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Noninvasive Brain Stimulation a Breakthrough for Hypnotherapy?
Less than 2 minutes of transcranial magnetic stimulation (TMS) targeting specific areas of the brain can boost an individual’s ability to be hypnotized, in new findings that could increase the efficacy of therapeutic hypnosis and expand the pool of patients who can benefit from it.
“We were able to increase hypnotizability, a neuropsychological trait previously shown to be as stable as IQ in adulthood,” said co-senior author David Spiegel, MD, professor of psychiatry and behavioral sciences, Stanford University, Palo Alto, California.
“Our findings would allow us to combine neurostimulation with hypnosis to expand the number of people able to benefit from hypnosis and enhance their responsiveness to treatment,” Dr. Spiegel added.
The study was published online on January 4, 2024, in Nature Mental Health.
A Breakthrough for Hypnotherapy?
About two thirds of the general adult population are estimated to be at least somewhat hypnotizable, and 15% are highly hypnotizable.
Through brain imaging, the Stanford team found that high hypnotizability is associated with greater functional connectivity between the left dorsolateral prefrontal cortex (DLPFC) and the dorsal anterior cingulate cortex.
In the double-blind study, they randomly assigned 80 patients (mean age, 48 years; 94% women) with fibromyalgia syndrome to active, or sham, continuous theta-burst stimulation over a personalized neuroimaging-derived left DLPFC target — a technique known as Stanford Hypnosis Integrated with Functional Connectivity-targeted Transcranial Stimulation (SHIFT). Individuals who were naturally highly hypnotizable were excluded.
“A novel aspect of this trial is that we used the person’s own brain networks, based on brain imaging, to target the right spot,” Co-senior author Nolan Williams, MD, with Stanford University, California, said in a news release.
The team chose patients with chronic pain because hypnosis has been shown to be a “highly effective analgesic that has a far better risk/benefit ratio than widely overutilized opioids that have serious fatal overdose potential,” Spiegel told this news organization.
The pre-to-post SHIFT change in hypnotic induction profile scores, a standardized measure of hypnotizability, was significantly greater in the active vs sham group after just 92 seconds of stimulation (P = .046).
Only the active SHIFT group showed a significant increase in hypnotizability following stimulation, an effect that lasted for about 1 hour.
“Increasing hypnotizability in people who are low-to-medium hypnotizable individuals could improve both the efficacy and effectiveness of therapeutic hypnosis as a clinical intervention,” the researchers wrote.
They note that because this was a “mechanistic study,” it did not explore the impact of increased hypnotizability on disease symptoms. They also note that further studies are needed to assess the dose-response relationships of SHIFT.
Transformative Research
“This line of research is fascinating,” Shaheen Lakhan, MD, PhD, neurologist, and researcher in Boston, told this news organization.
“We are nearing an era of personalized, noninvasive brain modulation. The ability to individually modulate the DLPFC opens new possibilities for brain health beyond hypnotizability for fibromyalgia,” said Dr. Lakhan, who wasn’t involved in the study.
“The DLPFC is involved in executive functions (and disorders) like attention (ADHD), emotional regulation (depression), motivation (schizophrenia), and impulse control (addiction),” he noted.
“Soon we may no longer need large expensive devices like transcranial magnetic stimulators as in this research study. Smartphones could deliver tailored digital therapeutics by engaging specific brain circuits,” Dr. Lakhan predicted.
“Imagine using an app to receive treatment customized to your unique brain and needs — all without anything implanted and delivered anywhere. The potential to precisely modulate the brain’s wiring to enhance cognition and mental health, without surgery or physical constraints, is incredibly promising. The possibilities are intriguing and could truly transform how we address brain diseases,” he added.
The study was supported by a grant from the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH). Dr. Williams is a named inventor on Stanford-owned intellectual property relating to accelerated TMS pulse pattern sequences and neuroimaging-based TMS targeting; has served on scientific advisory boards for Otsuka, NeuraWell, Magnus Medical, and Nooma as a paid advisor; and holds equity/stock options in Magnus Medical, NeuraWell, and Nooma. Dr. Spiegel is a cofounder of Reveri Health, Inc., an interactive hypnosis app (not utilized in the current study).
A version of this article appeared on Medscape.com.
Less than 2 minutes of transcranial magnetic stimulation (TMS) targeting specific areas of the brain can boost an individual’s ability to be hypnotized, in new findings that could increase the efficacy of therapeutic hypnosis and expand the pool of patients who can benefit from it.
“We were able to increase hypnotizability, a neuropsychological trait previously shown to be as stable as IQ in adulthood,” said co-senior author David Spiegel, MD, professor of psychiatry and behavioral sciences, Stanford University, Palo Alto, California.
“Our findings would allow us to combine neurostimulation with hypnosis to expand the number of people able to benefit from hypnosis and enhance their responsiveness to treatment,” Dr. Spiegel added.
The study was published online on January 4, 2024, in Nature Mental Health.
A Breakthrough for Hypnotherapy?
About two thirds of the general adult population are estimated to be at least somewhat hypnotizable, and 15% are highly hypnotizable.
Through brain imaging, the Stanford team found that high hypnotizability is associated with greater functional connectivity between the left dorsolateral prefrontal cortex (DLPFC) and the dorsal anterior cingulate cortex.
In the double-blind study, they randomly assigned 80 patients (mean age, 48 years; 94% women) with fibromyalgia syndrome to active, or sham, continuous theta-burst stimulation over a personalized neuroimaging-derived left DLPFC target — a technique known as Stanford Hypnosis Integrated with Functional Connectivity-targeted Transcranial Stimulation (SHIFT). Individuals who were naturally highly hypnotizable were excluded.
“A novel aspect of this trial is that we used the person’s own brain networks, based on brain imaging, to target the right spot,” Co-senior author Nolan Williams, MD, with Stanford University, California, said in a news release.
The team chose patients with chronic pain because hypnosis has been shown to be a “highly effective analgesic that has a far better risk/benefit ratio than widely overutilized opioids that have serious fatal overdose potential,” Spiegel told this news organization.
The pre-to-post SHIFT change in hypnotic induction profile scores, a standardized measure of hypnotizability, was significantly greater in the active vs sham group after just 92 seconds of stimulation (P = .046).
Only the active SHIFT group showed a significant increase in hypnotizability following stimulation, an effect that lasted for about 1 hour.
“Increasing hypnotizability in people who are low-to-medium hypnotizable individuals could improve both the efficacy and effectiveness of therapeutic hypnosis as a clinical intervention,” the researchers wrote.
They note that because this was a “mechanistic study,” it did not explore the impact of increased hypnotizability on disease symptoms. They also note that further studies are needed to assess the dose-response relationships of SHIFT.
Transformative Research
“This line of research is fascinating,” Shaheen Lakhan, MD, PhD, neurologist, and researcher in Boston, told this news organization.
“We are nearing an era of personalized, noninvasive brain modulation. The ability to individually modulate the DLPFC opens new possibilities for brain health beyond hypnotizability for fibromyalgia,” said Dr. Lakhan, who wasn’t involved in the study.
“The DLPFC is involved in executive functions (and disorders) like attention (ADHD), emotional regulation (depression), motivation (schizophrenia), and impulse control (addiction),” he noted.
“Soon we may no longer need large expensive devices like transcranial magnetic stimulators as in this research study. Smartphones could deliver tailored digital therapeutics by engaging specific brain circuits,” Dr. Lakhan predicted.
“Imagine using an app to receive treatment customized to your unique brain and needs — all without anything implanted and delivered anywhere. The potential to precisely modulate the brain’s wiring to enhance cognition and mental health, without surgery or physical constraints, is incredibly promising. The possibilities are intriguing and could truly transform how we address brain diseases,” he added.
The study was supported by a grant from the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH). Dr. Williams is a named inventor on Stanford-owned intellectual property relating to accelerated TMS pulse pattern sequences and neuroimaging-based TMS targeting; has served on scientific advisory boards for Otsuka, NeuraWell, Magnus Medical, and Nooma as a paid advisor; and holds equity/stock options in Magnus Medical, NeuraWell, and Nooma. Dr. Spiegel is a cofounder of Reveri Health, Inc., an interactive hypnosis app (not utilized in the current study).
A version of this article appeared on Medscape.com.
Less than 2 minutes of transcranial magnetic stimulation (TMS) targeting specific areas of the brain can boost an individual’s ability to be hypnotized, in new findings that could increase the efficacy of therapeutic hypnosis and expand the pool of patients who can benefit from it.
“We were able to increase hypnotizability, a neuropsychological trait previously shown to be as stable as IQ in adulthood,” said co-senior author David Spiegel, MD, professor of psychiatry and behavioral sciences, Stanford University, Palo Alto, California.
“Our findings would allow us to combine neurostimulation with hypnosis to expand the number of people able to benefit from hypnosis and enhance their responsiveness to treatment,” Dr. Spiegel added.
The study was published online on January 4, 2024, in Nature Mental Health.
A Breakthrough for Hypnotherapy?
About two thirds of the general adult population are estimated to be at least somewhat hypnotizable, and 15% are highly hypnotizable.
Through brain imaging, the Stanford team found that high hypnotizability is associated with greater functional connectivity between the left dorsolateral prefrontal cortex (DLPFC) and the dorsal anterior cingulate cortex.
In the double-blind study, they randomly assigned 80 patients (mean age, 48 years; 94% women) with fibromyalgia syndrome to active, or sham, continuous theta-burst stimulation over a personalized neuroimaging-derived left DLPFC target — a technique known as Stanford Hypnosis Integrated with Functional Connectivity-targeted Transcranial Stimulation (SHIFT). Individuals who were naturally highly hypnotizable were excluded.
“A novel aspect of this trial is that we used the person’s own brain networks, based on brain imaging, to target the right spot,” Co-senior author Nolan Williams, MD, with Stanford University, California, said in a news release.
The team chose patients with chronic pain because hypnosis has been shown to be a “highly effective analgesic that has a far better risk/benefit ratio than widely overutilized opioids that have serious fatal overdose potential,” Spiegel told this news organization.
The pre-to-post SHIFT change in hypnotic induction profile scores, a standardized measure of hypnotizability, was significantly greater in the active vs sham group after just 92 seconds of stimulation (P = .046).
Only the active SHIFT group showed a significant increase in hypnotizability following stimulation, an effect that lasted for about 1 hour.
“Increasing hypnotizability in people who are low-to-medium hypnotizable individuals could improve both the efficacy and effectiveness of therapeutic hypnosis as a clinical intervention,” the researchers wrote.
They note that because this was a “mechanistic study,” it did not explore the impact of increased hypnotizability on disease symptoms. They also note that further studies are needed to assess the dose-response relationships of SHIFT.
Transformative Research
“This line of research is fascinating,” Shaheen Lakhan, MD, PhD, neurologist, and researcher in Boston, told this news organization.
“We are nearing an era of personalized, noninvasive brain modulation. The ability to individually modulate the DLPFC opens new possibilities for brain health beyond hypnotizability for fibromyalgia,” said Dr. Lakhan, who wasn’t involved in the study.
“The DLPFC is involved in executive functions (and disorders) like attention (ADHD), emotional regulation (depression), motivation (schizophrenia), and impulse control (addiction),” he noted.
“Soon we may no longer need large expensive devices like transcranial magnetic stimulators as in this research study. Smartphones could deliver tailored digital therapeutics by engaging specific brain circuits,” Dr. Lakhan predicted.
“Imagine using an app to receive treatment customized to your unique brain and needs — all without anything implanted and delivered anywhere. The potential to precisely modulate the brain’s wiring to enhance cognition and mental health, without surgery or physical constraints, is incredibly promising. The possibilities are intriguing and could truly transform how we address brain diseases,” he added.
