User login
Solid therapeutic hierarchy for eosinophilic esophagitis still unclear
, shows a meta-analysis published in Gut.
Among agents available outside of clinical trials, the corticosteroid budesonide had the broadest evidence base for efficacy, while EoE-specific topical steroids typically outperformed adapted asthma formulations, wrote authors who were led by Edoardo Savarino, MD, PhD, of the department of surgery, oncology and gastroenterology at the University of Padua, Italy.
The AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters published clinical practice guidelines for eosinophilic esophagitis in 2020. The group issued 12 recommendations with only 1, the topical use of glucocorticosteroids over no treatment, being a “strong recommendation.” Both the AGA/JTF guidelines and guidelines issued May 23, 2022 , by the British Society of Gastroenterology and British Society of Pediatric Gastroenterology, Hepatology and Nutrition, recommend the use of proton pump inhibitors (PPIs) and topical glucocorticosteroids in certain cases. Neither set of guidelines addresses the use of dupilumab, which was approved in the United States on May 20, 2022, for adults and pediatric patients 12 years and older, and in January of this year by the European Commission for the same condition.
The current study is a meta-analysis that compared data from 1,813 subjects with active EoE who participated in 15 randomized controlled trials. All drugs tested in EoE were included, each compared against one another and placebo. Efficacy was characterized by induction of histological remission, symptomatic response, and endoscopic response. Topical steroids formulated for EoE were evaluated separately from off-label topical steroids for asthma.
This approach yielded a litany of efficacy findings.
Of note, budesonide orally disintegrating tablets ranked first for histological remission defined by no more than 15 eosinophils/high-powered field (HPF), while lirentelimab was best at achieving the lesser used histological remission threshold of 6 eosinophils/HPF. On the same topic of inducing histological remission, EoE-specific steroid formulations, along with dupilumab, showed greater efficacy than off-label topical steroids.
The investigators also highlighted that budesonide suspension and tablets were significantly better than placebo in terms of failure to achieve symptom improvement and failure to achieve endoscopic improvement according to EoE Endoscopic Reference Score.
Collectively, the analysis showed that most available drugs are significantly more effective than placebo for treating EoE, yet differences in study designs and population characteristics stand in the way of a clear road map to treatment selection.
“In summary, this network meta-analysis supports the efficacy of most available drugs over placebo for the treatment of EoE. All EoE-specific steroid formulations and dupilumab ranked higher than off-label topical steroids for the induction of histological remission in active EoE, and most EoE-specific steroid formulations and dupilumab ranked higher than esomeprazole, despite having comparable safety,” the authors wrote. “These results prompt further research to better understand the mechanisms underlying symptom generation in EoE, to target their cause and achieve better outcomes.”
Joy Weiling Chang, MD, a gastroenterologist and assistant professor of medicine at the University of Michigan Medicine, Ann Arbor, offered a similar perspective.
“This study tells us that we still need more data to establish this clear hierarchy of medication treatments,” she said in an interview.
Still, Dr. Chang added, these findings are applicable to clinical practice. Because most EoE drugs demonstrate significant efficacy over placebo, and the best starting option remains unclear, then shared decision-making should focus on patient preferences, she said in an interview.
“As clinicians, we need to be working with our patients to consider which strategies work best for their lifestyles,” Dr. Chang said.
The investigators disclosed relationships with AbbVie, Biogen, Sanofi, and others. Dr. Chang reported consulting fees for Sanofi-Regeneron, the maker of Dupixent.
, shows a meta-analysis published in Gut.
Among agents available outside of clinical trials, the corticosteroid budesonide had the broadest evidence base for efficacy, while EoE-specific topical steroids typically outperformed adapted asthma formulations, wrote authors who were led by Edoardo Savarino, MD, PhD, of the department of surgery, oncology and gastroenterology at the University of Padua, Italy.
The AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters published clinical practice guidelines for eosinophilic esophagitis in 2020. The group issued 12 recommendations with only 1, the topical use of glucocorticosteroids over no treatment, being a “strong recommendation.” Both the AGA/JTF guidelines and guidelines issued May 23, 2022 , by the British Society of Gastroenterology and British Society of Pediatric Gastroenterology, Hepatology and Nutrition, recommend the use of proton pump inhibitors (PPIs) and topical glucocorticosteroids in certain cases. Neither set of guidelines addresses the use of dupilumab, which was approved in the United States on May 20, 2022, for adults and pediatric patients 12 years and older, and in January of this year by the European Commission for the same condition.
The current study is a meta-analysis that compared data from 1,813 subjects with active EoE who participated in 15 randomized controlled trials. All drugs tested in EoE were included, each compared against one another and placebo. Efficacy was characterized by induction of histological remission, symptomatic response, and endoscopic response. Topical steroids formulated for EoE were evaluated separately from off-label topical steroids for asthma.
This approach yielded a litany of efficacy findings.
Of note, budesonide orally disintegrating tablets ranked first for histological remission defined by no more than 15 eosinophils/high-powered field (HPF), while lirentelimab was best at achieving the lesser used histological remission threshold of 6 eosinophils/HPF. On the same topic of inducing histological remission, EoE-specific steroid formulations, along with dupilumab, showed greater efficacy than off-label topical steroids.
The investigators also highlighted that budesonide suspension and tablets were significantly better than placebo in terms of failure to achieve symptom improvement and failure to achieve endoscopic improvement according to EoE Endoscopic Reference Score.
Collectively, the analysis showed that most available drugs are significantly more effective than placebo for treating EoE, yet differences in study designs and population characteristics stand in the way of a clear road map to treatment selection.
“In summary, this network meta-analysis supports the efficacy of most available drugs over placebo for the treatment of EoE. All EoE-specific steroid formulations and dupilumab ranked higher than off-label topical steroids for the induction of histological remission in active EoE, and most EoE-specific steroid formulations and dupilumab ranked higher than esomeprazole, despite having comparable safety,” the authors wrote. “These results prompt further research to better understand the mechanisms underlying symptom generation in EoE, to target their cause and achieve better outcomes.”
Joy Weiling Chang, MD, a gastroenterologist and assistant professor of medicine at the University of Michigan Medicine, Ann Arbor, offered a similar perspective.
“This study tells us that we still need more data to establish this clear hierarchy of medication treatments,” she said in an interview.
Still, Dr. Chang added, these findings are applicable to clinical practice. Because most EoE drugs demonstrate significant efficacy over placebo, and the best starting option remains unclear, then shared decision-making should focus on patient preferences, she said in an interview.
“As clinicians, we need to be working with our patients to consider which strategies work best for their lifestyles,” Dr. Chang said.
The investigators disclosed relationships with AbbVie, Biogen, Sanofi, and others. Dr. Chang reported consulting fees for Sanofi-Regeneron, the maker of Dupixent.
, shows a meta-analysis published in Gut.
Among agents available outside of clinical trials, the corticosteroid budesonide had the broadest evidence base for efficacy, while EoE-specific topical steroids typically outperformed adapted asthma formulations, wrote authors who were led by Edoardo Savarino, MD, PhD, of the department of surgery, oncology and gastroenterology at the University of Padua, Italy.
The AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters published clinical practice guidelines for eosinophilic esophagitis in 2020. The group issued 12 recommendations with only 1, the topical use of glucocorticosteroids over no treatment, being a “strong recommendation.” Both the AGA/JTF guidelines and guidelines issued May 23, 2022 , by the British Society of Gastroenterology and British Society of Pediatric Gastroenterology, Hepatology and Nutrition, recommend the use of proton pump inhibitors (PPIs) and topical glucocorticosteroids in certain cases. Neither set of guidelines addresses the use of dupilumab, which was approved in the United States on May 20, 2022, for adults and pediatric patients 12 years and older, and in January of this year by the European Commission for the same condition.
The current study is a meta-analysis that compared data from 1,813 subjects with active EoE who participated in 15 randomized controlled trials. All drugs tested in EoE were included, each compared against one another and placebo. Efficacy was characterized by induction of histological remission, symptomatic response, and endoscopic response. Topical steroids formulated for EoE were evaluated separately from off-label topical steroids for asthma.
This approach yielded a litany of efficacy findings.
Of note, budesonide orally disintegrating tablets ranked first for histological remission defined by no more than 15 eosinophils/high-powered field (HPF), while lirentelimab was best at achieving the lesser used histological remission threshold of 6 eosinophils/HPF. On the same topic of inducing histological remission, EoE-specific steroid formulations, along with dupilumab, showed greater efficacy than off-label topical steroids.
The investigators also highlighted that budesonide suspension and tablets were significantly better than placebo in terms of failure to achieve symptom improvement and failure to achieve endoscopic improvement according to EoE Endoscopic Reference Score.
Collectively, the analysis showed that most available drugs are significantly more effective than placebo for treating EoE, yet differences in study designs and population characteristics stand in the way of a clear road map to treatment selection.
“In summary, this network meta-analysis supports the efficacy of most available drugs over placebo for the treatment of EoE. All EoE-specific steroid formulations and dupilumab ranked higher than off-label topical steroids for the induction of histological remission in active EoE, and most EoE-specific steroid formulations and dupilumab ranked higher than esomeprazole, despite having comparable safety,” the authors wrote. “These results prompt further research to better understand the mechanisms underlying symptom generation in EoE, to target their cause and achieve better outcomes.”
Joy Weiling Chang, MD, a gastroenterologist and assistant professor of medicine at the University of Michigan Medicine, Ann Arbor, offered a similar perspective.
“This study tells us that we still need more data to establish this clear hierarchy of medication treatments,” she said in an interview.
Still, Dr. Chang added, these findings are applicable to clinical practice. Because most EoE drugs demonstrate significant efficacy over placebo, and the best starting option remains unclear, then shared decision-making should focus on patient preferences, she said in an interview.
“As clinicians, we need to be working with our patients to consider which strategies work best for their lifestyles,” Dr. Chang said.
The investigators disclosed relationships with AbbVie, Biogen, Sanofi, and others. Dr. Chang reported consulting fees for Sanofi-Regeneron, the maker of Dupixent.
FROM GUT
AGA CPU stresses brain-gut aspects of bloating, distention and belching
A new Clinical Practice Update from the AGA on belching, abdominal bloating, and distention offers practical management strategies for a class of disorders that, while highly prevalent, can be confusing to clinicians because of their nonspecific and overlapping symptomatology and wide range of possible causes.
The expert review, published online in Gastroenterology, is dedicated to these specific disorders, which, when not caused by bacteria, food intolerance, or autoimmune disease, are increasingly viewed as stemming from dysregulation of the brain-gut axis, and therefore responsive to interventions such as biofeedback therapy and central nervous system modulators, including antidepressants referred to as neuromodulators due to their pain modulating effects in the gut.
Baharak Moshiree, MD, of Atrium Health, Wake Forest Medical University, Charlotte, N.C., the lead author, said the guidance is aimed at GI specialists as much as primary care physicians and other providers who treat patients with these disorders.
Clinicians may not always know which diagnostic studies to order for a patient with bloating, distention, or belching, Dr. Moshiree said, and since large randomized controlled trials in these patient groups are not available, making evidence-based treatment recommendations is challenging. Because the disorders are ubiquitous, “there’s a lot of social media attention around them, and these include fad diets and drugs labeled as medical foods, like probiotics, that patients will often try.”
The guidance includes 15 best practice advice statements along with two diagnostic and treatment algorithms, one for belching and the other for bloating and distention.
For belching, the authors stress discerning between gastric and supragastric belching using clinical history and examination, and if needed, impedance Ph monitoring. For supragastric belching, or esophageal belching, treatment considerations may include cognitive behavioral therapy, biofeedback training, and neuromodulator (antidepressant) drugs either alone or combined with psychological therapies.
Abdominal bloating and distention should be diagnosed using the Rome IV criteria, and in patients with suspected carbohydrate enzyme deficiencies, dietary restriction of potentially problematic carbohydrates or breath testing may be used to rule out intolerance. In a subset of at-risk patients, “small bowel aspiration and glucose- or lactulose-based hydrogen breath testing may be used to evaluate for small intestinal bacterial overgrowth,” the guidance says. Blood testing may be used to rule out celiac disease, and, if positive, a definitive diagnosis should be confirmed with small bowel tissue biopsy obtained during an upper endoscopy, Dr. Moshiree and her colleagues wrote.
Endoscopy and imaging should be restricted to patients with alarm features such as vomiting or weight loss, rapid worsening of symptoms, or an abnormal physical exam. Tests such as gastric emptying transit studies should not be routinely ordered unless nausea and vomiting are present. Similarly, whole-gut motility studies should be ordered only if there are symptoms suggestive of motility disorders, with testing carried out at specialized centers.
When constipation occurs with bloating, clinicians should use anorectal physiology testing to rule out a pelvic-floor disorder, which, if present, can be treated with pelvic floor biofeedback training. Constipation in the context of bloating may also be treated with laxatives. Probiotics are not advised as treatment for bloating and distention in this guidance, given a lack of robust studies. However, neuromodulators may help reduce visceral or gut hypersensitivity and improve psychological comorbidities if these are present, the authors wrote.
Conditions treated with dietary modifications should be overseen by dietitians, and diaphragmatic breathing and neuromodulators can be used to treat a condition called abdominophrenic dyssynergia, the guidance says.
