User login
Why Veterans May Conceal Suicidal Thoughts
Veterans at risk of suicide may not share their suicidal ideation with their psychotherapists or may choose not to disclose enough detail to illustrate the depths of those thoughts due to feelings of shame or embarrassment, according to a newly published study. These individuals may view suicidal thoughts as a sign of weakness, fear involuntary hospitalization or prescriptions, or belong to marginalized groups who do not feel comfortable (or safe) to reveal their thoughts or intentions. This can make it difficult for mental health professionals to identify the exact details of a patient’s mindset and provide appropriate care.
A veteran’s first—and sometimes only—stop may be their primary care practitioner (PCPs) rather than a mental health professional. A review of 40 studies found that although 45% of individuals who died by suicide had contact with PCPs within 1 month of their death, only 19% had contact with mental health services. Studies have also found that veterans disclose suicidal ideation during primary care visits closest to the actual suicide less than half the time.
Patients may have an appointment for medical, but not psychological reasons. In a study conducted at Portland Veterans Affairs Medical Center (VAMC), researchers reviewed the medical records of 112 veterans who died by suicide and had contact with a VAMC within 1 year prior to death. Of those last contacts, 32% were patient-initiated for new or exacerbated medical concerns, and 68% were follow-ups.
In that study, health care professionals (HCPs) noted that 41 patients (37%) were experiencing emotional distress at the last contact, but 13 of 18 patients (72%) who were assessed for suicidal ideation at their last contact denied such thoughts. The study says this finding “highlights the complexity of addressing suicidal ideation and associated risk factors in health care settings.” Additionally, a number of veterans who died by suicide either did not have suicidal thoughts at the time of their last contact with HCPs or denied such thoughts even when questioned.
In 2018, the Veterans Health Administration (VHA) implemented the Suicide Risk Identification Strategy (Risk ID), an evidence-informed assessment that includes initial screening and subsequent evaluation. Veterans receiving VHA care are screened annually for suicidal ideation and behaviors. Most screening takes place in primary care and mental health specialty settings, but timely screening may not be enough to assess who is at risk if the patients aren’t being forthcoming about their thoughts and plans.
A recent cross-sectional national survey examined the frequency of self-reported “inaccurate disclosure” of suicidal ideation during initial screening and subsequent evaluation among 734 VHA patients screened in primary care.
Using the Risk ID process with the Columbia Suicide Severity Rating Scale Screener (C-SSRS), the study asked respondents about their previous suicide screening in 2021. Of the 734 respondents, 306 screened positive and 428 screened negative. One survey item asked about the extent to which veterans had accurately responded to the HCP when asked about suicidal thoughts, while another asked how likely they would discuss when they felt suicidal with their PCP.
The study found that inaccurate disclosure is not uncommon: When asked about suicidal thoughts, about one-fifth of screen-negative participants and two-fifths of screen-positive participants said they responded, “less than very accurately.”
In the screen-positive group, women and those who reported more barriers to care were less likely to discuss feeling suicidal. Veterans who had lower ratings of satisfaction with the screening process, patient-staff communication, and the therapeutic relationship reported being less likely to discuss times they were suicidal. Notably, among C-SSRS-negative patients, Black, American Indian/Alaska Native, Hispanic, Asian, and multiracial veterans were more likely than White veterans to inaccurately report suicidal thoughts.
This is consistent with studies on medical mistrust and other research suggesting that veterans who have experienced identity-based discrimination may be less inclined to discuss suicidal thoughts with VHA HCPs. A large 2023 study surveyed veterans about why they might hold back such information. One Gulf War-era veteran, a Black woman, had encountered discrimination when filing her VA benefits claim, leading her to feel like the care system was not interested in helping her.
“It’s one of the main reasons why when I do go in, they don’t get an honest response,” she wrote in her survey response. “I feel that you’re not for me, you’re not trying to help me, you don’t wanna help me, and why even go through it, go through the motions it seems. So, I can come in feeling suicidal and I leave out feeling suicidal then.”
Veterans typically welcome screening for suicidal risk. In a 2023 study, > 90% of veterans reported that it is appropriate to be asked about thoughts of suicide during primary care visits, and about one-half agreed that veterans should be asked about suicidal thoughts at every visit.
For many, though, the level of trust they have with HCPs makes or breaks whether they discuss their suicidal ideation. Higher ratings of the therapeutic relationship with clinicians are associated with more frequent disclosure. However, the screen-positive group demonstrated higher rates of inaccurate disclosure than the screen-negative group. While this may seem counterintuitive, it is possible that screen-positive individuals did not fully disclose their thoughts on the initial screen, or did not fully disclose the severity of their thoughts during follow-up evaluations. Individuals who disclose suicidal thoughts during initial screening may be ambivalent about disclosure and/or become more concerned about consequences of disclosure as additional evaluation ensues.
A 2013 study of 34 Operation Enduring Freedom/Operation Iraqi Freedom veterans found that veterans felt trying to suppress and avoid thoughts of suicide was “burdensome and exhausting.” Despite this, they often failed to disclose severe and pervasive suicidal thoughts when screened. Among the reasons was that they perceived the templated computer reminder process as “perfunctory and disrespectful.”
Research has found that HCPs who focuses on building relationships, demonstrates genuineness and empathy, and uses straightforward and understandable language promotes the trust that can result in more honest disclosure of suicidal thoughts. In the “inaccurate disclosure” study, some veterans reported they did not understand the screening questions, or the questions did not make sense to them. This aligns with prior research, which demonstrates that how HCPs and researchers conceptualize suicidal thoughts may not fit with patients’ experiences. A lack of shared terminology, they note, “may confound how we think about ‘under-disclosure,’ such that perhaps patients may not be trying to hide their thoughts so much as not finding screening questions applicable to their unique situations or experiences.”
Veterans at risk of suicide may not share their suicidal ideation with their psychotherapists or may choose not to disclose enough detail to illustrate the depths of those thoughts due to feelings of shame or embarrassment, according to a newly published study. These individuals may view suicidal thoughts as a sign of weakness, fear involuntary hospitalization or prescriptions, or belong to marginalized groups who do not feel comfortable (or safe) to reveal their thoughts or intentions. This can make it difficult for mental health professionals to identify the exact details of a patient’s mindset and provide appropriate care.
A veteran’s first—and sometimes only—stop may be their primary care practitioner (PCPs) rather than a mental health professional. A review of 40 studies found that although 45% of individuals who died by suicide had contact with PCPs within 1 month of their death, only 19% had contact with mental health services. Studies have also found that veterans disclose suicidal ideation during primary care visits closest to the actual suicide less than half the time.
Patients may have an appointment for medical, but not psychological reasons. In a study conducted at Portland Veterans Affairs Medical Center (VAMC), researchers reviewed the medical records of 112 veterans who died by suicide and had contact with a VAMC within 1 year prior to death. Of those last contacts, 32% were patient-initiated for new or exacerbated medical concerns, and 68% were follow-ups.
In that study, health care professionals (HCPs) noted that 41 patients (37%) were experiencing emotional distress at the last contact, but 13 of 18 patients (72%) who were assessed for suicidal ideation at their last contact denied such thoughts. The study says this finding “highlights the complexity of addressing suicidal ideation and associated risk factors in health care settings.” Additionally, a number of veterans who died by suicide either did not have suicidal thoughts at the time of their last contact with HCPs or denied such thoughts even when questioned.
In 2018, the Veterans Health Administration (VHA) implemented the Suicide Risk Identification Strategy (Risk ID), an evidence-informed assessment that includes initial screening and subsequent evaluation. Veterans receiving VHA care are screened annually for suicidal ideation and behaviors. Most screening takes place in primary care and mental health specialty settings, but timely screening may not be enough to assess who is at risk if the patients aren’t being forthcoming about their thoughts and plans.
A recent cross-sectional national survey examined the frequency of self-reported “inaccurate disclosure” of suicidal ideation during initial screening and subsequent evaluation among 734 VHA patients screened in primary care.
Using the Risk ID process with the Columbia Suicide Severity Rating Scale Screener (C-SSRS), the study asked respondents about their previous suicide screening in 2021. Of the 734 respondents, 306 screened positive and 428 screened negative. One survey item asked about the extent to which veterans had accurately responded to the HCP when asked about suicidal thoughts, while another asked how likely they would discuss when they felt suicidal with their PCP.
The study found that inaccurate disclosure is not uncommon: When asked about suicidal thoughts, about one-fifth of screen-negative participants and two-fifths of screen-positive participants said they responded, “less than very accurately.”
In the screen-positive group, women and those who reported more barriers to care were less likely to discuss feeling suicidal. Veterans who had lower ratings of satisfaction with the screening process, patient-staff communication, and the therapeutic relationship reported being less likely to discuss times they were suicidal. Notably, among C-SSRS-negative patients, Black, American Indian/Alaska Native, Hispanic, Asian, and multiracial veterans were more likely than White veterans to inaccurately report suicidal thoughts.
This is consistent with studies on medical mistrust and other research suggesting that veterans who have experienced identity-based discrimination may be less inclined to discuss suicidal thoughts with VHA HCPs. A large 2023 study surveyed veterans about why they might hold back such information. One Gulf War-era veteran, a Black woman, had encountered discrimination when filing her VA benefits claim, leading her to feel like the care system was not interested in helping her.
“It’s one of the main reasons why when I do go in, they don’t get an honest response,” she wrote in her survey response. “I feel that you’re not for me, you’re not trying to help me, you don’t wanna help me, and why even go through it, go through the motions it seems. So, I can come in feeling suicidal and I leave out feeling suicidal then.”
Veterans typically welcome screening for suicidal risk. In a 2023 study, > 90% of veterans reported that it is appropriate to be asked about thoughts of suicide during primary care visits, and about one-half agreed that veterans should be asked about suicidal thoughts at every visit.
For many, though, the level of trust they have with HCPs makes or breaks whether they discuss their suicidal ideation. Higher ratings of the therapeutic relationship with clinicians are associated with more frequent disclosure. However, the screen-positive group demonstrated higher rates of inaccurate disclosure than the screen-negative group. While this may seem counterintuitive, it is possible that screen-positive individuals did not fully disclose their thoughts on the initial screen, or did not fully disclose the severity of their thoughts during follow-up evaluations. Individuals who disclose suicidal thoughts during initial screening may be ambivalent about disclosure and/or become more concerned about consequences of disclosure as additional evaluation ensues.
A 2013 study of 34 Operation Enduring Freedom/Operation Iraqi Freedom veterans found that veterans felt trying to suppress and avoid thoughts of suicide was “burdensome and exhausting.” Despite this, they often failed to disclose severe and pervasive suicidal thoughts when screened. Among the reasons was that they perceived the templated computer reminder process as “perfunctory and disrespectful.”
Research has found that HCPs who focuses on building relationships, demonstrates genuineness and empathy, and uses straightforward and understandable language promotes the trust that can result in more honest disclosure of suicidal thoughts. In the “inaccurate disclosure” study, some veterans reported they did not understand the screening questions, or the questions did not make sense to them. This aligns with prior research, which demonstrates that how HCPs and researchers conceptualize suicidal thoughts may not fit with patients’ experiences. A lack of shared terminology, they note, “may confound how we think about ‘under-disclosure,’ such that perhaps patients may not be trying to hide their thoughts so much as not finding screening questions applicable to their unique situations or experiences.”
Veterans at risk of suicide may not share their suicidal ideation with their psychotherapists or may choose not to disclose enough detail to illustrate the depths of those thoughts due to feelings of shame or embarrassment, according to a newly published study. These individuals may view suicidal thoughts as a sign of weakness, fear involuntary hospitalization or prescriptions, or belong to marginalized groups who do not feel comfortable (or safe) to reveal their thoughts or intentions. This can make it difficult for mental health professionals to identify the exact details of a patient’s mindset and provide appropriate care.
A veteran’s first—and sometimes only—stop may be their primary care practitioner (PCPs) rather than a mental health professional. A review of 40 studies found that although 45% of individuals who died by suicide had contact with PCPs within 1 month of their death, only 19% had contact with mental health services. Studies have also found that veterans disclose suicidal ideation during primary care visits closest to the actual suicide less than half the time.
Patients may have an appointment for medical, but not psychological reasons. In a study conducted at Portland Veterans Affairs Medical Center (VAMC), researchers reviewed the medical records of 112 veterans who died by suicide and had contact with a VAMC within 1 year prior to death. Of those last contacts, 32% were patient-initiated for new or exacerbated medical concerns, and 68% were follow-ups.
In that study, health care professionals (HCPs) noted that 41 patients (37%) were experiencing emotional distress at the last contact, but 13 of 18 patients (72%) who were assessed for suicidal ideation at their last contact denied such thoughts. The study says this finding “highlights the complexity of addressing suicidal ideation and associated risk factors in health care settings.” Additionally, a number of veterans who died by suicide either did not have suicidal thoughts at the time of their last contact with HCPs or denied such thoughts even when questioned.
In 2018, the Veterans Health Administration (VHA) implemented the Suicide Risk Identification Strategy (Risk ID), an evidence-informed assessment that includes initial screening and subsequent evaluation. Veterans receiving VHA care are screened annually for suicidal ideation and behaviors. Most screening takes place in primary care and mental health specialty settings, but timely screening may not be enough to assess who is at risk if the patients aren’t being forthcoming about their thoughts and plans.
A recent cross-sectional national survey examined the frequency of self-reported “inaccurate disclosure” of suicidal ideation during initial screening and subsequent evaluation among 734 VHA patients screened in primary care.
Using the Risk ID process with the Columbia Suicide Severity Rating Scale Screener (C-SSRS), the study asked respondents about their previous suicide screening in 2021. Of the 734 respondents, 306 screened positive and 428 screened negative. One survey item asked about the extent to which veterans had accurately responded to the HCP when asked about suicidal thoughts, while another asked how likely they would discuss when they felt suicidal with their PCP.
The study found that inaccurate disclosure is not uncommon: When asked about suicidal thoughts, about one-fifth of screen-negative participants and two-fifths of screen-positive participants said they responded, “less than very accurately.”
In the screen-positive group, women and those who reported more barriers to care were less likely to discuss feeling suicidal. Veterans who had lower ratings of satisfaction with the screening process, patient-staff communication, and the therapeutic relationship reported being less likely to discuss times they were suicidal. Notably, among C-SSRS-negative patients, Black, American Indian/Alaska Native, Hispanic, Asian, and multiracial veterans were more likely than White veterans to inaccurately report suicidal thoughts.
This is consistent with studies on medical mistrust and other research suggesting that veterans who have experienced identity-based discrimination may be less inclined to discuss suicidal thoughts with VHA HCPs. A large 2023 study surveyed veterans about why they might hold back such information. One Gulf War-era veteran, a Black woman, had encountered discrimination when filing her VA benefits claim, leading her to feel like the care system was not interested in helping her.
“It’s one of the main reasons why when I do go in, they don’t get an honest response,” she wrote in her survey response. “I feel that you’re not for me, you’re not trying to help me, you don’t wanna help me, and why even go through it, go through the motions it seems. So, I can come in feeling suicidal and I leave out feeling suicidal then.”
Veterans typically welcome screening for suicidal risk. In a 2023 study, > 90% of veterans reported that it is appropriate to be asked about thoughts of suicide during primary care visits, and about one-half agreed that veterans should be asked about suicidal thoughts at every visit.
For many, though, the level of trust they have with HCPs makes or breaks whether they discuss their suicidal ideation. Higher ratings of the therapeutic relationship with clinicians are associated with more frequent disclosure. However, the screen-positive group demonstrated higher rates of inaccurate disclosure than the screen-negative group. While this may seem counterintuitive, it is possible that screen-positive individuals did not fully disclose their thoughts on the initial screen, or did not fully disclose the severity of their thoughts during follow-up evaluations. Individuals who disclose suicidal thoughts during initial screening may be ambivalent about disclosure and/or become more concerned about consequences of disclosure as additional evaluation ensues.
A 2013 study of 34 Operation Enduring Freedom/Operation Iraqi Freedom veterans found that veterans felt trying to suppress and avoid thoughts of suicide was “burdensome and exhausting.” Despite this, they often failed to disclose severe and pervasive suicidal thoughts when screened. Among the reasons was that they perceived the templated computer reminder process as “perfunctory and disrespectful.”
