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Long-Term Data Support Reduced-Dose Maintenance in EoE

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Biologic and corticosteroid maintenance therapies for eosinophilic esophagitis (EoE) are generally safe and effective, even at reduced doses, according to a recent meta-analysis of long-term data.

These findings support keeping patients on long-term maintenance therapy to prevent relapse, lead author Alberto Barchi, MD, of IRCCS Ospedale San Raffaele, Milan, Italy, and colleagues, reported.

Dr. Alberto Barchi



“Given the high relapse rate after treatment cessation, despite good initial response after induction, there is need for further information about long-term outcomes of maintenance treatments,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, few studies have focused on long-term effects of EoE therapies.”

In response, Dr. Barchi and colleagues conducted the present systematic review and meta-analysis, which included studies evaluating maintenance therapies for EoE with at least 48 weeks of follow-up. Eligible studies enrolled patients with confirmed EoE who had received an induction regimen and continued therapy long-term. The final dataset comprised 9 randomized controlled trials (RCTs) and 11 observational studies, with long-term outcomes were reported among 1,819 patients.

The primary outcome was histologic success, defined as fewer than 15 or 6 eosinophils per high-power field (HPF). Secondary outcomes included clinical and endoscopic response, treatment adherence, and safety events.

Random-effects meta-analyses were performed, with randomized trials and observational studies analyzed separately. Risk ratios for sustained remission versus placebo or induction therapy were calculated, and heterogeneity was assessed using the I² statistic. Safety outcomes included pooled rates of adverse events, severe adverse events, and treatment discontinuation.

Across 9 randomized controlled trials, swallowed topical corticosteroids (STCs) maintained histologic remission (less than 15 eosinophils/HPF) in 86% of patients, while biologics achieved a rate of 79%. At the stricter threshold of less than 6 eosinophils/HPF, remission rates for STCs and biologics were 59% and 70%, respectively.

Clinical remission rates were lower, at 58% for STCs and 59% for biologics. Endoscopic outcomes were less consistent-ly reported, but most trials showed stable or improved scores during long-term treatment.

In observational cohorts, proton pump inhibitors (PPIs) maintained histologic remission in 64% of patients and clinical remission in 80%. For STCs in the real-world setting, histologic and clinical remission rates were 49% and 51%, respectively.

Stepping down the dose of maintenance therapy—whether conventional or biologic—did not increase relapse risk (RR 1.04; 95% CI, 0.72–1.51). In contrast, treatment withdrawal was clearly associated with higher relapse rates: in pooled analyses, continuing therapy yielded nearly an 8-fold greater likelihood of sustained remission compared with discontinuation (RR 7.87; 95% CI, 4.19–14.77).

Safety signals were favorable. Severe adverse events occurred in 3% of patients in randomized trials and 5% in observational studies, while overall withdrawal rates were 10% and 4%, respectively. The most common adverse events with STCs were oropharyngeal candidiasis and reductions in morning cortisol, while biologics were mainly associated with injection-site reactions, headache, and nasopharyngitis.

“Results suggest that prolonging treatment is efficient in maintaining histologic and clinical remission, with overall drug-related safe profiles both in randomized trials and observational studies,” the investigators concluded, noting that more work is needed to determine if there is an optimal drug for maintenance therapy, and if certain patients can successfully discontinue treatment.

The investigators disclosed relationships with Pfizer, UCB Pharma, AstraZeneca, and others.
 

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Biologic and corticosteroid maintenance therapies for eosinophilic esophagitis (EoE) are generally safe and effective, even at reduced doses, according to a recent meta-analysis of long-term data.

These findings support keeping patients on long-term maintenance therapy to prevent relapse, lead author Alberto Barchi, MD, of IRCCS Ospedale San Raffaele, Milan, Italy, and colleagues, reported.

Dr. Alberto Barchi



“Given the high relapse rate after treatment cessation, despite good initial response after induction, there is need for further information about long-term outcomes of maintenance treatments,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, few studies have focused on long-term effects of EoE therapies.”

In response, Dr. Barchi and colleagues conducted the present systematic review and meta-analysis, which included studies evaluating maintenance therapies for EoE with at least 48 weeks of follow-up. Eligible studies enrolled patients with confirmed EoE who had received an induction regimen and continued therapy long-term. The final dataset comprised 9 randomized controlled trials (RCTs) and 11 observational studies, with long-term outcomes were reported among 1,819 patients.

The primary outcome was histologic success, defined as fewer than 15 or 6 eosinophils per high-power field (HPF). Secondary outcomes included clinical and endoscopic response, treatment adherence, and safety events.

Random-effects meta-analyses were performed, with randomized trials and observational studies analyzed separately. Risk ratios for sustained remission versus placebo or induction therapy were calculated, and heterogeneity was assessed using the I² statistic. Safety outcomes included pooled rates of adverse events, severe adverse events, and treatment discontinuation.

Across 9 randomized controlled trials, swallowed topical corticosteroids (STCs) maintained histologic remission (less than 15 eosinophils/HPF) in 86% of patients, while biologics achieved a rate of 79%. At the stricter threshold of less than 6 eosinophils/HPF, remission rates for STCs and biologics were 59% and 70%, respectively.

Clinical remission rates were lower, at 58% for STCs and 59% for biologics. Endoscopic outcomes were less consistent-ly reported, but most trials showed stable or improved scores during long-term treatment.

In observational cohorts, proton pump inhibitors (PPIs) maintained histologic remission in 64% of patients and clinical remission in 80%. For STCs in the real-world setting, histologic and clinical remission rates were 49% and 51%, respectively.

Stepping down the dose of maintenance therapy—whether conventional or biologic—did not increase relapse risk (RR 1.04; 95% CI, 0.72–1.51). In contrast, treatment withdrawal was clearly associated with higher relapse rates: in pooled analyses, continuing therapy yielded nearly an 8-fold greater likelihood of sustained remission compared with discontinuation (RR 7.87; 95% CI, 4.19–14.77).

Safety signals were favorable. Severe adverse events occurred in 3% of patients in randomized trials and 5% in observational studies, while overall withdrawal rates were 10% and 4%, respectively. The most common adverse events with STCs were oropharyngeal candidiasis and reductions in morning cortisol, while biologics were mainly associated with injection-site reactions, headache, and nasopharyngitis.

“Results suggest that prolonging treatment is efficient in maintaining histologic and clinical remission, with overall drug-related safe profiles both in randomized trials and observational studies,” the investigators concluded, noting that more work is needed to determine if there is an optimal drug for maintenance therapy, and if certain patients can successfully discontinue treatment.

The investigators disclosed relationships with Pfizer, UCB Pharma, AstraZeneca, and others.
 

Biologic and corticosteroid maintenance therapies for eosinophilic esophagitis (EoE) are generally safe and effective, even at reduced doses, according to a recent meta-analysis of long-term data.

These findings support keeping patients on long-term maintenance therapy to prevent relapse, lead author Alberto Barchi, MD, of IRCCS Ospedale San Raffaele, Milan, Italy, and colleagues, reported.

Dr. Alberto Barchi



“Given the high relapse rate after treatment cessation, despite good initial response after induction, there is need for further information about long-term outcomes of maintenance treatments,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, few studies have focused on long-term effects of EoE therapies.”

In response, Dr. Barchi and colleagues conducted the present systematic review and meta-analysis, which included studies evaluating maintenance therapies for EoE with at least 48 weeks of follow-up. Eligible studies enrolled patients with confirmed EoE who had received an induction regimen and continued therapy long-term. The final dataset comprised 9 randomized controlled trials (RCTs) and 11 observational studies, with long-term outcomes were reported among 1,819 patients.

The primary outcome was histologic success, defined as fewer than 15 or 6 eosinophils per high-power field (HPF). Secondary outcomes included clinical and endoscopic response, treatment adherence, and safety events.

Random-effects meta-analyses were performed, with randomized trials and observational studies analyzed separately. Risk ratios for sustained remission versus placebo or induction therapy were calculated, and heterogeneity was assessed using the I² statistic. Safety outcomes included pooled rates of adverse events, severe adverse events, and treatment discontinuation.

Across 9 randomized controlled trials, swallowed topical corticosteroids (STCs) maintained histologic remission (less than 15 eosinophils/HPF) in 86% of patients, while biologics achieved a rate of 79%. At the stricter threshold of less than 6 eosinophils/HPF, remission rates for STCs and biologics were 59% and 70%, respectively.

Clinical remission rates were lower, at 58% for STCs and 59% for biologics. Endoscopic outcomes were less consistent-ly reported, but most trials showed stable or improved scores during long-term treatment.

In observational cohorts, proton pump inhibitors (PPIs) maintained histologic remission in 64% of patients and clinical remission in 80%. For STCs in the real-world setting, histologic and clinical remission rates were 49% and 51%, respectively.

Stepping down the dose of maintenance therapy—whether conventional or biologic—did not increase relapse risk (RR 1.04; 95% CI, 0.72–1.51). In contrast, treatment withdrawal was clearly associated with higher relapse rates: in pooled analyses, continuing therapy yielded nearly an 8-fold greater likelihood of sustained remission compared with discontinuation (RR 7.87; 95% CI, 4.19–14.77).

Safety signals were favorable. Severe adverse events occurred in 3% of patients in randomized trials and 5% in observational studies, while overall withdrawal rates were 10% and 4%, respectively. The most common adverse events with STCs were oropharyngeal candidiasis and reductions in morning cortisol, while biologics were mainly associated with injection-site reactions, headache, and nasopharyngitis.

“Results suggest that prolonging treatment is efficient in maintaining histologic and clinical remission, with overall drug-related safe profiles both in randomized trials and observational studies,” the investigators concluded, noting that more work is needed to determine if there is an optimal drug for maintenance therapy, and if certain patients can successfully discontinue treatment.

The investigators disclosed relationships with Pfizer, UCB Pharma, AstraZeneca, and others.
 

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Simpler Approach Increases Diagnostic Accuracy of Timed Barium Esophagram for Achalasia

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Thu, 10/02/2025 - 15:24

Interpreting timed barium esophagram (TBE) results with a multimetric classification tree is more accurate for identifying disorders of achalasia than conventional interpretation, according to investigators.

The classification tree offers a practical alternative for evaluating esophagogastric junction (EGJ) outflow disorders when more advanced methods like high-resolution manometry (HRM) or functional lumen imaging probe (FLIP) panometry are unavailable, lead author Ofer Z. Fass, MD, of Northwestern University, Chicago, and colleagues reported.

“[T]here are limited data on normative TBE values,” the investigators wrote in Gastroenterology. “Furthermore, data supporting the accuracy of TBE as a screening test for esophageal motility disorders, as well as clinically relevant test thresholds, remains limited.”

TBE is conventionally interpreted using a handful of single measurements, most often the barium column height at 1, 2, or 5 minutes. Although these metrics are simple to obtain, variability in technique, cutoff values, and interpretation across centers limits reproducibility and weakens diagnostic accuracy, according to the investigators. The role of TBE has therefore been largely confined to adjudicating inconclusive manometry findings, but even in that setting, the absence of validated reference standards constrains its utility as a reliable screening tool.

To address this gap, Fass and colleagues conducted a prospective analysis of 290 patients who underwent TBE at Northwestern Memorial Hospital, Chicago, with HRM and FLIP panometry, interpreted according to the Chicago Classification version 4.0 (CCv4.0), serving as the diagnostic reference standards.

Patients were included if they had both TBE and manometry performed within a short interval, ensuring that the two tests could be meaningfully compared. The study population represented a broad spectrum of esophageal motility presentations, allowing the model to be trained on clinically relevant variation.

Beyond column height, the investigators measured barium height at multiple timepoints, maximal esophageal body width, maximum EGJ diameter, and tablet passage. These variables were incorporated into a recursive partitioning algorithm to build a multimetric classification tree aimed at distinguishing EGJ outflow obstruction from other motility disorders.

The optimal tree incorporated three sequential decision levels. At the top was maximum esophageal body width, followed by EGJ diameter and barium height at the second level, and tablet passage at the third. This stepwise structure allowed the model to refine diagnoses by combining simple, reproducible TBE metrics that are already collected in routine practice.

Among the 290 patients, 121 (42%) had EGJ outflow disorders, 151 (52%) had no outflow disorder, and 18 (6%) had inconclusive manometry findings. Using conventional interpretation with column height and tablet passage, TBE demonstrated a sensitivity of 77.8%, a specificity of 86.0%, and an accuracy of 82.2%. The multimetric classification tree improved diagnostic performance across all parameters, with a sensitivity of 84.2%, a specificity of 92.1%, and an accuracy of 88.3%.

The advantages of multimetric interpretation were most notable in patients with borderline column heights, which single-metric approaches often misclassify, underscoring the value of integrating multiple measurements into a unified model.

“[T]his study demonstrated that TBE can accurately identify achalasia when analyzed using multiple metrics in a classification tree model,” Fass and colleagues wrote. “Future studies should explore the use of TBE metrics and models to identify more specific esophageal motor disorders (such as esophageal spasm and absent contractility), as well as validation in a larger, multicenter cohort.”

 

Clinical Takeaways

Rishi Naik, MD, of the Center for Swallowing and Esophageal Disorders, Vanderbilt University Medical Center, Nashville, Tennessee, said the study represents a step forward in how clinicians can use a widely accessible esophageal imaging test.

“This study is important in that it has updated the way we use a very common, readily available imaging test and compared it to the current gold standard of HRM and FLIP,” he told GI & Hepatology News. “This provides a practical, standardized framework for clinicians evaluating patients with suspected esophageal motility disorders.”

Naik noted that while HRM and FLIP provide highly detailed information, both carry drawbacks that limit their universal adoption.

“Practically, HRM is a transnasal test that can be cumbersome, and FLIP is performed during a sedated procedure,” he said. “From a comfort and cost perspective, the esophagram outcompetes. What the TBE lacked was adequate sensitivity and specificity when just looking at column height, which is how the authors overcame this by leveraging the comparisons using CCv4.0.”

Implementation, however, requires discipline.

“A timed barium esophagram is a protocol, not a single esophagram,” Naik said. “Without proper measurements, you can’t follow the decision tree.”

Still, he pointed to radiology’s increasing adoption of artificial intelligence (AI) as a promising way forward.

“AI has already transformed radiological reads, and I’m optimistic it will eventually allow us to incorporate not only width, height, and tablet clearance but also 3D [three-dimensional] reconstructions of bolus retention and pressure to enhance predictive modeling,” Naik said.

This study was supported by the Public Health Service.

The investigators disclosed having relationships with Takeda, Phathom Pharmaceuticals, Medtronic, and others. Naik is a consultant for Sanofi/Regeneron, Eli Lilly and Company, and Renexxion.

A version of this article appeared on Medscape.com.

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Interpreting timed barium esophagram (TBE) results with a multimetric classification tree is more accurate for identifying disorders of achalasia than conventional interpretation, according to investigators.

The classification tree offers a practical alternative for evaluating esophagogastric junction (EGJ) outflow disorders when more advanced methods like high-resolution manometry (HRM) or functional lumen imaging probe (FLIP) panometry are unavailable, lead author Ofer Z. Fass, MD, of Northwestern University, Chicago, and colleagues reported.