The study was supported by a grant from the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH). Dr. Williams is a named inventor on Stanford-owned intellectual property relating to accelerated TMS pulse pattern sequences and neuroimaging-based TMS targeting; has served on scientific advisory boards for Otsuka, NeuraWell, Magnus Medical, and Nooma as a paid advisor; and holds equity/stock options in Magnus Medical, NeuraWell, and Nooma. Dr. Spiegel is a cofounder of Reveri Health, Inc., an interactive hypnosis app (not utilized in the current study).
A version of this article appeared on Medscape.com.
FDA Investigates Three Side Effects Reported With Weight Loss Drugs
or two other health problems.
A new FDA report listed potential links between the medications and alopecia, aspiration, or suicidal ideation, CBS News reported. The investigation centers on reports of the health problems among people taking GLP-1 receptor agonists, some of which are Ozempic, Wegovy, Mounjaro, and Zepbound. The drugs are used to treat diabetes and overweight or obesity.
An investigation by the FDA doesn’t mean that the FDA has concluded a risk exists, the FDA’s webpage for risk evaluation cautions.
“It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk,” the FDA site states.
Possible next steps after an investigation could include updating drug labels with new information, putting a risk management plan in place to prevent or manage the health risks, or gathering more information.
“The FDA monitors the safety of drugs throughout their life cycle,” even after the drugs are approved. In addition, the FDA uses “surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process,” FDA spokesperson Chanapa Tantibanchachai said in an email published by multiple news outlets.
Although an investigation may lead to no changes in how a drug is regulated by the FDA, this isn’t the first time that the popular medicines have landed on the FDA’s radar for safety reevaluation. Last year, the label for the drug Ozempic was updated to acknowledge reports of intestinal obstructions, CBS News reported.
European regulators are also looking into reports of suicidal thoughts among people taking GLP-1 receptor agonists, although no link has been established.
Concerns about aspiration during surgery resulted in the American Society of Anesthesiologists advising in June that people should stop taking GLP-1 receptor agonists before they have elective surgeries.
“While there is currently a lack of scientific data on how GLP-1 receptor agonists affect patients having surgery and interact with anesthesia, we’ve received anecdotal reports that the delay in stomach emptying could be associated with an increased risk of regurgitation and aspiration of food into the airways and lungs during general anesthesia and deep sedation,” the society’s president, Michael W. Champeau, MD, said in a statement at the time.
According to CBS News, the FDA’s drug reporting system links the medications to 201 reports of suicide or suicidal ideation, 18 reports that mention aspiration, and 422 reports that mention alopecia.
Novo Nordisk, whose portfolio includes Wegovy and Ozempic, told CNN that it works with the FDA to monitor safety and is aware of the reports of side effects.
“Novo Nordisk stands behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional,” the company said in a statement to CNN.
A spokesperson for Eli Lilly, which makes Mounjaro and Zepbound, told CBS News in a statement, “Currently, the FDA is reviewing data on certain potential risks for GLP-1 receptor agonist medicines. Patient safety is our priority, and we are collaborating with the FDA on these potential signals.”
A version of this article appeared on WebMD.com .
or two other health problems.
A new FDA report listed potential links between the medications and alopecia, aspiration, or suicidal ideation, CBS News reported. The investigation centers on reports of the health problems among people taking GLP-1 receptor agonists, some of which are Ozempic, Wegovy, Mounjaro, and Zepbound. The drugs are used to treat diabetes and overweight or obesity.
An investigation by the FDA doesn’t mean that the FDA has concluded a risk exists, the FDA’s webpage for risk evaluation cautions.
“It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk,” the FDA site states.
Possible next steps after an investigation could include updating drug labels with new information, putting a risk management plan in place to prevent or manage the health risks, or gathering more information.
“The FDA monitors the safety of drugs throughout their life cycle,” even after the drugs are approved. In addition, the FDA uses “surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process,” FDA spokesperson Chanapa Tantibanchachai said in an email published by multiple news outlets.
Although an investigation may lead to no changes in how a drug is regulated by the FDA, this isn’t the first time that the popular medicines have landed on the FDA’s radar for safety reevaluation. Last year, the label for the drug Ozempic was updated to acknowledge reports of intestinal obstructions, CBS News reported.
European regulators are also looking into reports of suicidal thoughts among people taking GLP-1 receptor agonists, although no link has been established.
Concerns about aspiration during surgery resulted in the American Society of Anesthesiologists advising in June that people should stop taking GLP-1 receptor agonists before they have elective surgeries.
“While there is currently a lack of scientific data on how GLP-1 receptor agonists affect patients having surgery and interact with anesthesia, we’ve received anecdotal reports that the delay in stomach emptying could be associated with an increased risk of regurgitation and aspiration of food into the airways and lungs during general anesthesia and deep sedation,” the society’s president, Michael W. Champeau, MD, said in a statement at the time.
According to CBS News, the FDA’s drug reporting system links the medications to 201 reports of suicide or suicidal ideation, 18 reports that mention aspiration, and 422 reports that mention alopecia.
Novo Nordisk, whose portfolio includes Wegovy and Ozempic, told CNN that it works with the FDA to monitor safety and is aware of the reports of side effects.
“Novo Nordisk stands behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional,” the company said in a statement to CNN.
A spokesperson for Eli Lilly, which makes Mounjaro and Zepbound, told CBS News in a statement, “Currently, the FDA is reviewing data on certain potential risks for GLP-1 receptor agonist medicines. Patient safety is our priority, and we are collaborating with the FDA on these potential signals.”
A version of this article appeared on WebMD.com .
or two other health problems.
A new FDA report listed potential links between the medications and alopecia, aspiration, or suicidal ideation, CBS News reported. The investigation centers on reports of the health problems among people taking GLP-1 receptor agonists, some of which are Ozempic, Wegovy, Mounjaro, and Zepbound. The drugs are used to treat diabetes and overweight or obesity.
An investigation by the FDA doesn’t mean that the FDA has concluded a risk exists, the FDA’s webpage for risk evaluation cautions.
“It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk,” the FDA site states.
Possible next steps after an investigation could include updating drug labels with new information, putting a risk management plan in place to prevent or manage the health risks, or gathering more information.
“The FDA monitors the safety of drugs throughout their life cycle,” even after the drugs are approved. In addition, the FDA uses “surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process,” FDA spokesperson Chanapa Tantibanchachai said in an email published by multiple news outlets.
Although an investigation may lead to no changes in how a drug is regulated by the FDA, this isn’t the first time that the popular medicines have landed on the FDA’s radar for safety reevaluation. Last year, the label for the drug Ozempic was updated to acknowledge reports of intestinal obstructions, CBS News reported.
European regulators are also looking into reports of suicidal thoughts among people taking GLP-1 receptor agonists, although no link has been established.
Concerns about aspiration during surgery resulted in the American Society of Anesthesiologists advising in June that people should stop taking GLP-1 receptor agonists before they have elective surgeries.
“While there is currently a lack of scientific data on how GLP-1 receptor agonists affect patients having surgery and interact with anesthesia, we’ve received anecdotal reports that the delay in stomach emptying could be associated with an increased risk of regurgitation and aspiration of food into the airways and lungs during general anesthesia and deep sedation,” the society’s president, Michael W. Champeau, MD, said in a statement at the time.
According to CBS News, the FDA’s drug reporting system links the medications to 201 reports of suicide or suicidal ideation, 18 reports that mention aspiration, and 422 reports that mention alopecia.
Novo Nordisk, whose portfolio includes Wegovy and Ozempic, told CNN that it works with the FDA to monitor safety and is aware of the reports of side effects.
“Novo Nordisk stands behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional,” the company said in a statement to CNN.
A spokesperson for Eli Lilly, which makes Mounjaro and Zepbound, told CBS News in a statement, “Currently, the FDA is reviewing data on certain potential risks for GLP-1 receptor agonist medicines. Patient safety is our priority, and we are collaborating with the FDA on these potential signals.”
A version of this article appeared on WebMD.com .
Chronicling Health Care Transformation: Federal Practitioner Looks Back 40 Years
When VA Practitioner published its first issue in January 1984, federal health care was at the cusp of a dramatic transformation. VA Practitioner stepped in to serve “as a forum, as a bulletin, as an easy means of communication with colleagues who share your unique concerns,” founding editor James McCloskey noted in the first issue.
The need for this forum was most acute at the US Department of Veterans Affairs (VA). The agency of about 200,000 employees was decentralizing its management, developing the first electronic health record system, and caring for an aging population of World War II and Vietnam War era veterans with high comorbidity burdens. In the 1980s, the VA was at a nadir and under increasing pressure to change. At that moment of challenge, VA Practitioner offered columns suggesting a way forward and focused on clinical improvements with articles like, “The ghosts of budgets past,” “Psychoenvironment: a therapeutic redesign plan,” and “The VA’s geriatric goals.” Within a few years, the journal had enlisted an editorial advisory board to help guide the journal and provide the first peer review process for articles.
Peer Review and Expanded Focus
Ten years later, tremendous changes were underway for both VA Practitioner and the VA. Ken Kizer, MD, MPH, was named Under Secretary of Health in 1994 and almost immediately started the massive process of reforming and reorganizing the VA’s health care arm: Veterans Health Administration (VHA). The VHA would expand from 2.7 million enrolled veteran patients in 1993 to 8.9 million in 2014. In the process, the VA transformed from an oft derided institution to a major source of research and care that hosted most US physician residents while delivering the “best care anywhere.”
In 1994, VA Practitioner changed its name, becoming Federal Practitioner with an expanded mandate to address the needs of US Department of Defense (DoD) and US Public Health Service (PHS) clinicians working at the Indian Health Service (IHS), Bureau of Prisons, and US Coast Guard. In addition, the journal instituted a double-blind peer review process. Health care reform was clearly on the agenda for the new journal.
A new vision for VHA sought to redistribute resources, decentralize decision making, and make care more patient centered. The VHA began development of the Computerized Patient Record System (CPRS), which was fully implemented by 1999 as one of the earliest electronic health record systems and shared it with the IHS.
The DoD, on the other hand, was in a long-term period of reduction and consolidation. The active-duty service member population dropped from 2.1 million to 1.6 million between 1984 and 1994 and would continue to drop to 1.4 million in 2001, even with the onset of the first Gulf War. The DoD rolled out the Civilian Health and Medical Program of the United States (CHAMPUS), which would later become TRICARE, that reshaped the way the DoD delivered health care for active-duty service members, their families, and retirees.
From the outset, Federal Practitioner sought to play a role in those transformations. For PHS officers stationed across the Centers for Disease Control and Prevention, US Food and Drug Administration, IHS, and Bureau of Prisons, the journal provided a new way to share findings and best practices. With a growing group of dedicated peer reviewers, Federal Practitioner articles became more clinical and more patient centered. Frequent columns gave way to clinical reviews, continuing medical education, and best practice articles.
Addressing Post-9/11 Veteran Needs
All of these changes were well under way on the eve of September 11, 2001. After years of reductions, the size of the military stabilized, but the demographics were shifting in important ways. Women made up a larger proportion of the active-duty population, growing from 5% in 1975 to 10% in 1985 and 14% in 2005. The military was also becoming more diverse, with a growing number of service members indicating Hispanic, Asian, Pacific Islander, and other identities. More importantly, a new set of health care concerns emerged to challenge DoD and VHA clinicians. A growing number of service members and veterans of the Gulf Wars were seeking care for respiratory diseases, cancers, blast injuries, and prosthetics.
