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Intervention reduces PPI use without worsening acid-related diseases
Proton pump inhibitor (PPI) use can safely be reduced by deprescribing efforts coupled with patient and clinician education, according to a retrospective study involving more than 4 million veterans.
After 1 year, the intervention was associated with a significant reduction in PPI use without worsening of acid-related diseases, reported lead author Jacob E. Kurlander, MD, of the University of Michigan, Ann Arbor, and the VA Ann Arbor Healthcare System’s Center for Clinical Management Research.
“There’s increasing interest in interventions to reduce PPI use,” Dr. Kurlander said during his virtual presentation at the annual Digestive Disease Week® (DDW). “Many of the interventions have come in the form of patient and provider education, like the Choosing Wisely campaign put out by the American Board of Internal Medicine. However, in rigorous studies, few interventions have actually proven effective, and many of these studies lack data on clinical outcomes, so it’s difficult to ascertain the real clinical benefits, or even harms.”
In an effort to address this gap, the investigators conducted a retrospective, difference-in-difference study spanning 10 years, from 2009 to 2019. The 1-year intervention, implemented in August 2013, included refill restrictions for PPIs without documented indication for long-term use, voiding of PPI prescriptions not filled within 6 months, a quick-order option for H2-receptor antagonists, reports to identify high-dose PPI prescribing, and patient and clinician education.
The intervention group consisted of 192,607-250,349 veterans in Veteran Integrated Service Network 17, whereas the control group consisted of 3,775,978-4,360,908 veterans in other service networks (ranges in population size are due to variations across 6-month intervals of analysis). For each 6-month interval, patients were included if they had at least two primary care visits within the past 2 years, and excluded if they received primary care at three other sites that joined the intervention site after initial implementation.
The investigators analyzed three main outcomes: Proportion of veterans dispensed a PPI prescription from the VA at any dose; incidence proportion of hospitalization for upper GI diseases, including upper GI bleeding other than from esophageal varices or angiodysplasia, as well as nonbleeding acid peptic disease; and rates of primary care visits, gastroenterology visits, and esophagogastroduodenoscopies (EGDs).
The analysis was divided into a preimplementation period, lasting approximately 5 years, and a postimplementation period with a similar duration. In the postimplementation period, the intervention group had a 5.9% relative reduction in PPI prescriptions, compared with the control group (P < .001). During the same period, the intervention site did not have a significant increase in the rate of patients hospitalized for upper GI diseases, primary care visits, GI clinic visits, or EGDs.
In a subgroup analysis of patients coprescribed PPIs during time at high-risk for upper GI bleeding (that is, when they possessed at least two high-risk medications, such as warfarin), there was a 4.6% relative reduction in time with PPI gastroprotection among the intervention group, compared with the control group (P = .003). In a second sensitivity analysis, hospitalization for upper GI diseases in high-risk patients at least 65 years of age was not significantly different between groups.
“[This] multicomponent PPI deprescribing program led to sustained reductions in PPI use,” Dr. Kurlander concluded. “However, this blunt intervention also reduced appropriate use of PPIs for gastroprotection, raising some concerns about clinical quality of care, but this did not appear to cause any measurable clinical harm in terms of hospitalizations for upper GI diseases.”
Debate around ‘unnecessary PPI use’
According to Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, the study “makes an attempt to do what others have tried in different ways, which is to develop a mechanism to help reduce or discontinue proton pump inhibitors when people believe they’re not indicated.”
Yet this latter element – appropriate indication – drives an ongoing debate.
“This is a very controversial area,” Dr. Katz said in an interview. “The concept of using the lowest effective dose of medication needed for a symptom or a disease is not new, but the push to reducing or eliminating ‘unnecessary PPI use’ is one that I believe should be carefully discussed, and that we have a clear understanding of what constitutes unnecessary use. And quite honestly, I’m willing to state that I don’t believe that’s been well defined.”
Dr. Katz, who recently coauthored an article about PPIs, suggested that more prospective research is needed to identify which patients need PPIs and which don’t.
“What we really need are more studies that look at who really needs [PPIs] long term,” Dr. Katz said, “as opposed to doing it ad hoc.”
The study was funded by the U.S. Department of Veterans Affairs and the National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest. Dr. Katz is a consultant for Phathom Pharma.
Proton pump inhibitor (PPI) use can safely be reduced by deprescribing efforts coupled with patient and clinician education, according to a retrospective study involving more than 4 million veterans.
After 1 year, the intervention was associated with a significant reduction in PPI use without worsening of acid-related diseases, reported lead author Jacob E. Kurlander, MD, of the University of Michigan, Ann Arbor, and the VA Ann Arbor Healthcare System’s Center for Clinical Management Research.
“There’s increasing interest in interventions to reduce PPI use,” Dr. Kurlander said during his virtual presentation at the annual Digestive Disease Week® (DDW). “Many of the interventions have come in the form of patient and provider education, like the Choosing Wisely campaign put out by the American Board of Internal Medicine. However, in rigorous studies, few interventions have actually proven effective, and many of these studies lack data on clinical outcomes, so it’s difficult to ascertain the real clinical benefits, or even harms.”
In an effort to address this gap, the investigators conducted a retrospective, difference-in-difference study spanning 10 years, from 2009 to 2019. The 1-year intervention, implemented in August 2013, included refill restrictions for PPIs without documented indication for long-term use, voiding of PPI prescriptions not filled within 6 months, a quick-order option for H2-receptor antagonists, reports to identify high-dose PPI prescribing, and patient and clinician education.
The intervention group consisted of 192,607-250,349 veterans in Veteran Integrated Service Network 17, whereas the control group consisted of 3,775,978-4,360,908 veterans in other service networks (ranges in population size are due to variations across 6-month intervals of analysis). For each 6-month interval, patients were included if they had at least two primary care visits within the past 2 years, and excluded if they received primary care at three other sites that joined the intervention site after initial implementation.
The investigators analyzed three main outcomes: Proportion of veterans dispensed a PPI prescription from the VA at any dose; incidence proportion of hospitalization for upper GI diseases, including upper GI bleeding other than from esophageal varices or angiodysplasia, as well as nonbleeding acid peptic disease; and rates of primary care visits, gastroenterology visits, and esophagogastroduodenoscopies (EGDs).
The analysis was divided into a preimplementation period, lasting approximately 5 years, and a postimplementation period with a similar duration. In the postimplementation period, the intervention group had a 5.9% relative reduction in PPI prescriptions, compared with the control group (P < .001). During the same period, the intervention site did not have a significant increase in the rate of patients hospitalized for upper GI diseases, primary care visits, GI clinic visits, or EGDs.
In a subgroup analysis of patients coprescribed PPIs during time at high-risk for upper GI bleeding (that is, when they possessed at least two high-risk medications, such as warfarin), there was a 4.6% relative reduction in time with PPI gastroprotection among the intervention group, compared with the control group (P = .003). In a second sensitivity analysis, hospitalization for upper GI diseases in high-risk patients at least 65 years of age was not significantly different between groups.
“[This] multicomponent PPI deprescribing program led to sustained reductions in PPI use,” Dr. Kurlander concluded. “However, this blunt intervention also reduced appropriate use of PPIs for gastroprotection, raising some concerns about clinical quality of care, but this did not appear to cause any measurable clinical harm in terms of hospitalizations for upper GI diseases.”
Debate around ‘unnecessary PPI use’
According to Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, the study “makes an attempt to do what others have tried in different ways, which is to develop a mechanism to help reduce or discontinue proton pump inhibitors when people believe they’re not indicated.”
Yet this latter element – appropriate indication – drives an ongoing debate.
“This is a very controversial area,” Dr. Katz said in an interview. “The concept of using the lowest effective dose of medication needed for a symptom or a disease is not new, but the push to reducing or eliminating ‘unnecessary PPI use’ is one that I believe should be carefully discussed, and that we have a clear understanding of what constitutes unnecessary use. And quite honestly, I’m willing to state that I don’t believe that’s been well defined.”
Dr. Katz, who recently coauthored an article about PPIs, suggested that more prospective research is needed to identify which patients need PPIs and which don’t.
“What we really need are more studies that look at who really needs [PPIs] long term,” Dr. Katz said, “as opposed to doing it ad hoc.”
The study was funded by the U.S. Department of Veterans Affairs and the National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest. Dr. Katz is a consultant for Phathom Pharma.
Proton pump inhibitor (PPI) use can safely be reduced by deprescribing efforts coupled with patient and clinician education, according to a retrospective study involving more than 4 million veterans.
After 1 year, the intervention was associated with a significant reduction in PPI use without worsening of acid-related diseases, reported lead author Jacob E. Kurlander, MD, of the University of Michigan, Ann Arbor, and the VA Ann Arbor Healthcare System’s Center for Clinical Management Research.
“There’s increasing interest in interventions to reduce PPI use,” Dr. Kurlander said during his virtual presentation at the annual Digestive Disease Week® (DDW). “Many of the interventions have come in the form of patient and provider education, like the Choosing Wisely campaign put out by the American Board of Internal Medicine. However, in rigorous studies, few interventions have actually proven effective, and many of these studies lack data on clinical outcomes, so it’s difficult to ascertain the real clinical benefits, or even harms.”
In an effort to address this gap, the investigators conducted a retrospective, difference-in-difference study spanning 10 years, from 2009 to 2019. The 1-year intervention, implemented in August 2013, included refill restrictions for PPIs without documented indication for long-term use, voiding of PPI prescriptions not filled within 6 months, a quick-order option for H2-receptor antagonists, reports to identify high-dose PPI prescribing, and patient and clinician education.
The intervention group consisted of 192,607-250,349 veterans in Veteran Integrated Service Network 17, whereas the control group consisted of 3,775,978-4,360,908 veterans in other service networks (ranges in population size are due to variations across 6-month intervals of analysis). For each 6-month interval, patients were included if they had at least two primary care visits within the past 2 years, and excluded if they received primary care at three other sites that joined the intervention site after initial implementation.
The investigators analyzed three main outcomes: Proportion of veterans dispensed a PPI prescription from the VA at any dose; incidence proportion of hospitalization for upper GI diseases, including upper GI bleeding other than from esophageal varices or angiodysplasia, as well as nonbleeding acid peptic disease; and rates of primary care visits, gastroenterology visits, and esophagogastroduodenoscopies (EGDs).
The analysis was divided into a preimplementation period, lasting approximately 5 years, and a postimplementation period with a similar duration. In the postimplementation period, the intervention group had a 5.9% relative reduction in PPI prescriptions, compared with the control group (P < .001). During the same period, the intervention site did not have a significant increase in the rate of patients hospitalized for upper GI diseases, primary care visits, GI clinic visits, or EGDs.
In a subgroup analysis of patients coprescribed PPIs during time at high-risk for upper GI bleeding (that is, when they possessed at least two high-risk medications, such as warfarin), there was a 4.6% relative reduction in time with PPI gastroprotection among the intervention group, compared with the control group (P = .003). In a second sensitivity analysis, hospitalization for upper GI diseases in high-risk patients at least 65 years of age was not significantly different between groups.
“[This] multicomponent PPI deprescribing program led to sustained reductions in PPI use,” Dr. Kurlander concluded. “However, this blunt intervention also reduced appropriate use of PPIs for gastroprotection, raising some concerns about clinical quality of care, but this did not appear to cause any measurable clinical harm in terms of hospitalizations for upper GI diseases.”
Debate around ‘unnecessary PPI use’
According to Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, the study “makes an attempt to do what others have tried in different ways, which is to develop a mechanism to help reduce or discontinue proton pump inhibitors when people believe they’re not indicated.”
Yet this latter element – appropriate indication – drives an ongoing debate.
“This is a very controversial area,” Dr. Katz said in an interview. “The concept of using the lowest effective dose of medication needed for a symptom or a disease is not new, but the push to reducing or eliminating ‘unnecessary PPI use’ is one that I believe should be carefully discussed, and that we have a clear understanding of what constitutes unnecessary use. And quite honestly, I’m willing to state that I don’t believe that’s been well defined.”
Dr. Katz, who recently coauthored an article about PPIs, suggested that more prospective research is needed to identify which patients need PPIs and which don’t.
“What we really need are more studies that look at who really needs [PPIs] long term,” Dr. Katz said, “as opposed to doing it ad hoc.”
The study was funded by the U.S. Department of Veterans Affairs and the National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest. Dr. Katz is a consultant for Phathom Pharma.
FROM DDW 2021
Admit or send home for GI bleeding? AI may help you decide
GI Genius recently became the first Food and Drug Administration–approved device to use artificial intelligence (AI) for endoscopy. Soon, similar technology may give gastroenterologists an edge before they even walk into the procedure room.
AI can provide highly accurate risk scores for patients with suspected upper GI bleeding, and make a recommendation for discharge or hospitalization, according to Dennis Shung, MD, MHS, a clinical instructor at Yale University, New Haven, Conn. And this could provide extensive benefit.
“Acute gastrointestinal bleeding is the most common gastrointestinal diagnosis requiring hospitalization. It costs around $19.2 billion per year,” Dr. Shung said, citing a study from Gastroenterology. He made these remarks during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.
Emergency department visits for upper GI bleeding increased 17% from 2006 to 2014, Dr. Shung added, suggesting a rising trend.