“We tried to make it clinically useful,” Dr. Moshiree said of the practice update, which was not the result of systematic reviews or meta-analyses of multicenter randomized controlled trials. The update contains no ratings on its recommendations and does not grade the evidence used. Rather, the three coauthors looked to results from published randomized trials and observational studies, along with their own expert opinion.
For example, the guidance’s best practice advice on abdominophrenic dyssynergia came from single center studies in Italy where bloating improved with use of biofeedback therapy for this condition. Although this was a single center study, experts have found that biofeedback therapy is helpful for relaxing the pelvic floor muscles which can help bloating and distension symptoms.
Dr. Moshiree also pointed to a 2021 narrative review by Brian E. Lacy, MD. and David Cangemi, MD, of the Mayo Clinic in Jacksonville, Fla., that helped inform the framework for this clinical practice update.
Dr. Moshiree disclosed financial relationships with several pharmaceutical companies including Salix, AbbVie, Medtronic, and Takeda. Her two coauthors, Douglas Drossman, MD, of the Rome Foundation and the University of North Carolina, Chapel Hill, and Aasma Shaukat, MD, of New York University, also disclosed industry support.
A new Clinical Practice Update from the AGA on belching, abdominal bloating, and distention offers practical management strategies for a class of disorders that, while highly prevalent, can be confusing to clinicians because of their nonspecific and overlapping symptomatology and wide range of possible causes.
The expert review, published online in Gastroenterology, is dedicated to these specific disorders, which, when not caused by bacteria, food intolerance, or autoimmune disease, are increasingly viewed as stemming from dysregulation of the brain-gut axis, and therefore responsive to interventions such as biofeedback therapy and central nervous system modulators, including antidepressants referred to as neuromodulators due to their pain modulating effects in the gut.
Baharak Moshiree, MD, of Atrium Health, Wake Forest Medical University, Charlotte, N.C., the lead author, said the guidance is aimed at GI specialists as much as primary care physicians and other providers who treat patients with these disorders.
Clinicians may not always know which diagnostic studies to order for a patient with bloating, distention, or belching, Dr. Moshiree said, and since large randomized controlled trials in these patient groups are not available, making evidence-based treatment recommendations is challenging. Because the disorders are ubiquitous, “there’s a lot of social media attention around them, and these include fad diets and drugs labeled as medical foods, like probiotics, that patients will often try.”
The guidance includes 15 best practice advice statements along with two diagnostic and treatment algorithms, one for belching and the other for bloating and distention.
For belching, the authors stress discerning between gastric and supragastric belching using clinical history and examination, and if needed, impedance Ph monitoring. For supragastric belching, or esophageal belching, treatment considerations may include cognitive behavioral therapy, biofeedback training, and neuromodulator (antidepressant) drugs either alone or combined with psychological therapies.
Abdominal bloating and distention should be diagnosed using the Rome IV criteria, and in patients with suspected carbohydrate enzyme deficiencies, dietary restriction of potentially problematic carbohydrates or breath testing may be used to rule out intolerance. In a subset of at-risk patients, “small bowel aspiration and glucose- or lactulose-based hydrogen breath testing may be used to evaluate for small intestinal bacterial overgrowth,” the guidance says. Blood testing may be used to rule out celiac disease, and, if positive, a definitive diagnosis should be confirmed with small bowel tissue biopsy obtained during an upper endoscopy, Dr. Moshiree and her colleagues wrote.
Endoscopy and imaging should be restricted to patients with alarm features such as vomiting or weight loss, rapid worsening of symptoms, or an abnormal physical exam. Tests such as gastric emptying transit studies should not be routinely ordered unless nausea and vomiting are present. Similarly, whole-gut motility studies should be ordered only if there are symptoms suggestive of motility disorders, with testing carried out at specialized centers.
When constipation occurs with bloating, clinicians should use anorectal physiology testing to rule out a pelvic-floor disorder, which, if present, can be treated with pelvic floor biofeedback training. Constipation in the context of bloating may also be treated with laxatives. Probiotics are not advised as treatment for bloating and distention in this guidance, given a lack of robust studies. However, neuromodulators may help reduce visceral or gut hypersensitivity and improve psychological comorbidities if these are present, the authors wrote.
Conditions treated with dietary modifications should be overseen by dietitians, and diaphragmatic breathing and neuromodulators can be used to treat a condition called abdominophrenic dyssynergia, the guidance says.
“We tried to make it clinically useful,” Dr. Moshiree said of the practice update, which was not the result of systematic reviews or meta-analyses of multicenter randomized controlled trials. The update contains no ratings on its recommendations and does not grade the evidence used. Rather, the three coauthors looked to results from published randomized trials and observational studies, along with their own expert opinion.
For example, the guidance’s best practice advice on abdominophrenic dyssynergia came from single center studies in Italy where bloating improved with use of biofeedback therapy for this condition. Although this was a single center study, experts have found that biofeedback therapy is helpful for relaxing the pelvic floor muscles which can help bloating and distension symptoms.
Dr. Moshiree also pointed to a 2021 narrative review by Brian E. Lacy, MD. and David Cangemi, MD, of the Mayo Clinic in Jacksonville, Fla., that helped inform the framework for this clinical practice update.
Dr. Moshiree disclosed financial relationships with several pharmaceutical companies including Salix, AbbVie, Medtronic, and Takeda. Her two coauthors, Douglas Drossman, MD, of the Rome Foundation and the University of North Carolina, Chapel Hill, and Aasma Shaukat, MD, of New York University, also disclosed industry support.
A new Clinical Practice Update from the AGA on belching, abdominal bloating, and distention offers practical management strategies for a class of disorders that, while highly prevalent, can be confusing to clinicians because of their nonspecific and overlapping symptomatology and wide range of possible causes.
The expert review, published online in Gastroenterology, is dedicated to these specific disorders, which, when not caused by bacteria, food intolerance, or autoimmune disease, are increasingly viewed as stemming from dysregulation of the brain-gut axis, and therefore responsive to interventions such as biofeedback therapy and central nervous system modulators, including antidepressants referred to as neuromodulators due to their pain modulating effects in the gut.
Baharak Moshiree, MD, of Atrium Health, Wake Forest Medical University, Charlotte, N.C., the lead author, said the guidance is aimed at GI specialists as much as primary care physicians and other providers who treat patients with these disorders.
Clinicians may not always know which diagnostic studies to order for a patient with bloating, distention, or belching, Dr. Moshiree said, and since large randomized controlled trials in these patient groups are not available, making evidence-based treatment recommendations is challenging. Because the disorders are ubiquitous, “there’s a lot of social media attention around them, and these include fad diets and drugs labeled as medical foods, like probiotics, that patients will often try.”
The guidance includes 15 best practice advice statements along with two diagnostic and treatment algorithms, one for belching and the other for bloating and distention.
For belching, the authors stress discerning between gastric and supragastric belching using clinical history and examination, and if needed, impedance Ph monitoring. For supragastric belching, or esophageal belching, treatment considerations may include cognitive behavioral therapy, biofeedback training, and neuromodulator (antidepressant) drugs either alone or combined with psychological therapies.
Abdominal bloating and distention should be diagnosed using the Rome IV criteria, and in patients with suspected carbohydrate enzyme deficiencies, dietary restriction of potentially problematic carbohydrates or breath testing may be used to rule out intolerance. In a subset of at-risk patients, “small bowel aspiration and glucose- or lactulose-based hydrogen breath testing may be used to evaluate for small intestinal bacterial overgrowth,” the guidance says. Blood testing may be used to rule out celiac disease, and, if positive, a definitive diagnosis should be confirmed with small bowel tissue biopsy obtained during an upper endoscopy, Dr. Moshiree and her colleagues wrote.
Endoscopy and imaging should be restricted to patients with alarm features such as vomiting or weight loss, rapid worsening of symptoms, or an abnormal physical exam. Tests such as gastric emptying transit studies should not be routinely ordered unless nausea and vomiting are present. Similarly, whole-gut motility studies should be ordered only if there are symptoms suggestive of motility disorders, with testing carried out at specialized centers.
When constipation occurs with bloating, clinicians should use anorectal physiology testing to rule out a pelvic-floor disorder, which, if present, can be treated with pelvic floor biofeedback training. Constipation in the context of bloating may also be treated with laxatives. Probiotics are not advised as treatment for bloating and distention in this guidance, given a lack of robust studies. However, neuromodulators may help reduce visceral or gut hypersensitivity and improve psychological comorbidities if these are present, the authors wrote.
Conditions treated with dietary modifications should be overseen by dietitians, and diaphragmatic breathing and neuromodulators can be used to treat a condition called abdominophrenic dyssynergia, the guidance says.
“We tried to make it clinically useful,” Dr. Moshiree said of the practice update, which was not the result of systematic reviews or meta-analyses of multicenter randomized controlled trials. The update contains no ratings on its recommendations and does not grade the evidence used. Rather, the three coauthors looked to results from published randomized trials and observational studies, along with their own expert opinion.
For example, the guidance’s best practice advice on abdominophrenic dyssynergia came from single center studies in Italy where bloating improved with use of biofeedback therapy for this condition. Although this was a single center study, experts have found that biofeedback therapy is helpful for relaxing the pelvic floor muscles which can help bloating and distension symptoms.
Dr. Moshiree also pointed to a 2021 narrative review by Brian E. Lacy, MD. and David Cangemi, MD, of the Mayo Clinic in Jacksonville, Fla., that helped inform the framework for this clinical practice update.
Dr. Moshiree disclosed financial relationships with several pharmaceutical companies including Salix, AbbVie, Medtronic, and Takeda. Her two coauthors, Douglas Drossman, MD, of the Rome Foundation and the University of North Carolina, Chapel Hill, and Aasma Shaukat, MD, of New York University, also disclosed industry support.
FROM GASTROENTEROLOGY
Frequency and duration of GERD symptoms associated with poor sleep
of the Nurses’ Health Study II published in JAMA Network Open.
The findings suggest that treating gastroesophageal reflux may do more than offer symptomatic relief, but it could improve the chances of a good night’s rest by addressing comorbidities associated with poor sleep quality, wrote authors who were led by Andrew T. Chan, MD, MPH, of the Clinical and Translational Epidemiology Unit at Massachusetts General Hospital, Boston.
“Approximately 20% of the U.S. population experiences gastroesophageal reflux (GER) symptoms at least once a week, and the worldwide prevalence of GER disease (GERD) has been increasing. Beyond its association with quality of life, GERD is also associated with long-term complications, including Barrett esophagus and esophageal adenocarcinoma,” the authors wrote. “In this prospective cohort study, we found that GER symptoms were associated with an increase in subsequent risk of poor sleep quality. Although risk was somewhat attenuated among women who regularly used PPIs [proton pump inhibitors] and/or H2RAs [histamine2-receptor antagonists], the risk of poor sleep quality remained significantly higher among those who experienced GER symptoms at least once a week.”
A growing body of evidence suggests that GERD may be one of those lesser known risk factors of poor sleep quality (trouble falling asleep, sleep disturbance, daytime sleepiness, or restlessness of sleep). But data on the subject are scarce, compelling researchers to conduct the present investigation.
The analysis drew data from the Nurses’ Health Study II, an ongoing prospective study involving 116,429 female participants. Among the 48,536 women included in this analysis, 7,929 (16.3%) developed poor sleep quality during a 4-year follow-up period.
The multivariable relative risk for poor sleep quality among women who experienced GER symptoms more than once a week was 1.53 (95% confidence interval, 1.45-1.62). For those who experienced GER symptoms more than twice a week, the RR was 1.49 (95% CI, 1.39-1.58) for difficulty in falling asleep, 1.47 (95% CI, 1.39-1.56) for excessive daytime sleepiness, and 1.44 (95% CI, 1.36-1.53) for restlessness of sleep.
GER was more common in women who had higher body mass index, were less physically active, and had asthma and depression. Among women who experienced GER more than once a week, 48.2% regularly used PPIs and/or H2RAs which are commonly prescribed for GERD. However, researchers found that frequent GER symptoms were significantly associated with higher risk of poor sleep quality regardless of whether patients used PPIs and/or H2RAs. But poor sleep quality, in this case, was more common among those who did not use PPIs or H2RAs.
In an interview, Bradley M. Morganstern, MD, medical director of the Inflammatory Bowel Disease Center at NYU Long Island, Mineola, N.Y., brought up the potential for confounding variables. For example, obesity could confound the analysis, he said, as people who are overweight have increased risk of reflux, but also sleep apnea, a strong risk factor for poor sleep.
Despite this possible limitation, Dr. Morganstern said the results are important because they point to a possible practice gap. Physicians typically screen for the classic symptoms of reflux like discomfort and burning, but not sleep quality.
“It’s not something we usually ask about unless the patient volunteers that they’re actually having reflux symptoms at nighttime,” Dr. Morganstern said. This possible link between reflux and poor sleep quality should be on the radar for both gastroenterologists and primary care providers, he added.
“I think different specialties could be asking about it for different reasons,” Dr. Morganstern said, suggesting that it may be worth discussing during diagnosis of reflux or detection of poor sleep quality, and when monitoring symptoms and responses to therapy.