Federal Practitioner articles primarily focused on quality improvement but increasingly the journal published original research and case studies. Columns like Common Errors in Internal Medicine and Advances in Geriatrics focused on quality improvement and innovative therapies, respectively. To supplement its 12 regular issues, in 2011 Federal Practitioner began publishing special issues to provide even more depth of coverage in specific disease states, including hematology/oncology (in cooperation with the Association of VA Hematology/Oncology), mental health, neurology, infectious diseases, diabetes, among other topics.
The Last 10 Years and the Next 40
In 2013, the DoD formally reorganized its health care operations under the Defense Health Agency, starting an entirely new process that would dramatically reshape health care delivery for 8 million beneficiaries and 140,000 employees. This started a long process of consolidating separate systems and priorities for each branch into a single approach. Meanwhile, controversies around long wait times for VHA appointments (and veterans who died while waiting) put it under intense scrutiny. Legislation to privatize some or all of health care for veterans were discussed and considered, which finally resulted in the creation of the Veterans Choice Program, which greatly expanded the use of private health care services for covered conditions.
In 2018, Federal Practitioner was accepted by the national Library of Medicine’s PubMed Central, ensuring the widest possible access to journal articles. The journal saw a steady growth in submissions and published a combined 21 regular and special issues that year driven by increased submissions and more original research studies.
More and more through the work of its authors, Federal Practitioner has been in the middle of critical and ongoing federal health care concerns. Federal Practitioner authors have turned to the journal to address issues ranging from the deprescribing of opioid medications to measures taken to decrease the incidence of veteran suicide and the challenges presented by artificial intelligence and telehealth delivery. Whether it was the federal responses to Ebola outbreaks in Africa or the myriad ways that the PHS and VA responded to the COVID-19 pandemic in the US, Federal Practitioner has been at the center of federal health care.
Further reading
To learn more about the past 40 years of federal health care visit mdedge.com/fedprac or doi:10.12788/fp.0453.
When VA Practitioner published its first issue in January 1984, federal health care was at the cusp of a dramatic transformation. VA Practitioner stepped in to serve “as a forum, as a bulletin, as an easy means of communication with colleagues who share your unique concerns,” founding editor James McCloskey noted in the first issue.
The need for this forum was most acute at the US Department of Veterans Affairs (VA). The agency of about 200,000 employees was decentralizing its management, developing the first electronic health record system, and caring for an aging population of World War II and Vietnam War era veterans with high comorbidity burdens. In the 1980s, the VA was at a nadir and under increasing pressure to change. At that moment of challenge, VA Practitioner offered columns suggesting a way forward and focused on clinical improvements with articles like, “The ghosts of budgets past,” “Psychoenvironment: a therapeutic redesign plan,” and “The VA’s geriatric goals.” Within a few years, the journal had enlisted an editorial advisory board to help guide the journal and provide the first peer review process for articles.
Peer Review and Expanded Focus
Ten years later, tremendous changes were underway for both VA Practitioner and the VA. Ken Kizer, MD, MPH, was named Under Secretary of Health in 1994 and almost immediately started the massive process of reforming and reorganizing the VA’s health care arm: Veterans Health Administration (VHA). The VHA would expand from 2.7 million enrolled veteran patients in 1993 to 8.9 million in 2014. In the process, the VA transformed from an oft derided institution to a major source of research and care that hosted most US physician residents while delivering the “best care anywhere.”
In 1994, VA Practitioner changed its name, becoming Federal Practitioner with an expanded mandate to address the needs of US Department of Defense (DoD) and US Public Health Service (PHS) clinicians working at the Indian Health Service (IHS), Bureau of Prisons, and US Coast Guard. In addition, the journal instituted a double-blind peer review process. Health care reform was clearly on the agenda for the new journal.
A new vision for VHA sought to redistribute resources, decentralize decision making, and make care more patient centered. The VHA began development of the Computerized Patient Record System (CPRS), which was fully implemented by 1999 as one of the earliest electronic health record systems and shared it with the IHS.
The DoD, on the other hand, was in a long-term period of reduction and consolidation. The active-duty service member population dropped from 2.1 million to 1.6 million between 1984 and 1994 and would continue to drop to 1.4 million in 2001, even with the onset of the first Gulf War. The DoD rolled out the Civilian Health and Medical Program of the United States (CHAMPUS), which would later become TRICARE, that reshaped the way the DoD delivered health care for active-duty service members, their families, and retirees.
From the outset, Federal Practitioner sought to play a role in those transformations. For PHS officers stationed across the Centers for Disease Control and Prevention, US Food and Drug Administration, IHS, and Bureau of Prisons, the journal provided a new way to share findings and best practices. With a growing group of dedicated peer reviewers, Federal Practitioner articles became more clinical and more patient centered. Frequent columns gave way to clinical reviews, continuing medical education, and best practice articles.
Addressing Post-9/11 Veteran Needs
All of these changes were well under way on the eve of September 11, 2001. After years of reductions, the size of the military stabilized, but the demographics were shifting in important ways. Women made up a larger proportion of the active-duty population, growing from 5% in 1975 to 10% in 1985 and 14% in 2005. The military was also becoming more diverse, with a growing number of service members indicating Hispanic, Asian, Pacific Islander, and other identities. More importantly, a new set of health care concerns emerged to challenge DoD and VHA clinicians. A growing number of service members and veterans of the Gulf Wars were seeking care for respiratory diseases, cancers, blast injuries, and prosthetics.
Federal Practitioner articles primarily focused on quality improvement but increasingly the journal published original research and case studies. Columns like Common Errors in Internal Medicine and Advances in Geriatrics focused on quality improvement and innovative therapies, respectively. To supplement its 12 regular issues, in 2011 Federal Practitioner began publishing special issues to provide even more depth of coverage in specific disease states, including hematology/oncology (in cooperation with the Association of VA Hematology/Oncology), mental health, neurology, infectious diseases, diabetes, among other topics.
The Last 10 Years and the Next 40
In 2013, the DoD formally reorganized its health care operations under the Defense Health Agency, starting an entirely new process that would dramatically reshape health care delivery for 8 million beneficiaries and 140,000 employees. This started a long process of consolidating separate systems and priorities for each branch into a single approach. Meanwhile, controversies around long wait times for VHA appointments (and veterans who died while waiting) put it under intense scrutiny. Legislation to privatize some or all of health care for veterans were discussed and considered, which finally resulted in the creation of the Veterans Choice Program, which greatly expanded the use of private health care services for covered conditions.
In 2018, Federal Practitioner was accepted by the national Library of Medicine’s PubMed Central, ensuring the widest possible access to journal articles. The journal saw a steady growth in submissions and published a combined 21 regular and special issues that year driven by increased submissions and more original research studies.
More and more through the work of its authors, Federal Practitioner has been in the middle of critical and ongoing federal health care concerns. Federal Practitioner authors have turned to the journal to address issues ranging from the deprescribing of opioid medications to measures taken to decrease the incidence of veteran suicide and the challenges presented by artificial intelligence and telehealth delivery. Whether it was the federal responses to Ebola outbreaks in Africa or the myriad ways that the PHS and VA responded to the COVID-19 pandemic in the US, Federal Practitioner has been at the center of federal health care.
Further reading
To learn more about the past 40 years of federal health care visit mdedge.com/fedprac or doi:10.12788/fp.0453.
When VA Practitioner published its first issue in January 1984, federal health care was at the cusp of a dramatic transformation. VA Practitioner stepped in to serve “as a forum, as a bulletin, as an easy means of communication with colleagues who share your unique concerns,” founding editor James McCloskey noted in the first issue.
The need for this forum was most acute at the US Department of Veterans Affairs (VA). The agency of about 200,000 employees was decentralizing its management, developing the first electronic health record system, and caring for an aging population of World War II and Vietnam War era veterans with high comorbidity burdens. In the 1980s, the VA was at a nadir and under increasing pressure to change. At that moment of challenge, VA Practitioner offered columns suggesting a way forward and focused on clinical improvements with articles like, “The ghosts of budgets past,” “Psychoenvironment: a therapeutic redesign plan,” and “The VA’s geriatric goals.” Within a few years, the journal had enlisted an editorial advisory board to help guide the journal and provide the first peer review process for articles.
Peer Review and Expanded Focus
Ten years later, tremendous changes were underway for both VA Practitioner and the VA. Ken Kizer, MD, MPH, was named Under Secretary of Health in 1994 and almost immediately started the massive process of reforming and reorganizing the VA’s health care arm: Veterans Health Administration (VHA). The VHA would expand from 2.7 million enrolled veteran patients in 1993 to 8.9 million in 2014. In the process, the VA transformed from an oft derided institution to a major source of research and care that hosted most US physician residents while delivering the “best care anywhere.”
In 1994, VA Practitioner changed its name, becoming Federal Practitioner with an expanded mandate to address the needs of US Department of Defense (DoD) and US Public Health Service (PHS) clinicians working at the Indian Health Service (IHS), Bureau of Prisons, and US Coast Guard. In addition, the journal instituted a double-blind peer review process. Health care reform was clearly on the agenda for the new journal.
A new vision for VHA sought to redistribute resources, decentralize decision making, and make care more patient centered. The VHA began development of the Computerized Patient Record System (CPRS), which was fully implemented by 1999 as one of the earliest electronic health record systems and shared it with the IHS.
The DoD, on the other hand, was in a long-term period of reduction and consolidation. The active-duty service member population dropped from 2.1 million to 1.6 million between 1984 and 1994 and would continue to drop to 1.4 million in 2001, even with the onset of the first Gulf War. The DoD rolled out the Civilian Health and Medical Program of the United States (CHAMPUS), which would later become TRICARE, that reshaped the way the DoD delivered health care for active-duty service members, their families, and retirees.
From the outset, Federal Practitioner sought to play a role in those transformations. For PHS officers stationed across the Centers for Disease Control and Prevention, US Food and Drug Administration, IHS, and Bureau of Prisons, the journal provided a new way to share findings and best practices. With a growing group of dedicated peer reviewers, Federal Practitioner articles became more clinical and more patient centered. Frequent columns gave way to clinical reviews, continuing medical education, and best practice articles.
Addressing Post-9/11 Veteran Needs
All of these changes were well under way on the eve of September 11, 2001. After years of reductions, the size of the military stabilized, but the demographics were shifting in important ways. Women made up a larger proportion of the active-duty population, growing from 5% in 1975 to 10% in 1985 and 14% in 2005. The military was also becoming more diverse, with a growing number of service members indicating Hispanic, Asian, Pacific Islander, and other identities. More importantly, a new set of health care concerns emerged to challenge DoD and VHA clinicians. A growing number of service members and veterans of the Gulf Wars were seeking care for respiratory diseases, cancers, blast injuries, and prosthetics.
Federal Practitioner articles primarily focused on quality improvement but increasingly the journal published original research and case studies. Columns like Common Errors in Internal Medicine and Advances in Geriatrics focused on quality improvement and innovative therapies, respectively. To supplement its 12 regular issues, in 2011 Federal Practitioner began publishing special issues to provide even more depth of coverage in specific disease states, including hematology/oncology (in cooperation with the Association of VA Hematology/Oncology), mental health, neurology, infectious diseases, diabetes, among other topics.
The Last 10 Years and the Next 40
In 2013, the DoD formally reorganized its health care operations under the Defense Health Agency, starting an entirely new process that would dramatically reshape health care delivery for 8 million beneficiaries and 140,000 employees. This started a long process of consolidating separate systems and priorities for each branch into a single approach. Meanwhile, controversies around long wait times for VHA appointments (and veterans who died while waiting) put it under intense scrutiny. Legislation to privatize some or all of health care for veterans were discussed and considered, which finally resulted in the creation of the Veterans Choice Program, which greatly expanded the use of private health care services for covered conditions.