The trouble with using risk scores
A variety of conventional risk scores are presently available to help manage these patients. Generally, they use a composite outcome of hemostatic intervention, transfusion, or death to determine which patients should be hospitalized (high risk) and which patients can go home (low risk). Although these models can offer high sensitivity, they remain underutilized.
“[Clinical risk scores] are cumbersome, it’s difficult to calculate them, [and] you may not remember to do that in your busy workflow,” Dr. Shung said.
He pointed out that low implementation may also stem from poorly defined clinical responsibilities.
“[Observing] providers caring for patients with GI bleeding showed that there was a culture of not taking ownership,” he said. “Emergency department physicians thought that it was the gastroenterologists who needed to [perform risk scoring]. Gastroenterologists thought it was the ED [physicians’ responsibility].”
To overcome these pitfalls, Dr. Shung and colleagues are developing AI that automates risk analysis for upper GI bleeding by integrating the process into the clinical workflow. Like GI Genius, their strategy relies upon machine learning, which is a type of AI that can improve automatically without being explicitly programmed.
Their most recent study (Sci Rep. 2021 Apr 23;11[1]:8827) involved a machine learning model that could predict transfusion in patients admitted for acute GI bleeding. The model was developed and internally validated in a cohort of 2,524 patients, then shown to outperform conventional regression-based models when externally validated in 1,526 patients similarly admitted at large urban hospitals.
Google Maps for GI bleeding
“The future, as I envision it, is a Google Maps for GI bleeding,” Dr. Shung said, referring to how the popular web-mapping product analyzes real-time data, such as weather and traffic patterns, to provide the best route and an estimated time of arrival. “With the electronic health record, we have the ability to personalize care by basically using data obtained during the clinical encounter to generate risk assessment in real time.”
In other words, machine learning software reads a patient’s electronic health record, runs relevant data through an algorithm, and produces both a risk score and a clinical recommendation. In the case of suspected upper GI bleeding, the clinician is advised to either discharge for outpatient endoscopy or hospitalize for inpatient evaluation.
Because the quality and consistency of data in EHRs can vary, the most advanced form of machine learning – deep learning – is needed to make this a clinical reality. Deep learning converts simpler concepts into complex ones. In this scenario, that would mean deciding which clinical data are relevant and which are just noise. Taking this a step further, deep learning can actually “draw conclusions” from what’s missing.
“There are huge challenges in [irregular data] that need to be overcome,” Dr. Shung said in an interview. “But I see it as an opportunity. When you see things that are irregularly sampled, when you see things are missing – they mean something. They mean that a human has decided that that is not the way we should do things because this patient doesn’t need it. And I think there is a lot of value in learning how to model those things.”
The road to clinical implementation
With further research and validation, deep learning models for gastroenterology are likely to play a role in clinical decision-making, according to Dr. Shung. But to reach the clinic floor, developers will need to outsmart some more fundamental obstacles. “The main thing that’s really barring [AI risk modeling] from being used is the reimbursement issue,” he said, referring to uncertainty in how payers will cover associated costs.
In an interview, Sushovan Guha, MD, PhD, moderator of the virtual session and codirector of the center for interventional gastroenterology at UTHealth (iGUT) in Houston, pointed out another financial unknown: liability.
“What happens if there is an error?” he asked. “It’s done by the computers, but who is at fault?”
In addition to these challenges, some clinicians may need to be persuaded before they are willing to trust an algorithm with a patient’s life.
“We have to have community physicians convinced about the importance of using these tools to further improve their clinical practice,” Dr. Guha said. To this end, he added, “It’s time for us to accept and adapt, and make our decision-making process much more efficient.”
The investigators disclosed no relevant conflicts of interest.
GI Genius recently became the first Food and Drug Administration–approved device to use artificial intelligence (AI) for endoscopy. Soon, similar technology may give gastroenterologists an edge before they even walk into the procedure room.
AI can provide highly accurate risk scores for patients with suspected upper GI bleeding, and make a recommendation for discharge or hospitalization, according to Dennis Shung, MD, MHS, a clinical instructor at Yale University, New Haven, Conn. And this could provide extensive benefit.
“Acute gastrointestinal bleeding is the most common gastrointestinal diagnosis requiring hospitalization. It costs around $19.2 billion per year,” Dr. Shung said, citing a study from Gastroenterology. He made these remarks during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.
Emergency department visits for upper GI bleeding increased 17% from 2006 to 2014, Dr. Shung added, suggesting a rising trend.
The trouble with using risk scores
A variety of conventional risk scores are presently available to help manage these patients. Generally, they use a composite outcome of hemostatic intervention, transfusion, or death to determine which patients should be hospitalized (high risk) and which patients can go home (low risk). Although these models can offer high sensitivity, they remain underutilized.
“[Clinical risk scores] are cumbersome, it’s difficult to calculate them, [and] you may not remember to do that in your busy workflow,” Dr. Shung said.
He pointed out that low implementation may also stem from poorly defined clinical responsibilities.
“[Observing] providers caring for patients with GI bleeding showed that there was a culture of not taking ownership,” he said. “Emergency department physicians thought that it was the gastroenterologists who needed to [perform risk scoring]. Gastroenterologists thought it was the ED [physicians’ responsibility].”
To overcome these pitfalls, Dr. Shung and colleagues are developing AI that automates risk analysis for upper GI bleeding by integrating the process into the clinical workflow. Like GI Genius, their strategy relies upon machine learning, which is a type of AI that can improve automatically without being explicitly programmed.
Their most recent study (Sci Rep. 2021 Apr 23;11[1]:8827) involved a machine learning model that could predict transfusion in patients admitted for acute GI bleeding. The model was developed and internally validated in a cohort of 2,524 patients, then shown to outperform conventional regression-based models when externally validated in 1,526 patients similarly admitted at large urban hospitals.
Google Maps for GI bleeding
“The future, as I envision it, is a Google Maps for GI bleeding,” Dr. Shung said, referring to how the popular web-mapping product analyzes real-time data, such as weather and traffic patterns, to provide the best route and an estimated time of arrival. “With the electronic health record, we have the ability to personalize care by basically using data obtained during the clinical encounter to generate risk assessment in real time.”
In other words, machine learning software reads a patient’s electronic health record, runs relevant data through an algorithm, and produces both a risk score and a clinical recommendation. In the case of suspected upper GI bleeding, the clinician is advised to either discharge for outpatient endoscopy or hospitalize for inpatient evaluation.
Because the quality and consistency of data in EHRs can vary, the most advanced form of machine learning – deep learning – is needed to make this a clinical reality. Deep learning converts simpler concepts into complex ones. In this scenario, that would mean deciding which clinical data are relevant and which are just noise. Taking this a step further, deep learning can actually “draw conclusions” from what’s missing.
“There are huge challenges in [irregular data] that need to be overcome,” Dr. Shung said in an interview. “But I see it as an opportunity. When you see things that are irregularly sampled, when you see things are missing – they mean something. They mean that a human has decided that that is not the way we should do things because this patient doesn’t need it. And I think there is a lot of value in learning how to model those things.”
The road to clinical implementation
With further research and validation, deep learning models for gastroenterology are likely to play a role in clinical decision-making, according to Dr. Shung. But to reach the clinic floor, developers will need to outsmart some more fundamental obstacles. “The main thing that’s really barring [AI risk modeling] from being used is the reimbursement issue,” he said, referring to uncertainty in how payers will cover associated costs.
In an interview, Sushovan Guha, MD, PhD, moderator of the virtual session and codirector of the center for interventional gastroenterology at UTHealth (iGUT) in Houston, pointed out another financial unknown: liability.
“What happens if there is an error?” he asked. “It’s done by the computers, but who is at fault?”
In addition to these challenges, some clinicians may need to be persuaded before they are willing to trust an algorithm with a patient’s life.
“We have to have community physicians convinced about the importance of using these tools to further improve their clinical practice,” Dr. Guha said. To this end, he added, “It’s time for us to accept and adapt, and make our decision-making process much more efficient.”
The investigators disclosed no relevant conflicts of interest.
GI Genius recently became the first Food and Drug Administration–approved device to use artificial intelligence (AI) for endoscopy. Soon, similar technology may give gastroenterologists an edge before they even walk into the procedure room.
AI can provide highly accurate risk scores for patients with suspected upper GI bleeding, and make a recommendation for discharge or hospitalization, according to Dennis Shung, MD, MHS, a clinical instructor at Yale University, New Haven, Conn. And this could provide extensive benefit.
“Acute gastrointestinal bleeding is the most common gastrointestinal diagnosis requiring hospitalization. It costs around $19.2 billion per year,” Dr. Shung said, citing a study from Gastroenterology. He made these remarks during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.
Emergency department visits for upper GI bleeding increased 17% from 2006 to 2014, Dr. Shung added, suggesting a rising trend.
The trouble with using risk scores
A variety of conventional risk scores are presently available to help manage these patients. Generally, they use a composite outcome of hemostatic intervention, transfusion, or death to determine which patients should be hospitalized (high risk) and which patients can go home (low risk). Although these models can offer high sensitivity, they remain underutilized.
“[Clinical risk scores] are cumbersome, it’s difficult to calculate them, [and] you may not remember to do that in your busy workflow,” Dr. Shung said.
He pointed out that low implementation may also stem from poorly defined clinical responsibilities.
“[Observing] providers caring for patients with GI bleeding showed that there was a culture of not taking ownership,” he said. “Emergency department physicians thought that it was the gastroenterologists who needed to [perform risk scoring]. Gastroenterologists thought it was the ED [physicians’ responsibility].”
To overcome these pitfalls, Dr. Shung and colleagues are developing AI that automates risk analysis for upper GI bleeding by integrating the process into the clinical workflow. Like GI Genius, their strategy relies upon machine learning, which is a type of AI that can improve automatically without being explicitly programmed.
Their most recent study (Sci Rep. 2021 Apr 23;11[1]:8827) involved a machine learning model that could predict transfusion in patients admitted for acute GI bleeding. The model was developed and internally validated in a cohort of 2,524 patients, then shown to outperform conventional regression-based models when externally validated in 1,526 patients similarly admitted at large urban hospitals.
Google Maps for GI bleeding
“The future, as I envision it, is a Google Maps for GI bleeding,” Dr. Shung said, referring to how the popular web-mapping product analyzes real-time data, such as weather and traffic patterns, to provide the best route and an estimated time of arrival. “With the electronic health record, we have the ability to personalize care by basically using data obtained during the clinical encounter to generate risk assessment in real time.”
In other words, machine learning software reads a patient’s electronic health record, runs relevant data through an algorithm, and produces both a risk score and a clinical recommendation. In the case of suspected upper GI bleeding, the clinician is advised to either discharge for outpatient endoscopy or hospitalize for inpatient evaluation.
Because the quality and consistency of data in EHRs can vary, the most advanced form of machine learning – deep learning – is needed to make this a clinical reality. Deep learning converts simpler concepts into complex ones. In this scenario, that would mean deciding which clinical data are relevant and which are just noise. Taking this a step further, deep learning can actually “draw conclusions” from what’s missing.
“There are huge challenges in [irregular data] that need to be overcome,” Dr. Shung said in an interview. “But I see it as an opportunity. When you see things that are irregularly sampled, when you see things are missing – they mean something. They mean that a human has decided that that is not the way we should do things because this patient doesn’t need it. And I think there is a lot of value in learning how to model those things.”
The road to clinical implementation
With further research and validation, deep learning models for gastroenterology are likely to play a role in clinical decision-making, according to Dr. Shung. But to reach the clinic floor, developers will need to outsmart some more fundamental obstacles. “The main thing that’s really barring [AI risk modeling] from being used is the reimbursement issue,” he said, referring to uncertainty in how payers will cover associated costs.
In an interview, Sushovan Guha, MD, PhD, moderator of the virtual session and codirector of the center for interventional gastroenterology at UTHealth (iGUT) in Houston, pointed out another financial unknown: liability.
“What happens if there is an error?” he asked. “It’s done by the computers, but who is at fault?”
In addition to these challenges, some clinicians may need to be persuaded before they are willing to trust an algorithm with a patient’s life.
“We have to have community physicians convinced about the importance of using these tools to further improve their clinical practice,” Dr. Guha said. To this end, he added, “It’s time for us to accept and adapt, and make our decision-making process much more efficient.”
The investigators disclosed no relevant conflicts of interest.
FROM 2021 AGA TECH SUMMIT
G-POEM: Is it the much-needed treatment for gastroparesis?
In refractory gastroparesis, gastric peroral endoscopic myotomy (G-POEM) led to improvements in some patients, but the benefits were modest overall, according to results from a multicenter prospective study.
The clinical success rate was 56% at 12 months, defined as a 1 unit or greater decrease in the Gastroparesis Cardinal Symptom Index (GCSI) score accompanied by a 25% or greater decrease in two subscales detailing specific symptoms. Though the results fell short of expectations, they represent progress. In a previous large, multicenter, prospective study of existing therapies, just 28% experienced an improvement of 1 or more in the GCSI after 48 weeks of standard of care treatment.
This recent study, led by Kia Vosoughi and senior author Mouen Khashab, MD, of Johns Hopkins Medicine, Baltimore, was published online March 19, 2021, in Gut.
Pylorospasm has been linked to the symptoms of gastroparesis, prompting pyloric-directed interventions such as botulinum toxin injection, transpyloric stent placement, and pneumatic dilation of the pylorus. However, none have proven to have long-term benefit. G-POEM was introduced in 2013 as a minimally invasive pyloric-directed procedure. Some small, retrospective studies showed encouraging results, but this was the first prospective study.
“There is a huge drive to find other ways of treating gastroparesis because our current methods are not very effective and potentially have side effects. Unfortunately, [G-POEM] was not as helpful as we expected, even though there was improvement,” said Gyanprakash A. Ketwaroo, MD, MSc, AGAF, who was asked to comment on the findings. Dr. Ketwaroo is an assistant professor of medicine at Baylor College of Medicine, Houston.
Dr. Ketwaroo still endorses G-POEM despite the results because of the limitations of existing treatments.
“Even though it’s disappointing, [G-POEM] may still be better than the other approaches for gastroparesis. The other potential benefit is that it may be more readily available to patients than such interventions as the neurostimulator,” said Dr. Ketwaroo.
He added that the results highlight the importance of patient selection, pointing out that the researchers classified patients by etiologies.
“It may not be as applicable to the wider variety of patients with gastroparesis as we had hoped. I think they initially tried to look for a group that may be more amenable to it. But I don’t think this study was able to pick up an outcome based on etiology,” said Dr. Ketwaroo.
He also noted that the study showed the procedure to be generally safe, despite being more invasive than some interventions for gastroparesis.
“The adverse events were very minimal,” Dr. Ketwaroo said.
The researchers analyzed data from 75 patients (mean age, 49.3 years) who underwent G-POEM and completed 12 months of follow-up. Out of this predominantly female (71.3%) group, 41.3% had idiopathic gastroparesis, 35% had postsurgical gastroparesis, and 23.8% had diabetic gastroparesis.
The clinical success was similar across the subgroups, in the 50%-60% range for all three (P = .913). On average, the GCSI score dropped from 2.8 at 1 month following the procedure, to 1.5 at 12 months (P < .001). All components of quality of life improved at 12 months, with the exception of physical functioning.
At 3 months, 66% of patients underwent a gastric emptying study, with gastric retention at 4 hours being compared with baseline values. From that group, 64.2% improved, and 47.1% achieved normalization. Those with improvement in gastric emptying at 3 months had a clinical success rate of 75.8% at the same time point, compared with 38.9% with no improvement (P = .015).
Five adverse events were reported (6.2%). All were mild and procedure related.
A multivariate analysis showed that predictors of clinical success at 12 months included a baseline GCSI score greater than 2.6 (odds ratio, 3.23; P = .04) and baseline gastric retention greater than 20% at 4 hours (OR, 3.65; P = .029).
“Our findings of mid-term clinical success and durability of G-POEM may help physicians to choose the best therapeutic strategy for patients with refractory gastroparesis. G-POEM may be considered in patients with more severe baseline symptoms and pre-G-POEM gastric retention,” the researchers concluded.
The authors disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
In refractory gastroparesis, gastric peroral endoscopic myotomy (G-POEM) led to improvements in some patients, but the benefits were modest overall, according to results from a multicenter prospective study.
The clinical success rate was 56% at 12 months, defined as a 1 unit or greater decrease in the Gastroparesis Cardinal Symptom Index (GCSI) score accompanied by a 25% or greater decrease in two subscales detailing specific symptoms. Though the results fell short of expectations, they represent progress. In a previous large, multicenter, prospective study of existing therapies, just 28% experienced an improvement of 1 or more in the GCSI after 48 weeks of standard of care treatment.
This recent study, led by Kia Vosoughi and senior author Mouen Khashab, MD, of Johns Hopkins Medicine, Baltimore, was published online March 19, 2021, in Gut.
Pylorospasm has been linked to the symptoms of gastroparesis, prompting pyloric-directed interventions such as botulinum toxin injection, transpyloric stent placement, and pneumatic dilation of the pylorus. However, none have proven to have long-term benefit. G-POEM was introduced in 2013 as a minimally invasive pyloric-directed procedure. Some small, retrospective studies showed encouraging results, but this was the first prospective study.
“There is a huge drive to find other ways of treating gastroparesis because our current methods are not very effective and potentially have side effects. Unfortunately, [G-POEM] was not as helpful as we expected, even though there was improvement,” said Gyanprakash A. Ketwaroo, MD, MSc, AGAF, who was asked to comment on the findings. Dr. Ketwaroo is an assistant professor of medicine at Baylor College of Medicine, Houston.
Dr. Ketwaroo still endorses G-POEM despite the results because of the limitations of existing treatments.
“Even though it’s disappointing, [G-POEM] may still be better than the other approaches for gastroparesis. The other potential benefit is that it may be more readily available to patients than such interventions as the neurostimulator,” said Dr. Ketwaroo.
He added that the results highlight the importance of patient selection, pointing out that the researchers classified patients by etiologies.
“It may not be as applicable to the wider variety of patients with gastroparesis as we had hoped. I think they initially tried to look for a group that may be more amenable to it. But I don’t think this study was able to pick up an outcome based on etiology,” said Dr. Ketwaroo.
He also noted that the study showed the procedure to be generally safe, despite being more invasive than some interventions for gastroparesis.
“The adverse events were very minimal,” Dr. Ketwaroo said.
The researchers analyzed data from 75 patients (mean age, 49.3 years) who underwent G-POEM and completed 12 months of follow-up. Out of this predominantly female (71.3%) group, 41.3% had idiopathic gastroparesis, 35% had postsurgical gastroparesis, and 23.8% had diabetic gastroparesis.
The clinical success was similar across the subgroups, in the 50%-60% range for all three (P = .913). On average, the GCSI score dropped from 2.8 at 1 month following the procedure, to 1.5 at 12 months (P < .001). All components of quality of life improved at 12 months, with the exception of physical functioning.
At 3 months, 66% of patients underwent a gastric emptying study, with gastric retention at 4 hours being compared with baseline values. From that group, 64.2% improved, and 47.1% achieved normalization. Those with improvement in gastric emptying at 3 months had a clinical success rate of 75.8% at the same time point, compared with 38.9% with no improvement (P = .015).
Five adverse events were reported (6.2%). All were mild and procedure related.
A multivariate analysis showed that predictors of clinical success at 12 months included a baseline GCSI score greater than 2.6 (odds ratio, 3.23; P = .04) and baseline gastric retention greater than 20% at 4 hours (OR, 3.65; P = .029).
“Our findings of mid-term clinical success and durability of G-POEM may help physicians to choose the best therapeutic strategy for patients with refractory gastroparesis. G-POEM may be considered in patients with more severe baseline symptoms and pre-G-POEM gastric retention,” the researchers concluded.
The authors disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
In refractory gastroparesis, gastric peroral endoscopic myotomy (G-POEM) led to improvements in some patients, but the benefits were modest overall, according to results from a multicenter prospective study.
The clinical success rate was 56% at 12 months, defined as a 1 unit or greater decrease in the Gastroparesis Cardinal Symptom Index (GCSI) score accompanied by a 25% or greater decrease in two subscales detailing specific symptoms. Though the results fell short of expectations, they represent progress. In a previous large, multicenter, prospective study of existing therapies, just 28% experienced an improvement of 1 or more in the GCSI after 48 weeks of standard of care treatment.
This recent study, led by Kia Vosoughi and senior author Mouen Khashab, MD, of Johns Hopkins Medicine, Baltimore, was published online March 19, 2021, in Gut.
Pylorospasm has been linked to the symptoms of gastroparesis, prompting pyloric-directed interventions such as botulinum toxin injection, transpyloric stent placement, and pneumatic dilation of the pylorus. However, none have proven to have long-term benefit. G-POEM was introduced in 2013 as a minimally invasive pyloric-directed procedure. Some small, retrospective studies showed encouraging results, but this was the first prospective study.
“There is a huge drive to find other ways of treating gastroparesis because our current methods are not very effective and potentially have side effects. Unfortunately, [G-POEM] was not as helpful as we expected, even though there was improvement,” said Gyanprakash A. Ketwaroo, MD, MSc, AGAF, who was asked to comment on the findings. Dr. Ketwaroo is an assistant professor of medicine at Baylor College of Medicine, Houston.
Dr. Ketwaroo still endorses G-POEM despite the results because of the limitations of existing treatments.
“Even though it’s disappointing, [G-POEM] may still be better than the other approaches for gastroparesis. The other potential benefit is that it may be more readily available to patients than such interventions as the neurostimulator,” said Dr. Ketwaroo.
He added that the results highlight the importance of patient selection, pointing out that the researchers classified patients by etiologies.
“It may not be as applicable to the wider variety of patients with gastroparesis as we had hoped. I think they initially tried to look for a group that may be more amenable to it. But I don’t think this study was able to pick up an outcome based on etiology,” said Dr. Ketwaroo.
He also noted that the study showed the procedure to be generally safe, despite being more invasive than some interventions for gastroparesis.
“The adverse events were very minimal,” Dr. Ketwaroo said.
The researchers analyzed data from 75 patients (mean age, 49.3 years) who underwent G-POEM and completed 12 months of follow-up. Out of this predominantly female (71.3%) group, 41.3% had idiopathic gastroparesis, 35% had postsurgical gastroparesis, and 23.8% had diabetic gastroparesis.
The clinical success was similar across the subgroups, in the 50%-60% range for all three (P = .913). On average, the GCSI score dropped from 2.8 at 1 month following the procedure, to 1.5 at 12 months (P < .001). All components of quality of life improved at 12 months, with the exception of physical functioning.
At 3 months, 66% of patients underwent a gastric emptying study, with gastric retention at 4 hours being compared with baseline values. From that group, 64.2% improved, and 47.1% achieved normalization. Those with improvement in gastric emptying at 3 months had a clinical success rate of 75.8% at the same time point, compared with 38.9% with no improvement (P = .015).
Five adverse events were reported (6.2%). All were mild and procedure related.
A multivariate analysis showed that predictors of clinical success at 12 months included a baseline GCSI score greater than 2.6 (odds ratio, 3.23; P = .04) and baseline gastric retention greater than 20% at 4 hours (OR, 3.65; P = .029).
“Our findings of mid-term clinical success and durability of G-POEM may help physicians to choose the best therapeutic strategy for patients with refractory gastroparesis. G-POEM may be considered in patients with more severe baseline symptoms and pre-G-POEM gastric retention,” the researchers concluded.
The authors disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
FROM GUT
Endoscopic device could expand treatment for GERD, reduce PPI use
In patients with proton pump inhibitor (PPI)–dependent gastroesophageal reflux disease (GERD), a procedure known as endoscopic full-thickness plication (EFTP) – performed with the novel GERD-X device – improved both symptoms and quality of life, compared with a sham procedure. It also had few side effects and a short procedure time, according to a new randomized, controlled trial.
“It seems like it is a quick, easy-to-use procedure,” Gyanprakash A. Ketwaroo, MD, MSc, who is an assistant professor of medicine at Baylor College of Medicine, Houston, commented in an interview. Dr. Ketwaroo was not involved in the study.
“Even though the objective measures were not as good as perhaps you had hoped, the subjective outcomes were good. [And] it seems that it may have more of a long-term benefit, compared to some of the other endoscopic procedures. But that wasn’t a [primary] outcome of the study, and we still need more long-term studies to figure that out,” he added.
The research, led by Rakesh Kalapala, MD, DNB, and D. Nageshwar Reddy, MD, FACG, of the Asian Institute of Gastroenterology, Hyderabad, India, appeared in Gut.
The fact that the EFTP procedure is relatively simple could reduce cost and ease the learning curve, which in turn could broaden accessibility if more gastroenterologists are trained on it.
“There are not many gastroenterologists who offer endoscopic approaches to GERD therapy, so increasing that cohort [could] potentially have a huge impact given the number of patients who have GERD in this country, and especially given the rising and persistent concern over long-term use of PPIs,” said Dr. Ketwaroo.
Addressing the drawbacks of long-term PPI use
Although PPIs are the most effective medical therapy for GERD, there are concerns that long-term use could increase the risk of acute and chronic kidney disease, hypomagnesaemia, Clostridioides difficile infection, and osteoporotic fractures. Surgical antireflux interventions are effective but may lead to dysphagia, bloating, and diarrhea.
EFTP applies transmural sutures to the gastroesophageal junction to strengthen the valvular mechanism, which reduces reflux. While the preponderance of published evidence supports the Esophyx device (EndoGastric Solutions), which has a 70% efficacy rate and few adverse events in one analysis, it requires advanced training and general anesthesia and takes 45-100 minutes.
“Endoscopic fundoplication is a minimally invasive antireflux therapy in patients with PPI dependence who refuse surgery; however, the majority of the endoscopic devices are cumbersome to use and robust data on their long-term efficacy are lacking,” Dr. Kalapala and colleagues noted in their new paper.
In 2014, the German company G-Surg introduced a novel endoscopic plication device called GERD-X. A prospective, single-arm study had shown efficacy in both patients taking PPIs and those with refractory GERD.
A closer look at the device
To bolster that evidence, Dr. Kalapala and colleagues conducted this new single-center, randomized, sham-controlled trial with 70 enrollees with PPI-dependent GERD, of which 70% had nonerosive reflux disease (mean DeMeester score, 18.9). The median participant age was 36 years, and 71.4% were male. The average procedure time was 17.4 minutes.
Of the subjects in the treatment group, 65.7% achieved at least a 50% improvement in GERD health-related quality of life (GERD-HRQL) after 3 months, compared with 2.9% in the sham group (P < .001). The median percentage improvement in GERD-HRQL score was higher in the treatment group at 6 months (81.4% vs. 8.0%; P < .001) and at 12 months (92.3% vs. 9.1%; P < .001). Similar improvements were seen at 6 months and 12 months in heartburn symptom score (75.0% vs. 13.0% and 89.7% vs. 15.4%, respectively; P < .001 for both) and regurgitation symptom score (96.2% vs. 6.9% and 100% vs. 3.4%, respectively; P < .001 for both). At 12 months, 62.8% of the treatment group no longer took PPIs, compared with 11.4% of the sham group (P < .001).
Objective measures of improvement were more modest. The treatment arm trended toward a reduction in esophageal acid exposure from baseline at 3 and 12 months, but the difference was not statistically significant. The median percentage of time with esophageal pH below 4 and the DeMeester score were similar between the groups at 3 and 12 months. The researchers also noted trends toward fewer reflux events in 24 hours in the treatment group at 6 months (P = .072) and 12 months (P = .051).
The treatment group had fewer non–acid reflux episodes at 12 months versus baseline (P = .038), but there was no difference in the median number of acid reflux episodes in 24 hours.
“Our study found endoscopic full-thickness fundoplication, using a novel device, was safe and significantly improved GERD-related quality of life and severity of reflux symptoms at short and long terms, compared with a sham procedure,” wrote the authors.
“This endoluminal procedure with a short operating time and very few side effects is a promising alternative option to surgery in appropriately selected group of patients, who may not want to continue PPI long term,” they concluded.
The authors of the study disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
This article was updated May 6, 2021.
In patients with proton pump inhibitor (PPI)–dependent gastroesophageal reflux disease (GERD), a procedure known as endoscopic full-thickness plication (EFTP) – performed with the novel GERD-X device – improved both symptoms and quality of life, compared with a sham procedure. It also had few side effects and a short procedure time, according to a new randomized, controlled trial.
“It seems like it is a quick, easy-to-use procedure,” Gyanprakash A. Ketwaroo, MD, MSc, who is an assistant professor of medicine at Baylor College of Medicine, Houston, commented in an interview. Dr. Ketwaroo was not involved in the study.
“Even though the objective measures were not as good as perhaps you had hoped, the subjective outcomes were good. [And] it seems that it may have more of a long-term benefit, compared to some of the other endoscopic procedures. But that wasn’t a [primary] outcome of the study, and we still need more long-term studies to figure that out,” he added.
The research, led by Rakesh Kalapala, MD, DNB, and D. Nageshwar Reddy, MD, FACG, of the Asian Institute of Gastroenterology, Hyderabad, India, appeared in Gut.
The fact that the EFTP procedure is relatively simple could reduce cost and ease the learning curve, which in turn could broaden accessibility if more gastroenterologists are trained on it.
“There are not many gastroenterologists who offer endoscopic approaches to GERD therapy, so increasing that cohort [could] potentially have a huge impact given the number of patients who have GERD in this country, and especially given the rising and persistent concern over long-term use of PPIs,” said Dr. Ketwaroo.
Addressing the drawbacks of long-term PPI use
Although PPIs are the most effective medical therapy for GERD, there are concerns that long-term use could increase the risk of acute and chronic kidney disease, hypomagnesaemia, Clostridioides difficile infection, and osteoporotic fractures. Surgical antireflux interventions are effective but may lead to dysphagia, bloating, and diarrhea.
EFTP applies transmural sutures to the gastroesophageal junction to strengthen the valvular mechanism, which reduces reflux. While the preponderance of published evidence supports the Esophyx device (EndoGastric Solutions), which has a 70% efficacy rate and few adverse events in one analysis, it requires advanced training and general anesthesia and takes 45-100 minutes.
“Endoscopic fundoplication is a minimally invasive antireflux therapy in patients with PPI dependence who refuse surgery; however, the majority of the endoscopic devices are cumbersome to use and robust data on their long-term efficacy are lacking,” Dr. Kalapala and colleagues noted in their new paper.
In 2014, the German company G-Surg introduced a novel endoscopic plication device called GERD-X. A prospective, single-arm study had shown efficacy in both patients taking PPIs and those with refractory GERD.
A closer look at the device
To bolster that evidence, Dr. Kalapala and colleagues conducted this new single-center, randomized, sham-controlled trial with 70 enrollees with PPI-dependent GERD, of which 70% had nonerosive reflux disease (mean DeMeester score, 18.9). The median participant age was 36 years, and 71.4% were male. The average procedure time was 17.4 minutes.
Of the subjects in the treatment group, 65.7% achieved at least a 50% improvement in GERD health-related quality of life (GERD-HRQL) after 3 months, compared with 2.9% in the sham group (P < .001). The median percentage improvement in GERD-HRQL score was higher in the treatment group at 6 months (81.4% vs. 8.0%; P < .001) and at 12 months (92.3% vs. 9.1%; P < .001). Similar improvements were seen at 6 months and 12 months in heartburn symptom score (75.0% vs. 13.0% and 89.7% vs. 15.4%, respectively; P < .001 for both) and regurgitation symptom score (96.2% vs. 6.9% and 100% vs. 3.4%, respectively; P < .001 for both). At 12 months, 62.8% of the treatment group no longer took PPIs, compared with 11.4% of the sham group (P < .001).
Objective measures of improvement were more modest. The treatment arm trended toward a reduction in esophageal acid exposure from baseline at 3 and 12 months, but the difference was not statistically significant. The median percentage of time with esophageal pH below 4 and the DeMeester score were similar between the groups at 3 and 12 months. The researchers also noted trends toward fewer reflux events in 24 hours in the treatment group at 6 months (P = .072) and 12 months (P = .051).
The treatment group had fewer non–acid reflux episodes at 12 months versus baseline (P = .038), but there was no difference in the median number of acid reflux episodes in 24 hours.
“Our study found endoscopic full-thickness fundoplication, using a novel device, was safe and significantly improved GERD-related quality of life and severity of reflux symptoms at short and long terms, compared with a sham procedure,” wrote the authors.
“This endoluminal procedure with a short operating time and very few side effects is a promising alternative option to surgery in appropriately selected group of patients, who may not want to continue PPI long term,” they concluded.
The authors of the study disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
This article was updated May 6, 2021.
In patients with proton pump inhibitor (PPI)–dependent gastroesophageal reflux disease (GERD), a procedure known as endoscopic full-thickness plication (EFTP) – performed with the novel GERD-X device – improved both symptoms and quality of life, compared with a sham procedure. It also had few side effects and a short procedure time, according to a new randomized, controlled trial.
“It seems like it is a quick, easy-to-use procedure,” Gyanprakash A. Ketwaroo, MD, MSc, who is an assistant professor of medicine at Baylor College of Medicine, Houston, commented in an interview. Dr. Ketwaroo was not involved in the study.
“Even though the objective measures were not as good as perhaps you had hoped, the subjective outcomes were good. [And] it seems that it may have more of a long-term benefit, compared to some of the other endoscopic procedures. But that wasn’t a [primary] outcome of the study, and we still need more long-term studies to figure that out,” he added.
The research, led by Rakesh Kalapala, MD, DNB, and D. Nageshwar Reddy, MD, FACG, of the Asian Institute of Gastroenterology, Hyderabad, India, appeared in Gut.
The fact that the EFTP procedure is relatively simple could reduce cost and ease the learning curve, which in turn could broaden accessibility if more gastroenterologists are trained on it.
“There are not many gastroenterologists who offer endoscopic approaches to GERD therapy, so increasing that cohort [could] potentially have a huge impact given the number of patients who have GERD in this country, and especially given the rising and persistent concern over long-term use of PPIs,” said Dr. Ketwaroo.
Addressing the drawbacks of long-term PPI use
Although PPIs are the most effective medical therapy for GERD, there are concerns that long-term use could increase the risk of acute and chronic kidney disease, hypomagnesaemia, Clostridioides difficile infection, and osteoporotic fractures. Surgical antireflux interventions are effective but may lead to dysphagia, bloating, and diarrhea.
EFTP applies transmural sutures to the gastroesophageal junction to strengthen the valvular mechanism, which reduces reflux. While the preponderance of published evidence supports the Esophyx device (EndoGastric Solutions), which has a 70% efficacy rate and few adverse events in one analysis, it requires advanced training and general anesthesia and takes 45-100 minutes.
“Endoscopic fundoplication is a minimally invasive antireflux therapy in patients with PPI dependence who refuse surgery; however, the majority of the endoscopic devices are cumbersome to use and robust data on their long-term efficacy are lacking,” Dr. Kalapala and colleagues noted in their new paper.
In 2014, the German company G-Surg introduced a novel endoscopic plication device called GERD-X. A prospective, single-arm study had shown efficacy in both patients taking PPIs and those with refractory GERD.
A closer look at the device
To bolster that evidence, Dr. Kalapala and colleagues conducted this new single-center, randomized, sham-controlled trial with 70 enrollees with PPI-dependent GERD, of which 70% had nonerosive reflux disease (mean DeMeester score, 18.9). The median participant age was 36 years, and 71.4% were male. The average procedure time was 17.4 minutes.
Of the subjects in the treatment group, 65.7% achieved at least a 50% improvement in GERD health-related quality of life (GERD-HRQL) after 3 months, compared with 2.9% in the sham group (P < .001). The median percentage improvement in GERD-HRQL score was higher in the treatment group at 6 months (81.4% vs. 8.0%; P < .001) and at 12 months (92.3% vs. 9.1%; P < .001). Similar improvements were seen at 6 months and 12 months in heartburn symptom score (75.0% vs. 13.0% and 89.7% vs. 15.4%, respectively; P < .001 for both) and regurgitation symptom score (96.2% vs. 6.9% and 100% vs. 3.4%, respectively; P < .001 for both). At 12 months, 62.8% of the treatment group no longer took PPIs, compared with 11.4% of the sham group (P < .001).
Objective measures of improvement were more modest. The treatment arm trended toward a reduction in esophageal acid exposure from baseline at 3 and 12 months, but the difference was not statistically significant. The median percentage of time with esophageal pH below 4 and the DeMeester score were similar between the groups at 3 and 12 months. The researchers also noted trends toward fewer reflux events in 24 hours in the treatment group at 6 months (P = .072) and 12 months (P = .051).
The treatment group had fewer non–acid reflux episodes at 12 months versus baseline (P = .038), but there was no difference in the median number of acid reflux episodes in 24 hours.
“Our study found endoscopic full-thickness fundoplication, using a novel device, was safe and significantly improved GERD-related quality of life and severity of reflux symptoms at short and long terms, compared with a sham procedure,” wrote the authors.
“This endoluminal procedure with a short operating time and very few side effects is a promising alternative option to surgery in appropriately selected group of patients, who may not want to continue PPI long term,” they concluded.
The authors of the study disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
This article was updated May 6, 2021.
FROM GUT
AGA Clinical Practice Update: Management of bleeding gastric varices
When classifying gastric varices during endoscopy, experts suggest not only describing their location but also their size and whether any high-risk stigmata, such as discolorations and platelet plugs, are present.
In a clinical practice update from the American Gastroenterological Association, Zachary Henry, MD, of the University of Virginia, Charlottesville, and associates also proposed an alternative nomenclature for locating gastric varices (GV). “In practice, most gastroenterologists use the Sarin classification with the main distinction being cardiofundal versus lesser curvature GV. However, the vascular supply and corresponding therapy for GV and esophageal varices are often different, so a merged classification, such as Sarin’s, can be problematic for therapeutic planning purposes,” they wrote in Clinical Gastroenterology and Hepatology, referring to the classification system published by Shiv K. Sarin, MD, DM, and colleagues. They suggested that a merged classification, such as Sarin’s, can be “problematic for therapeutic and planning purposes” because “the vascular supply and corresponding therapy for GV and [esophageal varices] are often different.” Instead, they advised that an “alternative nomenclature based on location within the stomach is clearer and facilitates correlation with vascular imaging.” Another approach is to add risk factors for bleeding, such as an estimate of variceal size and high-risk stigmata (discolored marks, platelet plugs), to Sarin classification.
Diagnosis and treatment of bleeding GV are complex, and multidisciplinary management by hepatologists, interventional radiologists, and interventional endoscopists is optimal, the experts wrote. Data and clinical guidelines do not support primary prophylaxis to prevent bleeding of GV. The authors offered an algorithm for initial management of suspected portal hypertensive GV bleeding based on both endoscopic and vascular anatomy; it includes assessment of circulatory and respiratory status, vasoactive drug administration, antibiotic prophylaxis, and more.
An early goal is confirming bleeding source and attempting to classify the bleeding site; this can be complicated by presence of intragastric blood that obscures the cardia and fundus and underlying GV. Further steps may include temporizing: “Temporizing measures to halt active bleeding are often not the definitive treatment of choice to prevent rebleeding from GV, whereas definitive measures such as endoscopic cyanoacrylate injection (ECI) or endovascular treatments are often not feasible in the acute, diagnostic setting.”
When definitive endoscopic treatment is preferred, ECI of bleeding GV is the therapy of choice because other approaches may be complicated by location and bleeding risk of GV, although band ligation may be appropriate in lesser curve GV. Specific ECI techniques have not been compared directly in studies, according to the update authors; however, “the specific cyanoacrylate agent should favor the fastest polymerization time to avoid embolization and inducing GV bleeding.” This has meant 4-carbon (butyl) preparations are preferred to 8-carbon (octyl) preparations, they noted.
After treatment, endoscopy is performed every 2-4 weeks so that the ECI can be repeated as needed until obliteration is complete. The experts suggested that, after eradication of GV, an endoscopic reevaluation within 3-6 months should be scheduled, then annually thereafter. Any de novo or recurrent GV during the long-term follow-up may require additional imaging and multidisciplinary exploration to determine potential mechanisms and need for alternative treatments, the authors advised.
According to the practice update, transjugular intrahepatic portosystemic shunt can be used when the GV is receiving significant inflow from the coronary vein or the patient has significant complications from portal hypertension. When TIPS is used, the experts suggest also performing endovascular sclerosis or direct embolization of GV, if possible. For patients with a gastrorenal shunt, balloon-occluded retrograde transvenous obliteration (BRTO) of bleeding GV is considered optimal if local expertise is available and the patient lacks severe complications from portal hypertension. Endoscopy should be performed within 48 hours after BRTO to confirm obliteration of the vascular flow. If residual flow is detected, “cyanoacrylate injection should be performed,” the experts wrote. To confirm that GV are obliterated and check for any vascular complications, they suggest performing CT or MR within 4-6 weeks after BRTO and then as clinically indicated. In addition, surveillance endoscopy is important to identify and treat any esophageal varices that could have been worsened by increased portal pressures.
No funding sources were reported. The experts reported having no conflicts of interest.
When classifying gastric varices during endoscopy, experts suggest not only describing their location but also their size and whether any high-risk stigmata, such as discolorations and platelet plugs, are present.
In a clinical practice update from the American Gastroenterological Association, Zachary Henry, MD, of the University of Virginia, Charlottesville, and associates also proposed an alternative nomenclature for locating gastric varices (GV). “In practice, most gastroenterologists use the Sarin classification with the main distinction being cardiofundal versus lesser curvature GV. However, the vascular supply and corresponding therapy for GV and esophageal varices are often different, so a merged classification, such as Sarin’s, can be problematic for therapeutic planning purposes,” they wrote in Clinical Gastroenterology and Hepatology, referring to the classification system published by Shiv K. Sarin, MD, DM, and colleagues. They suggested that a merged classification, such as Sarin’s, can be “problematic for therapeutic and planning purposes” because “the vascular supply and corresponding therapy for GV and [esophageal varices] are often different.” Instead, they advised that an “alternative nomenclature based on location within the stomach is clearer and facilitates correlation with vascular imaging.” Another approach is to add risk factors for bleeding, such as an estimate of variceal size and high-risk stigmata (discolored marks, platelet plugs), to Sarin classification.
Diagnosis and treatment of bleeding GV are complex, and multidisciplinary management by hepatologists, interventional radiologists, and interventional endoscopists is optimal, the experts wrote. Data and clinical guidelines do not support primary prophylaxis to prevent bleeding of GV. The authors offered an algorithm for initial management of suspected portal hypertensive GV bleeding based on both endoscopic and vascular anatomy; it includes assessment of circulatory and respiratory status, vasoactive drug administration, antibiotic prophylaxis, and more.
An early goal is confirming bleeding source and attempting to classify the bleeding site; this can be complicated by presence of intragastric blood that obscures the cardia and fundus and underlying GV. Further steps may include temporizing: “Temporizing measures to halt active bleeding are often not the definitive treatment of choice to prevent rebleeding from GV, whereas definitive measures such as endoscopic cyanoacrylate injection (ECI) or endovascular treatments are often not feasible in the acute, diagnostic setting.”
When definitive endoscopic treatment is preferred, ECI of bleeding GV is the therapy of choice because other approaches may be complicated by location and bleeding risk of GV, although band ligation may be appropriate in lesser curve GV. Specific ECI techniques have not been compared directly in studies, according to the update authors; however, “the specific cyanoacrylate agent should favor the fastest polymerization time to avoid embolization and inducing GV bleeding.” This has meant 4-carbon (butyl) preparations are preferred to 8-carbon (octyl) preparations, they noted.
After treatment, endoscopy is performed every 2-4 weeks so that the ECI can be repeated as needed until obliteration is complete. The experts suggested that, after eradication of GV, an endoscopic reevaluation within 3-6 months should be scheduled, then annually thereafter. Any de novo or recurrent GV during the long-term follow-up may require additional imaging and multidisciplinary exploration to determine potential mechanisms and need for alternative treatments, the authors advised.
According to the practice update, transjugular intrahepatic portosystemic shunt can be used when the GV is receiving significant inflow from the coronary vein or the patient has significant complications from portal hypertension. When TIPS is used, the experts suggest also performing endovascular sclerosis or direct embolization of GV, if possible. For patients with a gastrorenal shunt, balloon-occluded retrograde transvenous obliteration (BRTO) of bleeding GV is considered optimal if local expertise is available and the patient lacks severe complications from portal hypertension. Endoscopy should be performed within 48 hours after BRTO to confirm obliteration of the vascular flow. If residual flow is detected, “cyanoacrylate injection should be performed,” the experts wrote. To confirm that GV are obliterated and check for any vascular complications, they suggest performing CT or MR within 4-6 weeks after BRTO and then as clinically indicated. In addition, surveillance endoscopy is important to identify and treat any esophageal varices that could have been worsened by increased portal pressures.
No funding sources were reported. The experts reported having no conflicts of interest.
When classifying gastric varices during endoscopy, experts suggest not only describing their location but also their size and whether any high-risk stigmata, such as discolorations and platelet plugs, are present.
In a clinical practice update from the American Gastroenterological Association, Zachary Henry, MD, of the University of Virginia, Charlottesville, and associates also proposed an alternative nomenclature for locating gastric varices (GV). “In practice, most gastroenterologists use the Sarin classification with the main distinction being cardiofundal versus lesser curvature GV. However, the vascular supply and corresponding therapy for GV and esophageal varices are often different, so a merged classification, such as Sarin’s, can be problematic for therapeutic planning purposes,” they wrote in Clinical Gastroenterology and Hepatology, referring to the classification system published by Shiv K. Sarin, MD, DM, and colleagues. They suggested that a merged classification, such as Sarin’s, can be “problematic for therapeutic and planning purposes” because “the vascular supply and corresponding therapy for GV and [esophageal varices] are often different.” Instead, they advised that an “alternative nomenclature based on location within the stomach is clearer and facilitates correlation with vascular imaging.” Another approach is to add risk factors for bleeding, such as an estimate of variceal size and high-risk stigmata (discolored marks, platelet plugs), to Sarin classification.
Diagnosis and treatment of bleeding GV are complex, and multidisciplinary management by hepatologists, interventional radiologists, and interventional endoscopists is optimal, the experts wrote. Data and clinical guidelines do not support primary prophylaxis to prevent bleeding of GV. The authors offered an algorithm for initial management of suspected portal hypertensive GV bleeding based on both endoscopic and vascular anatomy; it includes assessment of circulatory and respiratory status, vasoactive drug administration, antibiotic prophylaxis, and more.
An early goal is confirming bleeding source and attempting to classify the bleeding site; this can be complicated by presence of intragastric blood that obscures the cardia and fundus and underlying GV. Further steps may include temporizing: “Temporizing measures to halt active bleeding are often not the definitive treatment of choice to prevent rebleeding from GV, whereas definitive measures such as endoscopic cyanoacrylate injection (ECI) or endovascular treatments are often not feasible in the acute, diagnostic setting.”
When definitive endoscopic treatment is preferred, ECI of bleeding GV is the therapy of choice because other approaches may be complicated by location and bleeding risk of GV, although band ligation may be appropriate in lesser curve GV. Specific ECI techniques have not been compared directly in studies, according to the update authors; however, “the specific cyanoacrylate agent should favor the fastest polymerization time to avoid embolization and inducing GV bleeding.” This has meant 4-carbon (butyl) preparations are preferred to 8-carbon (octyl) preparations, they noted.
After treatment, endoscopy is performed every 2-4 weeks so that the ECI can be repeated as needed until obliteration is complete. The experts suggested that, after eradication of GV, an endoscopic reevaluation within 3-6 months should be scheduled, then annually thereafter. Any de novo or recurrent GV during the long-term follow-up may require additional imaging and multidisciplinary exploration to determine potential mechanisms and need for alternative treatments, the authors advised.
According to the practice update, transjugular intrahepatic portosystemic shunt can be used when the GV is receiving significant inflow from the coronary vein or the patient has significant complications from portal hypertension. When TIPS is used, the experts suggest also performing endovascular sclerosis or direct embolization of GV, if possible. For patients with a gastrorenal shunt, balloon-occluded retrograde transvenous obliteration (BRTO) of bleeding GV is considered optimal if local expertise is available and the patient lacks severe complications from portal hypertension. Endoscopy should be performed within 48 hours after BRTO to confirm obliteration of the vascular flow. If residual flow is detected, “cyanoacrylate injection should be performed,” the experts wrote. To confirm that GV are obliterated and check for any vascular complications, they suggest performing CT or MR within 4-6 weeks after BRTO and then as clinically indicated. In addition, surveillance endoscopy is important to identify and treat any esophageal varices that could have been worsened by increased portal pressures.
No funding sources were reported. The experts reported having no conflicts of interest.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Consider risk for Barrett’s esophagus after bariatric surgery
Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.
Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.
In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.
Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).
However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.
Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.
The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.
“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
Consider surveillance for Barrett’s
The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.
“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”
Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.
“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.
Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”
The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.
Help your patients better understand the risks, testing, and treatment options for Barrett’s esophagus by sharing education from the AGA GI Patient Center: www.gastro.org/BE.
Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.
Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.
In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.
Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).
However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.
Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.
The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.
“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
Consider surveillance for Barrett’s
The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.
“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”
Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.
“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.
Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”
The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.
Help your patients better understand the risks, testing, and treatment options for Barrett’s esophagus by sharing education from the AGA GI Patient Center: www.gastro.org/BE.
Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.
Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.
In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.
Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).
However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.
Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.
The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.
“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
Consider surveillance for Barrett’s
The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.
“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”
Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.
“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.
Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”
The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.
Help your patients better understand the risks, testing, and treatment options for Barrett’s esophagus by sharing education from the AGA GI Patient Center: www.gastro.org/BE.
FROM GASTROINTESTINAL ENDOSCOPY
Bedtime soon after meals raises reflux risk in pregnancy
A shorter period between eating and going to sleep increased the risk of GERD during pregnancy by approximately 12%, according to data from 400 women.
Gastroesophageal reflux disease (GERD) is a common condition in pregnancy because of changes in gastrointestinal motility caused by hormonal changes, and a short meal-to-bed time (MTBT) also has been associated with increased GERD symptoms, but data on the impact of MTBT on GERD in pregnant women in particular are lacking, wrote Duc T. Quach, MD, of the University of Medicine and Pharmacy in Ho Chi Minh City, Vietnam, and colleagues.
In a cross-sectional study published in the Journal of Clinical Gastroenterology, the researchers identified 400 pregnant women aged 18 years and older in various stages of pregnancy who were seen at a single hospital in Vietnam. A short MTBT was defined as going to bed 2 hours or less after eating. Primary outcomes were GERD, defined as troublesome heartburn and/or regurgitation at least once a week, and reflux-related insomnia, defined as trouble initiating or maintaining nighttime sleep. Participants also reported the number of days of troublesome reflux symptoms and frequency of reflux-related insomnia over the last 7 days.
A total of 154 participants had a diagnosis of GERD, for an overall prevalence of 38.5%, similar to that seen in GERD studies of GERD and pregnancy, the researchers noted, and of those with GERD, 20 participants (13.0%) reported reflux-related insomnia.
The overall prevalence of heartburn, regurgitation, nausea with or without vomiting, and epigastric pain were 11.8%, 35.8%, 30.0%, and 5.5%, respectively. A total of 139 women reported reflux symptoms on at least 2 of the past 7 days, and 40 women reported both daytime and nighttime reflux symptoms.
Short meal-to-bed time shows strongest association
A short MTBT was the strongest predictor of GERD in multivariate analysis (odds ratio, 12.73; 95% confidence interval, 2.92-55.45; P = .001); previous history of reflux symptoms (OR, 9.05; 95% CI, 5.29-15.50; P < 001) and being in the third trimester versus first or second of pregnancy (OR, 1.66, 95% CI, 1.03-2.69; P = .039) also remained significant predictors in a multivariate analysis. In addition, nighttime short MTBT (but not daytime short MTBT) was the strongest risk factor for reflux-related insomnia (OR, 4.60), although alcohol consumption and a history of reflux-related symptoms also remained significant in multivariate analysis.
“Interestingly, the number of days during which reflux symptoms were experienced during the last 7 days sequentially increased across subgroups of participants with no short MTBT, either daytime or nighttime short MTBT, and with both daytime and nighttime MTBT,” the researchers wrote. At 4-7 days, none of the patients with no short MTBT reported reflux symptoms, compared with 7.5% of those with either daytime or nighttime MTBT and 20.9% of those with both daytime and nighttime MTBT.
The study findings were limited by several factors, including the inability to accurately record participants’ diets and the potential for overestimating the odds ratio of risk factors in patients with reflux-related insomnia because of the small numbers. However, the results support findings from previous studies and suggest that dietary modifications could provide a nonpharmacological treatment target for managing GERD in pregnant women, they concluded.
Behavioral intervention may benefit pregnant women
The study is important because heartburn and regurgitation are common challenges during pregnancy, Ziad F. Gellad, MD, of Duke University, Durham, N.C., said in an interview. “Understanding risk factors for these conditions can be helpful in designing behavioral and pharmaceutical therapeutic interventions.”
The link between short MTBT and increased risk for GERD is well-known, said Dr. Gellad. “Lengthening the time to laying supine after a meal is a common recommendation given to patients with GERD and is included in published GERD guidelines.” Although pregnant woman may have been excluded from trials on which the guidelines and recommendations are based, “it is reasonable to expect that findings would translate to this population that is generally higher risk for reflux,” he noted.
Dr. Gellad was interested to see the dose response between MTBT and reflux, with those patients having both daytime and nighttime short MTBT experiencing reflux more often than those with short MTBT in only one of those time periods (4-7 days vs. 1-3 days).
The key message for clinicians is that, for all individuals, pregnant or not, “avoiding late night meals and short meal-to-bed time is an appropriate behavioral intervention to recommend for patients with troublesome heartburn or regurgitation,” Dr. Gellad emphasized. However, more research is needed in some areas, “implementation studies would be helpful to understand how best to educate patients on behavioral modifications known to decrease reflux symptoms.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gellad had no relevant financial disclosures, but serves as a member of the GI & Hepatology News board of editors.
A shorter period between eating and going to sleep increased the risk of GERD during pregnancy by approximately 12%, according to data from 400 women.
Gastroesophageal reflux disease (GERD) is a common condition in pregnancy because of changes in gastrointestinal motility caused by hormonal changes, and a short meal-to-bed time (MTBT) also has been associated with increased GERD symptoms, but data on the impact of MTBT on GERD in pregnant women in particular are lacking, wrote Duc T. Quach, MD, of the University of Medicine and Pharmacy in Ho Chi Minh City, Vietnam, and colleagues.
In a cross-sectional study published in the Journal of Clinical Gastroenterology, the researchers identified 400 pregnant women aged 18 years and older in various stages of pregnancy who were seen at a single hospital in Vietnam. A short MTBT was defined as going to bed 2 hours or less after eating. Primary outcomes were GERD, defined as troublesome heartburn and/or regurgitation at least once a week, and reflux-related insomnia, defined as trouble initiating or maintaining nighttime sleep. Participants also reported the number of days of troublesome reflux symptoms and frequency of reflux-related insomnia over the last 7 days.
A total of 154 participants had a diagnosis of GERD, for an overall prevalence of 38.5%, similar to that seen in GERD studies of GERD and pregnancy, the researchers noted, and of those with GERD, 20 participants (13.0%) reported reflux-related insomnia.
The overall prevalence of heartburn, regurgitation, nausea with or without vomiting, and epigastric pain were 11.8%, 35.8%, 30.0%, and 5.5%, respectively. A total of 139 women reported reflux symptoms on at least 2 of the past 7 days, and 40 women reported both daytime and nighttime reflux symptoms.
Short meal-to-bed time shows strongest association
A short MTBT was the strongest predictor of GERD in multivariate analysis (odds ratio, 12.73; 95% confidence interval, 2.92-55.45; P = .001); previous history of reflux symptoms (OR, 9.05; 95% CI, 5.29-15.50; P < 001) and being in the third trimester versus first or second of pregnancy (OR, 1.66, 95% CI, 1.03-2.69; P = .039) also remained significant predictors in a multivariate analysis. In addition, nighttime short MTBT (but not daytime short MTBT) was the strongest risk factor for reflux-related insomnia (OR, 4.60), although alcohol consumption and a history of reflux-related symptoms also remained significant in multivariate analysis.
“Interestingly, the number of days during which reflux symptoms were experienced during the last 7 days sequentially increased across subgroups of participants with no short MTBT, either daytime or nighttime short MTBT, and with both daytime and nighttime MTBT,” the researchers wrote. At 4-7 days, none of the patients with no short MTBT reported reflux symptoms, compared with 7.5% of those with either daytime or nighttime MTBT and 20.9% of those with both daytime and nighttime MTBT.
The study findings were limited by several factors, including the inability to accurately record participants’ diets and the potential for overestimating the odds ratio of risk factors in patients with reflux-related insomnia because of the small numbers. However, the results support findings from previous studies and suggest that dietary modifications could provide a nonpharmacological treatment target for managing GERD in pregnant women, they concluded.
Behavioral intervention may benefit pregnant women
The study is important because heartburn and regurgitation are common challenges during pregnancy, Ziad F. Gellad, MD, of Duke University, Durham, N.C., said in an interview. “Understanding risk factors for these conditions can be helpful in designing behavioral and pharmaceutical therapeutic interventions.”
The link between short MTBT and increased risk for GERD is well-known, said Dr. Gellad. “Lengthening the time to laying supine after a meal is a common recommendation given to patients with GERD and is included in published GERD guidelines.” Although pregnant woman may have been excluded from trials on which the guidelines and recommendations are based, “it is reasonable to expect that findings would translate to this population that is generally higher risk for reflux,” he noted.
Dr. Gellad was interested to see the dose response between MTBT and reflux, with those patients having both daytime and nighttime short MTBT experiencing reflux more often than those with short MTBT in only one of those time periods (4-7 days vs. 1-3 days).
The key message for clinicians is that, for all individuals, pregnant or not, “avoiding late night meals and short meal-to-bed time is an appropriate behavioral intervention to recommend for patients with troublesome heartburn or regurgitation,” Dr. Gellad emphasized. However, more research is needed in some areas, “implementation studies would be helpful to understand how best to educate patients on behavioral modifications known to decrease reflux symptoms.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gellad had no relevant financial disclosures, but serves as a member of the GI & Hepatology News board of editors.
A shorter period between eating and going to sleep increased the risk of GERD during pregnancy by approximately 12%, according to data from 400 women.
Gastroesophageal reflux disease (GERD) is a common condition in pregnancy because of changes in gastrointestinal motility caused by hormonal changes, and a short meal-to-bed time (MTBT) also has been associated with increased GERD symptoms, but data on the impact of MTBT on GERD in pregnant women in particular are lacking, wrote Duc T. Quach, MD, of the University of Medicine and Pharmacy in Ho Chi Minh City, Vietnam, and colleagues.
In a cross-sectional study published in the Journal of Clinical Gastroenterology, the researchers identified 400 pregnant women aged 18 years and older in various stages of pregnancy who were seen at a single hospital in Vietnam. A short MTBT was defined as going to bed 2 hours or less after eating. Primary outcomes were GERD, defined as troublesome heartburn and/or regurgitation at least once a week, and reflux-related insomnia, defined as trouble initiating or maintaining nighttime sleep. Participants also reported the number of days of troublesome reflux symptoms and frequency of reflux-related insomnia over the last 7 days.
A total of 154 participants had a diagnosis of GERD, for an overall prevalence of 38.5%, similar to that seen in GERD studies of GERD and pregnancy, the researchers noted, and of those with GERD, 20 participants (13.0%) reported reflux-related insomnia.
The overall prevalence of heartburn, regurgitation, nausea with or without vomiting, and epigastric pain were 11.8%, 35.8%, 30.0%, and 5.5%, respectively. A total of 139 women reported reflux symptoms on at least 2 of the past 7 days, and 40 women reported both daytime and nighttime reflux symptoms.
Short meal-to-bed time shows strongest association
A short MTBT was the strongest predictor of GERD in multivariate analysis (odds ratio, 12.73; 95% confidence interval, 2.92-55.45; P = .001); previous history of reflux symptoms (OR, 9.05; 95% CI, 5.29-15.50; P < 001) and being in the third trimester versus first or second of pregnancy (OR, 1.66, 95% CI, 1.03-2.69; P = .039) also remained significant predictors in a multivariate analysis. In addition, nighttime short MTBT (but not daytime short MTBT) was the strongest risk factor for reflux-related insomnia (OR, 4.60), although alcohol consumption and a history of reflux-related symptoms also remained significant in multivariate analysis.
“Interestingly, the number of days during which reflux symptoms were experienced during the last 7 days sequentially increased across subgroups of participants with no short MTBT, either daytime or nighttime short MTBT, and with both daytime and nighttime MTBT,” the researchers wrote. At 4-7 days, none of the patients with no short MTBT reported reflux symptoms, compared with 7.5% of those with either daytime or nighttime MTBT and 20.9% of those with both daytime and nighttime MTBT.
The study findings were limited by several factors, including the inability to accurately record participants’ diets and the potential for overestimating the odds ratio of risk factors in patients with reflux-related insomnia because of the small numbers. However, the results support findings from previous studies and suggest that dietary modifications could provide a nonpharmacological treatment target for managing GERD in pregnant women, they concluded.
Behavioral intervention may benefit pregnant women
The study is important because heartburn and regurgitation are common challenges during pregnancy, Ziad F. Gellad, MD, of Duke University, Durham, N.C., said in an interview. “Understanding risk factors for these conditions can be helpful in designing behavioral and pharmaceutical therapeutic interventions.”
The link between short MTBT and increased risk for GERD is well-known, said Dr. Gellad. “Lengthening the time to laying supine after a meal is a common recommendation given to patients with GERD and is included in published GERD guidelines.” Although pregnant woman may have been excluded from trials on which the guidelines and recommendations are based, “it is reasonable to expect that findings would translate to this population that is generally higher risk for reflux,” he noted.
Dr. Gellad was interested to see the dose response between MTBT and reflux, with those patients having both daytime and nighttime short MTBT experiencing reflux more often than those with short MTBT in only one of those time periods (4-7 days vs. 1-3 days).
The key message for clinicians is that, for all individuals, pregnant or not, “avoiding late night meals and short meal-to-bed time is an appropriate behavioral intervention to recommend for patients with troublesome heartburn or regurgitation,” Dr. Gellad emphasized. However, more research is needed in some areas, “implementation studies would be helpful to understand how best to educate patients on behavioral modifications known to decrease reflux symptoms.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gellad had no relevant financial disclosures, but serves as a member of the GI & Hepatology News board of editors.
FROM THE JOURNAL OF CLINICAL GASTROENTEROLOGY
Adherence to antireflux lifestyle factors shows benefit in women
Antireflux lifestyle factors may significantly reduce the risk of gastroesophageal reflux disease (GERD), according to an analysis involving almost 43,000 women.
Even alongside therapy with a proton-pump inhibitor (PPI) and/or a histamine-receptor antagonist (H2RA), adherence to five antireflux lifestyle factors had a meaningful impact on risk for GERD symptoms, possibly preventing nearly 40% of cases with weekly GERD symptoms, reported lead author Raaj S. Mehta, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.
“Clinicians recommend dietary and lifestyle modifications to prevent GERD symptoms, but no prospective data are available to inform these recommendations,” Dr. Mehta and colleagues wrote in JAMA Internal Medicine.
To address this gap, the investigators turned to the Nurses’ Health Study II, a nationwide, prospective study involving 116,671 women. The study, which has a follow-up rate exceeding 90%, began in 1989 and is ongoing. Participants complete biennial questionnaires that include a variety of health and lifestyle factors. In 2005, 2009, 2013, and 2017, the questionnaire inquired about heartburn or acid reflux.
The present analysis included data from 42,955 women aged 42-62 years. Participants were excluded at baseline if they had cancer, lacked dietary data, were lost to follow-up, already had GERD symptoms at least weekly, or used a PPI and/or H2RA on a regular basis. The final dataset included 392,215 person-years of follow-up, with 9,291 incident cases of GERD symptoms.
For each participant, the presence of five possible antireflux lifestyle factors were added together for a score ranging from 0 to 5: no more than two cups of soda, tea, or coffee per day; never smoking; normal body weight (BMI ≥18.5 and <25.0 kg/m2); “prudent” diet, based on top 40% of dietary pattern score; and at least 30 minutes of moderate to vigorous physical activity each day.
Multivariate logistic regression modeling showed that women who reported all five antireflux lifestyle factors had a 50% decreased risk of GERD symptoms (hazard ratio, 0.50; 95% confidence interval, 0.42-0.59), compared with women who adhered to none of them. Further analysis suggested that the collective effect of all five factors could reduce GERD symptom case volume by 37% (95% CI, 28%-46%).
Nonadherence to each antireflux lifestyle factor was independently associated with an increased risk of GERD symptoms. After mutual adjustment for other variables, BMI was associated with the highest population-attributable risk (19%), followed by physical activity (8%), food intake (7%), beverage intake (4%), and nonsmoker status (3%).
Dr. Mehta and colleagues also explored the relationship between GERD symptoms, antireflux medications, and lifestyle factors. Presence of all five antireflux factors was associated with a 53% decreased risk of GERD symptoms or initiation of PPI and/or H2RA therapy (HR, 0.47; 95% CI, 0.41-0.54). Among a group of 3,625 women who reported regular use of a PPI and/or H2RA and were free of GERD symptoms at baseline, adherence to all five lifestyle factors reduced risk of GERD symptoms by 68% (HR, 0.32; 95% CI, 0.18-0.57).
One limitation of the study was that its population was primarily White women; however, the authors noted a study suggesting GERD is more common in White women aged 30-60 years.
“Adherence to an antireflux lifestyle, even among regular users of PPIs and/or H2RAs, was associated with a decreased risk of GERD symptoms,” the investigators concluded.
Lifestyle matters
According to Ronnie Fass, MD, medical director of the Digestive Health Center at Case Western Reserve University, Cleveland, “This is the first study to show the incremental effect and thus the benefit of lifestyle factors in reducing the risk of GERD symptoms. While only five lifestyle factors were assessed in this study, potentially others may further decrease the risk for symptoms.”
Dr. Fass suggested that the nature of the data, which was self-reported, and the entirely female patient population, should inform interpretation of the findings.
“While nonerosive reflux disease is relatively more common in women, erosive esophagitis and Barrett’s esophagus are more common in men,” he said. “Furthermore, male gender is associated with more severe GERD and GERD complications.”
Yet Dr. Fass concluded by again emphasizing the merit of the analysis: “This is an important study that further supports the value of certain lifestyle factors in reducing the risk of GERD symptoms,” he said. “What is challenging for practicing physicians is to get patients to follow these lifestyle factors long term.”
The study was funded by the National Institutes of Health and by a Stuart and Suzanne Steele Massachusetts General Hospital Research Scholar Award. The investigators and Dr. Fass disclosed no conflicts of interest.
Antireflux lifestyle factors may significantly reduce the risk of gastroesophageal reflux disease (GERD), according to an analysis involving almost 43,000 women.
Even alongside therapy with a proton-pump inhibitor (PPI) and/or a histamine-receptor antagonist (H2RA), adherence to five antireflux lifestyle factors had a meaningful impact on risk for GERD symptoms, possibly preventing nearly 40% of cases with weekly GERD symptoms, reported lead author Raaj S. Mehta, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.
“Clinicians recommend dietary and lifestyle modifications to prevent GERD symptoms, but no prospective data are available to inform these recommendations,” Dr. Mehta and colleagues wrote in JAMA Internal Medicine.
To address this gap, the investigators turned to the Nurses’ Health Study II, a nationwide, prospective study involving 116,671 women. The study, which has a follow-up rate exceeding 90%, began in 1989 and is ongoing. Participants complete biennial questionnaires that include a variety of health and lifestyle factors. In 2005, 2009, 2013, and 2017, the questionnaire inquired about heartburn or acid reflux.
The present analysis included data from 42,955 women aged 42-62 years. Participants were excluded at baseline if they had cancer, lacked dietary data, were lost to follow-up, already had GERD symptoms at least weekly, or used a PPI and/or H2RA on a regular basis. The final dataset included 392,215 person-years of follow-up, with 9,291 incident cases of GERD symptoms.
For each participant, the presence of five possible antireflux lifestyle factors were added together for a score ranging from 0 to 5: no more than two cups of soda, tea, or coffee per day; never smoking; normal body weight (BMI ≥18.5 and <25.0 kg/m2); “prudent” diet, based on top 40% of dietary pattern score; and at least 30 minutes of moderate to vigorous physical activity each day.
Multivariate logistic regression modeling showed that women who reported all five antireflux lifestyle factors had a 50% decreased risk of GERD symptoms (hazard ratio, 0.50; 95% confidence interval, 0.42-0.59), compared with women who adhered to none of them. Further analysis suggested that the collective effect of all five factors could reduce GERD symptom case volume by 37% (95% CI, 28%-46%).
Nonadherence to each antireflux lifestyle factor was independently associated with an increased risk of GERD symptoms. After mutual adjustment for other variables, BMI was associated with the highest population-attributable risk (19%), followed by physical activity (8%), food intake (7%), beverage intake (4%), and nonsmoker status (3%).
Dr. Mehta and colleagues also explored the relationship between GERD symptoms, antireflux medications, and lifestyle factors. Presence of all five antireflux factors was associated with a 53% decreased risk of GERD symptoms or initiation of PPI and/or H2RA therapy (HR, 0.47; 95% CI, 0.41-0.54). Among a group of 3,625 women who reported regular use of a PPI and/or H2RA and were free of GERD symptoms at baseline, adherence to all five lifestyle factors reduced risk of GERD symptoms by 68% (HR, 0.32; 95% CI, 0.18-0.57).
One limitation of the study was that its population was primarily White women; however, the authors noted a study suggesting GERD is more common in White women aged 30-60 years.
“Adherence to an antireflux lifestyle, even among regular users of PPIs and/or H2RAs, was associated with a decreased risk of GERD symptoms,” the investigators concluded.
Lifestyle matters
According to Ronnie Fass, MD, medical director of the Digestive Health Center at Case Western Reserve University, Cleveland, “This is the first study to show the incremental effect and thus the benefit of lifestyle factors in reducing the risk of GERD symptoms. While only five lifestyle factors were assessed in this study, potentially others may further decrease the risk for symptoms.”
Dr. Fass suggested that the nature of the data, which was self-reported, and the entirely female patient population, should inform interpretation of the findings.
“While nonerosive reflux disease is relatively more common in women, erosive esophagitis and Barrett’s esophagus are more common in men,” he said. “Furthermore, male gender is associated with more severe GERD and GERD complications.”
Yet Dr. Fass concluded by again emphasizing the merit of the analysis: “This is an important study that further supports the value of certain lifestyle factors in reducing the risk of GERD symptoms,” he said. “What is challenging for practicing physicians is to get patients to follow these lifestyle factors long term.”
The study was funded by the National Institutes of Health and by a Stuart and Suzanne Steele Massachusetts General Hospital Research Scholar Award. The investigators and Dr. Fass disclosed no conflicts of interest.
Antireflux lifestyle factors may significantly reduce the risk of gastroesophageal reflux disease (GERD), according to an analysis involving almost 43,000 women.
Even alongside therapy with a proton-pump inhibitor (PPI) and/or a histamine-receptor antagonist (H2RA), adherence to five antireflux lifestyle factors had a meaningful impact on risk for GERD symptoms, possibly preventing nearly 40% of cases with weekly GERD symptoms, reported lead author Raaj S. Mehta, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.
“Clinicians recommend dietary and lifestyle modifications to prevent GERD symptoms, but no prospective data are available to inform these recommendations,” Dr. Mehta and colleagues wrote in JAMA Internal Medicine.
To address this gap, the investigators turned to the Nurses’ Health Study II, a nationwide, prospective study involving 116,671 women. The study, which has a follow-up rate exceeding 90%, began in 1989 and is ongoing. Participants complete biennial questionnaires that include a variety of health and lifestyle factors. In 2005, 2009, 2013, and 2017, the questionnaire inquired about heartburn or acid reflux.
The present analysis included data from 42,955 women aged 42-62 years. Participants were excluded at baseline if they had cancer, lacked dietary data, were lost to follow-up, already had GERD symptoms at least weekly, or used a PPI and/or H2RA on a regular basis. The final dataset included 392,215 person-years of follow-up, with 9,291 incident cases of GERD symptoms.
For each participant, the presence of five possible antireflux lifestyle factors were added together for a score ranging from 0 to 5: no more than two cups of soda, tea, or coffee per day; never smoking; normal body weight (BMI ≥18.5 and <25.0 kg/m2); “prudent” diet, based on top 40% of dietary pattern score; and at least 30 minutes of moderate to vigorous physical activity each day.
Multivariate logistic regression modeling showed that women who reported all five antireflux lifestyle factors had a 50% decreased risk of GERD symptoms (hazard ratio, 0.50; 95% confidence interval, 0.42-0.59), compared with women who adhered to none of them. Further analysis suggested that the collective effect of all five factors could reduce GERD symptom case volume by 37% (95% CI, 28%-46%).
Nonadherence to each antireflux lifestyle factor was independently associated with an increased risk of GERD symptoms. After mutual adjustment for other variables, BMI was associated with the highest population-attributable risk (19%), followed by physical activity (8%), food intake (7%), beverage intake (4%), and nonsmoker status (3%).
Dr. Mehta and colleagues also explored the relationship between GERD symptoms, antireflux medications, and lifestyle factors. Presence of all five antireflux factors was associated with a 53% decreased risk of GERD symptoms or initiation of PPI and/or H2RA therapy (HR, 0.47; 95% CI, 0.41-0.54). Among a group of 3,625 women who reported regular use of a PPI and/or H2RA and were free of GERD symptoms at baseline, adherence to all five lifestyle factors reduced risk of GERD symptoms by 68% (HR, 0.32; 95% CI, 0.18-0.57).
One limitation of the study was that its population was primarily White women; however, the authors noted a study suggesting GERD is more common in White women aged 30-60 years.
“Adherence to an antireflux lifestyle, even among regular users of PPIs and/or H2RAs, was associated with a decreased risk of GERD symptoms,” the investigators concluded.
Lifestyle matters
According to Ronnie Fass, MD, medical director of the Digestive Health Center at Case Western Reserve University, Cleveland, “This is the first study to show the incremental effect and thus the benefit of lifestyle factors in reducing the risk of GERD symptoms. While only five lifestyle factors were assessed in this study, potentially others may further decrease the risk for symptoms.”
Dr. Fass suggested that the nature of the data, which was self-reported, and the entirely female patient population, should inform interpretation of the findings.
“While nonerosive reflux disease is relatively more common in women, erosive esophagitis and Barrett’s esophagus are more common in men,” he said. “Furthermore, male gender is associated with more severe GERD and GERD complications.”
Yet Dr. Fass concluded by again emphasizing the merit of the analysis: “This is an important study that further supports the value of certain lifestyle factors in reducing the risk of GERD symptoms,” he said. “What is challenging for practicing physicians is to get patients to follow these lifestyle factors long term.”
The study was funded by the National Institutes of Health and by a Stuart and Suzanne Steele Massachusetts General Hospital Research Scholar Award. The investigators and Dr. Fass disclosed no conflicts of interest.
FROM JAMA INTERNAL MEDICINE
PPIs improve functional dyspepsia via anti-inflammatory effects
Proton pump inhibitors (PPIs) improve functional dyspepsia (FD) by reducing duodenal eosinophils and mast cells, according to a prospective study.
This suggests that the anti-inflammatory effects of PPIs are responsible for symptom improvement, and not barrier-protective or acid-suppressive effects, a finding that may guide future therapies and biomarkers, reported lead author Lucas Wauters, PhD, of University Hospitals Leuven (Belgium), and colleagues reported in Gastroenterology.
“FD is a common and unexplained disorder with unknown pathophysiology, hampering a conclusive diagnosis and the development of effective drugs,” the investigators wrote.
Although PPIs are currently used as first-line FD therapy, ostensibly for acid suppression, “the exact mechanism of action of PPIs in FD is unknown,” the investigators noted.
According to Dr. Wauters and colleagues, previous FD studies, such as a 2020 study published in Gut, have reported a variety of pathophysiological findings in the duodenum, including increased eosinophils and mast cells, as well as activation of duodenogastric reflexes, which suggests “a primary role for duodenal pathology in FD symptom generation.” Several drivers of this pathology have been proposed. Some, such as aberrations in bile salts and acidity, point to local, luminal changes, whereas others, such as dysregulated hypothalamic-pituitary-adrenal axis responsiveness and psychosocial factors, implicate a broader set of drivers, the investigators wrote.
The present study explored this landscape through a prospective trial that enrolled 30 healthy volunteers and 47 patients with FD (2 patients with FD did not complete the study).
Patients with FD were subgrouped into “FD-starters” who had not taken PPIs and/or acid suppression for at least 3 months leading up to the trial (n = 28) and “FD-stoppers” who had refractory symptoms after at least 1 month of daily PPI usage (n = 19). Among participants with FD, 25 had postprandial distress syndrome (PDS), 9 had epigastric pain syndrome (EPS), and 13 had subtype overlap.
For the trial, FD-starters and healthy volunteers took 4 weeks of pantoprazole 40 mg once daily, whereas FD-stoppers ceased PPI therapy for 8 weeks. Before and after these respective periods, certain study procedures were conducted, including duodenal biopsy collection, duodenal fluid aspiration, and questionnaires for symptoms and stress. The study also included use of Ussing chambers for biopsies, immunohistochemistry, and bile salt measurements.
FD-starters were significantly more symptomatic than healthy volunteers were at baseline. After starting PPIs, those with FD had symptom improvements, confirming “clinical efficacy of a standard course of PPIs in all FD subtypes,” whereas healthy volunteers showed no significant change in symptoms.
