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Housing Program Expansion Opens Doors to More Veterans
TOPLINE:Expanding United States Department of Housing and Urban Development-Veterans Affairs Supportive Housing (HUD-VASH) eligibility to veterans with other-than-honorable (OTH) discharge significantly increased their program enrollments without impacting services for those with honorable discharge. Emergency department visits increased for honorable discharge veterans while hospitalizations rose for both groups.
METHODOLOGY:
- A quality improvement study following SQUIRE 2.0 reporting guidelines analyzed data from 129,873 veterans enrolled in HUD-VASH between June 1, 2019, and September 30, 2021.
- Analysis included 127,876 veterans (98.5%) with honorable/general discharge and 1997 veterans (1.5%) with OTH discharge, with a mean age of 53.7 years.
- Researchers utilized an interrupted time series design to compare program enrollments and healthcare utilization before (June 2019-December 2020) and after (January 2021-September 2021) policy implementation.
- Data linkage between the Homeless Operations and Management Evaluation System database and VA Corporate Data Warehouse enabled tracking of emergency department visits, hospitalizations, and primary care visits.
TAKEAWAY:
- Monthly HUD-VASH enrollments showed a significant increase for OTH veterans after the policy change (difference in slopes, 1.90; 95% confidence interval [CI], 1.28-2.52), while honorable/general veterans experienced a non-significant increase (difference in slopes, 9.23; 95% CI, −20.35-38.79).
- Emergency department visits demonstrated a significant increase for honorable/general veterans (change in slope, 0.24; 95% CI, 0.12-0.35) but not for OTH veterans (change in slope, 0.08;
95% CI, −0.12-0.28). - Hospitalizations significantly increased for both OTH veterans (change in slope, 0.098; 95% CI, 0.009-0.170) and honorable/general veterans (change in slope, 0.078; 95% CI, 0.004-0.060).
- Primary care visits showed no significant changes for either group after the policy implementation (OTH: change in slope, −0.12; 95% CI, −0.65-0.42; honorable/general: change in slope, 0.20;
95% CI, −0.13-0.53).
IN PRACTICE:“Expanding HUD-VASH eligibility increased access to housing and social support for OTH veterans without disrupting services for those with honorable discharges,” the authors reported. “Efforts should focus on improving access to connecting OTH veterans with clinical services outside of HUD-VASH.”
SOURCE:The study was led by Thomas F. Nubong, MD, Center of Innovation for Long-Term Services and Supports, Providence Veterans Affairs Medical Center in Providence. It was published online on August 5 in JAMA Network Open.
LIMITATIONS: According to the authors, the study period overlapped with the COVID-19 pandemic, potentially affecting results. Additionally, staff training on the policy change varied across US Department of Veterans Affairs (VA) sites, introducing implementation inconsistencies. The single-group interrupted time series design, while effective for tracking temporal trends, limited formal comparisons between discharge groups.
DISCLOSURES: The analyses were conducted under the VA Homeless Programs Office with operational funding support. Jack Tsai, PhD, and Eric Jutkowitz, PhD, reported being principal investigators of a VA Merit study on the Impact of COVID-19 for the HUD-VASH program. James L. Rudolph, MD, reported receiving grants from Icosavax outside the submitted work and being a United States government employee.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE:Expanding United States Department of Housing and Urban Development-Veterans Affairs Supportive Housing (HUD-VASH) eligibility to veterans with other-than-honorable (OTH) discharge significantly increased their program enrollments without impacting services for those with honorable discharge. Emergency department visits increased for honorable discharge veterans while hospitalizations rose for both groups.
METHODOLOGY:
- A quality improvement study following SQUIRE 2.0 reporting guidelines analyzed data from 129,873 veterans enrolled in HUD-VASH between June 1, 2019, and September 30, 2021.
- Analysis included 127,876 veterans (98.5%) with honorable/general discharge and 1997 veterans (1.5%) with OTH discharge, with a mean age of 53.7 years.
- Researchers utilized an interrupted time series design to compare program enrollments and healthcare utilization before (June 2019-December 2020) and after (January 2021-September 2021) policy implementation.
- Data linkage between the Homeless Operations and Management Evaluation System database and VA Corporate Data Warehouse enabled tracking of emergency department visits, hospitalizations, and primary care visits.
TAKEAWAY:
- Monthly HUD-VASH enrollments showed a significant increase for OTH veterans after the policy change (difference in slopes, 1.90; 95% confidence interval [CI], 1.28-2.52), while honorable/general veterans experienced a non-significant increase (difference in slopes, 9.23; 95% CI, −20.35-38.79).
- Emergency department visits demonstrated a significant increase for honorable/general veterans (change in slope, 0.24; 95% CI, 0.12-0.35) but not for OTH veterans (change in slope, 0.08;
95% CI, −0.12-0.28). - Hospitalizations significantly increased for both OTH veterans (change in slope, 0.098; 95% CI, 0.009-0.170) and honorable/general veterans (change in slope, 0.078; 95% CI, 0.004-0.060).
- Primary care visits showed no significant changes for either group after the policy implementation (OTH: change in slope, −0.12; 95% CI, −0.65-0.42; honorable/general: change in slope, 0.20;
95% CI, −0.13-0.53).
IN PRACTICE:“Expanding HUD-VASH eligibility increased access to housing and social support for OTH veterans without disrupting services for those with honorable discharges,” the authors reported. “Efforts should focus on improving access to connecting OTH veterans with clinical services outside of HUD-VASH.”
SOURCE:The study was led by Thomas F. Nubong, MD, Center of Innovation for Long-Term Services and Supports, Providence Veterans Affairs Medical Center in Providence. It was published online on August 5 in JAMA Network Open.
LIMITATIONS: According to the authors, the study period overlapped with the COVID-19 pandemic, potentially affecting results. Additionally, staff training on the policy change varied across US Department of Veterans Affairs (VA) sites, introducing implementation inconsistencies. The single-group interrupted time series design, while effective for tracking temporal trends, limited formal comparisons between discharge groups.
DISCLOSURES: The analyses were conducted under the VA Homeless Programs Office with operational funding support. Jack Tsai, PhD, and Eric Jutkowitz, PhD, reported being principal investigators of a VA Merit study on the Impact of COVID-19 for the HUD-VASH program. James L. Rudolph, MD, reported receiving grants from Icosavax outside the submitted work and being a United States government employee.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE:Expanding United States Department of Housing and Urban Development-Veterans Affairs Supportive Housing (HUD-VASH) eligibility to veterans with other-than-honorable (OTH) discharge significantly increased their program enrollments without impacting services for those with honorable discharge. Emergency department visits increased for honorable discharge veterans while hospitalizations rose for both groups.
METHODOLOGY:
- A quality improvement study following SQUIRE 2.0 reporting guidelines analyzed data from 129,873 veterans enrolled in HUD-VASH between June 1, 2019, and September 30, 2021.
- Analysis included 127,876 veterans (98.5%) with honorable/general discharge and 1997 veterans (1.5%) with OTH discharge, with a mean age of 53.7 years.
- Researchers utilized an interrupted time series design to compare program enrollments and healthcare utilization before (June 2019-December 2020) and after (January 2021-September 2021) policy implementation.
- Data linkage between the Homeless Operations and Management Evaluation System database and VA Corporate Data Warehouse enabled tracking of emergency department visits, hospitalizations, and primary care visits.
TAKEAWAY:
- Monthly HUD-VASH enrollments showed a significant increase for OTH veterans after the policy change (difference in slopes, 1.90; 95% confidence interval [CI], 1.28-2.52), while honorable/general veterans experienced a non-significant increase (difference in slopes, 9.23; 95% CI, −20.35-38.79).
- Emergency department visits demonstrated a significant increase for honorable/general veterans (change in slope, 0.24; 95% CI, 0.12-0.35) but not for OTH veterans (change in slope, 0.08;
95% CI, −0.12-0.28). - Hospitalizations significantly increased for both OTH veterans (change in slope, 0.098; 95% CI, 0.009-0.170) and honorable/general veterans (change in slope, 0.078; 95% CI, 0.004-0.060).
- Primary care visits showed no significant changes for either group after the policy implementation (OTH: change in slope, −0.12; 95% CI, −0.65-0.42; honorable/general: change in slope, 0.20;
95% CI, −0.13-0.53).
IN PRACTICE:“Expanding HUD-VASH eligibility increased access to housing and social support for OTH veterans without disrupting services for those with honorable discharges,” the authors reported. “Efforts should focus on improving access to connecting OTH veterans with clinical services outside of HUD-VASH.”
SOURCE:The study was led by Thomas F. Nubong, MD, Center of Innovation for Long-Term Services and Supports, Providence Veterans Affairs Medical Center in Providence. It was published online on August 5 in JAMA Network Open.
LIMITATIONS: According to the authors, the study period overlapped with the COVID-19 pandemic, potentially affecting results. Additionally, staff training on the policy change varied across US Department of Veterans Affairs (VA) sites, introducing implementation inconsistencies. The single-group interrupted time series design, while effective for tracking temporal trends, limited formal comparisons between discharge groups.
DISCLOSURES: The analyses were conducted under the VA Homeless Programs Office with operational funding support. Jack Tsai, PhD, and Eric Jutkowitz, PhD, reported being principal investigators of a VA Merit study on the Impact of COVID-19 for the HUD-VASH program. James L. Rudolph, MD, reported receiving grants from Icosavax outside the submitted work and being a United States government employee.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Critical Access for Veterans Bill Would Undermine VA Care
The Critical Access for Veterans Care Act, S.1868, introduced in May by Senators Kevin Cramer (R-ND) and Tim Sheehy (R-MT), would fundamentally reshape how veterans living in rural communities access private health care. The legislation establishes a new paradigm impacting veterans enrolled in US Department of Veterans Affairs (VA) health care who reside within 35 miles of any Centers for Medicare & Medicaid Services-designated Critical Access Hospital (CAH) or affiliated clinic. The bill would allow veterans unprecedented autonomy to self-refer directly to these facilities.
However, despite its seemingly straightforward title, the bill will not expedite care delivery, reduce travel burdens, or enhance network critical care capacity for veterans living in rural areas. Instead, the bill would further privatize veteran health care delivery by permitting veterans within this geographic radius to independently pursue care at CAHs and clinics without prior authorization. The legislation would establish a parallel referral system that erodes the Veterans Community Care Program (VCCP) eligibility determinations that were meticulously developed under the VA MISSION Act of 2018.
Some lawmakers have repeatedly pushed to eliminate VA's authorization role in the past 6 years, seeking to grant unrestricted private sector access to various veteran populations, particularly those requiring mental health services. Sponsors of the current bill are explicitly pursuing this same objective, characterizing VA authorization as an “unnecessary roadblock” that should be removed. However, this characterization misrepresents the actual function and value of the authorization process.
Over the past 6 years, provisions in the VA MISSION Act and other laws for predetermining veteran eligibility for private care have provided veterans with broad access while maintaining oversight and accountability. Enrolled veterans may receive comprehensive emergency medical and psychiatric care at any health care facility, including CAHs. They are guaranteed unrestricted walk-in urgent care access anywhere in the country. Veterans can also obtain outpatient and inpatient services through VCCP clinicians when they meet the following established access criteria: VA facilities exceed 30-minute travel times for primary and mental health services or 60 minutes for specialty care, or when appointment wait times surpass 20 days for primary/mental health care or 28 days for specialty services. Nearly half of covered veterans used this option in FY2023.
This bill does more than upend the established paradigm of VCCP eligibility requirements: it also eliminates the critical function of utilization review and accountability. Its passage would establish a dangerous precedent. By eliminating drive time and wait time eligibility standards and simultaneously removing VA’s ability to manage use, the bill generates powerful political momentum to extend identical provisions to all enrolled veterans. Furthermore, this legislation could specifically precipitate the downsizing or closure of VA community-based outpatient clinics (CBOCs) in areas served by CAHs. North Dakota, for example, operates 5 CBOCs that could be affected. Veterans who live in rural areas within the standard 30- to 60-minute drive time of a CBOC and can secure appointments within the established 20- to 28-day timeframes would no longer be subject to the same eligibility criteria that govern all covered veterans.
The Veterans Healthcare Policy Institute (VHPI) has serious reservations about legislation that eliminates VA's indispensable authorization and referral functions for supplemental private care. Founded in 2016, the VHPI is a nonprofit, nonpartisan organization dedicated to analyzing health care, disability compensation, and benefits for US veterans and their families. It provides fact-based research to educate the public and improve care quality both within and outside the VA.
New initiatives threaten to drastically reduce veterans' health and disability benefits through staff cuts and service reductions that will limit access to earned benefits and life-sustaining health care. Attacks against the VA also threaten to erode the training that produces new cohorts of health professionals, dramatically exacerbating the nation’s already dire shortages of physicians, nurses, psychologists and social workers.
VHPI’s coverage of Veterans Health Administration downsizing within rural health care provides important context. Starting with a comprehensive 15-page white paper published in 2024, VHPI has consistently highlighted how veterans living in rural communities face the same health care access challenges as all rural Americans—living in regions with severe shortages of health care facilities, professionals, and support staff. Lawmakers who assume veterans living in rural areas will experience shorter wait times and drive distances through private sector care fundamentally misunderstand these systemic issues
VHPI is committed to rigorously scrutinize policies that may compromise high quality care for veterans, especially those living in rural areas. The organization recently examined the flawed assumptions underlying these misguided policies. On August 12, VHPI released an in-depth analysis of private sector clinicians’ capacity to care for veterans in across all 50 states titled “Veterans’ Health Care Choice—Myth or Reality? A State- by- State Reality Check of the False Promise of VA Privatization.” This analysis revealed that, in most states, and in all rural states, the private sector system was struggling to meet even the basic needs of non-veterans. As one long time VA expert stated, to imagine that the system could absorb an influx of millions of veterans – particularly when new cuts to Medicaid and other healthcare funding are implemented, is “delusional.”
Russell Lemle and Suzanne Gordon are senior policy analysts at the Veterans Healthcare Policy Institute. Suzanne Gordon is author of Wounds of War.