Research has found that HCPs who focuses on building relationships, demonstrates genuineness and empathy, and uses straightforward and understandable language promotes the trust that can result in more honest disclosure of suicidal thoughts. In the “inaccurate disclosure” study, some veterans reported they did not understand the screening questions, or the questions did not make sense to them. This aligns with prior research, which demonstrates that how HCPs and researchers conceptualize suicidal thoughts may not fit with patients’ experiences. A lack of shared terminology, they note, “may confound how we think about ‘under-disclosure,’ such that perhaps patients may not be trying to hide their thoughts so much as not finding screening questions applicable to their unique situations or experiences.”
More Than 100 GIs Strong for Advocacy Day 2025!
For our leaders, showing up on behalf of their patients is a privilege and an opportunity to represent the specialty with individuals who have a role in dictating health care policy.
In total, 124 members, patient advocates, and AGA staffers met with lawmakers and attended 130 meetings – 70 unique House districts and 60 unique Senate districts – with Republican and Democratic staff.
Our advocacy contingent represented the diversity of the country with 30 states represented from coast-to-coast. No matter the home state, everyone was united in the calls to Congress: to reform prior authorization, increase digestive disease funding, and secure a permanent solution for Medicare physician reimbursement.
As in past years, patient advocates participated alongside GI clinicians and researchers.
Their participation underscored the importance of including diverse voices. As patients with chronic health conditions, they were able to convey how their experiences navigating insurance barriers or managing delays to care as prescribed by their health care provider impacted their well-being and quality of life.
Throughout the day, patient advocates and GIs alike were encouraged by their meetings with congressional staffers. Conversations were constructive, engaging, and meaningful as everyone collaborated on common ground: seeking solutions to ensure GI patients have timely access to care that they need.
Many AGA leaders appreciated the value of being able to unite with colleagues to advocate and share their firsthand experiences in the lab or clinic in meetings with House and Senate staffers.
While Advocacy Day lasts a single day, its value hasn’t diminished. Thanks to the engagement and participation of the more than 100 AGA leaders and patient advocates, we can continue to build positive relationships with influential policymakers and make strides to improve and protect access to GI patient care.
For our leaders, showing up on behalf of their patients is a privilege and an opportunity to represent the specialty with individuals who have a role in dictating health care policy.
In total, 124 members, patient advocates, and AGA staffers met with lawmakers and attended 130 meetings – 70 unique House districts and 60 unique Senate districts – with Republican and Democratic staff.
Our advocacy contingent represented the diversity of the country with 30 states represented from coast-to-coast. No matter the home state, everyone was united in the calls to Congress: to reform prior authorization, increase digestive disease funding, and secure a permanent solution for Medicare physician reimbursement.
As in past years, patient advocates participated alongside GI clinicians and researchers.
Their participation underscored the importance of including diverse voices. As patients with chronic health conditions, they were able to convey how their experiences navigating insurance barriers or managing delays to care as prescribed by their health care provider impacted their well-being and quality of life.
Throughout the day, patient advocates and GIs alike were encouraged by their meetings with congressional staffers. Conversations were constructive, engaging, and meaningful as everyone collaborated on common ground: seeking solutions to ensure GI patients have timely access to care that they need.
Many AGA leaders appreciated the value of being able to unite with colleagues to advocate and share their firsthand experiences in the lab or clinic in meetings with House and Senate staffers.
While Advocacy Day lasts a single day, its value hasn’t diminished. Thanks to the engagement and participation of the more than 100 AGA leaders and patient advocates, we can continue to build positive relationships with influential policymakers and make strides to improve and protect access to GI patient care.
For our leaders, showing up on behalf of their patients is a privilege and an opportunity to represent the specialty with individuals who have a role in dictating health care policy.
In total, 124 members, patient advocates, and AGA staffers met with lawmakers and attended 130 meetings – 70 unique House districts and 60 unique Senate districts – with Republican and Democratic staff.
Our advocacy contingent represented the diversity of the country with 30 states represented from coast-to-coast. No matter the home state, everyone was united in the calls to Congress: to reform prior authorization, increase digestive disease funding, and secure a permanent solution for Medicare physician reimbursement.
As in past years, patient advocates participated alongside GI clinicians and researchers.
Their participation underscored the importance of including diverse voices. As patients with chronic health conditions, they were able to convey how their experiences navigating insurance barriers or managing delays to care as prescribed by their health care provider impacted their well-being and quality of life.
Throughout the day, patient advocates and GIs alike were encouraged by their meetings with congressional staffers. Conversations were constructive, engaging, and meaningful as everyone collaborated on common ground: seeking solutions to ensure GI patients have timely access to care that they need.
Many AGA leaders appreciated the value of being able to unite with colleagues to advocate and share their firsthand experiences in the lab or clinic in meetings with House and Senate staffers.
While Advocacy Day lasts a single day, its value hasn’t diminished. Thanks to the engagement and participation of the more than 100 AGA leaders and patient advocates, we can continue to build positive relationships with influential policymakers and make strides to improve and protect access to GI patient care.
Physicians Face Medicare Telehealth Woes Amid Federal Government Shutdown
Physicians Face Medicare Telehealth Woes Amid Federal Government Shutdown
The ongoing US government partial shutdown has unintended consequences for seniors and their doctors as most telehealth appointments are now no longer being covered by Medicare.
That's because without a budget deal, federal lawmakers did not renew some pandemic-era telehealth flexibilities allowing Medicare beneficiaries to have medical appointments with doctors over audio or video at home.
This policy was first put into place under the first Trump Administration in 2020 during the COVID-19 pandemic. Previously, Medicare covered very limited telehealth services for rural patients.
For the past 5 years, lawmakers have always managed to renew the telehealth flexibilities in every government funding bill before the expiration date. This year, however, they expired for the first time on October 1.
Federal lawmakers remain at odds on the 2026 federal funding bill, meaning the shutdown could last into more days and even weeks.
But with Congress in a standoff, clinicians and patients outside Washington, DC, are already grappling with the consequences of the funding impasse.
Clinicians, Patients Already Feeling Effects
For the South Dakota-based Sanford Health System, which is the largest rural health system in the country, the past week without the Medicare telehealth waivers being in place has caused a lot of anxiety and uncertainty for both patients and clinicians.
Dave Newman, an endocrinologist and chief medical officer of virtual care at Sanford, said the health system decided to keep providing Medicare telehealth appointments to patients for now.
"We're maintaining telehealth access because we know that's the best thing for our patients. We've got full confidence that reimbursement will follow, but patients can't wait for Congress to act at this point," Newman told Medscape Medical News. "They still need access to their specialists. They still need access to their primary care providers, and this is one of the only ways that a lot of our patients get access. For them, it's either virtual care or no care at all."
Newman said as the shutdown continues, Sanford may reconsidered whether it can keep providing these appointments without reimbursement.
Some health systems have stopped providing an Medicare telehealth appointments, said Alexis Apple, director of federal affairs at the American Telemedicine Association. That means patients must appear in person for their doctor's appointment or cancel.
NYU Langone Health system's website currently has a banner that reads: "Due to the federal government shutdown, Medicare and Medicaid patients are unable to schedule new telehealth/video visits. If you already have a visit scheduled, it will continue as planned. If not, contact your doctor's office to schedule an in-person appointment.
"It's creating lots of confusion in the industry from patients, providers, hospital systems. You know, what do we do next? How do we grapple with this shutdown?" said Apple. "Patients have been able to receive care within their homes over the past 5 years, and now, all of a sudden, they've been stripped of that access."
Medicare patients who continue telehealth after October 1 may find out they're on the hook for the bill, if Congress doesn't act, said Apple.
Some physicians worry that commercial insurance payers may follow suit and no longer cover virtual appointments. Medicare, which is the largest health care payer in the country, is often seen as the standard for what services should be covered.
Patients and doctors have come to rely on telehealth as an integral part of health care, said Richard Chou, an anesthesiologist at the US Department of Veterans Affairs (VA) in Sacramento, California.
"You're seeing that postpandemic, telehealth is kind of a new way of doing things. It's part of the day for us as doctors," said Chou. He said tha tmany of his VA patients do their preliminary surgery appointments via telehealth before coming into the facility.
"Telehealth is that bridge to making sure patients get the care they need, and when these patients don't get that preliminary care they need, this builds up and builds up," said Chou. "And next thing you know, you have people flooding the emergency rooms, and we can't have that."
Will Telehealth Reimbursement See a Permanent Fix?
With Congressional budget negotiations at an impasse, it remains unclear when the shutdown will end.
Health care spending disagreements weigh heavily in negotiations. Democrats are currently unwilling to give the votes to pass the 60-vote threshold in the Senate unless Republicans agree to extend Affordable Care Act subsidies that expire at the end of the year. Democrats also want to reverse the Medicaid cuts that were part of the large Republican domestic tax and spending bill passed by Congress earlier this year.
When lawmakers do reach an agreement and reopen the government, it's likely telehealth flexibilities will be included in any package but for how long remains in question.
A newly introduced bipartisan bill would permanently allow Medicare patients to access telehealth appointments in their homes. But the legislation has been estimated to be very costly.
Federal data does show that telehealth appointments have been popular with Medicare recipients and increased over time since telehealth became more accessible.
"I used to say that virtual care was the future of medicine, and now it's just kind of the present of medicine. It used to be like a cool technology that we used to advertise, now it's just the standard of care," said Newman. "We think that permanent coverage would mean stability for both patients and providers."
Victoria Knight is a freelance reporter based in Washington, DC.
A version of this article first appeared on Medscape.com.
The ongoing US government partial shutdown has unintended consequences for seniors and their doctors as most telehealth appointments are now no longer being covered by Medicare.
That's because without a budget deal, federal lawmakers did not renew some pandemic-era telehealth flexibilities allowing Medicare beneficiaries to have medical appointments with doctors over audio or video at home.
This policy was first put into place under the first Trump Administration in 2020 during the COVID-19 pandemic. Previously, Medicare covered very limited telehealth services for rural patients.
For the past 5 years, lawmakers have always managed to renew the telehealth flexibilities in every government funding bill before the expiration date. This year, however, they expired for the first time on October 1.
Federal lawmakers remain at odds on the 2026 federal funding bill, meaning the shutdown could last into more days and even weeks.
But with Congress in a standoff, clinicians and patients outside Washington, DC, are already grappling with the consequences of the funding impasse.
Clinicians, Patients Already Feeling Effects
For the South Dakota-based Sanford Health System, which is the largest rural health system in the country, the past week without the Medicare telehealth waivers being in place has caused a lot of anxiety and uncertainty for both patients and clinicians.
Dave Newman, an endocrinologist and chief medical officer of virtual care at Sanford, said the health system decided to keep providing Medicare telehealth appointments to patients for now.
"We're maintaining telehealth access because we know that's the best thing for our patients. We've got full confidence that reimbursement will follow, but patients can't wait for Congress to act at this point," Newman told Medscape Medical News. "They still need access to their specialists. They still need access to their primary care providers, and this is one of the only ways that a lot of our patients get access. For them, it's either virtual care or no care at all."
Newman said as the shutdown continues, Sanford may reconsidered whether it can keep providing these appointments without reimbursement.
Some health systems have stopped providing an Medicare telehealth appointments, said Alexis Apple, director of federal affairs at the American Telemedicine Association. That means patients must appear in person for their doctor's appointment or cancel.
NYU Langone Health system's website currently has a banner that reads: "Due to the federal government shutdown, Medicare and Medicaid patients are unable to schedule new telehealth/video visits. If you already have a visit scheduled, it will continue as planned. If not, contact your doctor's office to schedule an in-person appointment.
"It's creating lots of confusion in the industry from patients, providers, hospital systems. You know, what do we do next? How do we grapple with this shutdown?" said Apple. "Patients have been able to receive care within their homes over the past 5 years, and now, all of a sudden, they've been stripped of that access."
Medicare patients who continue telehealth after October 1 may find out they're on the hook for the bill, if Congress doesn't act, said Apple.
Some physicians worry that commercial insurance payers may follow suit and no longer cover virtual appointments. Medicare, which is the largest health care payer in the country, is often seen as the standard for what services should be covered.
Patients and doctors have come to rely on telehealth as an integral part of health care, said Richard Chou, an anesthesiologist at the US Department of Veterans Affairs (VA) in Sacramento, California.
"You're seeing that postpandemic, telehealth is kind of a new way of doing things. It's part of the day for us as doctors," said Chou. He said tha tmany of his VA patients do their preliminary surgery appointments via telehealth before coming into the facility.
"Telehealth is that bridge to making sure patients get the care they need, and when these patients don't get that preliminary care they need, this builds up and builds up," said Chou. "And next thing you know, you have people flooding the emergency rooms, and we can't have that."
Will Telehealth Reimbursement See a Permanent Fix?
With Congressional budget negotiations at an impasse, it remains unclear when the shutdown will end.
Health care spending disagreements weigh heavily in negotiations. Democrats are currently unwilling to give the votes to pass the 60-vote threshold in the Senate unless Republicans agree to extend Affordable Care Act subsidies that expire at the end of the year. Democrats also want to reverse the Medicaid cuts that were part of the large Republican domestic tax and spending bill passed by Congress earlier this year.
When lawmakers do reach an agreement and reopen the government, it's likely telehealth flexibilities will be included in any package but for how long remains in question.
A newly introduced bipartisan bill would permanently allow Medicare patients to access telehealth appointments in their homes. But the legislation has been estimated to be very costly.
Federal data does show that telehealth appointments have been popular with Medicare recipients and increased over time since telehealth became more accessible.
"I used to say that virtual care was the future of medicine, and now it's just kind of the present of medicine. It used to be like a cool technology that we used to advertise, now it's just the standard of care," said Newman. "We think that permanent coverage would mean stability for both patients and providers."
Victoria Knight is a freelance reporter based in Washington, DC.
A version of this article first appeared on Medscape.com.
The ongoing US government partial shutdown has unintended consequences for seniors and their doctors as most telehealth appointments are now no longer being covered by Medicare.
That's because without a budget deal, federal lawmakers did not renew some pandemic-era telehealth flexibilities allowing Medicare beneficiaries to have medical appointments with doctors over audio or video at home.
This policy was first put into place under the first Trump Administration in 2020 during the COVID-19 pandemic. Previously, Medicare covered very limited telehealth services for rural patients.
For the past 5 years, lawmakers have always managed to renew the telehealth flexibilities in every government funding bill before the expiration date. This year, however, they expired for the first time on October 1.
Federal lawmakers remain at odds on the 2026 federal funding bill, meaning the shutdown could last into more days and even weeks.
But with Congress in a standoff, clinicians and patients outside Washington, DC, are already grappling with the consequences of the funding impasse.
Clinicians, Patients Already Feeling Effects
For the South Dakota-based Sanford Health System, which is the largest rural health system in the country, the past week without the Medicare telehealth waivers being in place has caused a lot of anxiety and uncertainty for both patients and clinicians.
Dave Newman, an endocrinologist and chief medical officer of virtual care at Sanford, said the health system decided to keep providing Medicare telehealth appointments to patients for now.
"We're maintaining telehealth access because we know that's the best thing for our patients. We've got full confidence that reimbursement will follow, but patients can't wait for Congress to act at this point," Newman told Medscape Medical News. "They still need access to their specialists. They still need access to their primary care providers, and this is one of the only ways that a lot of our patients get access. For them, it's either virtual care or no care at all."
Newman said as the shutdown continues, Sanford may reconsidered whether it can keep providing these appointments without reimbursement.
Some health systems have stopped providing an Medicare telehealth appointments, said Alexis Apple, director of federal affairs at the American Telemedicine Association. That means patients must appear in person for their doctor's appointment or cancel.
NYU Langone Health system's website currently has a banner that reads: "Due to the federal government shutdown, Medicare and Medicaid patients are unable to schedule new telehealth/video visits. If you already have a visit scheduled, it will continue as planned. If not, contact your doctor's office to schedule an in-person appointment.
"It's creating lots of confusion in the industry from patients, providers, hospital systems. You know, what do we do next? How do we grapple with this shutdown?" said Apple. "Patients have been able to receive care within their homes over the past 5 years, and now, all of a sudden, they've been stripped of that access."
Medicare patients who continue telehealth after October 1 may find out they're on the hook for the bill, if Congress doesn't act, said Apple.
Some physicians worry that commercial insurance payers may follow suit and no longer cover virtual appointments. Medicare, which is the largest health care payer in the country, is often seen as the standard for what services should be covered.
Patients and doctors have come to rely on telehealth as an integral part of health care, said Richard Chou, an anesthesiologist at the US Department of Veterans Affairs (VA) in Sacramento, California.
"You're seeing that postpandemic, telehealth is kind of a new way of doing things. It's part of the day for us as doctors," said Chou. He said tha tmany of his VA patients do their preliminary surgery appointments via telehealth before coming into the facility.