In 2018, Federal Practitioner was accepted by the national Library of Medicine’s PubMed Central, ensuring the widest possible access to journal articles. The journal saw a steady growth in submissions and published a combined 21 regular and special issues that year driven by increased submissions and more original research studies.
More and more through the work of its authors, Federal Practitioner has been in the middle of critical and ongoing federal health care concerns. Federal Practitioner authors have turned to the journal to address issues ranging from the deprescribing of opioid medications to measures taken to decrease the incidence of veteran suicide and the challenges presented by artificial intelligence and telehealth delivery. Whether it was the federal responses to Ebola outbreaks in Africa or the myriad ways that the PHS and VA responded to the COVID-19 pandemic in the US, Federal Practitioner has been at the center of federal health care.
Further reading
To learn more about the past 40 years of federal health care visit mdedge.com/fedprac or doi:10.12788/fp.0453.
Public Citizen seeks stronger warning for Botox, related products
.
The nonprofit watchdog group successfully petitioned the FDA in 2008 to require a warning for Botox and related products regarding the risk of distant spread of the toxin. In its latest petition to the agency, it says that the injectables need additional warnings about the possibility of iatrogenic botulism with initial and repeated doses and that individuals who contract the condition may need botulinum antitoxin to avert temporary muscle paralysis, hospitalization, and death.
The current warning does not contain any information about the potential need for antitoxin and downplays the need for giving antitoxin in the settings of excessive dosing, accidental injection, and oral ingestion, said Public Citizen.
“Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no ‘definitive’ cases of botulism have occurred with recommended doses,” Azza AbuDagga, PhD, health services researcher at Public Citizen’s Health Research Group, said in a statement.
Public Citizen said that using data from the FDA’s Adverse Event Reporting System (FAERS), it found 5414 reports of serious outcomes from botulinum toxin products from January 1989 through March 2021. Almost 22% involved cosmetic indications and about 78% involved therapeutic indications.
Of the 5414 reports, 121 (2%) specified botulism as an adverse reaction; 89 involved therapeutic uses of a botulinum toxin products, and 32 involved cosmetic uses. Many of those 121 reports involved doses within the recommended range for the indication, according to Public Citizen.
The group is also asking the FDA to remove what it calls misleading promotional statements in the labeling of Botox and Botox Cosmetic and from the medication guides for those products. The labels state that there have been “no definitive serious adverse event reports of distant spread of toxin effect” with either the cosmetic use or for use in treating chronic migraine, severe underarm sweating, blepharospasm, or strabismus. These statements do not appear in similar labeling in other countries, such as Canada and the United Kingdom, said Public Citizen.
“The FDA needs to implement our two requested actions quickly to warn the public in unambiguous terms about the risk of botulism associated with the use of Botox and related drugs,” Dr. AbuDagga said in the Public Citizen statement. “This will allow health care professionals and patients to make more informed decisions about the benefit-risk profile of these widely used drugs.”
The Public Citizen petition would apply to all seven approved botulinum toxin biological products: abobotulinumtoxinA (Dysport), daxibotulinumtoxinA-lanm (Daxxify), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox, Botox Cosmetic), prabotulinumtoxinA-xvfs (Jeuveau) and rimabotulinumtoxinB (Myobloc).
An FDA spokesperson said the agency is reviewing the citizen petition, and that generally the agency does not comment on pending petitions. “When we respond to the petition, we will respond directly to the petitioner and post the response in the designated agency docket,” the spokesperson told this news organization. At press time, Botox manufacturer AbbVie had not responded to a request for a comment.
Botulinum toxin is the most-used product for nonsurgical cosmetic procedures, according to the International Society of Aesthetic Plastic Surgery (ISAPS). The ISAPS reported that there were more than 7 million botulinum toxin procedures performed by plastic surgeons worldwide in 2021.
The American Society of Plastic Surgery reported that its members performed 4.4 million Botox procedures in 2020, while the American Society of Dermatologic Surgery (ASDS) said its members performed 2.3 million wrinkle-relaxing procedures in 2019, a 60% increase since 2012.
.
The nonprofit watchdog group successfully petitioned the FDA in 2008 to require a warning for Botox and related products regarding the risk of distant spread of the toxin. In its latest petition to the agency, it says that the injectables need additional warnings about the possibility of iatrogenic botulism with initial and repeated doses and that individuals who contract the condition may need botulinum antitoxin to avert temporary muscle paralysis, hospitalization, and death.
The current warning does not contain any information about the potential need for antitoxin and downplays the need for giving antitoxin in the settings of excessive dosing, accidental injection, and oral ingestion, said Public Citizen.
“Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no ‘definitive’ cases of botulism have occurred with recommended doses,” Azza AbuDagga, PhD, health services researcher at Public Citizen’s Health Research Group, said in a statement.
Public Citizen said that using data from the FDA’s Adverse Event Reporting System (FAERS), it found 5414 reports of serious outcomes from botulinum toxin products from January 1989 through March 2021. Almost 22% involved cosmetic indications and about 78% involved therapeutic indications.
Of the 5414 reports, 121 (2%) specified botulism as an adverse reaction; 89 involved therapeutic uses of a botulinum toxin products, and 32 involved cosmetic uses. Many of those 121 reports involved doses within the recommended range for the indication, according to Public Citizen.
The group is also asking the FDA to remove what it calls misleading promotional statements in the labeling of Botox and Botox Cosmetic and from the medication guides for those products. The labels state that there have been “no definitive serious adverse event reports of distant spread of toxin effect” with either the cosmetic use or for use in treating chronic migraine, severe underarm sweating, blepharospasm, or strabismus. These statements do not appear in similar labeling in other countries, such as Canada and the United Kingdom, said Public Citizen.
“The FDA needs to implement our two requested actions quickly to warn the public in unambiguous terms about the risk of botulism associated with the use of Botox and related drugs,” Dr. AbuDagga said in the Public Citizen statement. “This will allow health care professionals and patients to make more informed decisions about the benefit-risk profile of these widely used drugs.”
The Public Citizen petition would apply to all seven approved botulinum toxin biological products: abobotulinumtoxinA (Dysport), daxibotulinumtoxinA-lanm (Daxxify), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox, Botox Cosmetic), prabotulinumtoxinA-xvfs (Jeuveau) and rimabotulinumtoxinB (Myobloc).
An FDA spokesperson said the agency is reviewing the citizen petition, and that generally the agency does not comment on pending petitions. “When we respond to the petition, we will respond directly to the petitioner and post the response in the designated agency docket,” the spokesperson told this news organization. At press time, Botox manufacturer AbbVie had not responded to a request for a comment.
Botulinum toxin is the most-used product for nonsurgical cosmetic procedures, according to the International Society of Aesthetic Plastic Surgery (ISAPS). The ISAPS reported that there were more than 7 million botulinum toxin procedures performed by plastic surgeons worldwide in 2021.
The American Society of Plastic Surgery reported that its members performed 4.4 million Botox procedures in 2020, while the American Society of Dermatologic Surgery (ASDS) said its members performed 2.3 million wrinkle-relaxing procedures in 2019, a 60% increase since 2012.
.
The nonprofit watchdog group successfully petitioned the FDA in 2008 to require a warning for Botox and related products regarding the risk of distant spread of the toxin. In its latest petition to the agency, it says that the injectables need additional warnings about the possibility of iatrogenic botulism with initial and repeated doses and that individuals who contract the condition may need botulinum antitoxin to avert temporary muscle paralysis, hospitalization, and death.
The current warning does not contain any information about the potential need for antitoxin and downplays the need for giving antitoxin in the settings of excessive dosing, accidental injection, and oral ingestion, said Public Citizen.
“Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no ‘definitive’ cases of botulism have occurred with recommended doses,” Azza AbuDagga, PhD, health services researcher at Public Citizen’s Health Research Group, said in a statement.
Public Citizen said that using data from the FDA’s Adverse Event Reporting System (FAERS), it found 5414 reports of serious outcomes from botulinum toxin products from January 1989 through March 2021. Almost 22% involved cosmetic indications and about 78% involved therapeutic indications.
Of the 5414 reports, 121 (2%) specified botulism as an adverse reaction; 89 involved therapeutic uses of a botulinum toxin products, and 32 involved cosmetic uses. Many of those 121 reports involved doses within the recommended range for the indication, according to Public Citizen.
The group is also asking the FDA to remove what it calls misleading promotional statements in the labeling of Botox and Botox Cosmetic and from the medication guides for those products. The labels state that there have been “no definitive serious adverse event reports of distant spread of toxin effect” with either the cosmetic use or for use in treating chronic migraine, severe underarm sweating, blepharospasm, or strabismus. These statements do not appear in similar labeling in other countries, such as Canada and the United Kingdom, said Public Citizen.
“The FDA needs to implement our two requested actions quickly to warn the public in unambiguous terms about the risk of botulism associated with the use of Botox and related drugs,” Dr. AbuDagga said in the Public Citizen statement. “This will allow health care professionals and patients to make more informed decisions about the benefit-risk profile of these widely used drugs.”
The Public Citizen petition would apply to all seven approved botulinum toxin biological products: abobotulinumtoxinA (Dysport), daxibotulinumtoxinA-lanm (Daxxify), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox, Botox Cosmetic), prabotulinumtoxinA-xvfs (Jeuveau) and rimabotulinumtoxinB (Myobloc).
An FDA spokesperson said the agency is reviewing the citizen petition, and that generally the agency does not comment on pending petitions. “When we respond to the petition, we will respond directly to the petitioner and post the response in the designated agency docket,” the spokesperson told this news organization. At press time, Botox manufacturer AbbVie had not responded to a request for a comment.
Botulinum toxin is the most-used product for nonsurgical cosmetic procedures, according to the International Society of Aesthetic Plastic Surgery (ISAPS). The ISAPS reported that there were more than 7 million botulinum toxin procedures performed by plastic surgeons worldwide in 2021.
The American Society of Plastic Surgery reported that its members performed 4.4 million Botox procedures in 2020, while the American Society of Dermatologic Surgery (ASDS) said its members performed 2.3 million wrinkle-relaxing procedures in 2019, a 60% increase since 2012.
We Want to Hear From You, Our Readers
Happy New Year, everyone. It’s hard to believe, but we are nearing the mid-point of our five-year term on the GI & Hepatology News (GIHN) board of editors. Our central goal over the past two-and-a-half years has been to curate thought-provoking content for GIHN that helps to inform clinical practice and keeps you up-to-date on emerging scientific innovations and policy changes impacting patients with digestive and liver diseases.
Your feedback is critical to ensuring the continued success of the newspaper as your go-to source for cutting edge news relevant to our field.
To start, we welcome your thoughts on the following questions:
- What do you want to see more of in the newspaper (e.g., a particular column, topic)?
- How can we continue to serve you best as a reader?
Please email your feedback to us at [email protected]. Your input is greatly appreciated by both the board and our larger editorial team and will help inform future coverage.
In this month’s issue of GIHN, we update you on the proceedings of AGA’s 2023 Innovation Conference, highlight a new Clinical Practice Guideline focused on the role of biomarkers in Crohn’s disease management, and summarize key AGA journal content.
The AGA Government Affairs Committee also details 2024 updates to Medicare payment rules, including a new add-on code for complex care, increased facility payment for POEM procedures, and continuation of expanded telehealth coverage through the end of 2024.
GIHN associate editor Dr. Avi Ketwaroo introduces this month’s Perspectives column focused on the impact of substance use (specifically alcohol and marijuana) on liver transplant candidacy.
In our January Member Spotlight, we feature Dr. Sonali Paul, a hepatologist and co-founder of Rainbows in Gastro. She shares her passion for promoting health equity in sexual and gender minority populations.