“[T]here are limited data on normative TBE values,” the investigators wrote in Gastroenterology. “Furthermore, data supporting the accuracy of TBE as a screening test for esophageal motility disorders, as well as clinically relevant test thresholds, remains limited.”

TBE is conventionally interpreted using a handful of single measurements, most often the barium column height at 1, 2, or 5 minutes. Although these metrics are simple to obtain, variability in technique, cutoff values, and interpretation across centers limits reproducibility and weakens diagnostic accuracy, according to the investigators. The role of TBE has therefore been largely confined to adjudicating inconclusive manometry findings, but even in that setting, the absence of validated reference standards constrains its utility as a reliable screening tool.

To address this gap, Fass and colleagues conducted a prospective analysis of 290 patients who underwent TBE at Northwestern Memorial Hospital, Chicago, with HRM and FLIP panometry, interpreted according to the Chicago Classification version 4.0 (CCv4.0), serving as the diagnostic reference standards.

Patients were included if they had both TBE and manometry performed within a short interval, ensuring that the two tests could be meaningfully compared. The study population represented a broad spectrum of esophageal motility presentations, allowing the model to be trained on clinically relevant variation.

Beyond column height, the investigators measured barium height at multiple timepoints, maximal esophageal body width, maximum EGJ diameter, and tablet passage. These variables were incorporated into a recursive partitioning algorithm to build a multimetric classification tree aimed at distinguishing EGJ outflow obstruction from other motility disorders.

The optimal tree incorporated three sequential decision levels. At the top was maximum esophageal body width, followed by EGJ diameter and barium height at the second level, and tablet passage at the third. This stepwise structure allowed the model to refine diagnoses by combining simple, reproducible TBE metrics that are already collected in routine practice.

Among the 290 patients, 121 (42%) had EGJ outflow disorders, 151 (52%) had no outflow disorder, and 18 (6%) had inconclusive manometry findings. Using conventional interpretation with column height and tablet passage, TBE demonstrated a sensitivity of 77.8%, a specificity of 86.0%, and an accuracy of 82.2%. The multimetric classification tree improved diagnostic performance across all parameters, with a sensitivity of 84.2%, a specificity of 92.1%, and an accuracy of 88.3%.

The advantages of multimetric interpretation were most notable in patients with borderline column heights, which single-metric approaches often misclassify, underscoring the value of integrating multiple measurements into a unified model.

“[T]his study demonstrated that TBE can accurately identify achalasia when analyzed using multiple metrics in a classification tree model,” Fass and colleagues wrote. “Future studies should explore the use of TBE metrics and models to identify more specific esophageal motor disorders (such as esophageal spasm and absent contractility), as well as validation in a larger, multicenter cohort.”

 

Clinical Takeaways

Rishi Naik, MD, of the Center for Swallowing and Esophageal Disorders, Vanderbilt University Medical Center, Nashville, Tennessee, said the study represents a step forward in how clinicians can use a widely accessible esophageal imaging test.

“This study is important in that it has updated the way we use a very common, readily available imaging test and compared it to the current gold standard of HRM and FLIP,” he told GI & Hepatology News. “This provides a practical, standardized framework for clinicians evaluating patients with suspected esophageal motility disorders.”

Naik noted that while HRM and FLIP provide highly detailed information, both carry drawbacks that limit their universal adoption.

“Practically, HRM is a transnasal test that can be cumbersome, and FLIP is performed during a sedated procedure,” he said. “From a comfort and cost perspective, the esophagram outcompetes. What the TBE lacked was adequate sensitivity and specificity when just looking at column height, which is how the authors overcame this by leveraging the comparisons using CCv4.0.”

Implementation, however, requires discipline.

“A timed barium esophagram is a protocol, not a single esophagram,” Naik said. “Without proper measurements, you can’t follow the decision tree.”

Still, he pointed to radiology’s increasing adoption of artificial intelligence (AI) as a promising way forward.

“AI has already transformed radiological reads, and I’m optimistic it will eventually allow us to incorporate not only width, height, and tablet clearance but also 3D [three-dimensional] reconstructions of bolus retention and pressure to enhance predictive modeling,” Naik said.

This study was supported by the Public Health Service.

The investigators disclosed having relationships with Takeda, Phathom Pharmaceuticals, Medtronic, and others. Naik is a consultant for Sanofi/Regeneron, Eli Lilly and Company, and Renexxion.

A version of this article appeared on Medscape.com.

Interpreting timed barium esophagram (TBE) results with a multimetric classification tree is more accurate for identifying disorders of achalasia than conventional interpretation, according to investigators.

The classification tree offers a practical alternative for evaluating esophagogastric junction (EGJ) outflow disorders when more advanced methods like high-resolution manometry (HRM) or functional lumen imaging probe (FLIP) panometry are unavailable, lead author Ofer Z. Fass, MD, of Northwestern University, Chicago, and colleagues reported.

“[T]here are limited data on normative TBE values,” the investigators wrote in Gastroenterology. “Furthermore, data supporting the accuracy of TBE as a screening test for esophageal motility disorders, as well as clinically relevant test thresholds, remains limited.”

TBE is conventionally interpreted using a handful of single measurements, most often the barium column height at 1, 2, or 5 minutes. Although these metrics are simple to obtain, variability in technique, cutoff values, and interpretation across centers limits reproducibility and weakens diagnostic accuracy, according to the investigators. The role of TBE has therefore been largely confined to adjudicating inconclusive manometry findings, but even in that setting, the absence of validated reference standards constrains its utility as a reliable screening tool.

To address this gap, Fass and colleagues conducted a prospective analysis of 290 patients who underwent TBE at Northwestern Memorial Hospital, Chicago, with HRM and FLIP panometry, interpreted according to the Chicago Classification version 4.0 (CCv4.0), serving as the diagnostic reference standards.

Patients were included if they had both TBE and manometry performed within a short interval, ensuring that the two tests could be meaningfully compared. The study population represented a broad spectrum of esophageal motility presentations, allowing the model to be trained on clinically relevant variation.

Beyond column height, the investigators measured barium height at multiple timepoints, maximal esophageal body width, maximum EGJ diameter, and tablet passage. These variables were incorporated into a recursive partitioning algorithm to build a multimetric classification tree aimed at distinguishing EGJ outflow obstruction from other motility disorders.

The optimal tree incorporated three sequential decision levels. At the top was maximum esophageal body width, followed by EGJ diameter and barium height at the second level, and tablet passage at the third. This stepwise structure allowed the model to refine diagnoses by combining simple, reproducible TBE metrics that are already collected in routine practice.

Among the 290 patients, 121 (42%) had EGJ outflow disorders, 151 (52%) had no outflow disorder, and 18 (6%) had inconclusive manometry findings. Using conventional interpretation with column height and tablet passage, TBE demonstrated a sensitivity of 77.8%, a specificity of 86.0%, and an accuracy of 82.2%. The multimetric classification tree improved diagnostic performance across all parameters, with a sensitivity of 84.2%, a specificity of 92.1%, and an accuracy of 88.3%.

The advantages of multimetric interpretation were most notable in patients with borderline column heights, which single-metric approaches often misclassify, underscoring the value of integrating multiple measurements into a unified model.

“[T]his study demonstrated that TBE can accurately identify achalasia when analyzed using multiple metrics in a classification tree model,” Fass and colleagues wrote. “Future studies should explore the use of TBE metrics and models to identify more specific esophageal motor disorders (such as esophageal spasm and absent contractility), as well as validation in a larger, multicenter cohort.”

 

Clinical Takeaways

Rishi Naik, MD, of the Center for Swallowing and Esophageal Disorders, Vanderbilt University Medical Center, Nashville, Tennessee, said the study represents a step forward in how clinicians can use a widely accessible esophageal imaging test.

“This study is important in that it has updated the way we use a very common, readily available imaging test and compared it to the current gold standard of HRM and FLIP,” he told GI & Hepatology News. “This provides a practical, standardized framework for clinicians evaluating patients with suspected esophageal motility disorders.”

Naik noted that while HRM and FLIP provide highly detailed information, both carry drawbacks that limit their universal adoption.

“Practically, HRM is a transnasal test that can be cumbersome, and FLIP is performed during a sedated procedure,” he said. “From a comfort and cost perspective, the esophagram outcompetes. What the TBE lacked was adequate sensitivity and specificity when just looking at column height, which is how the authors overcame this by leveraging the comparisons using CCv4.0.”

Implementation, however, requires discipline.

“A timed barium esophagram is a protocol, not a single esophagram,” Naik said. “Without proper measurements, you can’t follow the decision tree.”

Still, he pointed to radiology’s increasing adoption of artificial intelligence (AI) as a promising way forward.

“AI has already transformed radiological reads, and I’m optimistic it will eventually allow us to incorporate not only width, height, and tablet clearance but also 3D [three-dimensional] reconstructions of bolus retention and pressure to enhance predictive modeling,” Naik said.

This study was supported by the Public Health Service.

The investigators disclosed having relationships with Takeda, Phathom Pharmaceuticals, Medtronic, and others. Naik is a consultant for Sanofi/Regeneron, Eli Lilly and Company, and Renexxion.

A version of this article appeared on Medscape.com.

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GLP-1s Increase GERD Risk Over SGLT2 Inhibitors in T2D

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In patients with type 2 diabetes (T2D), the risks for gastroesophageal reflux disease (GERD) and GERD-related complications were greater with GLP-1 receptor agonist (RA) use than with SGLT2 inhibitor use in a cohort study of new users.

Risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and patients with gastric comorbidities.

“The findings were not entirely surprising,” principal author Laurent Azoulay, PhD, of McGill University and Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada, told GI & Hepatology News. “There is a plausible biological mechanism through which GLP-1 RAs could increase the risk of GERD — namely, by delaying gastric emptying, which can lead to symptoms of reflux. Still, it’s always valuable to see whether the clinical data support what we suspect from a physiological standpoint.”

“As with any medication, it’s about balancing benefits and risks — and being proactive when side effects emerge,” he added.

The study was published online in Annals of Internal Medicine.

 

Duration of Use, Drug Action

Researchers designed an active comparator new-user cohort study emulating a target trial to estimate the effects of GLP-1 RAs compared with SGLT2 inhibitors on the risk for GERD and its complications among patients with T2D.

The study included 24,708 new users of GLP-1 RAs and 89,096 new users of SGLT2 inhibitors. Participants had a mean age of 56 years, and 55% were men. They initiated treatment with the drugs from January 2013 through December 2021, with follow-up through March 2022.

Three-year risk differences (RDs) and risk ratios (RRs) were estimated and weighted using propensity score fine stratification.

Overall, during follow-up, the incidence rate of GERD was 7.9 per 1000 person-years; 138 complications of GERD were observed, with over 90% of them being Barrett’s esophagus.

Over a median follow-up of 3 years, among GLP-1 RA users compared with SGLT2 inhibitor users, the RRs were 1.27 for GERD, with an RD of 0.7 per 100 patients, and 1.55 for complications, with an RD of 0.8 per 1000 patients.

Further analyses found that risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and those with gastric comorbidities associated with gastric motility. The findings remained robust across sensitivity analyses addressing various types of biases.

The widening incidence curves with duration of use may indicate that mucosal injury and symptom severity correlate with reflux frequency and duration of esophageal acid exposure, the authors suggested.

GERD risk also was higher with long-acting GLP-1 RA use, suggesting that long-acting GLP-1 RAs (liraglutide, exenatide once weekly, dulaglutide, and semaglutide) may have more sustained delaying effects, they noted.

“These potential risks should be weighed against the established clinical benefits of this drug class, particularly in patients at high risk for gastroparesis and GERD,” the authors concluded.

“Given the mechanism through which these drugs may cause GERD, we can reasonably speculate that a similar effect might be observed in individuals without diabetes,” Azoulay added. “That said, a dedicated study would be needed to confirm that.”

 

Close Monitoring Advised

Caroline Collins, MD, assistant professor at Emory University School of Medicine in Atlanta, agreed with the findings and said the association between GLP-1s and GERD is consistent with what she has observed in her practice.

“I routinely counsel patients about the potential for GERD symptoms as well as other side effects before initiating GLP-1 therapy,” she told GI & Hepatology News. “Several patients on GLP-1s have reported new or worsening reflux symptoms after initiating therapy. Sometimes, we can lower the dose, and the GERD resolves. Other times initiating GERD treatment or discontinuing the medication is appropriate.”

“Patients with T2D are already at increased risk for delayed gastric emptying, which in itself is a contributor to GERD,” said Collins, who was not involved in the study. “Therefore, adding a GLP-1 RA, which further slows gastric motility, may compound this risk. I consider this when assessing which patients are the best candidates for these medications and often monitor more closely in patients with long-standing diabetes and other predisposing factors to GERD.”

Barrett’s esophagus and esophageal cancer generally occur over many years, she noted. “A median follow-up of 3 years may be insufficient to fully assess the long-term risks of serious complications.”

Chronic cough, a common but often overlooked manifestation of GERD, was not included in the outcome definitions,” she added. Including chronic cough “may have captured a broader picture of reflux-related symptoms.”

The study was funded by a Foundation Scheme grant from the Canadian Institutes of Health Research. Azoulay holds a Distinguished Research Scholar award from the Fonds de recherche du Quebec – Sante and is the recipient of a William Dawson Scholar award from McGill University.

A version of this article appeared on Medscape.com.

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In patients with type 2 diabetes (T2D), the risks for gastroesophageal reflux disease (GERD) and GERD-related complications were greater with GLP-1 receptor agonist (RA) use than with SGLT2 inhibitor use in a cohort study of new users.

Risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and patients with gastric comorbidities.

“The findings were not entirely surprising,” principal author Laurent Azoulay, PhD, of McGill University and Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada, told GI & Hepatology News. “There is a plausible biological mechanism through which GLP-1 RAs could increase the risk of GERD — namely, by delaying gastric emptying, which can lead to symptoms of reflux. Still, it’s always valuable to see whether the clinical data support what we suspect from a physiological standpoint.”

“As with any medication, it’s about balancing benefits and risks — and being proactive when side effects emerge,” he added.

The study was published online in Annals of Internal Medicine.

 

Duration of Use, Drug Action

Researchers designed an active comparator new-user cohort study emulating a target trial to estimate the effects of GLP-1 RAs compared with SGLT2 inhibitors on the risk for GERD and its complications among patients with T2D.

The study included 24,708 new users of GLP-1 RAs and 89,096 new users of SGLT2 inhibitors. Participants had a mean age of 56 years, and 55% were men. They initiated treatment with the drugs from January 2013 through December 2021, with follow-up through March 2022.

Three-year risk differences (RDs) and risk ratios (RRs) were estimated and weighted using propensity score fine stratification.

Overall, during follow-up, the incidence rate of GERD was 7.9 per 1000 person-years; 138 complications of GERD were observed, with over 90% of them being Barrett’s esophagus.

Over a median follow-up of 3 years, among GLP-1 RA users compared with SGLT2 inhibitor users, the RRs were 1.27 for GERD, with an RD of 0.7 per 100 patients, and 1.55 for complications, with an RD of 0.8 per 1000 patients.