Similarly, baseline duodenal eosinophil counts were higher in FD-starters than in healthy volunteers. On starting PPIs, however, eosinophil counts in these two groups moved in opposite directions: FD-starters’ counts dropped from a mean of 331 to 183 eosinophils/mm2, whereas healthy volunteers’ counts rose from a mean of 115 to 229 eosinophils/mm2 (P < .0001). Changes in mast cells and paracellular passage followed the same pattern, falling in FD-starters and rising in healthy volunteers. On the other hand, symptoms actually improved in the FD-stoppers after they went off PPIs, although they did not reach symptom levels of the healthy volunteers.
“Differential effects of PPIs in healthy volunteers point to the role of luminal changes in determining low-grade mucosal immune activation in the duodenum, which can also occur in FD after long-term use and provide arguments against continued use in refractory patients,” the investigators wrote.
Dr. Wauters and colleagues suggested that their findings could guide future approaches to FD management.
“Our results suggest that quantification of duodenal eosinophils has the potential to become part of diagnostic workup and guide therapeutic decisions in FD,” they wrote. “Additional study of the underlying mediators might lead to the discovery of new potential biomarkers or novel therapeutic targets, potentially allowing the identification of subgroups responding to biologically targeted rather than symptom-based treatments.”
The study was supported by the clinical research fund of the University Hospitals Leuven. The investigators reported no conflicts of interest.
Functional dyspepsia (FD) is a commonly encountered diagnosis among primary care and gastroenterology clinics with estimated prevalence of 5%-11% worldwide. However, the pathophysiology of this entity is not well understood, and most of the patients who undergo upper endoscopy for dyspepsia tend to have normal findings.
The differential effects of PPIs on duodenal inflammation among the groups in this study are perplexing and the findings are limited by the short duration of follow-up testing and lack of a placebo group. Duodenal eosinophils, mast cells, and permeability were higher in treatment-naive FD, and a 4-week course of PPIs reduced this inflammation in FD but apparently increased it in healthy volunteers. Furthermore, when patients with PPI-refractory FD were studied, withdrawal of the PPI lead to improvement in symptoms and trends toward less duodenal inflammation.
The discordant impact of PPIs among these groups on duodenal inflammation raises questions regarding the true effect from PPIs or changes driven by other systemic factors (brain-gut axis). This is hard to differentiate without a placebo group. Focus in future studies should be placed on how to clinically phenotype and predict PPI responders versus nonresponders along with use of longer durations to see if even PPI responders tend to lose response over time, regardless of changes in the duodenal inflammation and permeability.
Dhyanesh A. Patel, MD, is an assistant professor of medicine at the center for esophageal disorders, Vanderbilt University Medical Center, Nashville, Tenn. He has no conflicts.
Functional dyspepsia (FD) is a commonly encountered diagnosis among primary care and gastroenterology clinics with estimated prevalence of 5%-11% worldwide. However, the pathophysiology of this entity is not well understood, and most of the patients who undergo upper endoscopy for dyspepsia tend to have normal findings.
The differential effects of PPIs on duodenal inflammation among the groups in this study are perplexing and the findings are limited by the short duration of follow-up testing and lack of a placebo group. Duodenal eosinophils, mast cells, and permeability were higher in treatment-naive FD, and a 4-week course of PPIs reduced this inflammation in FD but apparently increased it in healthy volunteers. Furthermore, when patients with PPI-refractory FD were studied, withdrawal of the PPI lead to improvement in symptoms and trends toward less duodenal inflammation.
The discordant impact of PPIs among these groups on duodenal inflammation raises questions regarding the true effect from PPIs or changes driven by other systemic factors (brain-gut axis). This is hard to differentiate without a placebo group. Focus in future studies should be placed on how to clinically phenotype and predict PPI responders versus nonresponders along with use of longer durations to see if even PPI responders tend to lose response over time, regardless of changes in the duodenal inflammation and permeability.
Dhyanesh A. Patel, MD, is an assistant professor of medicine at the center for esophageal disorders, Vanderbilt University Medical Center, Nashville, Tenn. He has no conflicts.
Functional dyspepsia (FD) is a commonly encountered diagnosis among primary care and gastroenterology clinics with estimated prevalence of 5%-11% worldwide. However, the pathophysiology of this entity is not well understood, and most of the patients who undergo upper endoscopy for dyspepsia tend to have normal findings.
The differential effects of PPIs on duodenal inflammation among the groups in this study are perplexing and the findings are limited by the short duration of follow-up testing and lack of a placebo group. Duodenal eosinophils, mast cells, and permeability were higher in treatment-naive FD, and a 4-week course of PPIs reduced this inflammation in FD but apparently increased it in healthy volunteers. Furthermore, when patients with PPI-refractory FD were studied, withdrawal of the PPI lead to improvement in symptoms and trends toward less duodenal inflammation.
The discordant impact of PPIs among these groups on duodenal inflammation raises questions regarding the true effect from PPIs or changes driven by other systemic factors (brain-gut axis). This is hard to differentiate without a placebo group. Focus in future studies should be placed on how to clinically phenotype and predict PPI responders versus nonresponders along with use of longer durations to see if even PPI responders tend to lose response over time, regardless of changes in the duodenal inflammation and permeability.
Dhyanesh A. Patel, MD, is an assistant professor of medicine at the center for esophageal disorders, Vanderbilt University Medical Center, Nashville, Tenn. He has no conflicts.
Proton pump inhibitors (PPIs) improve functional dyspepsia (FD) by reducing duodenal eosinophils and mast cells, according to a prospective study.
This suggests that the anti-inflammatory effects of PPIs are responsible for symptom improvement, and not barrier-protective or acid-suppressive effects, a finding that may guide future therapies and biomarkers, reported lead author Lucas Wauters, PhD, of University Hospitals Leuven (Belgium), and colleagues reported in Gastroenterology.
“FD is a common and unexplained disorder with unknown pathophysiology, hampering a conclusive diagnosis and the development of effective drugs,” the investigators wrote.
Although PPIs are currently used as first-line FD therapy, ostensibly for acid suppression, “the exact mechanism of action of PPIs in FD is unknown,” the investigators noted.
According to Dr. Wauters and colleagues, previous FD studies, such as a 2020 study published in Gut, have reported a variety of pathophysiological findings in the duodenum, including increased eosinophils and mast cells, as well as activation of duodenogastric reflexes, which suggests “a primary role for duodenal pathology in FD symptom generation.” Several drivers of this pathology have been proposed. Some, such as aberrations in bile salts and acidity, point to local, luminal changes, whereas others, such as dysregulated hypothalamic-pituitary-adrenal axis responsiveness and psychosocial factors, implicate a broader set of drivers, the investigators wrote.
The present study explored this landscape through a prospective trial that enrolled 30 healthy volunteers and 47 patients with FD (2 patients with FD did not complete the study).
Patients with FD were subgrouped into “FD-starters” who had not taken PPIs and/or acid suppression for at least 3 months leading up to the trial (n = 28) and “FD-stoppers” who had refractory symptoms after at least 1 month of daily PPI usage (n = 19). Among participants with FD, 25 had postprandial distress syndrome (PDS), 9 had epigastric pain syndrome (EPS), and 13 had subtype overlap.
For the trial, FD-starters and healthy volunteers took 4 weeks of pantoprazole 40 mg once daily, whereas FD-stoppers ceased PPI therapy for 8 weeks. Before and after these respective periods, certain study procedures were conducted, including duodenal biopsy collection, duodenal fluid aspiration, and questionnaires for symptoms and stress. The study also included use of Ussing chambers for biopsies, immunohistochemistry, and bile salt measurements.
FD-starters were significantly more symptomatic than healthy volunteers were at baseline. After starting PPIs, those with FD had symptom improvements, confirming “clinical efficacy of a standard course of PPIs in all FD subtypes,” whereas healthy volunteers showed no significant change in symptoms.
Similarly, baseline duodenal eosinophil counts were higher in FD-starters than in healthy volunteers. On starting PPIs, however, eosinophil counts in these two groups moved in opposite directions: FD-starters’ counts dropped from a mean of 331 to 183 eosinophils/mm2, whereas healthy volunteers’ counts rose from a mean of 115 to 229 eosinophils/mm2 (P < .0001). Changes in mast cells and paracellular passage followed the same pattern, falling in FD-starters and rising in healthy volunteers. On the other hand, symptoms actually improved in the FD-stoppers after they went off PPIs, although they did not reach symptom levels of the healthy volunteers.
“Differential effects of PPIs in healthy volunteers point to the role of luminal changes in determining low-grade mucosal immune activation in the duodenum, which can also occur in FD after long-term use and provide arguments against continued use in refractory patients,” the investigators wrote.
Dr. Wauters and colleagues suggested that their findings could guide future approaches to FD management.
“Our results suggest that quantification of duodenal eosinophils has the potential to become part of diagnostic workup and guide therapeutic decisions in FD,” they wrote. “Additional study of the underlying mediators might lead to the discovery of new potential biomarkers or novel therapeutic targets, potentially allowing the identification of subgroups responding to biologically targeted rather than symptom-based treatments.”
The study was supported by the clinical research fund of the University Hospitals Leuven. The investigators reported no conflicts of interest.
Proton pump inhibitors (PPIs) improve functional dyspepsia (FD) by reducing duodenal eosinophils and mast cells, according to a prospective study.
This suggests that the anti-inflammatory effects of PPIs are responsible for symptom improvement, and not barrier-protective or acid-suppressive effects, a finding that may guide future therapies and biomarkers, reported lead author Lucas Wauters, PhD, of University Hospitals Leuven (Belgium), and colleagues reported in Gastroenterology.
“FD is a common and unexplained disorder with unknown pathophysiology, hampering a conclusive diagnosis and the development of effective drugs,” the investigators wrote.
Although PPIs are currently used as first-line FD therapy, ostensibly for acid suppression, “the exact mechanism of action of PPIs in FD is unknown,” the investigators noted.
According to Dr. Wauters and colleagues, previous FD studies, such as a 2020 study published in Gut, have reported a variety of pathophysiological findings in the duodenum, including increased eosinophils and mast cells, as well as activation of duodenogastric reflexes, which suggests “a primary role for duodenal pathology in FD symptom generation.” Several drivers of this pathology have been proposed. Some, such as aberrations in bile salts and acidity, point to local, luminal changes, whereas others, such as dysregulated hypothalamic-pituitary-adrenal axis responsiveness and psychosocial factors, implicate a broader set of drivers, the investigators wrote.
The present study explored this landscape through a prospective trial that enrolled 30 healthy volunteers and 47 patients with FD (2 patients with FD did not complete the study).
Patients with FD were subgrouped into “FD-starters” who had not taken PPIs and/or acid suppression for at least 3 months leading up to the trial (n = 28) and “FD-stoppers” who had refractory symptoms after at least 1 month of daily PPI usage (n = 19). Among participants with FD, 25 had postprandial distress syndrome (PDS), 9 had epigastric pain syndrome (EPS), and 13 had subtype overlap.
For the trial, FD-starters and healthy volunteers took 4 weeks of pantoprazole 40 mg once daily, whereas FD-stoppers ceased PPI therapy for 8 weeks. Before and after these respective periods, certain study procedures were conducted, including duodenal biopsy collection, duodenal fluid aspiration, and questionnaires for symptoms and stress. The study also included use of Ussing chambers for biopsies, immunohistochemistry, and bile salt measurements.
FD-starters were significantly more symptomatic than healthy volunteers were at baseline. After starting PPIs, those with FD had symptom improvements, confirming “clinical efficacy of a standard course of PPIs in all FD subtypes,” whereas healthy volunteers showed no significant change in symptoms.
Similarly, baseline duodenal eosinophil counts were higher in FD-starters than in healthy volunteers. On starting PPIs, however, eosinophil counts in these two groups moved in opposite directions: FD-starters’ counts dropped from a mean of 331 to 183 eosinophils/mm2, whereas healthy volunteers’ counts rose from a mean of 115 to 229 eosinophils/mm2 (P < .0001). Changes in mast cells and paracellular passage followed the same pattern, falling in FD-starters and rising in healthy volunteers. On the other hand, symptoms actually improved in the FD-stoppers after they went off PPIs, although they did not reach symptom levels of the healthy volunteers.
“Differential effects of PPIs in healthy volunteers point to the role of luminal changes in determining low-grade mucosal immune activation in the duodenum, which can also occur in FD after long-term use and provide arguments against continued use in refractory patients,” the investigators wrote.
Dr. Wauters and colleagues suggested that their findings could guide future approaches to FD management.
“Our results suggest that quantification of duodenal eosinophils has the potential to become part of diagnostic workup and guide therapeutic decisions in FD,” they wrote. “Additional study of the underlying mediators might lead to the discovery of new potential biomarkers or novel therapeutic targets, potentially allowing the identification of subgroups responding to biologically targeted rather than symptom-based treatments.”
The study was supported by the clinical research fund of the University Hospitals Leuven. The investigators reported no conflicts of interest.
FROM GASTROENTEROLOGY
AGA Clinical Practice Update: Eradication strategies for H. pylori infection
Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.
“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.
H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”
A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.
Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).
Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.
Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.
Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.
“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.
H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”
A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.
Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).
Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.
Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.
Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.
“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.
H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”
A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.
Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).
Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.
Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.
FROM GASTROENTEROLOGY