Dr. Chan reported receiving grants from Pfizer, Zoe, and Freenome and receiving personal fees from Pfizer and Boehringer Ingelheim outside the submitted work. Other authors disclosed receiving fees and grants from a number of companies, but outside of the scope of this work.
of the Nurses’ Health Study II published in JAMA Network Open.
The findings suggest that treating gastroesophageal reflux may do more than offer symptomatic relief, but it could improve the chances of a good night’s rest by addressing comorbidities associated with poor sleep quality, wrote authors who were led by Andrew T. Chan, MD, MPH, of the Clinical and Translational Epidemiology Unit at Massachusetts General Hospital, Boston.
“Approximately 20% of the U.S. population experiences gastroesophageal reflux (GER) symptoms at least once a week, and the worldwide prevalence of GER disease (GERD) has been increasing. Beyond its association with quality of life, GERD is also associated with long-term complications, including Barrett esophagus and esophageal adenocarcinoma,” the authors wrote. “In this prospective cohort study, we found that GER symptoms were associated with an increase in subsequent risk of poor sleep quality. Although risk was somewhat attenuated among women who regularly used PPIs [proton pump inhibitors] and/or H2RAs [histamine2-receptor antagonists], the risk of poor sleep quality remained significantly higher among those who experienced GER symptoms at least once a week.”
A growing body of evidence suggests that GERD may be one of those lesser known risk factors of poor sleep quality (trouble falling asleep, sleep disturbance, daytime sleepiness, or restlessness of sleep). But data on the subject are scarce, compelling researchers to conduct the present investigation.
The analysis drew data from the Nurses’ Health Study II, an ongoing prospective study involving 116,429 female participants. Among the 48,536 women included in this analysis, 7,929 (16.3%) developed poor sleep quality during a 4-year follow-up period.
The multivariable relative risk for poor sleep quality among women who experienced GER symptoms more than once a week was 1.53 (95% confidence interval, 1.45-1.62). For those who experienced GER symptoms more than twice a week, the RR was 1.49 (95% CI, 1.39-1.58) for difficulty in falling asleep, 1.47 (95% CI, 1.39-1.56) for excessive daytime sleepiness, and 1.44 (95% CI, 1.36-1.53) for restlessness of sleep.
GER was more common in women who had higher body mass index, were less physically active, and had asthma and depression. Among women who experienced GER more than once a week, 48.2% regularly used PPIs and/or H2RAs which are commonly prescribed for GERD. However, researchers found that frequent GER symptoms were significantly associated with higher risk of poor sleep quality regardless of whether patients used PPIs and/or H2RAs. But poor sleep quality, in this case, was more common among those who did not use PPIs or H2RAs.
In an interview, Bradley M. Morganstern, MD, medical director of the Inflammatory Bowel Disease Center at NYU Long Island, Mineola, N.Y., brought up the potential for confounding variables. For example, obesity could confound the analysis, he said, as people who are overweight have increased risk of reflux, but also sleep apnea, a strong risk factor for poor sleep.
Despite this possible limitation, Dr. Morganstern said the results are important because they point to a possible practice gap. Physicians typically screen for the classic symptoms of reflux like discomfort and burning, but not sleep quality.
“It’s not something we usually ask about unless the patient volunteers that they’re actually having reflux symptoms at nighttime,” Dr. Morganstern said. This possible link between reflux and poor sleep quality should be on the radar for both gastroenterologists and primary care providers, he added.
“I think different specialties could be asking about it for different reasons,” Dr. Morganstern said, suggesting that it may be worth discussing during diagnosis of reflux or detection of poor sleep quality, and when monitoring symptoms and responses to therapy.
Dr. Chan reported receiving grants from Pfizer, Zoe, and Freenome and receiving personal fees from Pfizer and Boehringer Ingelheim outside the submitted work. Other authors disclosed receiving fees and grants from a number of companies, but outside of the scope of this work.
of the Nurses’ Health Study II published in JAMA Network Open.
The findings suggest that treating gastroesophageal reflux may do more than offer symptomatic relief, but it could improve the chances of a good night’s rest by addressing comorbidities associated with poor sleep quality, wrote authors who were led by Andrew T. Chan, MD, MPH, of the Clinical and Translational Epidemiology Unit at Massachusetts General Hospital, Boston.
“Approximately 20% of the U.S. population experiences gastroesophageal reflux (GER) symptoms at least once a week, and the worldwide prevalence of GER disease (GERD) has been increasing. Beyond its association with quality of life, GERD is also associated with long-term complications, including Barrett esophagus and esophageal adenocarcinoma,” the authors wrote. “In this prospective cohort study, we found that GER symptoms were associated with an increase in subsequent risk of poor sleep quality. Although risk was somewhat attenuated among women who regularly used PPIs [proton pump inhibitors] and/or H2RAs [histamine2-receptor antagonists], the risk of poor sleep quality remained significantly higher among those who experienced GER symptoms at least once a week.”
A growing body of evidence suggests that GERD may be one of those lesser known risk factors of poor sleep quality (trouble falling asleep, sleep disturbance, daytime sleepiness, or restlessness of sleep). But data on the subject are scarce, compelling researchers to conduct the present investigation.
The analysis drew data from the Nurses’ Health Study II, an ongoing prospective study involving 116,429 female participants. Among the 48,536 women included in this analysis, 7,929 (16.3%) developed poor sleep quality during a 4-year follow-up period.
The multivariable relative risk for poor sleep quality among women who experienced GER symptoms more than once a week was 1.53 (95% confidence interval, 1.45-1.62). For those who experienced GER symptoms more than twice a week, the RR was 1.49 (95% CI, 1.39-1.58) for difficulty in falling asleep, 1.47 (95% CI, 1.39-1.56) for excessive daytime sleepiness, and 1.44 (95% CI, 1.36-1.53) for restlessness of sleep.
GER was more common in women who had higher body mass index, were less physically active, and had asthma and depression. Among women who experienced GER more than once a week, 48.2% regularly used PPIs and/or H2RAs which are commonly prescribed for GERD. However, researchers found that frequent GER symptoms were significantly associated with higher risk of poor sleep quality regardless of whether patients used PPIs and/or H2RAs. But poor sleep quality, in this case, was more common among those who did not use PPIs or H2RAs.
In an interview, Bradley M. Morganstern, MD, medical director of the Inflammatory Bowel Disease Center at NYU Long Island, Mineola, N.Y., brought up the potential for confounding variables. For example, obesity could confound the analysis, he said, as people who are overweight have increased risk of reflux, but also sleep apnea, a strong risk factor for poor sleep.
Despite this possible limitation, Dr. Morganstern said the results are important because they point to a possible practice gap. Physicians typically screen for the classic symptoms of reflux like discomfort and burning, but not sleep quality.
“It’s not something we usually ask about unless the patient volunteers that they’re actually having reflux symptoms at nighttime,” Dr. Morganstern said. This possible link between reflux and poor sleep quality should be on the radar for both gastroenterologists and primary care providers, he added.
“I think different specialties could be asking about it for different reasons,” Dr. Morganstern said, suggesting that it may be worth discussing during diagnosis of reflux or detection of poor sleep quality, and when monitoring symptoms and responses to therapy.
Dr. Chan reported receiving grants from Pfizer, Zoe, and Freenome and receiving personal fees from Pfizer and Boehringer Ingelheim outside the submitted work. Other authors disclosed receiving fees and grants from a number of companies, but outside of the scope of this work.
FROM JAMA NETWORK OPEN
First guidelines developed for childhood eosinophilic GI disorders beyond eosinophilic esophagitis
The limited scope and depth of existing literature on childhood eosinophilic gastrointestinal disorders (EGIDs) beyond eosinophilic esophagitis (EoE) spurred an international group of researchers and clinicians to develop the first clinical practice guidelines for diagnosing and treating these rare conditions.
They were developed jointly by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.
Non-EoE EGIDs are rare chronic inflammatory disorders of the gastrointestinal tract, estimated at less than 200,000 cases annually in the United States, with unknown long-term consequences, Glenn Furuta, MD, professor of pediatrics at the University of Colorado at Denver and section head of gastroenterology at Children’s Hospital Colorado, both in Aurora, said in an interview
“There are many unmet needs. Research has been limited and has not progressed at the pace we want it to,” added Dr. Furuta, who is corresponding author of the guidelines.
The guidelines were published online in the Journal of Pediatric Gastroenterology & Nutrition, by lead author Alexandra Papadopoulou, MD, division of gastroenterology and hepatology, first department of pediatrics, University of Athens, and Children’s Hospital Agia Sofia, also in Athens, and colleagues.
With these, we provide guidance for clinicians to better understand the conditions and also how to diagnose and initiate care for patients with these rare diseases, said Dr. Furuta.
Difficult-to-diagnose conditions
Guideline development involved a working group of 26 pediatric gastroenterologists, adult gastroenterologists, allergists/immunologists, and pathologists from 16 countries across five continents. The consensus document includes 34 statements based on available evidence and 41 recommendations based on expert opinion and best clinical practices. In cases where the supporting evidence was weak but agreement was strong, the authors issued conditional recommendations.
The guidelines subdivide the non-EoE EGIDs according to inflammation location: eosinophilic gastritis, eosinophilic duodenitis (EoD), eosinophilic colitis, and eosinophilic enteritis. The latter can be further subdivided into EoD, eosinophilic jejunitis, and eosinophilic ileitis.
Non-EoE EGIDs are hard to diagnose because symptoms are relatively nonspecific and may include abdominal pain, vomiting, diarrhea, and bloody stools, all of which could have any number of underlying causes, Dr. Furuta said.
If you are treating a patient who is not getting better with such symptoms as persisting infections, acid-related problems, significant bleeding leading to anemia, intestinal perforation or obstruction, or low serum protein leading to swelling, then you should think that something else is going on that requires more of an evaluation, Dr. Furuta noted.
Patients with personal or family histories of eosinophilic or allergic disease should raise greater suspicion, Dr. Furuta said. “The next step requires an endoscopy and biopsy.”
Awareness of non-EoE EGIDs has been higher among pediatric gastroenterologists than among those treating adult disease because pediatric gastroenterologists have always obtained biopsies of the intestinal tract, Dr. Furuta noted.
The guidelines recommend that diagnosis of non-EoE EGIDs in children and adolescents must include signs or symptoms of gastrointestinal dysfunction, dense eosinophilic infiltrates found in mucosal or full-thickness biopsies above organ-specific threshold values included in the document, and absence of other diseases associated with GI mucosal eosinophilic inflammation.
Individualized treatment
The authors noted that the strength of recommendations varies with the often-modest availability of randomized controlled trial data on treatment efficacy.
For example, they recommended that systemic steroids be considered to induce remission but only conditionally recommend topical steroids. They conditionally recommend consideration of empiric elimination diets and conditionally recommend against using food allergy testing to guide diet.
The choice of treatment should be individualized on the basis of the affected GI segment, severity of the disease, patient characteristics, and family resources and capabilities, the authors wrote.
“We’ve provided guidance on how to care for patients based on the consensus of experts who have the necessary experience and knowledge base,” Dr. Furuta said. “Our ability to say: ‘Here are the established treatments,’ is lacking, though. We need research studies to verify that our recommended approaches are indeed correct.”
The authors conditionally recommended that treatment goals include achieving symptom resolution, improving gross endoscopic and histologic abnormalities, promoting normal childhood growth and development, and preventing disease complications.
No pediatric study has determined the natural history of non-EoE EGIDs, and no study of maintenance therapy has been conducted, the authors noted.
For this reason, they conditionally recommended that the clinical decision to continue therapy should be discussed with patients and their parents/caregivers, and those discussions include the benefits and risk of long-term treatment, its cost, and its impact on health-related quality of life.
A starting point for patient management
In a comment, Vincent Mukkada, MD, professor of pediatrics at the University of Cincinnati and an attending physician in gastroenterology, hepatology, and nutrition at Cincinnati Children’s Hospital and Medical Center, observed that, though improved awareness among pediatric gastroenterologists may account for some of the increase in GI eosinophil disease, the incidence is also likely growing.
“We’re looking for them much more,” said Dr. Mukkada.
“But I also think they’re increasing, just like all other atopic diseases. We’re not sure why,” he added.
“The hope is that these guidelines will allow nonsubspecialized gastroenterologists and allergists feel comfortable to at least start on the journey of managing these patients. And, for pediatricians who learn that their patient has received a non-EoE EGID diagnosis, they can go to the summary figures in this one document and very quickly get an overview of the disease and its course,” Dr. Mukkada said.
Guideline development was funded by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology and Nutrition. The authors and Dr. Mukkada reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The limited scope and depth of existing literature on childhood eosinophilic gastrointestinal disorders (EGIDs) beyond eosinophilic esophagitis (EoE) spurred an international group of researchers and clinicians to develop the first clinical practice guidelines for diagnosing and treating these rare conditions.
They were developed jointly by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.
Non-EoE EGIDs are rare chronic inflammatory disorders of the gastrointestinal tract, estimated at less than 200,000 cases annually in the United States, with unknown long-term consequences, Glenn Furuta, MD, professor of pediatrics at the University of Colorado at Denver and section head of gastroenterology at Children’s Hospital Colorado, both in Aurora, said in an interview
“There are many unmet needs. Research has been limited and has not progressed at the pace we want it to,” added Dr. Furuta, who is corresponding author of the guidelines.
The guidelines were published online in the Journal of Pediatric Gastroenterology & Nutrition, by lead author Alexandra Papadopoulou, MD, division of gastroenterology and hepatology, first department of pediatrics, University of Athens, and Children’s Hospital Agia Sofia, also in Athens, and colleagues.
With these, we provide guidance for clinicians to better understand the conditions and also how to diagnose and initiate care for patients with these rare diseases, said Dr. Furuta.
Difficult-to-diagnose conditions
Guideline development involved a working group of 26 pediatric gastroenterologists, adult gastroenterologists, allergists/immunologists, and pathologists from 16 countries across five continents. The consensus document includes 34 statements based on available evidence and 41 recommendations based on expert opinion and best clinical practices. In cases where the supporting evidence was weak but agreement was strong, the authors issued conditional recommendations.
The guidelines subdivide the non-EoE EGIDs according to inflammation location: eosinophilic gastritis, eosinophilic duodenitis (EoD), eosinophilic colitis, and eosinophilic enteritis. The latter can be further subdivided into EoD, eosinophilic jejunitis, and eosinophilic ileitis.
Non-EoE EGIDs are hard to diagnose because symptoms are relatively nonspecific and may include abdominal pain, vomiting, diarrhea, and bloody stools, all of which could have any number of underlying causes, Dr. Furuta said.
If you are treating a patient who is not getting better with such symptoms as persisting infections, acid-related problems, significant bleeding leading to anemia, intestinal perforation or obstruction, or low serum protein leading to swelling, then you should think that something else is going on that requires more of an evaluation, Dr. Furuta noted.
Patients with personal or family histories of eosinophilic or allergic disease should raise greater suspicion, Dr. Furuta said. “The next step requires an endoscopy and biopsy.”
Awareness of non-EoE EGIDs has been higher among pediatric gastroenterologists than among those treating adult disease because pediatric gastroenterologists have always obtained biopsies of the intestinal tract, Dr. Furuta noted.
The guidelines recommend that diagnosis of non-EoE EGIDs in children and adolescents must include signs or symptoms of gastrointestinal dysfunction, dense eosinophilic infiltrates found in mucosal or full-thickness biopsies above organ-specific threshold values included in the document, and absence of other diseases associated with GI mucosal eosinophilic inflammation.
Individualized treatment
The authors noted that the strength of recommendations varies with the often-modest availability of randomized controlled trial data on treatment efficacy.
For example, they recommended that systemic steroids be considered to induce remission but only conditionally recommend topical steroids. They conditionally recommend consideration of empiric elimination diets and conditionally recommend against using food allergy testing to guide diet.
The choice of treatment should be individualized on the basis of the affected GI segment, severity of the disease, patient characteristics, and family resources and capabilities, the authors wrote.
“We’ve provided guidance on how to care for patients based on the consensus of experts who have the necessary experience and knowledge base,” Dr. Furuta said. “Our ability to say: ‘Here are the established treatments,’ is lacking, though. We need research studies to verify that our recommended approaches are indeed correct.”
The authors conditionally recommended that treatment goals include achieving symptom resolution, improving gross endoscopic and histologic abnormalities, promoting normal childhood growth and development, and preventing disease complications.
No pediatric study has determined the natural history of non-EoE EGIDs, and no study of maintenance therapy has been conducted, the authors noted.
For this reason, they conditionally recommended that the clinical decision to continue therapy should be discussed with patients and their parents/caregivers, and those discussions include the benefits and risk of long-term treatment, its cost, and its impact on health-related quality of life.
A starting point for patient management
In a comment, Vincent Mukkada, MD, professor of pediatrics at the University of Cincinnati and an attending physician in gastroenterology, hepatology, and nutrition at Cincinnati Children’s Hospital and Medical Center, observed that, though improved awareness among pediatric gastroenterologists may account for some of the increase in GI eosinophil disease, the incidence is also likely growing.
“We’re looking for them much more,” said Dr. Mukkada.
“But I also think they’re increasing, just like all other atopic diseases. We’re not sure why,” he added.
“The hope is that these guidelines will allow nonsubspecialized gastroenterologists and allergists feel comfortable to at least start on the journey of managing these patients. And, for pediatricians who learn that their patient has received a non-EoE EGID diagnosis, they can go to the summary figures in this one document and very quickly get an overview of the disease and its course,” Dr. Mukkada said.
Guideline development was funded by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology and Nutrition. The authors and Dr. Mukkada reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The limited scope and depth of existing literature on childhood eosinophilic gastrointestinal disorders (EGIDs) beyond eosinophilic esophagitis (EoE) spurred an international group of researchers and clinicians to develop the first clinical practice guidelines for diagnosing and treating these rare conditions.
They were developed jointly by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.
Non-EoE EGIDs are rare chronic inflammatory disorders of the gastrointestinal tract, estimated at less than 200,000 cases annually in the United States, with unknown long-term consequences, Glenn Furuta, MD, professor of pediatrics at the University of Colorado at Denver and section head of gastroenterology at Children’s Hospital Colorado, both in Aurora, said in an interview
“There are many unmet needs. Research has been limited and has not progressed at the pace we want it to,” added Dr. Furuta, who is corresponding author of the guidelines.
The guidelines were published online in the Journal of Pediatric Gastroenterology & Nutrition, by lead author Alexandra Papadopoulou, MD, division of gastroenterology and hepatology, first department of pediatrics, University of Athens, and Children’s Hospital Agia Sofia, also in Athens, and colleagues.
With these, we provide guidance for clinicians to better understand the conditions and also how to diagnose and initiate care for patients with these rare diseases, said Dr. Furuta.
Difficult-to-diagnose conditions
Guideline development involved a working group of 26 pediatric gastroenterologists, adult gastroenterologists, allergists/immunologists, and pathologists from 16 countries across five continents. The consensus document includes 34 statements based on available evidence and 41 recommendations based on expert opinion and best clinical practices. In cases where the supporting evidence was weak but agreement was strong, the authors issued conditional recommendations.
The guidelines subdivide the non-EoE EGIDs according to inflammation location: eosinophilic gastritis, eosinophilic duodenitis (EoD), eosinophilic colitis, and eosinophilic enteritis. The latter can be further subdivided into EoD, eosinophilic jejunitis, and eosinophilic ileitis.
Non-EoE EGIDs are hard to diagnose because symptoms are relatively nonspecific and may include abdominal pain, vomiting, diarrhea, and bloody stools, all of which could have any number of underlying causes, Dr. Furuta said.
If you are treating a patient who is not getting better with such symptoms as persisting infections, acid-related problems, significant bleeding leading to anemia, intestinal perforation or obstruction, or low serum protein leading to swelling, then you should think that something else is going on that requires more of an evaluation, Dr. Furuta noted.
Patients with personal or family histories of eosinophilic or allergic disease should raise greater suspicion, Dr. Furuta said. “The next step requires an endoscopy and biopsy.”
Awareness of non-EoE EGIDs has been higher among pediatric gastroenterologists than among those treating adult disease because pediatric gastroenterologists have always obtained biopsies of the intestinal tract, Dr. Furuta noted.
The guidelines recommend that diagnosis of non-EoE EGIDs in children and adolescents must include signs or symptoms of gastrointestinal dysfunction, dense eosinophilic infiltrates found in mucosal or full-thickness biopsies above organ-specific threshold values included in the document, and absence of other diseases associated with GI mucosal eosinophilic inflammation.
Individualized treatment
The authors noted that the strength of recommendations varies with the often-modest availability of randomized controlled trial data on treatment efficacy.
For example, they recommended that systemic steroids be considered to induce remission but only conditionally recommend topical steroids. They conditionally recommend consideration of empiric elimination diets and conditionally recommend against using food allergy testing to guide diet.
The choice of treatment should be individualized on the basis of the affected GI segment, severity of the disease, patient characteristics, and family resources and capabilities, the authors wrote.
“We’ve provided guidance on how to care for patients based on the consensus of experts who have the necessary experience and knowledge base,” Dr. Furuta said. “Our ability to say: ‘Here are the established treatments,’ is lacking, though. We need research studies to verify that our recommended approaches are indeed correct.”
The authors conditionally recommended that treatment goals include achieving symptom resolution, improving gross endoscopic and histologic abnormalities, promoting normal childhood growth and development, and preventing disease complications.
No pediatric study has determined the natural history of non-EoE EGIDs, and no study of maintenance therapy has been conducted, the authors noted.
For this reason, they conditionally recommended that the clinical decision to continue therapy should be discussed with patients and their parents/caregivers, and those discussions include the benefits and risk of long-term treatment, its cost, and its impact on health-related quality of life.
A starting point for patient management
In a comment, Vincent Mukkada, MD, professor of pediatrics at the University of Cincinnati and an attending physician in gastroenterology, hepatology, and nutrition at Cincinnati Children’s Hospital and Medical Center, observed that, though improved awareness among pediatric gastroenterologists may account for some of the increase in GI eosinophil disease, the incidence is also likely growing.
“We’re looking for them much more,” said Dr. Mukkada.
“But I also think they’re increasing, just like all other atopic diseases. We’re not sure why,” he added.
“The hope is that these guidelines will allow nonsubspecialized gastroenterologists and allergists feel comfortable to at least start on the journey of managing these patients. And, for pediatricians who learn that their patient has received a non-EoE EGID diagnosis, they can go to the summary figures in this one document and very quickly get an overview of the disease and its course,” Dr. Mukkada said.
Guideline development was funded by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology and Nutrition. The authors and Dr. Mukkada reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF PEDIATRIC GASTROENTEROLOGY & NUTRITION
Another study links PPIs and dementia: AGA expert weighs in
A new study published in Neurology found an association between long–term proton-pump inhibitors (PPI) use and dementia. This was an observational study and does not prove that acid reflux drugs cause dementia.
“In this study, the authors note that long-term PPI use, defined as more than 4.5 years of use, was associated with dementia. It is important to note, however, that this does not necessarily mean that PPIs cause dementia. With observational studies, there is an inherent risk of bias and confounding, as the authors report. Some of these confounders include Helicobacter pylori status, vitamin B12 deficiency, depression, and socioeconomic status,” said Fouad J. Moawad, MD, graduate of the AGA FORWARD Program and gastroenterologist at Scripps Health in San Diego. A 2017 study led by Andrew T. Chan, MD, MPH, of Mass General Brigham, Boston, examined the association between proton pump inhibitor use and cognitive function in women. The investigators found no “convincing association between PPI use and cognitive function. Our data do not support the suggestion that PPI use increases dementia risk.”
A new article in press in Gastroenterology by Raaj S. Mehta and colleagues also studied this issue and concluded that in adults 65 years of age or older, PPIs were not associated with dementia or decline in cognition over time. These data provide reassurance about the safety of long-term use of PPIs among older adults.
The headlines may be confusing for patients. Here are AGA’s three talking points for communicating with patients about PPIs:
Talk to your doctor, before making any changes to your medication.
You have been prescribed PPIs for a reason, to treat a diagnosed medical condition. We can discuss the reason for your prescription, the dose and the timeframe for treatment.
Consider lifestyle modifications.
These may reduce or eliminate the need for PPIs for long-term use. These may include weight loss, avoiding tobacco or a change in your eating patterns. We can work together to determine the changes that are right for you.
Keep in touch.
Research continues to be done on PPI use. Current research recommends that patients who have a diagnosed condition that is helped by PPIs should stay on them, as benefits can outweigh risks.
A new study published in Neurology found an association between long–term proton-pump inhibitors (PPI) use and dementia. This was an observational study and does not prove that acid reflux drugs cause dementia.
“In this study, the authors note that long-term PPI use, defined as more than 4.5 years of use, was associated with dementia. It is important to note, however, that this does not necessarily mean that PPIs cause dementia. With observational studies, there is an inherent risk of bias and confounding, as the authors report. Some of these confounders include Helicobacter pylori status, vitamin B12 deficiency, depression, and socioeconomic status,” said Fouad J. Moawad, MD, graduate of the AGA FORWARD Program and gastroenterologist at Scripps Health in San Diego. A 2017 study led by Andrew T. Chan, MD, MPH, of Mass General Brigham, Boston, examined the association between proton pump inhibitor use and cognitive function in women. The investigators found no “convincing association between PPI use and cognitive function. Our data do not support the suggestion that PPI use increases dementia risk.”
A new article in press in Gastroenterology by Raaj S. Mehta and colleagues also studied this issue and concluded that in adults 65 years of age or older, PPIs were not associated with dementia or decline in cognition over time. These data provide reassurance about the safety of long-term use of PPIs among older adults.
The headlines may be confusing for patients. Here are AGA’s three talking points for communicating with patients about PPIs:
Talk to your doctor, before making any changes to your medication.
You have been prescribed PPIs for a reason, to treat a diagnosed medical condition. We can discuss the reason for your prescription, the dose and the timeframe for treatment.
Consider lifestyle modifications.
These may reduce or eliminate the need for PPIs for long-term use. These may include weight loss, avoiding tobacco or a change in your eating patterns. We can work together to determine the changes that are right for you.
Keep in touch.
Research continues to be done on PPI use. Current research recommends that patients who have a diagnosed condition that is helped by PPIs should stay on them, as benefits can outweigh risks.
A new study published in Neurology found an association between long–term proton-pump inhibitors (PPI) use and dementia. This was an observational study and does not prove that acid reflux drugs cause dementia.
“In this study, the authors note that long-term PPI use, defined as more than 4.5 years of use, was associated with dementia. It is important to note, however, that this does not necessarily mean that PPIs cause dementia. With observational studies, there is an inherent risk of bias and confounding, as the authors report. Some of these confounders include Helicobacter pylori status, vitamin B12 deficiency, depression, and socioeconomic status,” said Fouad J. Moawad, MD, graduate of the AGA FORWARD Program and gastroenterologist at Scripps Health in San Diego. A 2017 study led by Andrew T. Chan, MD, MPH, of Mass General Brigham, Boston, examined the association between proton pump inhibitor use and cognitive function in women. The investigators found no “convincing association between PPI use and cognitive function. Our data do not support the suggestion that PPI use increases dementia risk.”
A new article in press in Gastroenterology by Raaj S. Mehta and colleagues also studied this issue and concluded that in adults 65 years of age or older, PPIs were not associated with dementia or decline in cognition over time. These data provide reassurance about the safety of long-term use of PPIs among older adults.
The headlines may be confusing for patients. Here are AGA’s three talking points for communicating with patients about PPIs:
Talk to your doctor, before making any changes to your medication.
You have been prescribed PPIs for a reason, to treat a diagnosed medical condition. We can discuss the reason for your prescription, the dose and the timeframe for treatment.
Consider lifestyle modifications.
These may reduce or eliminate the need for PPIs for long-term use. These may include weight loss, avoiding tobacco or a change in your eating patterns. We can work together to determine the changes that are right for you.
Keep in touch.
Research continues to be done on PPI use. Current research recommends that patients who have a diagnosed condition that is helped by PPIs should stay on them, as benefits can outweigh risks.
Advancements help guide achalasia management, experts say
at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.
“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”
High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.
“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”
HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.
In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.
Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.
In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.
The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.
“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”
Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.
16% of the U.S. population experience dysphagia, only half of whom seek medical care and the others manage their symptoms by modifying diet.
X-ray barium swallow and endoscopy with biopsy to exclude eosinophilic esophagitis are the initial tests for dysphagia diagnosis. If the above are normal, a high-resolution esophageal manometry impedance (HRMZ) is recommended to diagnose primary and secondary esophageal motility disorder.
However, only in a minority of patients is it likely to cause dysphagia because uncontrolled studies show that therapeutic strategies to address EGJOO (botox, dilation, and myotomy) relieve dysphagia symptoms in a minority of patients. Hence, in significant number of patients the cause of dysphagia symptoms remains obscure. It might be that our testing is inadequate, or possibly, patients have functional dysphagia (sensory dysfunction of the esophagus). My opinion is that it is the former.
The esophagus has only one simple function, that is, to transfer the pharyngeal pump driven, that is, swallowed contents to the stomach, for which its luminal cross-sectional area must be larger than that of the swallowed bolus and contraction (measured by manometry) behind the bolus must be of adequate strength. The latter is likely less relevant because humans eat in the upright position and gravity provides propulsion for the bolus. Stated simply, as long as esophagus can distend well and there is no resistance to the outflow at the EGJ, esophagus can achieve its goal. However, until recently, there was no single test to determine the distension and contraction, the two essential elements of primary esophageal peristalsis.
Endoscopy and x-ray barium swallow are tests to determine the luminal diameter but have limitations. Endoflip measures the opening function of the EGJ and is useful when the HRM is normal. However, pressures that are currently being used to measure the EGJ distensibility by Endoflip are not physiological. Furthermore, esophageal body motor function assessed by a bag that distends a long segment of the esophagus under high pressure is unphysiological. The distension-contraction plots, which determines the luminal CSA and contraction simultaneously during primary peristalsis is ideally suited to study the pathophysiology of esophageal motility disorders. Several studies from my laboratory show that in patients with nutcracker esophagus, EGJOO and normal HRM, the esophagus distends significantly less than that of normal subjects during primary peristalsis. I suspect that an esophageal contraction pushing bolus through a narrow lumen esophagus is the cause of dysphagia sensation in many patients that have been labeled as functional dysphagia.
The last 2 decades have seen significant progress in the diagnosis of esophageal motility disorders using HRM, Endoflip, and distension-contraction plots of peristalsis. Furthermore, endoscopic treatment of achalasia and “achalasia-like syndromes” is revolutionary. What is desperately needed is an understanding of the pathogenesis of esophageal motor disorders, pharmacotherapy of esophageal symptoms, such as chest pain, proton pump inhibitor–resistant heartburn, and others because dysfunctional esophagus is a huge burden on health care expenditures worldwide.
Ravinder K. Mittal, MD, is a professor of medicine and gastroenterologist with UC San Diego Health. He has patent application pending on the computer software Dplots.
16% of the U.S. population experience dysphagia, only half of whom seek medical care and the others manage their symptoms by modifying diet.
X-ray barium swallow and endoscopy with biopsy to exclude eosinophilic esophagitis are the initial tests for dysphagia diagnosis. If the above are normal, a high-resolution esophageal manometry impedance (HRMZ) is recommended to diagnose primary and secondary esophageal motility disorder.
However, only in a minority of patients is it likely to cause dysphagia because uncontrolled studies show that therapeutic strategies to address EGJOO (botox, dilation, and myotomy) relieve dysphagia symptoms in a minority of patients. Hence, in significant number of patients the cause of dysphagia symptoms remains obscure. It might be that our testing is inadequate, or possibly, patients have functional dysphagia (sensory dysfunction of the esophagus). My opinion is that it is the former.
The esophagus has only one simple function, that is, to transfer the pharyngeal pump driven, that is, swallowed contents to the stomach, for which its luminal cross-sectional area must be larger than that of the swallowed bolus and contraction (measured by manometry) behind the bolus must be of adequate strength. The latter is likely less relevant because humans eat in the upright position and gravity provides propulsion for the bolus. Stated simply, as long as esophagus can distend well and there is no resistance to the outflow at the EGJ, esophagus can achieve its goal. However, until recently, there was no single test to determine the distension and contraction, the two essential elements of primary esophageal peristalsis.
Endoscopy and x-ray barium swallow are tests to determine the luminal diameter but have limitations. Endoflip measures the opening function of the EGJ and is useful when the HRM is normal. However, pressures that are currently being used to measure the EGJ distensibility by Endoflip are not physiological. Furthermore, esophageal body motor function assessed by a bag that distends a long segment of the esophagus under high pressure is unphysiological. The distension-contraction plots, which determines the luminal CSA and contraction simultaneously during primary peristalsis is ideally suited to study the pathophysiology of esophageal motility disorders. Several studies from my laboratory show that in patients with nutcracker esophagus, EGJOO and normal HRM, the esophagus distends significantly less than that of normal subjects during primary peristalsis. I suspect that an esophageal contraction pushing bolus through a narrow lumen esophagus is the cause of dysphagia sensation in many patients that have been labeled as functional dysphagia.
The last 2 decades have seen significant progress in the diagnosis of esophageal motility disorders using HRM, Endoflip, and distension-contraction plots of peristalsis. Furthermore, endoscopic treatment of achalasia and “achalasia-like syndromes” is revolutionary. What is desperately needed is an understanding of the pathogenesis of esophageal motor disorders, pharmacotherapy of esophageal symptoms, such as chest pain, proton pump inhibitor–resistant heartburn, and others because dysfunctional esophagus is a huge burden on health care expenditures worldwide.
Ravinder K. Mittal, MD, is a professor of medicine and gastroenterologist with UC San Diego Health. He has patent application pending on the computer software Dplots.
16% of the U.S. population experience dysphagia, only half of whom seek medical care and the others manage their symptoms by modifying diet.
X-ray barium swallow and endoscopy with biopsy to exclude eosinophilic esophagitis are the initial tests for dysphagia diagnosis. If the above are normal, a high-resolution esophageal manometry impedance (HRMZ) is recommended to diagnose primary and secondary esophageal motility disorder.
However, only in a minority of patients is it likely to cause dysphagia because uncontrolled studies show that therapeutic strategies to address EGJOO (botox, dilation, and myotomy) relieve dysphagia symptoms in a minority of patients. Hence, in significant number of patients the cause of dysphagia symptoms remains obscure. It might be that our testing is inadequate, or possibly, patients have functional dysphagia (sensory dysfunction of the esophagus). My opinion is that it is the former.
The esophagus has only one simple function, that is, to transfer the pharyngeal pump driven, that is, swallowed contents to the stomach, for which its luminal cross-sectional area must be larger than that of the swallowed bolus and contraction (measured by manometry) behind the bolus must be of adequate strength. The latter is likely less relevant because humans eat in the upright position and gravity provides propulsion for the bolus. Stated simply, as long as esophagus can distend well and there is no resistance to the outflow at the EGJ, esophagus can achieve its goal. However, until recently, there was no single test to determine the distension and contraction, the two essential elements of primary esophageal peristalsis.
Endoscopy and x-ray barium swallow are tests to determine the luminal diameter but have limitations. Endoflip measures the opening function of the EGJ and is useful when the HRM is normal. However, pressures that are currently being used to measure the EGJ distensibility by Endoflip are not physiological. Furthermore, esophageal body motor function assessed by a bag that distends a long segment of the esophagus under high pressure is unphysiological. The distension-contraction plots, which determines the luminal CSA and contraction simultaneously during primary peristalsis is ideally suited to study the pathophysiology of esophageal motility disorders. Several studies from my laboratory show that in patients with nutcracker esophagus, EGJOO and normal HRM, the esophagus distends significantly less than that of normal subjects during primary peristalsis. I suspect that an esophageal contraction pushing bolus through a narrow lumen esophagus is the cause of dysphagia sensation in many patients that have been labeled as functional dysphagia.
The last 2 decades have seen significant progress in the diagnosis of esophageal motility disorders using HRM, Endoflip, and distension-contraction plots of peristalsis. Furthermore, endoscopic treatment of achalasia and “achalasia-like syndromes” is revolutionary. What is desperately needed is an understanding of the pathogenesis of esophageal motor disorders, pharmacotherapy of esophageal symptoms, such as chest pain, proton pump inhibitor–resistant heartburn, and others because dysfunctional esophagus is a huge burden on health care expenditures worldwide.
Ravinder K. Mittal, MD, is a professor of medicine and gastroenterologist with UC San Diego Health. He has patent application pending on the computer software Dplots.
at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.
“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”
High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.
“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”
HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.
In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.
Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.
In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.
The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.
“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”
Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.
at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.
“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”
High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.
“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”
HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.
In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.
Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.
In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.
The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.
“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”
Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.
FROM GASTRO HEP ADVANCES
Can ChatGPT help clinicians manage GERD?
managing gastroesophageal reflux disease (GERD), investigators have found.
The researchers say the tool’s conversational format could improve clinical efficiency and reduce the volume of patient messages and calls, potentially diminishing clinician burnout.
However, inconsistencies and content errors observed require a certain level of clinical oversight, caution the researchers, led by Jacqueline Henson, MD, with the division of gastroenterology, Duke University, Durham, N.C.
The study was published online in the American Journal of Gastroenterology.
Putting ChatGPT to the GERD test
Affecting nearly 30% of U.S. adults, GERD is a common and increasingly complex condition to manage. AI technologies like ChatGPT (Open AI/Microsoft) have demonstrated an increasing role in medicine, although the ability of ChatGPT to provide guidance for GERD management is uncertain.
Dr. Henson and colleagues assessed ChatGPT’s ability to provide accurate and specific responses to questions regarding GERD care.
They generated 23 GERD management prompts based on published clinical guidelines and expert consensus recommendations. Five questions were about diagnosis, eleven on treatment, and seven on both diagnosis and treatment.
Each prompt was submitted to ChatGPT 3.5 (version 3/14/2023) three times on separate occasions without feedback to assess the consistency of the answer. Responses were rated by three board-certified gastroenterologists for appropriateness and specificity.
ChatGPT returned appropriate responses to 63 of 69 (91.3%) queries, with 29% considered completely appropriate and 62.3% mostly appropriate.
However, responses to the same prompt were often inconsistent, with 16 of 23 (70%) prompts yielding varying appropriateness, including three (13%) with both inappropriate and appropriate responses.
Prompts regarding treatment received the highest proportion of completely appropriate responses (39.4%), while prompts for diagnosis and management had the highest proportion of mostly inappropriate responses (14.3%).
For example, the chatbot failed to recommend consideration of Roux-en-Y gastric bypass for ongoing GERD symptoms with pathologic acid exposure in the setting of obesity, and some potential risks associated with proton pump inhibitor therapy were stated as fact.
However, the majority (78.3%) of responses contained at least some specific guidance, especially for prompts assessing diagnosis (93.3%). In all responses, ChatGPT suggested contacting a health care professional for further advice.
Eight patients from a range of educational backgrounds who provided feedback on the responses generally felt that the ChatGPT responses were both understandable and useful.
Overall, ChatGPT “provided largely appropriate and at least some specific guidance for GERD management, highlighting the potential for this technology to serve as a source of information for patients, as well as an aid for clinicians,” Dr. Henson and colleagues write.
However, “the presence of inappropriate responses with inconsistencies to the same prompt largely preclude its application within health care in its present state, at least for GERD,” they add.
