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Upping CO2 does not benefit OHCA patients: TAME
The Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest (TAME) study showed that the intervention failed to improve neurologic or functional outcomes or quality of life at 6 months. However, the researchers also found that slightly elevated CO2 levels were not associated with worse outcomes.
“I think these results show that our hypothesis – that raising CO2 levels as applied in this trial may be beneficial for these patients – was not effective, even though previous work suggested that it would be,” co–lead investigator Alistair Nichol, MD, said in an interview.
“This was a rigorous trial; the intervention was well delivered, and the results are pretty clear. Unfortunately, we have proved a null hypothesis – that this approach doesn’t seem to work,” Dr. Nichol, who is professor of critical care medicine at University College Dublin, said.
“However, we did find that hypercapnia was safe. This is an important finding, as sometimes in very sick patients such as those who develop pneumonia, we have to drive the ventilator less hard to minimize injury to the lungs, and this can lead to higher CO2 levels,” he added. “Our results show that this practice should not be harmful, which is reassuring.”
The TAME study was presented at the Critical Care Reviews 2023 Meeting (CCR23) held in Belfast, Northern Ireland.
It was simultaneously published online in the New England Journal of Medicine.
The researchers explain that after the return of spontaneous circulation, brain hypoperfusion may contribute to cerebral hypoxia, exacerbate brain damage, and lead to poor neurologic outcomes. The partial pressure of arterial carbon dioxide (PaCO2) is the major physiologic regulator of cerebrovascular tone, and increasing CO2 levels increases cerebral blood flow.
Two previous observational studies showed that exposure to hypercapnia was associated with an increase in the likelihood of being discharged home and better neurologic outcomes at 12 months, compared with hypocapnia or normocapnia.
In addition, a physiologic study showed that deliberate increases in PaCO2 induced higher cerebral oxygen saturations, compared with normocapnia. A phase 2 randomized trial showed that hypercapnia significantly attenuated the release of neuron-specific enolase, a biomarker of brain injury, and also suggested better 6-month neurologic recovery with hypercapnia compared with normocapnia.
The current TAME trial was conducted to try to confirm these results in a larger, more definitive study.
For the trial, 1,700 adults with coma who had been resuscitated after out-of-hospital cardiac arrest were randomly assigned to receive either 24 hours of mild hypercapnia (target PaCO2, 50-55 mm Hg) or normocapnia (target PaCO2, 35-45 mm Hg).
The primary outcome – a favorable neurologic outcome, defined as a score of 5 or higher on the Glasgow Outcome Scale–Extended at 6 months – occurred in 43.5% in the mild hypercapnia group and in 44.6% in the normocapnia group (relative risk, 0.98; P = .76).
By 6 months, 48.2% of those in the mild hypercapnia group and 45.9% in the normocapnia group had died (relative risk with mild hypercapnia, 1.05; 95% confidence interval, 0.94-1.16). In the mild hypercapnia group, 53.4% had a poor functional outcome, defined as a Modified Rankin Scale score of 4-6, compared with 51.3% in the normocapnia group.
Health-related quality of life, as assessed by the EQ Visual Analogue Scale component of the EuroQol-5D-5L, was similar in the two groups.
In terms of safety, results showed that mild hypercapnia did not increase the incidence of prespecified adverse events.
The authors note that there is concern that mild hypercapnia may worsen cerebral edema and elevate intracranial pressure; however, elevated intracranial pressure is uncommon in the first 72 hours after the return of spontaneous circulation.
In the TAME trial, there was one case of cerebral edema in the hypercapnia group. “This is a very low rate and would be expected in a group this size, so this does not indicate a safety concern,” Dr. Nichol commented.
The researchers are planning further analyses of biological samples to look for possible prognostic markers.
“These out-of-hospital cardiac arrest patients are a very diverse group, and it may be possible that some patients could have benefited from hypercapnia while others may have been harmed,” Dr. Nichol noted.
“Raising CO2 levels does improve overall delivery of oxygen to the brain, but this might not have occurred in the right areas. It may be possible that some patients benefited, and analysis of biological samples will help us look more closely at this.”
He added that other ongoing trials are investigating hypercapnia in patients with traumatic brain injury.
“These patients are managed differently and often have probes in their brain to measure the response to CO2, so more of a precision medicine approach is possible,” he explained.
He also noted that the TAME study, which was conducted in conjunction with the TTM-2 study investigating hypothermia in out-of-hospital cardiac arrest patients, has established a network of ICU teams around the world, providing an infrastructure for further trials to be performed in this patient population in the future.
The TAME trial was funded by the National Health and Medical Research Council of Australia, the Health Research Board of Ireland, and the Health Research Council of New Zealand.
A version of this article originally appeared on Medscape.com.
The Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest (TAME) study showed that the intervention failed to improve neurologic or functional outcomes or quality of life at 6 months. However, the researchers also found that slightly elevated CO2 levels were not associated with worse outcomes.
“I think these results show that our hypothesis – that raising CO2 levels as applied in this trial may be beneficial for these patients – was not effective, even though previous work suggested that it would be,” co–lead investigator Alistair Nichol, MD, said in an interview.
“This was a rigorous trial; the intervention was well delivered, and the results are pretty clear. Unfortunately, we have proved a null hypothesis – that this approach doesn’t seem to work,” Dr. Nichol, who is professor of critical care medicine at University College Dublin, said.
“However, we did find that hypercapnia was safe. This is an important finding, as sometimes in very sick patients such as those who develop pneumonia, we have to drive the ventilator less hard to minimize injury to the lungs, and this can lead to higher CO2 levels,” he added. “Our results show that this practice should not be harmful, which is reassuring.”
The TAME study was presented at the Critical Care Reviews 2023 Meeting (CCR23) held in Belfast, Northern Ireland.
It was simultaneously published online in the New England Journal of Medicine.
The researchers explain that after the return of spontaneous circulation, brain hypoperfusion may contribute to cerebral hypoxia, exacerbate brain damage, and lead to poor neurologic outcomes. The partial pressure of arterial carbon dioxide (PaCO2) is the major physiologic regulator of cerebrovascular tone, and increasing CO2 levels increases cerebral blood flow.
Two previous observational studies showed that exposure to hypercapnia was associated with an increase in the likelihood of being discharged home and better neurologic outcomes at 12 months, compared with hypocapnia or normocapnia.
In addition, a physiologic study showed that deliberate increases in PaCO2 induced higher cerebral oxygen saturations, compared with normocapnia. A phase 2 randomized trial showed that hypercapnia significantly attenuated the release of neuron-specific enolase, a biomarker of brain injury, and also suggested better 6-month neurologic recovery with hypercapnia compared with normocapnia.
The current TAME trial was conducted to try to confirm these results in a larger, more definitive study.
For the trial, 1,700 adults with coma who had been resuscitated after out-of-hospital cardiac arrest were randomly assigned to receive either 24 hours of mild hypercapnia (target PaCO2, 50-55 mm Hg) or normocapnia (target PaCO2, 35-45 mm Hg).
The primary outcome – a favorable neurologic outcome, defined as a score of 5 or higher on the Glasgow Outcome Scale–Extended at 6 months – occurred in 43.5% in the mild hypercapnia group and in 44.6% in the normocapnia group (relative risk, 0.98; P = .76).
By 6 months, 48.2% of those in the mild hypercapnia group and 45.9% in the normocapnia group had died (relative risk with mild hypercapnia, 1.05; 95% confidence interval, 0.94-1.16). In the mild hypercapnia group, 53.4% had a poor functional outcome, defined as a Modified Rankin Scale score of 4-6, compared with 51.3% in the normocapnia group.
Health-related quality of life, as assessed by the EQ Visual Analogue Scale component of the EuroQol-5D-5L, was similar in the two groups.
In terms of safety, results showed that mild hypercapnia did not increase the incidence of prespecified adverse events.
The authors note that there is concern that mild hypercapnia may worsen cerebral edema and elevate intracranial pressure; however, elevated intracranial pressure is uncommon in the first 72 hours after the return of spontaneous circulation.
In the TAME trial, there was one case of cerebral edema in the hypercapnia group. “This is a very low rate and would be expected in a group this size, so this does not indicate a safety concern,” Dr. Nichol commented.
The researchers are planning further analyses of biological samples to look for possible prognostic markers.
“These out-of-hospital cardiac arrest patients are a very diverse group, and it may be possible that some patients could have benefited from hypercapnia while others may have been harmed,” Dr. Nichol noted.
“Raising CO2 levels does improve overall delivery of oxygen to the brain, but this might not have occurred in the right areas. It may be possible that some patients benefited, and analysis of biological samples will help us look more closely at this.”
He added that other ongoing trials are investigating hypercapnia in patients with traumatic brain injury.
“These patients are managed differently and often have probes in their brain to measure the response to CO2, so more of a precision medicine approach is possible,” he explained.
He also noted that the TAME study, which was conducted in conjunction with the TTM-2 study investigating hypothermia in out-of-hospital cardiac arrest patients, has established a network of ICU teams around the world, providing an infrastructure for further trials to be performed in this patient population in the future.
The TAME trial was funded by the National Health and Medical Research Council of Australia, the Health Research Board of Ireland, and the Health Research Council of New Zealand.
A version of this article originally appeared on Medscape.com.
The Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest (TAME) study showed that the intervention failed to improve neurologic or functional outcomes or quality of life at 6 months. However, the researchers also found that slightly elevated CO2 levels were not associated with worse outcomes.
“I think these results show that our hypothesis – that raising CO2 levels as applied in this trial may be beneficial for these patients – was not effective, even though previous work suggested that it would be,” co–lead investigator Alistair Nichol, MD, said in an interview.
“This was a rigorous trial; the intervention was well delivered, and the results are pretty clear. Unfortunately, we have proved a null hypothesis – that this approach doesn’t seem to work,” Dr. Nichol, who is professor of critical care medicine at University College Dublin, said.
“However, we did find that hypercapnia was safe. This is an important finding, as sometimes in very sick patients such as those who develop pneumonia, we have to drive the ventilator less hard to minimize injury to the lungs, and this can lead to higher CO2 levels,” he added. “Our results show that this practice should not be harmful, which is reassuring.”
The TAME study was presented at the Critical Care Reviews 2023 Meeting (CCR23) held in Belfast, Northern Ireland.
It was simultaneously published online in the New England Journal of Medicine.
The researchers explain that after the return of spontaneous circulation, brain hypoperfusion may contribute to cerebral hypoxia, exacerbate brain damage, and lead to poor neurologic outcomes. The partial pressure of arterial carbon dioxide (PaCO2) is the major physiologic regulator of cerebrovascular tone, and increasing CO2 levels increases cerebral blood flow.
Two previous observational studies showed that exposure to hypercapnia was associated with an increase in the likelihood of being discharged home and better neurologic outcomes at 12 months, compared with hypocapnia or normocapnia.
In addition, a physiologic study showed that deliberate increases in PaCO2 induced higher cerebral oxygen saturations, compared with normocapnia. A phase 2 randomized trial showed that hypercapnia significantly attenuated the release of neuron-specific enolase, a biomarker of brain injury, and also suggested better 6-month neurologic recovery with hypercapnia compared with normocapnia.
The current TAME trial was conducted to try to confirm these results in a larger, more definitive study.
For the trial, 1,700 adults with coma who had been resuscitated after out-of-hospital cardiac arrest were randomly assigned to receive either 24 hours of mild hypercapnia (target PaCO2, 50-55 mm Hg) or normocapnia (target PaCO2, 35-45 mm Hg).
The primary outcome – a favorable neurologic outcome, defined as a score of 5 or higher on the Glasgow Outcome Scale–Extended at 6 months – occurred in 43.5% in the mild hypercapnia group and in 44.6% in the normocapnia group (relative risk, 0.98; P = .76).
By 6 months, 48.2% of those in the mild hypercapnia group and 45.9% in the normocapnia group had died (relative risk with mild hypercapnia, 1.05; 95% confidence interval, 0.94-1.16). In the mild hypercapnia group, 53.4% had a poor functional outcome, defined as a Modified Rankin Scale score of 4-6, compared with 51.3% in the normocapnia group.
Health-related quality of life, as assessed by the EQ Visual Analogue Scale component of the EuroQol-5D-5L, was similar in the two groups.
In terms of safety, results showed that mild hypercapnia did not increase the incidence of prespecified adverse events.
The authors note that there is concern that mild hypercapnia may worsen cerebral edema and elevate intracranial pressure; however, elevated intracranial pressure is uncommon in the first 72 hours after the return of spontaneous circulation.
In the TAME trial, there was one case of cerebral edema in the hypercapnia group. “This is a very low rate and would be expected in a group this size, so this does not indicate a safety concern,” Dr. Nichol commented.
The researchers are planning further analyses of biological samples to look for possible prognostic markers.
“These out-of-hospital cardiac arrest patients are a very diverse group, and it may be possible that some patients could have benefited from hypercapnia while others may have been harmed,” Dr. Nichol noted.
“Raising CO2 levels does improve overall delivery of oxygen to the brain, but this might not have occurred in the right areas. It may be possible that some patients benefited, and analysis of biological samples will help us look more closely at this.”
He added that other ongoing trials are investigating hypercapnia in patients with traumatic brain injury.
“These patients are managed differently and often have probes in their brain to measure the response to CO2, so more of a precision medicine approach is possible,” he explained.
He also noted that the TAME study, which was conducted in conjunction with the TTM-2 study investigating hypothermia in out-of-hospital cardiac arrest patients, has established a network of ICU teams around the world, providing an infrastructure for further trials to be performed in this patient population in the future.
The TAME trial was funded by the National Health and Medical Research Council of Australia, the Health Research Board of Ireland, and the Health Research Council of New Zealand.
A version of this article originally appeared on Medscape.com.
FROM CCR23
Tips for addressing uptick in mental health visits: Primary care providers collaborate, innovate
This growth in the number of patients needing behavioral health–related care is likely driven by multiple factors, including a shortage of mental health care providers, an increasing incidence of psychiatric illness, and destigmatization of mental health in general, suggested Swetha P. Iruku, MD, MPH, associate professor of family medicine and community health at the University of Pennsylvania and Penn Medicine family physician in Philadelphia.
The Centers for Disease Control and Prevention noted that “the COVID-19 pandemic has been associated with mental health challenges related to the morbidity and mortality caused by the disease and to mitigation activities, including the impact of physical distancing and stay-at-home orders,” in a Morbidity and Mortality Weekly Report.
From June 24 to 30, 2020, U.S. adults reported considerably elevated adverse mental health conditions associated with COVID-19, and symptoms of anxiety disorder and depressive disorder climbed during the months of April through June of the same year, compared with the same period in 2019, they wrote.
Even before the pandemic got underway, multiple studies of national data published this year suggested mental issues were on the rise in the United States. For example, the proportion of adult patient visits to primary care providers that addressed mental health concerns rose from 10.7% to 15.9% from 2006 to 2018, according to research published in Health Affairs. Plus, the number and proportion of pediatric acute care hospitalizations because of mental health diagnoses increased significantly between 2009 and 2019, according to a paper published in JAMA.
“I truly believe that we can’t, as primary care physicians, take care of someone’s physical health without also taking care of their mental health,” Dr. Iruku said in an interview. “It’s all intertwined.”
To rise to this challenge, PCPs first need a collaborative mindset, she suggested, as well as familiarity with available resources, both locally and virtually.
This article examines strategies for managing mental illness in primary care, outlines clinical resources, and reviews related educational opportunities.
In addition, clinical pearls are shared by Dr. Iruku and five other clinicians who provide or have provided mental health care to primary care patients or work in close collaboration with a primary care practice, including a clinical psychologist, a nurse practitioner licensed in psychiatric health, a pediatrician, and a licensed clinical social worker.
Build a network
Most of the providers interviewed cited the importance of collaboration in mental health care, particularly for complex cases.
“I would recommend [that primary care providers get] to know the psychiatric providers [in their area],” said Jessica Viton, DNP, FNP, PMHNP, who delivers mental health care through a community-based primary care practice in Colorado which she requested remain anonymous.
Dr. Iruku suggested making an in-person connection first, if possible.