Further analyses found that risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and those with gastric comorbidities associated with gastric motility. The findings remained robust across sensitivity analyses addressing various types of biases.

The widening incidence curves with duration of use may indicate that mucosal injury and symptom severity correlate with reflux frequency and duration of esophageal acid exposure, the authors suggested.

GERD risk also was higher with long-acting GLP-1 RA use, suggesting that long-acting GLP-1 RAs (liraglutide, exenatide once weekly, dulaglutide, and semaglutide) may have more sustained delaying effects, they noted.

“These potential risks should be weighed against the established clinical benefits of this drug class, particularly in patients at high risk for gastroparesis and GERD,” the authors concluded.

“Given the mechanism through which these drugs may cause GERD, we can reasonably speculate that a similar effect might be observed in individuals without diabetes,” Azoulay added. “That said, a dedicated study would be needed to confirm that.”

 

Close Monitoring Advised

Caroline Collins, MD, assistant professor at Emory University School of Medicine in Atlanta, agreed with the findings and said the association between GLP-1s and GERD is consistent with what she has observed in her practice.

“I routinely counsel patients about the potential for GERD symptoms as well as other side effects before initiating GLP-1 therapy,” she told GI & Hepatology News. “Several patients on GLP-1s have reported new or worsening reflux symptoms after initiating therapy. Sometimes, we can lower the dose, and the GERD resolves. Other times initiating GERD treatment or discontinuing the medication is appropriate.”

“Patients with T2D are already at increased risk for delayed gastric emptying, which in itself is a contributor to GERD,” said Collins, who was not involved in the study. “Therefore, adding a GLP-1 RA, which further slows gastric motility, may compound this risk. I consider this when assessing which patients are the best candidates for these medications and often monitor more closely in patients with long-standing diabetes and other predisposing factors to GERD.”

Barrett’s esophagus and esophageal cancer generally occur over many years, she noted. “A median follow-up of 3 years may be insufficient to fully assess the long-term risks of serious complications.”

Chronic cough, a common but often overlooked manifestation of GERD, was not included in the outcome definitions,” she added. Including chronic cough “may have captured a broader picture of reflux-related symptoms.”

The study was funded by a Foundation Scheme grant from the Canadian Institutes of Health Research. Azoulay holds a Distinguished Research Scholar award from the Fonds de recherche du Quebec – Sante and is the recipient of a William Dawson Scholar award from McGill University.

A version of this article appeared on Medscape.com.

In patients with type 2 diabetes (T2D), the risks for gastroesophageal reflux disease (GERD) and GERD-related complications were greater with GLP-1 receptor agonist (RA) use than with SGLT2 inhibitor use in a cohort study of new users.

Risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and patients with gastric comorbidities.

“The findings were not entirely surprising,” principal author Laurent Azoulay, PhD, of McGill University and Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada, told GI & Hepatology News. “There is a plausible biological mechanism through which GLP-1 RAs could increase the risk of GERD — namely, by delaying gastric emptying, which can lead to symptoms of reflux. Still, it’s always valuable to see whether the clinical data support what we suspect from a physiological standpoint.”

“As with any medication, it’s about balancing benefits and risks — and being proactive when side effects emerge,” he added.

The study was published online in Annals of Internal Medicine.

 

Duration of Use, Drug Action

Researchers designed an active comparator new-user cohort study emulating a target trial to estimate the effects of GLP-1 RAs compared with SGLT2 inhibitors on the risk for GERD and its complications among patients with T2D.

The study included 24,708 new users of GLP-1 RAs and 89,096 new users of SGLT2 inhibitors. Participants had a mean age of 56 years, and 55% were men. They initiated treatment with the drugs from January 2013 through December 2021, with follow-up through March 2022.

Three-year risk differences (RDs) and risk ratios (RRs) were estimated and weighted using propensity score fine stratification.

Overall, during follow-up, the incidence rate of GERD was 7.9 per 1000 person-years; 138 complications of GERD were observed, with over 90% of them being Barrett’s esophagus.

Over a median follow-up of 3 years, among GLP-1 RA users compared with SGLT2 inhibitor users, the RRs were 1.27 for GERD, with an RD of 0.7 per 100 patients, and 1.55 for complications, with an RD of 0.8 per 1000 patients.

Further analyses found that risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and those with gastric comorbidities associated with gastric motility. The findings remained robust across sensitivity analyses addressing various types of biases.

The widening incidence curves with duration of use may indicate that mucosal injury and symptom severity correlate with reflux frequency and duration of esophageal acid exposure, the authors suggested.

GERD risk also was higher with long-acting GLP-1 RA use, suggesting that long-acting GLP-1 RAs (liraglutide, exenatide once weekly, dulaglutide, and semaglutide) may have more sustained delaying effects, they noted.

“These potential risks should be weighed against the established clinical benefits of this drug class, particularly in patients at high risk for gastroparesis and GERD,” the authors concluded.

“Given the mechanism through which these drugs may cause GERD, we can reasonably speculate that a similar effect might be observed in individuals without diabetes,” Azoulay added. “That said, a dedicated study would be needed to confirm that.”

 

Close Monitoring Advised

Caroline Collins, MD, assistant professor at Emory University School of Medicine in Atlanta, agreed with the findings and said the association between GLP-1s and GERD is consistent with what she has observed in her practice.

“I routinely counsel patients about the potential for GERD symptoms as well as other side effects before initiating GLP-1 therapy,” she told GI & Hepatology News. “Several patients on GLP-1s have reported new or worsening reflux symptoms after initiating therapy. Sometimes, we can lower the dose, and the GERD resolves. Other times initiating GERD treatment or discontinuing the medication is appropriate.”

“Patients with T2D are already at increased risk for delayed gastric emptying, which in itself is a contributor to GERD,” said Collins, who was not involved in the study. “Therefore, adding a GLP-1 RA, which further slows gastric motility, may compound this risk. I consider this when assessing which patients are the best candidates for these medications and often monitor more closely in patients with long-standing diabetes and other predisposing factors to GERD.”

Barrett’s esophagus and esophageal cancer generally occur over many years, she noted. “A median follow-up of 3 years may be insufficient to fully assess the long-term risks of serious complications.”

Chronic cough, a common but often overlooked manifestation of GERD, was not included in the outcome definitions,” she added. Including chronic cough “may have captured a broader picture of reflux-related symptoms.”

The study was funded by a Foundation Scheme grant from the Canadian Institutes of Health Research. Azoulay holds a Distinguished Research Scholar award from the Fonds de recherche du Quebec – Sante and is the recipient of a William Dawson Scholar award from McGill University.

A version of this article appeared on Medscape.com.

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How Chronic Stress Disrupts the Gut Microbiome

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Chronic psychological stress is common. A 2023 survey revealed that about one quarter of US adults reported high stress levels, and three quarters reported that chronic stress affects their daily lives.

Emerging evidence suggests that chronic stress not only exacts a high toll on mental health but also can wreak havoc on all levels of gastrointestinal (GI) functioning, all the way down to the microbiome.

“Chronic stress can change the diversity and composition of the gut microbiome and essentially tips us toward an imbalance or dysbiosis,” Aasma Shaukat, MD, MPH, AGAF, gastroenterologist with NYU Langone Health and director of GI Outcomes Research, Gastroenterology at NYU Grossman School of Medicine in New York City, said in an interview with GI & Hepatology News.

Dr. Aasma Shaukat



“This basically means that the normal balance of microorganisms that essentially we think are beneficial gets reduced, and the colonies considered to be more harmful proliferate,” she explained.

 

What Does the Science Tell Us?

Numerous studies published in the past 5 years have linked chronic stress to modest but reproducible shifts in the composition of the microbiome.

A study of frontline healthcare workers during COVID-19 revealed that the pandemic was associated with significant depression, anxiety, and stress, as well as gut dysbiosis that persisted for at least half a year.

Notably, healthcare workers had low gut alpha diversity, indicating a less resilient and diverse microbiome, a state often associated with dysbiosis and increased risk for various diseases and negative health outcomes.

A two-cohort study of healthy adults found higher alpha diversity in those reporting low stress levels. It also found a link between stress and enriched levels of Escherichia/Shigella, an overgrowth of which has been linked to various conditions, including inflammatory bowel disease.

In addition, a 2023 systematic review of human studies concluded that stress is associated with changes in specific genera — namely reductions in gut-healthy Lachnospira/Lachnospiraceae and Phascolarctobacterium, which produce beneficial short-chain fatty acids that support the health of the intestinal lining and modulate the immune system.

Stress during specific life stages also appears to alter the gut microbiome.

For example, in a study of postpartum women, those at an increased risk for parenting stress showed lower alpha diversity on the Shannon diversity index.

Research involving mother-child pairs tied adversity — such as maltreatment of the mother during her childhood, prenatal anxiety, and hardship in the child’s early life — to distinct microbiome profiles in 2-year-olds, supporting a stress-microbiome pathway relevant to socioemotional outcomes, the authors said.

Emerging evidence indicates a link between the gut microbiome and posttraumatic stress disorder (PTSD).

A recent systematic review found differences in gut microbial taxa between individuals with PTSD and trauma-exposed controls without PTSD. A separate analysis pointed to a potential causal impact of gut microbiomes on the development of PTSD.

 

Mechanisms Behind the Link

Stress interferes with the brain’s production of neurotransmitters, such as serotonin, which controls anxiety, mood, sleep, and many other functions in the brain, Shaukat told GI & Hepatology News.

“But serotonin also crosses the blood-brain barrier, and actually, the gut has more serotonin receptors than the brain, so an imbalance of serotonin can actually affect the gut microbiome through signaling at the neurotransmitter level,” Shaukat explained.

Stress can also affect sleep, and sleep itself has regulatory properties for gut bacteria, Shaukat noted.

“Stress also lowers our immunity, and this can make the gut barrier susceptible or permeable to bacterial toxins that can pass through and breach the gut barrier and be released into the bloodstream, which can trigger inflammation,” Shaukat explained.

 

Implications for Patient Care

The gut-brain-microbiome axis remains an emerging field of study. “We’re learning more and more about this, and we need to because the microbial colonies are so diverse and we haven’t nailed it down yet,” Shaukat said.

In the meantime, what can clinicians tell patients?

Aside from managing stress, which “is easier said than done,” patients can improve their diet, Shaukat said.

“What we tell patients is to essentially increase their intake of gut-friendly foods that preferentially grow the bacterial colonies that are beneficial for us,” Shaukat said. This includes fermented foods, yogurt, kimchi, chia seeds, kombucha, pickled vegetables, and whole grains.

A recent randomized controlled trial of healthy adults found a “psychobiotic diet” — a diet high in prebiotic and fermented foods — was associated with less perceived stress and subtle beneficial shifts in microbial composition.

“These foods can help keep the gut in good health and may actually also reduce or mitigate some of the effects of stress,” Shaukat said.

“Eating well is something I think we should all think about and maybe prioritize when we’re going through a stressful situation or looking to kind of mitigate the effects of stress and the anxiety and depression it can cause,” she advised.

Shaukat said she also encourages patients to engage in regular physical activity, which benefits the gut microbiome by helping to regulate gut motility. Exercise can also boost mood and help relieve stress.

“A balanced Mediterranean diet and regular activity is truly the secret for gut health,” Shaukat said.

Patients may be tempted by the probiotic supplements lining drugstore shelves, but there “isn’t great evidence for probiotic supplements,” she said. “What we can get from dietary sources far outweighs what can be put in a pill.”

Shaukat disclosed having no relevant disclosures.

A version of this article appeared on Medscape.com.

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Chronic psychological stress is common. A 2023 survey revealed that about one quarter of US adults reported high stress levels, and three quarters reported that chronic stress affects their daily lives.

Emerging evidence suggests that chronic stress not only exacts a high toll on mental health but also can wreak havoc on all levels of gastrointestinal (GI) functioning, all the way down to the microbiome.

“Chronic stress can change the diversity and composition of the gut microbiome and essentially tips us toward an imbalance or dysbiosis,” Aasma Shaukat, MD, MPH, AGAF, gastroenterologist with NYU Langone Health and director of GI Outcomes Research, Gastroenterology at NYU Grossman School of Medicine in New York City, said in an interview with GI & Hepatology News.

Dr. Aasma Shaukat



“This basically means that the normal balance of microorganisms that essentially we think are beneficial gets reduced, and the colonies considered to be more harmful proliferate,” she explained.

 

What Does the Science Tell Us?

Numerous studies published in the past 5 years have linked chronic stress to modest but reproducible shifts in the composition of the microbiome.

A study of frontline healthcare workers during COVID-19 revealed that the pandemic was associated with significant depression, anxiety, and stress, as well as gut dysbiosis that persisted for at least half a year.

Notably, healthcare workers had low gut alpha diversity, indicating a less resilient and diverse microbiome, a state often associated with dysbiosis and increased risk for various diseases and negative health outcomes.

A two-cohort study of healthy adults found higher alpha diversity in those reporting low stress levels. It also found a link between stress and enriched levels of Escherichia/Shigella, an overgrowth of which has been linked to various conditions, including inflammatory bowel disease.

In addition, a 2023 systematic review of human studies concluded that stress is associated with changes in specific genera — namely reductions in gut-healthy Lachnospira/Lachnospiraceae and Phascolarctobacterium, which produce beneficial short-chain fatty acids that support the health of the intestinal lining and modulate the immune system.

Stress during specific life stages also appears to alter the gut microbiome.

For example, in a study of postpartum women, those at an increased risk for parenting stress showed lower alpha diversity on the Shannon diversity index.

Research involving mother-child pairs tied adversity — such as maltreatment of the mother during her childhood, prenatal anxiety, and hardship in the child’s early life — to distinct microbiome profiles in 2-year-olds, supporting a stress-microbiome pathway relevant to socioemotional outcomes, the authors said.

Emerging evidence indicates a link between the gut microbiome and posttraumatic stress disorder (PTSD).

A recent systematic review found differences in gut microbial taxa between individuals with PTSD and trauma-exposed controls without PTSD. A separate analysis pointed to a potential causal impact of gut microbiomes on the development of PTSD.

 

Mechanisms Behind the Link

Stress interferes with the brain’s production of neurotransmitters, such as serotonin, which controls anxiety, mood, sleep, and many other functions in the brain, Shaukat told GI & Hepatology News.

“But serotonin also crosses the blood-brain barrier, and actually, the gut has more serotonin receptors than the brain, so an imbalance of serotonin can actually affect the gut microbiome through signaling at the neurotransmitter level,” Shaukat explained.

Stress can also affect sleep, and sleep itself has regulatory properties for gut bacteria, Shaukat noted.

“Stress also lowers our immunity, and this can make the gut barrier susceptible or permeable to bacterial toxins that can pass through and breach the gut barrier and be released into the bloodstream, which can trigger inflammation,” Shaukat explained.

 

Implications for Patient Care

The gut-brain-microbiome axis remains an emerging field of study. “We’re learning more and more about this, and we need to because the microbial colonies are so diverse and we haven’t nailed it down yet,” Shaukat said.

In the meantime, what can clinicians tell patients?

Aside from managing stress, which “is easier said than done,” patients can improve their diet, Shaukat said.