The study had no commercial funding. Dr. Henson has served as a consultant for Medtronic.
A version of this article first appeared on Medscape.com.
managing gastroesophageal reflux disease (GERD), investigators have found.
The researchers say the tool’s conversational format could improve clinical efficiency and reduce the volume of patient messages and calls, potentially diminishing clinician burnout.
However, inconsistencies and content errors observed require a certain level of clinical oversight, caution the researchers, led by Jacqueline Henson, MD, with the division of gastroenterology, Duke University, Durham, N.C.
The study was published online in the American Journal of Gastroenterology.
Putting ChatGPT to the GERD test
Affecting nearly 30% of U.S. adults, GERD is a common and increasingly complex condition to manage. AI technologies like ChatGPT (Open AI/Microsoft) have demonstrated an increasing role in medicine, although the ability of ChatGPT to provide guidance for GERD management is uncertain.
Dr. Henson and colleagues assessed ChatGPT’s ability to provide accurate and specific responses to questions regarding GERD care.
They generated 23 GERD management prompts based on published clinical guidelines and expert consensus recommendations. Five questions were about diagnosis, eleven on treatment, and seven on both diagnosis and treatment.
Each prompt was submitted to ChatGPT 3.5 (version 3/14/2023) three times on separate occasions without feedback to assess the consistency of the answer. Responses were rated by three board-certified gastroenterologists for appropriateness and specificity.
ChatGPT returned appropriate responses to 63 of 69 (91.3%) queries, with 29% considered completely appropriate and 62.3% mostly appropriate.
However, responses to the same prompt were often inconsistent, with 16 of 23 (70%) prompts yielding varying appropriateness, including three (13%) with both inappropriate and appropriate responses.
Prompts regarding treatment received the highest proportion of completely appropriate responses (39.4%), while prompts for diagnosis and management had the highest proportion of mostly inappropriate responses (14.3%).
For example, the chatbot failed to recommend consideration of Roux-en-Y gastric bypass for ongoing GERD symptoms with pathologic acid exposure in the setting of obesity, and some potential risks associated with proton pump inhibitor therapy were stated as fact.
However, the majority (78.3%) of responses contained at least some specific guidance, especially for prompts assessing diagnosis (93.3%). In all responses, ChatGPT suggested contacting a health care professional for further advice.
Eight patients from a range of educational backgrounds who provided feedback on the responses generally felt that the ChatGPT responses were both understandable and useful.
Overall, ChatGPT “provided largely appropriate and at least some specific guidance for GERD management, highlighting the potential for this technology to serve as a source of information for patients, as well as an aid for clinicians,” Dr. Henson and colleagues write.
However, “the presence of inappropriate responses with inconsistencies to the same prompt largely preclude its application within health care in its present state, at least for GERD,” they add.
The study had no commercial funding. Dr. Henson has served as a consultant for Medtronic.
A version of this article first appeared on Medscape.com.
managing gastroesophageal reflux disease (GERD), investigators have found.
The researchers say the tool’s conversational format could improve clinical efficiency and reduce the volume of patient messages and calls, potentially diminishing clinician burnout.
However, inconsistencies and content errors observed require a certain level of clinical oversight, caution the researchers, led by Jacqueline Henson, MD, with the division of gastroenterology, Duke University, Durham, N.C.
The study was published online in the American Journal of Gastroenterology.
Putting ChatGPT to the GERD test
Affecting nearly 30% of U.S. adults, GERD is a common and increasingly complex condition to manage. AI technologies like ChatGPT (Open AI/Microsoft) have demonstrated an increasing role in medicine, although the ability of ChatGPT to provide guidance for GERD management is uncertain.
Dr. Henson and colleagues assessed ChatGPT’s ability to provide accurate and specific responses to questions regarding GERD care.
They generated 23 GERD management prompts based on published clinical guidelines and expert consensus recommendations. Five questions were about diagnosis, eleven on treatment, and seven on both diagnosis and treatment.
Each prompt was submitted to ChatGPT 3.5 (version 3/14/2023) three times on separate occasions without feedback to assess the consistency of the answer. Responses were rated by three board-certified gastroenterologists for appropriateness and specificity.
ChatGPT returned appropriate responses to 63 of 69 (91.3%) queries, with 29% considered completely appropriate and 62.3% mostly appropriate.
However, responses to the same prompt were often inconsistent, with 16 of 23 (70%) prompts yielding varying appropriateness, including three (13%) with both inappropriate and appropriate responses.
Prompts regarding treatment received the highest proportion of completely appropriate responses (39.4%), while prompts for diagnosis and management had the highest proportion of mostly inappropriate responses (14.3%).
For example, the chatbot failed to recommend consideration of Roux-en-Y gastric bypass for ongoing GERD symptoms with pathologic acid exposure in the setting of obesity, and some potential risks associated with proton pump inhibitor therapy were stated as fact.
However, the majority (78.3%) of responses contained at least some specific guidance, especially for prompts assessing diagnosis (93.3%). In all responses, ChatGPT suggested contacting a health care professional for further advice.
Eight patients from a range of educational backgrounds who provided feedback on the responses generally felt that the ChatGPT responses were both understandable and useful.
Overall, ChatGPT “provided largely appropriate and at least some specific guidance for GERD management, highlighting the potential for this technology to serve as a source of information for patients, as well as an aid for clinicians,” Dr. Henson and colleagues write.
However, “the presence of inappropriate responses with inconsistencies to the same prompt largely preclude its application within health care in its present state, at least for GERD,” they add.
The study had no commercial funding. Dr. Henson has served as a consultant for Medtronic.
A version of this article first appeared on Medscape.com.
Eosinophilic esophagitis: A year in review
At the AGA postgraduate course in May, we highlighted recent noteworthy randomized controlled trials (RCT) using eosinophil-targeting biologic therapy, esophageal-optimized corticosteroid preparations, and dietary elimination in EoE.
Dupilumab, a monoclonal antibody that blocks interleukin-4 and IL-13 signaling, was tested in a phase 3 trial for adults and adolescents with EoE.1 In this double-blind, randomized, placebo-controlled trial, the efficacy of subcutaneous dupilumab 300 mg weekly or every other week was compared against placebo. Stringent histologic remission (≤ 6 eosinophils/high power field) occurred in approximately 60% who received dupilumab (either dose) versus 5% in placebo. However, significant symptom improvement was seen only with 300 g weekly dupilumab.
On the topical corticosteroid front, the results of two RCTs using fluticasone orally disintegrating tablet (APT-1011) and budesonide oral suspension (BOS) were published. In the APT-1011 phase 2b trial, patients were randomized to receive 1.5 mg or 3 mg daily or b.i.d. versus placebo for 12 weeks.2 High histologic response rates and improvement in dysphagia frequency were seen with all ≥ 3-mg daily-dose APT-1011, compared with placebo. However, adverse events (that is, candidiasis) were highest among those on 3 mg b.i.d. Thus, 3 mg daily APT-1011 was thought to offer the most favorable risk-benefit profile. In the BOS phase 3 trial, patients were randomized 2:1 to received BOS 2 mg b.i.d. or placebo for 12 weeks.3 BOS was superior to placebo in histologic, symptomatic, and endoscopic outcomes.
Diet remains the only therapy targeting the cause of EoE and offers a potential drug-free remission. In the randomized, open label trial of 1- versus 6-food elimination diet, adult patients were allocated 1:1 to 1FED (animal milk) or 6FED (animal milk, wheat, egg, soy, fish/shellfish, and peanuts/tree nuts) for 6 weeks.4 No significant difference in partial or stringent remission was found between the two groups. Step-up therapy resulted in an additional 43% histologic response in those who underwent 6FED after failing 1FED and 82% histologic response in those who received swallowed fluticasone 880 mcg b.i.d after failing 6FED. Hence, eliminating animal milk alone in a step-up treatment approach is reasonable.
We have witnessed major progress to expand EoE treatment options in the last year. Long-term efficacy and side-effect data, as well as studies comparing between therapies are needed to improve shared decision-making and strategies to implement tailored care in EoE.
Dr. Chen is with the division of gastroenterology and hepatology, department of internal medicine at the University of Michigan, Ann Arbor. She disclosed consultancy work with Phathom Pharmaceuticals.
References
1. Dellon ES et al. N Engl J Med. 2022;387(25):2317-30.
2. Dellon ES et al. Clin Gastroenterol Hepatol. 2022;20(11):2485-94e15.
3. Hirano I et al. Budesonide. Clin Gastroenterol Hepatol. 2022;20(3):525-34e10.
4. Kliewer KL et al. Lancet Gastroenterol Hepatol. 2023;8(5):408-21.
At the AGA postgraduate course in May, we highlighted recent noteworthy randomized controlled trials (RCT) using eosinophil-targeting biologic therapy, esophageal-optimized corticosteroid preparations, and dietary elimination in EoE.
Dupilumab, a monoclonal antibody that blocks interleukin-4 and IL-13 signaling, was tested in a phase 3 trial for adults and adolescents with EoE.1 In this double-blind, randomized, placebo-controlled trial, the efficacy of subcutaneous dupilumab 300 mg weekly or every other week was compared against placebo. Stringent histologic remission (≤ 6 eosinophils/high power field) occurred in approximately 60% who received dupilumab (either dose) versus 5% in placebo. However, significant symptom improvement was seen only with 300 g weekly dupilumab.
On the topical corticosteroid front, the results of two RCTs using fluticasone orally disintegrating tablet (APT-1011) and budesonide oral suspension (BOS) were published. In the APT-1011 phase 2b trial, patients were randomized to receive 1.5 mg or 3 mg daily or b.i.d. versus placebo for 12 weeks.2 High histologic response rates and improvement in dysphagia frequency were seen with all ≥ 3-mg daily-dose APT-1011, compared with placebo. However, adverse events (that is, candidiasis) were highest among those on 3 mg b.i.d. Thus, 3 mg daily APT-1011 was thought to offer the most favorable risk-benefit profile. In the BOS phase 3 trial, patients were randomized 2:1 to received BOS 2 mg b.i.d. or placebo for 12 weeks.3 BOS was superior to placebo in histologic, symptomatic, and endoscopic outcomes.
Diet remains the only therapy targeting the cause of EoE and offers a potential drug-free remission. In the randomized, open label trial of 1- versus 6-food elimination diet, adult patients were allocated 1:1 to 1FED (animal milk) or 6FED (animal milk, wheat, egg, soy, fish/shellfish, and peanuts/tree nuts) for 6 weeks.4 No significant difference in partial or stringent remission was found between the two groups. Step-up therapy resulted in an additional 43% histologic response in those who underwent 6FED after failing 1FED and 82% histologic response in those who received swallowed fluticasone 880 mcg b.i.d after failing 6FED. Hence, eliminating animal milk alone in a step-up treatment approach is reasonable.
We have witnessed major progress to expand EoE treatment options in the last year. Long-term efficacy and side-effect data, as well as studies comparing between therapies are needed to improve shared decision-making and strategies to implement tailored care in EoE.
Dr. Chen is with the division of gastroenterology and hepatology, department of internal medicine at the University of Michigan, Ann Arbor. She disclosed consultancy work with Phathom Pharmaceuticals.
References
1. Dellon ES et al. N Engl J Med. 2022;387(25):2317-30.
2. Dellon ES et al. Clin Gastroenterol Hepatol. 2022;20(11):2485-94e15.
3. Hirano I et al. Budesonide. Clin Gastroenterol Hepatol. 2022;20(3):525-34e10.
4. Kliewer KL et al. Lancet Gastroenterol Hepatol. 2023;8(5):408-21.
At the AGA postgraduate course in May, we highlighted recent noteworthy randomized controlled trials (RCT) using eosinophil-targeting biologic therapy, esophageal-optimized corticosteroid preparations, and dietary elimination in EoE.
Dupilumab, a monoclonal antibody that blocks interleukin-4 and IL-13 signaling, was tested in a phase 3 trial for adults and adolescents with EoE.1 In this double-blind, randomized, placebo-controlled trial, the efficacy of subcutaneous dupilumab 300 mg weekly or every other week was compared against placebo. Stringent histologic remission (≤ 6 eosinophils/high power field) occurred in approximately 60% who received dupilumab (either dose) versus 5% in placebo. However, significant symptom improvement was seen only with 300 g weekly dupilumab.
On the topical corticosteroid front, the results of two RCTs using fluticasone orally disintegrating tablet (APT-1011) and budesonide oral suspension (BOS) were published. In the APT-1011 phase 2b trial, patients were randomized to receive 1.5 mg or 3 mg daily or b.i.d. versus placebo for 12 weeks.2 High histologic response rates and improvement in dysphagia frequency were seen with all ≥ 3-mg daily-dose APT-1011, compared with placebo. However, adverse events (that is, candidiasis) were highest among those on 3 mg b.i.d. Thus, 3 mg daily APT-1011 was thought to offer the most favorable risk-benefit profile. In the BOS phase 3 trial, patients were randomized 2:1 to received BOS 2 mg b.i.d. or placebo for 12 weeks.3 BOS was superior to placebo in histologic, symptomatic, and endoscopic outcomes.