The Critical Access for Veterans Care Act, S.1868, introduced in May by Senators Kevin Cramer (R-ND) and Tim Sheehy (R-MT), would fundamentally reshape how veterans living in rural communities access private health care. The legislation establishes a new paradigm impacting veterans enrolled in US Department of Veterans Affairs (VA) health care who reside within 35 miles of any Centers for Medicare & Medicaid Services-designated Critical Access Hospital (CAH) or affiliated clinic. The bill would allow veterans unprecedented autonomy to self-refer directly to these facilities.
However, despite its seemingly straightforward title, the bill will not expedite care delivery, reduce travel burdens, or enhance network critical care capacity for veterans living in rural areas. Instead, the bill would further privatize veteran health care delivery by permitting veterans within this geographic radius to independently pursue care at CAHs and clinics without prior authorization. The legislation would establish a parallel referral system that erodes the Veterans Community Care Program (VCCP) eligibility determinations that were meticulously developed under the VA MISSION Act of 2018.
Some lawmakers have repeatedly pushed to eliminate VA's authorization role in the past 6 years, seeking to grant unrestricted private sector access to various veteran populations, particularly those requiring mental health services. Sponsors of the current bill are explicitly pursuing this same objective, characterizing VA authorization as an “unnecessary roadblock” that should be removed. However, this characterization misrepresents the actual function and value of the authorization process.
Over the past 6 years, provisions in the VA MISSION Act and other laws for predetermining veteran eligibility for private care have provided veterans with broad access while maintaining oversight and accountability. Enrolled veterans may receive comprehensive emergency medical and psychiatric care at any health care facility, including CAHs. They are guaranteed unrestricted walk-in urgent care access anywhere in the country. Veterans can also obtain outpatient and inpatient services through VCCP clinicians when they meet the following established access criteria: VA facilities exceed 30-minute travel times for primary and mental health services or 60 minutes for specialty care, or when appointment wait times surpass 20 days for primary/mental health care or 28 days for specialty services. Nearly half of covered veterans used this option in FY2023.
This bill does more than upend the established paradigm of VCCP eligibility requirements: it also eliminates the critical function of utilization review and accountability. Its passage would establish a dangerous precedent. By eliminating drive time and wait time eligibility standards and simultaneously removing VA’s ability to manage use, the bill generates powerful political momentum to extend identical provisions to all enrolled veterans. Furthermore, this legislation could specifically precipitate the downsizing or closure of VA community-based outpatient clinics (CBOCs) in areas served by CAHs. North Dakota, for example, operates 5 CBOCs that could be affected. Veterans who live in rural areas within the standard 30- to 60-minute drive time of a CBOC and can secure appointments within the established 20- to 28-day timeframes would no longer be subject to the same eligibility criteria that govern all covered veterans.
The Veterans Healthcare Policy Institute (VHPI) has serious reservations about legislation that eliminates VA's indispensable authorization and referral functions for supplemental private care. Founded in 2016, the VHPI is a nonprofit, nonpartisan organization dedicated to analyzing health care, disability compensation, and benefits for US veterans and their families. It provides fact-based research to educate the public and improve care quality both within and outside the VA.
New initiatives threaten to drastically reduce veterans' health and disability benefits through staff cuts and service reductions that will limit access to earned benefits and life-sustaining health care. Attacks against the VA also threaten to erode the training that produces new cohorts of health professionals, dramatically exacerbating the nation’s already dire shortages of physicians, nurses, psychologists and social workers.
VHPI’s coverage of Veterans Health Administration downsizing within rural health care provides important context. Starting with a comprehensive 15-page white paper published in 2024, VHPI has consistently highlighted how veterans living in rural communities face the same health care access challenges as all rural Americans—living in regions with severe shortages of health care facilities, professionals, and support staff. Lawmakers who assume veterans living in rural areas will experience shorter wait times and drive distances through private sector care fundamentally misunderstand these systemic issues
VHPI is committed to rigorously scrutinize policies that may compromise high quality care for veterans, especially those living in rural areas. The organization recently examined the flawed assumptions underlying these misguided policies. On August 12, VHPI released an in-depth analysis of private sector clinicians’ capacity to care for veterans in across all 50 states titled “Veterans’ Health Care Choice—Myth or Reality? A State- by- State Reality Check of the False Promise of VA Privatization.” This analysis revealed that, in most states, and in all rural states, the private sector system was struggling to meet even the basic needs of non-veterans. As one long time VA expert stated, to imagine that the system could absorb an influx of millions of veterans – particularly when new cuts to Medicaid and other healthcare funding are implemented, is “delusional.”
Russell Lemle and Suzanne Gordon are senior policy analysts at the Veterans Healthcare Policy Institute. Suzanne Gordon is author of Wounds of War.
The Critical Access for Veterans Care Act, S.1868, introduced in May by Senators Kevin Cramer (R-ND) and Tim Sheehy (R-MT), would fundamentally reshape how veterans living in rural communities access private health care. The legislation establishes a new paradigm impacting veterans enrolled in US Department of Veterans Affairs (VA) health care who reside within 35 miles of any Centers for Medicare & Medicaid Services-designated Critical Access Hospital (CAH) or affiliated clinic. The bill would allow veterans unprecedented autonomy to self-refer directly to these facilities.
However, despite its seemingly straightforward title, the bill will not expedite care delivery, reduce travel burdens, or enhance network critical care capacity for veterans living in rural areas. Instead, the bill would further privatize veteran health care delivery by permitting veterans within this geographic radius to independently pursue care at CAHs and clinics without prior authorization. The legislation would establish a parallel referral system that erodes the Veterans Community Care Program (VCCP) eligibility determinations that were meticulously developed under the VA MISSION Act of 2018.
Some lawmakers have repeatedly pushed to eliminate VA's authorization role in the past 6 years, seeking to grant unrestricted private sector access to various veteran populations, particularly those requiring mental health services. Sponsors of the current bill are explicitly pursuing this same objective, characterizing VA authorization as an “unnecessary roadblock” that should be removed. However, this characterization misrepresents the actual function and value of the authorization process.
Over the past 6 years, provisions in the VA MISSION Act and other laws for predetermining veteran eligibility for private care have provided veterans with broad access while maintaining oversight and accountability. Enrolled veterans may receive comprehensive emergency medical and psychiatric care at any health care facility, including CAHs. They are guaranteed unrestricted walk-in urgent care access anywhere in the country. Veterans can also obtain outpatient and inpatient services through VCCP clinicians when they meet the following established access criteria: VA facilities exceed 30-minute travel times for primary and mental health services or 60 minutes for specialty care, or when appointment wait times surpass 20 days for primary/mental health care or 28 days for specialty services. Nearly half of covered veterans used this option in FY2023.
This bill does more than upend the established paradigm of VCCP eligibility requirements: it also eliminates the critical function of utilization review and accountability. Its passage would establish a dangerous precedent. By eliminating drive time and wait time eligibility standards and simultaneously removing VA’s ability to manage use, the bill generates powerful political momentum to extend identical provisions to all enrolled veterans. Furthermore, this legislation could specifically precipitate the downsizing or closure of VA community-based outpatient clinics (CBOCs) in areas served by CAHs. North Dakota, for example, operates 5 CBOCs that could be affected. Veterans who live in rural areas within the standard 30- to 60-minute drive time of a CBOC and can secure appointments within the established 20- to 28-day timeframes would no longer be subject to the same eligibility criteria that govern all covered veterans.
The Veterans Healthcare Policy Institute (VHPI) has serious reservations about legislation that eliminates VA's indispensable authorization and referral functions for supplemental private care. Founded in 2016, the VHPI is a nonprofit, nonpartisan organization dedicated to analyzing health care, disability compensation, and benefits for US veterans and their families. It provides fact-based research to educate the public and improve care quality both within and outside the VA.
New initiatives threaten to drastically reduce veterans' health and disability benefits through staff cuts and service reductions that will limit access to earned benefits and life-sustaining health care. Attacks against the VA also threaten to erode the training that produces new cohorts of health professionals, dramatically exacerbating the nation’s already dire shortages of physicians, nurses, psychologists and social workers.
VHPI’s coverage of Veterans Health Administration downsizing within rural health care provides important context. Starting with a comprehensive 15-page white paper published in 2024, VHPI has consistently highlighted how veterans living in rural communities face the same health care access challenges as all rural Americans—living in regions with severe shortages of health care facilities, professionals, and support staff. Lawmakers who assume veterans living in rural areas will experience shorter wait times and drive distances through private sector care fundamentally misunderstand these systemic issues
VHPI is committed to rigorously scrutinize policies that may compromise high quality care for veterans, especially those living in rural areas. The organization recently examined the flawed assumptions underlying these misguided policies. On August 12, VHPI released an in-depth analysis of private sector clinicians’ capacity to care for veterans in across all 50 states titled “Veterans’ Health Care Choice—Myth or Reality? A State- by- State Reality Check of the False Promise of VA Privatization.” This analysis revealed that, in most states, and in all rural states, the private sector system was struggling to meet even the basic needs of non-veterans. As one long time VA expert stated, to imagine that the system could absorb an influx of millions of veterans – particularly when new cuts to Medicaid and other healthcare funding are implemented, is “delusional.”
Russell Lemle and Suzanne Gordon are senior policy analysts at the Veterans Healthcare Policy Institute. Suzanne Gordon is author of Wounds of War.
How IBS Disrupts Daily Life: AGA Survey
A new survey from AGA, in partnership with The Harris Poll, revealed that IBS symptoms interfere with people’s lives an average of 19 days each month — about 11 days affecting work or school and 8 days curtailing personal activities.
Missed work or school has climbed to 3.6 days per month from 2.1 days in 2015 — the last time the AGA released the “IBS in America” survey. And more patients report spending less time with family and friends because of their symptoms (58% now, up from 48% in 2015).
The latest survey was conducted in fall 2024 among more than 2000 patients with IBS and 600 healthcare providers, including gastroenterologists, primary care physicians, and advanced practitioners.
Stark Realities of Life With IBS
Fewer patients in 2024 described their IBS symptoms as very or extremely bothersome (43%, compared to 62% in 2015), yet three quarters said it’s tough to manage their symptoms and most can’t accurately predict whether they will experience symptoms on a given day.
All this affects patients’ willingness or ability to make plans. More than three quarters (77%) said they avoid situations where bathroom access is limited, and nearly that many (72%) said their symptoms cause them to stay home more often.
About 7 in 10 patients said their IBS symptoms make them feel like they’re not “normal” or that their symptoms prevent them from reaching their full potential.
“The findings of this survey underscore the persistent challenges and impact IBS has on patients’ lives,” said Andrea Shin, MD, gastroenterologist with UCLA Health, Los Angeles, and AGA patient education advisor.
“Despite progress in the medical community’s approach to diagnosing and managing IBS, patients continue to suffer significant disruptions to their personal and professional lives,” Shin noted.
How Is IBS Treated?
Treatment options for IBS have evolved over the last decade or so and now include several FDA-approved agents, such as plecanatide (Trulance) and tenapanor (Ibsrela) for IBS with constipation (IBS-C) and rifaximin (Xifaxan) and eluxadoline (Viberzi) for IBS with diarrhea (IBS-D).
According to patients who have tried them, prescription medications are among the most helpful treatments (18% for IBS-C and 19% for IBS-D).
Yet, clinicians tend to prioritize fiber, nonprescription laxatives, and exercise for IBS-C, and diet changes, antidiarrheals, and probiotics for IBS-D, over prescription medications, the survey found.
Nonetheless, about 78% of patients reported being satisfied with what they take for their symptoms, with about one quarter very satisfied.
Compared to 10 years ago, more physicians in the latest survey said effective relief of abdominal pain (49% vs 39%) or diarrhea/constipation (47% vs 33%) and the availability of treatment options (49% vs 34%) are what is most lacking in IBS treatment today, despite advancements in the IBS treatment landscape.
“IBS is a condition that continues to challenge patients to find a treatment that consistently works for them,” said Jeffrey Roberts, founder of the IBS Patient Support Group community and World IBS Day.
“The AGA IBS in America Survey sheds light on patients who are still not being offered a variety of treatments that could provide them with a better quality of life. This continues to result in disruptions to their career, schooling, and life with their families and friends,” Roberts added.
A version of this article appeared on Medscape.com.
A new survey from AGA, in partnership with The Harris Poll, revealed that IBS symptoms interfere with people’s lives an average of 19 days each month — about 11 days affecting work or school and 8 days curtailing personal activities.
Missed work or school has climbed to 3.6 days per month from 2.1 days in 2015 — the last time the AGA released the “IBS in America” survey. And more patients report spending less time with family and friends because of their symptoms (58% now, up from 48% in 2015).
The latest survey was conducted in fall 2024 among more than 2000 patients with IBS and 600 healthcare providers, including gastroenterologists, primary care physicians, and advanced practitioners.
Stark Realities of Life With IBS
Fewer patients in 2024 described their IBS symptoms as very or extremely bothersome (43%, compared to 62% in 2015), yet three quarters said it’s tough to manage their symptoms and most can’t accurately predict whether they will experience symptoms on a given day.
All this affects patients’ willingness or ability to make plans. More than three quarters (77%) said they avoid situations where bathroom access is limited, and nearly that many (72%) said their symptoms cause them to stay home more often.
About 7 in 10 patients said their IBS symptoms make them feel like they’re not “normal” or that their symptoms prevent them from reaching their full potential.
“The findings of this survey underscore the persistent challenges and impact IBS has on patients’ lives,” said Andrea Shin, MD, gastroenterologist with UCLA Health, Los Angeles, and AGA patient education advisor.
“Despite progress in the medical community’s approach to diagnosing and managing IBS, patients continue to suffer significant disruptions to their personal and professional lives,” Shin noted.
How Is IBS Treated?
Treatment options for IBS have evolved over the last decade or so and now include several FDA-approved agents, such as plecanatide (Trulance) and tenapanor (Ibsrela) for IBS with constipation (IBS-C) and rifaximin (Xifaxan) and eluxadoline (Viberzi) for IBS with diarrhea (IBS-D).