“So much of what we do is ‘see one, do one, teach one,’ so learn a little bit, then go off and trial,” she said. “[It can be valuable] having someone in your back pocket that you can contact in the case of an emergency, or in a situation where you just don’t know how to tackle it.”
Screen for depression and anxiety
William J. Sieber, PhD, a clinical psychologist, director of integrated behavioral health, and professor in the department of family medicine and public health and the department of psychiatry at the University of California, San Diego, said primary care providers should screen all adult patients for depression and anxiety with the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder Assessment (GAD-7), respectively.
To save time, he suggested a cascading approach.
“In primary care, everybody’s in a hurry,” Dr. Sieber said. “[With the cascading approach,] the first two items [from each questionnaire] are given, and if a person endorses either of those items … then they are asked to complete the other items.”
Jennifer Mullally, MD, a pediatrician at Sanford Health in Fargo, N.D., uses this cascading approach to depression and anxiety screening with all her patients aged 13-18. For younger kids, she screens only those who present with signs or symptoms of mental health issues, or if the parent shares a concern.
This approach differs slightly from U.S. Preventive Services Task Force recommendations, which suggest screening for anxiety in patients aged 8-18 years and depression in patients aged 12-18 years.
Use other screening tools only as needed
Dr. Sieber, the research director for the division of family medicine at UC San Diego, collaborates regularly with primary care providers via hallway consultations, by sharing cases, and through providing oversight of psychiatric care at 13 primary care practices within the UC San Diego network. He recommended against routine screening beyond depression and anxiety in the primary care setting.
“There are a lot of screening tools,” Dr. Sieber said. “It depends on what you’re presented with. The challenge in primary care is you’re going to see all kinds of things. It’s not like running a depression clinic.”
Other than the PHQ-9 and GAD-7, he suggested primary care providers establish familiarity with screening tools for posttraumatic stress disorder and attention-deficit/hyperactivity disorder, noting again that these should be used only when one of the conditions is already suspected.
Dr. Mullally follows a similar approach with her pediatric population. In addition to the GAD-7, she investigates whether a patient has anxiety with the Screen for Child Anxiety Related Disorders (SCARED). For depression, she couples the PHQ-9 with the Columbia Suicide Severity Rating Scale.
While additional screening tools like these are readily available online, Dr. Viton suggested that they should be employed only if the provider is trained to interpret and respond to those findings, and only if they know which tool to use, and when.
For example, she has recently observed PCPs diagnosing adults with ADHD using a three-question test, when in fact a full-length, standardized instrument should be administered by a provider with necessary training.
She also pointed out that bipolar disorder continues to be underdiagnosed, possibly because of providers detecting depression using a questionnaire like the PHQ-9, while failing to inquire about manic episodes.
Leverage online resources
If depression is confirmed, Dr. Iruku often directs the patient to the Mayo Clinic Depression Medication Choice Decision Aid. This website steers patients through medication options based on their answers to a questionnaire. Choices are listed alongside possible adverse effects.
For clinician use, Dr. Iruku recommended The Waco Guide to Psychopharmacology in Primary Care, which aids clinical decision-making for mental illness and substance abuse. The app processes case details to suggest first-, second-, and third-line pharmacotherapies, as well as modifications based on patient needs.
Even with tools like these, however, a referral may be needed.
“[Primary care providers] may not be the best fit for what the patient is looking for, from a mental health or behavioral standpoint,” Dr. Sieber said.
In this case, he encourages patients to visit Psychology Today, a “quite popular portal” that helps patients locate a suitable provider based on location, insurance, driving radius, and mental health concern. This usually generates 10-20 options, Dr. Sieber said, although results can vary.
“It may be discouraging, because maybe only three [providers] pop up based on your criteria, and the closest one is miles away,” he said.
Consider virtual support
If no local psychiatric help is available, Dr. Sieber suggested virtual support, highlighting that “it’s much easier now than it was 3 or 4 years ago” to connect patients with external mental health care.
But this strategy should be reserved for cases of actual need instead of pure convenience, cautioned Dr. Viton, who noted that virtual visits may fail to capture the nuance of an in-person meeting, as body language, mode of dress, and other clues can provide insights into mental health status.
“Occasionally, I think you do have to have an in-person visit, especially when you’re developing a rapport with someone,” Dr. Viton said.
Claire McArdle, a licensed clinical social worker in Fort Collins, Colo., noted that virtual care from an outside provider may also impede the collaboration needed to effectively address mental illness.
In her 11 years in primary care at Associates in Family Medicine, Ms. McArdle had countless interactions with colleagues seeking support when managing a complex case. “I’m coaching providers, front desk staff, and nursing staff on how to interact with patients [with] behavioral health needs,” she said, citing the multitude of nonmedical factors that need to be considered, such as family relationships and patient preferences.
These unscheduled conversations with colleagues throughout the day are impossible to have when sharing a case with an unknown, remote peer.
Ms. McArdle speaks from experience. She recently resigned from Associates in Family Medicine to start her own private therapy practice after her former employer was acquired by VillageMD, a national provider that terminated employment of most other social workers in the practice and began outsourcing mental health care to Mindoula Health, a virtual provider.
Dr. Sieber offered a similar perspective on in-person collaboration as the psychiatric specialist at his center. He routinely offers on-site support for both providers and patients, serving as “another set of eyes and ears” when there is a concern about patient safety or directly managing care when a patient is hospitalized for mental illness.
While virtual solutions may fall short of in-person management, they can offer care at a scale and cost impossible through traditional practice.
This could even be free. Zero-cost, automated software now allows individuals who are uninsured or unable to afford care at least one avenue to manage their mental health concerns.
For example, Bliss is a free, 8-session, interactive online therapy program for depression that was created by the Centre for Interactive Mental Health Solutions. The program offers a tool for monitoring mood and quizzes to test understanding of personal mental health management, among other features.
More advanced programs are emerging as artificial intelligence (AI) enables dialogues between humans and machines. This is the case with Woebot, an app that asks the user about their mood throughout the day, and responds with evidence-based strategies for managing concerns, all for free at press time.
Keep learning
A range of educational options and professional resources are available for primary care providers who would like to improve their knowledge of mental health care. These include formal fellowships in primary care psychiatry/behavioral health integration, free mental health webinars, and various other opportunities.
Eric Eschweiler, DNP, APRN, FNP-C, PHN, completed the University of California, Irvine, Train New Trainers (TNT) Primary Care Psychiatry (PCP) Fellowship in 2016, when he was working as a solo nurse practitioner.
“I was drowning in practice,” said Dr. Eschweiler, director of nursing and public health outreach services at Riverside-San Bernardino County Indian Health, Grand Terrace, Calif., in an interview. “I was a solo NP. There was no physician on site. We were seeing a lot of [individuals with] schizoaffective [disorder] in downtown San Bernardino, the homeless, unhoused – a lot of substance use. I felt I needed to have the skills to be able to treat them effectively. That’s what the fellowship did.”
The skills Dr. Eschweiler learned from participating in his fellowship allowed him to manage more cases of mental illness without need for referral. When a referral was needed for a complex or severe case, he had the confidence to bridge care and collaborate more effectively with psychiatric specialists.
“It was awesome, because we were able to communicate using the same language,” Dr. Eschweiler said of these collaborations. “It’s [about] talking that same language, starting those initial treatments, and then moving forward with specialty care, and vice versa. [Psychiatric specialists] would send me patients that needed medical care because of the types of medications they were taking. And I was then very well aware of those side effects and other issues that might come up from those treatments. So it’s a two-way street.”
Dr. Eschweiler was so impressed by his fellowship that he has since ushered multiple providers through the program since transitioning to an administrative role as director of nursing.
In Fargo, where psychiatric care is sparse and wait times for referral can be months long, Dr. Mullally, like Dr. Eschweiler, knew that she needed more training in mental health.
“I don’t feel like we get enough training in residency,” Dr. Mullally said. “So you do need to look at your options for further CME.”
Out of several CME courses she has taken to further her understanding of pediatric psychiatry, Dr. Mullally recommended The Reach Institute above all others, as their courses involve in-depth discussions and valuable handouts, particularly for medication selection.
“I think that a lot of the other CMEs tend to involve a lot more PowerPoint presentations,” Dr. Mullally said. “And you don’t necessarily leave with a lot of good documents. I still use my Reach handouts. I have them sitting right next to me. I use them every single day.”
Providers interested in The Reach Institute, however, should be prepared to invest both time and money, she added, citing a 2-3 day commitment, and calling it “not cheap.” To overcome these barriers, she suggested that providers get their institution to support their attendance.
For a lighter commitment, Dr. Iruku recommended the American Academy of Family Physicians CME portal, as this offers 13 online, accredited courses covering a range of topics, from adolescent health to substance abuse disorders.
Dr. Sieber suggested that primary care providers join the Collaborative Family Healthcare Association, which aims to integrate physical and behavioral health in routine practice. CFHA, of which he is a member, offers a “bevy of different resources” for interested providers, including a conference in Phoenix this October.
The interviewees disclosed no conflicts of interest.
This growth in the number of patients needing behavioral health–related care is likely driven by multiple factors, including a shortage of mental health care providers, an increasing incidence of psychiatric illness, and destigmatization of mental health in general, suggested Swetha P. Iruku, MD, MPH, associate professor of family medicine and community health at the University of Pennsylvania and Penn Medicine family physician in Philadelphia.
The Centers for Disease Control and Prevention noted that “the COVID-19 pandemic has been associated with mental health challenges related to the morbidity and mortality caused by the disease and to mitigation activities, including the impact of physical distancing and stay-at-home orders,” in a Morbidity and Mortality Weekly Report.
From June 24 to 30, 2020, U.S. adults reported considerably elevated adverse mental health conditions associated with COVID-19, and symptoms of anxiety disorder and depressive disorder climbed during the months of April through June of the same year, compared with the same period in 2019, they wrote.
Even before the pandemic got underway, multiple studies of national data published this year suggested mental issues were on the rise in the United States. For example, the proportion of adult patient visits to primary care providers that addressed mental health concerns rose from 10.7% to 15.9% from 2006 to 2018, according to research published in Health Affairs. Plus, the number and proportion of pediatric acute care hospitalizations because of mental health diagnoses increased significantly between 2009 and 2019, according to a paper published in JAMA.
“I truly believe that we can’t, as primary care physicians, take care of someone’s physical health without also taking care of their mental health,” Dr. Iruku said in an interview. “It’s all intertwined.”
To rise to this challenge, PCPs first need a collaborative mindset, she suggested, as well as familiarity with available resources, both locally and virtually.
This article examines strategies for managing mental illness in primary care, outlines clinical resources, and reviews related educational opportunities.
In addition, clinical pearls are shared by Dr. Iruku and five other clinicians who provide or have provided mental health care to primary care patients or work in close collaboration with a primary care practice, including a clinical psychologist, a nurse practitioner licensed in psychiatric health, a pediatrician, and a licensed clinical social worker.
Build a network
Most of the providers interviewed cited the importance of collaboration in mental health care, particularly for complex cases.
“I would recommend [that primary care providers get] to know the psychiatric providers [in their area],” said Jessica Viton, DNP, FNP, PMHNP, who delivers mental health care through a community-based primary care practice in Colorado which she requested remain anonymous.
Dr. Iruku suggested making an in-person connection first, if possible.
“So much of what we do is ‘see one, do one, teach one,’ so learn a little bit, then go off and trial,” she said. “[It can be valuable] having someone in your back pocket that you can contact in the case of an emergency, or in a situation where you just don’t know how to tackle it.”
Screen for depression and anxiety
William J. Sieber, PhD, a clinical psychologist, director of integrated behavioral health, and professor in the department of family medicine and public health and the department of psychiatry at the University of California, San Diego, said primary care providers should screen all adult patients for depression and anxiety with the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder Assessment (GAD-7), respectively.
To save time, he suggested a cascading approach.
“In primary care, everybody’s in a hurry,” Dr. Sieber said. “[With the cascading approach,] the first two items [from each questionnaire] are given, and if a person endorses either of those items … then they are asked to complete the other items.”
Jennifer Mullally, MD, a pediatrician at Sanford Health in Fargo, N.D., uses this cascading approach to depression and anxiety screening with all her patients aged 13-18. For younger kids, she screens only those who present with signs or symptoms of mental health issues, or if the parent shares a concern.
This approach differs slightly from U.S. Preventive Services Task Force recommendations, which suggest screening for anxiety in patients aged 8-18 years and depression in patients aged 12-18 years.
Use other screening tools only as needed
Dr. Sieber, the research director for the division of family medicine at UC San Diego, collaborates regularly with primary care providers via hallway consultations, by sharing cases, and through providing oversight of psychiatric care at 13 primary care practices within the UC San Diego network. He recommended against routine screening beyond depression and anxiety in the primary care setting.
“There are a lot of screening tools,” Dr. Sieber said. “It depends on what you’re presented with. The challenge in primary care is you’re going to see all kinds of things. It’s not like running a depression clinic.”
Other than the PHQ-9 and GAD-7, he suggested primary care providers establish familiarity with screening tools for posttraumatic stress disorder and attention-deficit/hyperactivity disorder, noting again that these should be used only when one of the conditions is already suspected.
Dr. Mullally follows a similar approach with her pediatric population. In addition to the GAD-7, she investigates whether a patient has anxiety with the Screen for Child Anxiety Related Disorders (SCARED). For depression, she couples the PHQ-9 with the Columbia Suicide Severity Rating Scale.
While additional screening tools like these are readily available online, Dr. Viton suggested that they should be employed only if the provider is trained to interpret and respond to those findings, and only if they know which tool to use, and when.
For example, she has recently observed PCPs diagnosing adults with ADHD using a three-question test, when in fact a full-length, standardized instrument should be administered by a provider with necessary training.
She also pointed out that bipolar disorder continues to be underdiagnosed, possibly because of providers detecting depression using a questionnaire like the PHQ-9, while failing to inquire about manic episodes.
Leverage online resources
If depression is confirmed, Dr. Iruku often directs the patient to the Mayo Clinic Depression Medication Choice Decision Aid. This website steers patients through medication options based on their answers to a questionnaire. Choices are listed alongside possible adverse effects.
For clinician use, Dr. Iruku recommended The Waco Guide to Psychopharmacology in Primary Care, which aids clinical decision-making for mental illness and substance abuse. The app processes case details to suggest first-, second-, and third-line pharmacotherapies, as well as modifications based on patient needs.
Even with tools like these, however, a referral may be needed.
“[Primary care providers] may not be the best fit for what the patient is looking for, from a mental health or behavioral standpoint,” Dr. Sieber said.
In this case, he encourages patients to visit Psychology Today, a “quite popular portal” that helps patients locate a suitable provider based on location, insurance, driving radius, and mental health concern. This usually generates 10-20 options, Dr. Sieber said, although results can vary.
“It may be discouraging, because maybe only three [providers] pop up based on your criteria, and the closest one is miles away,” he said.
Consider virtual support
If no local psychiatric help is available, Dr. Sieber suggested virtual support, highlighting that “it’s much easier now than it was 3 or 4 years ago” to connect patients with external mental health care.
But this strategy should be reserved for cases of actual need instead of pure convenience, cautioned Dr. Viton, who noted that virtual visits may fail to capture the nuance of an in-person meeting, as body language, mode of dress, and other clues can provide insights into mental health status.
“Occasionally, I think you do have to have an in-person visit, especially when you’re developing a rapport with someone,” Dr. Viton said.
Claire McArdle, a licensed clinical social worker in Fort Collins, Colo., noted that virtual care from an outside provider may also impede the collaboration needed to effectively address mental illness.
In her 11 years in primary care at Associates in Family Medicine, Ms. McArdle had countless interactions with colleagues seeking support when managing a complex case. “I’m coaching providers, front desk staff, and nursing staff on how to interact with patients [with] behavioral health needs,” she said, citing the multitude of nonmedical factors that need to be considered, such as family relationships and patient preferences.
These unscheduled conversations with colleagues throughout the day are impossible to have when sharing a case with an unknown, remote peer.
Ms. McArdle speaks from experience. She recently resigned from Associates in Family Medicine to start her own private therapy practice after her former employer was acquired by VillageMD, a national provider that terminated employment of most other social workers in the practice and began outsourcing mental health care to Mindoula Health, a virtual provider.