We hope you enjoy this, and all the exciting content included in our January issue.
Megan A. Adams, MD, JD, MSc
Editor-in-Chief
Happy New Year, everyone. It’s hard to believe, but we are nearing the mid-point of our five-year term on the GI & Hepatology News (GIHN) board of editors. Our central goal over the past two-and-a-half years has been to curate thought-provoking content for GIHN that helps to inform clinical practice and keeps you up-to-date on emerging scientific innovations and policy changes impacting patients with digestive and liver diseases.
Your feedback is critical to ensuring the continued success of the newspaper as your go-to source for cutting edge news relevant to our field.
To start, we welcome your thoughts on the following questions:
- What do you want to see more of in the newspaper (e.g., a particular column, topic)?
- How can we continue to serve you best as a reader?
Please email your feedback to us at [email protected]. Your input is greatly appreciated by both the board and our larger editorial team and will help inform future coverage.
In this month’s issue of GIHN, we update you on the proceedings of AGA’s 2023 Innovation Conference, highlight a new Clinical Practice Guideline focused on the role of biomarkers in Crohn’s disease management, and summarize key AGA journal content.
The AGA Government Affairs Committee also details 2024 updates to Medicare payment rules, including a new add-on code for complex care, increased facility payment for POEM procedures, and continuation of expanded telehealth coverage through the end of 2024.
GIHN associate editor Dr. Avi Ketwaroo introduces this month’s Perspectives column focused on the impact of substance use (specifically alcohol and marijuana) on liver transplant candidacy.
In our January Member Spotlight, we feature Dr. Sonali Paul, a hepatologist and co-founder of Rainbows in Gastro. She shares her passion for promoting health equity in sexual and gender minority populations.
We hope you enjoy this, and all the exciting content included in our January issue.
Megan A. Adams, MD, JD, MSc
Editor-in-Chief
Happy New Year, everyone. It’s hard to believe, but we are nearing the mid-point of our five-year term on the GI & Hepatology News (GIHN) board of editors. Our central goal over the past two-and-a-half years has been to curate thought-provoking content for GIHN that helps to inform clinical practice and keeps you up-to-date on emerging scientific innovations and policy changes impacting patients with digestive and liver diseases.
Your feedback is critical to ensuring the continued success of the newspaper as your go-to source for cutting edge news relevant to our field.
To start, we welcome your thoughts on the following questions:
- What do you want to see more of in the newspaper (e.g., a particular column, topic)?
- How can we continue to serve you best as a reader?
Please email your feedback to us at [email protected]. Your input is greatly appreciated by both the board and our larger editorial team and will help inform future coverage.
In this month’s issue of GIHN, we update you on the proceedings of AGA’s 2023 Innovation Conference, highlight a new Clinical Practice Guideline focused on the role of biomarkers in Crohn’s disease management, and summarize key AGA journal content.
The AGA Government Affairs Committee also details 2024 updates to Medicare payment rules, including a new add-on code for complex care, increased facility payment for POEM procedures, and continuation of expanded telehealth coverage through the end of 2024.
GIHN associate editor Dr. Avi Ketwaroo introduces this month’s Perspectives column focused on the impact of substance use (specifically alcohol and marijuana) on liver transplant candidacy.
In our January Member Spotlight, we feature Dr. Sonali Paul, a hepatologist and co-founder of Rainbows in Gastro. She shares her passion for promoting health equity in sexual and gender minority populations.
We hope you enjoy this, and all the exciting content included in our January issue.
Megan A. Adams, MD, JD, MSc
Editor-in-Chief
Hepatologist finds purpose as health equity advocate for LGBTQI+
Sonali Paul, MD, once thought she was an anomaly in the world of medicine. “As I was going through training, I didn’t think others like me existed, a gay South Asian transplant hepatologist. I certainly didn’t have mentors that looked like me. I didn’t have anyone to look up to,” she said.
Fighting to promote health care equity in the LGBTQI+ population has been a cornerstone of her career. As cofounder and an executive board member of Rainbows in Gastro, a sexual and gender minorities affinity group that builds community among LGBTQI+ medical trainees and physicians in gastroenterology, Dr. Paul often goes into the community to promote open discussions about health equity in sexual and gender minority populations.
“Our mission is CHARM: community, healing, advocacy, research, and mentorship,” said Dr. Paul, a transplant hepatologist with the University of Chicago Medicine with a specific niche within fatty liver disease and obesity medicine. She serves as an associate program director for the Internal Medicine Residency Program specifically for diversity, equity, and inclusion.
In 2022 she received the University of Chicago’s Department of Medicine Diversity Award.
Rainbows in Gastro has shown trainees they can be open about their sexual orientation and gender identity without fear of retribution. “I’ve had medical students and residents come to me and say they were going to go into endocrine or some other field because they thought it was more gay friendly, until they saw our group and the work we’re doing,” Dr. Paul said.
In an interview, she talks more about her two key passions: reducing disparities and promoting health equity.
Q: You presented “Embrace the Rainbow: Creating Inclusive LGBTQ+ Spaces in Medicine” at the University of Chicago Medicine Grand Rounds. What were some of the key takeaways of that presentation?
Dr. Paul: One is education. Knowing the history of the LGBT community and how marginalization and discrimination affects the individual coming into that clinic is important. Having little things like pronoun badges or a rainbow flag, having nondiscrimination policies that include sexual orientation, gender identity that are displayed in the clinics, are very small things that seem almost trivial to some people. But I can tell you for myself, it matters if I walk into a door and there’s a rainbow flag there. I feel immediately safer.
Q: What are your hopes and aspirations for the field of GI moving forward?
Dr. Paul: I didn’t learn about social determinants of health in medical school, but more and more I think we’re starting to pivot and really look at those things. I hope GI and hepatology continues to do that.
For me, it’s looking at everything through a health disparities lens, seeing the health disparities across communities and finding solutions to mitigate them. How do we get people access to transplant for all our patients, and really examining the social determinants of health in the health care we provide?
Q: Your clinical focus has been on nonalcoholic fatty liver disease. Can you tell me how you got interested in that area of medicine?
Dr. Paul: There’s been a name change for the disease itself. It’s now metabolic dysfunction-associated steatotic liver disease (MASLD). I got interested from an obesity medicine perspective. I thought the liver pathology was interesting but I wanted to approach it from a different kind of perspective and not just focus on the liver, but also the metabolic factors.
I practice from that kind of lens: Looking at a lot of the metabolic comorbidities that happen with fatty liver disease to help patients with weight loss.
Q: What do you think about the new weight loss drugs?
Dr. Paul: I think they’re very effective. They’re obviously very popular. Weight loss is a really hard thing and I think they are really changing the game. A newer one that was just approved, tirzepatide (Zepbound, Lilly) resulted in up to 20% body weight loss. I think if there’s a medicine that we can give to avoid surgery for some people, I think that’s great. I think what is quite disheartening is insurance access to the medications.
Q: Is there any type of research you’re doing in this area right now?
Dr. Paul: I’m interested in the changes in fatty liver with gender-affirming hormone therapy with estrogen and testosterone, an area that’s never been studied.
Q: Describe how you would spend a free Saturday afternoon.
Dr. Paul: With my wife, my 9-year-old son, and two dogs. One of our favorite places to go is the Lincoln Park Zoo. We go there, especially over the summer, sometimes every week just to walk around. And, my son loves animals. Or, play with our dogs.
LIGHTNING ROUND
What is your favorite junk food?
Doritos
What is your favorite holiday?
Thanksgiving
Is there a book that you reread often?
“Interpreter of Maladies” by Jhumpa Lahiri
What is your favorite movie genre?
Comedy
Are you an introvert or extrovert?
Somewhere in the middle.
Sonali Paul, MD, once thought she was an anomaly in the world of medicine. “As I was going through training, I didn’t think others like me existed, a gay South Asian transplant hepatologist. I certainly didn’t have mentors that looked like me. I didn’t have anyone to look up to,” she said.
Fighting to promote health care equity in the LGBTQI+ population has been a cornerstone of her career. As cofounder and an executive board member of Rainbows in Gastro, a sexual and gender minorities affinity group that builds community among LGBTQI+ medical trainees and physicians in gastroenterology, Dr. Paul often goes into the community to promote open discussions about health equity in sexual and gender minority populations.
“Our mission is CHARM: community, healing, advocacy, research, and mentorship,” said Dr. Paul, a transplant hepatologist with the University of Chicago Medicine with a specific niche within fatty liver disease and obesity medicine. She serves as an associate program director for the Internal Medicine Residency Program specifically for diversity, equity, and inclusion.
In 2022 she received the University of Chicago’s Department of Medicine Diversity Award.
Rainbows in Gastro has shown trainees they can be open about their sexual orientation and gender identity without fear of retribution. “I’ve had medical students and residents come to me and say they were going to go into endocrine or some other field because they thought it was more gay friendly, until they saw our group and the work we’re doing,” Dr. Paul said.
In an interview, she talks more about her two key passions: reducing disparities and promoting health equity.
Q: You presented “Embrace the Rainbow: Creating Inclusive LGBTQ+ Spaces in Medicine” at the University of Chicago Medicine Grand Rounds. What were some of the key takeaways of that presentation?
Dr. Paul: One is education. Knowing the history of the LGBT community and how marginalization and discrimination affects the individual coming into that clinic is important. Having little things like pronoun badges or a rainbow flag, having nondiscrimination policies that include sexual orientation, gender identity that are displayed in the clinics, are very small things that seem almost trivial to some people. But I can tell you for myself, it matters if I walk into a door and there’s a rainbow flag there. I feel immediately safer.
Q: What are your hopes and aspirations for the field of GI moving forward?
Dr. Paul: I didn’t learn about social determinants of health in medical school, but more and more I think we’re starting to pivot and really look at those things. I hope GI and hepatology continues to do that.
For me, it’s looking at everything through a health disparities lens, seeing the health disparities across communities and finding solutions to mitigate them. How do we get people access to transplant for all our patients, and really examining the social determinants of health in the health care we provide?
Q: Your clinical focus has been on nonalcoholic fatty liver disease. Can you tell me how you got interested in that area of medicine?
Dr. Paul: There’s been a name change for the disease itself. It’s now metabolic dysfunction-associated steatotic liver disease (MASLD). I got interested from an obesity medicine perspective. I thought the liver pathology was interesting but I wanted to approach it from a different kind of perspective and not just focus on the liver, but also the metabolic factors.
I practice from that kind of lens: Looking at a lot of the metabolic comorbidities that happen with fatty liver disease to help patients with weight loss.
Q: What do you think about the new weight loss drugs?
Dr. Paul: I think they’re very effective. They’re obviously very popular. Weight loss is a really hard thing and I think they are really changing the game. A newer one that was just approved, tirzepatide (Zepbound, Lilly) resulted in up to 20% body weight loss. I think if there’s a medicine that we can give to avoid surgery for some people, I think that’s great. I think what is quite disheartening is insurance access to the medications.
Q: Is there any type of research you’re doing in this area right now?
Dr. Paul: I’m interested in the changes in fatty liver with gender-affirming hormone therapy with estrogen and testosterone, an area that’s never been studied.
Q: Describe how you would spend a free Saturday afternoon.
Dr. Paul: With my wife, my 9-year-old son, and two dogs. One of our favorite places to go is the Lincoln Park Zoo. We go there, especially over the summer, sometimes every week just to walk around. And, my son loves animals. Or, play with our dogs.
LIGHTNING ROUND
What is your favorite junk food?
Doritos
What is your favorite holiday?
Thanksgiving
Is there a book that you reread often?