According to patients who have tried them, prescription medications are among the most helpful treatments (18% for IBS-C and 19% for IBS-D).
Yet, clinicians tend to prioritize fiber, nonprescription laxatives, and exercise for IBS-C, and diet changes, antidiarrheals, and probiotics for IBS-D, over prescription medications, the survey found.
Nonetheless, about 78% of patients reported being satisfied with what they take for their symptoms, with about one quarter very satisfied.
Compared to 10 years ago, more physicians in the latest survey said effective relief of abdominal pain (49% vs 39%) or diarrhea/constipation (47% vs 33%) and the availability of treatment options (49% vs 34%) are what is most lacking in IBS treatment today, despite advancements in the IBS treatment landscape.
“IBS is a condition that continues to challenge patients to find a treatment that consistently works for them,” said Jeffrey Roberts, founder of the IBS Patient Support Group community and World IBS Day.
“The AGA IBS in America Survey sheds light on patients who are still not being offered a variety of treatments that could provide them with a better quality of life. This continues to result in disruptions to their career, schooling, and life with their families and friends,” Roberts added.
A version of this article appeared on Medscape.com.
A new survey from AGA, in partnership with The Harris Poll, revealed that IBS symptoms interfere with people’s lives an average of 19 days each month — about 11 days affecting work or school and 8 days curtailing personal activities.
Missed work or school has climbed to 3.6 days per month from 2.1 days in 2015 — the last time the AGA released the “IBS in America” survey. And more patients report spending less time with family and friends because of their symptoms (58% now, up from 48% in 2015).
The latest survey was conducted in fall 2024 among more than 2000 patients with IBS and 600 healthcare providers, including gastroenterologists, primary care physicians, and advanced practitioners.
Stark Realities of Life With IBS
Fewer patients in 2024 described their IBS symptoms as very or extremely bothersome (43%, compared to 62% in 2015), yet three quarters said it’s tough to manage their symptoms and most can’t accurately predict whether they will experience symptoms on a given day.
All this affects patients’ willingness or ability to make plans. More than three quarters (77%) said they avoid situations where bathroom access is limited, and nearly that many (72%) said their symptoms cause them to stay home more often.
About 7 in 10 patients said their IBS symptoms make them feel like they’re not “normal” or that their symptoms prevent them from reaching their full potential.
“The findings of this survey underscore the persistent challenges and impact IBS has on patients’ lives,” said Andrea Shin, MD, gastroenterologist with UCLA Health, Los Angeles, and AGA patient education advisor.
“Despite progress in the medical community’s approach to diagnosing and managing IBS, patients continue to suffer significant disruptions to their personal and professional lives,” Shin noted.
How Is IBS Treated?
Treatment options for IBS have evolved over the last decade or so and now include several FDA-approved agents, such as plecanatide (Trulance) and tenapanor (Ibsrela) for IBS with constipation (IBS-C) and rifaximin (Xifaxan) and eluxadoline (Viberzi) for IBS with diarrhea (IBS-D).
According to patients who have tried them, prescription medications are among the most helpful treatments (18% for IBS-C and 19% for IBS-D).
Yet, clinicians tend to prioritize fiber, nonprescription laxatives, and exercise for IBS-C, and diet changes, antidiarrheals, and probiotics for IBS-D, over prescription medications, the survey found.
Nonetheless, about 78% of patients reported being satisfied with what they take for their symptoms, with about one quarter very satisfied.
Compared to 10 years ago, more physicians in the latest survey said effective relief of abdominal pain (49% vs 39%) or diarrhea/constipation (47% vs 33%) and the availability of treatment options (49% vs 34%) are what is most lacking in IBS treatment today, despite advancements in the IBS treatment landscape.
“IBS is a condition that continues to challenge patients to find a treatment that consistently works for them,” said Jeffrey Roberts, founder of the IBS Patient Support Group community and World IBS Day.
“The AGA IBS in America Survey sheds light on patients who are still not being offered a variety of treatments that could provide them with a better quality of life. This continues to result in disruptions to their career, schooling, and life with their families and friends,” Roberts added.
A version of this article appeared on Medscape.com.
Elevated Serologic Markers Insufficient to Diagnose Celiac Disease
, a large pediatric cohort study in North America found.
Because tTG-IgA assay performance varied widely across labs, diagnostic confirmation by a specialist is essential before gluten-targeted dietary changes are made, according to Denis Chang, MD, MS, of the Division of Gastroenterology and Nutrition at Boston Children’s Hospital in Boston, and colleagues reported in Pediatrics.
“Currently, small intestinal biopsy is the gold standard for diagnosing pediatric celiac disease, but recent European diagnostic criteria allow a nonbiopsy pathway for serologic diagnosis,” Chang told GI & Heaptology News. The European guidelines allow this pathway when a very high tTG-IgA is confirmed by a positive endomysial IgA antibody (EMA) in a second blood sample.
Those guidelines have not been adopted on this continent, however, so Chang’s group assessed the positive predictive value (PPV) of the North American tTG-IgA assay to identify histologic findings of celiac disease.
Another issue is the absence of a universal standard threshold across labs for a high antibody value. “Common assays used in North America differ in performance, and there are not many large multicenter studies looking at this issue. Hopefully, a standard will be developed in the near future. Before this serologic pathway can enter into our guidelines, this question needs to be addressed.”
Study Details
The multicenter retrospective study by Dr. Chang’s team looked at patients younger than 18 years from three pediatric hospitals in Canada and nine in the US who had an elevated tTG-IgA within 6 months of an esophagogastroduodenoscopy from January 2016 to December 2021. Biopsy-confirmed celiac disease was determined by the presence of intraepithelial lymphocytosis and villous atrophy. The primary outcomes were the PPV of an elevated tTG-IgA and a tTG-IgA at least 10 times the upper limit of normal (10x ULN).
The study cohort included 4019 children (63.3% female, 9% with type 1 diabetes, and 2% with Down syndrome). Histologic findings were consistent with celiac disease for 3321 children, for a PPV of 82.6% (95% CI, 81.4%-83.8%).
Among the 1739 (43.2%) children with tTG-IgA of at least 10x ULN, 1651 had biopsy-confirmed celiac disease, for a PPV 10x ULN of 94.9% (95% CI, 93.8%-95.9%). About 5% (n = 88) of positive-testing children did not have histologic findings of celiac disease, including 2% (n = 41) with normal histology.
Diagnostic accuracy of tTG-IgA varied widely among the assays used in North America, with a PPV range of 71.5%-88.8% and a PPV 10x ULN range of 89.3%-97.3%. Assays did not perform as well in children with type 1 diabetes: PPV 10x ULN of 89% (95% CI, 83.5%-92.8%).
In other notable findings, the EMA blood test only marginally improved specificity, as 76% of children without celiac disease, but with a tTG-IgA of at least 10x ULN had a positive EMA in the same sample.
While the study lends credence to the notion that a highly positive tTG-IgA correlates with enteropathy in most children, the 1 in 20 with a tTG-IgA greater than 10x ULN who did not have histologic findings diagnostic of celiac disease cannot be ignored. “This included 2% who had normal small intestinal biopsies on a gluten-containing unrestricted diet, highlighting the limitations of making a celiac disease diagnosis based solely upon a single, highly positive tTG-IgA level,” Chang and colleagues wrote.
Does this mean that substantial numbers of children with suspected celiac disease are being unnecessarily placed on gluten-restricted diets to no avail? “That’s a good question, but our retrospective data do not provide an answer to that,” Chang said. And what causes elevated autoantibodies in children who are not diagnosed with celiac disease? “That is also a question that will require further research,” he said.
Commenting on the study but not involved in it, Supriya Nair, MD, a pediatric gastroenterologist at UTHealth Houston, called it “very interesting because it highlights for primary care physicians that we may need endoscopic evaluation more than we thought.” This is particularly true given the lack of standardized laboratory values noted in the study.
Nair said that some children with high seromarker levels but no discernible lesions may develop celiac disease later. “It may be that the markers are not yet causing inflammation in the bowel. These patients must be monitored to see if levels stay high or come down.”
In her practice, she has seen some children who have been put on gluten-free diets prematurely. “But it’s very important to get an accurate, official confirmation with endoscopy because of the ramifications of a celiac diagnosis,” she said. “This is a lifelong condition, and the diet is not easy to follow, especially in North America.” And for children, especially, there are restrictive social impacts and the constant need to be aware of what they’re eating and the danger of cross-contamination in foods, she said.
Chang hopes these data will be pivotal in helping medical societies develop new North American guidelines. In the meantime, pediatricians and primary doctors need to be aware that a high number on a tTG-IgA test does not always mean the presence of celiac disease, although it could be a harbinger of its future development. “Further confirmation by a specialist is essential.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Chang and Nair reported having no competing interests. Several study authors reported receiving research support from and serving as consultants or members of data safety monitoring boards for pharmaceutical companies.
A version of this article appeared on Medscape.com.
, a large pediatric cohort study in North America found.
Because tTG-IgA assay performance varied widely across labs, diagnostic confirmation by a specialist is essential before gluten-targeted dietary changes are made, according to Denis Chang, MD, MS, of the Division of Gastroenterology and Nutrition at Boston Children’s Hospital in Boston, and colleagues reported in Pediatrics.
“Currently, small intestinal biopsy is the gold standard for diagnosing pediatric celiac disease, but recent European diagnostic criteria allow a nonbiopsy pathway for serologic diagnosis,” Chang told GI & Heaptology News. The European guidelines allow this pathway when a very high tTG-IgA is confirmed by a positive endomysial IgA antibody (EMA) in a second blood sample.
Those guidelines have not been adopted on this continent, however, so Chang’s group assessed the positive predictive value (PPV) of the North American tTG-IgA assay to identify histologic findings of celiac disease.
Another issue is the absence of a universal standard threshold across labs for a high antibody value. “Common assays used in North America differ in performance, and there are not many large multicenter studies looking at this issue. Hopefully, a standard will be developed in the near future. Before this serologic pathway can enter into our guidelines, this question needs to be addressed.”
Study Details
The multicenter retrospective study by Dr. Chang’s team looked at patients younger than 18 years from three pediatric hospitals in Canada and nine in the US who had an elevated tTG-IgA within 6 months of an esophagogastroduodenoscopy from January 2016 to December 2021. Biopsy-confirmed celiac disease was determined by the presence of intraepithelial lymphocytosis and villous atrophy. The primary outcomes were the PPV of an elevated tTG-IgA and a tTG-IgA at least 10 times the upper limit of normal (10x ULN).
The study cohort included 4019 children (63.3% female, 9% with type 1 diabetes, and 2% with Down syndrome). Histologic findings were consistent with celiac disease for 3321 children, for a PPV of 82.6% (95% CI, 81.4%-83.8%).
Among the 1739 (43.2%) children with tTG-IgA of at least 10x ULN, 1651 had biopsy-confirmed celiac disease, for a PPV 10x ULN of 94.9% (95% CI, 93.8%-95.9%). About 5% (n = 88) of positive-testing children did not have histologic findings of celiac disease, including 2% (n = 41) with normal histology.
Diagnostic accuracy of tTG-IgA varied widely among the assays used in North America, with a PPV range of 71.5%-88.8% and a PPV 10x ULN range of 89.3%-97.3%. Assays did not perform as well in children with type 1 diabetes: PPV 10x ULN of 89% (95% CI, 83.5%-92.8%).
In other notable findings, the EMA blood test only marginally improved specificity, as 76% of children without celiac disease, but with a tTG-IgA of at least 10x ULN had a positive EMA in the same sample.
While the study lends credence to the notion that a highly positive tTG-IgA correlates with enteropathy in most children, the 1 in 20 with a tTG-IgA greater than 10x ULN who did not have histologic findings diagnostic of celiac disease cannot be ignored. “This included 2% who had normal small intestinal biopsies on a gluten-containing unrestricted diet, highlighting the limitations of making a celiac disease diagnosis based solely upon a single, highly positive tTG-IgA level,” Chang and colleagues wrote.
Does this mean that substantial numbers of children with suspected celiac disease are being unnecessarily placed on gluten-restricted diets to no avail? “That’s a good question, but our retrospective data do not provide an answer to that,” Chang said. And what causes elevated autoantibodies in children who are not diagnosed with celiac disease? “That is also a question that will require further research,” he said.
Commenting on the study but not involved in it, Supriya Nair, MD, a pediatric gastroenterologist at UTHealth Houston, called it “very interesting because it highlights for primary care physicians that we may need endoscopic evaluation more than we thought.” This is particularly true given the lack of standardized laboratory values noted in the study.
Nair said that some children with high seromarker levels but no discernible lesions may develop celiac disease later. “It may be that the markers are not yet causing inflammation in the bowel. These patients must be monitored to see if levels stay high or come down.”
In her practice, she has seen some children who have been put on gluten-free diets prematurely. “But it’s very important to get an accurate, official confirmation with endoscopy because of the ramifications of a celiac diagnosis,” she said. “This is a lifelong condition, and the diet is not easy to follow, especially in North America.” And for children, especially, there are restrictive social impacts and the constant need to be aware of what they’re eating and the danger of cross-contamination in foods, she said.
Chang hopes these data will be pivotal in helping medical societies develop new North American guidelines. In the meantime, pediatricians and primary doctors need to be aware that a high number on a tTG-IgA test does not always mean the presence of celiac disease, although it could be a harbinger of its future development. “Further confirmation by a specialist is essential.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Chang and Nair reported having no competing interests. Several study authors reported receiving research support from and serving as consultants or members of data safety monitoring boards for pharmaceutical companies.
A version of this article appeared on Medscape.com.
, a large pediatric cohort study in North America found.
Because tTG-IgA assay performance varied widely across labs, diagnostic confirmation by a specialist is essential before gluten-targeted dietary changes are made, according to Denis Chang, MD, MS, of the Division of Gastroenterology and Nutrition at Boston Children’s Hospital in Boston, and colleagues reported in Pediatrics.
“Currently, small intestinal biopsy is the gold standard for diagnosing pediatric celiac disease, but recent European diagnostic criteria allow a nonbiopsy pathway for serologic diagnosis,” Chang told GI & Heaptology News. The European guidelines allow this pathway when a very high tTG-IgA is confirmed by a positive endomysial IgA antibody (EMA) in a second blood sample.