"Telehealth is that bridge to making sure patients get the care they need, and when these patients don't get that preliminary care they need, this builds up and builds up," said Chou. "And next thing you know, you have people flooding the emergency rooms, and we can't have that."
Will Telehealth Reimbursement See a Permanent Fix?
With Congressional budget negotiations at an impasse, it remains unclear when the shutdown will end.
Health care spending disagreements weigh heavily in negotiations. Democrats are currently unwilling to give the votes to pass the 60-vote threshold in the Senate unless Republicans agree to extend Affordable Care Act subsidies that expire at the end of the year. Democrats also want to reverse the Medicaid cuts that were part of the large Republican domestic tax and spending bill passed by Congress earlier this year.
When lawmakers do reach an agreement and reopen the government, it's likely telehealth flexibilities will be included in any package but for how long remains in question.
A newly introduced bipartisan bill would permanently allow Medicare patients to access telehealth appointments in their homes. But the legislation has been estimated to be very costly.
Federal data does show that telehealth appointments have been popular with Medicare recipients and increased over time since telehealth became more accessible.
"I used to say that virtual care was the future of medicine, and now it's just kind of the present of medicine. It used to be like a cool technology that we used to advertise, now it's just the standard of care," said Newman. "We think that permanent coverage would mean stability for both patients and providers."
Victoria Knight is a freelance reporter based in Washington, DC.
A version of this article first appeared on Medscape.com.
Physicians Face Medicare Telehealth Woes Amid Federal Government Shutdown
Physicians Face Medicare Telehealth Woes Amid Federal Government Shutdown
Time to Reconsider Tramadol for Chronic Pain?
Time to Reconsider Tramadol for Chronic Pain?
Tramadol, a commonly prescribed opioid often viewed as a safer option for chronic pain, provided limited pain relief while increasing the risk for serious adverse effects, results of a new analysis showed.
In a systematic review and meta-analysis, investigators found that tramadol offered clinically insignificant pain relief, while doubling the likelihood of serious adverse events, most commonly cardiac complications.
"Given the limited analgesic benefits and increased risk of harm, tramadol use for chronic pain should be reconsidered," Jehad Ahmad Barakji, MD, of the Centre for Clinical Intervention Research at Rigshospitalet in Copenhagen, Denmark, told Medscape Medical News.
"Across different chronic pain conditions, tramadol's pain-relieving effect appears modest, and while some patients may experience relief, most will not gain substantial benefit," he added.
However, the researchers cautioned that the certainty of the evidence was low-to-moderate and that the quality of the underlying trials varied substantially.
The study was published on October 7 in BMJ Evidence-Based Medicine.
Popularity Outpacing Proof
Tramadol, a dual-action opioid that modulates serotonin and norepinephrine pathways, has long been promoted as a middle-ground analgesic - less addictive than morphine but stronger than nonopioid medications. It is approved for moderate-to-severe pain, including postoperative and chronic conditions.
Prescriptions have risen sharply worldwide, fueled by perceptions of safety and a belief that tramadol carries a lower risk for dependence. A recent global analysis estimated that nearly 18% of adults have used tramadol in their lifetime, and > 80% of those users combined it with at least 1 other substance.
Despite its widespread use, evidence supporting tramadol's long-term effectiveness and safety in chronic pain has been limited and inconsistent. Previous research has largely focused on short-term or condition-specific outcomes, such as osteoarthritis or neuropathic pain, leaving uncertainty about the drug's overall risk-benefit profile.
Small Benefit, Big Risk
The current study is the first comprehensive systematic review to evaluate tramadol alone for chronic pain using both meta-analysis and trail sequential analysis, provided a broader view of efficacy and safety across pain types.
"We sought to fill this gap by evaluating the totality of evidence to guide clinical practice," Barakji said.
The analysis included 19 randomized, placebo-controlled trials with 6569 adults. The average participant age was 56 years, and study durations ranged from 4 to 16 weeks. Pain intensity was typically assessed with the 0-10 numeric rating scale (NRS), while function and quality of life were measured with validated patient-reported tools.
Across the pooled analysis, participants receiving tramadol experienced an average pain reduction of 0.9 points on the NRS compared with placebo - a difference below the 1-point threshold considered clinically meaningful. About 7% more patients in the tramadol groups achieved noticeable pain relief, but investigators said the benefit was modest and uncertain.
Serious adverse events were twice as common among tramadol users, most often involving cardiac complications such as chest pain, coronary artery disease, or heart failure. Nonserious adverse effects, including nausea, dizziness, constipation, and drowsiness, were frequent and contributed to higher discontinuation rates among tramadol recipients.
The researchers acknowledged that most included trials were at a high risk for bias due to incomplete outcome reporting, small sample sizes, and inconsistent assessment methods, factors that may have exaggerated benefits and underestimated harms.
Reevaluating Tramadol's Role
Commenting on the research, Jessica Otte, MD, clinical associate professor in the Department of Family Medicine at The University of British Columbia, Vancouver, British Columbia, Canada, said the new review stands out for examining tramadol's use across a range of chronic pain conditions, an area where clinicians often struggle to help patients achieve meaningful and sustained relief.
Otte, who has studied the drug's safety and effectiveness through The University of British Columbia's Therapeutics Initiative, said the Danish team's analysis expands on earlier research that largely focused on single pain conditions. The findings, she said, add weight to growing evidence that challenges tramadol's perceived advantages over other analgesics.
"This review doesn't change the narrative but strengthens it: Tramdol's reputation as a safer or uniquely effective opioid is increasingly difficult to defend," she told Medscape Medical News.
While she believes the study makes an important contribution, Otte said the results should be interpreted with caution because of gaps in the underlying evidence. The Danish authors noted similar concerns, and Otte agreed that many of the included trials had methodological shortcomings.
"A lot of the studies had biases that made use less certain about what was reported," she said. "Many outcomes that matter to patients - like quality of life, functional improvement, or withdrawal - were either inconsistently measured or not reported at all."
She added that patients assigned to tramadol were more likely to discontinue early, both overall and because of adverse effects, raising concern about tolerability and attrition bias.
Also commenting, Houman Danesh, MD, professor and medical director of pain management at the Icahn School of Medicine at Mount Sinai in New York City, said the review provides moderate-certainty evidence that tramadol increases the risk for serious adverse events; but its broad approach - evaluating efficacy and safety across multiple chronic pain conditions - could be a confounding factor.
"Tramadol may benefit some conditions more than others," he noted, which could alter the overall risk-benefit profile.
In his clinical experience, Danesh said severe complications such as cardiac events are uncommon. He explained that heart rhythm disturbances occasionally associated with tramadol generally arise when patients are taking other medications that affect cardiac conduction.
Danesh emphasized that clinicians should weigh the study alongside other research and their own experience when deciding whether to prescribe the drug.
"It's important to take this study into consideration," he said, "but there are multiple studies that support the use of tramadol, and we have to look at the totality of the evidence."
Written by Carla Cantor.
The authors declared no competing interests and received no specific grant from any funding agency. Otte and Danesh reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Tramadol, a commonly prescribed opioid often viewed as a safer option for chronic pain, provided limited pain relief while increasing the risk for serious adverse effects, results of a new analysis showed.
In a systematic review and meta-analysis, investigators found that tramadol offered clinically insignificant pain relief, while doubling the likelihood of serious adverse events, most commonly cardiac complications.
"Given the limited analgesic benefits and increased risk of harm, tramadol use for chronic pain should be reconsidered," Jehad Ahmad Barakji, MD, of the Centre for Clinical Intervention Research at Rigshospitalet in Copenhagen, Denmark, told Medscape Medical News.
"Across different chronic pain conditions, tramadol's pain-relieving effect appears modest, and while some patients may experience relief, most will not gain substantial benefit," he added.
However, the researchers cautioned that the certainty of the evidence was low-to-moderate and that the quality of the underlying trials varied substantially.
The study was published on October 7 in BMJ Evidence-Based Medicine.
Popularity Outpacing Proof
Tramadol, a dual-action opioid that modulates serotonin and norepinephrine pathways, has long been promoted as a middle-ground analgesic - less addictive than morphine but stronger than nonopioid medications. It is approved for moderate-to-severe pain, including postoperative and chronic conditions.
Prescriptions have risen sharply worldwide, fueled by perceptions of safety and a belief that tramadol carries a lower risk for dependence. A recent global analysis estimated that nearly 18% of adults have used tramadol in their lifetime, and > 80% of those users combined it with at least 1 other substance.
Despite its widespread use, evidence supporting tramadol's long-term effectiveness and safety in chronic pain has been limited and inconsistent. Previous research has largely focused on short-term or condition-specific outcomes, such as osteoarthritis or neuropathic pain, leaving uncertainty about the drug's overall risk-benefit profile.
Small Benefit, Big Risk
The current study is the first comprehensive systematic review to evaluate tramadol alone for chronic pain using both meta-analysis and trail sequential analysis, provided a broader view of efficacy and safety across pain types.
"We sought to fill this gap by evaluating the totality of evidence to guide clinical practice," Barakji said.
The analysis included 19 randomized, placebo-controlled trials with 6569 adults. The average participant age was 56 years, and study durations ranged from 4 to 16 weeks. Pain intensity was typically assessed with the 0-10 numeric rating scale (NRS), while function and quality of life were measured with validated patient-reported tools.
Across the pooled analysis, participants receiving tramadol experienced an average pain reduction of 0.9 points on the NRS compared with placebo - a difference below the 1-point threshold considered clinically meaningful. About 7% more patients in the tramadol groups achieved noticeable pain relief, but investigators said the benefit was modest and uncertain.
Serious adverse events were twice as common among tramadol users, most often involving cardiac complications such as chest pain, coronary artery disease, or heart failure. Nonserious adverse effects, including nausea, dizziness, constipation, and drowsiness, were frequent and contributed to higher discontinuation rates among tramadol recipients.
The researchers acknowledged that most included trials were at a high risk for bias due to incomplete outcome reporting, small sample sizes, and inconsistent assessment methods, factors that may have exaggerated benefits and underestimated harms.
Reevaluating Tramadol's Role
Commenting on the research, Jessica Otte, MD, clinical associate professor in the Department of Family Medicine at The University of British Columbia, Vancouver, British Columbia, Canada, said the new review stands out for examining tramadol's use across a range of chronic pain conditions, an area where clinicians often struggle to help patients achieve meaningful and sustained relief.
Otte, who has studied the drug's safety and effectiveness through The University of British Columbia's Therapeutics Initiative, said the Danish team's analysis expands on earlier research that largely focused on single pain conditions. The findings, she said, add weight to growing evidence that challenges tramadol's perceived advantages over other analgesics.
"This review doesn't change the narrative but strengthens it: Tramdol's reputation as a safer or uniquely effective opioid is increasingly difficult to defend," she told Medscape Medical News.
While she believes the study makes an important contribution, Otte said the results should be interpreted with caution because of gaps in the underlying evidence. The Danish authors noted similar concerns, and Otte agreed that many of the included trials had methodological shortcomings.
"A lot of the studies had biases that made use less certain about what was reported," she said. "Many outcomes that matter to patients - like quality of life, functional improvement, or withdrawal - were either inconsistently measured or not reported at all."
She added that patients assigned to tramadol were more likely to discontinue early, both overall and because of adverse effects, raising concern about tolerability and attrition bias.
Also commenting, Houman Danesh, MD, professor and medical director of pain management at the Icahn School of Medicine at Mount Sinai in New York City, said the review provides moderate-certainty evidence that tramadol increases the risk for serious adverse events; but its broad approach - evaluating efficacy and safety across multiple chronic pain conditions - could be a confounding factor.
"Tramadol may benefit some conditions more than others," he noted, which could alter the overall risk-benefit profile.
In his clinical experience, Danesh said severe complications such as cardiac events are uncommon. He explained that heart rhythm disturbances occasionally associated with tramadol generally arise when patients are taking other medications that affect cardiac conduction.
Danesh emphasized that clinicians should weigh the study alongside other research and their own experience when deciding whether to prescribe the drug.
"It's important to take this study into consideration," he said, "but there are multiple studies that support the use of tramadol, and we have to look at the totality of the evidence."
Written by Carla Cantor.
The authors declared no competing interests and received no specific grant from any funding agency. Otte and Danesh reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Tramadol, a commonly prescribed opioid often viewed as a safer option for chronic pain, provided limited pain relief while increasing the risk for serious adverse effects, results of a new analysis showed.
In a systematic review and meta-analysis, investigators found that tramadol offered clinically insignificant pain relief, while doubling the likelihood of serious adverse events, most commonly cardiac complications.
"Given the limited analgesic benefits and increased risk of harm, tramadol use for chronic pain should be reconsidered," Jehad Ahmad Barakji, MD, of the Centre for Clinical Intervention Research at Rigshospitalet in Copenhagen, Denmark, told Medscape Medical News.
"Across different chronic pain conditions, tramadol's pain-relieving effect appears modest, and while some patients may experience relief, most will not gain substantial benefit," he added.
However, the researchers cautioned that the certainty of the evidence was low-to-moderate and that the quality of the underlying trials varied substantially.
The study was published on October 7 in BMJ Evidence-Based Medicine.
Popularity Outpacing Proof
Tramadol, a dual-action opioid that modulates serotonin and norepinephrine pathways, has long been promoted as a middle-ground analgesic - less addictive than morphine but stronger than nonopioid medications. It is approved for moderate-to-severe pain, including postoperative and chronic conditions.
Prescriptions have risen sharply worldwide, fueled by perceptions of safety and a belief that tramadol carries a lower risk for dependence. A recent global analysis estimated that nearly 18% of adults have used tramadol in their lifetime, and > 80% of those users combined it with at least 1 other substance.
Despite its widespread use, evidence supporting tramadol's long-term effectiveness and safety in chronic pain has been limited and inconsistent. Previous research has largely focused on short-term or condition-specific outcomes, such as osteoarthritis or neuropathic pain, leaving uncertainty about the drug's overall risk-benefit profile.
Small Benefit, Big Risk
The current study is the first comprehensive systematic review to evaluate tramadol alone for chronic pain using both meta-analysis and trail sequential analysis, provided a broader view of efficacy and safety across pain types.
"We sought to fill this gap by evaluating the totality of evidence to guide clinical practice," Barakji said.
The analysis included 19 randomized, placebo-controlled trials with 6569 adults. The average participant age was 56 years, and study durations ranged from 4 to 16 weeks. Pain intensity was typically assessed with the 0-10 numeric rating scale (NRS), while function and quality of life were measured with validated patient-reported tools.
Across the pooled analysis, participants receiving tramadol experienced an average pain reduction of 0.9 points on the NRS compared with placebo - a difference below the 1-point threshold considered clinically meaningful. About 7% more patients in the tramadol groups achieved noticeable pain relief, but investigators said the benefit was modest and uncertain.
Serious adverse events were twice as common among tramadol users, most often involving cardiac complications such as chest pain, coronary artery disease, or heart failure. Nonserious adverse effects, including nausea, dizziness, constipation, and drowsiness, were frequent and contributed to higher discontinuation rates among tramadol recipients.
The researchers acknowledged that most included trials were at a high risk for bias due to incomplete outcome reporting, small sample sizes, and inconsistent assessment methods, factors that may have exaggerated benefits and underestimated harms.
Reevaluating Tramadol's Role
Commenting on the research, Jessica Otte, MD, clinical associate professor in the Department of Family Medicine at The University of British Columbia, Vancouver, British Columbia, Canada, said the new review stands out for examining tramadol's use across a range of chronic pain conditions, an area where clinicians often struggle to help patients achieve meaningful and sustained relief.
Otte, who has studied the drug's safety and effectiveness through The University of British Columbia's Therapeutics Initiative, said the Danish team's analysis expands on earlier research that largely focused on single pain conditions. The findings, she said, add weight to growing evidence that challenges tramadol's perceived advantages over other analgesics.
"This review doesn't change the narrative but strengthens it: Tramdol's reputation as a safer or uniquely effective opioid is increasingly difficult to defend," she told Medscape Medical News.
While she believes the study makes an important contribution, Otte said the results should be interpreted with caution because of gaps in the underlying evidence. The Danish authors noted similar concerns, and Otte agreed that many of the included trials had methodological shortcomings.
"A lot of the studies had biases that made use less certain about what was reported," she said. "Many outcomes that matter to patients - like quality of life, functional improvement, or withdrawal - were either inconsistently measured or not reported at all."