“What we tell patients is to essentially increase their intake of gut-friendly foods that preferentially grow the bacterial colonies that are beneficial for us,” Shaukat said. This includes fermented foods, yogurt, kimchi, chia seeds, kombucha, pickled vegetables, and whole grains.

A recent randomized controlled trial of healthy adults found a “psychobiotic diet” — a diet high in prebiotic and fermented foods — was associated with less perceived stress and subtle beneficial shifts in microbial composition.

“These foods can help keep the gut in good health and may actually also reduce or mitigate some of the effects of stress,” Shaukat said.

“Eating well is something I think we should all think about and maybe prioritize when we’re going through a stressful situation or looking to kind of mitigate the effects of stress and the anxiety and depression it can cause,” she advised.

Shaukat said she also encourages patients to engage in regular physical activity, which benefits the gut microbiome by helping to regulate gut motility. Exercise can also boost mood and help relieve stress.

“A balanced Mediterranean diet and regular activity is truly the secret for gut health,” Shaukat said.

Patients may be tempted by the probiotic supplements lining drugstore shelves, but there “isn’t great evidence for probiotic supplements,” she said. “What we can get from dietary sources far outweighs what can be put in a pill.”

Shaukat disclosed having no relevant disclosures.

A version of this article appeared on Medscape.com.

Chronic psychological stress is common. A 2023 survey revealed that about one quarter of US adults reported high stress levels, and three quarters reported that chronic stress affects their daily lives.

Emerging evidence suggests that chronic stress not only exacts a high toll on mental health but also can wreak havoc on all levels of gastrointestinal (GI) functioning, all the way down to the microbiome.

“Chronic stress can change the diversity and composition of the gut microbiome and essentially tips us toward an imbalance or dysbiosis,” Aasma Shaukat, MD, MPH, AGAF, gastroenterologist with NYU Langone Health and director of GI Outcomes Research, Gastroenterology at NYU Grossman School of Medicine in New York City, said in an interview with GI & Hepatology News.

Dr. Aasma Shaukat



“This basically means that the normal balance of microorganisms that essentially we think are beneficial gets reduced, and the colonies considered to be more harmful proliferate,” she explained.

 

What Does the Science Tell Us?

Numerous studies published in the past 5 years have linked chronic stress to modest but reproducible shifts in the composition of the microbiome.

A study of frontline healthcare workers during COVID-19 revealed that the pandemic was associated with significant depression, anxiety, and stress, as well as gut dysbiosis that persisted for at least half a year.

Notably, healthcare workers had low gut alpha diversity, indicating a less resilient and diverse microbiome, a state often associated with dysbiosis and increased risk for various diseases and negative health outcomes.

A two-cohort study of healthy adults found higher alpha diversity in those reporting low stress levels. It also found a link between stress and enriched levels of Escherichia/Shigella, an overgrowth of which has been linked to various conditions, including inflammatory bowel disease.

In addition, a 2023 systematic review of human studies concluded that stress is associated with changes in specific genera — namely reductions in gut-healthy Lachnospira/Lachnospiraceae and Phascolarctobacterium, which produce beneficial short-chain fatty acids that support the health of the intestinal lining and modulate the immune system.

Stress during specific life stages also appears to alter the gut microbiome.

For example, in a study of postpartum women, those at an increased risk for parenting stress showed lower alpha diversity on the Shannon diversity index.

Research involving mother-child pairs tied adversity — such as maltreatment of the mother during her childhood, prenatal anxiety, and hardship in the child’s early life — to distinct microbiome profiles in 2-year-olds, supporting a stress-microbiome pathway relevant to socioemotional outcomes, the authors said.

Emerging evidence indicates a link between the gut microbiome and posttraumatic stress disorder (PTSD).

A recent systematic review found differences in gut microbial taxa between individuals with PTSD and trauma-exposed controls without PTSD. A separate analysis pointed to a potential causal impact of gut microbiomes on the development of PTSD.

 

Mechanisms Behind the Link

Stress interferes with the brain’s production of neurotransmitters, such as serotonin, which controls anxiety, mood, sleep, and many other functions in the brain, Shaukat told GI & Hepatology News.

“But serotonin also crosses the blood-brain barrier, and actually, the gut has more serotonin receptors than the brain, so an imbalance of serotonin can actually affect the gut microbiome through signaling at the neurotransmitter level,” Shaukat explained.

Stress can also affect sleep, and sleep itself has regulatory properties for gut bacteria, Shaukat noted.

“Stress also lowers our immunity, and this can make the gut barrier susceptible or permeable to bacterial toxins that can pass through and breach the gut barrier and be released into the bloodstream, which can trigger inflammation,” Shaukat explained.

 

Implications for Patient Care

The gut-brain-microbiome axis remains an emerging field of study. “We’re learning more and more about this, and we need to because the microbial colonies are so diverse and we haven’t nailed it down yet,” Shaukat said.

In the meantime, what can clinicians tell patients?

Aside from managing stress, which “is easier said than done,” patients can improve their diet, Shaukat said.

“What we tell patients is to essentially increase their intake of gut-friendly foods that preferentially grow the bacterial colonies that are beneficial for us,” Shaukat said. This includes fermented foods, yogurt, kimchi, chia seeds, kombucha, pickled vegetables, and whole grains.

A recent randomized controlled trial of healthy adults found a “psychobiotic diet” — a diet high in prebiotic and fermented foods — was associated with less perceived stress and subtle beneficial shifts in microbial composition.

“These foods can help keep the gut in good health and may actually also reduce or mitigate some of the effects of stress,” Shaukat said.

“Eating well is something I think we should all think about and maybe prioritize when we’re going through a stressful situation or looking to kind of mitigate the effects of stress and the anxiety and depression it can cause,” she advised.

Shaukat said she also encourages patients to engage in regular physical activity, which benefits the gut microbiome by helping to regulate gut motility. Exercise can also boost mood and help relieve stress.

“A balanced Mediterranean diet and regular activity is truly the secret for gut health,” Shaukat said.

Patients may be tempted by the probiotic supplements lining drugstore shelves, but there “isn’t great evidence for probiotic supplements,” she said. “What we can get from dietary sources far outweighs what can be put in a pill.”

Shaukat disclosed having no relevant disclosures.

A version of this article appeared on Medscape.com.

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Helicobacter pylori May Shift Gastric Cancer Earlier

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Helicobacter pylori May Shift Gastric Cancer Earlier

Infection with Helicobacter pylori appears to increase the likelihood of gastric cancer developing earlier in life compared with gastric cancers not linked to the bacteria, new data suggested.

H pylori infection is a leading risk factor for gastric carcinoma, accounting for as many as 90% of cases. As the new data show, failure to screen routinely for the bacteria could be leading to younger people developing easily preventable forms of gastric cancer, experts said.

“The most concerning and the most interesting finding for us was we found higher prevalence” of gastric cancer linked to H pylori in the younger group, Neel Patel, MD, MPH, with the Department of Pathology at Staten Island University Hospital in Staten Island, New York, told GI & Hepatology News.

“This does not mean most patients are young. Rather, it means H pylori increases the likelihood of gastric cancer appearing earlier in life compared with non-H pylori cases.”

For the study, Patel and his colleagues, who presented their findings at the annual meeting of the College of American Pathologists (CAP) 2025, used 2016-2020 data from the Nationwide Inpatient Sample, which included records for adults with primary diagnoses of gastric cancer. They looked at outcomes of those whose cancer was associated with H pylori compared with the non-H pylori group.

Among 91,670 adult hospitalizations, 1830 (2%) had gastric cancer linked to H pylori (2016-2020). Patel said the low percentage resulted from focusing solely on diagnostic codes for primary diagnoses of gastric cancer and excluding secondary diagnoses.

These cancers were twice as prevalent in patients aged 18-49 years (3.97%) as in those older than 65 years (1.65%).

 

Septicemia Odds Higher in H pylori Group

Patients in the H pylori group also had a higher burden of comorbidities such as anemia, chronic blood loss, and metastatic cancer, according to the data. The researcher found these patients also had significantly higher odds of septicemia (odds ratio, 1.62; 95% CI, 1.17-2.24; P = .003) and spent an average of 8 days in the hospital — two more than those with cancers not associated with the infection.

Dipti M. Karamchandani, MD, a professor of pathology at the University of Texas Southwestern Medical Center in Dallas, who was not part of the study, said the longer hospital stays and greater risk for septicemia may be related to increased comorbidities among people who get H pylori infection in general. The infection often is caused by unsanitary conditions, and the groups infected may also be more likely to experience malnutrition, anemia, or lower body reserves, for example, she said.

“Also, H pylori often causes gastric ulcers, even before causing cancer, and those patients may be prone to chronic blood loss,” Karamchandani said. “These are all reasons that these patients may be more prone to longer hospital stay.”

 

US Guidelines Lacking

H pylori infection is a strong predictor of gastric cancer, but it often goes undetected. “Sometimes we ignore the symptoms,” Patel said.

“There are no standard guidelines for screening for H pylori,” he added. “We need to stop the transition from H pylori to gastric cancer.”

“This abstract highlights an important issue: Gastric cancer is rising among younger adults in the US, particularly in noncardia gastric cancer, which is most often associated with Helicobacter pylori infection,” said Chul S. Hyun, MD, PhD, MPH, director of the Gastric Cancer Prevention and Screening Program at Yale School of Medicine in New Haven, Connecticut.

Hyun said the 2% of patients in the study diagnosed with gastric cancer associated with H pylori likely reflected undercoding and “incomplete capture” in the database and noted that subgroup comparisons “become difficult to interpret reliably.” By extension, the findings also underscore, “We are not adequately capturing H pylori in routine US coding and claims.”

“What we do know is that H pylori is the central, modifiable driver of risk, and that prevention efforts should focus on high prevalence populations — including Asian, Hispanic, and immigrant communities — where systematic H pylori screening remains a major unmet need,” said Hyun, who was not involved in the new research.

Currently no US society guideline recommends systematic screening, Hyun said. “Other high-incidence countries, such as Japan and Korea, already incorporate H pylori and gastroscopy screening into national policy,” he said. “For these reasons, guidelines urgently need to evolve to recommend targeted H pylori screening in high prevalence groups.”

Patel, Karamchandani, and Hyun reported having no relevant financial conflicts of interest.

 

A version of this article appeared on Medscape.com.

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Infection with Helicobacter pylori appears to increase the likelihood of gastric cancer developing earlier in life compared with gastric cancers not linked to the bacteria, new data suggested.

H pylori infection is a leading risk factor for gastric carcinoma, accounting for as many as 90% of cases. As the new data show, failure to screen routinely for the bacteria could be leading to younger people developing easily preventable forms of gastric cancer, experts said.

“The most concerning and the most interesting finding for us was we found higher prevalence” of gastric cancer linked to H pylori in the younger group, Neel Patel, MD, MPH, with the Department of Pathology at Staten Island University Hospital in Staten Island, New York, told GI & Hepatology News.

“This does not mean most patients are young. Rather, it means H pylori increases the likelihood of gastric cancer appearing earlier in life compared with non-H pylori cases.”

For the study, Patel and his colleagues, who presented their findings at the annual meeting of the College of American Pathologists (CAP) 2025, used 2016-2020 data from the Nationwide Inpatient Sample, which included records for adults with primary diagnoses of gastric cancer. They looked at outcomes of those whose cancer was associated with H pylori compared with the non-H pylori group.

Among 91,670 adult hospitalizations, 1830 (2%) had gastric cancer linked to H pylori (2016-2020). Patel said the low percentage resulted from focusing solely on diagnostic codes for primary diagnoses of gastric cancer and excluding secondary diagnoses.

These cancers were twice as prevalent in patients aged 18-49 years (3.97%) as in those older than 65 years (1.65%).

 

Septicemia Odds Higher in H pylori Group

Patients in the H pylori group also had a higher burden of comorbidities such as anemia, chronic blood loss, and metastatic cancer, according to the data. The researcher found these patients also had significantly higher odds of septicemia (odds ratio, 1.62; 95% CI, 1.17-2.24; P = .003) and spent an average of 8 days in the hospital — two more than those with cancers not associated with the infection.

Dipti M. Karamchandani, MD, a professor of pathology at the University of Texas Southwestern Medical Center in Dallas, who was not part of the study, said the longer hospital stays and greater risk for septicemia may be related to increased comorbidities among people who get H pylori infection in general. The infection often is caused by unsanitary conditions, and the groups infected may also be more likely to experience malnutrition, anemia, or lower body reserves, for example, she said.

“Also, H pylori often causes gastric ulcers, even before causing cancer, and those patients may be prone to chronic blood loss,” Karamchandani said. “These are all reasons that these patients may be more prone to longer hospital stay.”

 

US Guidelines Lacking

H pylori infection is a strong predictor of gastric cancer, but it often goes undetected. “Sometimes we ignore the symptoms,” Patel said.

“There are no standard guidelines for screening for H pylori,” he added. “We need to stop the transition from H pylori to gastric cancer.”

“This abstract highlights an important issue: Gastric cancer is rising among younger adults in the US, particularly in noncardia gastric cancer, which is most often associated with Helicobacter pylori infection,” said Chul S. Hyun, MD, PhD, MPH, director of the Gastric Cancer Prevention and Screening Program at Yale School of Medicine in New Haven, Connecticut.

Hyun said the 2% of patients in the study diagnosed with gastric cancer associated with H pylori likely reflected undercoding and “incomplete capture” in the database and noted that subgroup comparisons “become difficult to interpret reliably.” By extension, the findings also underscore, “We are not adequately capturing H pylori in routine US coding and claims.”

“What we do know is that H pylori is the central, modifiable driver of risk, and that prevention efforts should focus on high prevalence populations — including Asian, Hispanic, and immigrant communities — where systematic H pylori screening remains a major unmet need,” said Hyun, who was not involved in the new research.

Currently no US society guideline recommends systematic screening, Hyun said. “Other high-incidence countries, such as Japan and Korea, already incorporate H pylori and gastroscopy screening into national policy,” he said. “For these reasons, guidelines urgently need to evolve to recommend targeted H pylori screening in high prevalence groups.”

Patel, Karamchandani, and Hyun reported having no relevant financial conflicts of interest.

 

A version of this article appeared on Medscape.com.

Infection with Helicobacter pylori appears to increase the likelihood of gastric cancer developing earlier in life compared with gastric cancers not linked to the bacteria, new data suggested.

H pylori infection is a leading risk factor for gastric carcinoma, accounting for as many as 90% of cases. As the new data show, failure to screen routinely for the bacteria could be leading to younger people developing easily preventable forms of gastric cancer, experts said.

“The most concerning and the most interesting finding for us was we found higher prevalence” of gastric cancer linked to H pylori in the younger group, Neel Patel, MD, MPH, with the Department of Pathology at Staten Island University Hospital in Staten Island, New York, told GI & Hepatology News.

“This does not mean most patients are young. Rather, it means H pylori increases the likelihood of gastric cancer appearing earlier in life compared with non-H pylori cases.”

For the study, Patel and his colleagues, who presented their findings at the annual meeting of the College of American Pathologists (CAP) 2025, used 2016-2020 data from the Nationwide Inpatient Sample, which included records for adults with primary diagnoses of gastric cancer. They looked at outcomes of those whose cancer was associated with H pylori compared with the non-H pylori group.

Among 91,670 adult hospitalizations, 1830 (2%) had gastric cancer linked to H pylori (2016-2020). Patel said the low percentage resulted from focusing solely on diagnostic codes for primary diagnoses of gastric cancer and excluding secondary diagnoses.

These cancers were twice as prevalent in patients aged 18-49 years (3.97%) as in those older than 65 years (1.65%).

 

Septicemia Odds Higher in H pylori Group

Patients in the H pylori group also had a higher burden of comorbidities such as anemia, chronic blood loss, and metastatic cancer, according to the data. The researcher found these patients also had significantly higher odds of septicemia (odds ratio, 1.62; 95% CI, 1.17-2.24; P = .003) and spent an average of 8 days in the hospital — two more than those with cancers not associated with the infection.

Dipti M. Karamchandani, MD, a professor of pathology at the University of Texas Southwestern Medical Center in Dallas, who was not part of the study, said the longer hospital stays and greater risk for septicemia may be related to increased comorbidities among people who get H pylori infection in general. The infection often is caused by unsanitary conditions, and the groups infected may also be more likely to experience malnutrition, anemia, or lower body reserves, for example, she said.

“Also, H pylori often causes gastric ulcers, even before causing cancer, and those patients may be prone to chronic blood loss,” Karamchandani said. “These are all reasons that these patients may be more prone to longer hospital stay.”

 

US Guidelines Lacking

H pylori infection is a strong predictor of gastric cancer, but it often goes undetected. “Sometimes we ignore the symptoms,” Patel said.

“There are no standard guidelines for screening for H pylori,” he added. “We need to stop the transition from H pylori to gastric cancer.”

“This abstract highlights an important issue: Gastric cancer is rising among younger adults in the US, particularly in noncardia gastric cancer, which is most often associated with Helicobacter pylori infection,” said Chul S. Hyun, MD, PhD, MPH, director of the Gastric Cancer Prevention and Screening Program at Yale School of Medicine in New Haven, Connecticut.

Hyun said the 2% of patients in the study diagnosed with gastric cancer associated with H pylori likely reflected undercoding and “incomplete capture” in the database and noted that subgroup comparisons “become difficult to interpret reliably.” By extension, the findings also underscore, “We are not adequately capturing H pylori in routine US coding and claims.”

“What we do know is that H pylori is the central, modifiable driver of risk, and that prevention efforts should focus on high prevalence populations — including Asian, Hispanic, and immigrant communities — where systematic H pylori screening remains a major unmet need,” said Hyun, who was not involved in the new research.

Currently no US society guideline recommends systematic screening, Hyun said. “Other high-incidence countries, such as Japan and Korea, already incorporate H pylori and gastroscopy screening into national policy,” he said. “For these reasons, guidelines urgently need to evolve to recommend targeted H pylori screening in high prevalence groups.”

Patel, Karamchandani, and Hyun reported having no relevant financial conflicts of interest.

 

A version of this article appeared on Medscape.com.

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Helicobacter pylori May Shift Gastric Cancer Earlier

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Getting Ahead of Gastrointestinal Cancer

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Early-onset gastrointestinal (GI) cancers are climbing among those younger than 50 years, in the US and globally. Although colorectal cancer accounts for approximately half of such cases, rates are also increasing for gastric, esophageal, pancreatic, and several rarer GI malignancies.

Because most in this age group are not included in screening protocols and may present with vague symptoms, diagnosis and treatment is frequently delayed. According to experts in the field, counteracting this trend requires establishing a lower threshold for evaluation, attention to modifiable risk factors, and embracing emerging noninvasive diagnostic tools.

 

Diagnostic Dilemmas

“Colorectal cancer in particular is often diagnosed later in life,” said Nicholas DeVito, MD, assistant professor at Duke University Medical Center, Durham, North Carolina, and a specialist in GI malignancies. “When the patient is too young for routine screening colonoscopy (< 45 years), they aren’t screened at all, they do not have alarming symptoms, or their symptoms are overlooked.” Other increasingly common GI cancers in young people (esophageal, gastric, pancreatic) lack routine screening guidelines due to limited evidence, he added.

Symptoms such as nausea, weight loss, upset stomach, and abdominal pain are often nonspecific and have many other potential causes, so GI cancers may not be high on the list of possible diagnoses in patients younger than 50 years, said DeVito.

“Insurance coverage, socioeconomic status, appointment availability, and awareness of symptoms and screening methods are all barriers to diagnosis as well, which affect the diagnostic timeline of many cancers,” he added.“While there are multiple factors that contribute to a cancer diagnosis, it seems that obesity, a Western diet, a sedentary lifestyle are all major contributors to the rise in early GI cancers,” DeVito told GI & Hepatology News. “There is no blame or judgement to go around as cancer can happen to anyone at any time, with none of these factors present,” he emphasized.

When counseling patients about GI cancer risk, DeVito recommends keeping advice simple and specific. In general, they should restrict red meat to once a week, emphasize fresh fruits and vegetables, cap alcohol to ≤ 1 serving per day, and limit ultraprocessed foods (e.g., packaged snacks, preprepared meals, and sugary beverages).

Exercise is another pillar. “Find an activity you enjoy and work toward 30 minutes of aerobic exercise three times a week,” he advised. He also encourages finding opportunities to incorporate physical activity in daily lives, such as using a standing desk at work, while keeping patients’ socioeconomic constraints in mind.

Evidence around GI cancer prevention interventions is still evolving. However, a randomized phase 3 trial presented at American Society of Clinical Oncology’s 2025 meeting found significant improvement in disease-free survival among adults with resected stage III or high-risk stage II colon cancer (median age, 61 years) who reported higher intake of anti-inflammatory foods and greater exercise than a comparator group.

“In general, clinicians should be aware of the risk factors, make referrals to physical therapy, weight-loss specialists, endocrinologists, and nutritionists when appropriate, and be consistent and clear with patients about recommendations and what’s achievable,” DeVito said. “Meeting patients where they are can help make incremental progress, as these interventions take time and patience, and we should be understanding of that.” 

Identifying at-risk younger adults goes beyond discussing family history and obesity to include diet, exercise, and daily lifestyle, he added.

“Symptoms of potential GI cancer need to be taken seriously in all patients, and there should be a lower threshold in 2025 to get a colonoscopy, endoscopy, or CT scan than in previous years given all that we know today. We then need to establish through clinical studies who needs screening tests and who doesn’t, and what interventions work best to reduce risk.” 

 

Vigilance in the Absence of Screening

“Most GI cancers, unfortunately, can grow a fair amount before symptoms arise, so many patients present with symptoms only when a tumor has grown enough to affect organ function,” said Miguel Burch, MD, chief of minimally invasive and GI surgery at Cedars-Sinai Medical Center, Los Angeles.

Early screening improves outcomes in gastric cancer, Burch noted, and survival benefits are reflected in several East Asian countries that offer gastric cancer screening starting at age 40. In one study from Korea, a single upper endoscopy was associated with an approximate 40% reduction in gastric cancer mortality compared with no screening.

In the US, lack of funding for GI cancer screening remains a barrier to early identification, Burch emphasized. The impact is wide-ranging, contributing to increased morbidity and mortality in younger adults often in their most productive years, leading to lost wages and emotional strains upon patients and their families.Routine endoscopic or imaging screening is not typically performed in the US, and newer blood-based tests such as circulating tumor DNA are not yet sensitive enough to reliably detect very early-stage disease. Nonetheless, there is evidence that noninvasive biomarkers could soon help expand GI cancer screening.

In a study published in JAMA Surgery, Sui and colleagues tested a 10-microRNA signature assay (Destinex) for early detection of gastric cancer and reported robust identification rates above 95%.

“In recent years, the liquid biopsy has gained momentum with the hope of augmenting cancer detection from peripheral blood, even indicating potential as a screening test for healthy populations,” wrote Max R. Coffey, MD, and Vivian E. Strong, MD, both of the Memorial Sloan Kettering Cancer Center in New York City, in an accompanying editorial.

“Early detection is absolutely critical; when gastric cancer is found early, outcomes are dramatically better,” Strong told GI & Hepatology News. Subtle symptoms — reflux, persistent GI discomfort, or unexplained weight loss — should never be ignored, she added.

Early detection should also focus on additional risk factors such as prior Helicobacter pylori infection, smoking, and family history.

“Anyone with a personal or family history of H pylori should have very careful follow-up, and if one household member tests positive, all should be checked,” Strong said. “Just as importantly, if one or more family members have had stomach cancer, that should be discussed with a healthcare provider, as it may warrant higher-level surveillance and genetic testing.” 

Individuals concerned about increased risk for GI cancer should proactively ask their doctors whether they might benefit from testing or surveillance, Strong added.

“Lifestyle changes, timely medical evaluation, and tailored surveillance all play a vital role in prevention.”

DeVito disclosed clinical trial funding from the Gateway foundation, Xilio, Phanes, Astellas, GSK, as well as consulting fees/advisory board participation for Guardant, Agenus, and Xilio. Strong disclosed speaking honoraria for Merck and Astra Zeneca.

The study by Sui and colleagues was supported by the National Cancer Institute, National Institutes of Health, as well as by a grant from the American Gastroenterological Association Robert & Sally Funderburg Research Award in Gastric Cancer, and the Stupid Strong Foundation.

Burch had no financial conflicts to disclose.

 

A version of this article appeared on Medscape.com.

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Early-onset gastrointestinal (GI) cancers are climbing among those younger than 50 years, in the US and globally. Although colorectal cancer accounts for approximately half of such cases, rates are also increasing for gastric, esophageal, pancreatic, and several rarer GI malignancies.

Because most in this age group are not included in screening protocols and may present with vague symptoms, diagnosis and treatment is frequently delayed. According to experts in the field, counteracting this trend requires establishing a lower threshold for evaluation, attention to modifiable risk factors, and embracing emerging noninvasive diagnostic tools.

 

Diagnostic Dilemmas

“Colorectal cancer in particular is often diagnosed later in life,” said Nicholas DeVito, MD, assistant professor at Duke University Medical Center, Durham, North Carolina, and a specialist in GI malignancies. “When the patient is too young for routine screening colonoscopy (< 45 years), they aren’t screened at all, they do not have alarming symptoms, or their symptoms are overlooked.” Other increasingly common GI cancers in young people (esophageal, gastric, pancreatic) lack routine screening guidelines due to limited evidence, he added.

Symptoms such as nausea, weight loss, upset stomach, and abdominal pain are often nonspecific and have many other potential causes, so GI cancers may not be high on the list of possible diagnoses in patients younger than 50 years, said DeVito.

“Insurance coverage, socioeconomic status, appointment availability, and awareness of symptoms and screening methods are all barriers to diagnosis as well, which affect the diagnostic timeline of many cancers,” he added.“While there are multiple factors that contribute to a cancer diagnosis, it seems that obesity, a Western diet, a sedentary lifestyle are all major contributors to the rise in early GI cancers,” DeVito told GI & Hepatology News. “There is no blame or judgement to go around as cancer can happen to anyone at any time, with none of these factors present,” he emphasized.

When counseling patients about GI cancer risk, DeVito recommends keeping advice simple and specific. In general, they should restrict red meat to once a week, emphasize fresh fruits and vegetables, cap alcohol to ≤ 1 serving per day, and limit ultraprocessed foods (e.g., packaged snacks, preprepared meals, and sugary beverages).

Exercise is another pillar. “Find an activity you enjoy and work toward 30 minutes of aerobic exercise three times a week,” he advised. He also encourages finding opportunities to incorporate physical activity in daily lives, such as using a standing desk at work, while keeping patients’ socioeconomic constraints in mind.

Evidence around GI cancer prevention interventions is still evolving. However, a randomized phase 3 trial presented at American Society of Clinical Oncology’s 2025 meeting found significant improvement in disease-free survival among adults with resected stage III or high-risk stage II colon cancer (median age, 61 years) who reported higher intake of anti-inflammatory foods and greater exercise than a comparator group.

“In general, clinicians should be aware of the risk factors, make referrals to physical therapy, weight-loss specialists, endocrinologists, and nutritionists when appropriate, and be consistent and clear with patients about recommendations and what’s achievable,” DeVito said. “Meeting patients where they are can help make incremental progress, as these interventions take time and patience, and we should be understanding of that.” 

Identifying at-risk younger adults goes beyond discussing family history and obesity to include diet, exercise, and daily lifestyle, he added.

“Symptoms of potential GI cancer need to be taken seriously in all patients, and there should be a lower threshold in 2025 to get a colonoscopy, endoscopy, or CT scan than in previous years given all that we know today. We then need to establish through clinical studies who needs screening tests and who doesn’t, and what interventions work best to reduce risk.” 

 

Vigilance in the Absence of Screening

“Most GI cancers, unfortunately, can grow a fair amount before symptoms arise, so many patients present with symptoms only when a tumor has grown enough to affect organ function,” said Miguel Burch, MD, chief of minimally invasive and GI surgery at Cedars-Sinai Medical Center, Los Angeles.

Early screening improves outcomes in gastric cancer, Burch noted, and survival benefits are reflected in several East Asian countries that offer gastric cancer screening starting at age 40. In one study from Korea, a single upper endoscopy was associated with an approximate 40% reduction in gastric cancer mortality compared with no screening.

In the US, lack of funding for GI cancer screening remains a barrier to early identification, Burch emphasized. The impact is wide-ranging, contributing to increased morbidity and mortality in younger adults often in their most productive years, leading to lost wages and emotional strains upon patients and their families.Routine endoscopic or imaging screening is not typically performed in the US, and newer blood-based tests such as circulating tumor DNA are not yet sensitive enough to reliably detect very early-stage disease. Nonetheless, there is evidence that noninvasive biomarkers could soon help expand GI cancer screening.

In a study published in JAMA Surgery, Sui and colleagues tested a 10-microRNA signature assay (Destinex) for early detection of gastric cancer and reported robust identification rates above 95%.

“In recent years, the liquid biopsy has gained momentum with the hope of augmenting cancer detection from peripheral blood, even indicating potential as a screening test for healthy populations,” wrote Max R. Coffey, MD, and Vivian E. Strong, MD, both of the Memorial Sloan Kettering Cancer Center in New York City, in an accompanying editorial.

“Early detection is absolutely critical; when gastric cancer is found early, outcomes are dramatically better,” Strong told GI & Hepatology News. Subtle symptoms — reflux, persistent GI discomfort, or unexplained weight loss — should never be ignored, she added.

Early detection should also focus on additional risk factors such as prior Helicobacter pylori infection, smoking, and family history.

“Anyone with a personal or family history of H pylori should have very careful follow-up, and if one household member tests positive, all should be checked,” Strong said. “Just as importantly, if one or more family members have had stomach cancer, that should be discussed with a healthcare provider, as it may warrant higher-level surveillance and genetic testing.” 

Individuals concerned about increased risk for GI cancer should proactively ask their doctors whether they might benefit from testing or surveillance, Strong added.

“Lifestyle changes, timely medical evaluation, and tailored surveillance all play a vital role in prevention.”

DeVito disclosed clinical trial funding from the Gateway foundation, Xilio, Phanes, Astellas, GSK, as well as consulting fees/advisory board participation for Guardant, Agenus, and Xilio. Strong disclosed speaking honoraria for Merck and Astra Zeneca.

The study by Sui and colleagues was supported by the National Cancer Institute, National Institutes of Health, as well as by a grant from the American Gastroenterological Association Robert & Sally Funderburg Research Award in Gastric Cancer, and the Stupid Strong Foundation.

Burch had no financial conflicts to disclose.

 

A version of this article appeared on Medscape.com.

Early-onset gastrointestinal (GI) cancers are climbing among those younger than 50 years, in the US and globally. Although colorectal cancer accounts for approximately half of such cases, rates are also increasing for gastric, esophageal, pancreatic, and several rarer GI malignancies.

Because most in this age group are not included in screening protocols and may present with vague symptoms, diagnosis and treatment is frequently delayed. According to experts in the field, counteracting this trend requires establishing a lower threshold for evaluation, attention to modifiable risk factors, and embracing emerging noninvasive diagnostic tools.

 

Diagnostic Dilemmas

“Colorectal cancer in particular is often diagnosed later in life,” said Nicholas DeVito, MD, assistant professor at Duke University Medical Center, Durham, North Carolina, and a specialist in GI malignancies. “When the patient is too young for routine screening colonoscopy (< 45 years), they aren’t screened at all, they do not have alarming symptoms, or their symptoms are overlooked.” Other increasingly common GI cancers in young people (esophageal, gastric, pancreatic) lack routine screening guidelines due to limited evidence, he added.

Symptoms such as nausea, weight loss, upset stomach, and abdominal pain are often nonspecific and have many other potential causes, so GI cancers may not be high on the list of possible diagnoses in patients younger than 50 years, said DeVito.

“Insurance coverage, socioeconomic status, appointment availability, and awareness of symptoms and screening methods are all barriers to diagnosis as well, which affect the diagnostic timeline of many cancers,” he added.“While there are multiple factors that contribute to a cancer diagnosis, it seems that obesity, a Western diet, a sedentary lifestyle are all major contributors to the rise in early GI cancers,” DeVito told GI & Hepatology News. “There is no blame or judgement to go around as cancer can happen to anyone at any time, with none of these factors present,” he emphasized.

When counseling patients about GI cancer risk, DeVito recommends keeping advice simple and specific. In general, they should restrict red meat to once a week, emphasize fresh fruits and vegetables, cap alcohol to ≤ 1 serving per day, and limit ultraprocessed foods (e.g., packaged snacks, preprepared meals, and sugary beverages).

Exercise is another pillar. “Find an activity you enjoy and work toward 30 minutes of aerobic exercise three times a week,” he advised. He also encourages finding opportunities to incorporate physical activity in daily lives, such as using a standing desk at work, while keeping patients’ socioeconomic constraints in mind.

Evidence around GI cancer prevention interventions is still evolving. However, a randomized phase 3 trial presented at American Society of Clinical Oncology’s 2025 meeting found significant improvement in disease-free survival among adults with resected stage III or high-risk stage II colon cancer (median age, 61 years) who reported higher intake of anti-inflammatory foods and greater exercise than a comparator group.

“In general, clinicians should be aware of the risk factors, make referrals to physical therapy, weight-loss specialists, endocrinologists, and nutritionists when appropriate, and be consistent and clear with patients about recommendations and what’s achievable,” DeVito said. “Meeting patients where they are can help make incremental progress, as these interventions take time and patience, and we should be understanding of that.” 

Identifying at-risk younger adults goes beyond discussing family history and obesity to include diet, exercise, and daily lifestyle, he added.

“Symptoms of potential GI cancer need to be taken seriously in all patients, and there should be a lower threshold in 2025 to get a colonoscopy, endoscopy, or CT scan than in previous years given all that we know today. We then need to establish through clinical studies who needs screening tests and who doesn’t, and what interventions work best to reduce risk.” 

 

Vigilance in the Absence of Screening

“Most GI cancers, unfortunately, can grow a fair amount before symptoms arise, so many patients present with symptoms only when a tumor has grown enough to affect organ function,” said Miguel Burch, MD, chief of minimally invasive and GI surgery at Cedars-Sinai Medical Center, Los Angeles.

Early screening improves outcomes in gastric cancer, Burch noted, and survival benefits are reflected in several East Asian countries that offer gastric cancer screening starting at age 40. In one study from Korea, a single upper endoscopy was associated with an approximate 40% reduction in gastric cancer mortality compared with no screening.

In the US, lack of funding for GI cancer screening remains a barrier to early identification, Burch emphasized. The impact is wide-ranging, contributing to increased morbidity and mortality in younger adults often in their most productive years, leading to lost wages and emotional strains upon patients and their families.Routine endoscopic or imaging screening is not typically performed in the US, and newer blood-based tests such as circulating tumor DNA are not yet sensitive enough to reliably detect very early-stage disease. Nonetheless, there is evidence that noninvasive biomarkers could soon help expand GI cancer screening.

In a study published in JAMA Surgery, Sui and colleagues tested a 10-microRNA signature assay (Destinex) for early detection of gastric cancer and reported robust identification rates above 95%.

“In recent years, the liquid biopsy has gained momentum with the hope of augmenting cancer detection from peripheral blood, even indicating potential as a screening test for healthy populations,” wrote Max R. Coffey, MD, and Vivian E. Strong, MD, both of the Memorial Sloan Kettering Cancer Center in New York City, in an accompanying editorial.

“Early detection is absolutely critical; when gastric cancer is found early, outcomes are dramatically better,” Strong told GI & Hepatology News. Subtle symptoms — reflux, persistent GI discomfort, or unexplained weight loss — should never be ignored, she added.

Early detection should also focus on additional risk factors such as prior Helicobacter pylori infection, smoking, and family history.

“Anyone with a personal or family history of H pylori should have very careful follow-up, and if one household member tests positive, all should be checked,” Strong said. “Just as importantly, if one or more family members have had stomach cancer, that should be discussed with a healthcare provider, as it may warrant higher-level surveillance and genetic testing.” 

Individuals concerned about increased risk for GI cancer should proactively ask their doctors whether they might benefit from testing or surveillance, Strong added.

“Lifestyle changes, timely medical evaluation, and tailored surveillance all play a vital role in prevention.”

DeVito disclosed clinical trial funding from the Gateway foundation, Xilio, Phanes, Astellas, GSK, as well as consulting fees/advisory board participation for Guardant, Agenus, and Xilio. Strong disclosed speaking honoraria for Merck and Astra Zeneca.

The study by Sui and colleagues was supported by the National Cancer Institute, National Institutes of Health, as well as by a grant from the American Gastroenterological Association Robert & Sally Funderburg Research Award in Gastric Cancer, and the Stupid Strong Foundation.

Burch had no financial conflicts to disclose.

 

A version of this article appeared on Medscape.com.

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Screening for H. pylori May Reduce Bleeding in Some Patients With MI

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Screening for H. pylori May Reduce Bleeding in Some Patients With MI

Routine screening for Helicobacter pylori in patients hospitalized for myocardial infarction (MI) did not significantly reduce the risk for upper gastrointestinal bleeding overall — but benefits were seen in high-risk subgroups, according to the HELP-MI SWEDEHEART trial published in JAMA and presented at the European Society of Cardiology (ESC) Congress 2025.

Bleeding in the upper gastrointestinal tract is a common complication after MI. It increases morbidity and mortality itself but can also reduce the effectiveness of antithrombotic treatments and lead to new cardiovascular events. It is often related to infection with H. pylori, the bacterium that can cause stomach inflammation, ulcers, and cancer, said Robin Hofmann, MD, PhD, a cardiologist at the Karolinska Institute in Stockholm, Sweden, who presented the trial results.Hofmann and his colleagues wondered whether screening for the bacterium using a simple urea breath test would help reduce the risk for bleeds. Using Sweden’s national SWEDEHEART registry, researchers performed a cluster-randomized crossover trial of more than 18,000 patients with MI at 35 Swedish hospitals. They found that screening for H. pylori reduced the risk for upper gastrointestinal bleeding by 10%, but the results were not statistically significant.

Several factors may have contributed to the neutral result, noted Hofmann. Just 70% of the people in the screening population were actually screened — though he said that is a fairly good number for a diagnostic test. A relatively small number, around 23%, were positive for H. pylori, a much lower rate than in many other parts of the world, and about 25% of participants in both arms of the trial were already taking proton pump inhibitors to reduce the risk for bleeding.

 

Signals of Benefit in High-Risk Patients

But in some high-risk subgroups, there was a clearer signal of benefit. Patients with anemia or kidney failure, for example, who are at higher risk for bleeding, saw a relative risk reduction of around 50% in the screening group — though the numbers were too small for formal statistical analysis.

“In unselected patients with myocardial infarction we could not show a significant reduction in bleeding,” said Hofmann. “But it’s very likely that there is a clinical effect, at least in those individuals at increased risk of bleeding.”

Discussant Paul Ridker, MD, a cardiologist at Harvard Medical School, Boston, said he agreed that the trial was technically neutral but clinically positive. He noted that in every subgroup, the trend was in the direction of benefit, with only the top end of the cardiac indices crossing over into no benefit. And the benefit appeared larger among high-risk patients with anemia or kidney failure.

“These are the very patients I’m most concerned about and don’t want to bleed,” he said.Because the urea breath test and eradication therapy are simple, safe, and inexpensive, Hofmann said he thinks there is “good evidence to recommend H. pylori screening in patients at higher risk of bleeding.”

“I’m very sure from a clinical perspective that we will be able to identify the groups that are low-hanging fruit,” he said. “But the guideline committees will have to decide if this evidence is enough.”

Hofmann and Ridker reported having no financial conflicts of interest.

 

A version of this article appeared on Medscape.com.

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Routine screening for Helicobacter pylori in patients hospitalized for myocardial infarction (MI) did not significantly reduce the risk for upper gastrointestinal bleeding overall — but benefits were seen in high-risk subgroups, according to the HELP-MI SWEDEHEART trial published in JAMA and presented at the European Society of Cardiology (ESC) Congress 2025.

Bleeding in the upper gastrointestinal tract is a common complication after MI. It increases morbidity and mortality itself but can also reduce the effectiveness of antithrombotic treatments and lead to new cardiovascular events. It is often related to infection with H. pylori, the bacterium that can cause stomach inflammation, ulcers, and cancer, said Robin Hofmann, MD, PhD, a cardiologist at the Karolinska Institute in Stockholm, Sweden, who presented the trial results.Hofmann and his colleagues wondered whether screening for the bacterium using a simple urea breath test would help reduce the risk for bleeds. Using Sweden’s national SWEDEHEART registry, researchers performed a cluster-randomized crossover trial of more than 18,000 patients with MI at 35 Swedish hospitals. They found that screening for H. pylori reduced the risk for upper gastrointestinal bleeding by 10%, but the results were not statistically significant.

Several factors may have contributed to the neutral result, noted Hofmann. Just 70% of the people in the screening population were actually screened — though he said that is a fairly good number for a diagnostic test. A relatively small number, around 23%, were positive for H. pylori, a much lower rate than in many other parts of the world, and about 25% of participants in both arms of the trial were already taking proton pump inhibitors to reduce the risk for bleeding.

 

Signals of Benefit in High-Risk Patients

But in some high-risk subgroups, there was a clearer signal of benefit. Patients with anemia or kidney failure, for example, who are at higher risk for bleeding, saw a relative risk reduction of around 50% in the screening group — though the numbers were too small for formal statistical analysis.

“In unselected patients with myocardial infarction we could not show a significant reduction in bleeding,” said Hofmann. “But it’s very likely that there is a clinical effect, at least in those individuals at increased risk of bleeding.”

Discussant Paul Ridker, MD, a cardiologist at Harvard Medical School, Boston, said he agreed that the trial was technically neutral but clinically positive. He noted that in every subgroup, the trend was in the direction of benefit, with only the top end of the cardiac indices crossing over into no benefit. And the benefit appeared larger among high-risk patients with anemia or kidney failure.

“These are the very patients I’m most concerned about and don’t want to bleed,” he said.Because the urea breath test and eradication therapy are simple, safe, and inexpensive, Hofmann said he thinks there is “good evidence to recommend H. pylori screening in patients at higher risk of bleeding.”

“I’m very sure from a clinical perspective that we will be able to identify the groups that are low-hanging fruit,” he said. “But the guideline committees will have to decide if this evidence is enough.”

Hofmann and Ridker reported having no financial conflicts of interest.

 

A version of this article appeared on Medscape.com.

Routine screening for Helicobacter pylori in patients hospitalized for myocardial infarction (MI) did not significantly reduce the risk for upper gastrointestinal bleeding overall — but benefits were seen in high-risk subgroups, according to the HELP-MI SWEDEHEART trial published in JAMA and presented at the European Society of Cardiology (ESC) Congress 2025.

Bleeding in the upper gastrointestinal tract is a common complication after MI. It increases morbidity and mortality itself but can also reduce the effectiveness of antithrombotic treatments and lead to new cardiovascular events. It is often related to infection with H. pylori, the bacterium that can cause stomach inflammation, ulcers, and cancer, said Robin Hofmann, MD, PhD, a cardiologist at the Karolinska Institute in Stockholm, Sweden, who presented the trial results.Hofmann and his colleagues wondered whether screening for the bacterium using a simple urea breath test would help reduce the risk for bleeds. Using Sweden’s national SWEDEHEART registry, researchers performed a cluster-randomized crossover trial of more than 18,000 patients with MI at 35 Swedish hospitals. They found that screening for H. pylori reduced the risk for upper gastrointestinal bleeding by 10%, but the results were not statistically significant.

Several factors may have contributed to the neutral result, noted Hofmann. Just 70% of the people in the screening population were actually screened — though he said that is a fairly good number for a diagnostic test. A relatively small number, around 23%, were positive for H. pylori, a much lower rate than in many other parts of the world, and about 25% of participants in both arms of the trial were already taking proton pump inhibitors to reduce the risk for bleeding.

 

Signals of Benefit in High-Risk Patients

But in some high-risk subgroups, there was a clearer signal of benefit. Patients with anemia or kidney failure, for example, who are at higher risk for bleeding, saw a relative risk reduction of around 50% in the screening group — though the numbers were too small for formal statistical analysis.

“In unselected patients with myocardial infarction we could not show a significant reduction in bleeding,” said Hofmann. “But it’s very likely that there is a clinical effect, at least in those individuals at increased risk of bleeding.”

Discussant Paul Ridker, MD, a cardiologist at Harvard Medical School, Boston, said he agreed that the trial was technically neutral but clinically positive. He noted that in every subgroup, the trend was in the direction of benefit, with only the top end of the cardiac indices crossing over into no benefit. And the benefit appeared larger among high-risk patients with anemia or kidney failure.

“These are the very patients I’m most concerned about and don’t want to bleed,” he said.Because the urea breath test and eradication therapy are simple, safe, and inexpensive, Hofmann said he thinks there is “good evidence to recommend H. pylori screening in patients at higher risk of bleeding.”

“I’m very sure from a clinical perspective that we will be able to identify the groups that are low-hanging fruit,” he said. “But the guideline committees will have to decide if this evidence is enough.”