Those guidelines have not been adopted on this continent, however, so Chang’s group assessed the positive predictive value (PPV) of the North American tTG-IgA assay to identify histologic findings of celiac disease.
Another issue is the absence of a universal standard threshold across labs for a high antibody value. “Common assays used in North America differ in performance, and there are not many large multicenter studies looking at this issue. Hopefully, a standard will be developed in the near future. Before this serologic pathway can enter into our guidelines, this question needs to be addressed.”
Study Details
The multicenter retrospective study by Dr. Chang’s team looked at patients younger than 18 years from three pediatric hospitals in Canada and nine in the US who had an elevated tTG-IgA within 6 months of an esophagogastroduodenoscopy from January 2016 to December 2021. Biopsy-confirmed celiac disease was determined by the presence of intraepithelial lymphocytosis and villous atrophy. The primary outcomes were the PPV of an elevated tTG-IgA and a tTG-IgA at least 10 times the upper limit of normal (10x ULN).
The study cohort included 4019 children (63.3% female, 9% with type 1 diabetes, and 2% with Down syndrome). Histologic findings were consistent with celiac disease for 3321 children, for a PPV of 82.6% (95% CI, 81.4%-83.8%).
Among the 1739 (43.2%) children with tTG-IgA of at least 10x ULN, 1651 had biopsy-confirmed celiac disease, for a PPV 10x ULN of 94.9% (95% CI, 93.8%-95.9%). About 5% (n = 88) of positive-testing children did not have histologic findings of celiac disease, including 2% (n = 41) with normal histology.
Diagnostic accuracy of tTG-IgA varied widely among the assays used in North America, with a PPV range of 71.5%-88.8% and a PPV 10x ULN range of 89.3%-97.3%. Assays did not perform as well in children with type 1 diabetes: PPV 10x ULN of 89% (95% CI, 83.5%-92.8%).
In other notable findings, the EMA blood test only marginally improved specificity, as 76% of children without celiac disease, but with a tTG-IgA of at least 10x ULN had a positive EMA in the same sample.
While the study lends credence to the notion that a highly positive tTG-IgA correlates with enteropathy in most children, the 1 in 20 with a tTG-IgA greater than 10x ULN who did not have histologic findings diagnostic of celiac disease cannot be ignored. “This included 2% who had normal small intestinal biopsies on a gluten-containing unrestricted diet, highlighting the limitations of making a celiac disease diagnosis based solely upon a single, highly positive tTG-IgA level,” Chang and colleagues wrote.
Does this mean that substantial numbers of children with suspected celiac disease are being unnecessarily placed on gluten-restricted diets to no avail? “That’s a good question, but our retrospective data do not provide an answer to that,” Chang said. And what causes elevated autoantibodies in children who are not diagnosed with celiac disease? “That is also a question that will require further research,” he said.
Commenting on the study but not involved in it, Supriya Nair, MD, a pediatric gastroenterologist at UTHealth Houston, called it “very interesting because it highlights for primary care physicians that we may need endoscopic evaluation more than we thought.” This is particularly true given the lack of standardized laboratory values noted in the study.
Nair said that some children with high seromarker levels but no discernible lesions may develop celiac disease later. “It may be that the markers are not yet causing inflammation in the bowel. These patients must be monitored to see if levels stay high or come down.”
In her practice, she has seen some children who have been put on gluten-free diets prematurely. “But it’s very important to get an accurate, official confirmation with endoscopy because of the ramifications of a celiac diagnosis,” she said. “This is a lifelong condition, and the diet is not easy to follow, especially in North America.” And for children, especially, there are restrictive social impacts and the constant need to be aware of what they’re eating and the danger of cross-contamination in foods, she said.
Chang hopes these data will be pivotal in helping medical societies develop new North American guidelines. In the meantime, pediatricians and primary doctors need to be aware that a high number on a tTG-IgA test does not always mean the presence of celiac disease, although it could be a harbinger of its future development. “Further confirmation by a specialist is essential.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Chang and Nair reported having no competing interests. Several study authors reported receiving research support from and serving as consultants or members of data safety monitoring boards for pharmaceutical companies.
A version of this article appeared on Medscape.com.
Wegovy Approved for MASH With Fibrosis, No Cirrhosis
The once-weekly 2.4 mg semaglutide subcutaneous injection is given in conjunction with a reduced calorie diet and increased physical activity.
Among people living with overweight or obesity globally, 1 in 3 also have MASH.
The accelerated approval was based on part-one results from the ongoing two-part, phase-3 ESSENCE trial, in which Wegovy demonstrated a significant improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis, compared with placebo at week 72. Those results were published online in April in The New England Journal of Medicine.
For the trial, 800 participants were randomly assigned to either Wegovy (534 participants) or placebo (266 participants) in addition to lifestyle changes. The mean age was 56 years and the mean BMI was 34. Most patients were white individuals (67.5%) and women (57.1%), and 55.9% of the patients had type 2 diabetes; 250 patients (31.3%) had stage II fibrosis and 550 (68.8%) had stage III fibrosis. Participants were on stable doses of lipid-lowering, glucose-management, and weight-loss medications.
At week 72, the first primary endpoint showed 63% of the 534 people treated with Wegovy achieved resolution of steatohepatitis and no worsening of liver fibrosis compared with 34% of 266 individuals treated with placebo — a statistically significant difference.
The second primary endpoint showed 37% of people treated with Wegovy achieved improvement in liver fibrosis and no worsening of steatohepatitis compared with 22% of those treated with placebo, also a significant difference.
A confirmatory secondary endpoint at week 72 showed 33% of patients treated with Wegovy achieved both resolution of steatohepatitis and improvement in liver fibrosis compared with 16% of those treated with placebo — a statistically significant difference in response rate of 17%.
In addition, 83.5% of the patients in the semaglutide group maintained the target dose of 2.4 mg until week 72.
Wegovy is also indicated, along with diet and physical activity, to reduce the risk for major cardiovascular events in adults with known heart disease and with either obesity or overweight. It is also indicated for adults and children aged 12 years or older with obesity, and some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off.
What’s Next for Wegovy?
In February 2025, Novo Nordisk filed for regulatory approval in the EU, followed by regulatory submission in Japan in May 2025. Also in May, the FDA accepted a filing application for oral semaglutide 25 mg.
Furthermore, “There’s an expected readout of part 2 of ESSENCE in 2029, which aims to demonstrate treatment with Wegovy lowers the risk of liver-related clinical events, compared to placebo, in patients with MASH and F2 or F3 fibrosis at week 240,” a Novo Nordisk spokesperson told GI & Hepatology News.
Although the company has the technology to produce semaglutide as a pill or tablet, she said, “the US launch of oral semaglutide for obesity will be contingent on portfolio prioritization and manufacturing capacity.” The company has not yet submitted the 50 mg oral semaglutide to regulatory authorities.
“The oral form requires more active pharmaceutical ingredient (API),” she noted. “Given that we have a fixed amount of API, the injectable form enables us to treat more patients. We are currently expanding our oral and injectable production capacities globally with the aim of serving as many patients as possible. It requires time to build, install, validate, and ramp-up these production processes.”
A version of this article appeared on Medscape.com.
The once-weekly 2.4 mg semaglutide subcutaneous injection is given in conjunction with a reduced calorie diet and increased physical activity.
Among people living with overweight or obesity globally, 1 in 3 also have MASH.
The accelerated approval was based on part-one results from the ongoing two-part, phase-3 ESSENCE trial, in which Wegovy demonstrated a significant improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis, compared with placebo at week 72. Those results were published online in April in The New England Journal of Medicine.
For the trial, 800 participants were randomly assigned to either Wegovy (534 participants) or placebo (266 participants) in addition to lifestyle changes. The mean age was 56 years and the mean BMI was 34. Most patients were white individuals (67.5%) and women (57.1%), and 55.9% of the patients had type 2 diabetes; 250 patients (31.3%) had stage II fibrosis and 550 (68.8%) had stage III fibrosis. Participants were on stable doses of lipid-lowering, glucose-management, and weight-loss medications.
At week 72, the first primary endpoint showed 63% of the 534 people treated with Wegovy achieved resolution of steatohepatitis and no worsening of liver fibrosis compared with 34% of 266 individuals treated with placebo — a statistically significant difference.
The second primary endpoint showed 37% of people treated with Wegovy achieved improvement in liver fibrosis and no worsening of steatohepatitis compared with 22% of those treated with placebo, also a significant difference.
A confirmatory secondary endpoint at week 72 showed 33% of patients treated with Wegovy achieved both resolution of steatohepatitis and improvement in liver fibrosis compared with 16% of those treated with placebo — a statistically significant difference in response rate of 17%.
In addition, 83.5% of the patients in the semaglutide group maintained the target dose of 2.4 mg until week 72.
Wegovy is also indicated, along with diet and physical activity, to reduce the risk for major cardiovascular events in adults with known heart disease and with either obesity or overweight. It is also indicated for adults and children aged 12 years or older with obesity, and some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off.
What’s Next for Wegovy?
In February 2025, Novo Nordisk filed for regulatory approval in the EU, followed by regulatory submission in Japan in May 2025. Also in May, the FDA accepted a filing application for oral semaglutide 25 mg.
Furthermore, “There’s an expected readout of part 2 of ESSENCE in 2029, which aims to demonstrate treatment with Wegovy lowers the risk of liver-related clinical events, compared to placebo, in patients with MASH and F2 or F3 fibrosis at week 240,” a Novo Nordisk spokesperson told GI & Hepatology News.
Although the company has the technology to produce semaglutide as a pill or tablet, she said, “the US launch of oral semaglutide for obesity will be contingent on portfolio prioritization and manufacturing capacity.” The company has not yet submitted the 50 mg oral semaglutide to regulatory authorities.
“The oral form requires more active pharmaceutical ingredient (API),” she noted. “Given that we have a fixed amount of API, the injectable form enables us to treat more patients. We are currently expanding our oral and injectable production capacities globally with the aim of serving as many patients as possible. It requires time to build, install, validate, and ramp-up these production processes.”
A version of this article appeared on Medscape.com.
The once-weekly 2.4 mg semaglutide subcutaneous injection is given in conjunction with a reduced calorie diet and increased physical activity.
Among people living with overweight or obesity globally, 1 in 3 also have MASH.
The accelerated approval was based on part-one results from the ongoing two-part, phase-3 ESSENCE trial, in which Wegovy demonstrated a significant improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis, compared with placebo at week 72. Those results were published online in April in The New England Journal of Medicine.
For the trial, 800 participants were randomly assigned to either Wegovy (534 participants) or placebo (266 participants) in addition to lifestyle changes. The mean age was 56 years and the mean BMI was 34. Most patients were white individuals (67.5%) and women (57.1%), and 55.9% of the patients had type 2 diabetes; 250 patients (31.3%) had stage II fibrosis and 550 (68.8%) had stage III fibrosis. Participants were on stable doses of lipid-lowering, glucose-management, and weight-loss medications.
At week 72, the first primary endpoint showed 63% of the 534 people treated with Wegovy achieved resolution of steatohepatitis and no worsening of liver fibrosis compared with 34% of 266 individuals treated with placebo — a statistically significant difference.
The second primary endpoint showed 37% of people treated with Wegovy achieved improvement in liver fibrosis and no worsening of steatohepatitis compared with 22% of those treated with placebo, also a significant difference.
A confirmatory secondary endpoint at week 72 showed 33% of patients treated with Wegovy achieved both resolution of steatohepatitis and improvement in liver fibrosis compared with 16% of those treated with placebo — a statistically significant difference in response rate of 17%.
In addition, 83.5% of the patients in the semaglutide group maintained the target dose of 2.4 mg until week 72.
Wegovy is also indicated, along with diet and physical activity, to reduce the risk for major cardiovascular events in adults with known heart disease and with either obesity or overweight. It is also indicated for adults and children aged 12 years or older with obesity, and some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off.
What’s Next for Wegovy?
In February 2025, Novo Nordisk filed for regulatory approval in the EU, followed by regulatory submission in Japan in May 2025. Also in May, the FDA accepted a filing application for oral semaglutide 25 mg.
Furthermore, “There’s an expected readout of part 2 of ESSENCE in 2029, which aims to demonstrate treatment with Wegovy lowers the risk of liver-related clinical events, compared to placebo, in patients with MASH and F2 or F3 fibrosis at week 240,” a Novo Nordisk spokesperson told GI & Hepatology News.
Although the company has the technology to produce semaglutide as a pill or tablet, she said, “the US launch of oral semaglutide for obesity will be contingent on portfolio prioritization and manufacturing capacity.” The company has not yet submitted the 50 mg oral semaglutide to regulatory authorities.
“The oral form requires more active pharmaceutical ingredient (API),” she noted. “Given that we have a fixed amount of API, the injectable form enables us to treat more patients. We are currently expanding our oral and injectable production capacities globally with the aim of serving as many patients as possible. It requires time to build, install, validate, and ramp-up these production processes.”
A version of this article appeared on Medscape.com.
Skip Antibiotic Prophylaxis for Upper GI Bleeding in Cirrhosis?
Pooled data from 14 randomized controlled trials (RCTs) found a high probability that no or shorter durations of antibiotic prophylaxis are not worse than longer durations in preventing death from any cause in these patients.
The findings suggest that recommendations for routine antibiotic prophylaxis in patients with cirrhosis and upper GI bleeding “should be reassessed,” the authors said.
They acknowledged, however, that the studies were of low-to-moderate quality and higher quality randomized clinical trial data are needed.
The study, with first author Connor Prosty, MD, of McGill University, in Montreal, Quebec, Canada, was published online in JAMA Internal Medicine.
Questionable Benefit?
Antibiotic prophylaxis became standard decades ago, when up to 60% of variceal bleeds were complicated by infections, which were thought to increase the risk for rebleeding and death.