She added that patients assigned to tramadol were more likely to discontinue early, both overall and because of adverse effects, raising concern about tolerability and attrition bias.
Also commenting, Houman Danesh, MD, professor and medical director of pain management at the Icahn School of Medicine at Mount Sinai in New York City, said the review provides moderate-certainty evidence that tramadol increases the risk for serious adverse events; but its broad approach - evaluating efficacy and safety across multiple chronic pain conditions - could be a confounding factor.
"Tramadol may benefit some conditions more than others," he noted, which could alter the overall risk-benefit profile.
In his clinical experience, Danesh said severe complications such as cardiac events are uncommon. He explained that heart rhythm disturbances occasionally associated with tramadol generally arise when patients are taking other medications that affect cardiac conduction.
Danesh emphasized that clinicians should weigh the study alongside other research and their own experience when deciding whether to prescribe the drug.
"It's important to take this study into consideration," he said, "but there are multiple studies that support the use of tramadol, and we have to look at the totality of the evidence."
Written by Carla Cantor.
The authors declared no competing interests and received no specific grant from any funding agency. Otte and Danesh reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Time to Reconsider Tramadol for Chronic Pain?
Time to Reconsider Tramadol for Chronic Pain?
Combining Upper-Lower GI Screening Feasible, Effective
BERLIN — , including malignancies and lesions requiring ongoing surveillance, according to an interim analysis from the TOGAS study.
“There was an abundance of benign but clinically relevant findings,” said lead investigator Jan Bornschein, MD, gastroenterologist at Oxford University Hospitals NHS Foundation Trust, Oxford, England, who presented the interim resuts of the study at United European Gastroenterology (UEG) Week 2025.
While the study found upper GI neoplasia in only 1.4% of participants, 17.8% of individuals were marked for upper GI endoscopic surveillance.
The results may inform how Europe develops gastric cancer prevention programs alongside those for colorectal cancer, said Bornschein. “If we can combine the upper GI endoscopy with other modalities [colonoscopy], the more likelihood there is that you can have a one-stop test package,” he said. “A combination, particularly for bowel and stomach, is more feasible and also more cost-effective. So far, the findings show that it’s definitely a strategy that, in my opinion, is worth implementing.”
Bornschein and the TOGAS study group hope that the combined approach will prove workable across diverse European settings and will help identify a spectrum of upper GI pathology, from cancers and dysplasia to atrophy and intestinal metaplasia, that can meaningfully affect follow-up surveillance.
Mixed Rates of GI Cancers Across Europe and the US
These findings come amid data showing rising rates of early-onset (younger than 50 years) GI cancers in the US, including colorectal, gastric, pancreatic, and esophageal tumors. These trends, previously reported by this news organization, point to environmental and lifestyle drivers, strengthening the case for earlier detection and risk-tailored strategies for upper GI neoplasia and preneoplastic conditions detected during existing colorectal cancer screening pathways.
However, Bornschein noted that prevalence varies considerably across Europe. “There are areas, particularly in the Eastern regions, and in some parts of the West, for example, Portugal, that have a very high incidence of GI cancers. In the UK or in Germany, we have noticed a decline over the years, so the numbers are actually much better than they used to be.”
The study is the second in a series of three TOGAS pilot studies and was conducted across eight centers (France, Germany, Ireland, Latvia, Lithuania, the Netherlands, Portugal, and Spain) in adults aged 50-74 years attending screening or polyp-surveillance colonoscopy.
A European Society of Gastrointestinal Endoscopy-aligned protocol defining image documentation, biopsy sampling, and quality parameters was followed to ensure a standardized approach. “Marked preneoplastic change” was defined as gastric glandular atrophy or intestinal metaplasia at the Operative Link on Gastritis Assessment/Operative Link on Gastric Intestinal Metaplasia Assessment stage III-IV and/or Endoscopic Grading of Gastric Intestinal Metaplasia > 5, triggering a need for endoscopic surveillance.
Data were gathered on colonoscopy findings (including polyp surveillance and family history), EGD findings plus biopsies, serum pepsinogen, and Helicobacter pylori serology. Outcome measures included the prevalence of gastric cancer and preneoplastic conditions, the diagnostic accuracy of pepsinogen testing, comparisons between national settings, the relevance of upper endoscopy in fecal immunochemical test-positive cases, and overall H pylori prevalence.
Neoplasia and Preneoplasia Found
A total of 846 participants were analyzed. At baseline, the mean age was 62 years, 52.2% were men, and 84.2% were White, despite efforts to recruit a more diverse population. Around 390 participants drank alcohol, and 190 smoked tobacco.
A total of 37.8% of participants had undergone prior EGD, of which 94.7% were performed more than 3 years before the study start. The history of GI surgery was 13.7%, and the history of cancer was 14.5%. Around 11% took aspirin, and 14% took proton pump inhibitors (PPIs). “We were surprised at the low prevalence of PPI use,” remarked Bornschein. “It was also good news that around half were never smokers.”
Key results for upper GI neoplasia included six patients (0.7%) with gastric cancers, three (0.4%) with esophageal cancers, and five (0.6%) with duodenal tumors. H pylori positivity was found in 303 patients (35.8%), with an additional 81 (9.6%) reporting a history of eradication.
Colorectal findings included 15 patients (1.8%) with cancers and colon polyps in 503 (59.5%) participants.
Regarding preneoplastic conditions, endoscopy identified intestinal metaplasia in 174 patients (20.6%), of which 65 (7.7%) were multifocal. Atrophy was observed in 220 patients (26.0%), with 59 (7.0%) showing multifocal atrophic changes. Both intestinal metaplasia and atrophy were found together in 105 (12.4%) patients. Barrett’s esophagus was detected in 31 (3.7%) patients.
“I’d really like to highlight these further benign gastric findings,” said Bornschein. These included gastric ulcers in 28 (3.3%) patients, erosive gastritis in 245 (29.0%) patients, esophageal ulcers in three (0.4%) patients, Los Angeles Community College District classification esophagitis in 13 (1.5%) patients, and duodenal ulcers in 10 (1.2%) patients. “These were asymptomatic, but we were able to identify them,” he noted.
“We’ve had a very low rate of complications (0.01%),” he added.” I don’t want to jinx that now. These were basically related to sedation.”
PROSPERO: Early Detection of Upper GI Conditions in a UK Population
Massimiliano di Pietro, MD, consultant gastroenterologist at Addenbrooke’s Hospital, Cambridge, England, and the principal investigator of the PROSPERO study, which aimed to determine the prevalence of premalignant upper GI conditions in routine endoscopy in the UK, commented on the findings. The TOGAS study focuses on asymptomatic individuals referred for colonoscopy and examines the value of performing an upper GI endoscopy at the same time, he explained. “This approach might identify upper GI conditions that require monitoring, in particular early cancer.”
“On the other hand, the PROSPERO study focuses on patients referred for upper GI symptoms and diagnosis,” he said. Preliminary data from that study, presented during the same session as the TOGAS trial, showed a 13.6% prevalence of premalignant upper GI conditions in a symptomatic UK patient population referred for endoscopy.
“In some respects, the findings were similar, particularly the rate of upper GI cancer at 1.4%, although there were differences in the prevalence of premalignant conditions,” he noted. “This may be explained by the fact that TOGAS is a European study, while PROSPERO is UK-based, where the distribution of upper GI cancers differs, with more esophageal adenocarcinoma vs gastric adenocarcinoma.”
Reflecting on both of the studies, Di Pietro said they are “really important in fulfilling an unmet need in the quality of upper GI endoscopy. Currently, there are no diagnostic quality indicators in upper GI endoscopy, so it’s difficult to rate the performance of endoscopists in the same way as we can in lower GI. It’s really important to understand the population prevalence, both in symptomatic and asymptomatic individuals, of premalignant and malignant upper GI conditions.”
TOGAS 2 is recruiting until February 2026, with 1200 of a potential 1600 participants recruited to date. The data will be used for implementation modeling and to inform quality indicators for future screening programs. Final results and plans for a follow-up study are expected in 2026.
Bornschein declared receiving advisory and speaker fees from Flynn Pharma and Juvisé Pharmaceuticals. Di Pietro reported having no disclosures relevant to the studies discussed.
A version of this article first appeared on Medscape.com.
BERLIN — , including malignancies and lesions requiring ongoing surveillance, according to an interim analysis from the TOGAS study.
“There was an abundance of benign but clinically relevant findings,” said lead investigator Jan Bornschein, MD, gastroenterologist at Oxford University Hospitals NHS Foundation Trust, Oxford, England, who presented the interim resuts of the study at United European Gastroenterology (UEG) Week 2025.
While the study found upper GI neoplasia in only 1.4% of participants, 17.8% of individuals were marked for upper GI endoscopic surveillance.
The results may inform how Europe develops gastric cancer prevention programs alongside those for colorectal cancer, said Bornschein. “If we can combine the upper GI endoscopy with other modalities [colonoscopy], the more likelihood there is that you can have a one-stop test package,” he said. “A combination, particularly for bowel and stomach, is more feasible and also more cost-effective. So far, the findings show that it’s definitely a strategy that, in my opinion, is worth implementing.”
Bornschein and the TOGAS study group hope that the combined approach will prove workable across diverse European settings and will help identify a spectrum of upper GI pathology, from cancers and dysplasia to atrophy and intestinal metaplasia, that can meaningfully affect follow-up surveillance.
Mixed Rates of GI Cancers Across Europe and the US
These findings come amid data showing rising rates of early-onset (younger than 50 years) GI cancers in the US, including colorectal, gastric, pancreatic, and esophageal tumors. These trends, previously reported by this news organization, point to environmental and lifestyle drivers, strengthening the case for earlier detection and risk-tailored strategies for upper GI neoplasia and preneoplastic conditions detected during existing colorectal cancer screening pathways.
However, Bornschein noted that prevalence varies considerably across Europe. “There are areas, particularly in the Eastern regions, and in some parts of the West, for example, Portugal, that have a very high incidence of GI cancers. In the UK or in Germany, we have noticed a decline over the years, so the numbers are actually much better than they used to be.”
The study is the second in a series of three TOGAS pilot studies and was conducted across eight centers (France, Germany, Ireland, Latvia, Lithuania, the Netherlands, Portugal, and Spain) in adults aged 50-74 years attending screening or polyp-surveillance colonoscopy.
A European Society of Gastrointestinal Endoscopy-aligned protocol defining image documentation, biopsy sampling, and quality parameters was followed to ensure a standardized approach. “Marked preneoplastic change” was defined as gastric glandular atrophy or intestinal metaplasia at the Operative Link on Gastritis Assessment/Operative Link on Gastric Intestinal Metaplasia Assessment stage III-IV and/or Endoscopic Grading of Gastric Intestinal Metaplasia > 5, triggering a need for endoscopic surveillance.
Data were gathered on colonoscopy findings (including polyp surveillance and family history), EGD findings plus biopsies, serum pepsinogen, and Helicobacter pylori serology. Outcome measures included the prevalence of gastric cancer and preneoplastic conditions, the diagnostic accuracy of pepsinogen testing, comparisons between national settings, the relevance of upper endoscopy in fecal immunochemical test-positive cases, and overall H pylori prevalence.
Neoplasia and Preneoplasia Found
A total of 846 participants were analyzed. At baseline, the mean age was 62 years, 52.2% were men, and 84.2% were White, despite efforts to recruit a more diverse population. Around 390 participants drank alcohol, and 190 smoked tobacco.
A total of 37.8% of participants had undergone prior EGD, of which 94.7% were performed more than 3 years before the study start. The history of GI surgery was 13.7%, and the history of cancer was 14.5%. Around 11% took aspirin, and 14% took proton pump inhibitors (PPIs). “We were surprised at the low prevalence of PPI use,” remarked Bornschein. “It was also good news that around half were never smokers.”
Key results for upper GI neoplasia included six patients (0.7%) with gastric cancers, three (0.4%) with esophageal cancers, and five (0.6%) with duodenal tumors. H pylori positivity was found in 303 patients (35.8%), with an additional 81 (9.6%) reporting a history of eradication.
Colorectal findings included 15 patients (1.8%) with cancers and colon polyps in 503 (59.5%) participants.
Regarding preneoplastic conditions, endoscopy identified intestinal metaplasia in 174 patients (20.6%), of which 65 (7.7%) were multifocal. Atrophy was observed in 220 patients (26.0%), with 59 (7.0%) showing multifocal atrophic changes. Both intestinal metaplasia and atrophy were found together in 105 (12.4%) patients. Barrett’s esophagus was detected in 31 (3.7%) patients.
“I’d really like to highlight these further benign gastric findings,” said Bornschein. These included gastric ulcers in 28 (3.3%) patients, erosive gastritis in 245 (29.0%) patients, esophageal ulcers in three (0.4%) patients, Los Angeles Community College District classification esophagitis in 13 (1.5%) patients, and duodenal ulcers in 10 (1.2%) patients. “These were asymptomatic, but we were able to identify them,” he noted.
“We’ve had a very low rate of complications (0.01%),” he added.” I don’t want to jinx that now. These were basically related to sedation.”
PROSPERO: Early Detection of Upper GI Conditions in a UK Population
Massimiliano di Pietro, MD, consultant gastroenterologist at Addenbrooke’s Hospital, Cambridge, England, and the principal investigator of the PROSPERO study, which aimed to determine the prevalence of premalignant upper GI conditions in routine endoscopy in the UK, commented on the findings. The TOGAS study focuses on asymptomatic individuals referred for colonoscopy and examines the value of performing an upper GI endoscopy at the same time, he explained. “This approach might identify upper GI conditions that require monitoring, in particular early cancer.”
“On the other hand, the PROSPERO study focuses on patients referred for upper GI symptoms and diagnosis,” he said. Preliminary data from that study, presented during the same session as the TOGAS trial, showed a 13.6% prevalence of premalignant upper GI conditions in a symptomatic UK patient population referred for endoscopy.
“In some respects, the findings were similar, particularly the rate of upper GI cancer at 1.4%, although there were differences in the prevalence of premalignant conditions,” he noted. “This may be explained by the fact that TOGAS is a European study, while PROSPERO is UK-based, where the distribution of upper GI cancers differs, with more esophageal adenocarcinoma vs gastric adenocarcinoma.”
Reflecting on both of the studies, Di Pietro said they are “really important in fulfilling an unmet need in the quality of upper GI endoscopy. Currently, there are no diagnostic quality indicators in upper GI endoscopy, so it’s difficult to rate the performance of endoscopists in the same way as we can in lower GI. It’s really important to understand the population prevalence, both in symptomatic and asymptomatic individuals, of premalignant and malignant upper GI conditions.”
TOGAS 2 is recruiting until February 2026, with 1200 of a potential 1600 participants recruited to date. The data will be used for implementation modeling and to inform quality indicators for future screening programs. Final results and plans for a follow-up study are expected in 2026.
Bornschein declared receiving advisory and speaker fees from Flynn Pharma and Juvisé Pharmaceuticals. Di Pietro reported having no disclosures relevant to the studies discussed.
A version of this article first appeared on Medscape.com.
BERLIN — , including malignancies and lesions requiring ongoing surveillance, according to an interim analysis from the TOGAS study.
“There was an abundance of benign but clinically relevant findings,” said lead investigator Jan Bornschein, MD, gastroenterologist at Oxford University Hospitals NHS Foundation Trust, Oxford, England, who presented the interim resuts of the study at United European Gastroenterology (UEG) Week 2025.
While the study found upper GI neoplasia in only 1.4% of participants, 17.8% of individuals were marked for upper GI endoscopic surveillance.
The results may inform how Europe develops gastric cancer prevention programs alongside those for colorectal cancer, said Bornschein. “If we can combine the upper GI endoscopy with other modalities [colonoscopy], the more likelihood there is that you can have a one-stop test package,” he said. “A combination, particularly for bowel and stomach, is more feasible and also more cost-effective. So far, the findings show that it’s definitely a strategy that, in my opinion, is worth implementing.”
Bornschein and the TOGAS study group hope that the combined approach will prove workable across diverse European settings and will help identify a spectrum of upper GI pathology, from cancers and dysplasia to atrophy and intestinal metaplasia, that can meaningfully affect follow-up surveillance.
Mixed Rates of GI Cancers Across Europe and the US
These findings come amid data showing rising rates of early-onset (younger than 50 years) GI cancers in the US, including colorectal, gastric, pancreatic, and esophageal tumors. These trends, previously reported by this news organization, point to environmental and lifestyle drivers, strengthening the case for earlier detection and risk-tailored strategies for upper GI neoplasia and preneoplastic conditions detected during existing colorectal cancer screening pathways.
However, Bornschein noted that prevalence varies considerably across Europe. “There are areas, particularly in the Eastern regions, and in some parts of the West, for example, Portugal, that have a very high incidence of GI cancers. In the UK or in Germany, we have noticed a decline over the years, so the numbers are actually much better than they used to be.”
The study is the second in a series of three TOGAS pilot studies and was conducted across eight centers (France, Germany, Ireland, Latvia, Lithuania, the Netherlands, Portugal, and Spain) in adults aged 50-74 years attending screening or polyp-surveillance colonoscopy.
A European Society of Gastrointestinal Endoscopy-aligned protocol defining image documentation, biopsy sampling, and quality parameters was followed to ensure a standardized approach. “Marked preneoplastic change” was defined as gastric glandular atrophy or intestinal metaplasia at the Operative Link on Gastritis Assessment/Operative Link on Gastric Intestinal Metaplasia Assessment stage III-IV and/or Endoscopic Grading of Gastric Intestinal Metaplasia > 5, triggering a need for endoscopic surveillance.
Data were gathered on colonoscopy findings (including polyp surveillance and family history), EGD findings plus biopsies, serum pepsinogen, and Helicobacter pylori serology. Outcome measures included the prevalence of gastric cancer and preneoplastic conditions, the diagnostic accuracy of pepsinogen testing, comparisons between national settings, the relevance of upper endoscopy in fecal immunochemical test-positive cases, and overall H pylori prevalence.
Neoplasia and Preneoplasia Found
A total of 846 participants were analyzed. At baseline, the mean age was 62 years, 52.2% were men, and 84.2% were White, despite efforts to recruit a more diverse population. Around 390 participants drank alcohol, and 190 smoked tobacco.
A total of 37.8% of participants had undergone prior EGD, of which 94.7% were performed more than 3 years before the study start. The history of GI surgery was 13.7%, and the history of cancer was 14.5%. Around 11% took aspirin, and 14% took proton pump inhibitors (PPIs). “We were surprised at the low prevalence of PPI use,” remarked Bornschein. “It was also good news that around half were never smokers.”
Key results for upper GI neoplasia included six patients (0.7%) with gastric cancers, three (0.4%) with esophageal cancers, and five (0.6%) with duodenal tumors. H pylori positivity was found in 303 patients (35.8%), with an additional 81 (9.6%) reporting a history of eradication.
Colorectal findings included 15 patients (1.8%) with cancers and colon polyps in 503 (59.5%) participants.
Regarding preneoplastic conditions, endoscopy identified intestinal metaplasia in 174 patients (20.6%), of which 65 (7.7%) were multifocal. Atrophy was observed in 220 patients (26.0%), with 59 (7.0%) showing multifocal atrophic changes. Both intestinal metaplasia and atrophy were found together in 105 (12.4%) patients. Barrett’s esophagus was detected in 31 (3.7%) patients.
“I’d really like to highlight these further benign gastric findings,” said Bornschein. These included gastric ulcers in 28 (3.3%) patients, erosive gastritis in 245 (29.0%) patients, esophageal ulcers in three (0.4%) patients, Los Angeles Community College District classification esophagitis in 13 (1.5%) patients, and duodenal ulcers in 10 (1.2%) patients. “These were asymptomatic, but we were able to identify them,” he noted.
“We’ve had a very low rate of complications (0.01%),” he added.” I don’t want to jinx that now. These were basically related to sedation.”
PROSPERO: Early Detection of Upper GI Conditions in a UK Population
Massimiliano di Pietro, MD, consultant gastroenterologist at Addenbrooke’s Hospital, Cambridge, England, and the principal investigator of the PROSPERO study, which aimed to determine the prevalence of premalignant upper GI conditions in routine endoscopy in the UK, commented on the findings. The TOGAS study focuses on asymptomatic individuals referred for colonoscopy and examines the value of performing an upper GI endoscopy at the same time, he explained. “This approach might identify upper GI conditions that require monitoring, in particular early cancer.”
“On the other hand, the PROSPERO study focuses on patients referred for upper GI symptoms and diagnosis,” he said. Preliminary data from that study, presented during the same session as the TOGAS trial, showed a 13.6% prevalence of premalignant upper GI conditions in a symptomatic UK patient population referred for endoscopy.
“In some respects, the findings were similar, particularly the rate of upper GI cancer at 1.4%, although there were differences in the prevalence of premalignant conditions,” he noted. “This may be explained by the fact that TOGAS is a European study, while PROSPERO is UK-based, where the distribution of upper GI cancers differs, with more esophageal adenocarcinoma vs gastric adenocarcinoma.”
Reflecting on both of the studies, Di Pietro said they are “really important in fulfilling an unmet need in the quality of upper GI endoscopy. Currently, there are no diagnostic quality indicators in upper GI endoscopy, so it’s difficult to rate the performance of endoscopists in the same way as we can in lower GI. It’s really important to understand the population prevalence, both in symptomatic and asymptomatic individuals, of premalignant and malignant upper GI conditions.”
TOGAS 2 is recruiting until February 2026, with 1200 of a potential 1600 participants recruited to date. The data will be used for implementation modeling and to inform quality indicators for future screening programs. Final results and plans for a follow-up study are expected in 2026.
Bornschein declared receiving advisory and speaker fees from Flynn Pharma and Juvisé Pharmaceuticals. Di Pietro reported having no disclosures relevant to the studies discussed.
A version of this article first appeared on Medscape.com.
Real-World Pros & Cons of the New Liver Disease Nomenclature
VIENNA – Maria Effenberger, MD, Medical University of Innsbruck, Berlin, Germany, told attendees at United European Gastroenterology (UEG) Week 2025 in Vienna, Austria.
In her presentation, “Sense and Nonsense of the New Nomenclature,” Effenberger highlighted the clinical implications of the new liver-disease terminology and pointed to a few factors still needing to be sorted out.
Both NAFLD and MASLD are steatotic liver diseasesand, notably, there are few differences between the two in clinical studies, which makes the terminology shift easier, said Effenberger. She cited a recent study showing demographic and clinical profiles of individuals classified as NAFLD and MASLD in the US were “strikingly similar,” as were the accuracy of the noninvasive tests and all-cause and cause-specific mortality rates for both conditions.
However, “the important thing about MASLD is that the term is really connected to metabolic dysfunction,” said Effenberger. To be diagnosed with MASLD, patients with liver disease need to have at least one of five cardiometabolic abnormalities: a high BMI — over 25 in White people and over 23 in Asian people; type 2 diabetes (T2D) or prediabetes; arterial hypertension; high levels of triglycerides; or a low level of high-density lipoprotein cholesterol.
“MASLD is a systemic disease, and that term represents it much better than only looking at it as a hepatological disease,” Effenberger said. “Many factors, especially inflammatory ones, influence steatosis, inflammation, and fibrosis.” These include influences from adipose tissue, the gut microbiome, the brain, a hypocaloric diet, and from steatosis of the liver itself. Proinflammatory cytokines induced by the disease can lead to inflammation throughout the body, with clinical outcomes such as stroke, heart failure, arrhythmias, myocardial infarction, chronic kidney disease.
MASLD, MetALD, or ALD?
“What is important now,” said Effenberger, is that “every patient who has liver disease should be asked two questions.” The first question is whether the patient has any of the cardiometabolic criteria outlined above. Second, is the patient consuming alcohol?
If the patient has one of the cardiometabolic criteria but doesn’t consume alcohol, “we are straight at the diagnosis of MASLD,” she explained. If the patient does consume alcohol, it depends on how much.
Patients who have at least one cardiometabolic risk factor and consume 140-350 g for men and 210-420 g for women are considered to have Metabolic and Alcohol-Associated Liver Disease (MetALD). And those with steatotic liver disease who drink alcohol above the MetALD thresholds are considered to have ALD.
Effenberger pointed to two “cons” of the new nomenclature that need to be clarified. Although MetALD has poorer outcomes than MASLD, “it’s really hard to differentiate between ALD and MASLD,” she said. Yet the distinction is important because risks for cirrhosis, hepatocellular carcinoma (HCC), and overall mortality increase more for patients diagnosed with ALD vs MASLD.
“Do MASLD patients drink alcohol? Yes they do,” Effenberger said. “And if you have MASLD and another trigger factor like alcohol, the rates of mortality, morbidity and cancer go up.”
Moderator Laurent Castera, MD, PhD, Université Paris-Cité, Paris, France, noted that a “pro” of the new nomenclature is that it is “shedding light on the importance of alcohol because when we discuss steatotic liver disease or MASLD, alcohol is always the elephant in the room,” he said. “We need to increase the awareness that even in the absence of alcohol, you can still develop cirrhosis if you have severe metabolic risk factors.”
On the other hand, he said, “We desperately need more statistics on the true prevalence of alcohol consumption. While studies suggest the prevalence is low, at around 4% or 5%, that does not match the reality, in my opinion.”
Effenberger agreed. There’s a problem in trying to zero in on alcohol consumption because of the stigma attached to it, she said. She pointed to an Austrian study assessing patients who are diagnosed with MASLD. The researchers asked them, “Do you drink alcohol?” and all the participants said “no.” However, after completing a questionnaire designed to identify alcohol use disorders, and undergoing glucuronide tests in the urine and hair, it became clear that 25%-30% of these patients actually drank alcohol on a regular basis.
Cancer, Cirrhosis, CVD
MASLD is a trigger for cancer, especially HCC, Effenberger said. A recent review affirmed that MASLD is strongly associated with HCC, especially in Southeast Asia and India. The same study showed that many patients with MASLD are getting HCC without cirrhosis, and their cancer is often detected at a later stage, however, it’s not yet clear why they are getting HCC, and further study is needed.
In addition, MASLD is also associated with higher rates of extrahepatic cancers, including cancers of the skin and androgenic cancers. This, too, requires further investigation.
Regarding cardiovascular disease (CVD) risk, Effenberger emphasized that cardiometabolic diseases are strongly linked to each other. “Therefore, if you have diabetes and MASLD, the rates of atherosclerosis and of heart insufficiency and arteriosclerotic events like stroke and heart attacks go up, leading to the question of whether a CVD risk assessment is necessary in patients with MASLD.”
One recent study suggests that yes, it is, she reported. “If a patient has MASLD and cardiometabolic risk factors, and a risk score that suggests the patient is at increased risk of CVD for 10 years, then a CT scan of the arteries of the heart is important. The increased risk could also lead to intensified medical therapy, including GLP-1s or SGLT2s.”
During the Q&A, one attendee asked whether all patients with noncirrhotic MASLD should be screened for HCC, given the increased risk. Effenberger agreed that would be the best way to identify those at high risk; however, she said, “I think science is not in a state where you can clearly define which patients will be at high risk, and so we don’t have any guidelines for that.”
Another attendee asked why HCC is more common in Indians and Asians. Effenberger said, “We don’t know, but it is likely that there is an HCC-driven genetic risk factor.”
Remaining Questions
And finally, there’s the question of “what do we do with burnt-out MASLD?” Effenberger asked. “We know the fat content of the liver decreases when liver severity goes up. Therefore, we have a lot of patients with cirrhosis whose disease is not defined as steatotic liver because the liver fat content is no longer more than 5%.”
The decrease in fat is an ongoing process, and therefore, these patients with MASLD and advanced hepatic disease need to be better represented in the nomenclature, she suggested.
No funding information was provided. Effenberger declared working with Ipsen as a potential conflict.
A version of this article first appeared on Medscape.com.
VIENNA – Maria Effenberger, MD, Medical University of Innsbruck, Berlin, Germany, told attendees at United European Gastroenterology (UEG) Week 2025 in Vienna, Austria.
In her presentation, “Sense and Nonsense of the New Nomenclature,” Effenberger highlighted the clinical implications of the new liver-disease terminology and pointed to a few factors still needing to be sorted out.
Both NAFLD and MASLD are steatotic liver diseasesand, notably, there are few differences between the two in clinical studies, which makes the terminology shift easier, said Effenberger. She cited a recent study showing demographic and clinical profiles of individuals classified as NAFLD and MASLD in the US were “strikingly similar,” as were the accuracy of the noninvasive tests and all-cause and cause-specific mortality rates for both conditions.
However, “the important thing about MASLD is that the term is really connected to metabolic dysfunction,” said Effenberger. To be diagnosed with MASLD, patients with liver disease need to have at least one of five cardiometabolic abnormalities: a high BMI — over 25 in White people and over 23 in Asian people; type 2 diabetes (T2D) or prediabetes; arterial hypertension; high levels of triglycerides; or a low level of high-density lipoprotein cholesterol.
“MASLD is a systemic disease, and that term represents it much better than only looking at it as a hepatological disease,” Effenberger said. “Many factors, especially inflammatory ones, influence steatosis, inflammation, and fibrosis.” These include influences from adipose tissue, the gut microbiome, the brain, a hypocaloric diet, and from steatosis of the liver itself. Proinflammatory cytokines induced by the disease can lead to inflammation throughout the body, with clinical outcomes such as stroke, heart failure, arrhythmias, myocardial infarction, chronic kidney disease.
MASLD, MetALD, or ALD?
“What is important now,” said Effenberger, is that “every patient who has liver disease should be asked two questions.” The first question is whether the patient has any of the cardiometabolic criteria outlined above. Second, is the patient consuming alcohol?
If the patient has one of the cardiometabolic criteria but doesn’t consume alcohol, “we are straight at the diagnosis of MASLD,” she explained. If the patient does consume alcohol, it depends on how much.
Patients who have at least one cardiometabolic risk factor and consume 140-350 g for men and 210-420 g for women are considered to have Metabolic and Alcohol-Associated Liver Disease (MetALD). And those with steatotic liver disease who drink alcohol above the MetALD thresholds are considered to have ALD.
Effenberger pointed to two “cons” of the new nomenclature that need to be clarified. Although MetALD has poorer outcomes than MASLD, “it’s really hard to differentiate between ALD and MASLD,” she said. Yet the distinction is important because risks for cirrhosis, hepatocellular carcinoma (HCC), and overall mortality increase more for patients diagnosed with ALD vs MASLD.
“Do MASLD patients drink alcohol? Yes they do,” Effenberger said. “And if you have MASLD and another trigger factor like alcohol, the rates of mortality, morbidity and cancer go up.”
Moderator Laurent Castera, MD, PhD, Université Paris-Cité, Paris, France, noted that a “pro” of the new nomenclature is that it is “shedding light on the importance of alcohol because when we discuss steatotic liver disease or MASLD, alcohol is always the elephant in the room,” he said. “We need to increase the awareness that even in the absence of alcohol, you can still develop cirrhosis if you have severe metabolic risk factors.”
On the other hand, he said, “We desperately need more statistics on the true prevalence of alcohol consumption. While studies suggest the prevalence is low, at around 4% or 5%, that does not match the reality, in my opinion.”
Effenberger agreed. There’s a problem in trying to zero in on alcohol consumption because of the stigma attached to it, she said. She pointed to an Austrian study assessing patients who are diagnosed with MASLD. The researchers asked them, “Do you drink alcohol?” and all the participants said “no.” However, after completing a questionnaire designed to identify alcohol use disorders, and undergoing glucuronide tests in the urine and hair, it became clear that 25%-30% of these patients actually drank alcohol on a regular basis.
Cancer, Cirrhosis, CVD
MASLD is a trigger for cancer, especially HCC, Effenberger said. A recent review affirmed that MASLD is strongly associated with HCC, especially in Southeast Asia and India. The same study showed that many patients with MASLD are getting HCC without cirrhosis, and their cancer is often detected at a later stage, however, it’s not yet clear why they are getting HCC, and further study is needed.
In addition, MASLD is also associated with higher rates of extrahepatic cancers, including cancers of the skin and androgenic cancers. This, too, requires further investigation.
Regarding cardiovascular disease (CVD) risk, Effenberger emphasized that cardiometabolic diseases are strongly linked to each other. “Therefore, if you have diabetes and MASLD, the rates of atherosclerosis and of heart insufficiency and arteriosclerotic events like stroke and heart attacks go up, leading to the question of whether a CVD risk assessment is necessary in patients with MASLD.”
One recent study suggests that yes, it is, she reported. “If a patient has MASLD and cardiometabolic risk factors, and a risk score that suggests the patient is at increased risk of CVD for 10 years, then a CT scan of the arteries of the heart is important. The increased risk could also lead to intensified medical therapy, including GLP-1s or SGLT2s.”
During the Q&A, one attendee asked whether all patients with noncirrhotic MASLD should be screened for HCC, given the increased risk. Effenberger agreed that would be the best way to identify those at high risk; however, she said, “I think science is not in a state where you can clearly define which patients will be at high risk, and so we don’t have any guidelines for that.”
Another attendee asked why HCC is more common in Indians and Asians. Effenberger said, “We don’t know, but it is likely that there is an HCC-driven genetic risk factor.”
Remaining Questions
And finally, there’s the question of “what do we do with burnt-out MASLD?” Effenberger asked. “We know the fat content of the liver decreases when liver severity goes up. Therefore, we have a lot of patients with cirrhosis whose disease is not defined as steatotic liver because the liver fat content is no longer more than 5%.”
The decrease in fat is an ongoing process, and therefore, these patients with MASLD and advanced hepatic disease need to be better represented in the nomenclature, she suggested.
No funding information was provided. Effenberger declared working with Ipsen as a potential conflict.
A version of this article first appeared on Medscape.com.
VIENNA – Maria Effenberger, MD, Medical University of Innsbruck, Berlin, Germany, told attendees at United European Gastroenterology (UEG) Week 2025 in Vienna, Austria.
In her presentation, “Sense and Nonsense of the New Nomenclature,” Effenberger highlighted the clinical implications of the new liver-disease terminology and pointed to a few factors still needing to be sorted out.
Both NAFLD and MASLD are steatotic liver diseasesand, notably, there are few differences between the two in clinical studies, which makes the terminology shift easier, said Effenberger. She cited a recent study showing demographic and clinical profiles of individuals classified as NAFLD and MASLD in the US were “strikingly similar,” as were the accuracy of the noninvasive tests and all-cause and cause-specific mortality rates for both conditions.
However, “the important thing about MASLD is that the term is really connected to metabolic dysfunction,” said Effenberger. To be diagnosed with MASLD, patients with liver disease need to have at least one of five cardiometabolic abnormalities: a high BMI — over 25 in White people and over 23 in Asian people; type 2 diabetes (T2D) or prediabetes; arterial hypertension; high levels of triglycerides; or a low level of high-density lipoprotein cholesterol.
“MASLD is a systemic disease, and that term represents it much better than only looking at it as a hepatological disease,” Effenberger said. “Many factors, especially inflammatory ones, influence steatosis, inflammation, and fibrosis.” These include influences from adipose tissue, the gut microbiome, the brain, a hypocaloric diet, and from steatosis of the liver itself. Proinflammatory cytokines induced by the disease can lead to inflammation throughout the body, with clinical outcomes such as stroke, heart failure, arrhythmias, myocardial infarction, chronic kidney disease.
MASLD, MetALD, or ALD?
“What is important now,” said Effenberger, is that “every patient who has liver disease should be asked two questions.” The first question is whether the patient has any of the cardiometabolic criteria outlined above. Second, is the patient consuming alcohol?
If the patient has one of the cardiometabolic criteria but doesn’t consume alcohol, “we are straight at the diagnosis of MASLD,” she explained. If the patient does consume alcohol, it depends on how much.
Patients who have at least one cardiometabolic risk factor and consume 140-350 g for men and 210-420 g for women are considered to have Metabolic and Alcohol-Associated Liver Disease (MetALD). And those with steatotic liver disease who drink alcohol above the MetALD thresholds are considered to have ALD.
Effenberger pointed to two “cons” of the new nomenclature that need to be clarified. Although MetALD has poorer outcomes than MASLD, “it’s really hard to differentiate between ALD and MASLD,” she said. Yet the distinction is important because risks for cirrhosis, hepatocellular carcinoma (HCC), and overall mortality increase more for patients diagnosed with ALD vs MASLD.
“Do MASLD patients drink alcohol? Yes they do,” Effenberger said. “And if you have MASLD and another trigger factor like alcohol, the rates of mortality, morbidity and cancer go up.”
Moderator Laurent Castera, MD, PhD, Université Paris-Cité, Paris, France, noted that a “pro” of the new nomenclature is that it is “shedding light on the importance of alcohol because when we discuss steatotic liver disease or MASLD, alcohol is always the elephant in the room,” he said. “We need to increase the awareness that even in the absence of alcohol, you can still develop cirrhosis if you have severe metabolic risk factors.”
On the other hand, he said, “We desperately need more statistics on the true prevalence of alcohol consumption. While studies suggest the prevalence is low, at around 4% or 5%, that does not match the reality, in my opinion.”
Effenberger agreed. There’s a problem in trying to zero in on alcohol consumption because of the stigma attached to it, she said. She pointed to an Austrian study assessing patients who are diagnosed with MASLD. The researchers asked them, “Do you drink alcohol?” and all the participants said “no.” However, after completing a questionnaire designed to identify alcohol use disorders, and undergoing glucuronide tests in the urine and hair, it became clear that 25%-30% of these patients actually drank alcohol on a regular basis.
Cancer, Cirrhosis, CVD
MASLD is a trigger for cancer, especially HCC, Effenberger said. A recent review affirmed that MASLD is strongly associated with HCC, especially in Southeast Asia and India. The same study showed that many patients with MASLD are getting HCC without cirrhosis, and their cancer is often detected at a later stage, however, it’s not yet clear why they are getting HCC, and further study is needed.
In addition, MASLD is also associated with higher rates of extrahepatic cancers, including cancers of the skin and androgenic cancers. This, too, requires further investigation.
Regarding cardiovascular disease (CVD) risk, Effenberger emphasized that cardiometabolic diseases are strongly linked to each other. “Therefore, if you have diabetes and MASLD, the rates of atherosclerosis and of heart insufficiency and arteriosclerotic events like stroke and heart attacks go up, leading to the question of whether a CVD risk assessment is necessary in patients with MASLD.”
One recent study suggests that yes, it is, she reported. “If a patient has MASLD and cardiometabolic risk factors, and a risk score that suggests the patient is at increased risk of CVD for 10 years, then a CT scan of the arteries of the heart is important. The increased risk could also lead to intensified medical therapy, including GLP-1s or SGLT2s.”
During the Q&A, one attendee asked whether all patients with noncirrhotic MASLD should be screened for HCC, given the increased risk. Effenberger agreed that would be the best way to identify those at high risk; however, she said, “I think science is not in a state where you can clearly define which patients will be at high risk, and so we don’t have any guidelines for that.”
Another attendee asked why HCC is more common in Indians and Asians. Effenberger said, “We don’t know, but it is likely that there is an HCC-driven genetic risk factor.”
Remaining Questions
And finally, there’s the question of “what do we do with burnt-out MASLD?” Effenberger asked. “We know the fat content of the liver decreases when liver severity goes up. Therefore, we have a lot of patients with cirrhosis whose disease is not defined as steatotic liver because the liver fat content is no longer more than 5%.”
The decrease in fat is an ongoing process, and therefore, these patients with MASLD and advanced hepatic disease need to be better represented in the nomenclature, she suggested.
No funding information was provided. Effenberger declared working with Ipsen as a potential conflict.
A version of this article first appeared on Medscape.com.
FDA OKs Simponi for Pediatric Ulcerative Colitis
Of the more than 1 million people in the US living with UC, roughly 20% are children, Johnson & Johnson noted in a statement announcing approval.
The pediatric indication for golimumab in UC was supported by the open-label PURSUIT 2 phase 3 study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab in children aged 2 years and older with moderately to severely active UC.
In the trial, the primary endpoint of clinical remission at week 6 was achieved by 32% of children. Clinical remission was defined as a Mayo score ≤ 2 points, with no individual subscore > 1.
The secondary endpoints of clinical response at week 6 was achieved by 58%, and endoscopic improvement at week 6 was achieved by 40% of patients receiving golimumab.
Clinical response was defined as a decrease from baseline in the Mayo score by > 30% and > 3 points, with either a decrease from baseline in the rectal bleeding subscore of > 1 or a rectal bleeding subscore of 0 or 1. Endoscopic remission was defined as an endoscopy subscore of 0 or 1 based on local endoscopy.
Among children treated with golimumab who were in clinical remission at 6 weeks, 57% maintained clinical remission of symptoms at week 54. Safety results in children were consistent with clinical trials of golimumab in adults with UC, the company said.
The recommended dose of golimumab for pediatric patients weighing at least 40 kg is 200 mg at week 0, followed by 100 mg at weeks 2, 6, and every 4 weeks thereafter; for those weighing at least 15 kg to less than 40 kg, golimumab is administered at 100 mg at week 0, followed by 50 mg at weeks 2, 6, and every 4 weeks thereafter.
Golimumab is administered as a prefilled syringe; children aged 12 and older can self-administer it after proper training by a healthcare provider.
This is the first pediatric approval for golimumab, which is already approved for four indications, including adults living with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active UC.
Full prescribing information and medication guide is available online.
A version of this article first appeared on Medscape.com.
Of the more than 1 million people in the US living with UC, roughly 20% are children, Johnson & Johnson noted in a statement announcing approval.
The pediatric indication for golimumab in UC was supported by the open-label PURSUIT 2 phase 3 study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab in children aged 2 years and older with moderately to severely active UC.
In the trial, the primary endpoint of clinical remission at week 6 was achieved by 32% of children. Clinical remission was defined as a Mayo score ≤ 2 points, with no individual subscore > 1.
The secondary endpoints of clinical response at week 6 was achieved by 58%, and endoscopic improvement at week 6 was achieved by 40% of patients receiving golimumab.
Clinical response was defined as a decrease from baseline in the Mayo score by > 30% and > 3 points, with either a decrease from baseline in the rectal bleeding subscore of > 1 or a rectal bleeding subscore of 0 or 1. Endoscopic remission was defined as an endoscopy subscore of 0 or 1 based on local endoscopy.
Among children treated with golimumab who were in clinical remission at 6 weeks, 57% maintained clinical remission of symptoms at week 54. Safety results in children were consistent with clinical trials of golimumab in adults with UC, the company said.
The recommended dose of golimumab for pediatric patients weighing at least 40 kg is 200 mg at week 0, followed by 100 mg at weeks 2, 6, and every 4 weeks thereafter; for those weighing at least 15 kg to less than 40 kg, golimumab is administered at 100 mg at week 0, followed by 50 mg at weeks 2, 6, and every 4 weeks thereafter.
Golimumab is administered as a prefilled syringe; children aged 12 and older can self-administer it after proper training by a healthcare provider.
This is the first pediatric approval for golimumab, which is already approved for four indications, including adults living with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active UC.
Full prescribing information and medication guide is available online.
A version of this article first appeared on Medscape.com.
Of the more than 1 million people in the US living with UC, roughly 20% are children, Johnson & Johnson noted in a statement announcing approval.
The pediatric indication for golimumab in UC was supported by the open-label PURSUIT 2 phase 3 study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab in children aged 2 years and older with moderately to severely active UC.
In the trial, the primary endpoint of clinical remission at week 6 was achieved by 32% of children. Clinical remission was defined as a Mayo score ≤ 2 points, with no individual subscore > 1.
The secondary endpoints of clinical response at week 6 was achieved by 58%, and endoscopic improvement at week 6 was achieved by 40% of patients receiving golimumab.
Clinical response was defined as a decrease from baseline in the Mayo score by > 30% and > 3 points, with either a decrease from baseline in the rectal bleeding subscore of > 1 or a rectal bleeding subscore of 0 or 1. Endoscopic remission was defined as an endoscopy subscore of 0 or 1 based on local endoscopy.
Among children treated with golimumab who were in clinical remission at 6 weeks, 57% maintained clinical remission of symptoms at week 54. Safety results in children were consistent with clinical trials of golimumab in adults with UC, the company said.
The recommended dose of golimumab for pediatric patients weighing at least 40 kg is 200 mg at week 0, followed by 100 mg at weeks 2, 6, and every 4 weeks thereafter; for those weighing at least 15 kg to less than 40 kg, golimumab is administered at 100 mg at week 0, followed by 50 mg at weeks 2, 6, and every 4 weeks thereafter.
Golimumab is administered as a prefilled syringe; children aged 12 and older can self-administer it after proper training by a healthcare provider.
This is the first pediatric approval for golimumab, which is already approved for four indications, including adults living with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active UC.
Full prescribing information and medication guide is available online.
A version of this article first appeared on Medscape.com.
Anti-TNF Exposure Influences Efficacy of Subsequent Therapies in UC
, based on results of a large meta-analysis.
Patients previously treated with TNF antagonists were less likely to respond to lymphocyte trafficking inhibitors but more likely to achieve remission on Janus kinase (JAK) inhibitors, Han Hee Lee, MD, PhD, of the University of California San Diego, and colleagues reported.
“Treatment options for patients with moderate-severe ulcerative colitis have increased in the last decade with the availability of six different classes of medications,” investigators wrote in Clinical Gastroenterology and Hepatology (2024 Dec. doi:10.1016/j.cgh.2024.12.007). “There is wide interindividual variability in response to specific medications, and drivers of this heterogeneity are critical to understand to be able to choose the best therapy for each individual patient.”
To learn more about the impacts of anti-TNF exposure on subsequent advanced therapies, the investigators conducted a systematic review and meta-analysis of 17 phase 2 and 3 trials. The dataset included 8,871 adults with moderate-severe UC.
The primary outcome was induction of clinical remission at 6–14 weeks, most often defined as a Mayo Clinic score of 2 or lower with no subscore greater than 1. Endoscopic improvement, generally defined as a Mayo endoscopic subscore of 0 or 1, was evaluated as a secondary endpoint.
Advanced therapies were grouped by mechanism of action, including lymphocyte trafficking inhibitors, JAK inhibitors, and interleukin (IL)-12/23 and IL-23 antagonists. Odds ratios for treatment versus placebo were calculated separately for each subgroup, and a ratio of odds ratios was then used to assess whether prior TNF exposure modified drug effect. Analyses were conducted on an intention-to-treat basis, restricted to approved dosing when multiple regimens were tested.
Across five trials of lymphocyte trafficking inhibitors including 2,046 patients, efficacy was significantly greater in TNF-naïve patients compared with those who had prior TNF exposure. The odds of achieving clinical remission were nearly doubled in the TNF-naïve group (ratio of odds ratios [ROR], 1.88; 95% CI, 1.02–3.49).
In six trials of JAK inhibitors including 3,015 patients, remission rates were higher among TNF-exposed patients com-pared with TNF-naïve patients (ROR, 0.47; 95% CI, 0.22–1.01).
In six trials of IL-12/23 and IL-23 antagonists, including 3,810 patients, prior TNF exposure did not significantly modify treatment outcomes (ROR, 1.07; 95% CI, 0.64–1.80). Within individual trials, ustekinumab showed a trend toward great-er efficacy in TNF-exposed patients, whereas selective IL-23 antagonists performed similarly regardless of TNF exposure history.
Secondary analyses of endoscopic improvement yielded results consistent with the primary endpoint. Statistical heterogeneity across trials was minimal, and all included studies were rated at low risk of bias.
The investigators noted several limitations. For example, therapies were grouped broadly by mechanism of action, although specific biologic effects could potentially differ within groups. The analysis also could not account for patients who had failed two or more classes of advanced therapy, which may independently reduce the likelihood of response.
Still, Lee and colleagues suggested that the findings deserve a closer look.
“[T]here is significant heterogeneity of treatment efficacy for induction of remission with different advanced therapies in patients with moderate-severe UC based on prior exposure to TNF antagonists,” they concluded. “Future studies on the mechanistic insight for these intriguing observations are warranted.”
The study was supported by the Leona and Harry B. Helmsley Trust, the National Institutes of Health, and the Centers for Disease Control and Prevention. The investigators disclosed relationships with AbbVie, Ferring, Pfizer, and others.
, based on results of a large meta-analysis.
Patients previously treated with TNF antagonists were less likely to respond to lymphocyte trafficking inhibitors but more likely to achieve remission on Janus kinase (JAK) inhibitors, Han Hee Lee, MD, PhD, of the University of California San Diego, and colleagues reported.
“Treatment options for patients with moderate-severe ulcerative colitis have increased in the last decade with the availability of six different classes of medications,” investigators wrote in Clinical Gastroenterology and Hepatology (2024 Dec. doi:10.1016/j.cgh.2024.12.007). “There is wide interindividual variability in response to specific medications, and drivers of this heterogeneity are critical to understand to be able to choose the best therapy for each individual patient.”
To learn more about the impacts of anti-TNF exposure on subsequent advanced therapies, the investigators conducted a systematic review and meta-analysis of 17 phase 2 and 3 trials. The dataset included 8,871 adults with moderate-severe UC.
The primary outcome was induction of clinical remission at 6–14 weeks, most often defined as a Mayo Clinic score of 2 or lower with no subscore greater than 1. Endoscopic improvement, generally defined as a Mayo endoscopic subscore of 0 or 1, was evaluated as a secondary endpoint.
Advanced therapies were grouped by mechanism of action, including lymphocyte trafficking inhibitors, JAK inhibitors, and interleukin (IL)-12/23 and IL-23 antagonists. Odds ratios for treatment versus placebo were calculated separately for each subgroup, and a ratio of odds ratios was then used to assess whether prior TNF exposure modified drug effect. Analyses were conducted on an intention-to-treat basis, restricted to approved dosing when multiple regimens were tested.
Across five trials of lymphocyte trafficking inhibitors including 2,046 patients, efficacy was significantly greater in TNF-naïve patients compared with those who had prior TNF exposure. The odds of achieving clinical remission were nearly doubled in the TNF-naïve group (ratio of odds ratios [ROR], 1.88; 95% CI, 1.02–3.49).
In six trials of JAK inhibitors including 3,015 patients, remission rates were higher among TNF-exposed patients com-pared with TNF-naïve patients (ROR, 0.47; 95% CI, 0.22–1.01).
In six trials of IL-12/23 and IL-23 antagonists, including 3,810 patients, prior TNF exposure did not significantly modify treatment outcomes (ROR, 1.07; 95% CI, 0.64–1.80). Within individual trials, ustekinumab showed a trend toward great-er efficacy in TNF-exposed patients, whereas selective IL-23 antagonists performed similarly regardless of TNF exposure history.
Secondary analyses of endoscopic improvement yielded results consistent with the primary endpoint. Statistical heterogeneity across trials was minimal, and all included studies were rated at low risk of bias.
The investigators noted several limitations. For example, therapies were grouped broadly by mechanism of action, although specific biologic effects could potentially differ within groups. The analysis also could not account for patients who had failed two or more classes of advanced therapy, which may independently reduce the likelihood of response.
Still, Lee and colleagues suggested that the findings deserve a closer look.
“[T]here is significant heterogeneity of treatment efficacy for induction of remission with different advanced therapies in patients with moderate-severe UC based on prior exposure to TNF antagonists,” they concluded. “Future studies on the mechanistic insight for these intriguing observations are warranted.”
The study was supported by the Leona and Harry B. Helmsley Trust, the National Institutes of Health, and the Centers for Disease Control and Prevention. The investigators disclosed relationships with AbbVie, Ferring, Pfizer, and others.
, based on results of a large meta-analysis.
Patients previously treated with TNF antagonists were less likely to respond to lymphocyte trafficking inhibitors but more likely to achieve remission on Janus kinase (JAK) inhibitors, Han Hee Lee, MD, PhD, of the University of California San Diego, and colleagues reported.
“Treatment options for patients with moderate-severe ulcerative colitis have increased in the last decade with the availability of six different classes of medications,” investigators wrote in Clinical Gastroenterology and Hepatology (2024 Dec. doi:10.1016/j.cgh.2024.12.007). “There is wide interindividual variability in response to specific medications, and drivers of this heterogeneity are critical to understand to be able to choose the best therapy for each individual patient.”
To learn more about the impacts of anti-TNF exposure on subsequent advanced therapies, the investigators conducted a systematic review and meta-analysis of 17 phase 2 and 3 trials. The dataset included 8,871 adults with moderate-severe UC.
The primary outcome was induction of clinical remission at 6–14 weeks, most often defined as a Mayo Clinic score of 2 or lower with no subscore greater than 1. Endoscopic improvement, generally defined as a Mayo endoscopic subscore of 0 or 1, was evaluated as a secondary endpoint.
Advanced therapies were grouped by mechanism of action, including lymphocyte trafficking inhibitors, JAK inhibitors, and interleukin (IL)-12/23 and IL-23 antagonists. Odds ratios for treatment versus placebo were calculated separately for each subgroup, and a ratio of odds ratios was then used to assess whether prior TNF exposure modified drug effect. Analyses were conducted on an intention-to-treat basis, restricted to approved dosing when multiple regimens were tested.
Across five trials of lymphocyte trafficking inhibitors including 2,046 patients, efficacy was significantly greater in TNF-naïve patients compared with those who had prior TNF exposure. The odds of achieving clinical remission were nearly doubled in the TNF-naïve group (ratio of odds ratios [ROR], 1.88; 95% CI, 1.02–3.49).
In six trials of JAK inhibitors including 3,015 patients, remission rates were higher among TNF-exposed patients com-pared with TNF-naïve patients (ROR, 0.47; 95% CI, 0.22–1.01).
In six trials of IL-12/23 and IL-23 antagonists, including 3,810 patients, prior TNF exposure did not significantly modify treatment outcomes (ROR, 1.07; 95% CI, 0.64–1.80). Within individual trials, ustekinumab showed a trend toward great-er efficacy in TNF-exposed patients, whereas selective IL-23 antagonists performed similarly regardless of TNF exposure history.
Secondary analyses of endoscopic improvement yielded results consistent with the primary endpoint. Statistical heterogeneity across trials was minimal, and all included studies were rated at low risk of bias.
The investigators noted several limitations. For example, therapies were grouped broadly by mechanism of action, although specific biologic effects could potentially differ within groups. The analysis also could not account for patients who had failed two or more classes of advanced therapy, which may independently reduce the likelihood of response.
Still, Lee and colleagues suggested that the findings deserve a closer look.
“[T]here is significant heterogeneity of treatment efficacy for induction of remission with different advanced therapies in patients with moderate-severe UC based on prior exposure to TNF antagonists,” they concluded. “Future studies on the mechanistic insight for these intriguing observations are warranted.”
The study was supported by the Leona and Harry B. Helmsley Trust, the National Institutes of Health, and the Centers for Disease Control and Prevention. The investigators disclosed relationships with AbbVie, Ferring, Pfizer, and others.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Making Surgery Safer for Patients With Cirrhosis
, according to an updated guideline from the American College of Gastroenterology.
Procedures such as cholecystectomy and hernia repair can be safely performed if precautions are taken, but surgical decision-making in patients with cirrhosis calls for a nuanced approach that takes into account several factors, including severity of liver disease, nonhepatic comorbidities, and procedure-specific considerations, wrote lead author Nadim Mahmud, MD, assistant professor of medicine and epidemiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, in the American Journal of Gastroenterology.
“Patients with cirrhosis face substantially higher risks from surgery than those without liver disease, and careful guidance and risk stratification are essential,” Mahmud told GI & Hepatology News.
“At the same time, more patients are living longer with cirrhosis and increasingly require nonhepatic surgeries. Clinicians need up-to-date, practical recommendations that go beyond liver scores alone by integrating liver disease severity, comorbidities, and procedure-specific risk,” Mahmud said. The new guideline provides a comprehensive framework to help ensure that patients with cirrhosis undergo necessary operations, while managing preventable complications, he explained.
The guideline includes four recommendations for preoperative care, of which three are conditional and one is strong. The strong recommendation calls for the use of thrombopoietin receptor agonists, dosed according to baseline platelet count, in patients with cirrhosis and severe thrombocytopenia who are undergoing invasive procedures to reduce the need for perioperative transfusions and potentially reduce the risk for periprocedural bleeding.
Three conditional recommendations:
- For patients with compensated cirrhosis and unclear presence of clinically significant portal hypertension (CSPH), preoperative liver stiffness measurement and platelet count assessment are recommended to determine whether CSPH is present due to increased perioperative risks associated with the condition. Cross-sectional imaging should be conducted to identify portosystemic collaterals and complications of portal hypertension.
- For patients with cirrhosis and CSPH with alternative indications for transjugular intrahepatic portosystemic shunt (TIPS), such as large varices or refractory ascites, preoperative TIPS is suggested to reduce postoperative morbidity and mortality attributable to portal hypertension.
- For patients with cirrhosis undergoing major hepatic surgery, referral to a high-volume liver surgery or transplant center, when feasible, is recommended.
The guideline also advises on 26 key concepts, including nutrition, alcohol and tobacco use, comorbidities such as frailty and sarcopenia, and preoperative treatment of liver disease drivers such as hepatitis B, hepatitis C, and autoimmune hepatitis.
What’s New and Notable?
New elements of the guideline include use of cirrhosis-specific risk calculators, especially the Veterans Outcomes and Costs Associated with Liver disease (VOCAL)-Penn Score, to estimate operative risk and facilitate shared decision-making regarding surgery. The VOCAL-Penn Score, developed by Mahmud and colleagues at the University of Pennsylvania, incorporates surgery type and has shown superiority to older tools that often overestimate risk, Mahmud told GI & Hepatology News.
The guideline highlights standardized assessment of portal hypertension using noninvasive liver stiffness measurement plus platelet count and imaging, Mahmud said. “The guideline also underscores the importance of considering liver transplant evaluation before surgery in higher-risk patients,” he noted.
Clinicians will find clear recommendations on optimizing the perioperative period through nutritional support and structured prehabilitation, as well as the use of viscoelastic testing to guide transfusion decisions and the use of thrombopoietin-receptor agonists for severe thrombocytopenia, he added.
“Importantly, in carefully selected patients with significant portal hypertension, a preoperative transjugular intrahepatic portosystemic shunt may be reasonable, though it is not recommended broadly,” Mahmud said. “Finally, procedure-specific guidance, such as elective hernia repair after ascites control, laparoscopic cholecystectomy in well-compensated cirrhosis, and sleeve gastrectomy as the bariatric procedure of choice, helps translate risk into action,” he said.
These elements address key challenges in managing perioperative risk in patients with cirrhosis, namely miscalibrated risk estimates, inconsistent portal hypertension assessment, hemostasis management, and wide variation in practice, Mahmud noted.
Tackling Clinical Challenges
The new guideline collates the latest evidence and assessment tools to provide practical advice for clinicians to not only estimate risk but also better prepare patients with cirrhosis for surgical procedures, Peter D. Block, MD, assistant professor of medicine in the section of digestive diseases at the Yale School of Medicine, New Haven, Connecticut, told GI & Hepatology News.
“The larger and more invasive the operation, the higher the risk,” said Block, who was not involved in writing the guideline. Surgeries associated with the highest risk for patients with cirrhosis include major open abdominal operations, chest or cardiothoracic surgery, and major vascular surgeries, as well as emergency operations, for which there is less time to optimize any liver-related problems in advance, he said.
“Cirrhosis affects clotting, fluid balance, immunity, kidney function, and medication clearance, and each of these factors influence surgical risk,” Block said. “The guideline recommends combining liver-specific risk assessment scores with surgery-specific factors and clinical judgement, rather than relying on a single test,” he noted.
For elective surgeries, “the guideline provides practical pathways for when and how to optimize first, and when surgery must proceed despite higher risk,” he said.
The guideline was supported by the American College of Gastroenterology. Mahmud disclosed receiving research support from the National Institute of Diabetes and Digestive and Kidney Diseases and investigator-initiated research funding from Grifols, unrelated to the guideline. Block had no financial conflicts to disclose.
A version of this article appeared on Medscape.com
, according to an updated guideline from the American College of Gastroenterology.
Procedures such as cholecystectomy and hernia repair can be safely performed if precautions are taken, but surgical decision-making in patients with cirrhosis calls for a nuanced approach that takes into account several factors, including severity of liver disease, nonhepatic comorbidities, and procedure-specific considerations, wrote lead author Nadim Mahmud, MD, assistant professor of medicine and epidemiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, in the American Journal of Gastroenterology.
“Patients with cirrhosis face substantially higher risks from surgery than those without liver disease, and careful guidance and risk stratification are essential,” Mahmud told GI & Hepatology News.
“At the same time, more patients are living longer with cirrhosis and increasingly require nonhepatic surgeries. Clinicians need up-to-date, practical recommendations that go beyond liver scores alone by integrating liver disease severity, comorbidities, and procedure-specific risk,” Mahmud said. The new guideline provides a comprehensive framework to help ensure that patients with cirrhosis undergo necessary operations, while managing preventable complications, he explained.
The guideline includes four recommendations for preoperative care, of which three are conditional and one is strong. The strong recommendation calls for the use of thrombopoietin receptor agonists, dosed according to baseline platelet count, in patients with cirrhosis and severe thrombocytopenia who are undergoing invasive procedures to reduce the need for perioperative transfusions and potentially reduce the risk for periprocedural bleeding.
Three conditional recommendations:
- For patients with compensated cirrhosis and unclear presence of clinically significant portal hypertension (CSPH), preoperative liver stiffness measurement and platelet count assessment are recommended to determine whether CSPH is present due to increased perioperative risks associated with the condition. Cross-sectional imaging should be conducted to identify portosystemic collaterals and complications of portal hypertension.
- For patients with cirrhosis and CSPH with alternative indications for transjugular intrahepatic portosystemic shunt (TIPS), such as large varices or refractory ascites, preoperative TIPS is suggested to reduce postoperative morbidity and mortality attributable to portal hypertension.
- For patients with cirrhosis undergoing major hepatic surgery, referral to a high-volume liver surgery or transplant center, when feasible, is recommended.
The guideline also advises on 26 key concepts, including nutrition, alcohol and tobacco use, comorbidities such as frailty and sarcopenia, and preoperative treatment of liver disease drivers such as hepatitis B, hepatitis C, and autoimmune hepatitis.
What’s New and Notable?
New elements of the guideline include use of cirrhosis-specific risk calculators, especially the Veterans Outcomes and Costs Associated with Liver disease (VOCAL)-Penn Score, to estimate operative risk and facilitate shared decision-making regarding surgery. The VOCAL-Penn Score, developed by Mahmud and colleagues at the University of Pennsylvania, incorporates surgery type and has shown superiority to older tools that often overestimate risk, Mahmud told GI & Hepatology News.
The guideline highlights standardized assessment of portal hypertension using noninvasive liver stiffness measurement plus platelet count and imaging, Mahmud said. “The guideline also underscores the importance of considering liver transplant evaluation before surgery in higher-risk patients,” he noted.
Clinicians will find clear recommendations on optimizing the perioperative period through nutritional support and structured prehabilitation, as well as the use of viscoelastic testing to guide transfusion decisions and the use of thrombopoietin-receptor agonists for severe thrombocytopenia, he added.
“Importantly, in carefully selected patients with significant portal hypertension, a preoperative transjugular intrahepatic portosystemic shunt may be reasonable, though it is not recommended broadly,” Mahmud said. “Finally, procedure-specific guidance, such as elective hernia repair after ascites control, laparoscopic cholecystectomy in well-compensated cirrhosis, and sleeve gastrectomy as the bariatric procedure of choice, helps translate risk into action,” he said.
These elements address key challenges in managing perioperative risk in patients with cirrhosis, namely miscalibrated risk estimates, inconsistent portal hypertension assessment, hemostasis management, and wide variation in practice, Mahmud noted.
Tackling Clinical Challenges
The new guideline collates the latest evidence and assessment tools to provide practical advice for clinicians to not only estimate risk but also better prepare patients with cirrhosis for surgical procedures, Peter D. Block, MD, assistant professor of medicine in the section of digestive diseases at the Yale School of Medicine, New Haven, Connecticut, told GI & Hepatology News.
“The larger and more invasive the operation, the higher the risk,” said Block, who was not involved in writing the guideline. Surgeries associated with the highest risk for patients with cirrhosis include major open abdominal operations, chest or cardiothoracic surgery, and major vascular surgeries, as well as emergency operations, for which there is less time to optimize any liver-related problems in advance, he said.
“Cirrhosis affects clotting, fluid balance, immunity, kidney function, and medication clearance, and each of these factors influence surgical risk,” Block said. “The guideline recommends combining liver-specific risk assessment scores with surgery-specific factors and clinical judgement, rather than relying on a single test,” he noted.
For elective surgeries, “the guideline provides practical pathways for when and how to optimize first, and when surgery must proceed despite higher risk,” he said.
The guideline was supported by the American College of Gastroenterology. Mahmud disclosed receiving research support from the National Institute of Diabetes and Digestive and Kidney Diseases and investigator-initiated research funding from Grifols, unrelated to the guideline. Block had no financial conflicts to disclose.
A version of this article appeared on Medscape.com
, according to an updated guideline from the American College of Gastroenterology.
Procedures such as cholecystectomy and hernia repair can be safely performed if precautions are taken, but surgical decision-making in patients with cirrhosis calls for a nuanced approach that takes into account several factors, including severity of liver disease, nonhepatic comorbidities, and procedure-specific considerations, wrote lead author Nadim Mahmud, MD, assistant professor of medicine and epidemiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, in the American Journal of Gastroenterology.
“Patients with cirrhosis face substantially higher risks from surgery than those without liver disease, and careful guidance and risk stratification are essential,” Mahmud told GI & Hepatology News.
“At the same time, more patients are living longer with cirrhosis and increasingly require nonhepatic surgeries. Clinicians need up-to-date, practical recommendations that go beyond liver scores alone by integrating liver disease severity, comorbidities, and procedure-specific risk,” Mahmud said. The new guideline provides a comprehensive framework to help ensure that patients with cirrhosis undergo necessary operations, while managing preventable complications, he explained.
The guideline includes four recommendations for preoperative care, of which three are conditional and one is strong. The strong recommendation calls for the use of thrombopoietin receptor agonists, dosed according to baseline platelet count, in patients with cirrhosis and severe thrombocytopenia who are undergoing invasive procedures to reduce the need for perioperative transfusions and potentially reduce the risk for periprocedural bleeding.
Three conditional recommendations:
- For patients with compensated cirrhosis and unclear presence of clinically significant portal hypertension (CSPH), preoperative liver stiffness measurement and platelet count assessment are recommended to determine whether CSPH is present due to increased perioperative risks associated with the condition. Cross-sectional imaging should be conducted to identify portosystemic collaterals and complications of portal hypertension.
- For patients with cirrhosis and CSPH with alternative indications for transjugular intrahepatic portosystemic shunt (TIPS), such as large varices or refractory ascites, preoperative TIPS is suggested to reduce postoperative morbidity and mortality attributable to portal hypertension.
- For patients with cirrhosis undergoing major hepatic surgery, referral to a high-volume liver surgery or transplant center, when feasible, is recommended.
The guideline also advises on 26 key concepts, including nutrition, alcohol and tobacco use, comorbidities such as frailty and sarcopenia, and preoperative treatment of liver disease drivers such as hepatitis B, hepatitis C, and autoimmune hepatitis.
What’s New and Notable?
New elements of the guideline include use of cirrhosis-specific risk calculators, especially the Veterans Outcomes and Costs Associated with Liver disease (VOCAL)-Penn Score, to estimate operative risk and facilitate shared decision-making regarding surgery. The VOCAL-Penn Score, developed by Mahmud and colleagues at the University of Pennsylvania, incorporates surgery type and has shown superiority to older tools that often overestimate risk, Mahmud told GI & Hepatology News.
The guideline highlights standardized assessment of portal hypertension using noninvasive liver stiffness measurement plus platelet count and imaging, Mahmud said. “The guideline also underscores the importance of considering liver transplant evaluation before surgery in higher-risk patients,” he noted.
Clinicians will find clear recommendations on optimizing the perioperative period through nutritional support and structured prehabilitation, as well as the use of viscoelastic testing to guide transfusion decisions and the use of thrombopoietin-receptor agonists for severe thrombocytopenia, he added.
“Importantly, in carefully selected patients with significant portal hypertension, a preoperative transjugular intrahepatic portosystemic shunt may be reasonable, though it is not recommended broadly,” Mahmud said. “Finally, procedure-specific guidance, such as elective hernia repair after ascites control, laparoscopic cholecystectomy in well-compensated cirrhosis, and sleeve gastrectomy as the bariatric procedure of choice, helps translate risk into action,” he said.
These elements address key challenges in managing perioperative risk in patients with cirrhosis, namely miscalibrated risk estimates, inconsistent portal hypertension assessment, hemostasis management, and wide variation in practice, Mahmud noted.
Tackling Clinical Challenges
The new guideline collates the latest evidence and assessment tools to provide practical advice for clinicians to not only estimate risk but also better prepare patients with cirrhosis for surgical procedures, Peter D. Block, MD, assistant professor of medicine in the section of digestive diseases at the Yale School of Medicine, New Haven, Connecticut, told GI & Hepatology News.
“The larger and more invasive the operation, the higher the risk,” said Block, who was not involved in writing the guideline. Surgeries associated with the highest risk for patients with cirrhosis include major open abdominal operations, chest or cardiothoracic surgery, and major vascular surgeries, as well as emergency operations, for which there is less time to optimize any liver-related problems in advance, he said.
“Cirrhosis affects clotting, fluid balance, immunity, kidney function, and medication clearance, and each of these factors influence surgical risk,” Block said. “The guideline recommends combining liver-specific risk assessment scores with surgery-specific factors and clinical judgement, rather than relying on a single test,” he noted.
For elective surgeries, “the guideline provides practical pathways for when and how to optimize first, and when surgery must proceed despite higher risk,” he said.
The guideline was supported by the American College of Gastroenterology. Mahmud disclosed receiving research support from the National Institute of Diabetes and Digestive and Kidney Diseases and investigator-initiated research funding from Grifols, unrelated to the guideline. Block had no financial conflicts to disclose.
A version of this article appeared on Medscape.com
Formula Type May Fuel NEC in Premature Infants
DENVER – , according to new data presented at the American Academy of Pediatrics (AAP) 2025 National Conference & Exhibition.
Necrotizing enterocolitis (NEC) can affect the intestinal wall of neonates, with potentially life-threatening results. The inflammatory condition is characterized by feeding intolerance, rectal bleeding, and bowel perforations, said presenting author Puja Kulkarni, medical student at California Northstate University College of Medicine, Elk Grove, California, and colleagues.
The etiology of NEC remains unclear, but previous research suggests that formula feeding may play a role, the researchers said. “NEC remains a leading cause of morbidity and mortality in premature infants, yet there is still no clear consensus on the optimal feeding strategy to reduce risk,” Kulkarni said in an interview with GI & Hepatology News.
Most hospital guidelines call for solely using SPFs in NICUs, especially in cases where maternal breast milk is not available, said Kulkarni. Therefore, “it was critical to investigate whether different types of formula, such as extensively hydrolyzed formula, could influence the incidence of NEC,” she said.
Kulkarni and colleagues conducted a literature search and identified three randomized, controlled trials that compared eHFs to SPFs in a study population of 1180 premature infants.
Overall, infants who received SPFs had a significantly greater risk for both NEC and feeding intolerance than those who received eHFs, with odds ratios of 2.54 and 2.87, respectively, and these associations remained after a sensitivity analysis.
Other research, such as the German Infant Nutritional Intervention (GINI) study, has shown similar results regarding the effect of formula type on childhood pathologies, Kulkarni noted. The GINI study showed that HFs can help prevent the development of allergic diseases in children with a family history of allergies, she said.
The results of the current analysis suggest a significantly increased risk for NEC, as well as feeding intolerance, which can be a precursor to NEC, in premature infants fed SPFs compared to those fed eHFs, said Kulkarni. “If validated by further research, this could lead to changes in NICU feeding protocols, especially in situations where donor breast milk is not available. Clinicians may want to consider the type of protein in formula as an important factor in NEC prevention,” she said. The current findings support the need for more research into the effects of formula throughout the infant and childhood years.
Additional studies are needed to validate the findings in larger, multicenter cohorts to ensure generalizability, especially in the US, where current guidelines favor SPFs based on limited data, said Kulkarni. Much of the research in the US has been conducted by the formula companies themselves, and she and her colleagues took this risk for bias into account in their meta-analysis.
Younger Babies at Greater Risk
Documented rates of NEC have remained stable or decreased slightly over the past 20 years, which supports the need for research on prevention and early identification, as well as effective medical treatment, said Catherine Haut, DNP, CPNP-AC/PC, in an interview.
“With improved neonatal intensive care, younger neonates are surviving, but these babies also have a higher risk of development of NEC,” said Haut, director of nursing research and evidence-based practice at Nemours Children’s Health, Delaware, New Jersey, who was not involved in the study.
“Historically, NEC has been related to feeding, among other variables, but the use of more specific or standardized feeding methods including increased use of human milk in very low-birth weight infants has resulted in better outcomes,” she said.
The finding from the current meta-analysis that the use of SPFs poses a higher risk for NEC than the use of eHFs was not unexpected, Haut told GI & Hepatology News. Some infants are allergic to cow’s milk, and replacing this type of formula with eHF is the recommended treatment as these formulas incorporate proteins which are more easily digested, she said.
Systematic reviews and meta-analyses are considered high levels of evidence, and the current study’s documentation of the benefits of eHF could help decrease the rate of NEC in premature infants, Haut said. “Despite a higher cost associated with eHF, in formula-fed preterm neonates, there would be benefit to using eHF vs risk of standard protein formulas,” she said.
However, the current study represents a very small population compared to the total number of infants born at less than 37 weeks’ gestation, which is reported to be 10% of all newborns in the US each year, Haut noted.
Additional large studies, including randomized control trials, are needed to further document the effects of using eHF in very young premature infants and potentially help reduce the incidence of NEC in this population, she said.
The study received no outside funding. The researchers and Haut had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
DENVER – , according to new data presented at the American Academy of Pediatrics (AAP) 2025 National Conference & Exhibition.
Necrotizing enterocolitis (NEC) can affect the intestinal wall of neonates, with potentially life-threatening results. The inflammatory condition is characterized by feeding intolerance, rectal bleeding, and bowel perforations, said presenting author Puja Kulkarni, medical student at California Northstate University College of Medicine, Elk Grove, California, and colleagues.
The etiology of NEC remains unclear, but previous research suggests that formula feeding may play a role, the researchers said. “NEC remains a leading cause of morbidity and mortality in premature infants, yet there is still no clear consensus on the optimal feeding strategy to reduce risk,” Kulkarni said in an interview with GI & Hepatology News.
Most hospital guidelines call for solely using SPFs in NICUs, especially in cases where maternal breast milk is not available, said Kulkarni. Therefore, “it was critical to investigate whether different types of formula, such as extensively hydrolyzed formula, could influence the incidence of NEC,” she said.
Kulkarni and colleagues conducted a literature search and identified three randomized, controlled trials that compared eHFs to SPFs in a study population of 1180 premature infants.
Overall, infants who received SPFs had a significantly greater risk for both NEC and feeding intolerance than those who received eHFs, with odds ratios of 2.54 and 2.87, respectively, and these associations remained after a sensitivity analysis.
Other research, such as the German Infant Nutritional Intervention (GINI) study, has shown similar results regarding the effect of formula type on childhood pathologies, Kulkarni noted. The GINI study showed that HFs can help prevent the development of allergic diseases in children with a family history of allergies, she said.
The results of the current analysis suggest a significantly increased risk for NEC, as well as feeding intolerance, which can be a precursor to NEC, in premature infants fed SPFs compared to those fed eHFs, said Kulkarni. “If validated by further research, this could lead to changes in NICU feeding protocols, especially in situations where donor breast milk is not available. Clinicians may want to consider the type of protein in formula as an important factor in NEC prevention,” she said. The current findings support the need for more research into the effects of formula throughout the infant and childhood years.
Additional studies are needed to validate the findings in larger, multicenter cohorts to ensure generalizability, especially in the US, where current guidelines favor SPFs based on limited data, said Kulkarni. Much of the research in the US has been conducted by the formula companies themselves, and she and her colleagues took this risk for bias into account in their meta-analysis.
Younger Babies at Greater Risk
Documented rates of NEC have remained stable or decreased slightly over the past 20 years, which supports the need for research on prevention and early identification, as well as effective medical treatment, said Catherine Haut, DNP, CPNP-AC/PC, in an interview.
“With improved neonatal intensive care, younger neonates are surviving, but these babies also have a higher risk of development of NEC,” said Haut, director of nursing research and evidence-based practice at Nemours Children’s Health, Delaware, New Jersey, who was not involved in the study.
“Historically, NEC has been related to feeding, among other variables, but the use of more specific or standardized feeding methods including increased use of human milk in very low-birth weight infants has resulted in better outcomes,” she said.
The finding from the current meta-analysis that the use of SPFs poses a higher risk for NEC than the use of eHFs was not unexpected, Haut told GI & Hepatology News. Some infants are allergic to cow’s milk, and replacing this type of formula with eHF is the recommended treatment as these formulas incorporate proteins which are more easily digested, she said.
Systematic reviews and meta-analyses are considered high levels of evidence, and the current study’s documentation of the benefits of eHF could help decrease the rate of NEC in premature infants, Haut said. “Despite a higher cost associated with eHF, in formula-fed preterm neonates, there would be benefit to using eHF vs risk of standard protein formulas,” she said.
However, the current study represents a very small population compared to the total number of infants born at less than 37 weeks’ gestation, which is reported to be 10% of all newborns in the US each year, Haut noted.
Additional large studies, including randomized control trials, are needed to further document the effects of using eHF in very young premature infants and potentially help reduce the incidence of NEC in this population, she said.
The study received no outside funding. The researchers and Haut had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
DENVER – , according to new data presented at the American Academy of Pediatrics (AAP) 2025 National Conference & Exhibition.
Necrotizing enterocolitis (NEC) can affect the intestinal wall of neonates, with potentially life-threatening results. The inflammatory condition is characterized by feeding intolerance, rectal bleeding, and bowel perforations, said presenting author Puja Kulkarni, medical student at California Northstate University College of Medicine, Elk Grove, California, and colleagues.
The etiology of NEC remains unclear, but previous research suggests that formula feeding may play a role, the researchers said. “NEC remains a leading cause of morbidity and mortality in premature infants, yet there is still no clear consensus on the optimal feeding strategy to reduce risk,” Kulkarni said in an interview with GI & Hepatology News.
Most hospital guidelines call for solely using SPFs in NICUs, especially in cases where maternal breast milk is not available, said Kulkarni. Therefore, “it was critical to investigate whether different types of formula, such as extensively hydrolyzed formula, could influence the incidence of NEC,” she said.
Kulkarni and colleagues conducted a literature search and identified three randomized, controlled trials that compared eHFs to SPFs in a study population of 1180 premature infants.
Overall, infants who received SPFs had a significantly greater risk for both NEC and feeding intolerance than those who received eHFs, with odds ratios of 2.54 and 2.87, respectively, and these associations remained after a sensitivity analysis.
Other research, such as the German Infant Nutritional Intervention (GINI) study, has shown similar results regarding the effect of formula type on childhood pathologies, Kulkarni noted. The GINI study showed that HFs can help prevent the development of allergic diseases in children with a family history of allergies, she said.
The results of the current analysis suggest a significantly increased risk for NEC, as well as feeding intolerance, which can be a precursor to NEC, in premature infants fed SPFs compared to those fed eHFs, said Kulkarni. “If validated by further research, this could lead to changes in NICU feeding protocols, especially in situations where donor breast milk is not available. Clinicians may want to consider the type of protein in formula as an important factor in NEC prevention,” she said. The current findings support the need for more research into the effects of formula throughout the infant and childhood years.
Additional studies are needed to validate the findings in larger, multicenter cohorts to ensure generalizability, especially in the US, where current guidelines favor SPFs based on limited data, said Kulkarni. Much of the research in the US has been conducted by the formula companies themselves, and she and her colleagues took this risk for bias into account in their meta-analysis.
Younger Babies at Greater Risk
Documented rates of NEC have remained stable or decreased slightly over the past 20 years, which supports the need for research on prevention and early identification, as well as effective medical treatment, said Catherine Haut, DNP, CPNP-AC/PC, in an interview.
“With improved neonatal intensive care, younger neonates are surviving, but these babies also have a higher risk of development of NEC,” said Haut, director of nursing research and evidence-based practice at Nemours Children’s Health, Delaware, New Jersey, who was not involved in the study.
“Historically, NEC has been related to feeding, among other variables, but the use of more specific or standardized feeding methods including increased use of human milk in very low-birth weight infants has resulted in better outcomes,” she said.
The finding from the current meta-analysis that the use of SPFs poses a higher risk for NEC than the use of eHFs was not unexpected, Haut told GI & Hepatology News. Some infants are allergic to cow’s milk, and replacing this type of formula with eHF is the recommended treatment as these formulas incorporate proteins which are more easily digested, she said.
Systematic reviews and meta-analyses are considered high levels of evidence, and the current study’s documentation of the benefits of eHF could help decrease the rate of NEC in premature infants, Haut said. “Despite a higher cost associated with eHF, in formula-fed preterm neonates, there would be benefit to using eHF vs risk of standard protein formulas,” she said.
However, the current study represents a very small population compared to the total number of infants born at less than 37 weeks’ gestation, which is reported to be 10% of all newborns in the US each year, Haut noted.
Additional large studies, including randomized control trials, are needed to further document the effects of using eHF in very young premature infants and potentially help reduce the incidence of NEC in this population, she said.
The study received no outside funding. The researchers and Haut had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.