“Interpreter of Maladies” by Jhumpa Lahiri
What is your favorite movie genre?
Comedy
Are you an introvert or extrovert?
Somewhere in the middle.
Sonali Paul, MD, once thought she was an anomaly in the world of medicine. “As I was going through training, I didn’t think others like me existed, a gay South Asian transplant hepatologist. I certainly didn’t have mentors that looked like me. I didn’t have anyone to look up to,” she said.
Fighting to promote health care equity in the LGBTQI+ population has been a cornerstone of her career. As cofounder and an executive board member of Rainbows in Gastro, a sexual and gender minorities affinity group that builds community among LGBTQI+ medical trainees and physicians in gastroenterology, Dr. Paul often goes into the community to promote open discussions about health equity in sexual and gender minority populations.
“Our mission is CHARM: community, healing, advocacy, research, and mentorship,” said Dr. Paul, a transplant hepatologist with the University of Chicago Medicine with a specific niche within fatty liver disease and obesity medicine. She serves as an associate program director for the Internal Medicine Residency Program specifically for diversity, equity, and inclusion.
In 2022 she received the University of Chicago’s Department of Medicine Diversity Award.
Rainbows in Gastro has shown trainees they can be open about their sexual orientation and gender identity without fear of retribution. “I’ve had medical students and residents come to me and say they were going to go into endocrine or some other field because they thought it was more gay friendly, until they saw our group and the work we’re doing,” Dr. Paul said.
In an interview, she talks more about her two key passions: reducing disparities and promoting health equity.
Q: You presented “Embrace the Rainbow: Creating Inclusive LGBTQ+ Spaces in Medicine” at the University of Chicago Medicine Grand Rounds. What were some of the key takeaways of that presentation?
Dr. Paul: One is education. Knowing the history of the LGBT community and how marginalization and discrimination affects the individual coming into that clinic is important. Having little things like pronoun badges or a rainbow flag, having nondiscrimination policies that include sexual orientation, gender identity that are displayed in the clinics, are very small things that seem almost trivial to some people. But I can tell you for myself, it matters if I walk into a door and there’s a rainbow flag there. I feel immediately safer.
Q: What are your hopes and aspirations for the field of GI moving forward?
Dr. Paul: I didn’t learn about social determinants of health in medical school, but more and more I think we’re starting to pivot and really look at those things. I hope GI and hepatology continues to do that.
For me, it’s looking at everything through a health disparities lens, seeing the health disparities across communities and finding solutions to mitigate them. How do we get people access to transplant for all our patients, and really examining the social determinants of health in the health care we provide?
Q: Your clinical focus has been on nonalcoholic fatty liver disease. Can you tell me how you got interested in that area of medicine?
Dr. Paul: There’s been a name change for the disease itself. It’s now metabolic dysfunction-associated steatotic liver disease (MASLD). I got interested from an obesity medicine perspective. I thought the liver pathology was interesting but I wanted to approach it from a different kind of perspective and not just focus on the liver, but also the metabolic factors.
I practice from that kind of lens: Looking at a lot of the metabolic comorbidities that happen with fatty liver disease to help patients with weight loss.
Q: What do you think about the new weight loss drugs?
Dr. Paul: I think they’re very effective. They’re obviously very popular. Weight loss is a really hard thing and I think they are really changing the game. A newer one that was just approved, tirzepatide (Zepbound, Lilly) resulted in up to 20% body weight loss. I think if there’s a medicine that we can give to avoid surgery for some people, I think that’s great. I think what is quite disheartening is insurance access to the medications.
Q: Is there any type of research you’re doing in this area right now?
Dr. Paul: I’m interested in the changes in fatty liver with gender-affirming hormone therapy with estrogen and testosterone, an area that’s never been studied.
Q: Describe how you would spend a free Saturday afternoon.
Dr. Paul: With my wife, my 9-year-old son, and two dogs. One of our favorite places to go is the Lincoln Park Zoo. We go there, especially over the summer, sometimes every week just to walk around. And, my son loves animals. Or, play with our dogs.
LIGHTNING ROUND
What is your favorite junk food?
Doritos
What is your favorite holiday?
Thanksgiving
Is there a book that you reread often?
“Interpreter of Maladies” by Jhumpa Lahiri
What is your favorite movie genre?
Comedy
Are you an introvert or extrovert?
Somewhere in the middle.
H pylori Infection Linked to Increased Alzheimer’s Risk
TOPLINE:
results of a large and lengthy population-based study suggest.
METHODOLOGY:
- Researchers identified all cases with a first-time diagnosis of AD and matched each AD case to up to 40 AD-free control cases on the basis of age, sex, cohort entry date, and duration of follow-up.
- The exposure of interest was CAHPI, defined based on an algorithm using clinical guidelines and recommendations on the management of H pylori (HP) infection, with researchers focusing on infected individuals presenting with symptoms or developing serious complications from the infection.
- Researchers performed several sensitivity analyses, which included repeating the primary analysis using alternate lag periods, restricting the cohort to participants with AD (not vascular, alcoholic, and unspecified dementia), and using salmonellosis, an infection not previously associated with AD, as a negative control exposure.
TAKEAWAY:
- Compared with no exposure to CAHPI, exposure to CAHPI was associated with a moderately increased risk for AD (odds ratio [OR], 1.11; 95% CI, 1.01-1.21), with no major effect modification by demographics or socioeconomic status.
- The increased risk peaked 7.3-10.8 years after CAHPI onset (OR, 1.24; 95% CI, 1.05-1.47) before decreasing.
- Sensitivity analyses yielded findings that were overall consistent with those of the primary analysis.
- The analysis with salmonellosis as a negative control exposure showed no association with the risk for AD (OR, 1.03; 95% CI, 0.82-1.29).
IN PRACTICE:
“These results support the notion of HP infection as a potential modifiable risk factor of AD” and “pave the way for future randomized controlled trials that would assess the impact and cost-effectiveness of population-based targeted interventions such as individualized HP eradication programs, on the development of AD,” the authors write.
SOURCE:
The study was conducted by Antonios Douros, Department of Medicine, and Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada, and colleagues. It was published online in Alzheimer’s & Dementia.
LIMITATIONS:
Given the observational nature of the study, residual confounding is possible. Because the exposure definition was on the basis of CAHPI recorded by general practitioners, exposure misclassification due to symptomatic patients not seeking primary care is possible, as is outcome misclassification. The authors can’t rule out the possibility of an association between asymptomatic H pylori infection and AD risk.
DISCLOSURES:
The study received funding from the Canadian Institutes of Health Research. Douros has no relevant conflicts of interest; see paper for disclosures of other authors.
Pauline Anderson has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
results of a large and lengthy population-based study suggest.
METHODOLOGY:
- Researchers identified all cases with a first-time diagnosis of AD and matched each AD case to up to 40 AD-free control cases on the basis of age, sex, cohort entry date, and duration of follow-up.
- The exposure of interest was CAHPI, defined based on an algorithm using clinical guidelines and recommendations on the management of H pylori (HP) infection, with researchers focusing on infected individuals presenting with symptoms or developing serious complications from the infection.
- Researchers performed several sensitivity analyses, which included repeating the primary analysis using alternate lag periods, restricting the cohort to participants with AD (not vascular, alcoholic, and unspecified dementia), and using salmonellosis, an infection not previously associated with AD, as a negative control exposure.
TAKEAWAY:
- Compared with no exposure to CAHPI, exposure to CAHPI was associated with a moderately increased risk for AD (odds ratio [OR], 1.11; 95% CI, 1.01-1.21), with no major effect modification by demographics or socioeconomic status.
- The increased risk peaked 7.3-10.8 years after CAHPI onset (OR, 1.24; 95% CI, 1.05-1.47) before decreasing.
- Sensitivity analyses yielded findings that were overall consistent with those of the primary analysis.
- The analysis with salmonellosis as a negative control exposure showed no association with the risk for AD (OR, 1.03; 95% CI, 0.82-1.29).
IN PRACTICE:
“These results support the notion of HP infection as a potential modifiable risk factor of AD” and “pave the way for future randomized controlled trials that would assess the impact and cost-effectiveness of population-based targeted interventions such as individualized HP eradication programs, on the development of AD,” the authors write.
SOURCE:
The study was conducted by Antonios Douros, Department of Medicine, and Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada, and colleagues. It was published online in Alzheimer’s & Dementia.
LIMITATIONS:
Given the observational nature of the study, residual confounding is possible. Because the exposure definition was on the basis of CAHPI recorded by general practitioners, exposure misclassification due to symptomatic patients not seeking primary care is possible, as is outcome misclassification. The authors can’t rule out the possibility of an association between asymptomatic H pylori infection and AD risk.
DISCLOSURES:
The study received funding from the Canadian Institutes of Health Research. Douros has no relevant conflicts of interest; see paper for disclosures of other authors.
Pauline Anderson has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
results of a large and lengthy population-based study suggest.
METHODOLOGY:
- Researchers identified all cases with a first-time diagnosis of AD and matched each AD case to up to 40 AD-free control cases on the basis of age, sex, cohort entry date, and duration of follow-up.
- The exposure of interest was CAHPI, defined based on an algorithm using clinical guidelines and recommendations on the management of H pylori (HP) infection, with researchers focusing on infected individuals presenting with symptoms or developing serious complications from the infection.
- Researchers performed several sensitivity analyses, which included repeating the primary analysis using alternate lag periods, restricting the cohort to participants with AD (not vascular, alcoholic, and unspecified dementia), and using salmonellosis, an infection not previously associated with AD, as a negative control exposure.
TAKEAWAY:
- Compared with no exposure to CAHPI, exposure to CAHPI was associated with a moderately increased risk for AD (odds ratio [OR], 1.11; 95% CI, 1.01-1.21), with no major effect modification by demographics or socioeconomic status.
- The increased risk peaked 7.3-10.8 years after CAHPI onset (OR, 1.24; 95% CI, 1.05-1.47) before decreasing.
- Sensitivity analyses yielded findings that were overall consistent with those of the primary analysis.
- The analysis with salmonellosis as a negative control exposure showed no association with the risk for AD (OR, 1.03; 95% CI, 0.82-1.29).
IN PRACTICE:
“These results support the notion of HP infection as a potential modifiable risk factor of AD” and “pave the way for future randomized controlled trials that would assess the impact and cost-effectiveness of population-based targeted interventions such as individualized HP eradication programs, on the development of AD,” the authors write.
SOURCE:
The study was conducted by Antonios Douros, Department of Medicine, and Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada, and colleagues. It was published online in Alzheimer’s & Dementia.
LIMITATIONS:
Given the observational nature of the study, residual confounding is possible. Because the exposure definition was on the basis of CAHPI recorded by general practitioners, exposure misclassification due to symptomatic patients not seeking primary care is possible, as is outcome misclassification. The authors can’t rule out the possibility of an association between asymptomatic H pylori infection and AD risk.
DISCLOSURES:
The study received funding from the Canadian Institutes of Health Research. Douros has no relevant conflicts of interest; see paper for disclosures of other authors.
Pauline Anderson has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
What Makes Patients Vulnerable to Delusions of Parasitosis?
, reported researchers in a small retrospective case-control study.
Delusions of parasitosis (DOP) affects mostly middle-aged women and has associations with renal failure and some medications, wrote corresponding author Colleen Reisz, MD, a dermatologist with the department of internal medicine at the University of Missouri–Kansas City School of Medicine, and her coauthors. The study was published online December 15, 2023, in the Journal of the American Academy of Dermatology.
“We hypothesize that vulnerability to DOP emerges when multiple factors combine, such as age, sex, medications, and changes in [drug] clearance capacity,” Dr. Reisz and her coauthors wrote. “Changes in health care, such as the dramatic increase in stimulant prescriptions and alternatives to opioids in pain management, may be contributing to off target drug effects on the brain.”