Hofmann and Ridker reported having no financial conflicts of interest.

 

A version of this article appeared on Medscape.com.

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Large Language Models Cut Time, Cost of Guideline Development

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Large language models (LLMs) may help streamline clinical guideline development by dramatically reducing the time and cost required for systematic reviews, according to a pilot study from the American Gastroenterological Association (AGA).

Faster, cheaper study screening could allow societies to update clinical recommendations more frequently, improving alignment with the latest evidence, lead author Sunny Chung, MD, of Yale School of Medicine, New Haven, Connecticut, and colleagues, reported.

Dr. Sunny Chung



“Each guideline typically requires 5 to 15 systematic reviews, making the process time-consuming (averaging more than 60 weeks) and costly (more than $140,000),” the investigators wrote in Gastroenterology . “One of the most critical yet time-consuming steps in systematic reviews is title and abstract screening. LLMs have the potential to make this step more efficient.”

To test this approach, the investigators developed, validated, and applied a dual-model LLM screening pipeline with human-in-the-loop oversight, focusing on randomized controlled trials in AGA guidelines. 

The system was built using the 2021 guideline on moderate-to-severe Crohn’s disease, targeting biologic therapies for induction and maintenance of remission. 

Using chain-of-thought prompting and structured inclusion criteria based on the PICO framework, the investigators deployed GPT-4o (OpenAI) and Gemini-1.5-Pro (Google DeepMind) as independent screeners, each assessing titles and abstracts according to standardized logic encoded in JavaScript Object Notation. This approach mimicked a traditional double-reviewer system.

After initial testing, the pipeline was validated in a 2025 update of the same guideline, this time spanning 6 focused clinical questions on advanced therapies and immunomodulators. Results were compared against manual screening by 2 experienced human reviewers, with total screening time documented. 

The system was then tested across 4 additional guideline topics: fecal microbiota transplantation (FMT) for irritable bowel syndrome and Clostridioides difficile, gastroparesis, and hepatocellular carcinoma. A final test applied the system to a forthcoming guideline on complications of acute pancreatitis.

Across all topics, the dual-LLM system achieved 100% sensitivity in identifying randomized controlled trials (RCTs). For the 2025 update of the AGA guideline on Crohn’s disease, the models flagged 418 of 4,377 abstracts for inclusion, captur-ing all 25 relevant RCTs in just 48 minutes. Manual screening of the same dataset previously took almost 13 hours.

Comparable accuracy and time savings were observed for the other topics. 

The pipeline correctly flagged all 13 RCTs in 4,820 studies on FMT for irritable bowel syndrome, and all 16 RCTs in 5,587 studies on FMT for Clostridioides difficile, requiring 27 and 66 minutes, respectively. Similarly, the system captured all 11 RCTs in 3,919 hepatocellular carcinoma abstracts and all 18 RCTs in 1,578 studies on gastroparesis, completing each task in under 65 minutes. Early testing on the upcoming guideline for pancreatitis yielded similar results.

Cost analysis underscored the efficiency of this approach. At an estimated $175–200 per hour for expert screeners, traditional abstract screening would cost around $2,500 per review, versus approximately $100 for the LLM approach—a 96% reduction.

The investigators cautioned that human oversight remains necessary to verify the relevance of studies flagged by the models. While the system’s sensitivity was consistent, it also selected articles that were ultimately excluded by expert reviewers. Broader validation will be required to assess performance across non-RCT study designs, such as observational or case-control studies, they added.

“As medical literature continues to expand, the integration of artificial intelligence into evidence synthesis processes will become increasingly vital,” Dr. Chung and colleagues wrote. “With further refinement and broader validation, this LLM-based pipeline has the potential to revolutionize evidence synthesis and set a new standard for guideline development.”

This study was funded by National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest.
 

Body

Ethan Goh, MD, executive director of the Stanford AI Research and Science Evaluation (ARISE) Network, described the AGA pilot as both timely and promising.

“I’m certainly bullish about the use case,” he said in an interview. “Their study design and application is also robust, so I would congratulate them.”

Dr. Ethan Goh



Goh, a general editor for BMJ Digital Health & AI, predicted “huge potential” in the strategy for both clinicians and the general population, who benefit from the most up-to-date guidelines possible.

“I believe that using AI can represent a much faster, more cost effective, efficient way of gathering all these information sources,” he said.

Still, humans will need to be involved in the process.

“[This AI-driven approach] will always need some degree of expert oversight and judgement,” Goh said. 

Speaking more broadly about automating study aggregation, Goh said AI may still struggle to determine which studies are most clinically relevant.

“When we use [AI models] to pull out medical references, anecdotally, I don’t think they’re always getting the best ones all the time, or even necessarily the right ones,” he said.

And as AI models grow more impressive, these shortcomings become less apparent, potentially lulling humans into overconfidence.

“Humans are humans,” Goh said. “We get lazy over time. That will be one of the challenges. As the systems get increasingly good, humans start to defer more and more of their judgment to them and say, ‘All right, AI, you’re doing good. Just do 100% automation.’ And then [people] start fact checking or reviewing even less.”

AI could also undermine automated reviews in another way: AI-generated publications that appear genuine, but aren’t, may creep into the dataset.

Despite these concerns, Goh concluded on an optimistic note. 

“I think that there are huge ways to use AI, tools, not to replace, but to augment and support human judgment,” he said.

Ethan Goh, MD, is senior research engineer and executive director of the Stanford AI Research and Science Evaluation (ARISE) Network, at Stanford (Calif.) University. He declared no conflicts of interest.

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Body

Ethan Goh, MD, executive director of the Stanford AI Research and Science Evaluation (ARISE) Network, described the AGA pilot as both timely and promising.

“I’m certainly bullish about the use case,” he said in an interview. “Their study design and application is also robust, so I would congratulate them.”

Dr. Ethan Goh



Goh, a general editor for BMJ Digital Health & AI, predicted “huge potential” in the strategy for both clinicians and the general population, who benefit from the most up-to-date guidelines possible.

“I believe that using AI can represent a much faster, more cost effective, efficient way of gathering all these information sources,” he said.

Still, humans will need to be involved in the process.

“[This AI-driven approach] will always need some degree of expert oversight and judgement,” Goh said. 

Speaking more broadly about automating study aggregation, Goh said AI may still struggle to determine which studies are most clinically relevant.

“When we use [AI models] to pull out medical references, anecdotally, I don’t think they’re always getting the best ones all the time, or even necessarily the right ones,” he said.

And as AI models grow more impressive, these shortcomings become less apparent, potentially lulling humans into overconfidence.

“Humans are humans,” Goh said. “We get lazy over time. That will be one of the challenges. As the systems get increasingly good, humans start to defer more and more of their judgment to them and say, ‘All right, AI, you’re doing good. Just do 100% automation.’ And then [people] start fact checking or reviewing even less.”

AI could also undermine automated reviews in another way: AI-generated publications that appear genuine, but aren’t, may creep into the dataset.

Despite these concerns, Goh concluded on an optimistic note. 

“I think that there are huge ways to use AI, tools, not to replace, but to augment and support human judgment,” he said.

Ethan Goh, MD, is senior research engineer and executive director of the Stanford AI Research and Science Evaluation (ARISE) Network, at Stanford (Calif.) University. He declared no conflicts of interest.

Body

Ethan Goh, MD, executive director of the Stanford AI Research and Science Evaluation (ARISE) Network, described the AGA pilot as both timely and promising.

“I’m certainly bullish about the use case,” he said in an interview. “Their study design and application is also robust, so I would congratulate them.”

Dr. Ethan Goh



Goh, a general editor for BMJ Digital Health & AI, predicted “huge potential” in the strategy for both clinicians and the general population, who benefit from the most up-to-date guidelines possible.

“I believe that using AI can represent a much faster, more cost effective, efficient way of gathering all these information sources,” he said.

Still, humans will need to be involved in the process.

“[This AI-driven approach] will always need some degree of expert oversight and judgement,” Goh said. 

Speaking more broadly about automating study aggregation, Goh said AI may still struggle to determine which studies are most clinically relevant.

“When we use [AI models] to pull out medical references, anecdotally, I don’t think they’re always getting the best ones all the time, or even necessarily the right ones,” he said.

And as AI models grow more impressive, these shortcomings become less apparent, potentially lulling humans into overconfidence.

“Humans are humans,” Goh said. “We get lazy over time. That will be one of the challenges. As the systems get increasingly good, humans start to defer more and more of their judgment to them and say, ‘All right, AI, you’re doing good. Just do 100% automation.’ And then [people] start fact checking or reviewing even less.”

AI could also undermine automated reviews in another way: AI-generated publications that appear genuine, but aren’t, may creep into the dataset.

Despite these concerns, Goh concluded on an optimistic note. 

“I think that there are huge ways to use AI, tools, not to replace, but to augment and support human judgment,” he said.

Ethan Goh, MD, is senior research engineer and executive director of the Stanford AI Research and Science Evaluation (ARISE) Network, at Stanford (Calif.) University. He declared no conflicts of interest.

Title
Timely and Promising
Timely and Promising

Large language models (LLMs) may help streamline clinical guideline development by dramatically reducing the time and cost required for systematic reviews, according to a pilot study from the American Gastroenterological Association (AGA).

Faster, cheaper study screening could allow societies to update clinical recommendations more frequently, improving alignment with the latest evidence, lead author Sunny Chung, MD, of Yale School of Medicine, New Haven, Connecticut, and colleagues, reported.

Dr. Sunny Chung



“Each guideline typically requires 5 to 15 systematic reviews, making the process time-consuming (averaging more than 60 weeks) and costly (more than $140,000),” the investigators wrote in Gastroenterology . “One of the most critical yet time-consuming steps in systematic reviews is title and abstract screening. LLMs have the potential to make this step more efficient.”

To test this approach, the investigators developed, validated, and applied a dual-model LLM screening pipeline with human-in-the-loop oversight, focusing on randomized controlled trials in AGA guidelines. 

The system was built using the 2021 guideline on moderate-to-severe Crohn’s disease, targeting biologic therapies for induction and maintenance of remission. 

Using chain-of-thought prompting and structured inclusion criteria based on the PICO framework, the investigators deployed GPT-4o (OpenAI) and Gemini-1.5-Pro (Google DeepMind) as independent screeners, each assessing titles and abstracts according to standardized logic encoded in JavaScript Object Notation. This approach mimicked a traditional double-reviewer system.

After initial testing, the pipeline was validated in a 2025 update of the same guideline, this time spanning 6 focused clinical questions on advanced therapies and immunomodulators. Results were compared against manual screening by 2 experienced human reviewers, with total screening time documented. 

The system was then tested across 4 additional guideline topics: fecal microbiota transplantation (FMT) for irritable bowel syndrome and Clostridioides difficile, gastroparesis, and hepatocellular carcinoma. A final test applied the system to a forthcoming guideline on complications of acute pancreatitis.

Across all topics, the dual-LLM system achieved 100% sensitivity in identifying randomized controlled trials (RCTs). For the 2025 update of the AGA guideline on Crohn’s disease, the models flagged 418 of 4,377 abstracts for inclusion, captur-ing all 25 relevant RCTs in just 48 minutes. Manual screening of the same dataset previously took almost 13 hours.

Comparable accuracy and time savings were observed for the other topics. 

The pipeline correctly flagged all 13 RCTs in 4,820 studies on FMT for irritable bowel syndrome, and all 16 RCTs in 5,587 studies on FMT for Clostridioides difficile, requiring 27 and 66 minutes, respectively. Similarly, the system captured all 11 RCTs in 3,919 hepatocellular carcinoma abstracts and all 18 RCTs in 1,578 studies on gastroparesis, completing each task in under 65 minutes. Early testing on the upcoming guideline for pancreatitis yielded similar results.

Cost analysis underscored the efficiency of this approach. At an estimated $175–200 per hour for expert screeners, traditional abstract screening would cost around $2,500 per review, versus approximately $100 for the LLM approach—a 96% reduction.

The investigators cautioned that human oversight remains necessary to verify the relevance of studies flagged by the models. While the system’s sensitivity was consistent, it also selected articles that were ultimately excluded by expert reviewers. Broader validation will be required to assess performance across non-RCT study designs, such as observational or case-control studies, they added.

“As medical literature continues to expand, the integration of artificial intelligence into evidence synthesis processes will become increasingly vital,” Dr. Chung and colleagues wrote. “With further refinement and broader validation, this LLM-based pipeline has the potential to revolutionize evidence synthesis and set a new standard for guideline development.”

This study was funded by National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest.
 

Large language models (LLMs) may help streamline clinical guideline development by dramatically reducing the time and cost required for systematic reviews, according to a pilot study from the American Gastroenterological Association (AGA).

Faster, cheaper study screening could allow societies to update clinical recommendations more frequently, improving alignment with the latest evidence, lead author Sunny Chung, MD, of Yale School of Medicine, New Haven, Connecticut, and colleagues, reported.

Dr. Sunny Chung



“Each guideline typically requires 5 to 15 systematic reviews, making the process time-consuming (averaging more than 60 weeks) and costly (more than $140,000),” the investigators wrote in Gastroenterology . “One of the most critical yet time-consuming steps in systematic reviews is title and abstract screening. LLMs have the potential to make this step more efficient.”

To test this approach, the investigators developed, validated, and applied a dual-model LLM screening pipeline with human-in-the-loop oversight, focusing on randomized controlled trials in AGA guidelines. 

The system was built using the 2021 guideline on moderate-to-severe Crohn’s disease, targeting biologic therapies for induction and maintenance of remission. 

Using chain-of-thought prompting and structured inclusion criteria based on the PICO framework, the investigators deployed GPT-4o (OpenAI) and Gemini-1.5-Pro (Google DeepMind) as independent screeners, each assessing titles and abstracts according to standardized logic encoded in JavaScript Object Notation. This approach mimicked a traditional double-reviewer system.

After initial testing, the pipeline was validated in a 2025 update of the same guideline, this time spanning 6 focused clinical questions on advanced therapies and immunomodulators. Results were compared against manual screening by 2 experienced human reviewers, with total screening time documented. 

The system was then tested across 4 additional guideline topics: fecal microbiota transplantation (FMT) for irritable bowel syndrome and Clostridioides difficile, gastroparesis, and hepatocellular carcinoma. A final test applied the system to a forthcoming guideline on complications of acute pancreatitis.

Across all topics, the dual-LLM system achieved 100% sensitivity in identifying randomized controlled trials (RCTs). For the 2025 update of the AGA guideline on Crohn’s disease, the models flagged 418 of 4,377 abstracts for inclusion, captur-ing all 25 relevant RCTs in just 48 minutes. Manual screening of the same dataset previously took almost 13 hours.

Comparable accuracy and time savings were observed for the other topics. 

The pipeline correctly flagged all 13 RCTs in 4,820 studies on FMT for irritable bowel syndrome, and all 16 RCTs in 5,587 studies on FMT for Clostridioides difficile, requiring 27 and 66 minutes, respectively. Similarly, the system captured all 11 RCTs in 3,919 hepatocellular carcinoma abstracts and all 18 RCTs in 1,578 studies on gastroparesis, completing each task in under 65 minutes. Early testing on the upcoming guideline for pancreatitis yielded similar results.