Dr. Sieber offered a similar perspective on in-person collaboration as the psychiatric specialist at his center. He routinely offers on-site support for both providers and patients, serving as “another set of eyes and ears” when there is a concern about patient safety or directly managing care when a patient is hospitalized for mental illness.
While virtual solutions may fall short of in-person management, they can offer care at a scale and cost impossible through traditional practice.
This could even be free. Zero-cost, automated software now allows individuals who are uninsured or unable to afford care at least one avenue to manage their mental health concerns.
For example, Bliss is a free, 8-session, interactive online therapy program for depression that was created by the Centre for Interactive Mental Health Solutions. The program offers a tool for monitoring mood and quizzes to test understanding of personal mental health management, among other features.
More advanced programs are emerging as artificial intelligence (AI) enables dialogues between humans and machines. This is the case with Woebot, an app that asks the user about their mood throughout the day, and responds with evidence-based strategies for managing concerns, all for free at press time.
Keep learning
A range of educational options and professional resources are available for primary care providers who would like to improve their knowledge of mental health care. These include formal fellowships in primary care psychiatry/behavioral health integration, free mental health webinars, and various other opportunities.
Eric Eschweiler, DNP, APRN, FNP-C, PHN, completed the University of California, Irvine, Train New Trainers (TNT) Primary Care Psychiatry (PCP) Fellowship in 2016, when he was working as a solo nurse practitioner.
“I was drowning in practice,” said Dr. Eschweiler, director of nursing and public health outreach services at Riverside-San Bernardino County Indian Health, Grand Terrace, Calif., in an interview. “I was a solo NP. There was no physician on site. We were seeing a lot of [individuals with] schizoaffective [disorder] in downtown San Bernardino, the homeless, unhoused – a lot of substance use. I felt I needed to have the skills to be able to treat them effectively. That’s what the fellowship did.”
The skills Dr. Eschweiler learned from participating in his fellowship allowed him to manage more cases of mental illness without need for referral. When a referral was needed for a complex or severe case, he had the confidence to bridge care and collaborate more effectively with psychiatric specialists.
“It was awesome, because we were able to communicate using the same language,” Dr. Eschweiler said of these collaborations. “It’s [about] talking that same language, starting those initial treatments, and then moving forward with specialty care, and vice versa. [Psychiatric specialists] would send me patients that needed medical care because of the types of medications they were taking. And I was then very well aware of those side effects and other issues that might come up from those treatments. So it’s a two-way street.”
Dr. Eschweiler was so impressed by his fellowship that he has since ushered multiple providers through the program since transitioning to an administrative role as director of nursing.
In Fargo, where psychiatric care is sparse and wait times for referral can be months long, Dr. Mullally, like Dr. Eschweiler, knew that she needed more training in mental health.
“I don’t feel like we get enough training in residency,” Dr. Mullally said. “So you do need to look at your options for further CME.”
Out of several CME courses she has taken to further her understanding of pediatric psychiatry, Dr. Mullally recommended The Reach Institute above all others, as their courses involve in-depth discussions and valuable handouts, particularly for medication selection.
“I think that a lot of the other CMEs tend to involve a lot more PowerPoint presentations,” Dr. Mullally said. “And you don’t necessarily leave with a lot of good documents. I still use my Reach handouts. I have them sitting right next to me. I use them every single day.”
Providers interested in The Reach Institute, however, should be prepared to invest both time and money, she added, citing a 2-3 day commitment, and calling it “not cheap.” To overcome these barriers, she suggested that providers get their institution to support their attendance.
For a lighter commitment, Dr. Iruku recommended the American Academy of Family Physicians CME portal, as this offers 13 online, accredited courses covering a range of topics, from adolescent health to substance abuse disorders.
Dr. Sieber suggested that primary care providers join the Collaborative Family Healthcare Association, which aims to integrate physical and behavioral health in routine practice. CFHA, of which he is a member, offers a “bevy of different resources” for interested providers, including a conference in Phoenix this October.
The interviewees disclosed no conflicts of interest.
This growth in the number of patients needing behavioral health–related care is likely driven by multiple factors, including a shortage of mental health care providers, an increasing incidence of psychiatric illness, and destigmatization of mental health in general, suggested Swetha P. Iruku, MD, MPH, associate professor of family medicine and community health at the University of Pennsylvania and Penn Medicine family physician in Philadelphia.
The Centers for Disease Control and Prevention noted that “the COVID-19 pandemic has been associated with mental health challenges related to the morbidity and mortality caused by the disease and to mitigation activities, including the impact of physical distancing and stay-at-home orders,” in a Morbidity and Mortality Weekly Report.
From June 24 to 30, 2020, U.S. adults reported considerably elevated adverse mental health conditions associated with COVID-19, and symptoms of anxiety disorder and depressive disorder climbed during the months of April through June of the same year, compared with the same period in 2019, they wrote.
Even before the pandemic got underway, multiple studies of national data published this year suggested mental issues were on the rise in the United States. For example, the proportion of adult patient visits to primary care providers that addressed mental health concerns rose from 10.7% to 15.9% from 2006 to 2018, according to research published in Health Affairs. Plus, the number and proportion of pediatric acute care hospitalizations because of mental health diagnoses increased significantly between 2009 and 2019, according to a paper published in JAMA.
“I truly believe that we can’t, as primary care physicians, take care of someone’s physical health without also taking care of their mental health,” Dr. Iruku said in an interview. “It’s all intertwined.”
To rise to this challenge, PCPs first need a collaborative mindset, she suggested, as well as familiarity with available resources, both locally and virtually.
This article examines strategies for managing mental illness in primary care, outlines clinical resources, and reviews related educational opportunities.
In addition, clinical pearls are shared by Dr. Iruku and five other clinicians who provide or have provided mental health care to primary care patients or work in close collaboration with a primary care practice, including a clinical psychologist, a nurse practitioner licensed in psychiatric health, a pediatrician, and a licensed clinical social worker.
Build a network
Most of the providers interviewed cited the importance of collaboration in mental health care, particularly for complex cases.
“I would recommend [that primary care providers get] to know the psychiatric providers [in their area],” said Jessica Viton, DNP, FNP, PMHNP, who delivers mental health care through a community-based primary care practice in Colorado which she requested remain anonymous.
Dr. Iruku suggested making an in-person connection first, if possible.
“So much of what we do is ‘see one, do one, teach one,’ so learn a little bit, then go off and trial,” she said. “[It can be valuable] having someone in your back pocket that you can contact in the case of an emergency, or in a situation where you just don’t know how to tackle it.”
Screen for depression and anxiety
William J. Sieber, PhD, a clinical psychologist, director of integrated behavioral health, and professor in the department of family medicine and public health and the department of psychiatry at the University of California, San Diego, said primary care providers should screen all adult patients for depression and anxiety with the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder Assessment (GAD-7), respectively.
To save time, he suggested a cascading approach.
“In primary care, everybody’s in a hurry,” Dr. Sieber said. “[With the cascading approach,] the first two items [from each questionnaire] are given, and if a person endorses either of those items … then they are asked to complete the other items.”
Jennifer Mullally, MD, a pediatrician at Sanford Health in Fargo, N.D., uses this cascading approach to depression and anxiety screening with all her patients aged 13-18. For younger kids, she screens only those who present with signs or symptoms of mental health issues, or if the parent shares a concern.
This approach differs slightly from U.S. Preventive Services Task Force recommendations, which suggest screening for anxiety in patients aged 8-18 years and depression in patients aged 12-18 years.
Use other screening tools only as needed
Dr. Sieber, the research director for the division of family medicine at UC San Diego, collaborates regularly with primary care providers via hallway consultations, by sharing cases, and through providing oversight of psychiatric care at 13 primary care practices within the UC San Diego network. He recommended against routine screening beyond depression and anxiety in the primary care setting.
“There are a lot of screening tools,” Dr. Sieber said. “It depends on what you’re presented with. The challenge in primary care is you’re going to see all kinds of things. It’s not like running a depression clinic.”
Other than the PHQ-9 and GAD-7, he suggested primary care providers establish familiarity with screening tools for posttraumatic stress disorder and attention-deficit/hyperactivity disorder, noting again that these should be used only when one of the conditions is already suspected.
Dr. Mullally follows a similar approach with her pediatric population. In addition to the GAD-7, she investigates whether a patient has anxiety with the Screen for Child Anxiety Related Disorders (SCARED). For depression, she couples the PHQ-9 with the Columbia Suicide Severity Rating Scale.
While additional screening tools like these are readily available online, Dr. Viton suggested that they should be employed only if the provider is trained to interpret and respond to those findings, and only if they know which tool to use, and when.
For example, she has recently observed PCPs diagnosing adults with ADHD using a three-question test, when in fact a full-length, standardized instrument should be administered by a provider with necessary training.
She also pointed out that bipolar disorder continues to be underdiagnosed, possibly because of providers detecting depression using a questionnaire like the PHQ-9, while failing to inquire about manic episodes.
Leverage online resources
If depression is confirmed, Dr. Iruku often directs the patient to the Mayo Clinic Depression Medication Choice Decision Aid. This website steers patients through medication options based on their answers to a questionnaire. Choices are listed alongside possible adverse effects.
For clinician use, Dr. Iruku recommended The Waco Guide to Psychopharmacology in Primary Care, which aids clinical decision-making for mental illness and substance abuse. The app processes case details to suggest first-, second-, and third-line pharmacotherapies, as well as modifications based on patient needs.
Even with tools like these, however, a referral may be needed.
“[Primary care providers] may not be the best fit for what the patient is looking for, from a mental health or behavioral standpoint,” Dr. Sieber said.
In this case, he encourages patients to visit Psychology Today, a “quite popular portal” that helps patients locate a suitable provider based on location, insurance, driving radius, and mental health concern. This usually generates 10-20 options, Dr. Sieber said, although results can vary.
“It may be discouraging, because maybe only three [providers] pop up based on your criteria, and the closest one is miles away,” he said.
Consider virtual support
If no local psychiatric help is available, Dr. Sieber suggested virtual support, highlighting that “it’s much easier now than it was 3 or 4 years ago” to connect patients with external mental health care.
But this strategy should be reserved for cases of actual need instead of pure convenience, cautioned Dr. Viton, who noted that virtual visits may fail to capture the nuance of an in-person meeting, as body language, mode of dress, and other clues can provide insights into mental health status.
“Occasionally, I think you do have to have an in-person visit, especially when you’re developing a rapport with someone,” Dr. Viton said.
Claire McArdle, a licensed clinical social worker in Fort Collins, Colo., noted that virtual care from an outside provider may also impede the collaboration needed to effectively address mental illness.
In her 11 years in primary care at Associates in Family Medicine, Ms. McArdle had countless interactions with colleagues seeking support when managing a complex case. “I’m coaching providers, front desk staff, and nursing staff on how to interact with patients [with] behavioral health needs,” she said, citing the multitude of nonmedical factors that need to be considered, such as family relationships and patient preferences.
These unscheduled conversations with colleagues throughout the day are impossible to have when sharing a case with an unknown, remote peer.
Ms. McArdle speaks from experience. She recently resigned from Associates in Family Medicine to start her own private therapy practice after her former employer was acquired by VillageMD, a national provider that terminated employment of most other social workers in the practice and began outsourcing mental health care to Mindoula Health, a virtual provider.
Dr. Sieber offered a similar perspective on in-person collaboration as the psychiatric specialist at his center. He routinely offers on-site support for both providers and patients, serving as “another set of eyes and ears” when there is a concern about patient safety or directly managing care when a patient is hospitalized for mental illness.
While virtual solutions may fall short of in-person management, they can offer care at a scale and cost impossible through traditional practice.
This could even be free. Zero-cost, automated software now allows individuals who are uninsured or unable to afford care at least one avenue to manage their mental health concerns.
For example, Bliss is a free, 8-session, interactive online therapy program for depression that was created by the Centre for Interactive Mental Health Solutions. The program offers a tool for monitoring mood and quizzes to test understanding of personal mental health management, among other features.
More advanced programs are emerging as artificial intelligence (AI) enables dialogues between humans and machines. This is the case with Woebot, an app that asks the user about their mood throughout the day, and responds with evidence-based strategies for managing concerns, all for free at press time.
Keep learning
A range of educational options and professional resources are available for primary care providers who would like to improve their knowledge of mental health care. These include formal fellowships in primary care psychiatry/behavioral health integration, free mental health webinars, and various other opportunities.
Eric Eschweiler, DNP, APRN, FNP-C, PHN, completed the University of California, Irvine, Train New Trainers (TNT) Primary Care Psychiatry (PCP) Fellowship in 2016, when he was working as a solo nurse practitioner.
“I was drowning in practice,” said Dr. Eschweiler, director of nursing and public health outreach services at Riverside-San Bernardino County Indian Health, Grand Terrace, Calif., in an interview. “I was a solo NP. There was no physician on site. We were seeing a lot of [individuals with] schizoaffective [disorder] in downtown San Bernardino, the homeless, unhoused – a lot of substance use. I felt I needed to have the skills to be able to treat them effectively. That’s what the fellowship did.”
The skills Dr. Eschweiler learned from participating in his fellowship allowed him to manage more cases of mental illness without need for referral. When a referral was needed for a complex or severe case, he had the confidence to bridge care and collaborate more effectively with psychiatric specialists.
“It was awesome, because we were able to communicate using the same language,” Dr. Eschweiler said of these collaborations. “It’s [about] talking that same language, starting those initial treatments, and then moving forward with specialty care, and vice versa. [Psychiatric specialists] would send me patients that needed medical care because of the types of medications they were taking. And I was then very well aware of those side effects and other issues that might come up from those treatments. So it’s a two-way street.”
Dr. Eschweiler was so impressed by his fellowship that he has since ushered multiple providers through the program since transitioning to an administrative role as director of nursing.
In Fargo, where psychiatric care is sparse and wait times for referral can be months long, Dr. Mullally, like Dr. Eschweiler, knew that she needed more training in mental health.
“I don’t feel like we get enough training in residency,” Dr. Mullally said. “So you do need to look at your options for further CME.”
Out of several CME courses she has taken to further her understanding of pediatric psychiatry, Dr. Mullally recommended The Reach Institute above all others, as their courses involve in-depth discussions and valuable handouts, particularly for medication selection.
“I think that a lot of the other CMEs tend to involve a lot more PowerPoint presentations,” Dr. Mullally said. “And you don’t necessarily leave with a lot of good documents. I still use my Reach handouts. I have them sitting right next to me. I use them every single day.”
Providers interested in The Reach Institute, however, should be prepared to invest both time and money, she added, citing a 2-3 day commitment, and calling it “not cheap.” To overcome these barriers, she suggested that providers get their institution to support their attendance.
For a lighter commitment, Dr. Iruku recommended the American Academy of Family Physicians CME portal, as this offers 13 online, accredited courses covering a range of topics, from adolescent health to substance abuse disorders.
Dr. Sieber suggested that primary care providers join the Collaborative Family Healthcare Association, which aims to integrate physical and behavioral health in routine practice. CFHA, of which he is a member, offers a “bevy of different resources” for interested providers, including a conference in Phoenix this October.
The interviewees disclosed no conflicts of interest.
A ‘one-stop shop’: New guidance on hormones and aging
The idea of the statement “is to be complete, but also to clarify some misunderstandings. ...We tried to be very clear in the language about what we know, where we can go, where we shouldn’t go, and what we still need to learn,” statement coauthor Cynthia A. Stuenkel, MD, of the University of California, San Diego, said in an interview.
The document is divided into nine parts or axes: growth hormone, adrenal, ovarian, testicular, thyroid, osteoporosis, vitamin D deficiency, type 2 diabetes, and water metabolism. Each section covers natural history and observational data in older individuals, available therapies, clinical trial data on efficacy and safety in older individuals, bulleted “key points,” and research gaps.
“Hormones and Aging: An Endocrine Society Scientific Statement” was presented at the annual meeting of the Endocrine Society and published online in the Journal of Clinical Endocrinology & Metabolism.
During a press briefing, writing group chair Anne R. Cappola, MD, of the University of Pennsylvania, Philadelphia, said the goal is to “provide a really concise summary across each of these areas. ... There are multiple hormonal changes that occur with age, so we really couldn’t limit ourselves to just one gland or the few that we commonly think about. We wanted to cover all the axes.”