To test their hypothesis, the researchers conducted a case-control study of biometric and pharmaceutical data from 34 patients with DOP which they compared to an age-matched control group of 53 women presenting with a dermatitis above the clavicle from a general dermatology practice between 2012 and 2020. They de-identified the data and performed statistical analysis on variables that included biometric data and intake of pharmaceuticals and nutraceuticals. Polypharmacy was defined as five or more drugs.
Of the 34 patients with DOP, 27 were women with a mean age of 58 years and 7 were men with a mean age of 60 years. Dr. Reisz and her colleagues observed statistical significance between cases and controls in terms of polypharmacy (P = .011), attention-deficit/hyperactivity disorder medications (P < .001), selective serotonin reuptake inhibitors (P = .005), opioids (P = .003), and gabapentin (P = .003).
In other findings, half of DOP cases presented with samples of perceived parasitic material, and four associated the perceived infestation with a single emotion-laden event. This prompted the researchers “to consider that DOP may share mechanisms with fear conditioning and extinction,” they wrote. “Fear conditioning refers to the process of memory acquisition and extinction. This process is essential for survival and has been studied in posttraumatic stress disorder.”
They acknowledged certain limitations of the study, including its retrospective single-center design and the lack of control for factors such as socioeconomic background and level of education.
“Patients with DOP should undergo detailed drug histories and examination of clearance profiles, especially renal function,” the researchers concluded.
Evan A. Rieder, MD, a New York City–based dermatologist and psychiatrist who was asked to comment on the study, said that delusional infestation is one of the most difficult medical conditions to treat and study.
“Though the numbers of cases in this research letter are small, they are instructive in demonstrating a high burden of polypharmacy including psychostimulants, opioids, and SSRIs in such patients,” he told this news organization. “Dermatologists should be performing detailed drug histories, obtaining comprehensive lab work, and considering the effects of medications — both illicit and prescribed — on clinical presentations. While in many cases, delusional patients refuse to consent to psychopharmacologic medications (or treatment in general), the elimination or decrease in dose of certain problematic medications may be helpful in and of themselves.”
The researchers reported having no financial disclosures. Dr. Rieder disclosed that he is a consultant for AbbVie, L’Oréal, Pierre Fabre, Procter & Gamble, and Unilever.
, reported researchers in a small retrospective case-control study.
Delusions of parasitosis (DOP) affects mostly middle-aged women and has associations with renal failure and some medications, wrote corresponding author Colleen Reisz, MD, a dermatologist with the department of internal medicine at the University of Missouri–Kansas City School of Medicine, and her coauthors. The study was published online December 15, 2023, in the Journal of the American Academy of Dermatology.
“We hypothesize that vulnerability to DOP emerges when multiple factors combine, such as age, sex, medications, and changes in [drug] clearance capacity,” Dr. Reisz and her coauthors wrote. “Changes in health care, such as the dramatic increase in stimulant prescriptions and alternatives to opioids in pain management, may be contributing to off target drug effects on the brain.”
To test their hypothesis, the researchers conducted a case-control study of biometric and pharmaceutical data from 34 patients with DOP which they compared to an age-matched control group of 53 women presenting with a dermatitis above the clavicle from a general dermatology practice between 2012 and 2020. They de-identified the data and performed statistical analysis on variables that included biometric data and intake of pharmaceuticals and nutraceuticals. Polypharmacy was defined as five or more drugs.
Of the 34 patients with DOP, 27 were women with a mean age of 58 years and 7 were men with a mean age of 60 years. Dr. Reisz and her colleagues observed statistical significance between cases and controls in terms of polypharmacy (P = .011), attention-deficit/hyperactivity disorder medications (P < .001), selective serotonin reuptake inhibitors (P = .005), opioids (P = .003), and gabapentin (P = .003).
In other findings, half of DOP cases presented with samples of perceived parasitic material, and four associated the perceived infestation with a single emotion-laden event. This prompted the researchers “to consider that DOP may share mechanisms with fear conditioning and extinction,” they wrote. “Fear conditioning refers to the process of memory acquisition and extinction. This process is essential for survival and has been studied in posttraumatic stress disorder.”
They acknowledged certain limitations of the study, including its retrospective single-center design and the lack of control for factors such as socioeconomic background and level of education.
“Patients with DOP should undergo detailed drug histories and examination of clearance profiles, especially renal function,” the researchers concluded.
Evan A. Rieder, MD, a New York City–based dermatologist and psychiatrist who was asked to comment on the study, said that delusional infestation is one of the most difficult medical conditions to treat and study.
“Though the numbers of cases in this research letter are small, they are instructive in demonstrating a high burden of polypharmacy including psychostimulants, opioids, and SSRIs in such patients,” he told this news organization. “Dermatologists should be performing detailed drug histories, obtaining comprehensive lab work, and considering the effects of medications — both illicit and prescribed — on clinical presentations. While in many cases, delusional patients refuse to consent to psychopharmacologic medications (or treatment in general), the elimination or decrease in dose of certain problematic medications may be helpful in and of themselves.”
The researchers reported having no financial disclosures. Dr. Rieder disclosed that he is a consultant for AbbVie, L’Oréal, Pierre Fabre, Procter & Gamble, and Unilever.
, reported researchers in a small retrospective case-control study.
Delusions of parasitosis (DOP) affects mostly middle-aged women and has associations with renal failure and some medications, wrote corresponding author Colleen Reisz, MD, a dermatologist with the department of internal medicine at the University of Missouri–Kansas City School of Medicine, and her coauthors. The study was published online December 15, 2023, in the Journal of the American Academy of Dermatology.
“We hypothesize that vulnerability to DOP emerges when multiple factors combine, such as age, sex, medications, and changes in [drug] clearance capacity,” Dr. Reisz and her coauthors wrote. “Changes in health care, such as the dramatic increase in stimulant prescriptions and alternatives to opioids in pain management, may be contributing to off target drug effects on the brain.”
To test their hypothesis, the researchers conducted a case-control study of biometric and pharmaceutical data from 34 patients with DOP which they compared to an age-matched control group of 53 women presenting with a dermatitis above the clavicle from a general dermatology practice between 2012 and 2020. They de-identified the data and performed statistical analysis on variables that included biometric data and intake of pharmaceuticals and nutraceuticals. Polypharmacy was defined as five or more drugs.
Of the 34 patients with DOP, 27 were women with a mean age of 58 years and 7 were men with a mean age of 60 years. Dr. Reisz and her colleagues observed statistical significance between cases and controls in terms of polypharmacy (P = .011), attention-deficit/hyperactivity disorder medications (P < .001), selective serotonin reuptake inhibitors (P = .005), opioids (P = .003), and gabapentin (P = .003).
In other findings, half of DOP cases presented with samples of perceived parasitic material, and four associated the perceived infestation with a single emotion-laden event. This prompted the researchers “to consider that DOP may share mechanisms with fear conditioning and extinction,” they wrote. “Fear conditioning refers to the process of memory acquisition and extinction. This process is essential for survival and has been studied in posttraumatic stress disorder.”
They acknowledged certain limitations of the study, including its retrospective single-center design and the lack of control for factors such as socioeconomic background and level of education.
“Patients with DOP should undergo detailed drug histories and examination of clearance profiles, especially renal function,” the researchers concluded.
Evan A. Rieder, MD, a New York City–based dermatologist and psychiatrist who was asked to comment on the study, said that delusional infestation is one of the most difficult medical conditions to treat and study.
“Though the numbers of cases in this research letter are small, they are instructive in demonstrating a high burden of polypharmacy including psychostimulants, opioids, and SSRIs in such patients,” he told this news organization. “Dermatologists should be performing detailed drug histories, obtaining comprehensive lab work, and considering the effects of medications — both illicit and prescribed — on clinical presentations. While in many cases, delusional patients refuse to consent to psychopharmacologic medications (or treatment in general), the elimination or decrease in dose of certain problematic medications may be helpful in and of themselves.”
The researchers reported having no financial disclosures. Dr. Rieder disclosed that he is a consultant for AbbVie, L’Oréal, Pierre Fabre, Procter & Gamble, and Unilever.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Lower olanzapine dose just as effective for chemotherapy-induced nausea, vomiting
SAN ANTONIO —
Although it’s highly effective in combination with standard antiemetic therapy, olanzapine at the standard dose of 10 mg makes people too drowsy. “This has prevented its widespread use in clinical practice,” medical oncologist Jyoti Bajpai, DM, of Tata Memorial Cancer Centre, Mumbai, India, explained at the San Antonio Breast Cancer Symposium.
She and her colleagues had a simple idea: Reduce the dose to 2.5 mg instead of 10 mg to prevent the problem. In a randomized trial with 267 patients that Dr. Bajpai presented at the meeting, they found that the lower dose was just as effective for nausea and vomiting prophylaxis, and it greatly reduced daytime somnolence.
“This merits consideration as an antiemetic regimen of choice for highly emetogenic chemotherapy.” The findings are “practice changing,” Dr. Bajpai, the lead investigator, said.
Laura Huppert, MD, a breast oncologist at the University of California, San Francisco, wasn’t surprised by the finding.
She said she and her colleagues at UCSF use a lot of olanzapine for nausea and vomiting prophylaxis. Like the team in India, they have found that 2.5 mg is effective and causes far less sleepiness. Some patients require 5 mg, but the full 10-mg dose is rarely needed.
Although the approach is familiar at UCSF, Dr. Huppert said she doesn’t think a lot of oncologists outside of academic centers know that olanzapine is “really helpful” and that “you don’t need a high dose.” It’s “a very good clinical pearl” and “definitely a new message for some,” she said in an interview.
Over 90% of the subjects in the study were women with breast cancer. Other cancers included sarcoma, germ cell tumors, and head and neck cancer. Subjects were scheduled for their first chemotherapy session with anthracycline-cyclophosphamide and high-dose cisplatin.
The trial randomized 135 patients to 10 mg of olanzapine and 132 to 2.5mg for 5 days, starting the day of their session. They were also on standard triple-antiemetic therapy (selective serotonin receptor (5-HT3) antagonist, neurokinin-1 receptor antagonist, and single-dose dexamethasone).
There were no significant differences between the two arms regarding nausea and vomiting, which patients tracked in daily journals using symptom severity and visual analog scales.
For instance, 44.7% in the 2.5-mg arm and 43.7% in the 10-mg arm reported no vomiting, no use of rescue medications, and no or only mild nausea (P = .87). Results were similar in the first 24 hours as well as on subsequent days.
There was also no difference in the proportion of patients who did have an emetic episode or needed rescue medication: 49.2% in the 2.5-mg arm versus 48.9% with 10 mg (P = .954).
Where the two groups split was on the incidence of daytime somnolence, which was reported by 65.2% of patients in the low-dose arm but 89.6% in the standard-dose group (P < .001). During the first 24 hours, 4.5% of low-dose patients reported severe somnolence versus 40% with 10-mg dosing (P < .001).
The overall incidence declined over the remaining study days, but the differences between the two groups were comparable. On day 5, for instance, 0.8% of low-dose patients but 8.1% of standard-dose patients reported severe somnolence (P = .004).
Low-dose patients also reported less appetite suppression.
The work was supported by the Progressive Ladies Welfare Association. Dr. Bajpai didn’t have any disclosures. Dr. Huppert is an adviser for AstraZeneca.
SAN ANTONIO —
Although it’s highly effective in combination with standard antiemetic therapy, olanzapine at the standard dose of 10 mg makes people too drowsy. “This has prevented its widespread use in clinical practice,” medical oncologist Jyoti Bajpai, DM, of Tata Memorial Cancer Centre, Mumbai, India, explained at the San Antonio Breast Cancer Symposium.