Cost analysis underscored the efficiency of this approach. At an estimated $175–200 per hour for expert screeners, traditional abstract screening would cost around $2,500 per review, versus approximately $100 for the LLM approach—a 96% reduction.

The investigators cautioned that human oversight remains necessary to verify the relevance of studies flagged by the models. While the system’s sensitivity was consistent, it also selected articles that were ultimately excluded by expert reviewers. Broader validation will be required to assess performance across non-RCT study designs, such as observational or case-control studies, they added.

“As medical literature continues to expand, the integration of artificial intelligence into evidence synthesis processes will become increasingly vital,” Dr. Chung and colleagues wrote. “With further refinement and broader validation, this LLM-based pipeline has the potential to revolutionize evidence synthesis and set a new standard for guideline development.”

This study was funded by National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest.
 

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GI Disorders Linked With Sleep Problems

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Mon, 09/08/2025 - 10:20

Adults with gastrointestinal (GI) diseases are significantly more likely to experience sleep disturbances than those without GI conditions, a new study involving more than 10,000 individuals has found.

“Emerging evidence suggests a bidirectional relationship between GI diseases and sleep disorders, whereby dysfunction in one domain may exacerbate the other,” wrote Shicheng Ye, PhD, of The Third Clinical Medical College of Guangzhou University of Chinese Medicine, and colleagues. However, previous studies on the association between GI and sleep problems have been small, and the role of depression as a mediator has not been well explored.

In the study, which was published online in BMC Gastroenterology, the researchers reviewed data from the US National Health and Nutrition Examination Survey between 2005 and 2014. The study population included 10,626 adults aged 20 years or older, with a mean age of 45.6 years, 50.8% of whom were women. Of these, 6444 were identified as having GI disease on the basis of a “yes” response to the question of whether they had a stomach or intestinal illness with vomiting or diarrhea within the past 30 days.

Researchers also examined responses to survey questions related to sleep duration, trouble sleeping, and diagnosis of a sleep disorder. Individuals with vs without GI diseases had a significantly higher prevalence of sleep trouble (37.99% vs 24.21%; P < .001) and a greater frequency of diagnosed sleep disorders (14.99% vs 8.08%; P < .001).

An analysis adjusted for demographic, lifestyle, and clinical factors found that individuals with vs without GI diseases were 70% more likely to have sleep trouble. Individuals with vs without GI diseases were also significantly more likely to have a diagnosed sleep disorder and a reduction in sleep duration (adjusted odds ratio, 1.8; adjusted beta, -0.15).

The association between GI diseases and sleep problems remained consistent across individuals of multiple subgroups, including those without hypertension, diabetes, or a history of smoking. It also remained significant among individuals with coronary heart disease and higher scores on the dietary index for gut microbiota. No significant interaction effects related to age, sex, or chronic disease appeared in any subgroup (P > .05).

An additional mediation analysis found that depression partly mediated the associations between GI diseases and sleep issues. Depression accounted for 21.29% of the total effect on sleep problems, 19.23% of the effect on sleep disorders, and 26.68% of the effect on sleep duration.

The mediating role of depression on the association between GI disease and sleep problems may not be exclusive, the researchers wrote. Other potential mechanisms may include systemic inflammation, visceral hypersensitivity, and metabolic dysfunction.

The findings were limited by several factors, including the possibly underpowered sample size for machine-learning models and the reliance on self-reports of GI diseases, sleep outcomes, and coronary heart disease, the researchers noted. Other limitations included the inability to adjust for confounding factors, including obstructive sleep apnea, chronic pain, and hypertension.

However, the results illustrate the need to address both psychological and GI factors in clinical practice to improve sleep health, the researchers wrote. More research is needed to identify causal pathways and develop targeted, multidimensional interventions for this interconnected trio of health problems.

 

Increasing Evidence for Gut-Brain Interaction

Both sleep disorders and disorders of GBI (DGBI) are highly prevalent worldwide, Jatin Roper, MD, gastroenterologist and associate professor of medicine at Duke University, Durham, North Carolina, told GI & Hepatology News.

Dr Jatin Roper

“A growing body of evidence suggests that DGBI, including irritable bowel syndrome, are caused by imbalances in signaling between the brain and the intestine, which include the vagus nerve, hormonal signals, the gut microbiota, and immune system,” said Roper, who was not involved in the current study.

“Since many sleep disturbances are centrally mediated, it is plausible that sleep and gastrointestinal disorders could be mechanistically linked,” he said. Rigorous analysis of patient databases for a possible association between sleep and GI disorders, as was done in the current study, is an important step.

The current study findings were not unexpected, “particularly the finding that depression may mediate a link between sleep and GI disorders, because depression is well known to be associated to sleep disturbances and DGBI,” Roper said.

However, GI doctors often do not ask patients about problems with sleep, and pulmonary doctors or sleep specialists may not ask patients about GI symptoms, Roper noted. Similarly, patients may not bring up all their symptoms when seeing these specialists.

“The current study underscores the need for comprehensive, multisystem evaluations in specialty clinics for sleep and GI conditions and appropriate referrals to specialists, when necessary,” he said.

The research raised an important question of whether sleep and GI disorders are associated with each other because of other underlying medical conditions, which may be difficult to control for in cross-sectional studies, or whether sleep problems cause GI problems or vice versa, Roper said. Other uncertainties include whether the conditions are biologically linked, possibly through shared changes in the brain-gut axis.

Long-term observational studies would be useful to identify whether sleep disturbances precede DGBI or vice versa, Roper added.

The study received no outside funding. The researchers and Roper had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

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Adults with gastrointestinal (GI) diseases are significantly more likely to experience sleep disturbances than those without GI conditions, a new study involving more than 10,000 individuals has found.

“Emerging evidence suggests a bidirectional relationship between GI diseases and sleep disorders, whereby dysfunction in one domain may exacerbate the other,” wrote Shicheng Ye, PhD, of The Third Clinical Medical College of Guangzhou University of Chinese Medicine, and colleagues. However, previous studies on the association between GI and sleep problems have been small, and the role of depression as a mediator has not been well explored.

In the study, which was published online in BMC Gastroenterology, the researchers reviewed data from the US National Health and Nutrition Examination Survey between 2005 and 2014. The study population included 10,626 adults aged 20 years or older, with a mean age of 45.6 years, 50.8% of whom were women. Of these, 6444 were identified as having GI disease on the basis of a “yes” response to the question of whether they had a stomach or intestinal illness with vomiting or diarrhea within the past 30 days.

Researchers also examined responses to survey questions related to sleep duration, trouble sleeping, and diagnosis of a sleep disorder. Individuals with vs without GI diseases had a significantly higher prevalence of sleep trouble (37.99% vs 24.21%; P < .001) and a greater frequency of diagnosed sleep disorders (14.99% vs 8.08%; P < .001).

An analysis adjusted for demographic, lifestyle, and clinical factors found that individuals with vs without GI diseases were 70% more likely to have sleep trouble. Individuals with vs without GI diseases were also significantly more likely to have a diagnosed sleep disorder and a reduction in sleep duration (adjusted odds ratio, 1.8; adjusted beta, -0.15).

The association between GI diseases and sleep problems remained consistent across individuals of multiple subgroups, including those without hypertension, diabetes, or a history of smoking. It also remained significant among individuals with coronary heart disease and higher scores on the dietary index for gut microbiota. No significant interaction effects related to age, sex, or chronic disease appeared in any subgroup (P > .05).

An additional mediation analysis found that depression partly mediated the associations between GI diseases and sleep issues. Depression accounted for 21.29% of the total effect on sleep problems, 19.23% of the effect on sleep disorders, and 26.68% of the effect on sleep duration.

The mediating role of depression on the association between GI disease and sleep problems may not be exclusive, the researchers wrote. Other potential mechanisms may include systemic inflammation, visceral hypersensitivity, and metabolic dysfunction.

The findings were limited by several factors, including the possibly underpowered sample size for machine-learning models and the reliance on self-reports of GI diseases, sleep outcomes, and coronary heart disease, the researchers noted. Other limitations included the inability to adjust for confounding factors, including obstructive sleep apnea, chronic pain, and hypertension.

However, the results illustrate the need to address both psychological and GI factors in clinical practice to improve sleep health, the researchers wrote. More research is needed to identify causal pathways and develop targeted, multidimensional interventions for this interconnected trio of health problems.

 

Increasing Evidence for Gut-Brain Interaction

Both sleep disorders and disorders of GBI (DGBI) are highly prevalent worldwide, Jatin Roper, MD, gastroenterologist and associate professor of medicine at Duke University, Durham, North Carolina, told GI & Hepatology News.

Dr Jatin Roper

“A growing body of evidence suggests that DGBI, including irritable bowel syndrome, are caused by imbalances in signaling between the brain and the intestine, which include the vagus nerve, hormonal signals, the gut microbiota, and immune system,” said Roper, who was not involved in the current study.

“Since many sleep disturbances are centrally mediated, it is plausible that sleep and gastrointestinal disorders could be mechanistically linked,” he said. Rigorous analysis of patient databases for a possible association between sleep and GI disorders, as was done in the current study, is an important step.

The current study findings were not unexpected, “particularly the finding that depression may mediate a link between sleep and GI disorders, because depression is well known to be associated to sleep disturbances and DGBI,” Roper said.

However, GI doctors often do not ask patients about problems with sleep, and pulmonary doctors or sleep specialists may not ask patients about GI symptoms, Roper noted. Similarly, patients may not bring up all their symptoms when seeing these specialists.

“The current study underscores the need for comprehensive, multisystem evaluations in specialty clinics for sleep and GI conditions and appropriate referrals to specialists, when necessary,” he said.

The research raised an important question of whether sleep and GI disorders are associated with each other because of other underlying medical conditions, which may be difficult to control for in cross-sectional studies, or whether sleep problems cause GI problems or vice versa, Roper said. Other uncertainties include whether the conditions are biologically linked, possibly through shared changes in the brain-gut axis.

Long-term observational studies would be useful to identify whether sleep disturbances precede DGBI or vice versa, Roper added.

The study received no outside funding. The researchers and Roper had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

Adults with gastrointestinal (GI) diseases are significantly more likely to experience sleep disturbances than those without GI conditions, a new study involving more than 10,000 individuals has found.

“Emerging evidence suggests a bidirectional relationship between GI diseases and sleep disorders, whereby dysfunction in one domain may exacerbate the other,” wrote Shicheng Ye, PhD, of The Third Clinical Medical College of Guangzhou University of Chinese Medicine, and colleagues. However, previous studies on the association between GI and sleep problems have been small, and the role of depression as a mediator has not been well explored.

In the study, which was published online in BMC Gastroenterology, the researchers reviewed data from the US National Health and Nutrition Examination Survey between 2005 and 2014. The study population included 10,626 adults aged 20 years or older, with a mean age of 45.6 years, 50.8% of whom were women. Of these, 6444 were identified as having GI disease on the basis of a “yes” response to the question of whether they had a stomach or intestinal illness with vomiting or diarrhea within the past 30 days.

Researchers also examined responses to survey questions related to sleep duration, trouble sleeping, and diagnosis of a sleep disorder. Individuals with vs without GI diseases had a significantly higher prevalence of sleep trouble (37.99% vs 24.21%; P < .001) and a greater frequency of diagnosed sleep disorders (14.99% vs 8.08%; P < .001).

An analysis adjusted for demographic, lifestyle, and clinical factors found that individuals with vs without GI diseases were 70% more likely to have sleep trouble. Individuals with vs without GI diseases were also significantly more likely to have a diagnosed sleep disorder and a reduction in sleep duration (adjusted odds ratio, 1.8; adjusted beta, -0.15).

The association between GI diseases and sleep problems remained consistent across individuals of multiple subgroups, including those without hypertension, diabetes, or a history of smoking. It also remained significant among individuals with coronary heart disease and higher scores on the dietary index for gut microbiota. No significant interaction effects related to age, sex, or chronic disease appeared in any subgroup (P > .05).

An additional mediation analysis found that depression partly mediated the associations between GI diseases and sleep issues. Depression accounted for 21.29% of the total effect on sleep problems, 19.23% of the effect on sleep disorders, and 26.68% of the effect on sleep duration.

The mediating role of depression on the association between GI disease and sleep problems may not be exclusive, the researchers wrote. Other potential mechanisms may include systemic inflammation, visceral hypersensitivity, and metabolic dysfunction.

The findings were limited by several factors, including the possibly underpowered sample size for machine-learning models and the reliance on self-reports of GI diseases, sleep outcomes, and coronary heart disease, the researchers noted. Other limitations included the inability to adjust for confounding factors, including obstructive sleep apnea, chronic pain, and hypertension.

However, the results illustrate the need to address both psychological and GI factors in clinical practice to improve sleep health, the researchers wrote. More research is needed to identify causal pathways and develop targeted, multidimensional interventions for this interconnected trio of health problems.

 

Increasing Evidence for Gut-Brain Interaction

Both sleep disorders and disorders of GBI (DGBI) are highly prevalent worldwide, Jatin Roper, MD, gastroenterologist and associate professor of medicine at Duke University, Durham, North Carolina, told GI & Hepatology News.

Dr Jatin Roper

“A growing body of evidence suggests that DGBI, including irritable bowel syndrome, are caused by imbalances in signaling between the brain and the intestine, which include the vagus nerve, hormonal signals, the gut microbiota, and immune system,” said Roper, who was not involved in the current study.

“Since many sleep disturbances are centrally mediated, it is plausible that sleep and gastrointestinal disorders could be mechanistically linked,” he said. Rigorous analysis of patient databases for a possible association between sleep and GI disorders, as was done in the current study, is an important step.

The current study findings were not unexpected, “particularly the finding that depression may mediate a link between sleep and GI disorders, because depression is well known to be associated to sleep disturbances and DGBI,” Roper said.

However, GI doctors often do not ask patients about problems with sleep, and pulmonary doctors or sleep specialists may not ask patients about GI symptoms, Roper noted. Similarly, patients may not bring up all their symptoms when seeing these specialists.

“The current study underscores the need for comprehensive, multisystem evaluations in specialty clinics for sleep and GI conditions and appropriate referrals to specialists, when necessary,” he said.

The research raised an important question of whether sleep and GI disorders are associated with each other because of other underlying medical conditions, which may be difficult to control for in cross-sectional studies, or whether sleep problems cause GI problems or vice versa, Roper said. Other uncertainties include whether the conditions are biologically linked, possibly through shared changes in the brain-gut axis.

Long-term observational studies would be useful to identify whether sleep disturbances precede DGBI or vice versa, Roper added.

The study received no outside funding. The researchers and Roper had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

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Elevated Serologic Markers Insufficient to Diagnose Celiac Disease

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Elevated tissue transglutaminase immunoglobulin A (tTG-IgA) in isolation is insufficient to diagnose celiac disease in children, 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.

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Elevated tissue transglutaminase immunoglobulin A (tTG-IgA) in isolation is insufficient to diagnose celiac disease in children, 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.

Elevated tissue transglutaminase immunoglobulin A (tTG-IgA) in isolation is insufficient to diagnose celiac disease in children, 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.

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