The statement tackles several controversial areas, including hormone therapy for menopausal symptoms in women and hypogonadal symptoms in men, diabetes treatment goals in older adults, distinguishing between age-associated changes in thyroid function and early hypothyroidism, and vitamin D supplementation in older adults.
“Hormones have these almost mythical qualities to some people. ... ‘If I just had my hormones back the way they were, it would all work out.’ What we want to do is make sure that patients are being treated appropriately and that their symptoms are being heard and managed and ascribed to the appropriate problems and not necessarily to hormonal problems when they are not. ... Part of what we need to do is [provide] the evidence that we have, which includes evidence of when not to prescribe as well as [when] to prescribe,” Dr. Cappola said.
Not designed to be read all at once
In the menopause section, for example, one “key point” is that menopausal symptoms are common, vary in degree and bother, and can be effectively treated with a variety of therapies proven effective in randomized clinical trials. Another key point is that menopausal hormone therapy is safest for women who are younger than 60 years and less than 10 years since starting menopause.
“It’s almost 20 years since the original Women’s Health Initiative, and that led to an incredible falloff of prescribing hormone therapy and a falloff in teaching of our students, residents, fellows, and practitioners about [menopausal] hormone therapy. ... Hopefully, by issuing this kind of aging statement it gets people to read, think, and learn more. And, hopefully, we can improve the education of physicians. ... Menopause is a universal experience. Clinicians should know about it,” noted Dr. Stuenkel, who chaired the menopause section writing panel.
In the type 2 diabetes section, in the bullet points it is noted that oral glucose tolerance testing may reveal abnormal glucose status in older adults that are not picked up with hemoglobin A1c or fasting glucose levels and that glycemic targets should be individualized.
Asked to comment on the statement, Michele Bellantoni, MD, said: “This was a huge undertaking because there are so many areas of expertise here. I thought they did a very good job of reviewing the literature and showing each of the different hormonal axes. ... It’s a good go-to review.”
“I thought it was a very good attempt to catalog and provide opportunities for policy, and particularly at [the National Institutes of Health], as they look at funding to show where are these gaps and to support appropriate research. I think the most important aspect to come of this is identifying research gaps for funding opportunities. I very much support that,” noted Dr. Bellantoni, who is clinical director of the division of geriatric medicine at Johns Hopkins University, Baltimore.
However, she also said that the 40-page document might be a bit much for busy clinicians, despite the bullet points at the end of each section.
“I would love to see an editorial that puts into perspective the take-home messages or a subsequent article that distills this into every day practice of care of older adults, both preventative and treatment care. ... I think that would be so useful.”
During the briefing, Dr. Cappola noted that the document need not be read all at once.
“It ended up being a large document, but you should not be intimidated by it because each section is only about 2,000 words. So, it’s really a kind of one-stop shop to be able to look across all these axes at once. We also wanted people to think about the common themes that occur across all these axes when considering what’s going on right now and for future research,” she said.
Dr. Stuenkel, Dr. Cappola, and Dr. Bellantoni reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The idea of the statement “is to be complete, but also to clarify some misunderstandings. ...We tried to be very clear in the language about what we know, where we can go, where we shouldn’t go, and what we still need to learn,” statement coauthor Cynthia A. Stuenkel, MD, of the University of California, San Diego, said in an interview.
The document is divided into nine parts or axes: growth hormone, adrenal, ovarian, testicular, thyroid, osteoporosis, vitamin D deficiency, type 2 diabetes, and water metabolism. Each section covers natural history and observational data in older individuals, available therapies, clinical trial data on efficacy and safety in older individuals, bulleted “key points,” and research gaps.
“Hormones and Aging: An Endocrine Society Scientific Statement” was presented at the annual meeting of the Endocrine Society and published online in the Journal of Clinical Endocrinology & Metabolism.
During a press briefing, writing group chair Anne R. Cappola, MD, of the University of Pennsylvania, Philadelphia, said the goal is to “provide a really concise summary across each of these areas. ... There are multiple hormonal changes that occur with age, so we really couldn’t limit ourselves to just one gland or the few that we commonly think about. We wanted to cover all the axes.”
The statement tackles several controversial areas, including hormone therapy for menopausal symptoms in women and hypogonadal symptoms in men, diabetes treatment goals in older adults, distinguishing between age-associated changes in thyroid function and early hypothyroidism, and vitamin D supplementation in older adults.
“Hormones have these almost mythical qualities to some people. ... ‘If I just had my hormones back the way they were, it would all work out.’ What we want to do is make sure that patients are being treated appropriately and that their symptoms are being heard and managed and ascribed to the appropriate problems and not necessarily to hormonal problems when they are not. ... Part of what we need to do is [provide] the evidence that we have, which includes evidence of when not to prescribe as well as [when] to prescribe,” Dr. Cappola said.
Not designed to be read all at once
In the menopause section, for example, one “key point” is that menopausal symptoms are common, vary in degree and bother, and can be effectively treated with a variety of therapies proven effective in randomized clinical trials. Another key point is that menopausal hormone therapy is safest for women who are younger than 60 years and less than 10 years since starting menopause.
“It’s almost 20 years since the original Women’s Health Initiative, and that led to an incredible falloff of prescribing hormone therapy and a falloff in teaching of our students, residents, fellows, and practitioners about [menopausal] hormone therapy. ... Hopefully, by issuing this kind of aging statement it gets people to read, think, and learn more. And, hopefully, we can improve the education of physicians. ... Menopause is a universal experience. Clinicians should know about it,” noted Dr. Stuenkel, who chaired the menopause section writing panel.
In the type 2 diabetes section, in the bullet points it is noted that oral glucose tolerance testing may reveal abnormal glucose status in older adults that are not picked up with hemoglobin A1c or fasting glucose levels and that glycemic targets should be individualized.
Asked to comment on the statement, Michele Bellantoni, MD, said: “This was a huge undertaking because there are so many areas of expertise here. I thought they did a very good job of reviewing the literature and showing each of the different hormonal axes. ... It’s a good go-to review.”
“I thought it was a very good attempt to catalog and provide opportunities for policy, and particularly at [the National Institutes of Health], as they look at funding to show where are these gaps and to support appropriate research. I think the most important aspect to come of this is identifying research gaps for funding opportunities. I very much support that,” noted Dr. Bellantoni, who is clinical director of the division of geriatric medicine at Johns Hopkins University, Baltimore.
However, she also said that the 40-page document might be a bit much for busy clinicians, despite the bullet points at the end of each section.
“I would love to see an editorial that puts into perspective the take-home messages or a subsequent article that distills this into every day practice of care of older adults, both preventative and treatment care. ... I think that would be so useful.”
During the briefing, Dr. Cappola noted that the document need not be read all at once.
“It ended up being a large document, but you should not be intimidated by it because each section is only about 2,000 words. So, it’s really a kind of one-stop shop to be able to look across all these axes at once. We also wanted people to think about the common themes that occur across all these axes when considering what’s going on right now and for future research,” she said.
Dr. Stuenkel, Dr. Cappola, and Dr. Bellantoni reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The idea of the statement “is to be complete, but also to clarify some misunderstandings. ...We tried to be very clear in the language about what we know, where we can go, where we shouldn’t go, and what we still need to learn,” statement coauthor Cynthia A. Stuenkel, MD, of the University of California, San Diego, said in an interview.
The document is divided into nine parts or axes: growth hormone, adrenal, ovarian, testicular, thyroid, osteoporosis, vitamin D deficiency, type 2 diabetes, and water metabolism. Each section covers natural history and observational data in older individuals, available therapies, clinical trial data on efficacy and safety in older individuals, bulleted “key points,” and research gaps.
“Hormones and Aging: An Endocrine Society Scientific Statement” was presented at the annual meeting of the Endocrine Society and published online in the Journal of Clinical Endocrinology & Metabolism.
During a press briefing, writing group chair Anne R. Cappola, MD, of the University of Pennsylvania, Philadelphia, said the goal is to “provide a really concise summary across each of these areas. ... There are multiple hormonal changes that occur with age, so we really couldn’t limit ourselves to just one gland or the few that we commonly think about. We wanted to cover all the axes.”
The statement tackles several controversial areas, including hormone therapy for menopausal symptoms in women and hypogonadal symptoms in men, diabetes treatment goals in older adults, distinguishing between age-associated changes in thyroid function and early hypothyroidism, and vitamin D supplementation in older adults.
“Hormones have these almost mythical qualities to some people. ... ‘If I just had my hormones back the way they were, it would all work out.’ What we want to do is make sure that patients are being treated appropriately and that their symptoms are being heard and managed and ascribed to the appropriate problems and not necessarily to hormonal problems when they are not. ... Part of what we need to do is [provide] the evidence that we have, which includes evidence of when not to prescribe as well as [when] to prescribe,” Dr. Cappola said.
Not designed to be read all at once
In the menopause section, for example, one “key point” is that menopausal symptoms are common, vary in degree and bother, and can be effectively treated with a variety of therapies proven effective in randomized clinical trials. Another key point is that menopausal hormone therapy is safest for women who are younger than 60 years and less than 10 years since starting menopause.
“It’s almost 20 years since the original Women’s Health Initiative, and that led to an incredible falloff of prescribing hormone therapy and a falloff in teaching of our students, residents, fellows, and practitioners about [menopausal] hormone therapy. ... Hopefully, by issuing this kind of aging statement it gets people to read, think, and learn more. And, hopefully, we can improve the education of physicians. ... Menopause is a universal experience. Clinicians should know about it,” noted Dr. Stuenkel, who chaired the menopause section writing panel.
In the type 2 diabetes section, in the bullet points it is noted that oral glucose tolerance testing may reveal abnormal glucose status in older adults that are not picked up with hemoglobin A1c or fasting glucose levels and that glycemic targets should be individualized.
Asked to comment on the statement, Michele Bellantoni, MD, said: “This was a huge undertaking because there are so many areas of expertise here. I thought they did a very good job of reviewing the literature and showing each of the different hormonal axes. ... It’s a good go-to review.”
“I thought it was a very good attempt to catalog and provide opportunities for policy, and particularly at [the National Institutes of Health], as they look at funding to show where are these gaps and to support appropriate research. I think the most important aspect to come of this is identifying research gaps for funding opportunities. I very much support that,” noted Dr. Bellantoni, who is clinical director of the division of geriatric medicine at Johns Hopkins University, Baltimore.
However, she also said that the 40-page document might be a bit much for busy clinicians, despite the bullet points at the end of each section.
“I would love to see an editorial that puts into perspective the take-home messages or a subsequent article that distills this into every day practice of care of older adults, both preventative and treatment care. ... I think that would be so useful.”
During the briefing, Dr. Cappola noted that the document need not be read all at once.
“It ended up being a large document, but you should not be intimidated by it because each section is only about 2,000 words. So, it’s really a kind of one-stop shop to be able to look across all these axes at once. We also wanted people to think about the common themes that occur across all these axes when considering what’s going on right now and for future research,” she said.
Dr. Stuenkel, Dr. Cappola, and Dr. Bellantoni reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ENDO 2023
MCL Prognosis and Patient Education
You’ve been warned
Recently, Canada announced new regulations on tobacco, with warnings printed on individual cigarettes, such as “poison in every puff.” This is on top of the packaging already required to have 75% of its space devoted to similar warnings, often with graphic pictures, of the potential consequences.
Make no mistake, I don’t like cigarettes and try to get smokers to quit.
But I have to wonder how successful this is going to be. I mean, you’d have to have lived under a rock for the last 70 years (or more) to not know that cigarettes (and tobacco in general) aren’t good for you, and can cause stroke, heart disease, and a multitude of cancers.
I suppose you could ban cigarettes, but that only opens up a black market. From 1920 to 1933 the United States set an example for the world with prohibition, showing how such an idea can backfire horribly.
Realistically, there are always going to be people making bad health decisions of one kind or another, including myself. Whether it’s tobacco, alcohol, or a cheeseburger and fries.
Tobacco, of course, has a much worse track record than that of the cheeseburger. We all have to eat, even though some choices are better than others. Tobacco has absolutely no biological necessity, as do food, air, and water.
But it’s remarkably addictive, not to mention profitable. Those factors will always guarantee it a place in society.
At this point,
There’s a legitimate argument to be made in trying to keep people from starting. The teenage years, where we all tend to believe we’re immortal, are when a lot of habits (good and bad) form. If gruesome pictures and repeated warnings cut down on those numbers, then in the long run it’s a very good thing. Given that Canada’s goal is to cut tobacco use from 13% down to less than 5% by 2035, this could happen. Only time will tell how it plays out.
On a side note, here in the United States tobacco use is 19% of the population. This is actually somewhat surprising to me, as a brief, not particularly scientific, review of my charts for the past few weeks found that less than 5% of my patients do it. So either some are lying or (more likely), it’s just the demographics of my practice area.
But at some point it doesn’t matter how many warnings or gory pictures people see, or where they encounter them. Some will keep smoking out of habit. Some because they actually like it. Some to be defiant. Some just because they can. And no amount of warnings is going to change their minds.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Recently, Canada announced new regulations on tobacco, with warnings printed on individual cigarettes, such as “poison in every puff.” This is on top of the packaging already required to have 75% of its space devoted to similar warnings, often with graphic pictures, of the potential consequences.
Make no mistake, I don’t like cigarettes and try to get smokers to quit.
But I have to wonder how successful this is going to be. I mean, you’d have to have lived under a rock for the last 70 years (or more) to not know that cigarettes (and tobacco in general) aren’t good for you, and can cause stroke, heart disease, and a multitude of cancers.
I suppose you could ban cigarettes, but that only opens up a black market. From 1920 to 1933 the United States set an example for the world with prohibition, showing how such an idea can backfire horribly.
Realistically, there are always going to be people making bad health decisions of one kind or another, including myself. Whether it’s tobacco, alcohol, or a cheeseburger and fries.
Tobacco, of course, has a much worse track record than that of the cheeseburger. We all have to eat, even though some choices are better than others. Tobacco has absolutely no biological necessity, as do food, air, and water.
But it’s remarkably addictive, not to mention profitable. Those factors will always guarantee it a place in society.
At this point,
There’s a legitimate argument to be made in trying to keep people from starting. The teenage years, where we all tend to believe we’re immortal, are when a lot of habits (good and bad) form. If gruesome pictures and repeated warnings cut down on those numbers, then in the long run it’s a very good thing. Given that Canada’s goal is to cut tobacco use from 13% down to less than 5% by 2035, this could happen. Only time will tell how it plays out.
On a side note, here in the United States tobacco use is 19% of the population. This is actually somewhat surprising to me, as a brief, not particularly scientific, review of my charts for the past few weeks found that less than 5% of my patients do it. So either some are lying or (more likely), it’s just the demographics of my practice area.
But at some point it doesn’t matter how many warnings or gory pictures people see, or where they encounter them. Some will keep smoking out of habit. Some because they actually like it. Some to be defiant. Some just because they can. And no amount of warnings is going to change their minds.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Recently, Canada announced new regulations on tobacco, with warnings printed on individual cigarettes, such as “poison in every puff.” This is on top of the packaging already required to have 75% of its space devoted to similar warnings, often with graphic pictures, of the potential consequences.
Make no mistake, I don’t like cigarettes and try to get smokers to quit.
But I have to wonder how successful this is going to be. I mean, you’d have to have lived under a rock for the last 70 years (or more) to not know that cigarettes (and tobacco in general) aren’t good for you, and can cause stroke, heart disease, and a multitude of cancers.
I suppose you could ban cigarettes, but that only opens up a black market. From 1920 to 1933 the United States set an example for the world with prohibition, showing how such an idea can backfire horribly.
Realistically, there are always going to be people making bad health decisions of one kind or another, including myself. Whether it’s tobacco, alcohol, or a cheeseburger and fries.
Tobacco, of course, has a much worse track record than that of the cheeseburger. We all have to eat, even though some choices are better than others. Tobacco has absolutely no biological necessity, as do food, air, and water.
But it’s remarkably addictive, not to mention profitable. Those factors will always guarantee it a place in society.
At this point,
There’s a legitimate argument to be made in trying to keep people from starting. The teenage years, where we all tend to believe we’re immortal, are when a lot of habits (good and bad) form. If gruesome pictures and repeated warnings cut down on those numbers, then in the long run it’s a very good thing. Given that Canada’s goal is to cut tobacco use from 13% down to less than 5% by 2035, this could happen. Only time will tell how it plays out.
On a side note, here in the United States tobacco use is 19% of the population. This is actually somewhat surprising to me, as a brief, not particularly scientific, review of my charts for the past few weeks found that less than 5% of my patients do it. So either some are lying or (more likely), it’s just the demographics of my practice area.
But at some point it doesn’t matter how many warnings or gory pictures people see, or where they encounter them. Some will keep smoking out of habit. Some because they actually like it. Some to be defiant. Some just because they can. And no amount of warnings is going to change their minds.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Altered gut bacteria a biomarker of preclinical Alzheimer’s?
The findings open up the possibility of analyzing the gut microbiome to identify individuals at a higher risk for dementia and perhaps designing microbiome-altering preventive treatments to help stave off cognitive decline, researchers noted.
Study investigator Gautam Dantas, PhD, cautioned that it’s not known whether the gut is influencing the brain, or the brain is influencing the gut, “but this association is valuable to know in either case.
“It could be that the changes in the gut microbiome are just a readout of pathological changes in the brain. The other alternative is that the gut microbiome is contributing to AD, in which case, altering the gut microbiome with probiotics or fecal transfers might help change the course of the disease,” Dr. Dantas, Washington University, St. Louis, said in a news release.
The study was published online in Science Translational Medicine.
Stool test?
Multiple lines of evidence suggest a role for gut microbes in the evolution of AD pathogenesis. However, less is known about gut microbiome changes in the preclinical (presymptomatic) phase of AD.
To investigate, Dr. Dantas and colleagues studied 164 cognitively normal adults, 49 of whom had biomarker evidence of preclinical AD.
After the researchers accounted for clinical covariates and diet, those with preclinical AD had distinct gut microbial taxonomic profiles compared with their healthy controls.
The observed microbiome features correlated with amyloid and tau but not neurodegeneration biomarkers, “suggesting that the gut microbial community changes early in the disease process,” the researchers suggested.
They identified specific taxa that were associated with preclinical AD and including these microbiome features improved the accuracy, sensitivity, and specificity of machine learning classifiers for predicting preclinical AD status.
The findings suggest “markers in the stool might complement early screening measures for preclinical AD,” the researchers noted.
“The nice thing about using the gut microbiome as a screening tool is its simplicity and ease,” Beau Ances, MD, PhD, professor of neurology, at Washington University, St. Louis, said in the release.
“One day, individuals may be able to provide a stool sample and find out if they are at increased risk for developing AD. It would be much easier and less invasive and more accessible for a large proportion of the population, especially underrepresented groups, compared to brain scans or spinal taps,” Dr. Ances added.
The researchers have launched a 5-year follow-up study designed to help determine whether the differences in the gut microbiome are a cause or a result of the brain changes seen in early AD.
Caveats, cautionary notes
In a comment, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, cautioned that the study design means that it’s “not possible to prove one thing causes another. What it can show is that two or more aspects are in some way related, thus setting the stage for further research.”
Dr. Sexton noted that though the authors accounted for a number of variables in their models, including age, sex, race, education, body mass index, hypertension, and diabetes, and observed no differences in intake of any major nutrient group, “it’s still not possible to rule out that additional factors beyond the variations in gut microbiome contributed to the changes in brain markers of Alzheimer’s.”
Dr. Sexton also noted that the study population is not representative of all people living with AD, with the vast majority of those with preclinical AD in the study being White.
“If these findings are replicated and confirmed in study groups that are representative of our communities, it is possible that gut microbiome signatures could be a further addition to the suite of diagnostic tools employed in certain settings,” Dr. Sexton said.
This research was supported by the Infection Disease Society of America Foundation, the National Institute on Aging, the Brennan Fund and the Paula and Rodger Riney Foundation. Dr. Dantas, Dr. Ances and Dr. Sexton have no relevant disclosures.
A version of this article first appeared on Medscape.com.
The findings open up the possibility of analyzing the gut microbiome to identify individuals at a higher risk for dementia and perhaps designing microbiome-altering preventive treatments to help stave off cognitive decline, researchers noted.
Study investigator Gautam Dantas, PhD, cautioned that it’s not known whether the gut is influencing the brain, or the brain is influencing the gut, “but this association is valuable to know in either case.
“It could be that the changes in the gut microbiome are just a readout of pathological changes in the brain. The other alternative is that the gut microbiome is contributing to AD, in which case, altering the gut microbiome with probiotics or fecal transfers might help change the course of the disease,” Dr. Dantas, Washington University, St. Louis, said in a news release.
The study was published online in Science Translational Medicine.
Stool test?
Multiple lines of evidence suggest a role for gut microbes in the evolution of AD pathogenesis. However, less is known about gut microbiome changes in the preclinical (presymptomatic) phase of AD.
To investigate, Dr. Dantas and colleagues studied 164 cognitively normal adults, 49 of whom had biomarker evidence of preclinical AD.
After the researchers accounted for clinical covariates and diet, those with preclinical AD had distinct gut microbial taxonomic profiles compared with their healthy controls.
The observed microbiome features correlated with amyloid and tau but not neurodegeneration biomarkers, “suggesting that the gut microbial community changes early in the disease process,” the researchers suggested.
They identified specific taxa that were associated with preclinical AD and including these microbiome features improved the accuracy, sensitivity, and specificity of machine learning classifiers for predicting preclinical AD status.
The findings suggest “markers in the stool might complement early screening measures for preclinical AD,” the researchers noted.
“The nice thing about using the gut microbiome as a screening tool is its simplicity and ease,” Beau Ances, MD, PhD, professor of neurology, at Washington University, St. Louis, said in the release.
“One day, individuals may be able to provide a stool sample and find out if they are at increased risk for developing AD. It would be much easier and less invasive and more accessible for a large proportion of the population, especially underrepresented groups, compared to brain scans or spinal taps,” Dr. Ances added.
The researchers have launched a 5-year follow-up study designed to help determine whether the differences in the gut microbiome are a cause or a result of the brain changes seen in early AD.
Caveats, cautionary notes
In a comment, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, cautioned that the study design means that it’s “not possible to prove one thing causes another. What it can show is that two or more aspects are in some way related, thus setting the stage for further research.”
Dr. Sexton noted that though the authors accounted for a number of variables in their models, including age, sex, race, education, body mass index, hypertension, and diabetes, and observed no differences in intake of any major nutrient group, “it’s still not possible to rule out that additional factors beyond the variations in gut microbiome contributed to the changes in brain markers of Alzheimer’s.”
Dr. Sexton also noted that the study population is not representative of all people living with AD, with the vast majority of those with preclinical AD in the study being White.
“If these findings are replicated and confirmed in study groups that are representative of our communities, it is possible that gut microbiome signatures could be a further addition to the suite of diagnostic tools employed in certain settings,” Dr. Sexton said.
This research was supported by the Infection Disease Society of America Foundation, the National Institute on Aging, the Brennan Fund and the Paula and Rodger Riney Foundation. Dr. Dantas, Dr. Ances and Dr. Sexton have no relevant disclosures.
A version of this article first appeared on Medscape.com.
The findings open up the possibility of analyzing the gut microbiome to identify individuals at a higher risk for dementia and perhaps designing microbiome-altering preventive treatments to help stave off cognitive decline, researchers noted.
Study investigator Gautam Dantas, PhD, cautioned that it’s not known whether the gut is influencing the brain, or the brain is influencing the gut, “but this association is valuable to know in either case.
“It could be that the changes in the gut microbiome are just a readout of pathological changes in the brain. The other alternative is that the gut microbiome is contributing to AD, in which case, altering the gut microbiome with probiotics or fecal transfers might help change the course of the disease,” Dr. Dantas, Washington University, St. Louis, said in a news release.
The study was published online in Science Translational Medicine.
Stool test?
Multiple lines of evidence suggest a role for gut microbes in the evolution of AD pathogenesis. However, less is known about gut microbiome changes in the preclinical (presymptomatic) phase of AD.
To investigate, Dr. Dantas and colleagues studied 164 cognitively normal adults, 49 of whom had biomarker evidence of preclinical AD.
After the researchers accounted for clinical covariates and diet, those with preclinical AD had distinct gut microbial taxonomic profiles compared with their healthy controls.
The observed microbiome features correlated with amyloid and tau but not neurodegeneration biomarkers, “suggesting that the gut microbial community changes early in the disease process,” the researchers suggested.
They identified specific taxa that were associated with preclinical AD and including these microbiome features improved the accuracy, sensitivity, and specificity of machine learning classifiers for predicting preclinical AD status.
The findings suggest “markers in the stool might complement early screening measures for preclinical AD,” the researchers noted.
“The nice thing about using the gut microbiome as a screening tool is its simplicity and ease,” Beau Ances, MD, PhD, professor of neurology, at Washington University, St. Louis, said in the release.
“One day, individuals may be able to provide a stool sample and find out if they are at increased risk for developing AD. It would be much easier and less invasive and more accessible for a large proportion of the population, especially underrepresented groups, compared to brain scans or spinal taps,” Dr. Ances added.
The researchers have launched a 5-year follow-up study designed to help determine whether the differences in the gut microbiome are a cause or a result of the brain changes seen in early AD.
Caveats, cautionary notes
In a comment, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, cautioned that the study design means that it’s “not possible to prove one thing causes another. What it can show is that two or more aspects are in some way related, thus setting the stage for further research.”
Dr. Sexton noted that though the authors accounted for a number of variables in their models, including age, sex, race, education, body mass index, hypertension, and diabetes, and observed no differences in intake of any major nutrient group, “it’s still not possible to rule out that additional factors beyond the variations in gut microbiome contributed to the changes in brain markers of Alzheimer’s.”
Dr. Sexton also noted that the study population is not representative of all people living with AD, with the vast majority of those with preclinical AD in the study being White.
“If these findings are replicated and confirmed in study groups that are representative of our communities, it is possible that gut microbiome signatures could be a further addition to the suite of diagnostic tools employed in certain settings,” Dr. Sexton said.
This research was supported by the Infection Disease Society of America Foundation, the National Institute on Aging, the Brennan Fund and the Paula and Rodger Riney Foundation. Dr. Dantas, Dr. Ances and Dr. Sexton have no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM SCIENCE TRANSLATIONAL MEDICINE
A new nonhormonal option for menopausal hot flashes: What prescribers should know
This transcript has been edited for clarity.
Hello. I am Dr. JoAnn Pinkerton, professor of obstetrics and gynecology at the University of Virginia and a North American Menopause Society–credentialed menopause specialist.
I am excited to tell you about a brand-new, just-approved non-estrogen therapy for treatment of menopausal symptoms. . The manufacturer, Astellas, is expected to make fezolinetant available at pharmacies before the end of this year. This medication binds to and blocks the neurokinin 3 (NK3) receptor, which plays a role in regulating body temperature, leading to a reduction in hot flashes.
For women suffering from frequent moderate to severe hot flashes, fezolinetant is an exciting breakthrough in women’s health as it is a highly effective nonhormonal treatment that reduces hot flashes and improves quality of life.
In two phase 3 clinical trials (Johnson et al. and Lederman et al.), fezolinetant 45 mg reduced the frequency of vasomotor symptoms by about 65%, significantly more than placebo, and similar to the 75% reduction seen with hormone therapy. Fezolinetant’s efficacy becomes evident within 1 week, reducing both frequency and severity of hot flashes.
With respect to side effects, 1%-2% of the menopausal women participating in clinical trials reported adverse events, including headaches, abdominal pain, diarrhea, insomnia, back pain, hot flushes, and reversible elevated hepatic transaminases. Serious adverse events were infrequent.
Subgroup analysis of data presented at ACOG’s 2023 annual meeting noted fezolinetant’s effectiveness among diverse populations, including White or Black race, body mass index of 30 or higher, those younger or older than age 55, smokers, former smokers, and never smokers, in U.S. as well as in European trial participants.
With respect to safety, a 52-week placebo-controlled safety trial confirmed safety for this time period. Adverse effects on the endometrium were neither seen nor expected, as fezolinetant is a centrally acting non–estrogen-containing medication. In addition, no loss of bone density was seen.
Prior trials of neurokinin receptor antagonists suggested the potential for hepatotoxicity. Increases in ALT or AST noted in one of the phase 3 trials of fezolinetant were described as asymptomatic, isolated, intermittent, or transient and returned to baseline during treatment or after discontinuation. However, the FDA placed a warning about liver injury potential. Package labeling recommends baseline liver function tests before starting fezolinetant and at 3, 6, and 9 months. In addition, concomitant use of moderate CYP1A2 inhibitors, including many antidepressants and cimetidine, should be avoided.
As with other recently approved medications, I am concerned that high cost could prevent appropriate candidates from having access.
Until now, the FDA had approved only one nonhormone therapy for vasomotor symptoms, 7.5 mg paroxetine salt. However, neither this formulation nor off-label use of other SSRIs, SNRIs, gabapentinoids, oxybutynin, or clonidine are as effective as hormone therapy or fezolinetant for moderate to severe vasomotor symptoms.
For women with bothersome menopausal hot flashes who can’t or choose not to use hormone therapy, including those with estrogen-sensitive breast or uterine cancers, fezolinetant offers a much-needed, highly effective, safe, nonhormone/non-estrogen option to treat their hot flashes.
The FDA approved it for treating vasomotor symptoms of menopause (hot flashes and night sweats) but it also appears to improve sleep disruption, mood, and quality of life.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hello. I am Dr. JoAnn Pinkerton, professor of obstetrics and gynecology at the University of Virginia and a North American Menopause Society–credentialed menopause specialist.
I am excited to tell you about a brand-new, just-approved non-estrogen therapy for treatment of menopausal symptoms. . The manufacturer, Astellas, is expected to make fezolinetant available at pharmacies before the end of this year. This medication binds to and blocks the neurokinin 3 (NK3) receptor, which plays a role in regulating body temperature, leading to a reduction in hot flashes.
For women suffering from frequent moderate to severe hot flashes, fezolinetant is an exciting breakthrough in women’s health as it is a highly effective nonhormonal treatment that reduces hot flashes and improves quality of life.
In two phase 3 clinical trials (Johnson et al. and Lederman et al.), fezolinetant 45 mg reduced the frequency of vasomotor symptoms by about 65%, significantly more than placebo, and similar to the 75% reduction seen with hormone therapy. Fezolinetant’s efficacy becomes evident within 1 week, reducing both frequency and severity of hot flashes.
With respect to side effects, 1%-2% of the menopausal women participating in clinical trials reported adverse events, including headaches, abdominal pain, diarrhea, insomnia, back pain, hot flushes, and reversible elevated hepatic transaminases. Serious adverse events were infrequent.
Subgroup analysis of data presented at ACOG’s 2023 annual meeting noted fezolinetant’s effectiveness among diverse populations, including White or Black race, body mass index of 30 or higher, those younger or older than age 55, smokers, former smokers, and never smokers, in U.S. as well as in European trial participants.
With respect to safety, a 52-week placebo-controlled safety trial confirmed safety for this time period. Adverse effects on the endometrium were neither seen nor expected, as fezolinetant is a centrally acting non–estrogen-containing medication. In addition, no loss of bone density was seen.
Prior trials of neurokinin receptor antagonists suggested the potential for hepatotoxicity. Increases in ALT or AST noted in one of the phase 3 trials of fezolinetant were described as asymptomatic, isolated, intermittent, or transient and returned to baseline during treatment or after discontinuation. However, the FDA placed a warning about liver injury potential. Package labeling recommends baseline liver function tests before starting fezolinetant and at 3, 6, and 9 months. In addition, concomitant use of moderate CYP1A2 inhibitors, including many antidepressants and cimetidine, should be avoided.
As with other recently approved medications, I am concerned that high cost could prevent appropriate candidates from having access.