Diet remains the only therapy targeting the cause of EoE and offers a potential drug-free remission. In the randomized, open label trial of 1- versus 6-food elimination diet, adult patients were allocated 1:1 to 1FED (animal milk) or 6FED (animal milk, wheat, egg, soy, fish/shellfish, and peanuts/tree nuts) for 6 weeks.4 No significant difference in partial or stringent remission was found between the two groups. Step-up therapy resulted in an additional 43% histologic response in those who underwent 6FED after failing 1FED and 82% histologic response in those who received swallowed fluticasone 880 mcg b.i.d after failing 6FED. Hence, eliminating animal milk alone in a step-up treatment approach is reasonable.
We have witnessed major progress to expand EoE treatment options in the last year. Long-term efficacy and side-effect data, as well as studies comparing between therapies are needed to improve shared decision-making and strategies to implement tailored care in EoE.
Dr. Chen is with the division of gastroenterology and hepatology, department of internal medicine at the University of Michigan, Ann Arbor. She disclosed consultancy work with Phathom Pharmaceuticals.
References
1. Dellon ES et al. N Engl J Med. 2022;387(25):2317-30.
2. Dellon ES et al. Clin Gastroenterol Hepatol. 2022;20(11):2485-94e15.
3. Hirano I et al. Budesonide. Clin Gastroenterol Hepatol. 2022;20(3):525-34e10.
4. Kliewer KL et al. Lancet Gastroenterol Hepatol. 2023;8(5):408-21.
Esophageal diseases: Key new concepts
CHICAGO – These include novel care approaches for esophageal diseases that were published in recent AGA best practice updates on gastroesophageal reflux disease (GERD), extraesophageal reflux, and Barrett’s esophagus, as well as randomized clinical trial data examining therapeutic approaches for erosive esophagitis and eosinophilic esophagitis.
Here are a few highlights: Complications of chronic gastroesophageal reflux include erosive esophagitis for which healing and maintenance of healing is crucial to reduce further erosive sequelae. Healing is typically achieved with pump inhibitor (PPI) therapy. Potassium competitive acid blockers are active prodrugs that bind to the H+/K+ ATPase and have been demonstrated to have a more potent and faster onset in suppressing gastric acid secretion, compared with PPIs.
In a recent phase 3 randomized trial of more than 1,000 adults with erosive esophagitis, the potassium competitive acid blocker vonoprazan was found to be noninferior to lansoprazole in inducing and maintaining healing of erosive esophagitis. Overall, the proportions of subjects that achieved healing by week 8 and maintained healing up to 24 weeks were higher with vonoprazan, when compared with lansoprazole, with a greater treatment effect seen in subjects with severe erosive esophagitis (Los Angeles grade C or D) (Laine L et al. Gastroenterology. Jan 2023;164[1]:61-71).
Screening patients at risk of Barrett’s esophagus (BE), another erosive sequelae of chronic GERD, is critical for early detection and prevention of esophageal cancer. Upper GI endoscopy is standard for Barrett’s screening; however, screening rates of at-risk populations are suboptimal.
In a recent retrospective analysis of a multipractice health care network, only 39% of a screen-eligible population were noted to have undergone upper GI endoscopy. These findings highlight the critical need to improve screening for Barrett’s, including potential of the newer nonendoscopic screening modalities such as swallowable capsule devices combined with a biomarker or cell-collection devices, as well as the need for risk stratification/prediction tools and collaboration with primary care physicians (Eluri S et al. Am J Gastroenterol. Nov 2022;117[11]:1764-71).
Therapeutic options for eosinophilic esophagitis (EoE) have expanded over the past year. Randomized trials demonstrate the efficacy of varied therapeutic approaches including the monoclonal antibody dupilumab as well as topical corticosteroids such as fluticasone propionate orally disintegrated tablet and budesonide oral suspension.
In terms of food elimination diets, a recent multicenter randomized open-label trial identified comparable rates of partial histologic remission with both a traditional six-food elimination diet and a one-food animal milk elimination diet in patients with EoE, though those treated with a six-food elimination were more likely to achieve complete remission (< 1 eosinophil/high power field). Results suggest elimination of animal milk alone is an acceptable initial dietary therapy for EoE, with potential to convert to six-food elimination or alternative therapy when histologic response is not achieved (Kliewer K. Lancet Gastroenterol Hepatol. [published online Feb 2023]).
Dr. Yadlapati is an associate professor in gastroenterology at the University of California, San Diego. She disclosed relationships with Medtronic (Institutional), Ironwood Pharmaceuticals (Institutional), Phathom Pharmaceuticals, and Ironwood Pharmaceuticals. She serves on the advisory board with stock options for RJS Mediagnostix.
These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2023.
DDW is sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and The Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – These include novel care approaches for esophageal diseases that were published in recent AGA best practice updates on gastroesophageal reflux disease (GERD), extraesophageal reflux, and Barrett’s esophagus, as well as randomized clinical trial data examining therapeutic approaches for erosive esophagitis and eosinophilic esophagitis.
Here are a few highlights: Complications of chronic gastroesophageal reflux include erosive esophagitis for which healing and maintenance of healing is crucial to reduce further erosive sequelae. Healing is typically achieved with pump inhibitor (PPI) therapy. Potassium competitive acid blockers are active prodrugs that bind to the H+/K+ ATPase and have been demonstrated to have a more potent and faster onset in suppressing gastric acid secretion, compared with PPIs.
In a recent phase 3 randomized trial of more than 1,000 adults with erosive esophagitis, the potassium competitive acid blocker vonoprazan was found to be noninferior to lansoprazole in inducing and maintaining healing of erosive esophagitis. Overall, the proportions of subjects that achieved healing by week 8 and maintained healing up to 24 weeks were higher with vonoprazan, when compared with lansoprazole, with a greater treatment effect seen in subjects with severe erosive esophagitis (Los Angeles grade C or D) (Laine L et al. Gastroenterology. Jan 2023;164[1]:61-71).
Screening patients at risk of Barrett’s esophagus (BE), another erosive sequelae of chronic GERD, is critical for early detection and prevention of esophageal cancer. Upper GI endoscopy is standard for Barrett’s screening; however, screening rates of at-risk populations are suboptimal.
In a recent retrospective analysis of a multipractice health care network, only 39% of a screen-eligible population were noted to have undergone upper GI endoscopy. These findings highlight the critical need to improve screening for Barrett’s, including potential of the newer nonendoscopic screening modalities such as swallowable capsule devices combined with a biomarker or cell-collection devices, as well as the need for risk stratification/prediction tools and collaboration with primary care physicians (Eluri S et al. Am J Gastroenterol. Nov 2022;117[11]:1764-71).
Therapeutic options for eosinophilic esophagitis (EoE) have expanded over the past year. Randomized trials demonstrate the efficacy of varied therapeutic approaches including the monoclonal antibody dupilumab as well as topical corticosteroids such as fluticasone propionate orally disintegrated tablet and budesonide oral suspension.
In terms of food elimination diets, a recent multicenter randomized open-label trial identified comparable rates of partial histologic remission with both a traditional six-food elimination diet and a one-food animal milk elimination diet in patients with EoE, though those treated with a six-food elimination were more likely to achieve complete remission (< 1 eosinophil/high power field). Results suggest elimination of animal milk alone is an acceptable initial dietary therapy for EoE, with potential to convert to six-food elimination or alternative therapy when histologic response is not achieved (Kliewer K. Lancet Gastroenterol Hepatol. [published online Feb 2023]).
Dr. Yadlapati is an associate professor in gastroenterology at the University of California, San Diego. She disclosed relationships with Medtronic (Institutional), Ironwood Pharmaceuticals (Institutional), Phathom Pharmaceuticals, and Ironwood Pharmaceuticals. She serves on the advisory board with stock options for RJS Mediagnostix.
These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2023.
DDW is sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and The Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – These include novel care approaches for esophageal diseases that were published in recent AGA best practice updates on gastroesophageal reflux disease (GERD), extraesophageal reflux, and Barrett’s esophagus, as well as randomized clinical trial data examining therapeutic approaches for erosive esophagitis and eosinophilic esophagitis.
Here are a few highlights: Complications of chronic gastroesophageal reflux include erosive esophagitis for which healing and maintenance of healing is crucial to reduce further erosive sequelae. Healing is typically achieved with pump inhibitor (PPI) therapy. Potassium competitive acid blockers are active prodrugs that bind to the H+/K+ ATPase and have been demonstrated to have a more potent and faster onset in suppressing gastric acid secretion, compared with PPIs.
In a recent phase 3 randomized trial of more than 1,000 adults with erosive esophagitis, the potassium competitive acid blocker vonoprazan was found to be noninferior to lansoprazole in inducing and maintaining healing of erosive esophagitis. Overall, the proportions of subjects that achieved healing by week 8 and maintained healing up to 24 weeks were higher with vonoprazan, when compared with lansoprazole, with a greater treatment effect seen in subjects with severe erosive esophagitis (Los Angeles grade C or D) (Laine L et al. Gastroenterology. Jan 2023;164[1]:61-71).
Screening patients at risk of Barrett’s esophagus (BE), another erosive sequelae of chronic GERD, is critical for early detection and prevention of esophageal cancer. Upper GI endoscopy is standard for Barrett’s screening; however, screening rates of at-risk populations are suboptimal.
In a recent retrospective analysis of a multipractice health care network, only 39% of a screen-eligible population were noted to have undergone upper GI endoscopy. These findings highlight the critical need to improve screening for Barrett’s, including potential of the newer nonendoscopic screening modalities such as swallowable capsule devices combined with a biomarker or cell-collection devices, as well as the need for risk stratification/prediction tools and collaboration with primary care physicians (Eluri S et al. Am J Gastroenterol. Nov 2022;117[11]:1764-71).
Therapeutic options for eosinophilic esophagitis (EoE) have expanded over the past year. Randomized trials demonstrate the efficacy of varied therapeutic approaches including the monoclonal antibody dupilumab as well as topical corticosteroids such as fluticasone propionate orally disintegrated tablet and budesonide oral suspension.
In terms of food elimination diets, a recent multicenter randomized open-label trial identified comparable rates of partial histologic remission with both a traditional six-food elimination diet and a one-food animal milk elimination diet in patients with EoE, though those treated with a six-food elimination were more likely to achieve complete remission (< 1 eosinophil/high power field). Results suggest elimination of animal milk alone is an acceptable initial dietary therapy for EoE, with potential to convert to six-food elimination or alternative therapy when histologic response is not achieved (Kliewer K. Lancet Gastroenterol Hepatol. [published online Feb 2023]).
Dr. Yadlapati is an associate professor in gastroenterology at the University of California, San Diego. She disclosed relationships with Medtronic (Institutional), Ironwood Pharmaceuticals (Institutional), Phathom Pharmaceuticals, and Ironwood Pharmaceuticals. She serves on the advisory board with stock options for RJS Mediagnostix.
These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2023.
DDW is sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and The Society for Surgery of the Alimentary Tract (SSAT).
AT DDW 2023
AGA clinical practice update: Extraesophageal gastroesophageal reflux disease
Extraesophageal reflux (EER) symptoms are a subset of gastroesophageal reflux disease (GERD) that can be difficult to diagnose because of its heterogeneous nature and symptoms that overlap with other conditions.
That puts the onus on physicians to take all symptoms into account and work across disciplines to diagnose, manage, and treat the condition, according to a new clinical practice update from the American Gastroenterological Association, which was published in Clinical Gastroenterology and Hepatology.
GERD is becoming increasingly common, which in turn has led to greater awareness and consideration of EER symptoms. EER symptoms can present a challenge because they may vary considerably and are not unique to GERD. The symptoms often do not respond well to proton pump inhibitor (PPI) therapy.
EER symptoms can include cough, laryngeal hoarseness, dysphonia, pulmonary fibrosis, asthma, dental erosions/caries, sinus disease, ear disease, postnasal drip, and throat clearing. Some patients with EER symptoms do not report heartburn or regurgitation, which leaves it up to the physician to determine if acid reflux is present and contributing to symptoms.
“The concept of extraesophageal symptoms secondary to GERD is complex and often controversial, leading to diagnostic and therapeutic challenges. Several extraesophageal symptoms have been associated with GERD, although the strength of evidence to support a causal relation varies,” wrote the authors, who were led by Joan W. Chen, MD, MS, a gastroenterologist with the University of Michigan, Ann Arbor.
There is also debate over whether fluid refluxate is the source of damage that causes EER symptoms, and if so, whether it is sufficient that the fluid be acidic or that pepsin be present, or if the cause is related to neurogenic signaling and resulting inflammation. Because of these questions, a PPI trial will not necessarily provide insight into the role of acid reflux in EER symptoms.
Best practice advice 1: The authors emphasized that gastroenterologists need to be aware of the potential extraesophageal symptoms of GERD. They should inquire with GERD patients to determine if laryngitis, chronic cough, asthma, and dental erosions are present.
Best practice advice 2: Consider a multidisciplinary approach to EER manifestations. Cases may require input from non-GI specialties. Tests performed by other specialists, such as bronchoscopy, thoracic imaging, or laryngoscopy, should be taken into account, since patients will also seek out multiple specialists to address their symptoms.
Best practice advice 3: There is no specific diagnostic test available to determine if GER is the cause of EER symptoms. Instead, physicians should interpret patient symptoms, response to GER therapy, and input from endoscopy and reflux tests.
Best practice advice 4: Rather than subject the patient to the cost and potential for even rare adverse events of a PPI trial, physicians should first consider conducting reflux testing. A PPI trial has clinical value but is insufficient on its own to help diagnose or manage EER. Initial single-dose PPI trial, titrating up to twice daily in those with typical GERD symptoms, is reasonable.
Best practice advice 5: The inconsistent therapeutic response to PPI therapy means that positive effects of PPI therapy on EER symptoms can’t confirm a GERD diagnosis because a placebo effect may be involved, and because symptom improvement can occur through mechanisms other than acid suppression. A meta-analysis found that a PPI trial has a sensitivity of 71%-78% and a specificity of 41%-54% with typical symptoms of heartburn and regurgitation. “Considering the greater variation expected with PPI response for extraesophageal symptoms, the diagnostic performance of empiric PPI trial for a diagnosis of EER would be anticipated to be substantially lower,” the authors wrote.
Best practice advice 6: When EER symptoms related to GERD are suspected and a PPI trial of up to 12 weeks does not lead to adequate improvement, the physician should consider testing for pathologic GER. Additional trials employing other PPIs are unlikely to succeed.
Best practice advice 7: Initial testing to evaluate for reflux should be tailored to patients’ clinical presentation. Potential methods to evaluate reflux include upper endoscopy and ambulatory reflux monitoring studies of acid suppressive therapy, which can assist with a GERD diagnosis, particularly when nonerosive reflux is present.
Best practice advice 8: About 50%-60% of patients with EER symptoms will not have GERD. Testing can be considered for those with an established objective diagnosis of GERD who do not respond well to high doses of acid suppression. Cost-effectiveness studies have confirmed the value of starting with ambulatory reflux monitoring, which can include a catheter-based pH sensor, pH impedance, or wireless pH capsule.
Ambulatory esophageal pH monitoring can also assist in making a GERD diagnosis, but it does not indicate whether GERD may be contributing to EER symptoms.
“Whichever the reflux testing modality, the strongest confidence for EER is achieved after ambulatory reflux testing showing pathologic acid exposure and a positive symptom-reflux association for EER symptoms,” the authors wrote. They also pointed out that ambulatory reflux monitoring in EER patients should be done in the absence of acid suppression unless there is already objective evidence for the presence of GERD.
Best practice advice 9: Aside from acid suppression, EER symptoms can also be managed through other means, including lifestyle modifications, such as eating avoidance prior to lying down, elevation of the head of the bed, sleeping on the left side, and weight loss. Or, alginate containing antacids, external upper esophageal sphincter compression device, cognitive behavioral therapy, and neuromodulators.
Best practice advice 10: In cases where the EER patient has objectively defined evidence of GERD, physicians should employ shared decision-making before considering anti-reflux surgery. If the patient did not respond to PPI therapy, this predicts a lack of response to antireflux surgery.
All four authors reported financial ties to multiple pharmaceutical companies.
Extraesophageal reflux (EER) symptoms are a subset of gastroesophageal reflux disease (GERD) that can be difficult to diagnose because of its heterogeneous nature and symptoms that overlap with other conditions.
That puts the onus on physicians to take all symptoms into account and work across disciplines to diagnose, manage, and treat the condition, according to a new clinical practice update from the American Gastroenterological Association, which was published in Clinical Gastroenterology and Hepatology.
GERD is becoming increasingly common, which in turn has led to greater awareness and consideration of EER symptoms. EER symptoms can present a challenge because they may vary considerably and are not unique to GERD. The symptoms often do not respond well to proton pump inhibitor (PPI) therapy.
EER symptoms can include cough, laryngeal hoarseness, dysphonia, pulmonary fibrosis, asthma, dental erosions/caries, sinus disease, ear disease, postnasal drip, and throat clearing. Some patients with EER symptoms do not report heartburn or regurgitation, which leaves it up to the physician to determine if acid reflux is present and contributing to symptoms.
“The concept of extraesophageal symptoms secondary to GERD is complex and often controversial, leading to diagnostic and therapeutic challenges. Several extraesophageal symptoms have been associated with GERD, although the strength of evidence to support a causal relation varies,” wrote the authors, who were led by Joan W. Chen, MD, MS, a gastroenterologist with the University of Michigan, Ann Arbor.
There is also debate over whether fluid refluxate is the source of damage that causes EER symptoms, and if so, whether it is sufficient that the fluid be acidic or that pepsin be present, or if the cause is related to neurogenic signaling and resulting inflammation. Because of these questions, a PPI trial will not necessarily provide insight into the role of acid reflux in EER symptoms.
Best practice advice 1: The authors emphasized that gastroenterologists need to be aware of the potential extraesophageal symptoms of GERD. They should inquire with GERD patients to determine if laryngitis, chronic cough, asthma, and dental erosions are present.
Best practice advice 2: Consider a multidisciplinary approach to EER manifestations. Cases may require input from non-GI specialties. Tests performed by other specialists, such as bronchoscopy, thoracic imaging, or laryngoscopy, should be taken into account, since patients will also seek out multiple specialists to address their symptoms.
Best practice advice 3: There is no specific diagnostic test available to determine if GER is the cause of EER symptoms. Instead, physicians should interpret patient symptoms, response to GER therapy, and input from endoscopy and reflux tests.
Best practice advice 4: Rather than subject the patient to the cost and potential for even rare adverse events of a PPI trial, physicians should first consider conducting reflux testing. A PPI trial has clinical value but is insufficient on its own to help diagnose or manage EER. Initial single-dose PPI trial, titrating up to twice daily in those with typical GERD symptoms, is reasonable.
Best practice advice 5: The inconsistent therapeutic response to PPI therapy means that positive effects of PPI therapy on EER symptoms can’t confirm a GERD diagnosis because a placebo effect may be involved, and because symptom improvement can occur through mechanisms other than acid suppression. A meta-analysis found that a PPI trial has a sensitivity of 71%-78% and a specificity of 41%-54% with typical symptoms of heartburn and regurgitation. “Considering the greater variation expected with PPI response for extraesophageal symptoms, the diagnostic performance of empiric PPI trial for a diagnosis of EER would be anticipated to be substantially lower,” the authors wrote.
Best practice advice 6: When EER symptoms related to GERD are suspected and a PPI trial of up to 12 weeks does not lead to adequate improvement, the physician should consider testing for pathologic GER. Additional trials employing other PPIs are unlikely to succeed.
Best practice advice 7: Initial testing to evaluate for reflux should be tailored to patients’ clinical presentation. Potential methods to evaluate reflux include upper endoscopy and ambulatory reflux monitoring studies of acid suppressive therapy, which can assist with a GERD diagnosis, particularly when nonerosive reflux is present.
Best practice advice 8: About 50%-60% of patients with EER symptoms will not have GERD. Testing can be considered for those with an established objective diagnosis of GERD who do not respond well to high doses of acid suppression. Cost-effectiveness studies have confirmed the value of starting with ambulatory reflux monitoring, which can include a catheter-based pH sensor, pH impedance, or wireless pH capsule.
Ambulatory esophageal pH monitoring can also assist in making a GERD diagnosis, but it does not indicate whether GERD may be contributing to EER symptoms.
“Whichever the reflux testing modality, the strongest confidence for EER is achieved after ambulatory reflux testing showing pathologic acid exposure and a positive symptom-reflux association for EER symptoms,” the authors wrote. They also pointed out that ambulatory reflux monitoring in EER patients should be done in the absence of acid suppression unless there is already objective evidence for the presence of GERD.
Best practice advice 9: Aside from acid suppression, EER symptoms can also be managed through other means, including lifestyle modifications, such as eating avoidance prior to lying down, elevation of the head of the bed, sleeping on the left side, and weight loss. Or, alginate containing antacids, external upper esophageal sphincter compression device, cognitive behavioral therapy, and neuromodulators.
Best practice advice 10: In cases where the EER patient has objectively defined evidence of GERD, physicians should employ shared decision-making before considering anti-reflux surgery. If the patient did not respond to PPI therapy, this predicts a lack of response to antireflux surgery.
All four authors reported financial ties to multiple pharmaceutical companies.
Extraesophageal reflux (EER) symptoms are a subset of gastroesophageal reflux disease (GERD) that can be difficult to diagnose because of its heterogeneous nature and symptoms that overlap with other conditions.
That puts the onus on physicians to take all symptoms into account and work across disciplines to diagnose, manage, and treat the condition, according to a new clinical practice update from the American Gastroenterological Association, which was published in Clinical Gastroenterology and Hepatology.
GERD is becoming increasingly common, which in turn has led to greater awareness and consideration of EER symptoms. EER symptoms can present a challenge because they may vary considerably and are not unique to GERD. The symptoms often do not respond well to proton pump inhibitor (PPI) therapy.
EER symptoms can include cough, laryngeal hoarseness, dysphonia, pulmonary fibrosis, asthma, dental erosions/caries, sinus disease, ear disease, postnasal drip, and throat clearing. Some patients with EER symptoms do not report heartburn or regurgitation, which leaves it up to the physician to determine if acid reflux is present and contributing to symptoms.
“The concept of extraesophageal symptoms secondary to GERD is complex and often controversial, leading to diagnostic and therapeutic challenges. Several extraesophageal symptoms have been associated with GERD, although the strength of evidence to support a causal relation varies,” wrote the authors, who were led by Joan W. Chen, MD, MS, a gastroenterologist with the University of Michigan, Ann Arbor.
There is also debate over whether fluid refluxate is the source of damage that causes EER symptoms, and if so, whether it is sufficient that the fluid be acidic or that pepsin be present, or if the cause is related to neurogenic signaling and resulting inflammation. Because of these questions, a PPI trial will not necessarily provide insight into the role of acid reflux in EER symptoms.
Best practice advice 1: The authors emphasized that gastroenterologists need to be aware of the potential extraesophageal symptoms of GERD. They should inquire with GERD patients to determine if laryngitis, chronic cough, asthma, and dental erosions are present.
Best practice advice 2: Consider a multidisciplinary approach to EER manifestations. Cases may require input from non-GI specialties. Tests performed by other specialists, such as bronchoscopy, thoracic imaging, or laryngoscopy, should be taken into account, since patients will also seek out multiple specialists to address their symptoms.
Best practice advice 3: There is no specific diagnostic test available to determine if GER is the cause of EER symptoms. Instead, physicians should interpret patient symptoms, response to GER therapy, and input from endoscopy and reflux tests.
Best practice advice 4: Rather than subject the patient to the cost and potential for even rare adverse events of a PPI trial, physicians should first consider conducting reflux testing. A PPI trial has clinical value but is insufficient on its own to help diagnose or manage EER. Initial single-dose PPI trial, titrating up to twice daily in those with typical GERD symptoms, is reasonable.
Best practice advice 5: The inconsistent therapeutic response to PPI therapy means that positive effects of PPI therapy on EER symptoms can’t confirm a GERD diagnosis because a placebo effect may be involved, and because symptom improvement can occur through mechanisms other than acid suppression. A meta-analysis found that a PPI trial has a sensitivity of 71%-78% and a specificity of 41%-54% with typical symptoms of heartburn and regurgitation. “Considering the greater variation expected with PPI response for extraesophageal symptoms, the diagnostic performance of empiric PPI trial for a diagnosis of EER would be anticipated to be substantially lower,” the authors wrote.
Best practice advice 6: When EER symptoms related to GERD are suspected and a PPI trial of up to 12 weeks does not lead to adequate improvement, the physician should consider testing for pathologic GER. Additional trials employing other PPIs are unlikely to succeed.
Best practice advice 7: Initial testing to evaluate for reflux should be tailored to patients’ clinical presentation. Potential methods to evaluate reflux include upper endoscopy and ambulatory reflux monitoring studies of acid suppressive therapy, which can assist with a GERD diagnosis, particularly when nonerosive reflux is present.
Best practice advice 8: About 50%-60% of patients with EER symptoms will not have GERD. Testing can be considered for those with an established objective diagnosis of GERD who do not respond well to high doses of acid suppression. Cost-effectiveness studies have confirmed the value of starting with ambulatory reflux monitoring, which can include a catheter-based pH sensor, pH impedance, or wireless pH capsule.
Ambulatory esophageal pH monitoring can also assist in making a GERD diagnosis, but it does not indicate whether GERD may be contributing to EER symptoms.
“Whichever the reflux testing modality, the strongest confidence for EER is achieved after ambulatory reflux testing showing pathologic acid exposure and a positive symptom-reflux association for EER symptoms,” the authors wrote. They also pointed out that ambulatory reflux monitoring in EER patients should be done in the absence of acid suppression unless there is already objective evidence for the presence of GERD.
Best practice advice 9: Aside from acid suppression, EER symptoms can also be managed through other means, including lifestyle modifications, such as eating avoidance prior to lying down, elevation of the head of the bed, sleeping on the left side, and weight loss. Or, alginate containing antacids, external upper esophageal sphincter compression device, cognitive behavioral therapy, and neuromodulators.
Best practice advice 10: In cases where the EER patient has objectively defined evidence of GERD, physicians should employ shared decision-making before considering anti-reflux surgery. If the patient did not respond to PPI therapy, this predicts a lack of response to antireflux surgery.
All four authors reported financial ties to multiple pharmaceutical companies.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY