (CRC).
A new analysis shows that the impact has been mixed. The policies led to significantly increased overall CRC screening and use of noninvasive testing in Oregon but not Kentucky.
The study was published online in JAMA Network Open.
The Affordable Care Act mandates that several CRC screening tests be covered without cost-sharing for people at average risk for CRC. However, lingering cost barriers remain for some people who have a positive initial screening test result and who need follow-up colonoscopy.
This led Kentucky in 2016 and Oregon in 2017 to enact policies that eliminate cost-sharing. Earlier this year, federal guidance eliminated cost-sharing for colonoscopies following noninvasive CRC screening tests for commercial insurers, and a similar policy is under consideration for Medicare.
For their study, Douglas Barthold, PhD, of the University of Washington, Seattle, and colleagues used claims data to evaluate CRC screening rates in Oregon and Kentucky, compared with rates in neighboring states that do not have cost-sharing policies.
The sample included more than 1.2 million individuals aged 45-64 living in Oregon, Kentucky, and nearby states from 2012 to 2019. Overall, about 15% of the cohort underwent any CRC screening; 8% underwent colonoscopy.
After the Oregon policy that eliminated cost-sharing went into effect, Oregonians had 6% higher odds of receiving any CRC screening (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.00-1.06; P = .03) and 35% higher odds of undergoing an initial noninvasive test (OR, 0.65; 95% CI, 0.58-0.73; P < .001), compared with neighboring states that did not implement a similar policy.
But there were no significant differences in total CRC screening use in Kentucky after policy implementation compared with neighboring states.
The odds of receiving a colonoscopy conditional on undergoing noninvasive CRC screening were not statistically different in Oregon or Kentucky, compared with neighboring states.
“These findings suggest that the enactment of policies that remove financial barriers is merely one of many elements (e.g., health literacy, outreach, transportation, access to care) that may help to achieve desired cancer screening outcomes,” wrote Dr. Barthold and colleagues.
The study had no commercial funding. Dr. Barthold reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Oregon and Kentucky recently enacted policies to eliminate financial disincentives that may have deterred people from undergoing a follow-up colonoscopy after a positive result on a noninvasive screening test for colorectal cancer (CRC).
A new analysis shows that the impact has been mixed. The policies led to significantly increased overall CRC screening and use of noninvasive testing in Oregon but not Kentucky.
The study was published online in JAMA Network Open.
The Affordable Care Act mandates that several CRC screening tests be covered without cost-sharing for people at average risk for CRC. However, lingering cost barriers remain for some people who have a positive initial screening test result and who need follow-up colonoscopy.
This led Kentucky in 2016 and Oregon in 2017 to enact policies that eliminate cost-sharing. Earlier this year, federal guidance eliminated cost-sharing for colonoscopies following noninvasive CRC screening tests for commercial insurers, and a similar policy is under consideration for Medicare.
For their study, Douglas Barthold, PhD, of the University of Washington, Seattle, and colleagues used claims data to evaluate CRC screening rates in Oregon and Kentucky, compared with rates in neighboring states that do not have cost-sharing policies.
The sample included more than 1.2 million individuals aged 45-64 living in Oregon, Kentucky, and nearby states from 2012 to 2019. Overall, about 15% of the cohort underwent any CRC screening; 8% underwent colonoscopy.
After the Oregon policy that eliminated cost-sharing went into effect, Oregonians had 6% higher odds of receiving any CRC screening (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.00-1.06; P = .03) and 35% higher odds of undergoing an initial noninvasive test (OR, 0.65; 95% CI, 0.58-0.73; P < .001), compared with neighboring states that did not implement a similar policy.
But there were no significant differences in total CRC screening use in Kentucky after policy implementation compared with neighboring states.
The odds of receiving a colonoscopy conditional on undergoing noninvasive CRC screening were not statistically different in Oregon or Kentucky, compared with neighboring states.
“These findings suggest that the enactment of policies that remove financial barriers is merely one of many elements (e.g., health literacy, outreach, transportation, access to care) that may help to achieve desired cancer screening outcomes,” wrote Dr. Barthold and colleagues.
The study had no commercial funding. Dr. Barthold reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Oregon and Kentucky recently enacted policies to eliminate financial disincentives that may have deterred people from undergoing a follow-up colonoscopy after a positive result on a noninvasive screening test for colorectal cancer (CRC).
A new analysis shows that the impact has been mixed. The policies led to significantly increased overall CRC screening and use of noninvasive testing in Oregon but not Kentucky.
The study was published online in JAMA Network Open.
The Affordable Care Act mandates that several CRC screening tests be covered without cost-sharing for people at average risk for CRC. However, lingering cost barriers remain for some people who have a positive initial screening test result and who need follow-up colonoscopy.
This led Kentucky in 2016 and Oregon in 2017 to enact policies that eliminate cost-sharing. Earlier this year, federal guidance eliminated cost-sharing for colonoscopies following noninvasive CRC screening tests for commercial insurers, and a similar policy is under consideration for Medicare.
For their study, Douglas Barthold, PhD, of the University of Washington, Seattle, and colleagues used claims data to evaluate CRC screening rates in Oregon and Kentucky, compared with rates in neighboring states that do not have cost-sharing policies.
The sample included more than 1.2 million individuals aged 45-64 living in Oregon, Kentucky, and nearby states from 2012 to 2019. Overall, about 15% of the cohort underwent any CRC screening; 8% underwent colonoscopy.
After the Oregon policy that eliminated cost-sharing went into effect, Oregonians had 6% higher odds of receiving any CRC screening (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.00-1.06; P = .03) and 35% higher odds of undergoing an initial noninvasive test (OR, 0.65; 95% CI, 0.58-0.73; P < .001), compared with neighboring states that did not implement a similar policy.
But there were no significant differences in total CRC screening use in Kentucky after policy implementation compared with neighboring states.
The odds of receiving a colonoscopy conditional on undergoing noninvasive CRC screening were not statistically different in Oregon or Kentucky, compared with neighboring states.
“These findings suggest that the enactment of policies that remove financial barriers is merely one of many elements (e.g., health literacy, outreach, transportation, access to care) that may help to achieve desired cancer screening outcomes,” wrote Dr. Barthold and colleagues.
The study had no commercial funding. Dr. Barthold reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Best strategy to prevent schizophrenia relapse yields unexpected results
A large meta-analysis sheds light on the best antipsychotic maintenance strategy to prevent relapse in clinically stable schizophrenia – with some unexpected results that have potential implications for changes to current guidelines.
Consistent with the researchers’ hypothesis, continuing antipsychotic treatment at the standard dose, switching to another antipsychotic, and reducing the dose were all significantly more effective than stopping antipsychotic treatment in preventing relapse.
However, contrary to the researchers’ hypothesis, which was based on current literature, switching to another antipsychotic was just as effective as continuing an antipsychotic at the standard dose.
Switching to another antipsychotic “does not increase the risk of relapse. This result was not expected, as previous literature suggested otherwise,” Giovanni Ostuzzi, MD, PhD, with University of Verona (Italy) said in an interview.
“On the other hand, reducing the dose below the standard range used in the acute phase carries a tangible risk of relapse, and should be limited to selected cases, for example those where the risk of withdrawing the treatment altogether is particularly high,” Dr. Ostuzzi said.
“These results should inform evidence-based guidelines, considering that clinical practices for relapse prevention are still heterogeneous and too often guided by clinical common sense only,” he added.
The study was published online in Lancet Psychiatry.
Guideline update warranted
The researchers evaluated the effect of different antipsychotic treatment strategies on risk for relapse in a network meta-analysis of 98 randomized controlled trials (RCTs) involving nearly 14,000 patients.
Compared to stopping the antipsychotic, all continuation strategies were effective in preventing relapse.
The risk for relapse was largely (and similarly) reduced when continuing the antipsychotic at the standard dose or switching to a different antipsychotic (relative risk, 0.37 and RR, 0.44, respectively), the researchers found.
Both strategies outperformed the strategy of reducing the antipsychotic dose below the standard (RR, 0.68), which was inferior to the other two strategies.
For every three patients continuing an antipsychotic at standard doses, one additional patient will avoid relapse, compared with patients stopping an antipsychotic, “which can be regarded as a large-effect magnitude according to commonly used thresholds and results from RCTs in acute schizophrenia,” the researchers write.
The number needed to treat (NNT) slightly increased to about 3.5 for patients who switched antipsychotic treatment – “still regarded as a large-effect magnitude,” they note.
“Currently, most psychiatrists are aware of the benefits of continuing antipsychotics in clinically stable individuals. However, they might face the necessity of changing the ongoing treatment strategy, generally because of burdening side effects, poor adherence, or both,” said Dr. Ostuzzi.
the investigators write.
More to the story
In an accompanying editorial, Marieke J.H. Begemann, PhD, University Medical Center Groningen (the Netherlands) and colleagues note the large number of patients included in the analysis provide “great credibility” to the findings, which are “trustworthy and important, yet only tell part of the story.”
They note that, while tapering information was often missing, antipsychotic discontinuation was probably abrupt for about two-thirds of the included studies.
“The issue of slow versus swift tapering is not yet settled, as there is a scarcity of RCTs that provide very gradual tapering over several months,” the editorialists write.
To fill this gap, several randomized trials are now in progress to specifically address the effects of gradual tapering or discontinuation vs. antipsychotic maintenance treatment in clinically stable schizophrenia.
“Time is pressing, as patients, their families, and clinicians need evidence-based data to weigh up the risks and benefits of maintaining, switching, or reducing medication with respect to a range of outcomes that are important to them, including social functioning, cognition, physical health, sexual health, and quality of life, thus going well beyond relapse prevention,” the editorialists note.
“Schizophrenia-spectrum disorders are heterogeneous with a largely unpredictable course, and we have known for a long time that a substantial proportion of patients who experienced a first psychosis can manage without antipsychotic medication. The challenge for future research is therefore to identify this subgroup on the basis of individual characteristics and guide them in tapering medication safely,” they add.
The study had no funding source. Dr. Ostuzzi reports no relevant financial relationships. A complete list of author disclosures is available with the original article. The editorialists have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A large meta-analysis sheds light on the best antipsychotic maintenance strategy to prevent relapse in clinically stable schizophrenia – with some unexpected results that have potential implications for changes to current guidelines.
Consistent with the researchers’ hypothesis, continuing antipsychotic treatment at the standard dose, switching to another antipsychotic, and reducing the dose were all significantly more effective than stopping antipsychotic treatment in preventing relapse.