Yet, the evidence to support the recommendation remains limited, and a recent RCT called into question the necessity of prophylaxis. The study showed no statistically significant difference in mortality or infection among patients with Child-Pugh class A cirrhosis randomized to receive no prophylaxis compared to third-generation cephalosporin.
While generally perceived as safe, antibiotics have potential adverse effects and can select for resistant superinfections, Prosty and colleagues pointed out.
They also noted that shorter courses of antibiotics have been proven to be as good, if not better, than longer courses across numerous other infectious indications. Recommendations for primary and secondary antibiotic prophylaxis for spontaneous bacterial peritonitis are being reassessed due to a weak evidence base, lack of mortality benefit, and potential for harm.
To revisit antibiotic prophylaxis for upper GI bleeding in patients with cirrhosis, Prosty and colleagues did a systematic review and meta-analysis of 14 RCTs involving 1322 patients.
Two of the trials compared longer (5-7 days) with shorter (2-3 days) antibiotics, and 12 compared any antibiotic prophylaxis (1-10 days) to none.
The primary outcome was all-cause mortality, with a prespecified noninferiority margin of 5% on the risk difference (RD) scale. Secondary outcomes included early rebleeding and bacterial infections.
Overall, shorter antibiotic durations (including none) had a 97.3% probability of noninferiority to longer durations for all-cause mortality (RD, 0.9%; 95% credible interval [CrI], -2.6% to 4.9%).
Shorter durations had a 73.8% probability of noninferiority for early rebleeding (RD, 2.9%; 95% CrI, -4.2% to 10.0%) but were associated with more study-defined bacterial infections (RD, 15.2%; 95% CrI, 5.0%-25.9%). However, the authors cited methodological concerns about the definitions of these infections in the included studies.
The probabilities of noninferiority of shorter durations for mortality, early rebleeding, and bacterial infections were higher in studies published after 2004.
Change Practice Now?
“Our findings re-open the discussion surrounding the long-standing and firmly held belief that antibiotic prophylaxis has a mortality benefit in patients with cirrhosis presenting with upper gastrointestinal bleeds,” Prosty and colleagues wrote.
They cautioned, however, that the study quality was “low to moderate, bacterial infections were heterogeneously defined, and no studies reported adverse events. Higher-quality RCTs are needed to determine the benefit and optimal duration of antibiotic prophylaxis in the modern era of advanced interventions.”
The authors of a commentary published with the study noted that management of upper GI bleeding in cirrhosis patients has “greatly improved” since the 1990s, when some of the trials included in the analysis were conducted.
Hepatologists Catherine Mezzacappa, MD, MPH, and Guadalupe Garcia-Tsao, MD, both at the Yale School of Medicine, New Haven, Connecticut, agree that it “may be time to revisit whether prophylactic antibiotics continue to provide benefit in patients with cirrhosis and upper GI bleeding, and if so, in which patients.”
They caution, however, that the current level of evidence is “inadequate to answer whether it is time to stop this practice, which has become the standard of care.
New trials for shorter duration and no antibiotic prophylaxis “should be designed in specific patient populations to compare sequelae of antibiotic prophylaxis, including subsequent infections and all-cause mortality,” Mezzacappa and Garcia-Tsao concluded.
The study received no specific funding. The authors and commentary writers had no relevant disclosures.
A version of this article appeared on Medscape.com.
Pooled data from 14 randomized controlled trials (RCTs) found a high probability that no or shorter durations of antibiotic prophylaxis are not worse than longer durations in preventing death from any cause in these patients.
The findings suggest that recommendations for routine antibiotic prophylaxis in patients with cirrhosis and upper GI bleeding “should be reassessed,” the authors said.
They acknowledged, however, that the studies were of low-to-moderate quality and higher quality randomized clinical trial data are needed.
The study, with first author Connor Prosty, MD, of McGill University, in Montreal, Quebec, Canada, was published online in JAMA Internal Medicine.
Questionable Benefit?
Antibiotic prophylaxis became standard decades ago, when up to 60% of variceal bleeds were complicated by infections, which were thought to increase the risk for rebleeding and death.
Yet, the evidence to support the recommendation remains limited, and a recent RCT called into question the necessity of prophylaxis. The study showed no statistically significant difference in mortality or infection among patients with Child-Pugh class A cirrhosis randomized to receive no prophylaxis compared to third-generation cephalosporin.
While generally perceived as safe, antibiotics have potential adverse effects and can select for resistant superinfections, Prosty and colleagues pointed out.
They also noted that shorter courses of antibiotics have been proven to be as good, if not better, than longer courses across numerous other infectious indications. Recommendations for primary and secondary antibiotic prophylaxis for spontaneous bacterial peritonitis are being reassessed due to a weak evidence base, lack of mortality benefit, and potential for harm.
To revisit antibiotic prophylaxis for upper GI bleeding in patients with cirrhosis, Prosty and colleagues did a systematic review and meta-analysis of 14 RCTs involving 1322 patients.
Two of the trials compared longer (5-7 days) with shorter (2-3 days) antibiotics, and 12 compared any antibiotic prophylaxis (1-10 days) to none.
The primary outcome was all-cause mortality, with a prespecified noninferiority margin of 5% on the risk difference (RD) scale. Secondary outcomes included early rebleeding and bacterial infections.
Overall, shorter antibiotic durations (including none) had a 97.3% probability of noninferiority to longer durations for all-cause mortality (RD, 0.9%; 95% credible interval [CrI], -2.6% to 4.9%).
Shorter durations had a 73.8% probability of noninferiority for early rebleeding (RD, 2.9%; 95% CrI, -4.2% to 10.0%) but were associated with more study-defined bacterial infections (RD, 15.2%; 95% CrI, 5.0%-25.9%). However, the authors cited methodological concerns about the definitions of these infections in the included studies.
The probabilities of noninferiority of shorter durations for mortality, early rebleeding, and bacterial infections were higher in studies published after 2004.
Change Practice Now?
“Our findings re-open the discussion surrounding the long-standing and firmly held belief that antibiotic prophylaxis has a mortality benefit in patients with cirrhosis presenting with upper gastrointestinal bleeds,” Prosty and colleagues wrote.
They cautioned, however, that the study quality was “low to moderate, bacterial infections were heterogeneously defined, and no studies reported adverse events. Higher-quality RCTs are needed to determine the benefit and optimal duration of antibiotic prophylaxis in the modern era of advanced interventions.”
The authors of a commentary published with the study noted that management of upper GI bleeding in cirrhosis patients has “greatly improved” since the 1990s, when some of the trials included in the analysis were conducted.
Hepatologists Catherine Mezzacappa, MD, MPH, and Guadalupe Garcia-Tsao, MD, both at the Yale School of Medicine, New Haven, Connecticut, agree that it “may be time to revisit whether prophylactic antibiotics continue to provide benefit in patients with cirrhosis and upper GI bleeding, and if so, in which patients.”
They caution, however, that the current level of evidence is “inadequate to answer whether it is time to stop this practice, which has become the standard of care.
New trials for shorter duration and no antibiotic prophylaxis “should be designed in specific patient populations to compare sequelae of antibiotic prophylaxis, including subsequent infections and all-cause mortality,” Mezzacappa and Garcia-Tsao concluded.
The study received no specific funding. The authors and commentary writers had no relevant disclosures.
A version of this article appeared on Medscape.com.
Pooled data from 14 randomized controlled trials (RCTs) found a high probability that no or shorter durations of antibiotic prophylaxis are not worse than longer durations in preventing death from any cause in these patients.
The findings suggest that recommendations for routine antibiotic prophylaxis in patients with cirrhosis and upper GI bleeding “should be reassessed,” the authors said.
They acknowledged, however, that the studies were of low-to-moderate quality and higher quality randomized clinical trial data are needed.
The study, with first author Connor Prosty, MD, of McGill University, in Montreal, Quebec, Canada, was published online in JAMA Internal Medicine.
Questionable Benefit?
Antibiotic prophylaxis became standard decades ago, when up to 60% of variceal bleeds were complicated by infections, which were thought to increase the risk for rebleeding and death.
Yet, the evidence to support the recommendation remains limited, and a recent RCT called into question the necessity of prophylaxis. The study showed no statistically significant difference in mortality or infection among patients with Child-Pugh class A cirrhosis randomized to receive no prophylaxis compared to third-generation cephalosporin.
While generally perceived as safe, antibiotics have potential adverse effects and can select for resistant superinfections, Prosty and colleagues pointed out.
They also noted that shorter courses of antibiotics have been proven to be as good, if not better, than longer courses across numerous other infectious indications. Recommendations for primary and secondary antibiotic prophylaxis for spontaneous bacterial peritonitis are being reassessed due to a weak evidence base, lack of mortality benefit, and potential for harm.
To revisit antibiotic prophylaxis for upper GI bleeding in patients with cirrhosis, Prosty and colleagues did a systematic review and meta-analysis of 14 RCTs involving 1322 patients.
Two of the trials compared longer (5-7 days) with shorter (2-3 days) antibiotics, and 12 compared any antibiotic prophylaxis (1-10 days) to none.
The primary outcome was all-cause mortality, with a prespecified noninferiority margin of 5% on the risk difference (RD) scale. Secondary outcomes included early rebleeding and bacterial infections.
Overall, shorter antibiotic durations (including none) had a 97.3% probability of noninferiority to longer durations for all-cause mortality (RD, 0.9%; 95% credible interval [CrI], -2.6% to 4.9%).
Shorter durations had a 73.8% probability of noninferiority for early rebleeding (RD, 2.9%; 95% CrI, -4.2% to 10.0%) but were associated with more study-defined bacterial infections (RD, 15.2%; 95% CrI, 5.0%-25.9%). However, the authors cited methodological concerns about the definitions of these infections in the included studies.
The probabilities of noninferiority of shorter durations for mortality, early rebleeding, and bacterial infections were higher in studies published after 2004.
Change Practice Now?
“Our findings re-open the discussion surrounding the long-standing and firmly held belief that antibiotic prophylaxis has a mortality benefit in patients with cirrhosis presenting with upper gastrointestinal bleeds,” Prosty and colleagues wrote.
They cautioned, however, that the study quality was “low to moderate, bacterial infections were heterogeneously defined, and no studies reported adverse events. Higher-quality RCTs are needed to determine the benefit and optimal duration of antibiotic prophylaxis in the modern era of advanced interventions.”
The authors of a commentary published with the study noted that management of upper GI bleeding in cirrhosis patients has “greatly improved” since the 1990s, when some of the trials included in the analysis were conducted.
Hepatologists Catherine Mezzacappa, MD, MPH, and Guadalupe Garcia-Tsao, MD, both at the Yale School of Medicine, New Haven, Connecticut, agree that it “may be time to revisit whether prophylactic antibiotics continue to provide benefit in patients with cirrhosis and upper GI bleeding, and if so, in which patients.”
They caution, however, that the current level of evidence is “inadequate to answer whether it is time to stop this practice, which has become the standard of care.
New trials for shorter duration and no antibiotic prophylaxis “should be designed in specific patient populations to compare sequelae of antibiotic prophylaxis, including subsequent infections and all-cause mortality,” Mezzacappa and Garcia-Tsao concluded.
The study received no specific funding. The authors and commentary writers had no relevant disclosures.
A version of this article appeared on Medscape.com.
Eating More Cruciferous Vegetables May Cut Colon Cancer Risk
TOPLINE:
A higher consumption of cruciferous vegetables such as broccoli and cauliflower was associated with a notably reduced risk for colon cancer (CC), with an optimal intake of 40-60 g/d providing a risk reduction of 20% to 26%.
METHODOLOGY:
- Previous meta-analyses have studied the association between the intake of cruciferous vegetables and the risk for CC; however, the quantitative dose-response relationship remained uncharacterized, limiting insights for dietary guidance.
- Researchers performed a systematic review and meta-analysis of 17 studies (seven cohort and 10 case-control studies) to analyze the dose-response association between the consumption of cruciferous vegetables and CC risk.
- Studies were included if they enrolled adults without CC at baseline (cohort studies) or adults with diagnosed cases who were matched with control individuals (case-control studies), quantified the dietary intake of cruciferous vegetables through standardized questionnaires, and included comparator groups with lower or no intake of such vegetables.
- The studies included 639,539 participants, of whom 97,595 had CC. Incident cases of CC were confirmed via medical records, pathology, registries, or validated self-report.
TAKEAWAY:
- A pooled analysis revealed that people who consumed the largest amounts of cruciferous vegetables had a 20% lower risk for CC than those who consumed the lowest amounts.
- A dose-response analysis showed that risk reduction was near maximal at an intake of 40-60 g/d (odds ratio, 0.74-0.8), with benefits plateauing beyond this range.
- The peak protective effect per gram occurred at an intake of 20-40 g/d of cruciferous vegetables and fell after 60 g/d.
IN PRACTICE:
“The pathophysiology of CC has been linked to dietary factors, specifically inadequate intake of vegetables and dietary fiber, as well as excessive alcohol and caffeine use. These empirical findings lend credence to our results, suggesting a potential chemopreventive role of CV [cruciferous vegetables] against CC development,” the authors wrote.
SOURCE:
This study, led by Bo Lai, Department of Interventional Radiology, The Second Clinical Medical School of Inner Mongolia University for the Nationalities, Yakeshi, China, was published online in BMC Gastroenterology.
LIMITATIONS:
The inclusion of both case-control and cohort studies and variations in the assessment of cruciferous vegetable intake across studies may have introduced methodological heterogeneity and measurement error, respectively. This study did not measure factors such as pesticide exposure and genetic susceptibility. The predominance of studies from North America and Asia — regions with an elevated incidence of CC — may have limited generalizability to other populations.
DISCLOSURES:
This study received no financial support. The authors declared having no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
A higher consumption of cruciferous vegetables such as broccoli and cauliflower was associated with a notably reduced risk for colon cancer (CC), with an optimal intake of 40-60 g/d providing a risk reduction of 20% to 26%.
METHODOLOGY:
- Previous meta-analyses have studied the association between the intake of cruciferous vegetables and the risk for CC; however, the quantitative dose-response relationship remained uncharacterized, limiting insights for dietary guidance.