Until now, the FDA had approved only one nonhormone therapy for vasomotor symptoms, 7.5 mg paroxetine salt. However, neither this formulation nor off-label use of other SSRIs, SNRIs, gabapentinoids, oxybutynin, or clonidine are as effective as hormone therapy or fezolinetant for moderate to severe vasomotor symptoms.
For women with bothersome menopausal hot flashes who can’t or choose not to use hormone therapy, including those with estrogen-sensitive breast or uterine cancers, fezolinetant offers a much-needed, highly effective, safe, nonhormone/non-estrogen option to treat their hot flashes.
The FDA approved it for treating vasomotor symptoms of menopause (hot flashes and night sweats) but it also appears to improve sleep disruption, mood, and quality of life.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hello. I am Dr. JoAnn Pinkerton, professor of obstetrics and gynecology at the University of Virginia and a North American Menopause Society–credentialed menopause specialist.
I am excited to tell you about a brand-new, just-approved non-estrogen therapy for treatment of menopausal symptoms. . The manufacturer, Astellas, is expected to make fezolinetant available at pharmacies before the end of this year. This medication binds to and blocks the neurokinin 3 (NK3) receptor, which plays a role in regulating body temperature, leading to a reduction in hot flashes.
For women suffering from frequent moderate to severe hot flashes, fezolinetant is an exciting breakthrough in women’s health as it is a highly effective nonhormonal treatment that reduces hot flashes and improves quality of life.
In two phase 3 clinical trials (Johnson et al. and Lederman et al.), fezolinetant 45 mg reduced the frequency of vasomotor symptoms by about 65%, significantly more than placebo, and similar to the 75% reduction seen with hormone therapy. Fezolinetant’s efficacy becomes evident within 1 week, reducing both frequency and severity of hot flashes.
With respect to side effects, 1%-2% of the menopausal women participating in clinical trials reported adverse events, including headaches, abdominal pain, diarrhea, insomnia, back pain, hot flushes, and reversible elevated hepatic transaminases. Serious adverse events were infrequent.
Subgroup analysis of data presented at ACOG’s 2023 annual meeting noted fezolinetant’s effectiveness among diverse populations, including White or Black race, body mass index of 30 or higher, those younger or older than age 55, smokers, former smokers, and never smokers, in U.S. as well as in European trial participants.
With respect to safety, a 52-week placebo-controlled safety trial confirmed safety for this time period. Adverse effects on the endometrium were neither seen nor expected, as fezolinetant is a centrally acting non–estrogen-containing medication. In addition, no loss of bone density was seen.
Prior trials of neurokinin receptor antagonists suggested the potential for hepatotoxicity. Increases in ALT or AST noted in one of the phase 3 trials of fezolinetant were described as asymptomatic, isolated, intermittent, or transient and returned to baseline during treatment or after discontinuation. However, the FDA placed a warning about liver injury potential. Package labeling recommends baseline liver function tests before starting fezolinetant and at 3, 6, and 9 months. In addition, concomitant use of moderate CYP1A2 inhibitors, including many antidepressants and cimetidine, should be avoided.
As with other recently approved medications, I am concerned that high cost could prevent appropriate candidates from having access.
Until now, the FDA had approved only one nonhormone therapy for vasomotor symptoms, 7.5 mg paroxetine salt. However, neither this formulation nor off-label use of other SSRIs, SNRIs, gabapentinoids, oxybutynin, or clonidine are as effective as hormone therapy or fezolinetant for moderate to severe vasomotor symptoms.
For women with bothersome menopausal hot flashes who can’t or choose not to use hormone therapy, including those with estrogen-sensitive breast or uterine cancers, fezolinetant offers a much-needed, highly effective, safe, nonhormone/non-estrogen option to treat their hot flashes.
The FDA approved it for treating vasomotor symptoms of menopause (hot flashes and night sweats) but it also appears to improve sleep disruption, mood, and quality of life.
A version of this article first appeared on Medscape.com.
Probiotics an effective adjunct to antidepressants for major depression
By the end of the 8-week pilot study, participants who had an incomplete response to antidepressants prior to taking probiotics scored better on measures of anxiety and depression versus placebo.
“This was a pilot study, designed as an initial exploration of whether improving gut health with probiotics could act as a new pathway for supporting mood and mental health,” study investigator Viktoriya Nikolova, PhD, Institute of Psychiatry, Psychology and Neuroscience at King’s College London, said in an interview.
“While very promising and exciting, our findings are only the first step, and larger trials are needed,” she noted.
The findings were published online in JAMA Psychiatry.
Gut-brain axis
It is estimated that up to 60% of people taking antidepressants for major depressive disorder (MDD) do not achieve full response.
With an eye on the so-called gut-brain axis as a treatment target for depression, the researchers conducted a meta-analysis of seven randomized controlled trials (RCT) in 2021 and found that probiotics appeared effective in reducing depressive symptoms when taken alongside antidepressants. The studies in this meta-analysis either reported poor adherence rates or did not investigate how well study participants tolerated probiotics.
To further investigate, Dr. Nikolova and team launched a pilot RCT by recruiting study participants from primary and secondary health care services, and through general advertising in London. Data were collected from September 2019 to May 2022.
They included 49 adults diagnosed with MDD with an incomplete antidepressant response, indicated by a score of greater than 13 on the Hamilton Depression Rating Scale-17 (HAMD-17).
Half of the participants were randomly assigned to receive a widely available, proprietary, 14-strain blend probiotic supplement, and half received placebo. Both groups took their study drug four times per day during the 8-week trial.
At baseline, 4 weeks, and 8 weeks, investigators assessed the participants for depression with the HAMD-17, the Inventory of Depressive Symptomatology (IDS) Self-Report, and anxiety with the Hamilton Anxiety Rating Scale (HAMA).
The majority of participants (80%) were female with a mean age of 32 years. Adherence was high, with 97% of the doses taken as required, and no adverse events were reported.
Standardized effect sizes from linear mixed models demonstrated that, when compared with the placebo group, the probiotic group had more improvement in depressive symptoms according to the HAMD-17 (week 4: SES, 0.70; 95% confidence interval, 0.01-0.98) and IDS Self Report (week 8: SES, 0.64; 95% CI, 0.03-0.87).
When compared with the placebo group, the probiotic group also experienced greater improvements in anxiety symptoms according to the HAMA (week 4: SES, 0.67; 95% CI, 0-0.95; week 8: SES, 0.79; 95% CI, 0.06-1.05).
Dr. Nikolova said a large follow-up trial is planned to further confirm the results.
Nutritional psychiatrist Drew Ramsey, MD, author of Eat to Beat Depression and Anxiety and assistant clinical professor of psychiatry at Columbia University, New York, said in an interview: “This randomized clinical trial adds to the considerable evidence that food choices impact depression outcomes.”
He further noted that, “in nutritional psychiatry, we recommend eating fermented foods as they have been shown to improve microbiome diversity and decrease markers of inflammation.”
Dr. Ramsey noted that the RCT used the equivalent colony-forming unit of a “single serving of kombucha.”
“In our clinical group and our nutritional psychiatry course for clinicians, we recommend fermented foods over probiotics as this is the most sustainable, evidence-based way to improve microbiome diversity,” said Dr. Ramsey, citing recent research by Gardner and colleagues at Stanford (Calif.) University.
“This is an industry-funded trial that adds to the evidence base but should be interpreted by patients and clinicians as promoting consumption of more kefir, kimchi, and kombucha, not that patients should take probiotics,” he said.
A key place for probiotics in mental health
Commenting on the study, Uma Naidoo, MD, said: “As I shared throughout my first book, This is Your Brain on Food, there is a real place for the use of probiotics in mental health, including the importance of the gut-brain connection.”
Dr. Naidoo is the director of nutritional and metabolic psychiatry at Massachusetts General Hospital and of nutritional psychiatry at the MGH Academy, both in Boston.
She noted that, when a person stops using a probiotic after trying it out, the positive changes in the gut are reversed, so “remaining consistent in taking the probiotic is important if you have found it helpful for your mood.”
Dr. Naidoo added that “each person’s gut microbiome is so unique that it is likely not every human being will have the same reaction to a probiotic.”
“Eating foods with live probiotics may also benefit gut health and, therefore, mood,” she said. The same goes with eating fermented foods with live active cultures.”
The study was funded by a Medical Research Council Industrial CASE PhD Studentship with ADM Protexin (supplier of the probiotics) as the industry partner and additional support from Freya Green. Dr. Nikolova has received grants from the Medical Research Council and ADM Protexin during the conduct of the study as well as personal fees from Janssen outside the submitted work.
A version of this article first appeared on Medscape.com.
By the end of the 8-week pilot study, participants who had an incomplete response to antidepressants prior to taking probiotics scored better on measures of anxiety and depression versus placebo.
“This was a pilot study, designed as an initial exploration of whether improving gut health with probiotics could act as a new pathway for supporting mood and mental health,” study investigator Viktoriya Nikolova, PhD, Institute of Psychiatry, Psychology and Neuroscience at King’s College London, said in an interview.
“While very promising and exciting, our findings are only the first step, and larger trials are needed,” she noted.
The findings were published online in JAMA Psychiatry.
Gut-brain axis
It is estimated that up to 60% of people taking antidepressants for major depressive disorder (MDD) do not achieve full response.
With an eye on the so-called gut-brain axis as a treatment target for depression, the researchers conducted a meta-analysis of seven randomized controlled trials (RCT) in 2021 and found that probiotics appeared effective in reducing depressive symptoms when taken alongside antidepressants. The studies in this meta-analysis either reported poor adherence rates or did not investigate how well study participants tolerated probiotics.
To further investigate, Dr. Nikolova and team launched a pilot RCT by recruiting study participants from primary and secondary health care services, and through general advertising in London. Data were collected from September 2019 to May 2022.
They included 49 adults diagnosed with MDD with an incomplete antidepressant response, indicated by a score of greater than 13 on the Hamilton Depression Rating Scale-17 (HAMD-17).
Half of the participants were randomly assigned to receive a widely available, proprietary, 14-strain blend probiotic supplement, and half received placebo. Both groups took their study drug four times per day during the 8-week trial.
At baseline, 4 weeks, and 8 weeks, investigators assessed the participants for depression with the HAMD-17, the Inventory of Depressive Symptomatology (IDS) Self-Report, and anxiety with the Hamilton Anxiety Rating Scale (HAMA).
The majority of participants (80%) were female with a mean age of 32 years. Adherence was high, with 97% of the doses taken as required, and no adverse events were reported.
Standardized effect sizes from linear mixed models demonstrated that, when compared with the placebo group, the probiotic group had more improvement in depressive symptoms according to the HAMD-17 (week 4: SES, 0.70; 95% confidence interval, 0.01-0.98) and IDS Self Report (week 8: SES, 0.64; 95% CI, 0.03-0.87).
When compared with the placebo group, the probiotic group also experienced greater improvements in anxiety symptoms according to the HAMA (week 4: SES, 0.67; 95% CI, 0-0.95; week 8: SES, 0.79; 95% CI, 0.06-1.05).
Dr. Nikolova said a large follow-up trial is planned to further confirm the results.
Nutritional psychiatrist Drew Ramsey, MD, author of Eat to Beat Depression and Anxiety and assistant clinical professor of psychiatry at Columbia University, New York, said in an interview: “This randomized clinical trial adds to the considerable evidence that food choices impact depression outcomes.”
He further noted that, “in nutritional psychiatry, we recommend eating fermented foods as they have been shown to improve microbiome diversity and decrease markers of inflammation.”
Dr. Ramsey noted that the RCT used the equivalent colony-forming unit of a “single serving of kombucha.”
“In our clinical group and our nutritional psychiatry course for clinicians, we recommend fermented foods over probiotics as this is the most sustainable, evidence-based way to improve microbiome diversity,” said Dr. Ramsey, citing recent research by Gardner and colleagues at Stanford (Calif.) University.
“This is an industry-funded trial that adds to the evidence base but should be interpreted by patients and clinicians as promoting consumption of more kefir, kimchi, and kombucha, not that patients should take probiotics,” he said.
A key place for probiotics in mental health
Commenting on the study, Uma Naidoo, MD, said: “As I shared throughout my first book, This is Your Brain on Food, there is a real place for the use of probiotics in mental health, including the importance of the gut-brain connection.”
Dr. Naidoo is the director of nutritional and metabolic psychiatry at Massachusetts General Hospital and of nutritional psychiatry at the MGH Academy, both in Boston.
She noted that, when a person stops using a probiotic after trying it out, the positive changes in the gut are reversed, so “remaining consistent in taking the probiotic is important if you have found it helpful for your mood.”
Dr. Naidoo added that “each person’s gut microbiome is so unique that it is likely not every human being will have the same reaction to a probiotic.”
“Eating foods with live probiotics may also benefit gut health and, therefore, mood,” she said. The same goes with eating fermented foods with live active cultures.”
The study was funded by a Medical Research Council Industrial CASE PhD Studentship with ADM Protexin (supplier of the probiotics) as the industry partner and additional support from Freya Green. Dr. Nikolova has received grants from the Medical Research Council and ADM Protexin during the conduct of the study as well as personal fees from Janssen outside the submitted work.
A version of this article first appeared on Medscape.com.
By the end of the 8-week pilot study, participants who had an incomplete response to antidepressants prior to taking probiotics scored better on measures of anxiety and depression versus placebo.
“This was a pilot study, designed as an initial exploration of whether improving gut health with probiotics could act as a new pathway for supporting mood and mental health,” study investigator Viktoriya Nikolova, PhD, Institute of Psychiatry, Psychology and Neuroscience at King’s College London, said in an interview.
“While very promising and exciting, our findings are only the first step, and larger trials are needed,” she noted.
The findings were published online in JAMA Psychiatry.
Gut-brain axis
It is estimated that up to 60% of people taking antidepressants for major depressive disorder (MDD) do not achieve full response.
With an eye on the so-called gut-brain axis as a treatment target for depression, the researchers conducted a meta-analysis of seven randomized controlled trials (RCT) in 2021 and found that probiotics appeared effective in reducing depressive symptoms when taken alongside antidepressants. The studies in this meta-analysis either reported poor adherence rates or did not investigate how well study participants tolerated probiotics.
To further investigate, Dr. Nikolova and team launched a pilot RCT by recruiting study participants from primary and secondary health care services, and through general advertising in London. Data were collected from September 2019 to May 2022.
They included 49 adults diagnosed with MDD with an incomplete antidepressant response, indicated by a score of greater than 13 on the Hamilton Depression Rating Scale-17 (HAMD-17).
Half of the participants were randomly assigned to receive a widely available, proprietary, 14-strain blend probiotic supplement, and half received placebo. Both groups took their study drug four times per day during the 8-week trial.
At baseline, 4 weeks, and 8 weeks, investigators assessed the participants for depression with the HAMD-17, the Inventory of Depressive Symptomatology (IDS) Self-Report, and anxiety with the Hamilton Anxiety Rating Scale (HAMA).
The majority of participants (80%) were female with a mean age of 32 years. Adherence was high, with 97% of the doses taken as required, and no adverse events were reported.
Standardized effect sizes from linear mixed models demonstrated that, when compared with the placebo group, the probiotic group had more improvement in depressive symptoms according to the HAMD-17 (week 4: SES, 0.70; 95% confidence interval, 0.01-0.98) and IDS Self Report (week 8: SES, 0.64; 95% CI, 0.03-0.87).
When compared with the placebo group, the probiotic group also experienced greater improvements in anxiety symptoms according to the HAMA (week 4: SES, 0.67; 95% CI, 0-0.95; week 8: SES, 0.79; 95% CI, 0.06-1.05).
Dr. Nikolova said a large follow-up trial is planned to further confirm the results.
Nutritional psychiatrist Drew Ramsey, MD, author of Eat to Beat Depression and Anxiety and assistant clinical professor of psychiatry at Columbia University, New York, said in an interview: “This randomized clinical trial adds to the considerable evidence that food choices impact depression outcomes.”
He further noted that, “in nutritional psychiatry, we recommend eating fermented foods as they have been shown to improve microbiome diversity and decrease markers of inflammation.”
Dr. Ramsey noted that the RCT used the equivalent colony-forming unit of a “single serving of kombucha.”
“In our clinical group and our nutritional psychiatry course for clinicians, we recommend fermented foods over probiotics as this is the most sustainable, evidence-based way to improve microbiome diversity,” said Dr. Ramsey, citing recent research by Gardner and colleagues at Stanford (Calif.) University.
“This is an industry-funded trial that adds to the evidence base but should be interpreted by patients and clinicians as promoting consumption of more kefir, kimchi, and kombucha, not that patients should take probiotics,” he said.
A key place for probiotics in mental health
Commenting on the study, Uma Naidoo, MD, said: “As I shared throughout my first book, This is Your Brain on Food, there is a real place for the use of probiotics in mental health, including the importance of the gut-brain connection.”
Dr. Naidoo is the director of nutritional and metabolic psychiatry at Massachusetts General Hospital and of nutritional psychiatry at the MGH Academy, both in Boston.
She noted that, when a person stops using a probiotic after trying it out, the positive changes in the gut are reversed, so “remaining consistent in taking the probiotic is important if you have found it helpful for your mood.”
Dr. Naidoo added that “each person’s gut microbiome is so unique that it is likely not every human being will have the same reaction to a probiotic.”
“Eating foods with live probiotics may also benefit gut health and, therefore, mood,” she said. The same goes with eating fermented foods with live active cultures.”
The study was funded by a Medical Research Council Industrial CASE PhD Studentship with ADM Protexin (supplier of the probiotics) as the industry partner and additional support from Freya Green. Dr. Nikolova has received grants from the Medical Research Council and ADM Protexin during the conduct of the study as well as personal fees from Janssen outside the submitted work.
A version of this article first appeared on Medscape.com.
FROM JAMA PSYCHIATRY
‘Deprescribing’: Should some older adults shed their meds?
Joanne Lynn, MD, has lost track of the number of times in her 40 years as a geriatrician she’s seen a new patient come to her office carrying a bucket full of prescription medications – many of which they don’t need.
Dr. Lynn, who is on the faculty of George Washington University,Washington, recalled one woman who unwittingly was taking two blood pressure medications with different names.
“The risks included all the side effects overdosing carries,” Dr. Lynn said, ranging from blurred vision and crankiness to organ failure and even death.
For doctors with patients who don’t know they’re taking too much of a medication, “you wonder whether the drug is causing the health problems, and it’s a symptom of the wrong medication,” rather than a symptom of an undiagnosed illness, she said.
Patients often assume their health providers check for drug interactions or assess if a medication is no longer needed, and will catch extra prescriptions. That could be a risky assumption. Some doctors may prescribe yet another prescription to manage the side effects of an unnecessary drug, instead of doing a medication review and potentially “deprescribing” or discontinuing, a treatment that’s no longer needed.
About 57% of people age 65 years or older take five or more medications regularly – a concept known as polypharmacy, a study published in 2020 in the Journal of the American Geriatrics Society shows. While doctors prescribe drugs to help patients manage various ailments, as a list of medications grows, so do potential complications.
An older adult might forget to tell their doctor what they’re taking, or maybe they don’t even know what they’re taking or why, Dr. Lynn said.
“In some cases, a doctor just added a drug to treat something, not realizing they were already taking something else for it,” she said. “Of course, the situation of whether these patients can even afford all these drugs matters a lot, too.”
Some older adults may pick and choose which medications to take based on cost, not knowing which prescriptions are necessary, Dr. Lynn said.
Finding the ‘right balance’
Indeed, if given the option, up to 80% of older adults ages 50-80 would be open to stopping one or more of their prescribed medications, according to a 2023 poll by researchers at the University of Michigan, Ann Arbor.
“A lot of drugs that people take might have been appropriate at one point, but might have outlived their usefulness for that individual,” said Michael Steinman, MD, a professor of medicine and a geriatrician at the University of California, San Francisco, and coprincipal investigator of the U.S. Deprescribing Research Network, a doctor group focused on improving medication use for older adults.
“Having fewer medications can actually be beneficial,” he said. “You can take too many medications; you can take too few. The optimal thing is finding what is the right balance for you.”
Defining how many medications is too many depends on each person, which is why caregivers and older adults can ask their doctor for a review of medications that have multiplied over time.
By reevaluating their medications, older adults can actually lower their chances of potentially harmful side effects, and avoid the spiral of being prescribed even more medications, said Sarah Vordenberg, PharmD, MPH, a clinical associate professor at the University of Michigan’s College of Pharmacy, Ann Arbor.
“It’s not really the number of medications, it’s [about] are they inappropriate or unnecessary medications for a patient,” she said.
Patients and caregivers can ask for an honest conversation with their doctor. The University of Michigan poll found that more than 90% of older adults who took prescription medications expected their health care provider to review their medicines during a regular visit.
But doctors often need prompting from patients to start a review.
“The clinical inertia, or maintaining the status quo, unfortunately is a lot of times easier than having time-intensive conversations,” Dr. Vordenberg said.
Ask questions
Sara Merwin spent many years helping manage her parents’ medical appointments and health as they transitioned from living independently in Colorado to a retirement community and finally a nursing home. Ms. Merwin, coauthor of “The Informed Patient,” said her father was taking a long list of medications, and she often asked his primary care doctor for a medication review.
“I felt that my father at his age and his frailty didn’t need as many meds as he was on,” said Ms. Merwin, who lives in Long Island, N.Y. “So we went over his meds, and I asked, ‘Does he really need to be on this?’ ‘Does he really need to be on that?’ ”
She questioned one medication in particular, a statin to lower his cholesterol and risk of a heart attack.
“I thought possibly the statin was causing some myalgia, some muscle aches in his legs, which is why I advocated for coming off it,” she said.
The primary care doctor discontinued the anticholesterol drug.
Local pharmacies can also serve as a starting point for older adults and caregivers, where a pharmacist can give them more information on whether a particular combination of the medications taken may be harmful. In states that allow for pharmacists to prescribe some medications, pharmacists may be able to consolidate some of the medications or advise that a patient stop taking one or more, Dr. Vordenberg said.
“All pharmacists have the training to do a comprehensive medication review,” she said. “All pharmacists have the ability to follow up with the patient to find out how the deprescribing is going.”
Ms. Merwin’s parents received their prescriptions from a “small mom-and-pop pharmacy, where they were on a first-name basis with the pharmacist who really looked out for them. So they had that expertise available to them,” she said.
With information in hand on potentially unnecessary medications, the work of shedding medications should be done along with health care providers, some of whom prescribed the medications in the first place.
Many older adults live in geographically isolated areas without pharmacies, or receive prescriptions from mail-order pharmacies. In this case, Medicare plans offer free medication reviews with a doctor or pharmacist – known as a medication therapy management program – and provide recommendations for taking each drug.
Ms. Merwin’s father died in early 2020. She sometimes questions whether he should have stayed on the statin for longer, or if the doctor agreed too quickly without doing more research. But overall, she doesn’t regret raising the question with his health care providers, and she advises other caregivers and older adults to pay attention to medication lists.
“It’s dangerous to be passive when it comes to one’s health care now,” Ms. Merwin said. “That’s a difficult message for older adults to hear because they have grown up with the primacy of the doctor and the authority of the doctor, as opposed to it being a collaborative relationship.”
A version of this article first appeared on WebMD.com.
Joanne Lynn, MD, has lost track of the number of times in her 40 years as a geriatrician she’s seen a new patient come to her office carrying a bucket full of prescription medications – many of which they don’t need.
Dr. Lynn, who is on the faculty of George Washington University,Washington, recalled one woman who unwittingly was taking two blood pressure medications with different names.
“The risks included all the side effects overdosing carries,” Dr. Lynn said, ranging from blurred vision and crankiness to organ failure and even death.
For doctors with patients who don’t know they’re taking too much of a medication, “you wonder whether the drug is causing the health problems, and it’s a symptom of the wrong medication,” rather than a symptom of an undiagnosed illness, she said.
Patients often assume their health providers check for drug interactions or assess if a medication is no longer needed, and will catch extra prescriptions. That could be a risky assumption. Some doctors may prescribe yet another prescription to manage the side effects of an unnecessary drug, instead of doing a medication review and potentially “deprescribing” or discontinuing, a treatment that’s no longer needed.
About 57% of people age 65 years or older take five or more medications regularly – a concept known as polypharmacy, a study published in 2020 in the Journal of the American Geriatrics Society shows. While doctors prescribe drugs to help patients manage various ailments, as a list of medications grows, so do potential complications.
An older adult might forget to tell their doctor what they’re taking, or maybe they don’t even know what they’re taking or why, Dr. Lynn said.
“In some cases, a doctor just added a drug to treat something, not realizing they were already taking something else for it,” she said. “Of course, the situation of whether these patients can even afford all these drugs matters a lot, too.”
Some older adults may pick and choose which medications to take based on cost, not knowing which prescriptions are necessary, Dr. Lynn said.
Finding the ‘right balance’
Indeed, if given the option, up to 80% of older adults ages 50-80 would be open to stopping one or more of their prescribed medications, according to a 2023 poll by researchers at the University of Michigan, Ann Arbor.
“A lot of drugs that people take might have been appropriate at one point, but might have outlived their usefulness for that individual,” said Michael Steinman, MD, a professor of medicine and a geriatrician at the University of California, San Francisco, and coprincipal investigator of the U.S. Deprescribing Research Network, a doctor group focused on improving medication use for older adults.
“Having fewer medications can actually be beneficial,” he said. “You can take too many medications; you can take too few. The optimal thing is finding what is the right balance for you.”
Defining how many medications is too many depends on each person, which is why caregivers and older adults can ask their doctor for a review of medications that have multiplied over time.
By reevaluating their medications, older adults can actually lower their chances of potentially harmful side effects, and avoid the spiral of being prescribed even more medications, said Sarah Vordenberg, PharmD, MPH, a clinical associate professor at the University of Michigan’s College of Pharmacy, Ann Arbor.
“It’s not really the number of medications, it’s [about] are they inappropriate or unnecessary medications for a patient,” she said.
Patients and caregivers can ask for an honest conversation with their doctor. The University of Michigan poll found that more than 90% of older adults who took prescription medications expected their health care provider to review their medicines during a regular visit.
But doctors often need prompting from patients to start a review.
“The clinical inertia, or maintaining the status quo, unfortunately is a lot of times easier than having time-intensive conversations,” Dr. Vordenberg said.
Ask questions
Sara Merwin spent many years helping manage her parents’ medical appointments and health as they transitioned from living independently in Colorado to a retirement community and finally a nursing home. Ms. Merwin, coauthor of “The Informed Patient,” said her father was taking a long list of medications, and she often asked his primary care doctor for a medication review.
“I felt that my father at his age and his frailty didn’t need as many meds as he was on,” said Ms. Merwin, who lives in Long Island, N.Y. “So we went over his meds, and I asked, ‘Does he really need to be on this?’ ‘Does he really need to be on that?’ ”
She questioned one medication in particular, a statin to lower his cholesterol and risk of a heart attack.
“I thought possibly the statin was causing some myalgia, some muscle aches in his legs, which is why I advocated for coming off it,” she said.
The primary care doctor discontinued the anticholesterol drug.
Local pharmacies can also serve as a starting point for older adults and caregivers, where a pharmacist can give them more information on whether a particular combination of the medications taken may be harmful. In states that allow for pharmacists to prescribe some medications, pharmacists may be able to consolidate some of the medications or advise that a patient stop taking one or more, Dr. Vordenberg said.
“All pharmacists have the training to do a comprehensive medication review,” she said. “All pharmacists have the ability to follow up with the patient to find out how the deprescribing is going.”
Ms. Merwin’s parents received their prescriptions from a “small mom-and-pop pharmacy, where they were on a first-name basis with the pharmacist who really looked out for them. So they had that expertise available to them,” she said.
With information in hand on potentially unnecessary medications, the work of shedding medications should be done along with health care providers, some of whom prescribed the medications in the first place.
Many older adults live in geographically isolated areas without pharmacies, or receive prescriptions from mail-order pharmacies. In this case, Medicare plans offer free medication reviews with a doctor or pharmacist – known as a medication therapy management program – and provide recommendations for taking each drug.
Ms. Merwin’s father died in early 2020. She sometimes questions whether he should have stayed on the statin for longer, or if the doctor agreed too quickly without doing more research. But overall, she doesn’t regret raising the question with his health care providers, and she advises other caregivers and older adults to pay attention to medication lists.
“It’s dangerous to be passive when it comes to one’s health care now,” Ms. Merwin said. “That’s a difficult message for older adults to hear because they have grown up with the primacy of the doctor and the authority of the doctor, as opposed to it being a collaborative relationship.”
A version of this article first appeared on WebMD.com.
Joanne Lynn, MD, has lost track of the number of times in her 40 years as a geriatrician she’s seen a new patient come to her office carrying a bucket full of prescription medications – many of which they don’t need.
Dr. Lynn, who is on the faculty of George Washington University,Washington, recalled one woman who unwittingly was taking two blood pressure medications with different names.
“The risks included all the side effects overdosing carries,” Dr. Lynn said, ranging from blurred vision and crankiness to organ failure and even death.
For doctors with patients who don’t know they’re taking too much of a medication, “you wonder whether the drug is causing the health problems, and it’s a symptom of the wrong medication,” rather than a symptom of an undiagnosed illness, she said.
Patients often assume their health providers check for drug interactions or assess if a medication is no longer needed, and will catch extra prescriptions. That could be a risky assumption. Some doctors may prescribe yet another prescription to manage the side effects of an unnecessary drug, instead of doing a medication review and potentially “deprescribing” or discontinuing, a treatment that’s no longer needed.
About 57% of people age 65 years or older take five or more medications regularly – a concept known as polypharmacy, a study published in 2020 in the Journal of the American Geriatrics Society shows. While doctors prescribe drugs to help patients manage various ailments, as a list of medications grows, so do potential complications.
An older adult might forget to tell their doctor what they’re taking, or maybe they don’t even know what they’re taking or why, Dr. Lynn said.
“In some cases, a doctor just added a drug to treat something, not realizing they were already taking something else for it,” she said. “Of course, the situation of whether these patients can even afford all these drugs matters a lot, too.”
Some older adults may pick and choose which medications to take based on cost, not knowing which prescriptions are necessary, Dr. Lynn said.
Finding the ‘right balance’
Indeed, if given the option, up to 80% of older adults ages 50-80 would be open to stopping one or more of their prescribed medications, according to a 2023 poll by researchers at the University of Michigan, Ann Arbor.
“A lot of drugs that people take might have been appropriate at one point, but might have outlived their usefulness for that individual,” said Michael Steinman, MD, a professor of medicine and a geriatrician at the University of California, San Francisco, and coprincipal investigator of the U.S. Deprescribing Research Network, a doctor group focused on improving medication use for older adults.
“Having fewer medications can actually be beneficial,” he said. “You can take too many medications; you can take too few. The optimal thing is finding what is the right balance for you.”
Defining how many medications is too many depends on each person, which is why caregivers and older adults can ask their doctor for a review of medications that have multiplied over time.
By reevaluating their medications, older adults can actually lower their chances of potentially harmful side effects, and avoid the spiral of being prescribed even more medications, said Sarah Vordenberg, PharmD, MPH, a clinical associate professor at the University of Michigan’s College of Pharmacy, Ann Arbor.
“It’s not really the number of medications, it’s [about] are they inappropriate or unnecessary medications for a patient,” she said.
Patients and caregivers can ask for an honest conversation with their doctor. The University of Michigan poll found that more than 90% of older adults who took prescription medications expected their health care provider to review their medicines during a regular visit.
But doctors often need prompting from patients to start a review.
“The clinical inertia, or maintaining the status quo, unfortunately is a lot of times easier than having time-intensive conversations,” Dr. Vordenberg said.
Ask questions
Sara Merwin spent many years helping manage her parents’ medical appointments and health as they transitioned from living independently in Colorado to a retirement community and finally a nursing home. Ms. Merwin, coauthor of “The Informed Patient,” said her father was taking a long list of medications, and she often asked his primary care doctor for a medication review.
“I felt that my father at his age and his frailty didn’t need as many meds as he was on,” said Ms. Merwin, who lives in Long Island, N.Y. “So we went over his meds, and I asked, ‘Does he really need to be on this?’ ‘Does he really need to be on that?’ ”
She questioned one medication in particular, a statin to lower his cholesterol and risk of a heart attack.
“I thought possibly the statin was causing some myalgia, some muscle aches in his legs, which is why I advocated for coming off it,” she said.
The primary care doctor discontinued the anticholesterol drug.
Local pharmacies can also serve as a starting point for older adults and caregivers, where a pharmacist can give them more information on whether a particular combination of the medications taken may be harmful. In states that allow for pharmacists to prescribe some medications, pharmacists may be able to consolidate some of the medications or advise that a patient stop taking one or more, Dr. Vordenberg said.
“All pharmacists have the training to do a comprehensive medication review,” she said. “All pharmacists have the ability to follow up with the patient to find out how the deprescribing is going.”
Ms. Merwin’s parents received their prescriptions from a “small mom-and-pop pharmacy, where they were on a first-name basis with the pharmacist who really looked out for them. So they had that expertise available to them,” she said.
With information in hand on potentially unnecessary medications, the work of shedding medications should be done along with health care providers, some of whom prescribed the medications in the first place.
Many older adults live in geographically isolated areas without pharmacies, or receive prescriptions from mail-order pharmacies. In this case, Medicare plans offer free medication reviews with a doctor or pharmacist – known as a medication therapy management program – and provide recommendations for taking each drug.
Ms. Merwin’s father died in early 2020. She sometimes questions whether he should have stayed on the statin for longer, or if the doctor agreed too quickly without doing more research. But overall, she doesn’t regret raising the question with his health care providers, and she advises other caregivers and older adults to pay attention to medication lists.
“It’s dangerous to be passive when it comes to one’s health care now,” Ms. Merwin said. “That’s a difficult message for older adults to hear because they have grown up with the primacy of the doctor and the authority of the doctor, as opposed to it being a collaborative relationship.”
A version of this article first appeared on WebMD.com.
Syncope not associated with increased risk for car crash
In a case-crossover study that examined health and driving data for about 3,000 drivers in British Columbia, researchers found similar rates of ED visits for syncope before the dates of car crashes (1.6%) and before control dates (1.2%).
“An emergency visit for syncope did not appear to increase the risk of subsequent traffic crash,” lead author John A. Staples, MD, MPH, clinical associate professor of general internal medicine at the University of British Columbia, Vancouver, said in an interview.
The findings were published online in the Canadian Journal of Cardiology.
Case-crossover study
Syncope prompts more than 1 million visits to EDs in the United States each year. About 9% of patients with syncope have recurrence within 1 year.
Some jurisdictions legally require clinicians to advise patients at higher risk for syncope recurrence to stop driving temporarily. But guidelines about when and whom to restrict are not standardized, said Dr. Staples.
“I came to this topic because I work as a physician in a hospital and, a few years ago, I advised a young woman who suffered a serious injury after she passed out while driving and crashed her car,” he added. “She wanted to know if she could drive again and when. I found out that there wasn’t much evidence that could guide my advice to her. That is what planted the seed that eventually grew into this study.”
The researchers examined driving data from the Insurance Corporation of British Columbia and detailed ED visit data from regional health authorities. They included licensed drivers who were diagnosed with syncope and collapse at an ED between 2010 and 2015 in their study. The researchers focused on eligible participants who were involved in a motor vehicle collision between August 2011 and December 2015.
For each patient, the date of the crash was used to establish three control dates without crashes. The control dates were 26 weeks, 52 weeks, and 78 weeks before the crash. The investigators compared the rate of emergency visit for syncope in the 28 days before the crash with the rate of emergency visit for syncope in the 28 days before each control date.
An emergency visit for syncope occurred in 47 of 3,026 precrash intervals and 112 of 9,078 control intervals. This result indicated that syncope was not significantly associated with subsequent crash (adjusted odds ratio, 1.27; P = .18).
In addition, there was no significant association between syncope and crash in subgroups considered to be at higher risk for adverse outcomes after syncope, such as patients older than 65 years and patients with cardiovascular disease or cardiac syncope.
Gaps in data
“It’s a complicated study design but one that’s helpful to understand the temporal relationship between syncope and crash,” said Dr. Staples. “If we had found that the syncope visit was more likely to occur in the 4 weeks before the crash than in earlier matched 4-week control periods, we would have concluded that syncope transiently increases crash risk.”
Dr. Staples emphasized that this was a real-world study and that some patients with syncope at higher risk for a car crash likely stopped driving. “This study doesn’t say there’s no relationship between syncope and subsequent crash, just that our current practices, including current driving restrictions, seem to do an acceptable job of preventing some crashes.”
Limitations of the study influence the interpretation of the results. For example, the data sources did not indicate how patients modified their driving, said Dr. Staples.
Also lacking is information about how physicians identified which patients were at heightened risk for another syncope episode and advised those patients not to drive. “Now would be a good time to start to think about what other studies are needed to better tailor driving restrictions for the right patient,” said Dr. Staples.
‘A messy situation’
In a comment, Deepak L. Bhatt, MD, MPH, professor of cardiovascular medicine at Icahn School of Medicine at Mount Sinai, New York, called the conclusions “well thought out.” He said the study addressed a common, often perplexing problem in a practical way. Dr. Bhatt was not involved in the research.
“This study is trying to address the issue of what to do with people who have had syncope or fainting and have had a car crash. In general, we don’t really know what to do with those people, but there’s a lot of concern for many reasons, for both the patient and the public. There are potential legal liabilities, and the whole thing, generally speaking, tends to be a messy situation. Usually, the default position physicians take is to be very cautious and conservative, and restrict driving,” said Dr. Bhatt.
The study is reassuring, he added. “The authors have contextualized this risk very nicely. Physicians worry a lot about patients who have had an episode of syncope while driving and restrict their patients’ driving, at least temporarily. But as a society, we are much more permissive about people who drive drunk or under the influence, or who drive without seat belts, or who speed, or text while driving. So, within that larger context, we are extremely worried about this one source of risk that is probably less than these other sources of risk.”
Most of the time, the cause of the syncope is benign, said Dr. Bhatt. “We rule out the bad things, like a heart attack or cardiac arrest, seizure, and arrhythmia. Afterwards, the risk from driving is relatively small.” The study results support current practices and suggest “that we probably don’t need to be excessive with our restrictions.
“There is going to be a wide variation in practice, with some physicians wanting to be more restrictive, but there is a lot of subjectivity in how these recommendations are acted on in real life. That’s why I think this study really should reassure physicians that it’s okay to use common sense and good medical judgment when giving advice on driving to their patients,” Dr. Bhatt concluded.
The study was supported by the Canadian Institutes of Health Research and the Heart and Stroke Foundation Canada. Dr. Staples and Dr. Bhatt reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a case-crossover study that examined health and driving data for about 3,000 drivers in British Columbia, researchers found similar rates of ED visits for syncope before the dates of car crashes (1.6%) and before control dates (1.2%).
“An emergency visit for syncope did not appear to increase the risk of subsequent traffic crash,” lead author John A. Staples, MD, MPH, clinical associate professor of general internal medicine at the University of British Columbia, Vancouver, said in an interview.
The findings were published online in the Canadian Journal of Cardiology.
Case-crossover study
Syncope prompts more than 1 million visits to EDs in the United States each year. About 9% of patients with syncope have recurrence within 1 year.
Some jurisdictions legally require clinicians to advise patients at higher risk for syncope recurrence to stop driving temporarily. But guidelines about when and whom to restrict are not standardized, said Dr. Staples.
“I came to this topic because I work as a physician in a hospital and, a few years ago, I advised a young woman who suffered a serious injury after she passed out while driving and crashed her car,” he added. “She wanted to know if she could drive again and when. I found out that there wasn’t much evidence that could guide my advice to her. That is what planted the seed that eventually grew into this study.”
The researchers examined driving data from the Insurance Corporation of British Columbia and detailed ED visit data from regional health authorities. They included licensed drivers who were diagnosed with syncope and collapse at an ED between 2010 and 2015 in their study. The researchers focused on eligible participants who were involved in a motor vehicle collision between August 2011 and December 2015.
For each patient, the date of the crash was used to establish three control dates without crashes. The control dates were 26 weeks, 52 weeks, and 78 weeks before the crash. The investigators compared the rate of emergency visit for syncope in the 28 days before the crash with the rate of emergency visit for syncope in the 28 days before each control date.
An emergency visit for syncope occurred in 47 of 3,026 precrash intervals and 112 of 9,078 control intervals. This result indicated that syncope was not significantly associated with subsequent crash (adjusted odds ratio, 1.27; P = .18).
In addition, there was no significant association between syncope and crash in subgroups considered to be at higher risk for adverse outcomes after syncope, such as patients older than 65 years and patients with cardiovascular disease or cardiac syncope.
Gaps in data
“It’s a complicated study design but one that’s helpful to understand the temporal relationship between syncope and crash,” said Dr. Staples. “If we had found that the syncope visit was more likely to occur in the 4 weeks before the crash than in earlier matched 4-week control periods, we would have concluded that syncope transiently increases crash risk.”
Dr. Staples emphasized that this was a real-world study and that some patients with syncope at higher risk for a car crash likely stopped driving. “This study doesn’t say there’s no relationship between syncope and subsequent crash, just that our current practices, including current driving restrictions, seem to do an acceptable job of preventing some crashes.”
Limitations of the study influence the interpretation of the results. For example, the data sources did not indicate how patients modified their driving, said Dr. Staples.
Also lacking is information about how physicians identified which patients were at heightened risk for another syncope episode and advised those patients not to drive. “Now would be a good time to start to think about what other studies are needed to better tailor driving restrictions for the right patient,” said Dr. Staples.
‘A messy situation’
In a comment, Deepak L. Bhatt, MD, MPH, professor of cardiovascular medicine at Icahn School of Medicine at Mount Sinai, New York, called the conclusions “well thought out.” He said the study addressed a common, often perplexing problem in a practical way. Dr. Bhatt was not involved in the research.
“This study is trying to address the issue of what to do with people who have had syncope or fainting and have had a car crash. In general, we don’t really know what to do with those people, but there’s a lot of concern for many reasons, for both the patient and the public. There are potential legal liabilities, and the whole thing, generally speaking, tends to be a messy situation. Usually, the default position physicians take is to be very cautious and conservative, and restrict driving,” said Dr. Bhatt.
The study is reassuring, he added. “The authors have contextualized this risk very nicely. Physicians worry a lot about patients who have had an episode of syncope while driving and restrict their patients’ driving, at least temporarily. But as a society, we are much more permissive about people who drive drunk or under the influence, or who drive without seat belts, or who speed, or text while driving. So, within that larger context, we are extremely worried about this one source of risk that is probably less than these other sources of risk.”
Most of the time, the cause of the syncope is benign, said Dr. Bhatt. “We rule out the bad things, like a heart attack or cardiac arrest, seizure, and arrhythmia. Afterwards, the risk from driving is relatively small.” The study results support current practices and suggest “that we probably don’t need to be excessive with our restrictions.
“There is going to be a wide variation in practice, with some physicians wanting to be more restrictive, but there is a lot of subjectivity in how these recommendations are acted on in real life. That’s why I think this study really should reassure physicians that it’s okay to use common sense and good medical judgment when giving advice on driving to their patients,” Dr. Bhatt concluded.
The study was supported by the Canadian Institutes of Health Research and the Heart and Stroke Foundation Canada. Dr. Staples and Dr. Bhatt reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a case-crossover study that examined health and driving data for about 3,000 drivers in British Columbia, researchers found similar rates of ED visits for syncope before the dates of car crashes (1.6%) and before control dates (1.2%).
“An emergency visit for syncope did not appear to increase the risk of subsequent traffic crash,” lead author John A. Staples, MD, MPH, clinical associate professor of general internal medicine at the University of British Columbia, Vancouver, said in an interview.
The findings were published online in the Canadian Journal of Cardiology.
Case-crossover study
Syncope prompts more than 1 million visits to EDs in the United States each year. About 9% of patients with syncope have recurrence within 1 year.
Some jurisdictions legally require clinicians to advise patients at higher risk for syncope recurrence to stop driving temporarily. But guidelines about when and whom to restrict are not standardized, said Dr. Staples.
“I came to this topic because I work as a physician in a hospital and, a few years ago, I advised a young woman who suffered a serious injury after she passed out while driving and crashed her car,” he added. “She wanted to know if she could drive again and when. I found out that there wasn’t much evidence that could guide my advice to her. That is what planted the seed that eventually grew into this study.”
The researchers examined driving data from the Insurance Corporation of British Columbia and detailed ED visit data from regional health authorities. They included licensed drivers who were diagnosed with syncope and collapse at an ED between 2010 and 2015 in their study. The researchers focused on eligible participants who were involved in a motor vehicle collision between August 2011 and December 2015.
For each patient, the date of the crash was used to establish three control dates without crashes. The control dates were 26 weeks, 52 weeks, and 78 weeks before the crash. The investigators compared the rate of emergency visit for syncope in the 28 days before the crash with the rate of emergency visit for syncope in the 28 days before each control date.
An emergency visit for syncope occurred in 47 of 3,026 precrash intervals and 112 of 9,078 control intervals. This result indicated that syncope was not significantly associated with subsequent crash (adjusted odds ratio, 1.27; P = .18).
In addition, there was no significant association between syncope and crash in subgroups considered to be at higher risk for adverse outcomes after syncope, such as patients older than 65 years and patients with cardiovascular disease or cardiac syncope.
Gaps in data
“It’s a complicated study design but one that’s helpful to understand the temporal relationship between syncope and crash,” said Dr. Staples. “If we had found that the syncope visit was more likely to occur in the 4 weeks before the crash than in earlier matched 4-week control periods, we would have concluded that syncope transiently increases crash risk.”
Dr. Staples emphasized that this was a real-world study and that some patients with syncope at higher risk for a car crash likely stopped driving. “This study doesn’t say there’s no relationship between syncope and subsequent crash, just that our current practices, including current driving restrictions, seem to do an acceptable job of preventing some crashes.”
Limitations of the study influence the interpretation of the results. For example, the data sources did not indicate how patients modified their driving, said Dr. Staples.
Also lacking is information about how physicians identified which patients were at heightened risk for another syncope episode and advised those patients not to drive. “Now would be a good time to start to think about what other studies are needed to better tailor driving restrictions for the right patient,” said Dr. Staples.
‘A messy situation’
In a comment, Deepak L. Bhatt, MD, MPH, professor of cardiovascular medicine at Icahn School of Medicine at Mount Sinai, New York, called the conclusions “well thought out.” He said the study addressed a common, often perplexing problem in a practical way. Dr. Bhatt was not involved in the research.
“This study is trying to address the issue of what to do with people who have had syncope or fainting and have had a car crash. In general, we don’t really know what to do with those people, but there’s a lot of concern for many reasons, for both the patient and the public. There are potential legal liabilities, and the whole thing, generally speaking, tends to be a messy situation. Usually, the default position physicians take is to be very cautious and conservative, and restrict driving,” said Dr. Bhatt.
The study is reassuring, he added. “The authors have contextualized this risk very nicely. Physicians worry a lot about patients who have had an episode of syncope while driving and restrict their patients’ driving, at least temporarily. But as a society, we are much more permissive about people who drive drunk or under the influence, or who drive without seat belts, or who speed, or text while driving. So, within that larger context, we are extremely worried about this one source of risk that is probably less than these other sources of risk.”
Most of the time, the cause of the syncope is benign, said Dr. Bhatt. “We rule out the bad things, like a heart attack or cardiac arrest, seizure, and arrhythmia. Afterwards, the risk from driving is relatively small.” The study results support current practices and suggest “that we probably don’t need to be excessive with our restrictions.
“There is going to be a wide variation in practice, with some physicians wanting to be more restrictive, but there is a lot of subjectivity in how these recommendations are acted on in real life. That’s why I think this study really should reassure physicians that it’s okay to use common sense and good medical judgment when giving advice on driving to their patients,” Dr. Bhatt concluded.
The study was supported by the Canadian Institutes of Health Research and the Heart and Stroke Foundation Canada. Dr. Staples and Dr. Bhatt reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE CANADIAN JOURNAL OF CARDIOLOGY