However, contrary to the researchers’ hypothesis, which was based on current literature, switching to another antipsychotic was just as effective as continuing an antipsychotic at the standard dose.
Switching to another antipsychotic “does not increase the risk of relapse. This result was not expected, as previous literature suggested otherwise,” Giovanni Ostuzzi, MD, PhD, with University of Verona (Italy) said in an interview.
“On the other hand, reducing the dose below the standard range used in the acute phase carries a tangible risk of relapse, and should be limited to selected cases, for example those where the risk of withdrawing the treatment altogether is particularly high,” Dr. Ostuzzi said.
“These results should inform evidence-based guidelines, considering that clinical practices for relapse prevention are still heterogeneous and too often guided by clinical common sense only,” he added.
The study was published online in Lancet Psychiatry.
Guideline update warranted
The researchers evaluated the effect of different antipsychotic treatment strategies on risk for relapse in a network meta-analysis of 98 randomized controlled trials (RCTs) involving nearly 14,000 patients.
Compared to stopping the antipsychotic, all continuation strategies were effective in preventing relapse.
The risk for relapse was largely (and similarly) reduced when continuing the antipsychotic at the standard dose or switching to a different antipsychotic (relative risk, 0.37 and RR, 0.44, respectively), the researchers found.
Both strategies outperformed the strategy of reducing the antipsychotic dose below the standard (RR, 0.68), which was inferior to the other two strategies.
For every three patients continuing an antipsychotic at standard doses, one additional patient will avoid relapse, compared with patients stopping an antipsychotic, “which can be regarded as a large-effect magnitude according to commonly used thresholds and results from RCTs in acute schizophrenia,” the researchers write.
The number needed to treat (NNT) slightly increased to about 3.5 for patients who switched antipsychotic treatment – “still regarded as a large-effect magnitude,” they note.
“Currently, most psychiatrists are aware of the benefits of continuing antipsychotics in clinically stable individuals. However, they might face the necessity of changing the ongoing treatment strategy, generally because of burdening side effects, poor adherence, or both,” said Dr. Ostuzzi.
the investigators write.
More to the story
In an accompanying editorial, Marieke J.H. Begemann, PhD, University Medical Center Groningen (the Netherlands) and colleagues note the large number of patients included in the analysis provide “great credibility” to the findings, which are “trustworthy and important, yet only tell part of the story.”
They note that, while tapering information was often missing, antipsychotic discontinuation was probably abrupt for about two-thirds of the included studies.
“The issue of slow versus swift tapering is not yet settled, as there is a scarcity of RCTs that provide very gradual tapering over several months,” the editorialists write.
To fill this gap, several randomized trials are now in progress to specifically address the effects of gradual tapering or discontinuation vs. antipsychotic maintenance treatment in clinically stable schizophrenia.
“Time is pressing, as patients, their families, and clinicians need evidence-based data to weigh up the risks and benefits of maintaining, switching, or reducing medication with respect to a range of outcomes that are important to them, including social functioning, cognition, physical health, sexual health, and quality of life, thus going well beyond relapse prevention,” the editorialists note.
“Schizophrenia-spectrum disorders are heterogeneous with a largely unpredictable course, and we have known for a long time that a substantial proportion of patients who experienced a first psychosis can manage without antipsychotic medication. The challenge for future research is therefore to identify this subgroup on the basis of individual characteristics and guide them in tapering medication safely,” they add.
The study had no funding source. Dr. Ostuzzi reports no relevant financial relationships. A complete list of author disclosures is available with the original article. The editorialists have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A large meta-analysis sheds light on the best antipsychotic maintenance strategy to prevent relapse in clinically stable schizophrenia – with some unexpected results that have potential implications for changes to current guidelines.
Consistent with the researchers’ hypothesis, continuing antipsychotic treatment at the standard dose, switching to another antipsychotic, and reducing the dose were all significantly more effective than stopping antipsychotic treatment in preventing relapse.
However, contrary to the researchers’ hypothesis, which was based on current literature, switching to another antipsychotic was just as effective as continuing an antipsychotic at the standard dose.
Switching to another antipsychotic “does not increase the risk of relapse. This result was not expected, as previous literature suggested otherwise,” Giovanni Ostuzzi, MD, PhD, with University of Verona (Italy) said in an interview.
“On the other hand, reducing the dose below the standard range used in the acute phase carries a tangible risk of relapse, and should be limited to selected cases, for example those where the risk of withdrawing the treatment altogether is particularly high,” Dr. Ostuzzi said.
“These results should inform evidence-based guidelines, considering that clinical practices for relapse prevention are still heterogeneous and too often guided by clinical common sense only,” he added.
The study was published online in Lancet Psychiatry.
Guideline update warranted
The researchers evaluated the effect of different antipsychotic treatment strategies on risk for relapse in a network meta-analysis of 98 randomized controlled trials (RCTs) involving nearly 14,000 patients.
Compared to stopping the antipsychotic, all continuation strategies were effective in preventing relapse.
The risk for relapse was largely (and similarly) reduced when continuing the antipsychotic at the standard dose or switching to a different antipsychotic (relative risk, 0.37 and RR, 0.44, respectively), the researchers found.
Both strategies outperformed the strategy of reducing the antipsychotic dose below the standard (RR, 0.68), which was inferior to the other two strategies.
For every three patients continuing an antipsychotic at standard doses, one additional patient will avoid relapse, compared with patients stopping an antipsychotic, “which can be regarded as a large-effect magnitude according to commonly used thresholds and results from RCTs in acute schizophrenia,” the researchers write.
The number needed to treat (NNT) slightly increased to about 3.5 for patients who switched antipsychotic treatment – “still regarded as a large-effect magnitude,” they note.
“Currently, most psychiatrists are aware of the benefits of continuing antipsychotics in clinically stable individuals. However, they might face the necessity of changing the ongoing treatment strategy, generally because of burdening side effects, poor adherence, or both,” said Dr. Ostuzzi.
the investigators write.
More to the story
In an accompanying editorial, Marieke J.H. Begemann, PhD, University Medical Center Groningen (the Netherlands) and colleagues note the large number of patients included in the analysis provide “great credibility” to the findings, which are “trustworthy and important, yet only tell part of the story.”
They note that, while tapering information was often missing, antipsychotic discontinuation was probably abrupt for about two-thirds of the included studies.
“The issue of slow versus swift tapering is not yet settled, as there is a scarcity of RCTs that provide very gradual tapering over several months,” the editorialists write.
To fill this gap, several randomized trials are now in progress to specifically address the effects of gradual tapering or discontinuation vs. antipsychotic maintenance treatment in clinically stable schizophrenia.
“Time is pressing, as patients, their families, and clinicians need evidence-based data to weigh up the risks and benefits of maintaining, switching, or reducing medication with respect to a range of outcomes that are important to them, including social functioning, cognition, physical health, sexual health, and quality of life, thus going well beyond relapse prevention,” the editorialists note.
“Schizophrenia-spectrum disorders are heterogeneous with a largely unpredictable course, and we have known for a long time that a substantial proportion of patients who experienced a first psychosis can manage without antipsychotic medication. The challenge for future research is therefore to identify this subgroup on the basis of individual characteristics and guide them in tapering medication safely,” they add.
The study had no funding source. Dr. Ostuzzi reports no relevant financial relationships. A complete list of author disclosures is available with the original article. The editorialists have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE LANCET PSYCHIATRY
ACC/AHA issue clinical lexicon for complications of COVID-19
The American College of Cardiology and the American Heart Association have jointly issued a comprehensive set of data standards to help clarify definitions of the cardiovascular (CV) and non-CV complications of COVID-19.
It’s the work of the ACC/AHA Task Force on Clinical Data Standards and has been endorsed by the Heart Failure Society of America and Society for Cardiac Angiography and Interventions.
There is increased importance to understanding the acute and long-term impact of COVID-19 on CV health, the writing group notes. Until now, however, there has not been “clarity or consensus” on definitions of CV conditions related to COVID-19, with different diagnostic terminologies being used for overlapping conditions, such as “myocardial injury,” “myocarditis,” “type Il myocardial infarction,” “stress cardiomyopathy,” and “inflammatory cardiomyopathy,” they point out.
“We, as a research community, did some things right and some things wrong surrounding the COVID pandemic,” Sandeep Das, MD, MPH, vice chair of the writing group, noted in an interview with this news organization.
“The things that we really did right is that everybody responded with enthusiasm, kind of all hands on deck with a massive crisis response, and that was fantastic,” Dr. Das said.
“However, because of the need to hurry, we didn’t structure and organize in the way that we typically would for something that was sort of a slow burn kind of problem rather than an emergency. One of the consequences of that was fragmentation of how things are collected, reported, et cetera, and that leads to confusion,” he added.
The report was published simultaneously June 23 in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes.
A necessary but not glamorous project
The new data standards for COVID-19 will help standardize definitions and set the framework to capture and better understand how COVID-19 affects CV health.
“It wasn’t exactly a glamorous-type project but, at the same time, it’s super necessary to kind of get everybody on the same page and working together,” Dr. Das said.
Broad agreement on common vocabulary and definitions will help with efforts to pool or compare data from electronic health records, clinical registries, administrative datasets, and other databases, and determine whether these data apply to clinical practice and research endeavors, the writing group says.
They considered data elements relevant to the full range of care provided to COVID-19 patients in all care settings. Among the key items included in the document are:
- Case definitions for confirmed, probable, and suspected acute COVID-19, as well as postacute sequelae of COVID-19.
- Definitions for acute CV complications related to COVID-19, including acute myocardial injury, heart failure, shock, arrhythmia, thromboembolic complications, and .
- Data elements related to COVID-19 vaccination status, comorbidities, and preexisting CV conditions.
- Definitions for postacute CV sequelae of SARS-CoV-2 infection and long-term CV complications of COVID-19.
- Data elements for CV mortality during acute COVID-19.
- Data elements for non-CV complications to help document severity of illness and other competing diagnoses and complications that might affect CV outcomes.
- A list of symptoms and signs related to COVID-19 and CV complications.
- Data elements for diagnostic and therapeutic strategies for COVID-19 and CV conditions.
- A discussion of advanced therapies, including , extracorporeal membrane oxygenation, and end-of-life management strategies.
These data standards will be useful for researchers, registry developers, and clinicians, and they are proposed as a framework for ICD-10 code development of COVID-19–related CV conditions, the writing group says.
The standards are also of “great importance” to patients, clinicians, investigators, scientists, administrators, public health officials, policymakers, and payers, the group says.
Dr. Das said that, although there is no formal plan in place to update the document, he could see sections that might be refined.
“For example, there’s a nice long list of all the various variants, and unfortunately, I suspect that that is going to change and evolve over time,” Dr. Das told this news organization.
“We tried very hard not to include things like specifying specific treatments so we didn’t get proscriptive. We wanted to make it descriptive, so hopefully it will stand the test of time pretty well,” he added.
This research had no commercial funding. The writing group has no relevant disclosures.
A version of this article first appeared on Medscape.com.
The American College of Cardiology and the American Heart Association have jointly issued a comprehensive set of data standards to help clarify definitions of the cardiovascular (CV) and non-CV complications of COVID-19.
It’s the work of the ACC/AHA Task Force on Clinical Data Standards and has been endorsed by the Heart Failure Society of America and Society for Cardiac Angiography and Interventions.
There is increased importance to understanding the acute and long-term impact of COVID-19 on CV health, the writing group notes. Until now, however, there has not been “clarity or consensus” on definitions of CV conditions related to COVID-19, with different diagnostic terminologies being used for overlapping conditions, such as “myocardial injury,” “myocarditis,” “type Il myocardial infarction,” “stress cardiomyopathy,” and “inflammatory cardiomyopathy,” they point out.
“We, as a research community, did some things right and some things wrong surrounding the COVID pandemic,” Sandeep Das, MD, MPH, vice chair of the writing group, noted in an interview with this news organization.
“The things that we really did right is that everybody responded with enthusiasm, kind of all hands on deck with a massive crisis response, and that was fantastic,” Dr. Das said.
“However, because of the need to hurry, we didn’t structure and organize in the way that we typically would for something that was sort of a slow burn kind of problem rather than an emergency. One of the consequences of that was fragmentation of how things are collected, reported, et cetera, and that leads to confusion,” he added.
The report was published simultaneously June 23 in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes.
A necessary but not glamorous project
The new data standards for COVID-19 will help standardize definitions and set the framework to capture and better understand how COVID-19 affects CV health.
“It wasn’t exactly a glamorous-type project but, at the same time, it’s super necessary to kind of get everybody on the same page and working together,” Dr. Das said.
Broad agreement on common vocabulary and definitions will help with efforts to pool or compare data from electronic health records, clinical registries, administrative datasets, and other databases, and determine whether these data apply to clinical practice and research endeavors, the writing group says.
They considered data elements relevant to the full range of care provided to COVID-19 patients in all care settings. Among the key items included in the document are:
- Case definitions for confirmed, probable, and suspected acute COVID-19, as well as postacute sequelae of COVID-19.
- Definitions for acute CV complications related to COVID-19, including acute myocardial injury, heart failure, shock, arrhythmia, thromboembolic complications, and .
- Data elements related to COVID-19 vaccination status, comorbidities, and preexisting CV conditions.
- Definitions for postacute CV sequelae of SARS-CoV-2 infection and long-term CV complications of COVID-19.
- Data elements for CV mortality during acute COVID-19.
- Data elements for non-CV complications to help document severity of illness and other competing diagnoses and complications that might affect CV outcomes.
- A list of symptoms and signs related to COVID-19 and CV complications.
- Data elements for diagnostic and therapeutic strategies for COVID-19 and CV conditions.
- A discussion of advanced therapies, including , extracorporeal membrane oxygenation, and end-of-life management strategies.
These data standards will be useful for researchers, registry developers, and clinicians, and they are proposed as a framework for ICD-10 code development of COVID-19–related CV conditions, the writing group says.
The standards are also of “great importance” to patients, clinicians, investigators, scientists, administrators, public health officials, policymakers, and payers, the group says.
Dr. Das said that, although there is no formal plan in place to update the document, he could see sections that might be refined.
“For example, there’s a nice long list of all the various variants, and unfortunately, I suspect that that is going to change and evolve over time,” Dr. Das told this news organization.
“We tried very hard not to include things like specifying specific treatments so we didn’t get proscriptive. We wanted to make it descriptive, so hopefully it will stand the test of time pretty well,” he added.
This research had no commercial funding. The writing group has no relevant disclosures.
A version of this article first appeared on Medscape.com.
The American College of Cardiology and the American Heart Association have jointly issued a comprehensive set of data standards to help clarify definitions of the cardiovascular (CV) and non-CV complications of COVID-19.
It’s the work of the ACC/AHA Task Force on Clinical Data Standards and has been endorsed by the Heart Failure Society of America and Society for Cardiac Angiography and Interventions.
There is increased importance to understanding the acute and long-term impact of COVID-19 on CV health, the writing group notes. Until now, however, there has not been “clarity or consensus” on definitions of CV conditions related to COVID-19, with different diagnostic terminologies being used for overlapping conditions, such as “myocardial injury,” “myocarditis,” “type Il myocardial infarction,” “stress cardiomyopathy,” and “inflammatory cardiomyopathy,” they point out.
“We, as a research community, did some things right and some things wrong surrounding the COVID pandemic,” Sandeep Das, MD, MPH, vice chair of the writing group, noted in an interview with this news organization.
“The things that we really did right is that everybody responded with enthusiasm, kind of all hands on deck with a massive crisis response, and that was fantastic,” Dr. Das said.
“However, because of the need to hurry, we didn’t structure and organize in the way that we typically would for something that was sort of a slow burn kind of problem rather than an emergency. One of the consequences of that was fragmentation of how things are collected, reported, et cetera, and that leads to confusion,” he added.
The report was published simultaneously June 23 in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes.
A necessary but not glamorous project
The new data standards for COVID-19 will help standardize definitions and set the framework to capture and better understand how COVID-19 affects CV health.
“It wasn’t exactly a glamorous-type project but, at the same time, it’s super necessary to kind of get everybody on the same page and working together,” Dr. Das said.
Broad agreement on common vocabulary and definitions will help with efforts to pool or compare data from electronic health records, clinical registries, administrative datasets, and other databases, and determine whether these data apply to clinical practice and research endeavors, the writing group says.
They considered data elements relevant to the full range of care provided to COVID-19 patients in all care settings. Among the key items included in the document are:
- Case definitions for confirmed, probable, and suspected acute COVID-19, as well as postacute sequelae of COVID-19.
- Definitions for acute CV complications related to COVID-19, including acute myocardial injury, heart failure, shock, arrhythmia, thromboembolic complications, and .
- Data elements related to COVID-19 vaccination status, comorbidities, and preexisting CV conditions.
- Definitions for postacute CV sequelae of SARS-CoV-2 infection and long-term CV complications of COVID-19.
- Data elements for CV mortality during acute COVID-19.
- Data elements for non-CV complications to help document severity of illness and other competing diagnoses and complications that might affect CV outcomes.
- A list of symptoms and signs related to COVID-19 and CV complications.
- Data elements for diagnostic and therapeutic strategies for COVID-19 and CV conditions.
- A discussion of advanced therapies, including , extracorporeal membrane oxygenation, and end-of-life management strategies.
These data standards will be useful for researchers, registry developers, and clinicians, and they are proposed as a framework for ICD-10 code development of COVID-19–related CV conditions, the writing group says.
The standards are also of “great importance” to patients, clinicians, investigators, scientists, administrators, public health officials, policymakers, and payers, the group says.
Dr. Das said that, although there is no formal plan in place to update the document, he could see sections that might be refined.
“For example, there’s a nice long list of all the various variants, and unfortunately, I suspect that that is going to change and evolve over time,” Dr. Das told this news organization.
“We tried very hard not to include things like specifying specific treatments so we didn’t get proscriptive. We wanted to make it descriptive, so hopefully it will stand the test of time pretty well,” he added.
This research had no commercial funding. The writing group has no relevant disclosures.
A version of this article first appeared on Medscape.com.
More evidence the flu vaccine may guard against Alzheimer’s
In a large propensity-matched cohort of older adults, those who had received at least one influenza inoculation were 40% less likely than unvaccinated peers to develop AD over the course of 4 years.
“Influenza infection can cause serious health complications, particularly in adults 65 and older. Our study’s findings – that vaccination against the flu virus may also reduce the risk of Alzheimer’s dementia for at least a few years – adds to the already compelling reasons get the flu vaccine annually,” Avram Bukhbinder, MD, of the University of Texas, Houston, said in an interview.
The new findings support earlier work by the same researchers that also suggested a protective effect of flu vaccination on dementia risk.
The latest study was published online in the Journal of Alzheimer’s Disease.
40% lower risk
Prior studies have found a lower risk of dementia of any etiology following influenza vaccination in selected populations, including veterans and patients with serious chronic health conditions.
However, the effect of influenza vaccination on AD risk in a general cohort of older U.S. adults has not been characterized.
Dr. Bukhbinder and colleagues used claims data to create a propensity-matched cohort of 935,887 influenza-vaccinated adults and a like number of unvaccinated adults aged 65 and older.
The median age of the persons in the matched sample was 73.7 years, and 57% were women. All were free of dementia during the 6-year look-back study period.
During median follow-up of 46 months, 47,889 (5.1%) flu-vaccinated adults and 79,630 (8.5%) unvaccinated adults developed AD.
The risk of AD was 40% lower in the vaccinated group (relative risk, 0.60; 95% confidence interval, 0.59-0.61). The absolute risk reduction was 0.034 (95% CI, 0.033-0.035), corresponding to a number needed to treat of 29.4.
Mechanism unclear
“Our study does not address the mechanism(s) underlying the apparent effect of influenza vaccination on Alzheimer’s risk, but we look forward to future research investigating this important question,” Dr. Bukhbinder said.
“One possible mechanism is that, by helping to prevent or mitigate infection with the flu virus and the systemic inflammation that follows such an infection, the flu vaccine helps to decrease the systemic inflammation that may have otherwise occurred,” he explained.
It’s also possible that influenza vaccination may trigger non–influenza-specific changes in the immune system that help to reduce the damage caused by AD pathology, including amyloid plaques and neurofibrillary tangles, he said.
“For example, the influenza vaccine may alter the brain’s immune cells such that they are better at clearing Alzheimer’s pathologies, an effect that has been seen in mice, or it may reprogram these immune cells to respond to Alzheimer’s pathologies in ways that are less likely to damage nearby healthy brain cells, or it may do both,” Dr. Bukhbinder noted.
Alzheimer’s expert weighs in
Heather M. Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said this study “suggests that flu vaccination may be valuable for maintaining cognition and memory as we age. This is even more relevant today in the COVID-19 environment.
“It is too early to tell if getting flu vaccine, on its own, can reduce risk of Alzheimer’s. More research is needed to understand the biological mechanisms behind the results in this study,” Dr. Snyder said in an interview.
“For example, it is possible that people who are getting vaccinated also take better care of their health in other ways, and these things add up to lower risk of Alzheimer’s and other dementias,” she noted.
“It is also possible that there are issues related to unequal access and/or vaccine hesitancy and how this may influence the study population and the research results,” Dr. Snyder said.
The study had no specific funding. Dr. Bukhbinder and Dr. Snyder disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a large propensity-matched cohort of older adults, those who had received at least one influenza inoculation were 40% less likely than unvaccinated peers to develop AD over the course of 4 years.
“Influenza infection can cause serious health complications, particularly in adults 65 and older. Our study’s findings – that vaccination against the flu virus may also reduce the risk of Alzheimer’s dementia for at least a few years – adds to the already compelling reasons get the flu vaccine annually,” Avram Bukhbinder, MD, of the University of Texas, Houston, said in an interview.
The new findings support earlier work by the same researchers that also suggested a protective effect of flu vaccination on dementia risk.
The latest study was published online in the Journal of Alzheimer’s Disease.
40% lower risk
Prior studies have found a lower risk of dementia of any etiology following influenza vaccination in selected populations, including veterans and patients with serious chronic health conditions.
However, the effect of influenza vaccination on AD risk in a general cohort of older U.S. adults has not been characterized.
Dr. Bukhbinder and colleagues used claims data to create a propensity-matched cohort of 935,887 influenza-vaccinated adults and a like number of unvaccinated adults aged 65 and older.
The median age of the persons in the matched sample was 73.7 years, and 57% were women. All were free of dementia during the 6-year look-back study period.
During median follow-up of 46 months, 47,889 (5.1%) flu-vaccinated adults and 79,630 (8.5%) unvaccinated adults developed AD.
The risk of AD was 40% lower in the vaccinated group (relative risk, 0.60; 95% confidence interval, 0.59-0.61). The absolute risk reduction was 0.034 (95% CI, 0.033-0.035), corresponding to a number needed to treat of 29.4.
Mechanism unclear
“Our study does not address the mechanism(s) underlying the apparent effect of influenza vaccination on Alzheimer’s risk, but we look forward to future research investigating this important question,” Dr. Bukhbinder said.
“One possible mechanism is that, by helping to prevent or mitigate infection with the flu virus and the systemic inflammation that follows such an infection, the flu vaccine helps to decrease the systemic inflammation that may have otherwise occurred,” he explained.
It’s also possible that influenza vaccination may trigger non–influenza-specific changes in the immune system that help to reduce the damage caused by AD pathology, including amyloid plaques and neurofibrillary tangles, he said.
“For example, the influenza vaccine may alter the brain’s immune cells such that they are better at clearing Alzheimer’s pathologies, an effect that has been seen in mice, or it may reprogram these immune cells to respond to Alzheimer’s pathologies in ways that are less likely to damage nearby healthy brain cells, or it may do both,” Dr. Bukhbinder noted.
Alzheimer’s expert weighs in
Heather M. Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said this study “suggests that flu vaccination may be valuable for maintaining cognition and memory as we age. This is even more relevant today in the COVID-19 environment.
“It is too early to tell if getting flu vaccine, on its own, can reduce risk of Alzheimer’s. More research is needed to understand the biological mechanisms behind the results in this study,” Dr. Snyder said in an interview.
“For example, it is possible that people who are getting vaccinated also take better care of their health in other ways, and these things add up to lower risk of Alzheimer’s and other dementias,” she noted.
“It is also possible that there are issues related to unequal access and/or vaccine hesitancy and how this may influence the study population and the research results,” Dr. Snyder said.
The study had no specific funding. Dr. Bukhbinder and Dr. Snyder disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a large propensity-matched cohort of older adults, those who had received at least one influenza inoculation were 40% less likely than unvaccinated peers to develop AD over the course of 4 years.
“Influenza infection can cause serious health complications, particularly in adults 65 and older. Our study’s findings – that vaccination against the flu virus may also reduce the risk of Alzheimer’s dementia for at least a few years – adds to the already compelling reasons get the flu vaccine annually,” Avram Bukhbinder, MD, of the University of Texas, Houston, said in an interview.
The new findings support earlier work by the same researchers that also suggested a protective effect of flu vaccination on dementia risk.
The latest study was published online in the Journal of Alzheimer’s Disease.
40% lower risk
Prior studies have found a lower risk of dementia of any etiology following influenza vaccination in selected populations, including veterans and patients with serious chronic health conditions.
However, the effect of influenza vaccination on AD risk in a general cohort of older U.S. adults has not been characterized.
Dr. Bukhbinder and colleagues used claims data to create a propensity-matched cohort of 935,887 influenza-vaccinated adults and a like number of unvaccinated adults aged 65 and older.
The median age of the persons in the matched sample was 73.7 years, and 57% were women. All were free of dementia during the 6-year look-back study period.
During median follow-up of 46 months, 47,889 (5.1%) flu-vaccinated adults and 79,630 (8.5%) unvaccinated adults developed AD.
The risk of AD was 40% lower in the vaccinated group (relative risk, 0.60; 95% confidence interval, 0.59-0.61). The absolute risk reduction was 0.034 (95% CI, 0.033-0.035), corresponding to a number needed to treat of 29.4.
Mechanism unclear
“Our study does not address the mechanism(s) underlying the apparent effect of influenza vaccination on Alzheimer’s risk, but we look forward to future research investigating this important question,” Dr. Bukhbinder said.
“One possible mechanism is that, by helping to prevent or mitigate infection with the flu virus and the systemic inflammation that follows such an infection, the flu vaccine helps to decrease the systemic inflammation that may have otherwise occurred,” he explained.
It’s also possible that influenza vaccination may trigger non–influenza-specific changes in the immune system that help to reduce the damage caused by AD pathology, including amyloid plaques and neurofibrillary tangles, he said.
“For example, the influenza vaccine may alter the brain’s immune cells such that they are better at clearing Alzheimer’s pathologies, an effect that has been seen in mice, or it may reprogram these immune cells to respond to Alzheimer’s pathologies in ways that are less likely to damage nearby healthy brain cells, or it may do both,” Dr. Bukhbinder noted.
Alzheimer’s expert weighs in
Heather M. Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said this study “suggests that flu vaccination may be valuable for maintaining cognition and memory as we age. This is even more relevant today in the COVID-19 environment.
“It is too early to tell if getting flu vaccine, on its own, can reduce risk of Alzheimer’s. More research is needed to understand the biological mechanisms behind the results in this study,” Dr. Snyder said in an interview.
“For example, it is possible that people who are getting vaccinated also take better care of their health in other ways, and these things add up to lower risk of Alzheimer’s and other dementias,” she noted.
“It is also possible that there are issues related to unequal access and/or vaccine hesitancy and how this may influence the study population and the research results,” Dr. Snyder said.
The study had no specific funding. Dr. Bukhbinder and Dr. Snyder disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF ALZHEIMER’S DISEASE
Anorexia linked to notable shrinkage of key brain structures
, a new brain imaging study shows.
The reductions of cortical thickness, subcortical volumes, and cortical surface area were “very pronounced in acutely underweight anorexia,” Stefan Ehrlich, MD, PhD, head of the Eating Disorder Treatment and Research Center, Technical University, Dresden, Germany, told this news organization.
Yet even a “partial weight gain brings some normalization of these shrinkages. From this it can be deduced that a fast/early normalization of weight is also very important for brain health,” said Dr. Ehrlich.
The study was published online in Biological Psychiatry.
‘A wake-up call’
Researchers with the international ENIGMA Eating Disorders Working Group analyzed T1-weighted structural magnetic resonance imaging scans for nearly 2,000 people with AN (including those in recovery) and healthy controls across 22 sites worldwide.
In the AN sample, reductions in cortical thickness, subcortical volumes, and, to a lesser extent, cortical surface area, were “sizable (Cohen’s d up to 0.95), widespread, and co-localized with hub regions,” they report.
These reductions were two and four times larger than the abnormalities in brain size and shape seen in patients with other mental illnesses, the researchers note.
Noting the harmful impact of anorexia-related undernutrition on the brain, these deficits were associated with lower body mass index in the AN sample and were less severe in partially weight-restored patients – implying that, with appropriate early treatment and support, the brain might be able to repair itself, the investigators note.
“This really is a wake-up call, showing the need for early interventions for people with eating disorders,” Paul Thompson, PhD, author and lead scientist for the ENIGMA Consortium, said in a news release.
“The international scale of this work is extraordinary. Scientists from 22 centers worldwide pooled their brain scans to create the most detailed picture to date of how anorexia affects the brain,” Dr. Thompson added.
“The brain changes in anorexia were more severe than in other any psychiatric condition we have studied. Effects of treatments and interventions can now be evaluated, using these new brain maps as a reference,” he noted.
Immediate clinical implications
Reached for comment, Allison Eliscu, MD, chief of the division of adolescent medicine, department of pediatrics, at Stony Brook (N.Y.) University, said the findings have immediate implications for clinical care.
“When we talk to our patients and the parents, a lot of them focus on things that they can see, such as the way they look. It adds a lot to the conversation to be able to say: You’re obviously not seeing these changes in the brain, but they’re happening and could be potentially long term if you don’t start weight restoring, or if you weight restore and then continue to drop again,” Dr. Eliscu said in an interview.
The findings, she said, really do highlight what anorexia can do to the brain.
“Adolescents need to know, anorexia can absolutely decrease the size of your brain in different areas; you’re not just losing weight in your belly and your thighs, you’re losing weight in the brain as well and that’s really concerning,” said Dr. Eliscu.
The study had no commercial funding. The authors and Dr. Eliscu report no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
, a new brain imaging study shows.
The reductions of cortical thickness, subcortical volumes, and cortical surface area were “very pronounced in acutely underweight anorexia,” Stefan Ehrlich, MD, PhD, head of the Eating Disorder Treatment and Research Center, Technical University, Dresden, Germany, told this news organization.
Yet even a “partial weight gain brings some normalization of these shrinkages. From this it can be deduced that a fast/early normalization of weight is also very important for brain health,” said Dr. Ehrlich.
The study was published online in Biological Psychiatry.
‘A wake-up call’
Researchers with the international ENIGMA Eating Disorders Working Group analyzed T1-weighted structural magnetic resonance imaging scans for nearly 2,000 people with AN (including those in recovery) and healthy controls across 22 sites worldwide.
In the AN sample, reductions in cortical thickness, subcortical volumes, and, to a lesser extent, cortical surface area, were “sizable (Cohen’s d up to 0.95), widespread, and co-localized with hub regions,” they report.
These reductions were two and four times larger than the abnormalities in brain size and shape seen in patients with other mental illnesses, the researchers note.
Noting the harmful impact of anorexia-related undernutrition on the brain, these deficits were associated with lower body mass index in the AN sample and were less severe in partially weight-restored patients – implying that, with appropriate early treatment and support, the brain might be able to repair itself, the investigators note.
“This really is a wake-up call, showing the need for early interventions for people with eating disorders,” Paul Thompson, PhD, author and lead scientist for the ENIGMA Consortium, said in a news release.
“The international scale of this work is extraordinary. Scientists from 22 centers worldwide pooled their brain scans to create the most detailed picture to date of how anorexia affects the brain,” Dr. Thompson added.
“The brain changes in anorexia were more severe than in other any psychiatric condition we have studied. Effects of treatments and interventions can now be evaluated, using these new brain maps as a reference,” he noted.
Immediate clinical implications
Reached for comment, Allison Eliscu, MD, chief of the division of adolescent medicine, department of pediatrics, at Stony Brook (N.Y.) University, said the findings have immediate implications for clinical care.
“When we talk to our patients and the parents, a lot of them focus on things that they can see, such as the way they look. It adds a lot to the conversation to be able to say: You’re obviously not seeing these changes in the brain, but they’re happening and could be potentially long term if you don’t start weight restoring, or if you weight restore and then continue to drop again,” Dr. Eliscu said in an interview.
The findings, she said, really do highlight what anorexia can do to the brain.
“Adolescents need to know, anorexia can absolutely decrease the size of your brain in different areas; you’re not just losing weight in your belly and your thighs, you’re losing weight in the brain as well and that’s really concerning,” said Dr. Eliscu.
The study had no commercial funding. The authors and Dr. Eliscu report no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
, a new brain imaging study shows.
The reductions of cortical thickness, subcortical volumes, and cortical surface area were “very pronounced in acutely underweight anorexia,” Stefan Ehrlich, MD, PhD, head of the Eating Disorder Treatment and Research Center, Technical University, Dresden, Germany, told this news organization.
Yet even a “partial weight gain brings some normalization of these shrinkages. From this it can be deduced that a fast/early normalization of weight is also very important for brain health,” said Dr. Ehrlich.
The study was published online in Biological Psychiatry.
‘A wake-up call’
Researchers with the international ENIGMA Eating Disorders Working Group analyzed T1-weighted structural magnetic resonance imaging scans for nearly 2,000 people with AN (including those in recovery) and healthy controls across 22 sites worldwide.
In the AN sample, reductions in cortical thickness, subcortical volumes, and, to a lesser extent, cortical surface area, were “sizable (Cohen’s d up to 0.95), widespread, and co-localized with hub regions,” they report.
These reductions were two and four times larger than the abnormalities in brain size and shape seen in patients with other mental illnesses, the researchers note.
Noting the harmful impact of anorexia-related undernutrition on the brain, these deficits were associated with lower body mass index in the AN sample and were less severe in partially weight-restored patients – implying that, with appropriate early treatment and support, the brain might be able to repair itself, the investigators note.
“This really is a wake-up call, showing the need for early interventions for people with eating disorders,” Paul Thompson, PhD, author and lead scientist for the ENIGMA Consortium, said in a news release.
“The international scale of this work is extraordinary. Scientists from 22 centers worldwide pooled their brain scans to create the most detailed picture to date of how anorexia affects the brain,” Dr. Thompson added.
“The brain changes in anorexia were more severe than in other any psychiatric condition we have studied. Effects of treatments and interventions can now be evaluated, using these new brain maps as a reference,” he noted.
Immediate clinical implications
Reached for comment, Allison Eliscu, MD, chief of the division of adolescent medicine, department of pediatrics, at Stony Brook (N.Y.) University, said the findings have immediate implications for clinical care.
“When we talk to our patients and the parents, a lot of them focus on things that they can see, such as the way they look. It adds a lot to the conversation to be able to say: You’re obviously not seeing these changes in the brain, but they’re happening and could be potentially long term if you don’t start weight restoring, or if you weight restore and then continue to drop again,” Dr. Eliscu said in an interview.
The findings, she said, really do highlight what anorexia can do to the brain.
“Adolescents need to know, anorexia can absolutely decrease the size of your brain in different areas; you’re not just losing weight in your belly and your thighs, you’re losing weight in the brain as well and that’s really concerning,” said Dr. Eliscu.
The study had no commercial funding. The authors and Dr. Eliscu report no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM BIOLOGICAL PSYCHIATRY
FDA unveils 5-year plan for ALS and other neurodegenerative diseases
The agency’s Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) aims to advance the development of safe and effective medical products and facilitate patient access to novel treatments.
“The effects of rare neurodegenerative diseases are devastating, with very few effective therapeutic options available to patients. We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” FDA Commissioner Robert M. Califf, MD, said in a news release.
“To face that challenge and to accelerate drug development, we need innovative approaches to better understand these diseases while also building on current scientific and research capabilities,” Dr. Califf acknowledged.
“This action plan, especially including the use of public-private partnerships and direct involvement of patients, will ensure the FDA is working toward meeting the task set forth by Congress to enhance the quality of life for those suffering by facilitating access to new therapies,” Dr. Califf added.
Blueprint to ‘aggressively’ move forward
The action plan represents a “blueprint” for how the agency will “aggressively” move forward to address challenges in drug development for rare neurodegenerative diseases to improve patient health, the FDA said.
The plan was created in accordance with provisions in the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) that President Biden signed into law in late 2021.
Targeted activities include establishing the FDA Rare Neurodegenerative Diseases Task Force and the public-private partnership for rare neurodegenerative diseases, developing disease-specific science strategies over the next 5 years, and leveraging ongoing FDA regulatory science efforts.
The ALS Science Strategy is part of the plan focused specifically on ALS. It provides a “forward-leaning” framework for FDA activities, which include efforts to improve characterization of disease pathogenesis and natural history, boost clinical trial infrastructure and agility to enable early selection of promising therapeutic candidates for further development, optimize clinical trial design, improve access to the trials, streamline clinical trial operations, and reduce the time and cost of drug development.
The FDA says patient engagement, public workshops, research projects, coordination across FDA centers and offices, and collaboration with the National Institutes of Health will be key to the success of implementation of the ALS Science Strategy.
A version of this article first appeared on Medscape.com.
The agency’s Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) aims to advance the development of safe and effective medical products and facilitate patient access to novel treatments.
“The effects of rare neurodegenerative diseases are devastating, with very few effective therapeutic options available to patients. We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” FDA Commissioner Robert M. Califf, MD, said in a news release.
“To face that challenge and to accelerate drug development, we need innovative approaches to better understand these diseases while also building on current scientific and research capabilities,” Dr. Califf acknowledged.
“This action plan, especially including the use of public-private partnerships and direct involvement of patients, will ensure the FDA is working toward meeting the task set forth by Congress to enhance the quality of life for those suffering by facilitating access to new therapies,” Dr. Califf added.
Blueprint to ‘aggressively’ move forward
The action plan represents a “blueprint” for how the agency will “aggressively” move forward to address challenges in drug development for rare neurodegenerative diseases to improve patient health, the FDA said.
The plan was created in accordance with provisions in the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) that President Biden signed into law in late 2021.
Targeted activities include establishing the FDA Rare Neurodegenerative Diseases Task Force and the public-private partnership for rare neurodegenerative diseases, developing disease-specific science strategies over the next 5 years, and leveraging ongoing FDA regulatory science efforts.
The ALS Science Strategy is part of the plan focused specifically on ALS. It provides a “forward-leaning” framework for FDA activities, which include efforts to improve characterization of disease pathogenesis and natural history, boost clinical trial infrastructure and agility to enable early selection of promising therapeutic candidates for further development, optimize clinical trial design, improve access to the trials, streamline clinical trial operations, and reduce the time and cost of drug development.
The FDA says patient engagement, public workshops, research projects, coordination across FDA centers and offices, and collaboration with the National Institutes of Health will be key to the success of implementation of the ALS Science Strategy.
A version of this article first appeared on Medscape.com.
The agency’s Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) aims to advance the development of safe and effective medical products and facilitate patient access to novel treatments.
“The effects of rare neurodegenerative diseases are devastating, with very few effective therapeutic options available to patients. We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” FDA Commissioner Robert M. Califf, MD, said in a news release.
“To face that challenge and to accelerate drug development, we need innovative approaches to better understand these diseases while also building on current scientific and research capabilities,” Dr. Califf acknowledged.
“This action plan, especially including the use of public-private partnerships and direct involvement of patients, will ensure the FDA is working toward meeting the task set forth by Congress to enhance the quality of life for those suffering by facilitating access to new therapies,” Dr. Califf added.
Blueprint to ‘aggressively’ move forward
The action plan represents a “blueprint” for how the agency will “aggressively” move forward to address challenges in drug development for rare neurodegenerative diseases to improve patient health, the FDA said.
The plan was created in accordance with provisions in the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) that President Biden signed into law in late 2021.
Targeted activities include establishing the FDA Rare Neurodegenerative Diseases Task Force and the public-private partnership for rare neurodegenerative diseases, developing disease-specific science strategies over the next 5 years, and leveraging ongoing FDA regulatory science efforts.
The ALS Science Strategy is part of the plan focused specifically on ALS. It provides a “forward-leaning” framework for FDA activities, which include efforts to improve characterization of disease pathogenesis and natural history, boost clinical trial infrastructure and agility to enable early selection of promising therapeutic candidates for further development, optimize clinical trial design, improve access to the trials, streamline clinical trial operations, and reduce the time and cost of drug development.
The FDA says patient engagement, public workshops, research projects, coordination across FDA centers and offices, and collaboration with the National Institutes of Health will be key to the success of implementation of the ALS Science Strategy.
A version of this article first appeared on Medscape.com.
‘Unexpected’: Breast cancer spreads most during sleep
a discovery the investigators called “striking and unexpected.”
“This has not been shown before [and] we were surprised, indeed,” Nicola Aceto, PhD, professor of molecular oncology, Swiss Federal Institute of Technology Zürich, said in an interview.
The findings carry potential implications for the timing of biopsy and treatment of metastasis-prone cancers, the authors said.
The study was published online in Nature.
Circulating tumor cells (CTCs) are generally believed to shed constantly or following particular events such as surgery or physical activity; however, the processes that regulate tumor cell metastasis and how circadian rhythms may play into tumorigenesis remain unclear.
To better understand these processes, Dr. Aceto and colleagues collected blood samples from 30 women with breast cancer at 4:00 a.m. and 10:00 a.m. – times representing the body’s resting and active phases, respectively.
The researchers observed that more than 78% of all CTCs obtained were from samples taken during the resting phase.
This finding is astounding, Harrison Ball, a PhD candidate, and Sunitha Nagrath, PhD, with the University of Michigan, Ann Arbor, wrote in Nature News & Views .
Dr. Aceto and colleagues also found that CTCs generated at night divide more quickly and therefore have a higher potential to metastasize, compared with those generated during the day, which “are devoid of metastatic ability,” according to the authors, who obtained similar results in a series of mouse models.
The team also observed that key circadian rhythm hormones (such as melatonin, testosterone, and glucocorticoids) regulate CTC generation, and insulin promotes tumor cell proliferation in a time-dependent manner, suggesting a “need for time-controlled approaches for the characterization and treatment of breast cancer,” the authors wrote.
Practice changing?
Dr. Ball and Dr. Nagrath said the time-dependent nature of CTC dynamics could very well transform how cancer patients are assessed and treated.
“The data pointing to CTC proliferation and release during the rest phase suggest that doctors might need to become more conscious of when to administer specific treatments,” they wrote.
Both cautioned, however, that large clinical trials would be needed before any consideration of circadian rhythms is incorporated into standard practice. It’s also unclear whether these results in breast cancer hold true for other tumor types.
Mariana G. Figueiro, PhD, who was not involved in the research, agreed that, if studies confirm more metastatic spread at night, “there is an opportunity to treat patients at strategic times.”
Dr. Figueiro, of the Icahn School of Medicine at Mount Sinai, New York, also saw a potential impact on the timing of blood draws. “I think tightening up on how people do biopsies and bloodwork based on circadian time is important.”
Marleen Meyers, MD, agreed that these findings could have many clinical implications.
“The most obvious is that the time of day [that] treatment is administered may influence efficacy,” said Dr. Meyers, clinical professor of medicine at New York University Langone’s Perlmutter Cancer Center.
But, Dr. Meyers noted, the benefits of treating someone at night would need to be weighed against the downsides of interrupting a person’s normal sleep-wake cycle. “If this finding is clinically important it will be a challenge incorporating this into clinical care,” she said.
The study had no funding reported. Dr. Aceto is a cofounder and member of the board of PAGE Therapeutics, listed as an inventor in patent applications related to circulating tumor cells, a paid consultant for several companies, and a Novartis shareholder. One coauthor is a cofounder of PAGE Therapeutics. All other authors declare no competing interests. Dr. Meyers and Dr. Figueiro reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
a discovery the investigators called “striking and unexpected.”
“This has not been shown before [and] we were surprised, indeed,” Nicola Aceto, PhD, professor of molecular oncology, Swiss Federal Institute of Technology Zürich, said in an interview.
The findings carry potential implications for the timing of biopsy and treatment of metastasis-prone cancers, the authors said.
The study was published online in Nature.
Circulating tumor cells (CTCs) are generally believed to shed constantly or following particular events such as surgery or physical activity; however, the processes that regulate tumor cell metastasis and how circadian rhythms may play into tumorigenesis remain unclear.
To better understand these processes, Dr. Aceto and colleagues collected blood samples from 30 women with breast cancer at 4:00 a.m. and 10:00 a.m. – times representing the body’s resting and active phases, respectively.
The researchers observed that more than 78% of all CTCs obtained were from samples taken during the resting phase.
This finding is astounding, Harrison Ball, a PhD candidate, and Sunitha Nagrath, PhD, with the University of Michigan, Ann Arbor, wrote in Nature News & Views .
Dr. Aceto and colleagues also found that CTCs generated at night divide more quickly and therefore have a higher potential to metastasize, compared with those generated during the day, which “are devoid of metastatic ability,” according to the authors, who obtained similar results in a series of mouse models.
The team also observed that key circadian rhythm hormones (such as melatonin, testosterone, and glucocorticoids) regulate CTC generation, and insulin promotes tumor cell proliferation in a time-dependent manner, suggesting a “need for time-controlled approaches for the characterization and treatment of breast cancer,” the authors wrote.
Practice changing?
Dr. Ball and Dr. Nagrath said the time-dependent nature of CTC dynamics could very well transform how cancer patients are assessed and treated.
“The data pointing to CTC proliferation and release during the rest phase suggest that doctors might need to become more conscious of when to administer specific treatments,” they wrote.
Both cautioned, however, that large clinical trials would be needed before any consideration of circadian rhythms is incorporated into standard practice. It’s also unclear whether these results in breast cancer hold true for other tumor types.
Mariana G. Figueiro, PhD, who was not involved in the research, agreed that, if studies confirm more metastatic spread at night, “there is an opportunity to treat patients at strategic times.”
Dr. Figueiro, of the Icahn School of Medicine at Mount Sinai, New York, also saw a potential impact on the timing of blood draws. “I think tightening up on how people do biopsies and bloodwork based on circadian time is important.”
Marleen Meyers, MD, agreed that these findings could have many clinical implications.
“The most obvious is that the time of day [that] treatment is administered may influence efficacy,” said Dr. Meyers, clinical professor of medicine at New York University Langone’s Perlmutter Cancer Center.
But, Dr. Meyers noted, the benefits of treating someone at night would need to be weighed against the downsides of interrupting a person’s normal sleep-wake cycle. “If this finding is clinically important it will be a challenge incorporating this into clinical care,” she said.
The study had no funding reported. Dr. Aceto is a cofounder and member of the board of PAGE Therapeutics, listed as an inventor in patent applications related to circulating tumor cells, a paid consultant for several companies, and a Novartis shareholder. One coauthor is a cofounder of PAGE Therapeutics. All other authors declare no competing interests. Dr. Meyers and Dr. Figueiro reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
a discovery the investigators called “striking and unexpected.”
“This has not been shown before [and] we were surprised, indeed,” Nicola Aceto, PhD, professor of molecular oncology, Swiss Federal Institute of Technology Zürich, said in an interview.
The findings carry potential implications for the timing of biopsy and treatment of metastasis-prone cancers, the authors said.
The study was published online in Nature.
Circulating tumor cells (CTCs) are generally believed to shed constantly or following particular events such as surgery or physical activity; however, the processes that regulate tumor cell metastasis and how circadian rhythms may play into tumorigenesis remain unclear.
To better understand these processes, Dr. Aceto and colleagues collected blood samples from 30 women with breast cancer at 4:00 a.m. and 10:00 a.m. – times representing the body’s resting and active phases, respectively.
The researchers observed that more than 78% of all CTCs obtained were from samples taken during the resting phase.
This finding is astounding, Harrison Ball, a PhD candidate, and Sunitha Nagrath, PhD, with the University of Michigan, Ann Arbor, wrote in Nature News & Views .
Dr. Aceto and colleagues also found that CTCs generated at night divide more quickly and therefore have a higher potential to metastasize, compared with those generated during the day, which “are devoid of metastatic ability,” according to the authors, who obtained similar results in a series of mouse models.
The team also observed that key circadian rhythm hormones (such as melatonin, testosterone, and glucocorticoids) regulate CTC generation, and insulin promotes tumor cell proliferation in a time-dependent manner, suggesting a “need for time-controlled approaches for the characterization and treatment of breast cancer,” the authors wrote.
Practice changing?
Dr. Ball and Dr. Nagrath said the time-dependent nature of CTC dynamics could very well transform how cancer patients are assessed and treated.
“The data pointing to CTC proliferation and release during the rest phase suggest that doctors might need to become more conscious of when to administer specific treatments,” they wrote.
Both cautioned, however, that large clinical trials would be needed before any consideration of circadian rhythms is incorporated into standard practice. It’s also unclear whether these results in breast cancer hold true for other tumor types.
Mariana G. Figueiro, PhD, who was not involved in the research, agreed that, if studies confirm more metastatic spread at night, “there is an opportunity to treat patients at strategic times.”
Dr. Figueiro, of the Icahn School of Medicine at Mount Sinai, New York, also saw a potential impact on the timing of blood draws. “I think tightening up on how people do biopsies and bloodwork based on circadian time is important.”
Marleen Meyers, MD, agreed that these findings could have many clinical implications.
“The most obvious is that the time of day [that] treatment is administered may influence efficacy,” said Dr. Meyers, clinical professor of medicine at New York University Langone’s Perlmutter Cancer Center.
But, Dr. Meyers noted, the benefits of treating someone at night would need to be weighed against the downsides of interrupting a person’s normal sleep-wake cycle. “If this finding is clinically important it will be a challenge incorporating this into clinical care,” she said.
The study had no funding reported. Dr. Aceto is a cofounder and member of the board of PAGE Therapeutics, listed as an inventor in patent applications related to circulating tumor cells, a paid consultant for several companies, and a Novartis shareholder. One coauthor is a cofounder of PAGE Therapeutics. All other authors declare no competing interests. Dr. Meyers and Dr. Figueiro reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM NATURE
Jury out on low-FODMAP diet for kids
There is scarce evidence to support the use of a FODMAP-lowering diet for children with irritable bowel syndrome (IBS), and there is no evidence to recommend its use for other gastrointestinal (GI) diseases and complaints in children, according to a position paper from the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN).
A low-FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet is increasingly being used to treat children with various GI complaints and disorders.
“Awareness of how and when to use the diet is crucial, as a restrictive diet may impact nutritional adequacy and/or promote distorted eating in vulnerable subjects,” the authors note.
Rut Anne Thomassen, department of pediatric medicine, Oslo University Hospital, and an international team of experts conducted a systematic literature review of the evidence on the safety and efficacy of the low-FODMAP diet in children.
The low-FODMAP diet has not been well studied in children, they report.
From 53 publications and registers that they screened, only seven studies (four randomized clinical trials and three interventions without control group or observational studies) were included in their assessment.
In the seven studies, only 111 children received the low-FODMAP diet, while 85 followed a control diet for comparison (a diet described as healthy, usual, or typical American diet for children).
All of the pediatric studies focused on functional abdominal pain disorders. None addressed nonceliac gluten sensitivity, small-intestinal bacterial overgrowth, or inflammatory bowel disease.
From their review, the authors conclude that, at present, there is “insufficient evidence” to routinely recommend the low-FODMAP diet for the treatment of functional GI disorders, nonceliac gluten sensitivity, inflammatory bowel diseases, or small-intestinal bacterial overgrowth in children.
When the low-FODMAP diet is considered for children, the authors recommend a thorough clinical history, physical examination, and assessment of nutritional status and GI symptoms by a multidisciplinary team.
“Ideally, a standardized questionnaire should be used before and following the start of the diet to assess objectively the effect of the low-FODMAP diet,” the authors advise.
A dietitian should assess the child’s diet to highlight any potential deficiencies, which could be exacerbated by the restrictions of the low-FODMAP diet.
To promote adherence to the diet, potential difficulties, such as how to provide a suitable lunch at school or what to do when the child is staying at a friend’s house, should be addressed.
The authors suggest providing parents with written information about sources of FODMAPs and suitable replacement foods. Offering meal plans can reduce the risk of diet mistakes as well as the risk of offering a diet insufficient in essential nutrients, they say.
‘Useful paper’
“This is a useful paper primarily to outline the paucity of data regarding dietary therapies in children and the importance of doing studies in this population,” Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, who wasn’t involved in the research, told this news organization.
Samuel Nurko, MD, MPH, director of the Center for Motility and Functional Gastrointestinal Disorders at Boston Children’s Hospital, Massachusetts, noted that some studies have shown that a low-FODMAP diet can be effective in controlling symptoms for both adults and kids.
“The problem in kids is that the trials are very small, and there’s not a lot of them, so the evidence is limited,” said Dr. Nurko, who wasn’t involved in writing the position paper.
That’s not to say that it should not be tried in appropriate cases. “There’s no question that in some patients, taking away the FODMAPs gives them a big improvement in GI symptoms,” Dr. Nurko told this news organization.
“The problem with the low-FODMAP diet is, if you don’t do it right, then you get into trouble with nutritional deficiencies,” he cautioned.
“If you are going to try the low-FODMAP diet, it has to be short, no more than 4-6 weeks, and you need to do a top-down approach. Take FODMAPs out, and then start to reintroduce them. Either kids will respond to the diet, or they won’t. If they don’t, there is no reason to keep them on the diet. It’s a very hard diet to take,” Dr. Nurko said.
No source of funding for the study was disclosed. The authors, Dr. Ananthakrishnan, and Dr. Nurko have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
There is scarce evidence to support the use of a FODMAP-lowering diet for children with irritable bowel syndrome (IBS), and there is no evidence to recommend its use for other gastrointestinal (GI) diseases and complaints in children, according to a position paper from the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN).
A low-FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet is increasingly being used to treat children with various GI complaints and disorders.
“Awareness of how and when to use the diet is crucial, as a restrictive diet may impact nutritional adequacy and/or promote distorted eating in vulnerable subjects,” the authors note.
Rut Anne Thomassen, department of pediatric medicine, Oslo University Hospital, and an international team of experts conducted a systematic literature review of the evidence on the safety and efficacy of the low-FODMAP diet in children.
The low-FODMAP diet has not been well studied in children, they report.
From 53 publications and registers that they screened, only seven studies (four randomized clinical trials and three interventions without control group or observational studies) were included in their assessment.
In the seven studies, only 111 children received the low-FODMAP diet, while 85 followed a control diet for comparison (a diet described as healthy, usual, or typical American diet for children).
All of the pediatric studies focused on functional abdominal pain disorders. None addressed nonceliac gluten sensitivity, small-intestinal bacterial overgrowth, or inflammatory bowel disease.
From their review, the authors conclude that, at present, there is “insufficient evidence” to routinely recommend the low-FODMAP diet for the treatment of functional GI disorders, nonceliac gluten sensitivity, inflammatory bowel diseases, or small-intestinal bacterial overgrowth in children.
When the low-FODMAP diet is considered for children, the authors recommend a thorough clinical history, physical examination, and assessment of nutritional status and GI symptoms by a multidisciplinary team.
“Ideally, a standardized questionnaire should be used before and following the start of the diet to assess objectively the effect of the low-FODMAP diet,” the authors advise.
A dietitian should assess the child’s diet to highlight any potential deficiencies, which could be exacerbated by the restrictions of the low-FODMAP diet.
To promote adherence to the diet, potential difficulties, such as how to provide a suitable lunch at school or what to do when the child is staying at a friend’s house, should be addressed.
The authors suggest providing parents with written information about sources of FODMAPs and suitable replacement foods. Offering meal plans can reduce the risk of diet mistakes as well as the risk of offering a diet insufficient in essential nutrients, they say.
‘Useful paper’
“This is a useful paper primarily to outline the paucity of data regarding dietary therapies in children and the importance of doing studies in this population,” Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, who wasn’t involved in the research, told this news organization.
Samuel Nurko, MD, MPH, director of the Center for Motility and Functional Gastrointestinal Disorders at Boston Children’s Hospital, Massachusetts, noted that some studies have shown that a low-FODMAP diet can be effective in controlling symptoms for both adults and kids.
“The problem in kids is that the trials are very small, and there’s not a lot of them, so the evidence is limited,” said Dr. Nurko, who wasn’t involved in writing the position paper.
That’s not to say that it should not be tried in appropriate cases. “There’s no question that in some patients, taking away the FODMAPs gives them a big improvement in GI symptoms,” Dr. Nurko told this news organization.
“The problem with the low-FODMAP diet is, if you don’t do it right, then you get into trouble with nutritional deficiencies,” he cautioned.
“If you are going to try the low-FODMAP diet, it has to be short, no more than 4-6 weeks, and you need to do a top-down approach. Take FODMAPs out, and then start to reintroduce them. Either kids will respond to the diet, or they won’t. If they don’t, there is no reason to keep them on the diet. It’s a very hard diet to take,” Dr. Nurko said.
No source of funding for the study was disclosed. The authors, Dr. Ananthakrishnan, and Dr. Nurko have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
There is scarce evidence to support the use of a FODMAP-lowering diet for children with irritable bowel syndrome (IBS), and there is no evidence to recommend its use for other gastrointestinal (GI) diseases and complaints in children, according to a position paper from the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN).
A low-FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet is increasingly being used to treat children with various GI complaints and disorders.
“Awareness of how and when to use the diet is crucial, as a restrictive diet may impact nutritional adequacy and/or promote distorted eating in vulnerable subjects,” the authors note.
Rut Anne Thomassen, department of pediatric medicine, Oslo University Hospital, and an international team of experts conducted a systematic literature review of the evidence on the safety and efficacy of the low-FODMAP diet in children.
The low-FODMAP diet has not been well studied in children, they report.
From 53 publications and registers that they screened, only seven studies (four randomized clinical trials and three interventions without control group or observational studies) were included in their assessment.
In the seven studies, only 111 children received the low-FODMAP diet, while 85 followed a control diet for comparison (a diet described as healthy, usual, or typical American diet for children).
All of the pediatric studies focused on functional abdominal pain disorders. None addressed nonceliac gluten sensitivity, small-intestinal bacterial overgrowth, or inflammatory bowel disease.
From their review, the authors conclude that, at present, there is “insufficient evidence” to routinely recommend the low-FODMAP diet for the treatment of functional GI disorders, nonceliac gluten sensitivity, inflammatory bowel diseases, or small-intestinal bacterial overgrowth in children.
When the low-FODMAP diet is considered for children, the authors recommend a thorough clinical history, physical examination, and assessment of nutritional status and GI symptoms by a multidisciplinary team.
“Ideally, a standardized questionnaire should be used before and following the start of the diet to assess objectively the effect of the low-FODMAP diet,” the authors advise.
A dietitian should assess the child’s diet to highlight any potential deficiencies, which could be exacerbated by the restrictions of the low-FODMAP diet.
To promote adherence to the diet, potential difficulties, such as how to provide a suitable lunch at school or what to do when the child is staying at a friend’s house, should be addressed.
The authors suggest providing parents with written information about sources of FODMAPs and suitable replacement foods. Offering meal plans can reduce the risk of diet mistakes as well as the risk of offering a diet insufficient in essential nutrients, they say.
‘Useful paper’
“This is a useful paper primarily to outline the paucity of data regarding dietary therapies in children and the importance of doing studies in this population,” Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, who wasn’t involved in the research, told this news organization.
Samuel Nurko, MD, MPH, director of the Center for Motility and Functional Gastrointestinal Disorders at Boston Children’s Hospital, Massachusetts, noted that some studies have shown that a low-FODMAP diet can be effective in controlling symptoms for both adults and kids.
“The problem in kids is that the trials are very small, and there’s not a lot of them, so the evidence is limited,” said Dr. Nurko, who wasn’t involved in writing the position paper.
That’s not to say that it should not be tried in appropriate cases. “There’s no question that in some patients, taking away the FODMAPs gives them a big improvement in GI symptoms,” Dr. Nurko told this news organization.
“The problem with the low-FODMAP diet is, if you don’t do it right, then you get into trouble with nutritional deficiencies,” he cautioned.
“If you are going to try the low-FODMAP diet, it has to be short, no more than 4-6 weeks, and you need to do a top-down approach. Take FODMAPs out, and then start to reintroduce them. Either kids will respond to the diet, or they won’t. If they don’t, there is no reason to keep them on the diet. It’s a very hard diet to take,” Dr. Nurko said.
No source of funding for the study was disclosed. The authors, Dr. Ananthakrishnan, and Dr. Nurko have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
$150K: Average industry payment to top 1% of oncologists
A small number of U.S. medical oncologists make more than $100,000 a year in general payments from drug companies, a new study shows.
These high-payment physicians represent just 1% of all U.S. medical oncologists, yet they account for 37% of industry payments. These oncologists often hold important leadership positions, draft treatment guidelines, and sit on journal editorial boards.
The findings highlight a risk for “perceived and real conflict of interest,” corresponding author Christopher Booth, MD, of Queen’s University Cancer Research Center, Kingston, Ont., said in an interview. “Because of the leadership positions they hold, the potential impact of this small group of physicians on oncology practice and policy may be substantial.”
The study was published online in JCO Oncology Practice.
‘We have a problem’
It’s no secret that many oncologists have financial relationships with pharmaceutical companies. They receive payments for research initiatives, but they also receive more general, personal payments in the form of honoraria, consultant fees, gifts, and reimbursement for travel and meals.
Prior studies have shown that these payments are typically modest, but a small subset of medical oncologists receive more than $100,000 annually. Dr. Booth and colleagues wanted to know more about the characteristics of these “high-payment” oncologists.
Using the national Open Payments database, the researchers identified a total of 139 medical oncologists who practice in the United States and who received $100,000 or more in general payments linked to cancer medications in 2018.
In U.S. dollars, the median payment was $154,613, and the total was $24.2 million.
The majority (95%) of high-payment oncologists were active in clinical work, 56% worked in an academic setting, 31% worked at National Cancer Institute–designated cancer centers, and 23% worked at National Comprehensive Cancer Network (NCCN) centers.
Many were based in California (17%), Texas (12%), Florida (10%), and New York (8%).
Most currently hold or have held hospital leadership positions (60%) or faculty appointments (72%) and 21% have held leadership positions in specialty associations in the past 5 years. Nearly one-quarter (24%) have served on journal editorial boards, and 10% have authored clinical practice guidelines in the past 5 years.
More specifically, three physicians authored NCCN guidelines, and two authored American Society of Clinical Oncology guidelines during 2016-2021; one guideline was published in 2018 when payments were made.
“Oncology specialty associations, guideline panels, and journal editorial boards should reconsider if it is appropriate for physicians with such large payments to hold these high-profile positions,” Dr. Booth said.
Following publication of the study, some oncologists took to Twitter with reactions, including Manni Mohyuddin, MD (@ManniMD1), from the Huntsman Cancer Institute, University of Utah, Salt Lake City, who wrote: “I recognize that some conflict of interest ‘may’ be unavoidable in order to run trials. But when greater than TWICE the average American household annual salary is taken in payments from industry by those in leadership/editorial roles, we have a problem.”
Weighing in on the results, ASCO CEO Clifford A. Hudis, MD, told this news organization that the “limitations of the study make it difficult to draw conclusions about the scope or potential impact of these payments on care.”
For example, he explained, some payments attributed to individuals may have been made directly to the physicians’ institutions or employers for sponsored research expenses.
Dr. Hudis also noted that the payments examined in the study were made in 2018, whereas the potentially relevant leadership positions could have been attained at a different time.
Furthermore, in 2020, an editorial appeared in Cancer, showing that errors in Open Payments are “fairly common,” Dr. Hudis said. It’s also unclear whether the reported financial relationships were appropriately disclosed and were managed at the time under relevant conflict of interest policies, he said.
“The question left unanswered by this study is whether or not these relationships influence patient care,” said Dr. Hudis. He noted that decisions about care should come from physicians and patients who are informed of the best available, unbiased, peer-reviewed, scientific evidence.
“The potential impact of financial conflicts of interest on this effort is an issue of concern, even if this study does not directly address it,” Dr. Hudis said.
The study had no specific funding. Dr. Booth has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article. Dr. Hudis has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A small number of U.S. medical oncologists make more than $100,000 a year in general payments from drug companies, a new study shows.
These high-payment physicians represent just 1% of all U.S. medical oncologists, yet they account for 37% of industry payments. These oncologists often hold important leadership positions, draft treatment guidelines, and sit on journal editorial boards.
The findings highlight a risk for “perceived and real conflict of interest,” corresponding author Christopher Booth, MD, of Queen’s University Cancer Research Center, Kingston, Ont., said in an interview. “Because of the leadership positions they hold, the potential impact of this small group of physicians on oncology practice and policy may be substantial.”
The study was published online in JCO Oncology Practice.
‘We have a problem’
It’s no secret that many oncologists have financial relationships with pharmaceutical companies. They receive payments for research initiatives, but they also receive more general, personal payments in the form of honoraria, consultant fees, gifts, and reimbursement for travel and meals.
Prior studies have shown that these payments are typically modest, but a small subset of medical oncologists receive more than $100,000 annually. Dr. Booth and colleagues wanted to know more about the characteristics of these “high-payment” oncologists.
Using the national Open Payments database, the researchers identified a total of 139 medical oncologists who practice in the United States and who received $100,000 or more in general payments linked to cancer medications in 2018.
In U.S. dollars, the median payment was $154,613, and the total was $24.2 million.
The majority (95%) of high-payment oncologists were active in clinical work, 56% worked in an academic setting, 31% worked at National Cancer Institute–designated cancer centers, and 23% worked at National Comprehensive Cancer Network (NCCN) centers.
Many were based in California (17%), Texas (12%), Florida (10%), and New York (8%).
Most currently hold or have held hospital leadership positions (60%) or faculty appointments (72%) and 21% have held leadership positions in specialty associations in the past 5 years. Nearly one-quarter (24%) have served on journal editorial boards, and 10% have authored clinical practice guidelines in the past 5 years.
More specifically, three physicians authored NCCN guidelines, and two authored American Society of Clinical Oncology guidelines during 2016-2021; one guideline was published in 2018 when payments were made.
“Oncology specialty associations, guideline panels, and journal editorial boards should reconsider if it is appropriate for physicians with such large payments to hold these high-profile positions,” Dr. Booth said.
Following publication of the study, some oncologists took to Twitter with reactions, including Manni Mohyuddin, MD (@ManniMD1), from the Huntsman Cancer Institute, University of Utah, Salt Lake City, who wrote: “I recognize that some conflict of interest ‘may’ be unavoidable in order to run trials. But when greater than TWICE the average American household annual salary is taken in payments from industry by those in leadership/editorial roles, we have a problem.”
Weighing in on the results, ASCO CEO Clifford A. Hudis, MD, told this news organization that the “limitations of the study make it difficult to draw conclusions about the scope or potential impact of these payments on care.”
For example, he explained, some payments attributed to individuals may have been made directly to the physicians’ institutions or employers for sponsored research expenses.
Dr. Hudis also noted that the payments examined in the study were made in 2018, whereas the potentially relevant leadership positions could have been attained at a different time.
Furthermore, in 2020, an editorial appeared in Cancer, showing that errors in Open Payments are “fairly common,” Dr. Hudis said. It’s also unclear whether the reported financial relationships were appropriately disclosed and were managed at the time under relevant conflict of interest policies, he said.
“The question left unanswered by this study is whether or not these relationships influence patient care,” said Dr. Hudis. He noted that decisions about care should come from physicians and patients who are informed of the best available, unbiased, peer-reviewed, scientific evidence.
“The potential impact of financial conflicts of interest on this effort is an issue of concern, even if this study does not directly address it,” Dr. Hudis said.
The study had no specific funding. Dr. Booth has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article. Dr. Hudis has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A small number of U.S. medical oncologists make more than $100,000 a year in general payments from drug companies, a new study shows.
These high-payment physicians represent just 1% of all U.S. medical oncologists, yet they account for 37% of industry payments. These oncologists often hold important leadership positions, draft treatment guidelines, and sit on journal editorial boards.
The findings highlight a risk for “perceived and real conflict of interest,” corresponding author Christopher Booth, MD, of Queen’s University Cancer Research Center, Kingston, Ont., said in an interview. “Because of the leadership positions they hold, the potential impact of this small group of physicians on oncology practice and policy may be substantial.”
The study was published online in JCO Oncology Practice.
‘We have a problem’
It’s no secret that many oncologists have financial relationships with pharmaceutical companies. They receive payments for research initiatives, but they also receive more general, personal payments in the form of honoraria, consultant fees, gifts, and reimbursement for travel and meals.
Prior studies have shown that these payments are typically modest, but a small subset of medical oncologists receive more than $100,000 annually. Dr. Booth and colleagues wanted to know more about the characteristics of these “high-payment” oncologists.
Using the national Open Payments database, the researchers identified a total of 139 medical oncologists who practice in the United States and who received $100,000 or more in general payments linked to cancer medications in 2018.
In U.S. dollars, the median payment was $154,613, and the total was $24.2 million.
The majority (95%) of high-payment oncologists were active in clinical work, 56% worked in an academic setting, 31% worked at National Cancer Institute–designated cancer centers, and 23% worked at National Comprehensive Cancer Network (NCCN) centers.
Many were based in California (17%), Texas (12%), Florida (10%), and New York (8%).
Most currently hold or have held hospital leadership positions (60%) or faculty appointments (72%) and 21% have held leadership positions in specialty associations in the past 5 years. Nearly one-quarter (24%) have served on journal editorial boards, and 10% have authored clinical practice guidelines in the past 5 years.
More specifically, three physicians authored NCCN guidelines, and two authored American Society of Clinical Oncology guidelines during 2016-2021; one guideline was published in 2018 when payments were made.
“Oncology specialty associations, guideline panels, and journal editorial boards should reconsider if it is appropriate for physicians with such large payments to hold these high-profile positions,” Dr. Booth said.
Following publication of the study, some oncologists took to Twitter with reactions, including Manni Mohyuddin, MD (@ManniMD1), from the Huntsman Cancer Institute, University of Utah, Salt Lake City, who wrote: “I recognize that some conflict of interest ‘may’ be unavoidable in order to run trials. But when greater than TWICE the average American household annual salary is taken in payments from industry by those in leadership/editorial roles, we have a problem.”
Weighing in on the results, ASCO CEO Clifford A. Hudis, MD, told this news organization that the “limitations of the study make it difficult to draw conclusions about the scope or potential impact of these payments on care.”
For example, he explained, some payments attributed to individuals may have been made directly to the physicians’ institutions or employers for sponsored research expenses.
Dr. Hudis also noted that the payments examined in the study were made in 2018, whereas the potentially relevant leadership positions could have been attained at a different time.
Furthermore, in 2020, an editorial appeared in Cancer, showing that errors in Open Payments are “fairly common,” Dr. Hudis said. It’s also unclear whether the reported financial relationships were appropriately disclosed and were managed at the time under relevant conflict of interest policies, he said.
“The question left unanswered by this study is whether or not these relationships influence patient care,” said Dr. Hudis. He noted that decisions about care should come from physicians and patients who are informed of the best available, unbiased, peer-reviewed, scientific evidence.
“The potential impact of financial conflicts of interest on this effort is an issue of concern, even if this study does not directly address it,” Dr. Hudis said.
The study had no specific funding. Dr. Booth has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article. Dr. Hudis has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JCO ONCOLOGY PRACTICE