She and her colleagues had a simple idea: Reduce the dose to 2.5 mg instead of 10 mg to prevent the problem. In a randomized trial with 267 patients that Dr. Bajpai presented at the meeting, they found that the lower dose was just as effective for nausea and vomiting prophylaxis, and it greatly reduced daytime somnolence.
“This merits consideration as an antiemetic regimen of choice for highly emetogenic chemotherapy.” The findings are “practice changing,” Dr. Bajpai, the lead investigator, said.
Laura Huppert, MD, a breast oncologist at the University of California, San Francisco, wasn’t surprised by the finding.
She said she and her colleagues at UCSF use a lot of olanzapine for nausea and vomiting prophylaxis. Like the team in India, they have found that 2.5 mg is effective and causes far less sleepiness. Some patients require 5 mg, but the full 10-mg dose is rarely needed.
Although the approach is familiar at UCSF, Dr. Huppert said she doesn’t think a lot of oncologists outside of academic centers know that olanzapine is “really helpful” and that “you don’t need a high dose.” It’s “a very good clinical pearl” and “definitely a new message for some,” she said in an interview.
Over 90% of the subjects in the study were women with breast cancer. Other cancers included sarcoma, germ cell tumors, and head and neck cancer. Subjects were scheduled for their first chemotherapy session with anthracycline-cyclophosphamide and high-dose cisplatin.
The trial randomized 135 patients to 10 mg of olanzapine and 132 to 2.5mg for 5 days, starting the day of their session. They were also on standard triple-antiemetic therapy (selective serotonin receptor (5-HT3) antagonist, neurokinin-1 receptor antagonist, and single-dose dexamethasone).
There were no significant differences between the two arms regarding nausea and vomiting, which patients tracked in daily journals using symptom severity and visual analog scales.
For instance, 44.7% in the 2.5-mg arm and 43.7% in the 10-mg arm reported no vomiting, no use of rescue medications, and no or only mild nausea (P = .87). Results were similar in the first 24 hours as well as on subsequent days.
There was also no difference in the proportion of patients who did have an emetic episode or needed rescue medication: 49.2% in the 2.5-mg arm versus 48.9% with 10 mg (P = .954).
Where the two groups split was on the incidence of daytime somnolence, which was reported by 65.2% of patients in the low-dose arm but 89.6% in the standard-dose group (P < .001). During the first 24 hours, 4.5% of low-dose patients reported severe somnolence versus 40% with 10-mg dosing (P < .001).
The overall incidence declined over the remaining study days, but the differences between the two groups were comparable. On day 5, for instance, 0.8% of low-dose patients but 8.1% of standard-dose patients reported severe somnolence (P = .004).
Low-dose patients also reported less appetite suppression.
The work was supported by the Progressive Ladies Welfare Association. Dr. Bajpai didn’t have any disclosures. Dr. Huppert is an adviser for AstraZeneca.
SAN ANTONIO —
Although it’s highly effective in combination with standard antiemetic therapy, olanzapine at the standard dose of 10 mg makes people too drowsy. “This has prevented its widespread use in clinical practice,” medical oncologist Jyoti Bajpai, DM, of Tata Memorial Cancer Centre, Mumbai, India, explained at the San Antonio Breast Cancer Symposium.
She and her colleagues had a simple idea: Reduce the dose to 2.5 mg instead of 10 mg to prevent the problem. In a randomized trial with 267 patients that Dr. Bajpai presented at the meeting, they found that the lower dose was just as effective for nausea and vomiting prophylaxis, and it greatly reduced daytime somnolence.
“This merits consideration as an antiemetic regimen of choice for highly emetogenic chemotherapy.” The findings are “practice changing,” Dr. Bajpai, the lead investigator, said.
Laura Huppert, MD, a breast oncologist at the University of California, San Francisco, wasn’t surprised by the finding.
She said she and her colleagues at UCSF use a lot of olanzapine for nausea and vomiting prophylaxis. Like the team in India, they have found that 2.5 mg is effective and causes far less sleepiness. Some patients require 5 mg, but the full 10-mg dose is rarely needed.
Although the approach is familiar at UCSF, Dr. Huppert said she doesn’t think a lot of oncologists outside of academic centers know that olanzapine is “really helpful” and that “you don’t need a high dose.” It’s “a very good clinical pearl” and “definitely a new message for some,” she said in an interview.
Over 90% of the subjects in the study were women with breast cancer. Other cancers included sarcoma, germ cell tumors, and head and neck cancer. Subjects were scheduled for their first chemotherapy session with anthracycline-cyclophosphamide and high-dose cisplatin.
The trial randomized 135 patients to 10 mg of olanzapine and 132 to 2.5mg for 5 days, starting the day of their session. They were also on standard triple-antiemetic therapy (selective serotonin receptor (5-HT3) antagonist, neurokinin-1 receptor antagonist, and single-dose dexamethasone).
There were no significant differences between the two arms regarding nausea and vomiting, which patients tracked in daily journals using symptom severity and visual analog scales.
For instance, 44.7% in the 2.5-mg arm and 43.7% in the 10-mg arm reported no vomiting, no use of rescue medications, and no or only mild nausea (P = .87). Results were similar in the first 24 hours as well as on subsequent days.
There was also no difference in the proportion of patients who did have an emetic episode or needed rescue medication: 49.2% in the 2.5-mg arm versus 48.9% with 10 mg (P = .954).
Where the two groups split was on the incidence of daytime somnolence, which was reported by 65.2% of patients in the low-dose arm but 89.6% in the standard-dose group (P < .001). During the first 24 hours, 4.5% of low-dose patients reported severe somnolence versus 40% with 10-mg dosing (P < .001).
The overall incidence declined over the remaining study days, but the differences between the two groups were comparable. On day 5, for instance, 0.8% of low-dose patients but 8.1% of standard-dose patients reported severe somnolence (P = .004).
Low-dose patients also reported less appetite suppression.
The work was supported by the Progressive Ladies Welfare Association. Dr. Bajpai didn’t have any disclosures. Dr. Huppert is an adviser for AstraZeneca.
AT SABCS 2023
Should BP Guidelines Be Sex-Specific?
This transcript has been edited for clarity.
This is Dr. JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. Current BP guidelines are sex-agnostic.
This study was done in the large-scale nationally representative NHANES cohort. It included more than 53,000 US men and women. The average age was about 45 years, with an average duration of follow-up of 9.5 years. During that time, about 2400 cardiovascular (CVD) deaths were documented at baseline. The BP was measured three times, and the results were averaged. About 20% of the cohort were taking antihypertensive medications, and 80% were not.
Sex differences were observed in the association between BP and CVD mortality. The systolic BP associated with the lowest risk for CVD death was 110-119 mm Hg in men and 100-109 mm Hg in women. In men, however, compared with a reference category of systolic BP of 100-109 mm Hg, the risk for CVD death began to increase significantly at a systolic BP ≥ 160 mm Hg, at which point, the hazard ratio was 1.76, or 76% higher risk.
In women, the risk for CVD death began to increase significantly at a lower threshold. Compared with a reference category of systolic BP of 100-109 mm Hg, women whose systolic BP was 130-139 mm Hg had a significant 61% increase in CVD death, and among those with a systolic BP of 140-159 mm Hg, the risk was increased by 75%. With a systolic BP ≥ 160 mm Hg, CVD deaths among women were more than doubled, with a hazard ratio of 2.13.
Overall, these findings suggest sex differences, with women having an increased risk for CVD death beginning at a lower elevation of their systolic BP. For diastolic BP, both men and women showed the typical U-shaped curve and the diastolic BP associated with the lowest risk for CVD death was 70-80 mm Hg.
If these findings can be replicated with additional research and other large-scale cohort studies, and randomized trials show differences in lowering BP, then sex-specific BP guidelines could have advantages and should be seriously considered. Furthermore, some of the CVD risk scores and risk modeling should perhaps use sex-specific blood pressure thresholds.Dr. Manson received study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
This is Dr. JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. Current BP guidelines are sex-agnostic.
This study was done in the large-scale nationally representative NHANES cohort. It included more than 53,000 US men and women. The average age was about 45 years, with an average duration of follow-up of 9.5 years. During that time, about 2400 cardiovascular (CVD) deaths were documented at baseline. The BP was measured three times, and the results were averaged. About 20% of the cohort were taking antihypertensive medications, and 80% were not.
Sex differences were observed in the association between BP and CVD mortality. The systolic BP associated with the lowest risk for CVD death was 110-119 mm Hg in men and 100-109 mm Hg in women. In men, however, compared with a reference category of systolic BP of 100-109 mm Hg, the risk for CVD death began to increase significantly at a systolic BP ≥ 160 mm Hg, at which point, the hazard ratio was 1.76, or 76% higher risk.
In women, the risk for CVD death began to increase significantly at a lower threshold. Compared with a reference category of systolic BP of 100-109 mm Hg, women whose systolic BP was 130-139 mm Hg had a significant 61% increase in CVD death, and among those with a systolic BP of 140-159 mm Hg, the risk was increased by 75%. With a systolic BP ≥ 160 mm Hg, CVD deaths among women were more than doubled, with a hazard ratio of 2.13.
Overall, these findings suggest sex differences, with women having an increased risk for CVD death beginning at a lower elevation of their systolic BP. For diastolic BP, both men and women showed the typical U-shaped curve and the diastolic BP associated with the lowest risk for CVD death was 70-80 mm Hg.
If these findings can be replicated with additional research and other large-scale cohort studies, and randomized trials show differences in lowering BP, then sex-specific BP guidelines could have advantages and should be seriously considered. Furthermore, some of the CVD risk scores and risk modeling should perhaps use sex-specific blood pressure thresholds.Dr. Manson received study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
This is Dr. JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. Current BP guidelines are sex-agnostic.
This study was done in the large-scale nationally representative NHANES cohort. It included more than 53,000 US men and women. The average age was about 45 years, with an average duration of follow-up of 9.5 years. During that time, about 2400 cardiovascular (CVD) deaths were documented at baseline. The BP was measured three times, and the results were averaged. About 20% of the cohort were taking antihypertensive medications, and 80% were not.
Sex differences were observed in the association between BP and CVD mortality. The systolic BP associated with the lowest risk for CVD death was 110-119 mm Hg in men and 100-109 mm Hg in women. In men, however, compared with a reference category of systolic BP of 100-109 mm Hg, the risk for CVD death began to increase significantly at a systolic BP ≥ 160 mm Hg, at which point, the hazard ratio was 1.76, or 76% higher risk.
In women, the risk for CVD death began to increase significantly at a lower threshold. Compared with a reference category of systolic BP of 100-109 mm Hg, women whose systolic BP was 130-139 mm Hg had a significant 61% increase in CVD death, and among those with a systolic BP of 140-159 mm Hg, the risk was increased by 75%. With a systolic BP ≥ 160 mm Hg, CVD deaths among women were more than doubled, with a hazard ratio of 2.13.
Overall, these findings suggest sex differences, with women having an increased risk for CVD death beginning at a lower elevation of their systolic BP. For diastolic BP, both men and women showed the typical U-shaped curve and the diastolic BP associated with the lowest risk for CVD death was 70-80 mm Hg.
If these findings can be replicated with additional research and other large-scale cohort studies, and randomized trials show differences in lowering BP, then sex-specific BP guidelines could have advantages and should be seriously considered. Furthermore, some of the CVD risk scores and risk modeling should perhaps use sex-specific blood pressure thresholds.Dr. Manson received study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).
A version of this article appeared on Medscape.com.