- Researchers performed a systematic review and meta-analysis of 17 studies (seven cohort and 10 case-control studies) to analyze the dose-response association between the consumption of cruciferous vegetables and CC risk.
- Studies were included if they enrolled adults without CC at baseline (cohort studies) or adults with diagnosed cases who were matched with control individuals (case-control studies), quantified the dietary intake of cruciferous vegetables through standardized questionnaires, and included comparator groups with lower or no intake of such vegetables.
- The studies included 639,539 participants, of whom 97,595 had CC. Incident cases of CC were confirmed via medical records, pathology, registries, or validated self-report.
TAKEAWAY:
- A pooled analysis revealed that people who consumed the largest amounts of cruciferous vegetables had a 20% lower risk for CC than those who consumed the lowest amounts.
- A dose-response analysis showed that risk reduction was near maximal at an intake of 40-60 g/d (odds ratio, 0.74-0.8), with benefits plateauing beyond this range.
- The peak protective effect per gram occurred at an intake of 20-40 g/d of cruciferous vegetables and fell after 60 g/d.
IN PRACTICE:
“The pathophysiology of CC has been linked to dietary factors, specifically inadequate intake of vegetables and dietary fiber, as well as excessive alcohol and caffeine use. These empirical findings lend credence to our results, suggesting a potential chemopreventive role of CV [cruciferous vegetables] against CC development,” the authors wrote.
SOURCE:
This study, led by Bo Lai, Department of Interventional Radiology, The Second Clinical Medical School of Inner Mongolia University for the Nationalities, Yakeshi, China, was published online in BMC Gastroenterology.
LIMITATIONS:
The inclusion of both case-control and cohort studies and variations in the assessment of cruciferous vegetable intake across studies may have introduced methodological heterogeneity and measurement error, respectively. This study did not measure factors such as pesticide exposure and genetic susceptibility. The predominance of studies from North America and Asia — regions with an elevated incidence of CC — may have limited generalizability to other populations.
DISCLOSURES:
This study received no financial support. The authors declared having no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
A higher consumption of cruciferous vegetables such as broccoli and cauliflower was associated with a notably reduced risk for colon cancer (CC), with an optimal intake of 40-60 g/d providing a risk reduction of 20% to 26%.
METHODOLOGY:
- Previous meta-analyses have studied the association between the intake of cruciferous vegetables and the risk for CC; however, the quantitative dose-response relationship remained uncharacterized, limiting insights for dietary guidance.
- Researchers performed a systematic review and meta-analysis of 17 studies (seven cohort and 10 case-control studies) to analyze the dose-response association between the consumption of cruciferous vegetables and CC risk.
- Studies were included if they enrolled adults without CC at baseline (cohort studies) or adults with diagnosed cases who were matched with control individuals (case-control studies), quantified the dietary intake of cruciferous vegetables through standardized questionnaires, and included comparator groups with lower or no intake of such vegetables.
- The studies included 639,539 participants, of whom 97,595 had CC. Incident cases of CC were confirmed via medical records, pathology, registries, or validated self-report.
TAKEAWAY:
- A pooled analysis revealed that people who consumed the largest amounts of cruciferous vegetables had a 20% lower risk for CC than those who consumed the lowest amounts.
- A dose-response analysis showed that risk reduction was near maximal at an intake of 40-60 g/d (odds ratio, 0.74-0.8), with benefits plateauing beyond this range.
- The peak protective effect per gram occurred at an intake of 20-40 g/d of cruciferous vegetables and fell after 60 g/d.
IN PRACTICE:
“The pathophysiology of CC has been linked to dietary factors, specifically inadequate intake of vegetables and dietary fiber, as well as excessive alcohol and caffeine use. These empirical findings lend credence to our results, suggesting a potential chemopreventive role of CV [cruciferous vegetables] against CC development,” the authors wrote.
SOURCE:
This study, led by Bo Lai, Department of Interventional Radiology, The Second Clinical Medical School of Inner Mongolia University for the Nationalities, Yakeshi, China, was published online in BMC Gastroenterology.
LIMITATIONS:
The inclusion of both case-control and cohort studies and variations in the assessment of cruciferous vegetable intake across studies may have introduced methodological heterogeneity and measurement error, respectively. This study did not measure factors such as pesticide exposure and genetic susceptibility. The predominance of studies from North America and Asia — regions with an elevated incidence of CC — may have limited generalizability to other populations.
DISCLOSURES:
This study received no financial support. The authors declared having no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
Weight Loss Before Military Training May Cut Injury Risk
TOPLINE:
Army recruits who lost excess weight to enter military training experienced fewer musculoskeletal injuries (MSKIs), particularly in the lower extremities, during basic combat training than those who did not lose weight to join the service.
METHODOLOGY:
- The nation’s obesity epidemic means that fewer individuals meet the US Army’s weight and body-fat standards for entering basic combat training. Only 29% of 17- to 24-year-olds in the country would have qualified to join the military in 2018, with overweight and obesity among the leading disqualifying factors.
- Researchers analyzed data from 3168 Army trainees (mean age, 20.96 years; 62.34% men; mean maximum-ever BMI, 26.71) to examine the association between weight loss before enlistment and rates of MSKI during basic combat training.
- Trainees completed a baseline questionnaire that asked whether the person lost weight to enter the Army and included follow-up questions about the amount of weight lost, duration of weight loss, methods used, and prior physical activity.
- MSKIs were classified as any injury to the musculoskeletal system and further categorized by body region (lower extremities, upper extremities, spine/back, and other areas, including the torso and head/neck).
- Researchers identified MSKIs from medical records collected throughout basic combat training and for up to 6 weeks afterward to capture injuries that occurred during training but were documented only after its completion.
TAKEAWAY:
- Overall, 829 trainees (26.16%) reported losing weight to enter the Army, and they tended to have higher mean maximum-ever BMI, body-fat percentage, and lean mass compared with those who did not lose weight to join the service. The mean weight loss was 9.06 kg at a rate of 1.27 kg/wk among the 723 trainees with complete data.
- The most commonly reported weight-loss methods were exercising more (83.7%), changing diet (61.0%), skipping meals (39.3%), and sweating using a sauna or rubber suit (25.6%).
- Trainees who lost weight to join the service had a lower risk of any MSKI (hazard ratio [HR], 0.86) and lower extremity MSKIs (HR, 0.84) during training than those who did not lose weight to enter the Army. No difference was found between the two groups in the risk of upper extremity, spine/back, or other MSKIs.
- Among trainees who lost weight to join the Army, the amount of time it took to lose weight was not associated with the risk for any MSKI or region-specific MSKIs.
IN PRACTICE:
“The findings highlight that losing excess weight before entering military training may reduce MSKI risk for incoming recruits, enforcing the benefits of healthy weight loss programs,” the authors wrote.
SOURCE:
The study, led by Vy T. Nguyen, MS, DSc, Military Performance Division, US Army Research Institute of Environmental Medicine, Natick, Massachusetts, was published online in Obesity .
LIMITATIONS:
The study did not assess whether the association between weight loss and the rate of MSKIs persisted over long-term military service. How the two most frequently reported weight loss methods — increased exercise and dietary changes — may have influenced the observed association remains unclear. Medical records may not have captured all MSKIs if trainees did not seek medical care due to concerns about graduating on time or being placed on limited duty.
DISCLOSURES:
The study was supported by the US Army Medical Research and Development Command’s Military Operational Medicine Program. Two authors received support from the funder.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Army recruits who lost excess weight to enter military training experienced fewer musculoskeletal injuries (MSKIs), particularly in the lower extremities, during basic combat training than those who did not lose weight to join the service.
METHODOLOGY:
- The nation’s obesity epidemic means that fewer individuals meet the US Army’s weight and body-fat standards for entering basic combat training. Only 29% of 17- to 24-year-olds in the country would have qualified to join the military in 2018, with overweight and obesity among the leading disqualifying factors.
- Researchers analyzed data from 3168 Army trainees (mean age, 20.96 years; 62.34% men; mean maximum-ever BMI, 26.71) to examine the association between weight loss before enlistment and rates of MSKI during basic combat training.
- Trainees completed a baseline questionnaire that asked whether the person lost weight to enter the Army and included follow-up questions about the amount of weight lost, duration of weight loss, methods used, and prior physical activity.
- MSKIs were classified as any injury to the musculoskeletal system and further categorized by body region (lower extremities, upper extremities, spine/back, and other areas, including the torso and head/neck).
- Researchers identified MSKIs from medical records collected throughout basic combat training and for up to 6 weeks afterward to capture injuries that occurred during training but were documented only after its completion.
TAKEAWAY:
- Overall, 829 trainees (26.16%) reported losing weight to enter the Army, and they tended to have higher mean maximum-ever BMI, body-fat percentage, and lean mass compared with those who did not lose weight to join the service. The mean weight loss was 9.06 kg at a rate of 1.27 kg/wk among the 723 trainees with complete data.
- The most commonly reported weight-loss methods were exercising more (83.7%), changing diet (61.0%), skipping meals (39.3%), and sweating using a sauna or rubber suit (25.6%).
- Trainees who lost weight to join the service had a lower risk of any MSKI (hazard ratio [HR], 0.86) and lower extremity MSKIs (HR, 0.84) during training than those who did not lose weight to enter the Army. No difference was found between the two groups in the risk of upper extremity, spine/back, or other MSKIs.
- Among trainees who lost weight to join the Army, the amount of time it took to lose weight was not associated with the risk for any MSKI or region-specific MSKIs.
IN PRACTICE:
“The findings highlight that losing excess weight before entering military training may reduce MSKI risk for incoming recruits, enforcing the benefits of healthy weight loss programs,” the authors wrote.
SOURCE:
The study, led by Vy T. Nguyen, MS, DSc, Military Performance Division, US Army Research Institute of Environmental Medicine, Natick, Massachusetts, was published online in Obesity .
LIMITATIONS:
The study did not assess whether the association between weight loss and the rate of MSKIs persisted over long-term military service. How the two most frequently reported weight loss methods — increased exercise and dietary changes — may have influenced the observed association remains unclear. Medical records may not have captured all MSKIs if trainees did not seek medical care due to concerns about graduating on time or being placed on limited duty.
DISCLOSURES:
The study was supported by the US Army Medical Research and Development Command’s Military Operational Medicine Program. Two authors received support from the funder.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Army recruits who lost excess weight to enter military training experienced fewer musculoskeletal injuries (MSKIs), particularly in the lower extremities, during basic combat training than those who did not lose weight to join the service.
METHODOLOGY:
- The nation’s obesity epidemic means that fewer individuals meet the US Army’s weight and body-fat standards for entering basic combat training. Only 29% of 17- to 24-year-olds in the country would have qualified to join the military in 2018, with overweight and obesity among the leading disqualifying factors.
- Researchers analyzed data from 3168 Army trainees (mean age, 20.96 years; 62.34% men; mean maximum-ever BMI, 26.71) to examine the association between weight loss before enlistment and rates of MSKI during basic combat training.
- Trainees completed a baseline questionnaire that asked whether the person lost weight to enter the Army and included follow-up questions about the amount of weight lost, duration of weight loss, methods used, and prior physical activity.
- MSKIs were classified as any injury to the musculoskeletal system and further categorized by body region (lower extremities, upper extremities, spine/back, and other areas, including the torso and head/neck).
- Researchers identified MSKIs from medical records collected throughout basic combat training and for up to 6 weeks afterward to capture injuries that occurred during training but were documented only after its completion.
TAKEAWAY:
- Overall, 829 trainees (26.16%) reported losing weight to enter the Army, and they tended to have higher mean maximum-ever BMI, body-fat percentage, and lean mass compared with those who did not lose weight to join the service. The mean weight loss was 9.06 kg at a rate of 1.27 kg/wk among the 723 trainees with complete data.
- The most commonly reported weight-loss methods were exercising more (83.7%), changing diet (61.0%), skipping meals (39.3%), and sweating using a sauna or rubber suit (25.6%).
- Trainees who lost weight to join the service had a lower risk of any MSKI (hazard ratio [HR], 0.86) and lower extremity MSKIs (HR, 0.84) during training than those who did not lose weight to enter the Army. No difference was found between the two groups in the risk of upper extremity, spine/back, or other MSKIs.
- Among trainees who lost weight to join the Army, the amount of time it took to lose weight was not associated with the risk for any MSKI or region-specific MSKIs.
IN PRACTICE:
“The findings highlight that losing excess weight before entering military training may reduce MSKI risk for incoming recruits, enforcing the benefits of healthy weight loss programs,” the authors wrote.
SOURCE:
The study, led by Vy T. Nguyen, MS, DSc, Military Performance Division, US Army Research Institute of Environmental Medicine, Natick, Massachusetts, was published online in Obesity .
LIMITATIONS:
The study did not assess whether the association between weight loss and the rate of MSKIs persisted over long-term military service. How the two most frequently reported weight loss methods — increased exercise and dietary changes — may have influenced the observed association remains unclear. Medical records may not have captured all MSKIs if trainees did not seek medical care due to concerns about graduating on time or being placed on limited duty.
DISCLOSURES:
The study was supported by the US Army Medical Research and Development Command’s Military Operational Medicine Program. Two authors received support from the funder.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
A New ADC for Lung Cancer: Datopotamab Deruxtecan Now Approved by FDA
This transcript has been edited for clarity.
Hello. It’s Mark Kris, from Memorial Sloan Kettering, talking about a birthday gift I received on June 23 when the FDA approved the indication of datopotamab deruxtecan for people with lung cancers. We have another drug, our third ADC (antibody-drug conjugate) to fight lung cancer, so that’s a gift.
Let’s talk a little bit about that agent. It’s an interesting twist in our practice patterns. What can the drug do? It had a response rate of 45%, which is really important in patients that had EGFR mutations with progression on osimertinib. We really need drugs in that space. The duration of response was about 7 months, which is significant.
One interesting thing in the approval, [was] that the response rate of the blinded folks was greater than that in the investigator-assessed response by about 10%. It’s very interesting. Clearly, we have another drug, and we have it in a space where we need it.
Let’s talk a bit about the toxicity. I’m going to focus more on the paper by Bardia et al that compared datopotamab deruxtecan to various chemo drugs in breast cancer, not in lung cancer. You can take this a little bit with a grain of salt.
First, they saw a whole different array of side effects with datopotamab deruxtecan, things that we don’t normally deal with here. Nausea, stomatitis, alopecia, dry eye, and vomiting. All of those were more than 10% more common in patients that received datopotamab deruxtecan compared to the control. The only things that were more common with the control were neutropenia, leukopenia, and hand-foot syndrome in patients that had capecitabine.
One thing, though, is while you say, “Oh, these weren’t dangerous side effects,” they surely were lifestyle altering. Nobody wants to have these side effects on a daily basis. Again, there’s an increasing awareness about these kinds of lower-grade but still lifestyle-disrupting side effects. When it goes on day after day, you really have to balance that into the benefit you’re going to receive.
I think the second important point is how, when we use this drug, we’re going to have to go to another level to deal with the adverse effects that we are going to see. The first would be nausea and emesis. It is a highly emetogenic regimen based on the NCCN (National Comprehensive Cancer Network) guidelines, so you would need either 3 or 4 antiemetic drugs. That’s number one.
Number two, because of the potential eye problems, you need an eye exam before treatment — and the label says at least annually — with any symptoms. I think it’s very important that you give the patients eyedrops, and in general, the preservative-free eyedrops are the ones that are most effective.
Stomatitis is a very common side effect with that agent. It’s really not seen with the other drugs that even contain the same warhead. There, dexamethasone rinses are important. Now, this is a compounded medicine so you need to be very careful in making sure that you identify pharmacies that will prepare this and will have it available for the patients that need it.
Last, there is the risk of hypersensitivity reactions and there’s a recommendation for premedication for that. As you think about using datopotamab deruxtecan, you need to have all your ducks in a row to treat side effects. You need prophylaxis for hypersensitivity reactions, nausea, and emesis.
The patient will need an eye exam. You need to prepare the patient for possible dry eye and teach them which eyedrops are the best. You also need to ensure the availability of dexamethasone rinses and mouth washes. All that needs to be in place to make sure that the patient can safely use the drug.
I think it’s going to be a useful drug. We don’t yet have a uniformly available way to select patients for its use other than EGFR. I should note that the approval is for EGFR-mutated lung cancers. It doesn’t say which type of mutation, so that would give you some latitude in giving it for exon 20 atypicals as well as for the common sensitizing mutation.
We have another drug. It’s clearly going to be a useful one. It clearly comes with many adverse effects that we don’t normally treat on an everyday basis, we’re used to the diarrhea and skin changes that come on with the EGFR TKIs.
This pattern of side effects is different and requires some additional attention, but with it, the drug can be useful. I’m glad that we have yet another way to fight this disease.
Mark G. Kris, MD, Professor of Medicine, Weill Cornell Medical College; Attending Physician, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York , has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Bristol-Myers Squibb; Merck; Daiichi Sankyo; Received research grant from: National Institute of Health; Received income in an amount equal to or greater than $250 from: AstraZeneca; Bristol-Myers Squibb; Merck; Daiichi Sankyo Others: Editorial support from Genentech
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hello. It’s Mark Kris, from Memorial Sloan Kettering, talking about a birthday gift I received on June 23 when the FDA approved the indication of datopotamab deruxtecan for people with lung cancers. We have another drug, our third ADC (antibody-drug conjugate) to fight lung cancer, so that’s a gift.
Let’s talk a little bit about that agent. It’s an interesting twist in our practice patterns. What can the drug do? It had a response rate of 45%, which is really important in patients that had EGFR mutations with progression on osimertinib. We really need drugs in that space. The duration of response was about 7 months, which is significant.
One interesting thing in the approval, [was] that the response rate of the blinded folks was greater than that in the investigator-assessed response by about 10%. It’s very interesting. Clearly, we have another drug, and we have it in a space where we need it.
Let’s talk a bit about the toxicity. I’m going to focus more on the paper by Bardia et al that compared datopotamab deruxtecan to various chemo drugs in breast cancer, not in lung cancer. You can take this a little bit with a grain of salt.
First, they saw a whole different array of side effects with datopotamab deruxtecan, things that we don’t normally deal with here. Nausea, stomatitis, alopecia, dry eye, and vomiting. All of those were more than 10% more common in patients that received datopotamab deruxtecan compared to the control. The only things that were more common with the control were neutropenia, leukopenia, and hand-foot syndrome in patients that had capecitabine.
One thing, though, is while you say, “Oh, these weren’t dangerous side effects,” they surely were lifestyle altering. Nobody wants to have these side effects on a daily basis. Again, there’s an increasing awareness about these kinds of lower-grade but still lifestyle-disrupting side effects. When it goes on day after day, you really have to balance that into the benefit you’re going to receive.
I think the second important point is how, when we use this drug, we’re going to have to go to another level to deal with the adverse effects that we are going to see. The first would be nausea and emesis. It is a highly emetogenic regimen based on the NCCN (National Comprehensive Cancer Network) guidelines, so you would need either 3 or 4 antiemetic drugs. That’s number one.
Number two, because of the potential eye problems, you need an eye exam before treatment — and the label says at least annually — with any symptoms. I think it’s very important that you give the patients eyedrops, and in general, the preservative-free eyedrops are the ones that are most effective.
Stomatitis is a very common side effect with that agent. It’s really not seen with the other drugs that even contain the same warhead. There, dexamethasone rinses are important. Now, this is a compounded medicine so you need to be very careful in making sure that you identify pharmacies that will prepare this and will have it available for the patients that need it.
Last, there is the risk of hypersensitivity reactions and there’s a recommendation for premedication for that. As you think about using datopotamab deruxtecan, you need to have all your ducks in a row to treat side effects. You need prophylaxis for hypersensitivity reactions, nausea, and emesis.
The patient will need an eye exam. You need to prepare the patient for possible dry eye and teach them which eyedrops are the best. You also need to ensure the availability of dexamethasone rinses and mouth washes. All that needs to be in place to make sure that the patient can safely use the drug.
I think it’s going to be a useful drug. We don’t yet have a uniformly available way to select patients for its use other than EGFR. I should note that the approval is for EGFR-mutated lung cancers. It doesn’t say which type of mutation, so that would give you some latitude in giving it for exon 20 atypicals as well as for the common sensitizing mutation.
We have another drug. It’s clearly going to be a useful one. It clearly comes with many adverse effects that we don’t normally treat on an everyday basis, we’re used to the diarrhea and skin changes that come on with the EGFR TKIs.
This pattern of side effects is different and requires some additional attention, but with it, the drug can be useful. I’m glad that we have yet another way to fight this disease.
Mark G. Kris, MD, Professor of Medicine, Weill Cornell Medical College; Attending Physician, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York , has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Bristol-Myers Squibb; Merck; Daiichi Sankyo; Received research grant from: National Institute of Health; Received income in an amount equal to or greater than $250 from: AstraZeneca; Bristol-Myers Squibb; Merck; Daiichi Sankyo Others: Editorial support from Genentech
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hello. It’s Mark Kris, from Memorial Sloan Kettering, talking about a birthday gift I received on June 23 when the FDA approved the indication of datopotamab deruxtecan for people with lung cancers. We have another drug, our third ADC (antibody-drug conjugate) to fight lung cancer, so that’s a gift.
Let’s talk a little bit about that agent. It’s an interesting twist in our practice patterns. What can the drug do? It had a response rate of 45%, which is really important in patients that had EGFR mutations with progression on osimertinib. We really need drugs in that space. The duration of response was about 7 months, which is significant.
One interesting thing in the approval, [was] that the response rate of the blinded folks was greater than that in the investigator-assessed response by about 10%. It’s very interesting. Clearly, we have another drug, and we have it in a space where we need it.
Let’s talk a bit about the toxicity. I’m going to focus more on the paper by Bardia et al that compared datopotamab deruxtecan to various chemo drugs in breast cancer, not in lung cancer. You can take this a little bit with a grain of salt.
First, they saw a whole different array of side effects with datopotamab deruxtecan, things that we don’t normally deal with here. Nausea, stomatitis, alopecia, dry eye, and vomiting. All of those were more than 10% more common in patients that received datopotamab deruxtecan compared to the control. The only things that were more common with the control were neutropenia, leukopenia, and hand-foot syndrome in patients that had capecitabine.
One thing, though, is while you say, “Oh, these weren’t dangerous side effects,” they surely were lifestyle altering. Nobody wants to have these side effects on a daily basis. Again, there’s an increasing awareness about these kinds of lower-grade but still lifestyle-disrupting side effects. When it goes on day after day, you really have to balance that into the benefit you’re going to receive.
I think the second important point is how, when we use this drug, we’re going to have to go to another level to deal with the adverse effects that we are going to see. The first would be nausea and emesis. It is a highly emetogenic regimen based on the NCCN (National Comprehensive Cancer Network) guidelines, so you would need either 3 or 4 antiemetic drugs. That’s number one.
Number two, because of the potential eye problems, you need an eye exam before treatment — and the label says at least annually — with any symptoms. I think it’s very important that you give the patients eyedrops, and in general, the preservative-free eyedrops are the ones that are most effective.
Stomatitis is a very common side effect with that agent. It’s really not seen with the other drugs that even contain the same warhead. There, dexamethasone rinses are important. Now, this is a compounded medicine so you need to be very careful in making sure that you identify pharmacies that will prepare this and will have it available for the patients that need it.
Last, there is the risk of hypersensitivity reactions and there’s a recommendation for premedication for that. As you think about using datopotamab deruxtecan, you need to have all your ducks in a row to treat side effects. You need prophylaxis for hypersensitivity reactions, nausea, and emesis.
The patient will need an eye exam. You need to prepare the patient for possible dry eye and teach them which eyedrops are the best. You also need to ensure the availability of dexamethasone rinses and mouth washes. All that needs to be in place to make sure that the patient can safely use the drug.
I think it’s going to be a useful drug. We don’t yet have a uniformly available way to select patients for its use other than EGFR. I should note that the approval is for EGFR-mutated lung cancers. It doesn’t say which type of mutation, so that would give you some latitude in giving it for exon 20 atypicals as well as for the common sensitizing mutation.
We have another drug. It’s clearly going to be a useful one. It clearly comes with many adverse effects that we don’t normally treat on an everyday basis, we’re used to the diarrhea and skin changes that come on with the EGFR TKIs.
This pattern of side effects is different and requires some additional attention, but with it, the drug can be useful. I’m glad that we have yet another way to fight this disease.
Mark G. Kris, MD, Professor of Medicine, Weill Cornell Medical College; Attending Physician, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York , has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Bristol-Myers Squibb; Merck; Daiichi Sankyo; Received research grant from: National Institute of Health; Received income in an amount equal to or greater than $250 from: AstraZeneca; Bristol-Myers Squibb; Merck; Daiichi Sankyo Others: Editorial support from Genentech
A version of this article first appeared on Medscape.com.
New Treatment Guidance Issued for Challenging Overlap of Hypermobility Syndromes and GI Symptoms
to help clinicians comprehend such cases.
“Recognizing and treating GI symptoms in patients with hEDS or hypermobility spectrum disorders and comorbid POTS or MCAS present major challenges for clinicians, who often feel under equipped to address their needs,” AGA reported in the update, published in Clinical Gastroenterology and Hepatology.
Importantly, “the poor understanding of these overlapping syndromes can lead to nonstandardized approaches to diagnostic evaluation and management,” the authors noted.
“Gastroenterology providers should be aware of the features of [these syndromes] to recognize the full complexity of patients presenting with multisystemic symptoms.”
Hypermobility spectrum disorders, which include hEDS, are typically genetic, and patients experience pain along with joint hypermobility, or extreme flexibility of joints beyond the normal range of motion.
With research showing that most of those patients — up to 98% — also experience GI symptoms, gastroenterologists may be encountering them more commonly than realized, Lucinda A. Harris, MD, AGAF, of the Mayo Clinic School of Medicine, in Scottsdale, Arizona, explained to GI & Hepatology News.
“As our knowledge in gastroenterology has progressed, we realize that hypermobility itself predisposes individuals to disorders of brain-gut interaction,” she said. “We may only be seeing the tip of the iceberg when it comes to diagnosing patients with hypermobility.”
Additionally, “many of these patients have POTS, which has also been increasingly diagnosed,” Harris added. “The strong overlap of these conditions prompted us to present this data.”
With a lack of evidence-based understanding of the overlapping syndromes, AGA’s guidance does not carry formal ratings but is drawn from a review of the published literature and expert opinion.
In addition to the key recommendation of being aware of the observed combination of syndromes, their recommendations include:
- Regarding testing: Testing for POTS/MCAS should be targeted to patients presenting with clinical manifestations of the disorders, but universal testing for POTS/MCAS in all patients with hEDS or hypermobility spectrum disorders is not currently supported by the evidence, the guidance advises.
- Gastroenterologists seeing patients with disorders of gut-brain interaction should inquire about joint hypermobility and strongly consider incorporating the Beighton score for assessing joint hypermobility into their practice as a screening tool; if the screen is positive, gastroenterologists may consider applying 2017 diagnostic criteria to diagnose hEDS or offer appropriate referral to a specialist where resources are available, the AGA recommends.
- Medical management: Management of GI symptoms in hEDS or hypermobility spectrum disorders and POTS/MCAS should focus on treating the most prominent GI symptoms and abnormal GI function test results.
- In addition to general disorders of gut-brain interactions and GI motility disorder treatment, management should also include treating any symptoms attributable to POTS and/or MCAS.
Treatment of POTS may include increasing fluid and salt intake, exercise training, and use of compression garments. Special pharmacological treatments for volume expansion, heart rate control, and vasoconstriction with integrated care from multiple specialties (eg, cardiology, neurology) should be considered in patients who do not respond to conservative lifestyle measures.
In patients presenting to gastroenterology providers, testing for mast cell disorders including MCAS should be considered in patients with hEDS or hypermobility spectrum disorders and disorders of gut-brain interaction with episodic symptoms that suggest a more generalized mast cell disorder involving two or more physiological systems. However, current data does not support the use of these tests for routine evaluation of GI symptoms in all patients with hEDS or hypermobility spectrum disorders without clinical or laboratory evidence of a primary or secondary mast cell disorder, the authors noted.
Harris explained that patients presenting with gut-brain disorders are often mistakenly classified as having irritable bowel syndrome or dyspepsia, whereas these conditions may be affecting the GI disorders they have.
“For example, a patient with Ehlers-Danlos syndrome might have problems with constipation, which is impacted by pelvic floor dysfunction,” she said. “Due to their hypermobility, they may experience more pelvic floor descent than usual.”
“If we do not recognize this, the patient risks developing rectal prolapse or not effectively addressing their constipation.”
Regarding patient characteristics, Harris said that those with hEDS and POTS appear to more likely be women and tend to present in younger patients, aged 18-50 years. Of note, there is no genetic test for hEDS.
“The take-home point for clinicians should be to consider POTS and Ehlers-Danlos syndrome when encountering young female patients with symptoms of palpitations, hypermobility, and orthostatic intolerance,” she said.
“Recognizing hypermobility is crucial, not only for GI symptoms but also to prevent joint dislocations, tendon ruptures, and other connective tissue issues.”
Clinicians are further urged to “offer informed counseling, and guide patients away from unreliable sources or fragmented care to foster therapeutic relationships and evidence-based care,” the authors added.
Deciphering Gut-Brain Disorder Challenges
Commenting to GI & Hepatology News, Clair Francomano, MD, a professor of medical and molecular genetics at the Indiana University School of Medicine, in Indianapolis, said the new guidance sheds important light on the syndromes.
“I’m delighted to see this guidance offered through the AGA as it will encourage gastroenterologists to think of EDS, POTS and MCAS when they are evaluating patients with disorders of gut-brain interaction,” Francomano said.
“This should allow patients to receive more accurate and timely diagnoses and appropriate management.”
Francomano noted that the Ehlers-Danlos Society, which provides information for clinicians and patients alike on the syndromes, and where she serves on the medical scientific board, has also been active in raising awareness.
“While co-occurrence of POTS and MCAS with EDS has in fact been recognized for many years, I do think awareness is increasing, in large part due to the advocacy and educational efforts of the Ehlers-Danlos Society,” she said.
The take-home message? “When clinicians see disorders of the gut-brain axis, POTS or MCAS, they should be thinking, ‘Could this be related to joint hypermobility or Ehlers-Danlos syndrome?’” Francomano said.
Harris reported serving as a consultant for AbbVie, Ardelyx, Salix, and Gemelli Biotech and reported receiving research support from Takeda and Anyx. Francomano did not report any relevant disclosures.
A version of this article appeared on Medscape.com.
to help clinicians comprehend such cases.
“Recognizing and treating GI symptoms in patients with hEDS or hypermobility spectrum disorders and comorbid POTS or MCAS present major challenges for clinicians, who often feel under equipped to address their needs,” AGA reported in the update, published in Clinical Gastroenterology and Hepatology.
Importantly, “the poor understanding of these overlapping syndromes can lead to nonstandardized approaches to diagnostic evaluation and management,” the authors noted.
“Gastroenterology providers should be aware of the features of [these syndromes] to recognize the full complexity of patients presenting with multisystemic symptoms.”
Hypermobility spectrum disorders, which include hEDS, are typically genetic, and patients experience pain along with joint hypermobility, or extreme flexibility of joints beyond the normal range of motion.
With research showing that most of those patients — up to 98% — also experience GI symptoms, gastroenterologists may be encountering them more commonly than realized, Lucinda A. Harris, MD, AGAF, of the Mayo Clinic School of Medicine, in Scottsdale, Arizona, explained to GI & Hepatology News.
“As our knowledge in gastroenterology has progressed, we realize that hypermobility itself predisposes individuals to disorders of brain-gut interaction,” she said. “We may only be seeing the tip of the iceberg when it comes to diagnosing patients with hypermobility.”
Additionally, “many of these patients have POTS, which has also been increasingly diagnosed,” Harris added. “The strong overlap of these conditions prompted us to present this data.”
With a lack of evidence-based understanding of the overlapping syndromes, AGA’s guidance does not carry formal ratings but is drawn from a review of the published literature and expert opinion.
In addition to the key recommendation of being aware of the observed combination of syndromes, their recommendations include:
- Regarding testing: Testing for POTS/MCAS should be targeted to patients presenting with clinical manifestations of the disorders, but universal testing for POTS/MCAS in all patients with hEDS or hypermobility spectrum disorders is not currently supported by the evidence, the guidance advises.
- Gastroenterologists seeing patients with disorders of gut-brain interaction should inquire about joint hypermobility and strongly consider incorporating the Beighton score for assessing joint hypermobility into their practice as a screening tool; if the screen is positive, gastroenterologists may consider applying 2017 diagnostic criteria to diagnose hEDS or offer appropriate referral to a specialist where resources are available, the AGA recommends.
- Medical management: Management of GI symptoms in hEDS or hypermobility spectrum disorders and POTS/MCAS should focus on treating the most prominent GI symptoms and abnormal GI function test results.
- In addition to general disorders of gut-brain interactions and GI motility disorder treatment, management should also include treating any symptoms attributable to POTS and/or MCAS.
Treatment of POTS may include increasing fluid and salt intake, exercise training, and use of compression garments. Special pharmacological treatments for volume expansion, heart rate control, and vasoconstriction with integrated care from multiple specialties (eg, cardiology, neurology) should be considered in patients who do not respond to conservative lifestyle measures.
In patients presenting to gastroenterology providers, testing for mast cell disorders including MCAS should be considered in patients with hEDS or hypermobility spectrum disorders and disorders of gut-brain interaction with episodic symptoms that suggest a more generalized mast cell disorder involving two or more physiological systems. However, current data does not support the use of these tests for routine evaluation of GI symptoms in all patients with hEDS or hypermobility spectrum disorders without clinical or laboratory evidence of a primary or secondary mast cell disorder, the authors noted.
Harris explained that patients presenting with gut-brain disorders are often mistakenly classified as having irritable bowel syndrome or dyspepsia, whereas these conditions may be affecting the GI disorders they have.
“For example, a patient with Ehlers-Danlos syndrome might have problems with constipation, which is impacted by pelvic floor dysfunction,” she said. “Due to their hypermobility, they may experience more pelvic floor descent than usual.”
“If we do not recognize this, the patient risks developing rectal prolapse or not effectively addressing their constipation.”
Regarding patient characteristics, Harris said that those with hEDS and POTS appear to more likely be women and tend to present in younger patients, aged 18-50 years. Of note, there is no genetic test for hEDS.
“The take-home point for clinicians should be to consider POTS and Ehlers-Danlos syndrome when encountering young female patients with symptoms of palpitations, hypermobility, and orthostatic intolerance,” she said.
“Recognizing hypermobility is crucial, not only for GI symptoms but also to prevent joint dislocations, tendon ruptures, and other connective tissue issues.”
Clinicians are further urged to “offer informed counseling, and guide patients away from unreliable sources or fragmented care to foster therapeutic relationships and evidence-based care,” the authors added.
Deciphering Gut-Brain Disorder Challenges
Commenting to GI & Hepatology News, Clair Francomano, MD, a professor of medical and molecular genetics at the Indiana University School of Medicine, in Indianapolis, said the new guidance sheds important light on the syndromes.
“I’m delighted to see this guidance offered through the AGA as it will encourage gastroenterologists to think of EDS, POTS and MCAS when they are evaluating patients with disorders of gut-brain interaction,” Francomano said.
“This should allow patients to receive more accurate and timely diagnoses and appropriate management.”
Francomano noted that the Ehlers-Danlos Society, which provides information for clinicians and patients alike on the syndromes, and where she serves on the medical scientific board, has also been active in raising awareness.
“While co-occurrence of POTS and MCAS with EDS has in fact been recognized for many years, I do think awareness is increasing, in large part due to the advocacy and educational efforts of the Ehlers-Danlos Society,” she said.
The take-home message? “When clinicians see disorders of the gut-brain axis, POTS or MCAS, they should be thinking, ‘Could this be related to joint hypermobility or Ehlers-Danlos syndrome?’” Francomano said.
Harris reported serving as a consultant for AbbVie, Ardelyx, Salix, and Gemelli Biotech and reported receiving research support from Takeda and Anyx. Francomano did not report any relevant disclosures.
A version of this article appeared on Medscape.com.
to help clinicians comprehend such cases.
“Recognizing and treating GI symptoms in patients with hEDS or hypermobility spectrum disorders and comorbid POTS or MCAS present major challenges for clinicians, who often feel under equipped to address their needs,” AGA reported in the update, published in Clinical Gastroenterology and Hepatology.
Importantly, “the poor understanding of these overlapping syndromes can lead to nonstandardized approaches to diagnostic evaluation and management,” the authors noted.
“Gastroenterology providers should be aware of the features of [these syndromes] to recognize the full complexity of patients presenting with multisystemic symptoms.”
Hypermobility spectrum disorders, which include hEDS, are typically genetic, and patients experience pain along with joint hypermobility, or extreme flexibility of joints beyond the normal range of motion.
With research showing that most of those patients — up to 98% — also experience GI symptoms, gastroenterologists may be encountering them more commonly than realized, Lucinda A. Harris, MD, AGAF, of the Mayo Clinic School of Medicine, in Scottsdale, Arizona, explained to GI & Hepatology News.
“As our knowledge in gastroenterology has progressed, we realize that hypermobility itself predisposes individuals to disorders of brain-gut interaction,” she said. “We may only be seeing the tip of the iceberg when it comes to diagnosing patients with hypermobility.”
Additionally, “many of these patients have POTS, which has also been increasingly diagnosed,” Harris added. “The strong overlap of these conditions prompted us to present this data.”
With a lack of evidence-based understanding of the overlapping syndromes, AGA’s guidance does not carry formal ratings but is drawn from a review of the published literature and expert opinion.
In addition to the key recommendation of being aware of the observed combination of syndromes, their recommendations include:
- Regarding testing: Testing for POTS/MCAS should be targeted to patients presenting with clinical manifestations of the disorders, but universal testing for POTS/MCAS in all patients with hEDS or hypermobility spectrum disorders is not currently supported by the evidence, the guidance advises.
- Gastroenterologists seeing patients with disorders of gut-brain interaction should inquire about joint hypermobility and strongly consider incorporating the Beighton score for assessing joint hypermobility into their practice as a screening tool; if the screen is positive, gastroenterologists may consider applying 2017 diagnostic criteria to diagnose hEDS or offer appropriate referral to a specialist where resources are available, the AGA recommends.
- Medical management: Management of GI symptoms in hEDS or hypermobility spectrum disorders and POTS/MCAS should focus on treating the most prominent GI symptoms and abnormal GI function test results.
- In addition to general disorders of gut-brain interactions and GI motility disorder treatment, management should also include treating any symptoms attributable to POTS and/or MCAS.
Treatment of POTS may include increasing fluid and salt intake, exercise training, and use of compression garments. Special pharmacological treatments for volume expansion, heart rate control, and vasoconstriction with integrated care from multiple specialties (eg, cardiology, neurology) should be considered in patients who do not respond to conservative lifestyle measures.
In patients presenting to gastroenterology providers, testing for mast cell disorders including MCAS should be considered in patients with hEDS or hypermobility spectrum disorders and disorders of gut-brain interaction with episodic symptoms that suggest a more generalized mast cell disorder involving two or more physiological systems. However, current data does not support the use of these tests for routine evaluation of GI symptoms in all patients with hEDS or hypermobility spectrum disorders without clinical or laboratory evidence of a primary or secondary mast cell disorder, the authors noted.
Harris explained that patients presenting with gut-brain disorders are often mistakenly classified as having irritable bowel syndrome or dyspepsia, whereas these conditions may be affecting the GI disorders they have.
“For example, a patient with Ehlers-Danlos syndrome might have problems with constipation, which is impacted by pelvic floor dysfunction,” she said. “Due to their hypermobility, they may experience more pelvic floor descent than usual.”
“If we do not recognize this, the patient risks developing rectal prolapse or not effectively addressing their constipation.”
Regarding patient characteristics, Harris said that those with hEDS and POTS appear to more likely be women and tend to present in younger patients, aged 18-50 years. Of note, there is no genetic test for hEDS.
“The take-home point for clinicians should be to consider POTS and Ehlers-Danlos syndrome when encountering young female patients with symptoms of palpitations, hypermobility, and orthostatic intolerance,” she said.
“Recognizing hypermobility is crucial, not only for GI symptoms but also to prevent joint dislocations, tendon ruptures, and other connective tissue issues.”
Clinicians are further urged to “offer informed counseling, and guide patients away from unreliable sources or fragmented care to foster therapeutic relationships and evidence-based care,” the authors added.
Deciphering Gut-Brain Disorder Challenges
Commenting to GI & Hepatology News, Clair Francomano, MD, a professor of medical and molecular genetics at the Indiana University School of Medicine, in Indianapolis, said the new guidance sheds important light on the syndromes.
“I’m delighted to see this guidance offered through the AGA as it will encourage gastroenterologists to think of EDS, POTS and MCAS when they are evaluating patients with disorders of gut-brain interaction,” Francomano said.
“This should allow patients to receive more accurate and timely diagnoses and appropriate management.”
Francomano noted that the Ehlers-Danlos Society, which provides information for clinicians and patients alike on the syndromes, and where she serves on the medical scientific board, has also been active in raising awareness.
“While co-occurrence of POTS and MCAS with EDS has in fact been recognized for many years, I do think awareness is increasing, in large part due to the advocacy and educational efforts of the Ehlers-Danlos Society,” she said.
The take-home message? “When clinicians see disorders of the gut-brain axis, POTS or MCAS, they should be thinking, ‘Could this be related to joint hypermobility or Ehlers-Danlos syndrome?’” Francomano said.
Harris reported serving as a consultant for AbbVie, Ardelyx, Salix, and Gemelli Biotech and reported receiving research support from Takeda and Anyx. Francomano did not report any relevant disclosures.
A version of this article appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY