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G-POEM: Is it the much-needed treatment for gastroparesis?
In refractory gastroparesis, gastric peroral endoscopic myotomy (G-POEM) led to improvements in some patients, but the benefits were modest overall, according to results from a multicenter prospective study.
The clinical success rate was 56% at 12 months, defined as a 1 unit or greater decrease in the Gastroparesis Cardinal Symptom Index (GCSI) score accompanied by a 25% or greater decrease in two subscales detailing specific symptoms. Though the results fell short of expectations, they represent progress. In a previous large, multicenter, prospective study of existing therapies, just 28% experienced an improvement of 1 or more in the GCSI after 48 weeks of standard of care treatment.
This recent study, led by Kia Vosoughi and senior author Mouen Khashab, MD, of Johns Hopkins Medicine, Baltimore, was published online March 19, 2021, in Gut.
Pylorospasm has been linked to the symptoms of gastroparesis, prompting pyloric-directed interventions such as botulinum toxin injection, transpyloric stent placement, and pneumatic dilation of the pylorus. However, none have proven to have long-term benefit. G-POEM was introduced in 2013 as a minimally invasive pyloric-directed procedure. Some small, retrospective studies showed encouraging results, but this was the first prospective study.
“There is a huge drive to find other ways of treating gastroparesis because our current methods are not very effective and potentially have side effects. Unfortunately, [G-POEM] was not as helpful as we expected, even though there was improvement,” said Gyanprakash A. Ketwaroo, MD, MSc, AGAF, who was asked to comment on the findings. Dr. Ketwaroo is an assistant professor of medicine at Baylor College of Medicine, Houston.
Dr. Ketwaroo still endorses G-POEM despite the results because of the limitations of existing treatments.
“Even though it’s disappointing, [G-POEM] may still be better than the other approaches for gastroparesis. The other potential benefit is that it may be more readily available to patients than such interventions as the neurostimulator,” said Dr. Ketwaroo.
He added that the results highlight the importance of patient selection, pointing out that the researchers classified patients by etiologies.
“It may not be as applicable to the wider variety of patients with gastroparesis as we had hoped. I think they initially tried to look for a group that may be more amenable to it. But I don’t think this study was able to pick up an outcome based on etiology,” said Dr. Ketwaroo.
He also noted that the study showed the procedure to be generally safe, despite being more invasive than some interventions for gastroparesis.
“The adverse events were very minimal,” Dr. Ketwaroo said.
The researchers analyzed data from 75 patients (mean age, 49.3 years) who underwent G-POEM and completed 12 months of follow-up. Out of this predominantly female (71.3%) group, 41.3% had idiopathic gastroparesis, 35% had postsurgical gastroparesis, and 23.8% had diabetic gastroparesis.
The clinical success was similar across the subgroups, in the 50%-60% range for all three (P = .913). On average, the GCSI score dropped from 2.8 at 1 month following the procedure, to 1.5 at 12 months (P < .001). All components of quality of life improved at 12 months, with the exception of physical functioning.
At 3 months, 66% of patients underwent a gastric emptying study, with gastric retention at 4 hours being compared with baseline values. From that group, 64.2% improved, and 47.1% achieved normalization. Those with improvement in gastric emptying at 3 months had a clinical success rate of 75.8% at the same time point, compared with 38.9% with no improvement (P = .015).
Five adverse events were reported (6.2%). All were mild and procedure related.
A multivariate analysis showed that predictors of clinical success at 12 months included a baseline GCSI score greater than 2.6 (odds ratio, 3.23; P = .04) and baseline gastric retention greater than 20% at 4 hours (OR, 3.65; P = .029).
“Our findings of mid-term clinical success and durability of G-POEM may help physicians to choose the best therapeutic strategy for patients with refractory gastroparesis. G-POEM may be considered in patients with more severe baseline symptoms and pre-G-POEM gastric retention,” the researchers concluded.
The authors disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
In refractory gastroparesis, gastric peroral endoscopic myotomy (G-POEM) led to improvements in some patients, but the benefits were modest overall, according to results from a multicenter prospective study.
The clinical success rate was 56% at 12 months, defined as a 1 unit or greater decrease in the Gastroparesis Cardinal Symptom Index (GCSI) score accompanied by a 25% or greater decrease in two subscales detailing specific symptoms. Though the results fell short of expectations, they represent progress. In a previous large, multicenter, prospective study of existing therapies, just 28% experienced an improvement of 1 or more in the GCSI after 48 weeks of standard of care treatment.
This recent study, led by Kia Vosoughi and senior author Mouen Khashab, MD, of Johns Hopkins Medicine, Baltimore, was published online March 19, 2021, in Gut.
Pylorospasm has been linked to the symptoms of gastroparesis, prompting pyloric-directed interventions such as botulinum toxin injection, transpyloric stent placement, and pneumatic dilation of the pylorus. However, none have proven to have long-term benefit. G-POEM was introduced in 2013 as a minimally invasive pyloric-directed procedure. Some small, retrospective studies showed encouraging results, but this was the first prospective study.
“There is a huge drive to find other ways of treating gastroparesis because our current methods are not very effective and potentially have side effects. Unfortunately, [G-POEM] was not as helpful as we expected, even though there was improvement,” said Gyanprakash A. Ketwaroo, MD, MSc, AGAF, who was asked to comment on the findings. Dr. Ketwaroo is an assistant professor of medicine at Baylor College of Medicine, Houston.
Dr. Ketwaroo still endorses G-POEM despite the results because of the limitations of existing treatments.
“Even though it’s disappointing, [G-POEM] may still be better than the other approaches for gastroparesis. The other potential benefit is that it may be more readily available to patients than such interventions as the neurostimulator,” said Dr. Ketwaroo.
He added that the results highlight the importance of patient selection, pointing out that the researchers classified patients by etiologies.
“It may not be as applicable to the wider variety of patients with gastroparesis as we had hoped. I think they initially tried to look for a group that may be more amenable to it. But I don’t think this study was able to pick up an outcome based on etiology,” said Dr. Ketwaroo.
He also noted that the study showed the procedure to be generally safe, despite being more invasive than some interventions for gastroparesis.
“The adverse events were very minimal,” Dr. Ketwaroo said.
The researchers analyzed data from 75 patients (mean age, 49.3 years) who underwent G-POEM and completed 12 months of follow-up. Out of this predominantly female (71.3%) group, 41.3% had idiopathic gastroparesis, 35% had postsurgical gastroparesis, and 23.8% had diabetic gastroparesis.
The clinical success was similar across the subgroups, in the 50%-60% range for all three (P = .913). On average, the GCSI score dropped from 2.8 at 1 month following the procedure, to 1.5 at 12 months (P < .001). All components of quality of life improved at 12 months, with the exception of physical functioning.
At 3 months, 66% of patients underwent a gastric emptying study, with gastric retention at 4 hours being compared with baseline values. From that group, 64.2% improved, and 47.1% achieved normalization. Those with improvement in gastric emptying at 3 months had a clinical success rate of 75.8% at the same time point, compared with 38.9% with no improvement (P = .015).
Five adverse events were reported (6.2%). All were mild and procedure related.
A multivariate analysis showed that predictors of clinical success at 12 months included a baseline GCSI score greater than 2.6 (odds ratio, 3.23; P = .04) and baseline gastric retention greater than 20% at 4 hours (OR, 3.65; P = .029).
“Our findings of mid-term clinical success and durability of G-POEM may help physicians to choose the best therapeutic strategy for patients with refractory gastroparesis. G-POEM may be considered in patients with more severe baseline symptoms and pre-G-POEM gastric retention,” the researchers concluded.
The authors disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
In refractory gastroparesis, gastric peroral endoscopic myotomy (G-POEM) led to improvements in some patients, but the benefits were modest overall, according to results from a multicenter prospective study.
The clinical success rate was 56% at 12 months, defined as a 1 unit or greater decrease in the Gastroparesis Cardinal Symptom Index (GCSI) score accompanied by a 25% or greater decrease in two subscales detailing specific symptoms. Though the results fell short of expectations, they represent progress. In a previous large, multicenter, prospective study of existing therapies, just 28% experienced an improvement of 1 or more in the GCSI after 48 weeks of standard of care treatment.
This recent study, led by Kia Vosoughi and senior author Mouen Khashab, MD, of Johns Hopkins Medicine, Baltimore, was published online March 19, 2021, in Gut.
Pylorospasm has been linked to the symptoms of gastroparesis, prompting pyloric-directed interventions such as botulinum toxin injection, transpyloric stent placement, and pneumatic dilation of the pylorus. However, none have proven to have long-term benefit. G-POEM was introduced in 2013 as a minimally invasive pyloric-directed procedure. Some small, retrospective studies showed encouraging results, but this was the first prospective study.
“There is a huge drive to find other ways of treating gastroparesis because our current methods are not very effective and potentially have side effects. Unfortunately, [G-POEM] was not as helpful as we expected, even though there was improvement,” said Gyanprakash A. Ketwaroo, MD, MSc, AGAF, who was asked to comment on the findings. Dr. Ketwaroo is an assistant professor of medicine at Baylor College of Medicine, Houston.
Dr. Ketwaroo still endorses G-POEM despite the results because of the limitations of existing treatments.
“Even though it’s disappointing, [G-POEM] may still be better than the other approaches for gastroparesis. The other potential benefit is that it may be more readily available to patients than such interventions as the neurostimulator,” said Dr. Ketwaroo.
He added that the results highlight the importance of patient selection, pointing out that the researchers classified patients by etiologies.
“It may not be as applicable to the wider variety of patients with gastroparesis as we had hoped. I think they initially tried to look for a group that may be more amenable to it. But I don’t think this study was able to pick up an outcome based on etiology,” said Dr. Ketwaroo.
He also noted that the study showed the procedure to be generally safe, despite being more invasive than some interventions for gastroparesis.
“The adverse events were very minimal,” Dr. Ketwaroo said.
The researchers analyzed data from 75 patients (mean age, 49.3 years) who underwent G-POEM and completed 12 months of follow-up. Out of this predominantly female (71.3%) group, 41.3% had idiopathic gastroparesis, 35% had postsurgical gastroparesis, and 23.8% had diabetic gastroparesis.
The clinical success was similar across the subgroups, in the 50%-60% range for all three (P = .913). On average, the GCSI score dropped from 2.8 at 1 month following the procedure, to 1.5 at 12 months (P < .001). All components of quality of life improved at 12 months, with the exception of physical functioning.
At 3 months, 66% of patients underwent a gastric emptying study, with gastric retention at 4 hours being compared with baseline values. From that group, 64.2% improved, and 47.1% achieved normalization. Those with improvement in gastric emptying at 3 months had a clinical success rate of 75.8% at the same time point, compared with 38.9% with no improvement (P = .015).
Five adverse events were reported (6.2%). All were mild and procedure related.
A multivariate analysis showed that predictors of clinical success at 12 months included a baseline GCSI score greater than 2.6 (odds ratio, 3.23; P = .04) and baseline gastric retention greater than 20% at 4 hours (OR, 3.65; P = .029).
“Our findings of mid-term clinical success and durability of G-POEM may help physicians to choose the best therapeutic strategy for patients with refractory gastroparesis. G-POEM may be considered in patients with more severe baseline symptoms and pre-G-POEM gastric retention,” the researchers concluded.
The authors disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
FROM GUT
Endoscopic device could expand treatment for GERD, reduce PPI use
In patients with proton pump inhibitor (PPI)–dependent gastroesophageal reflux disease (GERD), a procedure known as endoscopic full-thickness plication (EFTP) – performed with the novel GERD-X device – improved both symptoms and quality of life, compared with a sham procedure. It also had few side effects and a short procedure time, according to a new randomized, controlled trial.
“It seems like it is a quick, easy-to-use procedure,” Gyanprakash A. Ketwaroo, MD, MSc, who is an assistant professor of medicine at Baylor College of Medicine, Houston, commented in an interview. Dr. Ketwaroo was not involved in the study.
“Even though the objective measures were not as good as perhaps you had hoped, the subjective outcomes were good. [And] it seems that it may have more of a long-term benefit, compared to some of the other endoscopic procedures. But that wasn’t a [primary] outcome of the study, and we still need more long-term studies to figure that out,” he added.
The research, led by Rakesh Kalapala, MD, DNB, and D. Nageshwar Reddy, MD, FACG, of the Asian Institute of Gastroenterology, Hyderabad, India, appeared in Gut.
The fact that the EFTP procedure is relatively simple could reduce cost and ease the learning curve, which in turn could broaden accessibility if more gastroenterologists are trained on it.
“There are not many gastroenterologists who offer endoscopic approaches to GERD therapy, so increasing that cohort [could] potentially have a huge impact given the number of patients who have GERD in this country, and especially given the rising and persistent concern over long-term use of PPIs,” said Dr. Ketwaroo.
Addressing the drawbacks of long-term PPI use
Although PPIs are the most effective medical therapy for GERD, there are concerns that long-term use could increase the risk of acute and chronic kidney disease, hypomagnesaemia, Clostridioides difficile infection, and osteoporotic fractures. Surgical antireflux interventions are effective but may lead to dysphagia, bloating, and diarrhea.
EFTP applies transmural sutures to the gastroesophageal junction to strengthen the valvular mechanism, which reduces reflux. While the preponderance of published evidence supports the Esophyx device (EndoGastric Solutions), which has a 70% efficacy rate and few adverse events in one analysis, it requires advanced training and general anesthesia and takes 45-100 minutes.
“Endoscopic fundoplication is a minimally invasive antireflux therapy in patients with PPI dependence who refuse surgery; however, the majority of the endoscopic devices are cumbersome to use and robust data on their long-term efficacy are lacking,” Dr. Kalapala and colleagues noted in their new paper.
In 2014, the German company G-Surg introduced a novel endoscopic plication device called GERD-X. A prospective, single-arm study had shown efficacy in both patients taking PPIs and those with refractory GERD.
A closer look at the device
To bolster that evidence, Dr. Kalapala and colleagues conducted this new single-center, randomized, sham-controlled trial with 70 enrollees with PPI-dependent GERD, of which 70% had nonerosive reflux disease (mean DeMeester score, 18.9). The median participant age was 36 years, and 71.4% were male. The average procedure time was 17.4 minutes.
Of the subjects in the treatment group, 65.7% achieved at least a 50% improvement in GERD health-related quality of life (GERD-HRQL) after 3 months, compared with 2.9% in the sham group (P < .001). The median percentage improvement in GERD-HRQL score was higher in the treatment group at 6 months (81.4% vs. 8.0%; P < .001) and at 12 months (92.3% vs. 9.1%; P < .001). Similar improvements were seen at 6 months and 12 months in heartburn symptom score (75.0% vs. 13.0% and 89.7% vs. 15.4%, respectively; P < .001 for both) and regurgitation symptom score (96.2% vs. 6.9% and 100% vs. 3.4%, respectively; P < .001 for both). At 12 months, 62.8% of the treatment group no longer took PPIs, compared with 11.4% of the sham group (P < .001).
Objective measures of improvement were more modest. The treatment arm trended toward a reduction in esophageal acid exposure from baseline at 3 and 12 months, but the difference was not statistically significant. The median percentage of time with esophageal pH below 4 and the DeMeester score were similar between the groups at 3 and 12 months. The researchers also noted trends toward fewer reflux events in 24 hours in the treatment group at 6 months (P = .072) and 12 months (P = .051).
The treatment group had fewer non–acid reflux episodes at 12 months versus baseline (P = .038), but there was no difference in the median number of acid reflux episodes in 24 hours.
“Our study found endoscopic full-thickness fundoplication, using a novel device, was safe and significantly improved GERD-related quality of life and severity of reflux symptoms at short and long terms, compared with a sham procedure,” wrote the authors.
“This endoluminal procedure with a short operating time and very few side effects is a promising alternative option to surgery in appropriately selected group of patients, who may not want to continue PPI long term,” they concluded.
The authors of the study disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
This article was updated May 6, 2021.
In patients with proton pump inhibitor (PPI)–dependent gastroesophageal reflux disease (GERD), a procedure known as endoscopic full-thickness plication (EFTP) – performed with the novel GERD-X device – improved both symptoms and quality of life, compared with a sham procedure. It also had few side effects and a short procedure time, according to a new randomized, controlled trial.
“It seems like it is a quick, easy-to-use procedure,” Gyanprakash A. Ketwaroo, MD, MSc, who is an assistant professor of medicine at Baylor College of Medicine, Houston, commented in an interview. Dr. Ketwaroo was not involved in the study.
“Even though the objective measures were not as good as perhaps you had hoped, the subjective outcomes were good. [And] it seems that it may have more of a long-term benefit, compared to some of the other endoscopic procedures. But that wasn’t a [primary] outcome of the study, and we still need more long-term studies to figure that out,” he added.
The research, led by Rakesh Kalapala, MD, DNB, and D. Nageshwar Reddy, MD, FACG, of the Asian Institute of Gastroenterology, Hyderabad, India, appeared in Gut.
The fact that the EFTP procedure is relatively simple could reduce cost and ease the learning curve, which in turn could broaden accessibility if more gastroenterologists are trained on it.
“There are not many gastroenterologists who offer endoscopic approaches to GERD therapy, so increasing that cohort [could] potentially have a huge impact given the number of patients who have GERD in this country, and especially given the rising and persistent concern over long-term use of PPIs,” said Dr. Ketwaroo.
Addressing the drawbacks of long-term PPI use
Although PPIs are the most effective medical therapy for GERD, there are concerns that long-term use could increase the risk of acute and chronic kidney disease, hypomagnesaemia, Clostridioides difficile infection, and osteoporotic fractures. Surgical antireflux interventions are effective but may lead to dysphagia, bloating, and diarrhea.
EFTP applies transmural sutures to the gastroesophageal junction to strengthen the valvular mechanism, which reduces reflux. While the preponderance of published evidence supports the Esophyx device (EndoGastric Solutions), which has a 70% efficacy rate and few adverse events in one analysis, it requires advanced training and general anesthesia and takes 45-100 minutes.
“Endoscopic fundoplication is a minimally invasive antireflux therapy in patients with PPI dependence who refuse surgery; however, the majority of the endoscopic devices are cumbersome to use and robust data on their long-term efficacy are lacking,” Dr. Kalapala and colleagues noted in their new paper.
In 2014, the German company G-Surg introduced a novel endoscopic plication device called GERD-X. A prospective, single-arm study had shown efficacy in both patients taking PPIs and those with refractory GERD.
A closer look at the device
To bolster that evidence, Dr. Kalapala and colleagues conducted this new single-center, randomized, sham-controlled trial with 70 enrollees with PPI-dependent GERD, of which 70% had nonerosive reflux disease (mean DeMeester score, 18.9). The median participant age was 36 years, and 71.4% were male. The average procedure time was 17.4 minutes.
Of the subjects in the treatment group, 65.7% achieved at least a 50% improvement in GERD health-related quality of life (GERD-HRQL) after 3 months, compared with 2.9% in the sham group (P < .001). The median percentage improvement in GERD-HRQL score was higher in the treatment group at 6 months (81.4% vs. 8.0%; P < .001) and at 12 months (92.3% vs. 9.1%; P < .001). Similar improvements were seen at 6 months and 12 months in heartburn symptom score (75.0% vs. 13.0% and 89.7% vs. 15.4%, respectively; P < .001 for both) and regurgitation symptom score (96.2% vs. 6.9% and 100% vs. 3.4%, respectively; P < .001 for both). At 12 months, 62.8% of the treatment group no longer took PPIs, compared with 11.4% of the sham group (P < .001).
Objective measures of improvement were more modest. The treatment arm trended toward a reduction in esophageal acid exposure from baseline at 3 and 12 months, but the difference was not statistically significant. The median percentage of time with esophageal pH below 4 and the DeMeester score were similar between the groups at 3 and 12 months. The researchers also noted trends toward fewer reflux events in 24 hours in the treatment group at 6 months (P = .072) and 12 months (P = .051).
The treatment group had fewer non–acid reflux episodes at 12 months versus baseline (P = .038), but there was no difference in the median number of acid reflux episodes in 24 hours.
“Our study found endoscopic full-thickness fundoplication, using a novel device, was safe and significantly improved GERD-related quality of life and severity of reflux symptoms at short and long terms, compared with a sham procedure,” wrote the authors.
“This endoluminal procedure with a short operating time and very few side effects is a promising alternative option to surgery in appropriately selected group of patients, who may not want to continue PPI long term,” they concluded.
The authors of the study disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
This article was updated May 6, 2021.
In patients with proton pump inhibitor (PPI)–dependent gastroesophageal reflux disease (GERD), a procedure known as endoscopic full-thickness plication (EFTP) – performed with the novel GERD-X device – improved both symptoms and quality of life, compared with a sham procedure. It also had few side effects and a short procedure time, according to a new randomized, controlled trial.
“It seems like it is a quick, easy-to-use procedure,” Gyanprakash A. Ketwaroo, MD, MSc, who is an assistant professor of medicine at Baylor College of Medicine, Houston, commented in an interview. Dr. Ketwaroo was not involved in the study.
“Even though the objective measures were not as good as perhaps you had hoped, the subjective outcomes were good. [And] it seems that it may have more of a long-term benefit, compared to some of the other endoscopic procedures. But that wasn’t a [primary] outcome of the study, and we still need more long-term studies to figure that out,” he added.
The research, led by Rakesh Kalapala, MD, DNB, and D. Nageshwar Reddy, MD, FACG, of the Asian Institute of Gastroenterology, Hyderabad, India, appeared in Gut.
The fact that the EFTP procedure is relatively simple could reduce cost and ease the learning curve, which in turn could broaden accessibility if more gastroenterologists are trained on it.
“There are not many gastroenterologists who offer endoscopic approaches to GERD therapy, so increasing that cohort [could] potentially have a huge impact given the number of patients who have GERD in this country, and especially given the rising and persistent concern over long-term use of PPIs,” said Dr. Ketwaroo.
Addressing the drawbacks of long-term PPI use
Although PPIs are the most effective medical therapy for GERD, there are concerns that long-term use could increase the risk of acute and chronic kidney disease, hypomagnesaemia, Clostridioides difficile infection, and osteoporotic fractures. Surgical antireflux interventions are effective but may lead to dysphagia, bloating, and diarrhea.
EFTP applies transmural sutures to the gastroesophageal junction to strengthen the valvular mechanism, which reduces reflux. While the preponderance of published evidence supports the Esophyx device (EndoGastric Solutions), which has a 70% efficacy rate and few adverse events in one analysis, it requires advanced training and general anesthesia and takes 45-100 minutes.
“Endoscopic fundoplication is a minimally invasive antireflux therapy in patients with PPI dependence who refuse surgery; however, the majority of the endoscopic devices are cumbersome to use and robust data on their long-term efficacy are lacking,” Dr. Kalapala and colleagues noted in their new paper.
In 2014, the German company G-Surg introduced a novel endoscopic plication device called GERD-X. A prospective, single-arm study had shown efficacy in both patients taking PPIs and those with refractory GERD.
A closer look at the device
To bolster that evidence, Dr. Kalapala and colleagues conducted this new single-center, randomized, sham-controlled trial with 70 enrollees with PPI-dependent GERD, of which 70% had nonerosive reflux disease (mean DeMeester score, 18.9). The median participant age was 36 years, and 71.4% were male. The average procedure time was 17.4 minutes.
Of the subjects in the treatment group, 65.7% achieved at least a 50% improvement in GERD health-related quality of life (GERD-HRQL) after 3 months, compared with 2.9% in the sham group (P < .001). The median percentage improvement in GERD-HRQL score was higher in the treatment group at 6 months (81.4% vs. 8.0%; P < .001) and at 12 months (92.3% vs. 9.1%; P < .001). Similar improvements were seen at 6 months and 12 months in heartburn symptom score (75.0% vs. 13.0% and 89.7% vs. 15.4%, respectively; P < .001 for both) and regurgitation symptom score (96.2% vs. 6.9% and 100% vs. 3.4%, respectively; P < .001 for both). At 12 months, 62.8% of the treatment group no longer took PPIs, compared with 11.4% of the sham group (P < .001).
Objective measures of improvement were more modest. The treatment arm trended toward a reduction in esophageal acid exposure from baseline at 3 and 12 months, but the difference was not statistically significant. The median percentage of time with esophageal pH below 4 and the DeMeester score were similar between the groups at 3 and 12 months. The researchers also noted trends toward fewer reflux events in 24 hours in the treatment group at 6 months (P = .072) and 12 months (P = .051).
The treatment group had fewer non–acid reflux episodes at 12 months versus baseline (P = .038), but there was no difference in the median number of acid reflux episodes in 24 hours.
“Our study found endoscopic full-thickness fundoplication, using a novel device, was safe and significantly improved GERD-related quality of life and severity of reflux symptoms at short and long terms, compared with a sham procedure,” wrote the authors.
“This endoluminal procedure with a short operating time and very few side effects is a promising alternative option to surgery in appropriately selected group of patients, who may not want to continue PPI long term,” they concluded.
The authors of the study disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
This article was updated May 6, 2021.
FROM GUT
AGA Clinical Practice Update: Management of bleeding gastric varices
When classifying gastric varices during endoscopy, experts suggest not only describing their location but also their size and whether any high-risk stigmata, such as discolorations and platelet plugs, are present.
In a clinical practice update from the American Gastroenterological Association, Zachary Henry, MD, of the University of Virginia, Charlottesville, and associates also proposed an alternative nomenclature for locating gastric varices (GV). “In practice, most gastroenterologists use the Sarin classification with the main distinction being cardiofundal versus lesser curvature GV. However, the vascular supply and corresponding therapy for GV and esophageal varices are often different, so a merged classification, such as Sarin’s, can be problematic for therapeutic planning purposes,” they wrote in Clinical Gastroenterology and Hepatology, referring to the classification system published by Shiv K. Sarin, MD, DM, and colleagues. They suggested that a merged classification, such as Sarin’s, can be “problematic for therapeutic and planning purposes” because “the vascular supply and corresponding therapy for GV and [esophageal varices] are often different.” Instead, they advised that an “alternative nomenclature based on location within the stomach is clearer and facilitates correlation with vascular imaging.” Another approach is to add risk factors for bleeding, such as an estimate of variceal size and high-risk stigmata (discolored marks, platelet plugs), to Sarin classification.
Diagnosis and treatment of bleeding GV are complex, and multidisciplinary management by hepatologists, interventional radiologists, and interventional endoscopists is optimal, the experts wrote. Data and clinical guidelines do not support primary prophylaxis to prevent bleeding of GV. The authors offered an algorithm for initial management of suspected portal hypertensive GV bleeding based on both endoscopic and vascular anatomy; it includes assessment of circulatory and respiratory status, vasoactive drug administration, antibiotic prophylaxis, and more.
An early goal is confirming bleeding source and attempting to classify the bleeding site; this can be complicated by presence of intragastric blood that obscures the cardia and fundus and underlying GV. Further steps may include temporizing: “Temporizing measures to halt active bleeding are often not the definitive treatment of choice to prevent rebleeding from GV, whereas definitive measures such as endoscopic cyanoacrylate injection (ECI) or endovascular treatments are often not feasible in the acute, diagnostic setting.”
When definitive endoscopic treatment is preferred, ECI of bleeding GV is the therapy of choice because other approaches may be complicated by location and bleeding risk of GV, although band ligation may be appropriate in lesser curve GV. Specific ECI techniques have not been compared directly in studies, according to the update authors; however, “the specific cyanoacrylate agent should favor the fastest polymerization time to avoid embolization and inducing GV bleeding.” This has meant 4-carbon (butyl) preparations are preferred to 8-carbon (octyl) preparations, they noted.
After treatment, endoscopy is performed every 2-4 weeks so that the ECI can be repeated as needed until obliteration is complete. The experts suggested that, after eradication of GV, an endoscopic reevaluation within 3-6 months should be scheduled, then annually thereafter. Any de novo or recurrent GV during the long-term follow-up may require additional imaging and multidisciplinary exploration to determine potential mechanisms and need for alternative treatments, the authors advised.
According to the practice update, transjugular intrahepatic portosystemic shunt can be used when the GV is receiving significant inflow from the coronary vein or the patient has significant complications from portal hypertension. When TIPS is used, the experts suggest also performing endovascular sclerosis or direct embolization of GV, if possible. For patients with a gastrorenal shunt, balloon-occluded retrograde transvenous obliteration (BRTO) of bleeding GV is considered optimal if local expertise is available and the patient lacks severe complications from portal hypertension. Endoscopy should be performed within 48 hours after BRTO to confirm obliteration of the vascular flow. If residual flow is detected, “cyanoacrylate injection should be performed,” the experts wrote. To confirm that GV are obliterated and check for any vascular complications, they suggest performing CT or MR within 4-6 weeks after BRTO and then as clinically indicated. In addition, surveillance endoscopy is important to identify and treat any esophageal varices that could have been worsened by increased portal pressures.
No funding sources were reported. The experts reported having no conflicts of interest.
When classifying gastric varices during endoscopy, experts suggest not only describing their location but also their size and whether any high-risk stigmata, such as discolorations and platelet plugs, are present.
In a clinical practice update from the American Gastroenterological Association, Zachary Henry, MD, of the University of Virginia, Charlottesville, and associates also proposed an alternative nomenclature for locating gastric varices (GV). “In practice, most gastroenterologists use the Sarin classification with the main distinction being cardiofundal versus lesser curvature GV. However, the vascular supply and corresponding therapy for GV and esophageal varices are often different, so a merged classification, such as Sarin’s, can be problematic for therapeutic planning purposes,” they wrote in Clinical Gastroenterology and Hepatology, referring to the classification system published by Shiv K. Sarin, MD, DM, and colleagues. They suggested that a merged classification, such as Sarin’s, can be “problematic for therapeutic and planning purposes” because “the vascular supply and corresponding therapy for GV and [esophageal varices] are often different.” Instead, they advised that an “alternative nomenclature based on location within the stomach is clearer and facilitates correlation with vascular imaging.” Another approach is to add risk factors for bleeding, such as an estimate of variceal size and high-risk stigmata (discolored marks, platelet plugs), to Sarin classification.
Diagnosis and treatment of bleeding GV are complex, and multidisciplinary management by hepatologists, interventional radiologists, and interventional endoscopists is optimal, the experts wrote. Data and clinical guidelines do not support primary prophylaxis to prevent bleeding of GV. The authors offered an algorithm for initial management of suspected portal hypertensive GV bleeding based on both endoscopic and vascular anatomy; it includes assessment of circulatory and respiratory status, vasoactive drug administration, antibiotic prophylaxis, and more.
An early goal is confirming bleeding source and attempting to classify the bleeding site; this can be complicated by presence of intragastric blood that obscures the cardia and fundus and underlying GV. Further steps may include temporizing: “Temporizing measures to halt active bleeding are often not the definitive treatment of choice to prevent rebleeding from GV, whereas definitive measures such as endoscopic cyanoacrylate injection (ECI) or endovascular treatments are often not feasible in the acute, diagnostic setting.”
When definitive endoscopic treatment is preferred, ECI of bleeding GV is the therapy of choice because other approaches may be complicated by location and bleeding risk of GV, although band ligation may be appropriate in lesser curve GV. Specific ECI techniques have not been compared directly in studies, according to the update authors; however, “the specific cyanoacrylate agent should favor the fastest polymerization time to avoid embolization and inducing GV bleeding.” This has meant 4-carbon (butyl) preparations are preferred to 8-carbon (octyl) preparations, they noted.
After treatment, endoscopy is performed every 2-4 weeks so that the ECI can be repeated as needed until obliteration is complete. The experts suggested that, after eradication of GV, an endoscopic reevaluation within 3-6 months should be scheduled, then annually thereafter. Any de novo or recurrent GV during the long-term follow-up may require additional imaging and multidisciplinary exploration to determine potential mechanisms and need for alternative treatments, the authors advised.
According to the practice update, transjugular intrahepatic portosystemic shunt can be used when the GV is receiving significant inflow from the coronary vein or the patient has significant complications from portal hypertension. When TIPS is used, the experts suggest also performing endovascular sclerosis or direct embolization of GV, if possible. For patients with a gastrorenal shunt, balloon-occluded retrograde transvenous obliteration (BRTO) of bleeding GV is considered optimal if local expertise is available and the patient lacks severe complications from portal hypertension. Endoscopy should be performed within 48 hours after BRTO to confirm obliteration of the vascular flow. If residual flow is detected, “cyanoacrylate injection should be performed,” the experts wrote. To confirm that GV are obliterated and check for any vascular complications, they suggest performing CT or MR within 4-6 weeks after BRTO and then as clinically indicated. In addition, surveillance endoscopy is important to identify and treat any esophageal varices that could have been worsened by increased portal pressures.
No funding sources were reported. The experts reported having no conflicts of interest.
When classifying gastric varices during endoscopy, experts suggest not only describing their location but also their size and whether any high-risk stigmata, such as discolorations and platelet plugs, are present.
In a clinical practice update from the American Gastroenterological Association, Zachary Henry, MD, of the University of Virginia, Charlottesville, and associates also proposed an alternative nomenclature for locating gastric varices (GV). “In practice, most gastroenterologists use the Sarin classification with the main distinction being cardiofundal versus lesser curvature GV. However, the vascular supply and corresponding therapy for GV and esophageal varices are often different, so a merged classification, such as Sarin’s, can be problematic for therapeutic planning purposes,” they wrote in Clinical Gastroenterology and Hepatology, referring to the classification system published by Shiv K. Sarin, MD, DM, and colleagues. They suggested that a merged classification, such as Sarin’s, can be “problematic for therapeutic and planning purposes” because “the vascular supply and corresponding therapy for GV and [esophageal varices] are often different.” Instead, they advised that an “alternative nomenclature based on location within the stomach is clearer and facilitates correlation with vascular imaging.” Another approach is to add risk factors for bleeding, such as an estimate of variceal size and high-risk stigmata (discolored marks, platelet plugs), to Sarin classification.
Diagnosis and treatment of bleeding GV are complex, and multidisciplinary management by hepatologists, interventional radiologists, and interventional endoscopists is optimal, the experts wrote. Data and clinical guidelines do not support primary prophylaxis to prevent bleeding of GV. The authors offered an algorithm for initial management of suspected portal hypertensive GV bleeding based on both endoscopic and vascular anatomy; it includes assessment of circulatory and respiratory status, vasoactive drug administration, antibiotic prophylaxis, and more.
An early goal is confirming bleeding source and attempting to classify the bleeding site; this can be complicated by presence of intragastric blood that obscures the cardia and fundus and underlying GV. Further steps may include temporizing: “Temporizing measures to halt active bleeding are often not the definitive treatment of choice to prevent rebleeding from GV, whereas definitive measures such as endoscopic cyanoacrylate injection (ECI) or endovascular treatments are often not feasible in the acute, diagnostic setting.”
When definitive endoscopic treatment is preferred, ECI of bleeding GV is the therapy of choice because other approaches may be complicated by location and bleeding risk of GV, although band ligation may be appropriate in lesser curve GV. Specific ECI techniques have not been compared directly in studies, according to the update authors; however, “the specific cyanoacrylate agent should favor the fastest polymerization time to avoid embolization and inducing GV bleeding.” This has meant 4-carbon (butyl) preparations are preferred to 8-carbon (octyl) preparations, they noted.
After treatment, endoscopy is performed every 2-4 weeks so that the ECI can be repeated as needed until obliteration is complete. The experts suggested that, after eradication of GV, an endoscopic reevaluation within 3-6 months should be scheduled, then annually thereafter. Any de novo or recurrent GV during the long-term follow-up may require additional imaging and multidisciplinary exploration to determine potential mechanisms and need for alternative treatments, the authors advised.
According to the practice update, transjugular intrahepatic portosystemic shunt can be used when the GV is receiving significant inflow from the coronary vein or the patient has significant complications from portal hypertension. When TIPS is used, the experts suggest also performing endovascular sclerosis or direct embolization of GV, if possible. For patients with a gastrorenal shunt, balloon-occluded retrograde transvenous obliteration (BRTO) of bleeding GV is considered optimal if local expertise is available and the patient lacks severe complications from portal hypertension. Endoscopy should be performed within 48 hours after BRTO to confirm obliteration of the vascular flow. If residual flow is detected, “cyanoacrylate injection should be performed,” the experts wrote. To confirm that GV are obliterated and check for any vascular complications, they suggest performing CT or MR within 4-6 weeks after BRTO and then as clinically indicated. In addition, surveillance endoscopy is important to identify and treat any esophageal varices that could have been worsened by increased portal pressures.
No funding sources were reported. The experts reported having no conflicts of interest.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Consider risk for Barrett’s esophagus after bariatric surgery
Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.
Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.
In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.
Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).
However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.
Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.
The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.
“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
Consider surveillance for Barrett’s
The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.
“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”
Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.
“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.
Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”
The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.
Help your patients better understand the risks, testing, and treatment options for Barrett’s esophagus by sharing education from the AGA GI Patient Center: www.gastro.org/BE.
Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.
Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.
In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.
Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).
However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.
Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.
The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.
“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
Consider surveillance for Barrett’s
The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.
“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”
Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.
“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.
Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”
The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.
Help your patients better understand the risks, testing, and treatment options for Barrett’s esophagus by sharing education from the AGA GI Patient Center: www.gastro.org/BE.
Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.
Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.
In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.
Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).
However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.
Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.
The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.
“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
Consider surveillance for Barrett’s
The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.
“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”
Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.
“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.
Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”
The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.
Help your patients better understand the risks, testing, and treatment options for Barrett’s esophagus by sharing education from the AGA GI Patient Center: www.gastro.org/BE.
FROM GASTROINTESTINAL ENDOSCOPY
Bedtime soon after meals raises reflux risk in pregnancy
A shorter period between eating and going to sleep increased the risk of GERD during pregnancy by approximately 12%, according to data from 400 women.
Gastroesophageal reflux disease (GERD) is a common condition in pregnancy because of changes in gastrointestinal motility caused by hormonal changes, and a short meal-to-bed time (MTBT) also has been associated with increased GERD symptoms, but data on the impact of MTBT on GERD in pregnant women in particular are lacking, wrote Duc T. Quach, MD, of the University of Medicine and Pharmacy in Ho Chi Minh City, Vietnam, and colleagues.
In a cross-sectional study published in the Journal of Clinical Gastroenterology, the researchers identified 400 pregnant women aged 18 years and older in various stages of pregnancy who were seen at a single hospital in Vietnam. A short MTBT was defined as going to bed 2 hours or less after eating. Primary outcomes were GERD, defined as troublesome heartburn and/or regurgitation at least once a week, and reflux-related insomnia, defined as trouble initiating or maintaining nighttime sleep. Participants also reported the number of days of troublesome reflux symptoms and frequency of reflux-related insomnia over the last 7 days.
A total of 154 participants had a diagnosis of GERD, for an overall prevalence of 38.5%, similar to that seen in GERD studies of GERD and pregnancy, the researchers noted, and of those with GERD, 20 participants (13.0%) reported reflux-related insomnia.
The overall prevalence of heartburn, regurgitation, nausea with or without vomiting, and epigastric pain were 11.8%, 35.8%, 30.0%, and 5.5%, respectively. A total of 139 women reported reflux symptoms on at least 2 of the past 7 days, and 40 women reported both daytime and nighttime reflux symptoms.
Short meal-to-bed time shows strongest association
A short MTBT was the strongest predictor of GERD in multivariate analysis (odds ratio, 12.73; 95% confidence interval, 2.92-55.45; P = .001); previous history of reflux symptoms (OR, 9.05; 95% CI, 5.29-15.50; P < 001) and being in the third trimester versus first or second of pregnancy (OR, 1.66, 95% CI, 1.03-2.69; P = .039) also remained significant predictors in a multivariate analysis. In addition, nighttime short MTBT (but not daytime short MTBT) was the strongest risk factor for reflux-related insomnia (OR, 4.60), although alcohol consumption and a history of reflux-related symptoms also remained significant in multivariate analysis.
“Interestingly, the number of days during which reflux symptoms were experienced during the last 7 days sequentially increased across subgroups of participants with no short MTBT, either daytime or nighttime short MTBT, and with both daytime and nighttime MTBT,” the researchers wrote. At 4-7 days, none of the patients with no short MTBT reported reflux symptoms, compared with 7.5% of those with either daytime or nighttime MTBT and 20.9% of those with both daytime and nighttime MTBT.
The study findings were limited by several factors, including the inability to accurately record participants’ diets and the potential for overestimating the odds ratio of risk factors in patients with reflux-related insomnia because of the small numbers. However, the results support findings from previous studies and suggest that dietary modifications could provide a nonpharmacological treatment target for managing GERD in pregnant women, they concluded.
Behavioral intervention may benefit pregnant women
The study is important because heartburn and regurgitation are common challenges during pregnancy, Ziad F. Gellad, MD, of Duke University, Durham, N.C., said in an interview. “Understanding risk factors for these conditions can be helpful in designing behavioral and pharmaceutical therapeutic interventions.”
The link between short MTBT and increased risk for GERD is well-known, said Dr. Gellad. “Lengthening the time to laying supine after a meal is a common recommendation given to patients with GERD and is included in published GERD guidelines.” Although pregnant woman may have been excluded from trials on which the guidelines and recommendations are based, “it is reasonable to expect that findings would translate to this population that is generally higher risk for reflux,” he noted.
Dr. Gellad was interested to see the dose response between MTBT and reflux, with those patients having both daytime and nighttime short MTBT experiencing reflux more often than those with short MTBT in only one of those time periods (4-7 days vs. 1-3 days).
The key message for clinicians is that, for all individuals, pregnant or not, “avoiding late night meals and short meal-to-bed time is an appropriate behavioral intervention to recommend for patients with troublesome heartburn or regurgitation,” Dr. Gellad emphasized. However, more research is needed in some areas, “implementation studies would be helpful to understand how best to educate patients on behavioral modifications known to decrease reflux symptoms.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gellad had no relevant financial disclosures, but serves as a member of the GI & Hepatology News board of editors.
A shorter period between eating and going to sleep increased the risk of GERD during pregnancy by approximately 12%, according to data from 400 women.
Gastroesophageal reflux disease (GERD) is a common condition in pregnancy because of changes in gastrointestinal motility caused by hormonal changes, and a short meal-to-bed time (MTBT) also has been associated with increased GERD symptoms, but data on the impact of MTBT on GERD in pregnant women in particular are lacking, wrote Duc T. Quach, MD, of the University of Medicine and Pharmacy in Ho Chi Minh City, Vietnam, and colleagues.
In a cross-sectional study published in the Journal of Clinical Gastroenterology, the researchers identified 400 pregnant women aged 18 years and older in various stages of pregnancy who were seen at a single hospital in Vietnam. A short MTBT was defined as going to bed 2 hours or less after eating. Primary outcomes were GERD, defined as troublesome heartburn and/or regurgitation at least once a week, and reflux-related insomnia, defined as trouble initiating or maintaining nighttime sleep. Participants also reported the number of days of troublesome reflux symptoms and frequency of reflux-related insomnia over the last 7 days.
A total of 154 participants had a diagnosis of GERD, for an overall prevalence of 38.5%, similar to that seen in GERD studies of GERD and pregnancy, the researchers noted, and of those with GERD, 20 participants (13.0%) reported reflux-related insomnia.
The overall prevalence of heartburn, regurgitation, nausea with or without vomiting, and epigastric pain were 11.8%, 35.8%, 30.0%, and 5.5%, respectively. A total of 139 women reported reflux symptoms on at least 2 of the past 7 days, and 40 women reported both daytime and nighttime reflux symptoms.
Short meal-to-bed time shows strongest association
A short MTBT was the strongest predictor of GERD in multivariate analysis (odds ratio, 12.73; 95% confidence interval, 2.92-55.45; P = .001); previous history of reflux symptoms (OR, 9.05; 95% CI, 5.29-15.50; P < 001) and being in the third trimester versus first or second of pregnancy (OR, 1.66, 95% CI, 1.03-2.69; P = .039) also remained significant predictors in a multivariate analysis. In addition, nighttime short MTBT (but not daytime short MTBT) was the strongest risk factor for reflux-related insomnia (OR, 4.60), although alcohol consumption and a history of reflux-related symptoms also remained significant in multivariate analysis.
“Interestingly, the number of days during which reflux symptoms were experienced during the last 7 days sequentially increased across subgroups of participants with no short MTBT, either daytime or nighttime short MTBT, and with both daytime and nighttime MTBT,” the researchers wrote. At 4-7 days, none of the patients with no short MTBT reported reflux symptoms, compared with 7.5% of those with either daytime or nighttime MTBT and 20.9% of those with both daytime and nighttime MTBT.
The study findings were limited by several factors, including the inability to accurately record participants’ diets and the potential for overestimating the odds ratio of risk factors in patients with reflux-related insomnia because of the small numbers. However, the results support findings from previous studies and suggest that dietary modifications could provide a nonpharmacological treatment target for managing GERD in pregnant women, they concluded.
Behavioral intervention may benefit pregnant women
The study is important because heartburn and regurgitation are common challenges during pregnancy, Ziad F. Gellad, MD, of Duke University, Durham, N.C., said in an interview. “Understanding risk factors for these conditions can be helpful in designing behavioral and pharmaceutical therapeutic interventions.”
The link between short MTBT and increased risk for GERD is well-known, said Dr. Gellad. “Lengthening the time to laying supine after a meal is a common recommendation given to patients with GERD and is included in published GERD guidelines.” Although pregnant woman may have been excluded from trials on which the guidelines and recommendations are based, “it is reasonable to expect that findings would translate to this population that is generally higher risk for reflux,” he noted.
Dr. Gellad was interested to see the dose response between MTBT and reflux, with those patients having both daytime and nighttime short MTBT experiencing reflux more often than those with short MTBT in only one of those time periods (4-7 days vs. 1-3 days).
The key message for clinicians is that, for all individuals, pregnant or not, “avoiding late night meals and short meal-to-bed time is an appropriate behavioral intervention to recommend for patients with troublesome heartburn or regurgitation,” Dr. Gellad emphasized. However, more research is needed in some areas, “implementation studies would be helpful to understand how best to educate patients on behavioral modifications known to decrease reflux symptoms.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gellad had no relevant financial disclosures, but serves as a member of the GI & Hepatology News board of editors.
A shorter period between eating and going to sleep increased the risk of GERD during pregnancy by approximately 12%, according to data from 400 women.
Gastroesophageal reflux disease (GERD) is a common condition in pregnancy because of changes in gastrointestinal motility caused by hormonal changes, and a short meal-to-bed time (MTBT) also has been associated with increased GERD symptoms, but data on the impact of MTBT on GERD in pregnant women in particular are lacking, wrote Duc T. Quach, MD, of the University of Medicine and Pharmacy in Ho Chi Minh City, Vietnam, and colleagues.
In a cross-sectional study published in the Journal of Clinical Gastroenterology, the researchers identified 400 pregnant women aged 18 years and older in various stages of pregnancy who were seen at a single hospital in Vietnam. A short MTBT was defined as going to bed 2 hours or less after eating. Primary outcomes were GERD, defined as troublesome heartburn and/or regurgitation at least once a week, and reflux-related insomnia, defined as trouble initiating or maintaining nighttime sleep. Participants also reported the number of days of troublesome reflux symptoms and frequency of reflux-related insomnia over the last 7 days.
A total of 154 participants had a diagnosis of GERD, for an overall prevalence of 38.5%, similar to that seen in GERD studies of GERD and pregnancy, the researchers noted, and of those with GERD, 20 participants (13.0%) reported reflux-related insomnia.
The overall prevalence of heartburn, regurgitation, nausea with or without vomiting, and epigastric pain were 11.8%, 35.8%, 30.0%, and 5.5%, respectively. A total of 139 women reported reflux symptoms on at least 2 of the past 7 days, and 40 women reported both daytime and nighttime reflux symptoms.
Short meal-to-bed time shows strongest association
A short MTBT was the strongest predictor of GERD in multivariate analysis (odds ratio, 12.73; 95% confidence interval, 2.92-55.45; P = .001); previous history of reflux symptoms (OR, 9.05; 95% CI, 5.29-15.50; P < 001) and being in the third trimester versus first or second of pregnancy (OR, 1.66, 95% CI, 1.03-2.69; P = .039) also remained significant predictors in a multivariate analysis. In addition, nighttime short MTBT (but not daytime short MTBT) was the strongest risk factor for reflux-related insomnia (OR, 4.60), although alcohol consumption and a history of reflux-related symptoms also remained significant in multivariate analysis.
“Interestingly, the number of days during which reflux symptoms were experienced during the last 7 days sequentially increased across subgroups of participants with no short MTBT, either daytime or nighttime short MTBT, and with both daytime and nighttime MTBT,” the researchers wrote. At 4-7 days, none of the patients with no short MTBT reported reflux symptoms, compared with 7.5% of those with either daytime or nighttime MTBT and 20.9% of those with both daytime and nighttime MTBT.
The study findings were limited by several factors, including the inability to accurately record participants’ diets and the potential for overestimating the odds ratio of risk factors in patients with reflux-related insomnia because of the small numbers. However, the results support findings from previous studies and suggest that dietary modifications could provide a nonpharmacological treatment target for managing GERD in pregnant women, they concluded.
Behavioral intervention may benefit pregnant women
The study is important because heartburn and regurgitation are common challenges during pregnancy, Ziad F. Gellad, MD, of Duke University, Durham, N.C., said in an interview. “Understanding risk factors for these conditions can be helpful in designing behavioral and pharmaceutical therapeutic interventions.”
The link between short MTBT and increased risk for GERD is well-known, said Dr. Gellad. “Lengthening the time to laying supine after a meal is a common recommendation given to patients with GERD and is included in published GERD guidelines.” Although pregnant woman may have been excluded from trials on which the guidelines and recommendations are based, “it is reasonable to expect that findings would translate to this population that is generally higher risk for reflux,” he noted.
Dr. Gellad was interested to see the dose response between MTBT and reflux, with those patients having both daytime and nighttime short MTBT experiencing reflux more often than those with short MTBT in only one of those time periods (4-7 days vs. 1-3 days).
The key message for clinicians is that, for all individuals, pregnant or not, “avoiding late night meals and short meal-to-bed time is an appropriate behavioral intervention to recommend for patients with troublesome heartburn or regurgitation,” Dr. Gellad emphasized. However, more research is needed in some areas, “implementation studies would be helpful to understand how best to educate patients on behavioral modifications known to decrease reflux symptoms.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gellad had no relevant financial disclosures, but serves as a member of the GI & Hepatology News board of editors.
FROM THE JOURNAL OF CLINICAL GASTROENTEROLOGY
Adherence to antireflux lifestyle factors shows benefit in women
Antireflux lifestyle factors may significantly reduce the risk of gastroesophageal reflux disease (GERD), according to an analysis involving almost 43,000 women.
Even alongside therapy with a proton-pump inhibitor (PPI) and/or a histamine-receptor antagonist (H2RA), adherence to five antireflux lifestyle factors had a meaningful impact on risk for GERD symptoms, possibly preventing nearly 40% of cases with weekly GERD symptoms, reported lead author Raaj S. Mehta, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.
“Clinicians recommend dietary and lifestyle modifications to prevent GERD symptoms, but no prospective data are available to inform these recommendations,” Dr. Mehta and colleagues wrote in JAMA Internal Medicine.
To address this gap, the investigators turned to the Nurses’ Health Study II, a nationwide, prospective study involving 116,671 women. The study, which has a follow-up rate exceeding 90%, began in 1989 and is ongoing. Participants complete biennial questionnaires that include a variety of health and lifestyle factors. In 2005, 2009, 2013, and 2017, the questionnaire inquired about heartburn or acid reflux.
The present analysis included data from 42,955 women aged 42-62 years. Participants were excluded at baseline if they had cancer, lacked dietary data, were lost to follow-up, already had GERD symptoms at least weekly, or used a PPI and/or H2RA on a regular basis. The final dataset included 392,215 person-years of follow-up, with 9,291 incident cases of GERD symptoms.
For each participant, the presence of five possible antireflux lifestyle factors were added together for a score ranging from 0 to 5: no more than two cups of soda, tea, or coffee per day; never smoking; normal body weight (BMI ≥18.5 and <25.0 kg/m2); “prudent” diet, based on top 40% of dietary pattern score; and at least 30 minutes of moderate to vigorous physical activity each day.
Multivariate logistic regression modeling showed that women who reported all five antireflux lifestyle factors had a 50% decreased risk of GERD symptoms (hazard ratio, 0.50; 95% confidence interval, 0.42-0.59), compared with women who adhered to none of them. Further analysis suggested that the collective effect of all five factors could reduce GERD symptom case volume by 37% (95% CI, 28%-46%).
Nonadherence to each antireflux lifestyle factor was independently associated with an increased risk of GERD symptoms. After mutual adjustment for other variables, BMI was associated with the highest population-attributable risk (19%), followed by physical activity (8%), food intake (7%), beverage intake (4%), and nonsmoker status (3%).
Dr. Mehta and colleagues also explored the relationship between GERD symptoms, antireflux medications, and lifestyle factors. Presence of all five antireflux factors was associated with a 53% decreased risk of GERD symptoms or initiation of PPI and/or H2RA therapy (HR, 0.47; 95% CI, 0.41-0.54). Among a group of 3,625 women who reported regular use of a PPI and/or H2RA and were free of GERD symptoms at baseline, adherence to all five lifestyle factors reduced risk of GERD symptoms by 68% (HR, 0.32; 95% CI, 0.18-0.57).
One limitation of the study was that its population was primarily White women; however, the authors noted a study suggesting GERD is more common in White women aged 30-60 years.
“Adherence to an antireflux lifestyle, even among regular users of PPIs and/or H2RAs, was associated with a decreased risk of GERD symptoms,” the investigators concluded.
Lifestyle matters
According to Ronnie Fass, MD, medical director of the Digestive Health Center at Case Western Reserve University, Cleveland, “This is the first study to show the incremental effect and thus the benefit of lifestyle factors in reducing the risk of GERD symptoms. While only five lifestyle factors were assessed in this study, potentially others may further decrease the risk for symptoms.”
Dr. Fass suggested that the nature of the data, which was self-reported, and the entirely female patient population, should inform interpretation of the findings.
“While nonerosive reflux disease is relatively more common in women, erosive esophagitis and Barrett’s esophagus are more common in men,” he said. “Furthermore, male gender is associated with more severe GERD and GERD complications.”
Yet Dr. Fass concluded by again emphasizing the merit of the analysis: “This is an important study that further supports the value of certain lifestyle factors in reducing the risk of GERD symptoms,” he said. “What is challenging for practicing physicians is to get patients to follow these lifestyle factors long term.”
The study was funded by the National Institutes of Health and by a Stuart and Suzanne Steele Massachusetts General Hospital Research Scholar Award. The investigators and Dr. Fass disclosed no conflicts of interest.
Antireflux lifestyle factors may significantly reduce the risk of gastroesophageal reflux disease (GERD), according to an analysis involving almost 43,000 women.
Even alongside therapy with a proton-pump inhibitor (PPI) and/or a histamine-receptor antagonist (H2RA), adherence to five antireflux lifestyle factors had a meaningful impact on risk for GERD symptoms, possibly preventing nearly 40% of cases with weekly GERD symptoms, reported lead author Raaj S. Mehta, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.
“Clinicians recommend dietary and lifestyle modifications to prevent GERD symptoms, but no prospective data are available to inform these recommendations,” Dr. Mehta and colleagues wrote in JAMA Internal Medicine.
To address this gap, the investigators turned to the Nurses’ Health Study II, a nationwide, prospective study involving 116,671 women. The study, which has a follow-up rate exceeding 90%, began in 1989 and is ongoing. Participants complete biennial questionnaires that include a variety of health and lifestyle factors. In 2005, 2009, 2013, and 2017, the questionnaire inquired about heartburn or acid reflux.
The present analysis included data from 42,955 women aged 42-62 years. Participants were excluded at baseline if they had cancer, lacked dietary data, were lost to follow-up, already had GERD symptoms at least weekly, or used a PPI and/or H2RA on a regular basis. The final dataset included 392,215 person-years of follow-up, with 9,291 incident cases of GERD symptoms.
For each participant, the presence of five possible antireflux lifestyle factors were added together for a score ranging from 0 to 5: no more than two cups of soda, tea, or coffee per day; never smoking; normal body weight (BMI ≥18.5 and <25.0 kg/m2); “prudent” diet, based on top 40% of dietary pattern score; and at least 30 minutes of moderate to vigorous physical activity each day.
Multivariate logistic regression modeling showed that women who reported all five antireflux lifestyle factors had a 50% decreased risk of GERD symptoms (hazard ratio, 0.50; 95% confidence interval, 0.42-0.59), compared with women who adhered to none of them. Further analysis suggested that the collective effect of all five factors could reduce GERD symptom case volume by 37% (95% CI, 28%-46%).
Nonadherence to each antireflux lifestyle factor was independently associated with an increased risk of GERD symptoms. After mutual adjustment for other variables, BMI was associated with the highest population-attributable risk (19%), followed by physical activity (8%), food intake (7%), beverage intake (4%), and nonsmoker status (3%).
Dr. Mehta and colleagues also explored the relationship between GERD symptoms, antireflux medications, and lifestyle factors. Presence of all five antireflux factors was associated with a 53% decreased risk of GERD symptoms or initiation of PPI and/or H2RA therapy (HR, 0.47; 95% CI, 0.41-0.54). Among a group of 3,625 women who reported regular use of a PPI and/or H2RA and were free of GERD symptoms at baseline, adherence to all five lifestyle factors reduced risk of GERD symptoms by 68% (HR, 0.32; 95% CI, 0.18-0.57).
One limitation of the study was that its population was primarily White women; however, the authors noted a study suggesting GERD is more common in White women aged 30-60 years.
“Adherence to an antireflux lifestyle, even among regular users of PPIs and/or H2RAs, was associated with a decreased risk of GERD symptoms,” the investigators concluded.
Lifestyle matters
According to Ronnie Fass, MD, medical director of the Digestive Health Center at Case Western Reserve University, Cleveland, “This is the first study to show the incremental effect and thus the benefit of lifestyle factors in reducing the risk of GERD symptoms. While only five lifestyle factors were assessed in this study, potentially others may further decrease the risk for symptoms.”
Dr. Fass suggested that the nature of the data, which was self-reported, and the entirely female patient population, should inform interpretation of the findings.
“While nonerosive reflux disease is relatively more common in women, erosive esophagitis and Barrett’s esophagus are more common in men,” he said. “Furthermore, male gender is associated with more severe GERD and GERD complications.”
Yet Dr. Fass concluded by again emphasizing the merit of the analysis: “This is an important study that further supports the value of certain lifestyle factors in reducing the risk of GERD symptoms,” he said. “What is challenging for practicing physicians is to get patients to follow these lifestyle factors long term.”
The study was funded by the National Institutes of Health and by a Stuart and Suzanne Steele Massachusetts General Hospital Research Scholar Award. The investigators and Dr. Fass disclosed no conflicts of interest.
Antireflux lifestyle factors may significantly reduce the risk of gastroesophageal reflux disease (GERD), according to an analysis involving almost 43,000 women.
Even alongside therapy with a proton-pump inhibitor (PPI) and/or a histamine-receptor antagonist (H2RA), adherence to five antireflux lifestyle factors had a meaningful impact on risk for GERD symptoms, possibly preventing nearly 40% of cases with weekly GERD symptoms, reported lead author Raaj S. Mehta, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.
“Clinicians recommend dietary and lifestyle modifications to prevent GERD symptoms, but no prospective data are available to inform these recommendations,” Dr. Mehta and colleagues wrote in JAMA Internal Medicine.
To address this gap, the investigators turned to the Nurses’ Health Study II, a nationwide, prospective study involving 116,671 women. The study, which has a follow-up rate exceeding 90%, began in 1989 and is ongoing. Participants complete biennial questionnaires that include a variety of health and lifestyle factors. In 2005, 2009, 2013, and 2017, the questionnaire inquired about heartburn or acid reflux.
The present analysis included data from 42,955 women aged 42-62 years. Participants were excluded at baseline if they had cancer, lacked dietary data, were lost to follow-up, already had GERD symptoms at least weekly, or used a PPI and/or H2RA on a regular basis. The final dataset included 392,215 person-years of follow-up, with 9,291 incident cases of GERD symptoms.
For each participant, the presence of five possible antireflux lifestyle factors were added together for a score ranging from 0 to 5: no more than two cups of soda, tea, or coffee per day; never smoking; normal body weight (BMI ≥18.5 and <25.0 kg/m2); “prudent” diet, based on top 40% of dietary pattern score; and at least 30 minutes of moderate to vigorous physical activity each day.
Multivariate logistic regression modeling showed that women who reported all five antireflux lifestyle factors had a 50% decreased risk of GERD symptoms (hazard ratio, 0.50; 95% confidence interval, 0.42-0.59), compared with women who adhered to none of them. Further analysis suggested that the collective effect of all five factors could reduce GERD symptom case volume by 37% (95% CI, 28%-46%).
Nonadherence to each antireflux lifestyle factor was independently associated with an increased risk of GERD symptoms. After mutual adjustment for other variables, BMI was associated with the highest population-attributable risk (19%), followed by physical activity (8%), food intake (7%), beverage intake (4%), and nonsmoker status (3%).
Dr. Mehta and colleagues also explored the relationship between GERD symptoms, antireflux medications, and lifestyle factors. Presence of all five antireflux factors was associated with a 53% decreased risk of GERD symptoms or initiation of PPI and/or H2RA therapy (HR, 0.47; 95% CI, 0.41-0.54). Among a group of 3,625 women who reported regular use of a PPI and/or H2RA and were free of GERD symptoms at baseline, adherence to all five lifestyle factors reduced risk of GERD symptoms by 68% (HR, 0.32; 95% CI, 0.18-0.57).
One limitation of the study was that its population was primarily White women; however, the authors noted a study suggesting GERD is more common in White women aged 30-60 years.
“Adherence to an antireflux lifestyle, even among regular users of PPIs and/or H2RAs, was associated with a decreased risk of GERD symptoms,” the investigators concluded.
Lifestyle matters
According to Ronnie Fass, MD, medical director of the Digestive Health Center at Case Western Reserve University, Cleveland, “This is the first study to show the incremental effect and thus the benefit of lifestyle factors in reducing the risk of GERD symptoms. While only five lifestyle factors were assessed in this study, potentially others may further decrease the risk for symptoms.”
Dr. Fass suggested that the nature of the data, which was self-reported, and the entirely female patient population, should inform interpretation of the findings.
“While nonerosive reflux disease is relatively more common in women, erosive esophagitis and Barrett’s esophagus are more common in men,” he said. “Furthermore, male gender is associated with more severe GERD and GERD complications.”
Yet Dr. Fass concluded by again emphasizing the merit of the analysis: “This is an important study that further supports the value of certain lifestyle factors in reducing the risk of GERD symptoms,” he said. “What is challenging for practicing physicians is to get patients to follow these lifestyle factors long term.”
The study was funded by the National Institutes of Health and by a Stuart and Suzanne Steele Massachusetts General Hospital Research Scholar Award. The investigators and Dr. Fass disclosed no conflicts of interest.
FROM JAMA INTERNAL MEDICINE
PPIs improve functional dyspepsia via anti-inflammatory effects
Proton pump inhibitors (PPIs) improve functional dyspepsia (FD) by reducing duodenal eosinophils and mast cells, according to a prospective study.
This suggests that the anti-inflammatory effects of PPIs are responsible for symptom improvement, and not barrier-protective or acid-suppressive effects, a finding that may guide future therapies and biomarkers, reported lead author Lucas Wauters, PhD, of University Hospitals Leuven (Belgium), and colleagues reported in Gastroenterology.
“FD is a common and unexplained disorder with unknown pathophysiology, hampering a conclusive diagnosis and the development of effective drugs,” the investigators wrote.
Although PPIs are currently used as first-line FD therapy, ostensibly for acid suppression, “the exact mechanism of action of PPIs in FD is unknown,” the investigators noted.
According to Dr. Wauters and colleagues, previous FD studies, such as a 2020 study published in Gut, have reported a variety of pathophysiological findings in the duodenum, including increased eosinophils and mast cells, as well as activation of duodenogastric reflexes, which suggests “a primary role for duodenal pathology in FD symptom generation.” Several drivers of this pathology have been proposed. Some, such as aberrations in bile salts and acidity, point to local, luminal changes, whereas others, such as dysregulated hypothalamic-pituitary-adrenal axis responsiveness and psychosocial factors, implicate a broader set of drivers, the investigators wrote.
The present study explored this landscape through a prospective trial that enrolled 30 healthy volunteers and 47 patients with FD (2 patients with FD did not complete the study).
Patients with FD were subgrouped into “FD-starters” who had not taken PPIs and/or acid suppression for at least 3 months leading up to the trial (n = 28) and “FD-stoppers” who had refractory symptoms after at least 1 month of daily PPI usage (n = 19). Among participants with FD, 25 had postprandial distress syndrome (PDS), 9 had epigastric pain syndrome (EPS), and 13 had subtype overlap.
For the trial, FD-starters and healthy volunteers took 4 weeks of pantoprazole 40 mg once daily, whereas FD-stoppers ceased PPI therapy for 8 weeks. Before and after these respective periods, certain study procedures were conducted, including duodenal biopsy collection, duodenal fluid aspiration, and questionnaires for symptoms and stress. The study also included use of Ussing chambers for biopsies, immunohistochemistry, and bile salt measurements.
FD-starters were significantly more symptomatic than healthy volunteers were at baseline. After starting PPIs, those with FD had symptom improvements, confirming “clinical efficacy of a standard course of PPIs in all FD subtypes,” whereas healthy volunteers showed no significant change in symptoms.
Similarly, baseline duodenal eosinophil counts were higher in FD-starters than in healthy volunteers. On starting PPIs, however, eosinophil counts in these two groups moved in opposite directions: FD-starters’ counts dropped from a mean of 331 to 183 eosinophils/mm2, whereas healthy volunteers’ counts rose from a mean of 115 to 229 eosinophils/mm2 (P < .0001). Changes in mast cells and paracellular passage followed the same pattern, falling in FD-starters and rising in healthy volunteers. On the other hand, symptoms actually improved in the FD-stoppers after they went off PPIs, although they did not reach symptom levels of the healthy volunteers.
“Differential effects of PPIs in healthy volunteers point to the role of luminal changes in determining low-grade mucosal immune activation in the duodenum, which can also occur in FD after long-term use and provide arguments against continued use in refractory patients,” the investigators wrote.
Dr. Wauters and colleagues suggested that their findings could guide future approaches to FD management.
“Our results suggest that quantification of duodenal eosinophils has the potential to become part of diagnostic workup and guide therapeutic decisions in FD,” they wrote. “Additional study of the underlying mediators might lead to the discovery of new potential biomarkers or novel therapeutic targets, potentially allowing the identification of subgroups responding to biologically targeted rather than symptom-based treatments.”
The study was supported by the clinical research fund of the University Hospitals Leuven. The investigators reported no conflicts of interest.
Functional dyspepsia (FD) is a commonly encountered diagnosis among primary care and gastroenterology clinics with estimated prevalence of 5%-11% worldwide. However, the pathophysiology of this entity is not well understood, and most of the patients who undergo upper endoscopy for dyspepsia tend to have normal findings.
The differential effects of PPIs on duodenal inflammation among the groups in this study are perplexing and the findings are limited by the short duration of follow-up testing and lack of a placebo group. Duodenal eosinophils, mast cells, and permeability were higher in treatment-naive FD, and a 4-week course of PPIs reduced this inflammation in FD but apparently increased it in healthy volunteers. Furthermore, when patients with PPI-refractory FD were studied, withdrawal of the PPI lead to improvement in symptoms and trends toward less duodenal inflammation.
The discordant impact of PPIs among these groups on duodenal inflammation raises questions regarding the true effect from PPIs or changes driven by other systemic factors (brain-gut axis). This is hard to differentiate without a placebo group. Focus in future studies should be placed on how to clinically phenotype and predict PPI responders versus nonresponders along with use of longer durations to see if even PPI responders tend to lose response over time, regardless of changes in the duodenal inflammation and permeability.
Dhyanesh A. Patel, MD, is an assistant professor of medicine at the center for esophageal disorders, Vanderbilt University Medical Center, Nashville, Tenn. He has no conflicts.
Functional dyspepsia (FD) is a commonly encountered diagnosis among primary care and gastroenterology clinics with estimated prevalence of 5%-11% worldwide. However, the pathophysiology of this entity is not well understood, and most of the patients who undergo upper endoscopy for dyspepsia tend to have normal findings.
The differential effects of PPIs on duodenal inflammation among the groups in this study are perplexing and the findings are limited by the short duration of follow-up testing and lack of a placebo group. Duodenal eosinophils, mast cells, and permeability were higher in treatment-naive FD, and a 4-week course of PPIs reduced this inflammation in FD but apparently increased it in healthy volunteers. Furthermore, when patients with PPI-refractory FD were studied, withdrawal of the PPI lead to improvement in symptoms and trends toward less duodenal inflammation.
The discordant impact of PPIs among these groups on duodenal inflammation raises questions regarding the true effect from PPIs or changes driven by other systemic factors (brain-gut axis). This is hard to differentiate without a placebo group. Focus in future studies should be placed on how to clinically phenotype and predict PPI responders versus nonresponders along with use of longer durations to see if even PPI responders tend to lose response over time, regardless of changes in the duodenal inflammation and permeability.
Dhyanesh A. Patel, MD, is an assistant professor of medicine at the center for esophageal disorders, Vanderbilt University Medical Center, Nashville, Tenn. He has no conflicts.
Functional dyspepsia (FD) is a commonly encountered diagnosis among primary care and gastroenterology clinics with estimated prevalence of 5%-11% worldwide. However, the pathophysiology of this entity is not well understood, and most of the patients who undergo upper endoscopy for dyspepsia tend to have normal findings.
The differential effects of PPIs on duodenal inflammation among the groups in this study are perplexing and the findings are limited by the short duration of follow-up testing and lack of a placebo group. Duodenal eosinophils, mast cells, and permeability were higher in treatment-naive FD, and a 4-week course of PPIs reduced this inflammation in FD but apparently increased it in healthy volunteers. Furthermore, when patients with PPI-refractory FD were studied, withdrawal of the PPI lead to improvement in symptoms and trends toward less duodenal inflammation.
The discordant impact of PPIs among these groups on duodenal inflammation raises questions regarding the true effect from PPIs or changes driven by other systemic factors (brain-gut axis). This is hard to differentiate without a placebo group. Focus in future studies should be placed on how to clinically phenotype and predict PPI responders versus nonresponders along with use of longer durations to see if even PPI responders tend to lose response over time, regardless of changes in the duodenal inflammation and permeability.
Dhyanesh A. Patel, MD, is an assistant professor of medicine at the center for esophageal disorders, Vanderbilt University Medical Center, Nashville, Tenn. He has no conflicts.
Proton pump inhibitors (PPIs) improve functional dyspepsia (FD) by reducing duodenal eosinophils and mast cells, according to a prospective study.
This suggests that the anti-inflammatory effects of PPIs are responsible for symptom improvement, and not barrier-protective or acid-suppressive effects, a finding that may guide future therapies and biomarkers, reported lead author Lucas Wauters, PhD, of University Hospitals Leuven (Belgium), and colleagues reported in Gastroenterology.
“FD is a common and unexplained disorder with unknown pathophysiology, hampering a conclusive diagnosis and the development of effective drugs,” the investigators wrote.
Although PPIs are currently used as first-line FD therapy, ostensibly for acid suppression, “the exact mechanism of action of PPIs in FD is unknown,” the investigators noted.
According to Dr. Wauters and colleagues, previous FD studies, such as a 2020 study published in Gut, have reported a variety of pathophysiological findings in the duodenum, including increased eosinophils and mast cells, as well as activation of duodenogastric reflexes, which suggests “a primary role for duodenal pathology in FD symptom generation.” Several drivers of this pathology have been proposed. Some, such as aberrations in bile salts and acidity, point to local, luminal changes, whereas others, such as dysregulated hypothalamic-pituitary-adrenal axis responsiveness and psychosocial factors, implicate a broader set of drivers, the investigators wrote.
The present study explored this landscape through a prospective trial that enrolled 30 healthy volunteers and 47 patients with FD (2 patients with FD did not complete the study).
Patients with FD were subgrouped into “FD-starters” who had not taken PPIs and/or acid suppression for at least 3 months leading up to the trial (n = 28) and “FD-stoppers” who had refractory symptoms after at least 1 month of daily PPI usage (n = 19). Among participants with FD, 25 had postprandial distress syndrome (PDS), 9 had epigastric pain syndrome (EPS), and 13 had subtype overlap.
For the trial, FD-starters and healthy volunteers took 4 weeks of pantoprazole 40 mg once daily, whereas FD-stoppers ceased PPI therapy for 8 weeks. Before and after these respective periods, certain study procedures were conducted, including duodenal biopsy collection, duodenal fluid aspiration, and questionnaires for symptoms and stress. The study also included use of Ussing chambers for biopsies, immunohistochemistry, and bile salt measurements.
FD-starters were significantly more symptomatic than healthy volunteers were at baseline. After starting PPIs, those with FD had symptom improvements, confirming “clinical efficacy of a standard course of PPIs in all FD subtypes,” whereas healthy volunteers showed no significant change in symptoms.
Similarly, baseline duodenal eosinophil counts were higher in FD-starters than in healthy volunteers. On starting PPIs, however, eosinophil counts in these two groups moved in opposite directions: FD-starters’ counts dropped from a mean of 331 to 183 eosinophils/mm2, whereas healthy volunteers’ counts rose from a mean of 115 to 229 eosinophils/mm2 (P < .0001). Changes in mast cells and paracellular passage followed the same pattern, falling in FD-starters and rising in healthy volunteers. On the other hand, symptoms actually improved in the FD-stoppers after they went off PPIs, although they did not reach symptom levels of the healthy volunteers.
“Differential effects of PPIs in healthy volunteers point to the role of luminal changes in determining low-grade mucosal immune activation in the duodenum, which can also occur in FD after long-term use and provide arguments against continued use in refractory patients,” the investigators wrote.
Dr. Wauters and colleagues suggested that their findings could guide future approaches to FD management.
“Our results suggest that quantification of duodenal eosinophils has the potential to become part of diagnostic workup and guide therapeutic decisions in FD,” they wrote. “Additional study of the underlying mediators might lead to the discovery of new potential biomarkers or novel therapeutic targets, potentially allowing the identification of subgroups responding to biologically targeted rather than symptom-based treatments.”
The study was supported by the clinical research fund of the University Hospitals Leuven. The investigators reported no conflicts of interest.
Proton pump inhibitors (PPIs) improve functional dyspepsia (FD) by reducing duodenal eosinophils and mast cells, according to a prospective study.
This suggests that the anti-inflammatory effects of PPIs are responsible for symptom improvement, and not barrier-protective or acid-suppressive effects, a finding that may guide future therapies and biomarkers, reported lead author Lucas Wauters, PhD, of University Hospitals Leuven (Belgium), and colleagues reported in Gastroenterology.
“FD is a common and unexplained disorder with unknown pathophysiology, hampering a conclusive diagnosis and the development of effective drugs,” the investigators wrote.
Although PPIs are currently used as first-line FD therapy, ostensibly for acid suppression, “the exact mechanism of action of PPIs in FD is unknown,” the investigators noted.
According to Dr. Wauters and colleagues, previous FD studies, such as a 2020 study published in Gut, have reported a variety of pathophysiological findings in the duodenum, including increased eosinophils and mast cells, as well as activation of duodenogastric reflexes, which suggests “a primary role for duodenal pathology in FD symptom generation.” Several drivers of this pathology have been proposed. Some, such as aberrations in bile salts and acidity, point to local, luminal changes, whereas others, such as dysregulated hypothalamic-pituitary-adrenal axis responsiveness and psychosocial factors, implicate a broader set of drivers, the investigators wrote.
The present study explored this landscape through a prospective trial that enrolled 30 healthy volunteers and 47 patients with FD (2 patients with FD did not complete the study).
Patients with FD were subgrouped into “FD-starters” who had not taken PPIs and/or acid suppression for at least 3 months leading up to the trial (n = 28) and “FD-stoppers” who had refractory symptoms after at least 1 month of daily PPI usage (n = 19). Among participants with FD, 25 had postprandial distress syndrome (PDS), 9 had epigastric pain syndrome (EPS), and 13 had subtype overlap.
For the trial, FD-starters and healthy volunteers took 4 weeks of pantoprazole 40 mg once daily, whereas FD-stoppers ceased PPI therapy for 8 weeks. Before and after these respective periods, certain study procedures were conducted, including duodenal biopsy collection, duodenal fluid aspiration, and questionnaires for symptoms and stress. The study also included use of Ussing chambers for biopsies, immunohistochemistry, and bile salt measurements.
FD-starters were significantly more symptomatic than healthy volunteers were at baseline. After starting PPIs, those with FD had symptom improvements, confirming “clinical efficacy of a standard course of PPIs in all FD subtypes,” whereas healthy volunteers showed no significant change in symptoms.
Similarly, baseline duodenal eosinophil counts were higher in FD-starters than in healthy volunteers. On starting PPIs, however, eosinophil counts in these two groups moved in opposite directions: FD-starters’ counts dropped from a mean of 331 to 183 eosinophils/mm2, whereas healthy volunteers’ counts rose from a mean of 115 to 229 eosinophils/mm2 (P < .0001). Changes in mast cells and paracellular passage followed the same pattern, falling in FD-starters and rising in healthy volunteers. On the other hand, symptoms actually improved in the FD-stoppers after they went off PPIs, although they did not reach symptom levels of the healthy volunteers.
“Differential effects of PPIs in healthy volunteers point to the role of luminal changes in determining low-grade mucosal immune activation in the duodenum, which can also occur in FD after long-term use and provide arguments against continued use in refractory patients,” the investigators wrote.
Dr. Wauters and colleagues suggested that their findings could guide future approaches to FD management.
“Our results suggest that quantification of duodenal eosinophils has the potential to become part of diagnostic workup and guide therapeutic decisions in FD,” they wrote. “Additional study of the underlying mediators might lead to the discovery of new potential biomarkers or novel therapeutic targets, potentially allowing the identification of subgroups responding to biologically targeted rather than symptom-based treatments.”
The study was supported by the clinical research fund of the University Hospitals Leuven. The investigators reported no conflicts of interest.
FROM GASTROENTEROLOGY
AGA Clinical Practice Update: Eradication strategies for H. pylori infection
Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.
“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.
H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”
A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.
Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).
Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.
Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.
Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.
“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.
H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”
A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.
Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).
Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.
Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.
Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.
“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.
H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”
A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.
Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).
Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.
Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.
FROM GASTROENTEROLOGY
Registry reveals H. pylori management mistakes
Many patients are receiving inadequate eradication therapy for Helicobacter pylori infection, according to analysis of a European registry.
In their analysis, published in the Journal of Clinical Gastroenterology, Olga P. Nyssen, BSc, PhD, of the Autonomous University of Madrid and colleagues discussed seven errors, which included prescribing a triple instead of quadruple regimen, prescribing therapy for too short of a duration, and prescribing a low dose of proton pump inhibitors (PPIs).
“[E]ven after more than 30 years of experience in H. pylori treatment, the ideal regimen to treat this infection remains undefined,” the investigators wrote. The European Registry on Helicobacter pylori management “represents a good mapping overview of the current situation regarding H. pylori management, allowing not only continuous assessment of the integration of clinical recommendations agreed on medical consensus, but also of the possible strategies for improvement.”
Patient data were drawn from registry-participating countries that each had more than 1,000 cases of H. pylori available; most came from Spain, followed by Russia, Italy, Slovenia, and Lithuania. Of these patients, data for 26,340 patients were analyzed, which ultimately represented 80% of the total registry from 2013 to 2019.
The first mistake discussed in the paper regarded use of less-effective triple therapies (typically PPI plus two antibiotics); one review showed that these regimens fail in 20%-40% of cases. Increasing antibiotic resistances have only worsened the success rate. According to this study, a triple regimen was given as first-line treatment in 46% of cases. Overall, frequency of triple-therapy prescriptions decreased from more than 50% in 2013 to about 40% in 2019. More significant improvements in this area were achieved in Spain, where use of triple therapies decreased from 24% in 2014 to 0% in 2019. According to the investigators, this finding serves as a “paradigmatic example of improvement with time.”
The authors pointed out that “overwhelming evidence” supports 14-day treatment; however, 69% of triple-therapy durations and 58% of quadruple therapy cases were for 7 or 10 days. Triple therapy at this duration showed only 81% cure rate, while it was 88% with 14 days, and quadruple therapy was only 80% effective at 7-10 days but 90% effective at 14 days.
“Fortunately,” the investigators wrote, “this mistake was progressively found less frequently and, at present, the prescription of 7-day standard triple therapy regimens has almost disappeared.”
The authors noted acid suppression via PPIs improves cure rates: In one meta-analysis, the cure rate of triple therapy regimens increased by 6%-10% with high doses of PPIs. However, the current study found that 48% of triple therapies included low-dose PPIs. This number decreased over time, the authors noted: from 67% in 2013 to 20% in 2019.
“From another perspective, the daily PPI dose has increased from a dose equivalent to 54 mg of omeprazole in 2013 to 104 mg in 2019,” they wrote.
The other four errors they discussed were failing to adequately consider penicillin allergies in prescription choices, failing to consider the importance of treatment compliance, repeating certain antibiotics after failures, and not checking eradication success after treatment.
Based on these findings, Dr. Nyssen and colleagues suggested that “penetration of recommendations in the participating European countries is still poor and delayed, even though some improvements from guidelines have been partially incorporated.”
According to Grigorios I. Leontiadis, MD, PhD, of McMaster University, Hamilton, Ont., who coauthored the 2017 American College of Gastroenterology H. pylori management guidelines and the Canadian Association of Gastroenterology “Toronto Consensus” in 2016, “This study is important and timely given the steadily increasing antibiotic resistance of H. pylori worldwide.”
Although Dr. Leontiadias described the results as “suboptimal,” he was partially reassured by the improvements over time, “especially following publication of the 2016 European clinical practice guidelines.” He also noted that some older clinical practice guidelines issued conditional recommendations, which could “justify the lower adherence seen in the early period of this study.”
“The unanswered question,” Dr. Leontiadias went on, “is whether the practice of gastroenterologists who volunteered to participate in this prospective registry is truly representative of how H. pylori is managed in Europe. Most likely it isn’t. Nonparticipating gastroenterologists and nongastroenterologist health care practitioners are probably less aware of and less adherent to clinical practice guidelines. This means that the actual situation in the real world is probably grimmer than what this study shows.”
William D. Chey, MD, Nostrant Collegiate Professor of Gastroenterology at the University of Michigan, Ann Arbor, considered the results “not entirely surprising, but nonetheless, noteworthy.”
Dr. Chey noted that the United States lacks a similar registry to compare real-world H. pylori management; even so, he suggested several findings that “bear reiteration” for clinicians in the United States.
“U.S. providers should consider regimens other than clarithromycin triple therapy when treating H. pylori infection,” Dr. Chey said. “Since U.S. providers do not have reliable data on H. pylori antimicrobial resistance, it is useful to ask about prior macrolide antibiotic exposure, and if a patient has received a macrolide for any reason, clarithromycin triple therapy should be avoided. Bismuth quadruple therapy remains a reliable first-line treatment option in the U.S. Another recently approved first-line treatment option is the combination of a proton pump inhibitor, rifabutin, and amoxicillin. Treatment regimens in the U.S. should be given for a minimum of 10 days and, preferably, for 14 days. Another point made by the article is that providers should be maximizing gastric acid suppression by using higher doses of proton pump inhibitors when treating H. pylori.”
Dr. Chey also noted an emerging treatment option that could soon be available. “Results from phase 3 trials in North America and Europe with the potassium-competitive acid blocker vonoprazan combined with amoxicillin, with and without clarithromycin, are expected in 2021 and may provide another novel first-line treatment option.”
Dr. Nyssen and colleagues disclosed relationships with Allergan, Mayoly, Janssen, and others. Dr. Chey is a consultant for Redhill, Phathom, and Takeda, which is developing vonoprazan. Dr. Leontiadias disclosed no conflicts of interest.
This article was updated 2/16/21.
Many patients are receiving inadequate eradication therapy for Helicobacter pylori infection, according to analysis of a European registry.
In their analysis, published in the Journal of Clinical Gastroenterology, Olga P. Nyssen, BSc, PhD, of the Autonomous University of Madrid and colleagues discussed seven errors, which included prescribing a triple instead of quadruple regimen, prescribing therapy for too short of a duration, and prescribing a low dose of proton pump inhibitors (PPIs).
“[E]ven after more than 30 years of experience in H. pylori treatment, the ideal regimen to treat this infection remains undefined,” the investigators wrote. The European Registry on Helicobacter pylori management “represents a good mapping overview of the current situation regarding H. pylori management, allowing not only continuous assessment of the integration of clinical recommendations agreed on medical consensus, but also of the possible strategies for improvement.”
Patient data were drawn from registry-participating countries that each had more than 1,000 cases of H. pylori available; most came from Spain, followed by Russia, Italy, Slovenia, and Lithuania. Of these patients, data for 26,340 patients were analyzed, which ultimately represented 80% of the total registry from 2013 to 2019.
The first mistake discussed in the paper regarded use of less-effective triple therapies (typically PPI plus two antibiotics); one review showed that these regimens fail in 20%-40% of cases. Increasing antibiotic resistances have only worsened the success rate. According to this study, a triple regimen was given as first-line treatment in 46% of cases. Overall, frequency of triple-therapy prescriptions decreased from more than 50% in 2013 to about 40% in 2019. More significant improvements in this area were achieved in Spain, where use of triple therapies decreased from 24% in 2014 to 0% in 2019. According to the investigators, this finding serves as a “paradigmatic example of improvement with time.”
The authors pointed out that “overwhelming evidence” supports 14-day treatment; however, 69% of triple-therapy durations and 58% of quadruple therapy cases were for 7 or 10 days. Triple therapy at this duration showed only 81% cure rate, while it was 88% with 14 days, and quadruple therapy was only 80% effective at 7-10 days but 90% effective at 14 days.
“Fortunately,” the investigators wrote, “this mistake was progressively found less frequently and, at present, the prescription of 7-day standard triple therapy regimens has almost disappeared.”
The authors noted acid suppression via PPIs improves cure rates: In one meta-analysis, the cure rate of triple therapy regimens increased by 6%-10% with high doses of PPIs. However, the current study found that 48% of triple therapies included low-dose PPIs. This number decreased over time, the authors noted: from 67% in 2013 to 20% in 2019.
“From another perspective, the daily PPI dose has increased from a dose equivalent to 54 mg of omeprazole in 2013 to 104 mg in 2019,” they wrote.
The other four errors they discussed were failing to adequately consider penicillin allergies in prescription choices, failing to consider the importance of treatment compliance, repeating certain antibiotics after failures, and not checking eradication success after treatment.
Based on these findings, Dr. Nyssen and colleagues suggested that “penetration of recommendations in the participating European countries is still poor and delayed, even though some improvements from guidelines have been partially incorporated.”
According to Grigorios I. Leontiadis, MD, PhD, of McMaster University, Hamilton, Ont., who coauthored the 2017 American College of Gastroenterology H. pylori management guidelines and the Canadian Association of Gastroenterology “Toronto Consensus” in 2016, “This study is important and timely given the steadily increasing antibiotic resistance of H. pylori worldwide.”
Although Dr. Leontiadias described the results as “suboptimal,” he was partially reassured by the improvements over time, “especially following publication of the 2016 European clinical practice guidelines.” He also noted that some older clinical practice guidelines issued conditional recommendations, which could “justify the lower adherence seen in the early period of this study.”
“The unanswered question,” Dr. Leontiadias went on, “is whether the practice of gastroenterologists who volunteered to participate in this prospective registry is truly representative of how H. pylori is managed in Europe. Most likely it isn’t. Nonparticipating gastroenterologists and nongastroenterologist health care practitioners are probably less aware of and less adherent to clinical practice guidelines. This means that the actual situation in the real world is probably grimmer than what this study shows.”
William D. Chey, MD, Nostrant Collegiate Professor of Gastroenterology at the University of Michigan, Ann Arbor, considered the results “not entirely surprising, but nonetheless, noteworthy.”
Dr. Chey noted that the United States lacks a similar registry to compare real-world H. pylori management; even so, he suggested several findings that “bear reiteration” for clinicians in the United States.
“U.S. providers should consider regimens other than clarithromycin triple therapy when treating H. pylori infection,” Dr. Chey said. “Since U.S. providers do not have reliable data on H. pylori antimicrobial resistance, it is useful to ask about prior macrolide antibiotic exposure, and if a patient has received a macrolide for any reason, clarithromycin triple therapy should be avoided. Bismuth quadruple therapy remains a reliable first-line treatment option in the U.S. Another recently approved first-line treatment option is the combination of a proton pump inhibitor, rifabutin, and amoxicillin. Treatment regimens in the U.S. should be given for a minimum of 10 days and, preferably, for 14 days. Another point made by the article is that providers should be maximizing gastric acid suppression by using higher doses of proton pump inhibitors when treating H. pylori.”
Dr. Chey also noted an emerging treatment option that could soon be available. “Results from phase 3 trials in North America and Europe with the potassium-competitive acid blocker vonoprazan combined with amoxicillin, with and without clarithromycin, are expected in 2021 and may provide another novel first-line treatment option.”
Dr. Nyssen and colleagues disclosed relationships with Allergan, Mayoly, Janssen, and others. Dr. Chey is a consultant for Redhill, Phathom, and Takeda, which is developing vonoprazan. Dr. Leontiadias disclosed no conflicts of interest.
This article was updated 2/16/21.
Many patients are receiving inadequate eradication therapy for Helicobacter pylori infection, according to analysis of a European registry.
In their analysis, published in the Journal of Clinical Gastroenterology, Olga P. Nyssen, BSc, PhD, of the Autonomous University of Madrid and colleagues discussed seven errors, which included prescribing a triple instead of quadruple regimen, prescribing therapy for too short of a duration, and prescribing a low dose of proton pump inhibitors (PPIs).
“[E]ven after more than 30 years of experience in H. pylori treatment, the ideal regimen to treat this infection remains undefined,” the investigators wrote. The European Registry on Helicobacter pylori management “represents a good mapping overview of the current situation regarding H. pylori management, allowing not only continuous assessment of the integration of clinical recommendations agreed on medical consensus, but also of the possible strategies for improvement.”
Patient data were drawn from registry-participating countries that each had more than 1,000 cases of H. pylori available; most came from Spain, followed by Russia, Italy, Slovenia, and Lithuania. Of these patients, data for 26,340 patients were analyzed, which ultimately represented 80% of the total registry from 2013 to 2019.
The first mistake discussed in the paper regarded use of less-effective triple therapies (typically PPI plus two antibiotics); one review showed that these regimens fail in 20%-40% of cases. Increasing antibiotic resistances have only worsened the success rate. According to this study, a triple regimen was given as first-line treatment in 46% of cases. Overall, frequency of triple-therapy prescriptions decreased from more than 50% in 2013 to about 40% in 2019. More significant improvements in this area were achieved in Spain, where use of triple therapies decreased from 24% in 2014 to 0% in 2019. According to the investigators, this finding serves as a “paradigmatic example of improvement with time.”
The authors pointed out that “overwhelming evidence” supports 14-day treatment; however, 69% of triple-therapy durations and 58% of quadruple therapy cases were for 7 or 10 days. Triple therapy at this duration showed only 81% cure rate, while it was 88% with 14 days, and quadruple therapy was only 80% effective at 7-10 days but 90% effective at 14 days.
“Fortunately,” the investigators wrote, “this mistake was progressively found less frequently and, at present, the prescription of 7-day standard triple therapy regimens has almost disappeared.”
The authors noted acid suppression via PPIs improves cure rates: In one meta-analysis, the cure rate of triple therapy regimens increased by 6%-10% with high doses of PPIs. However, the current study found that 48% of triple therapies included low-dose PPIs. This number decreased over time, the authors noted: from 67% in 2013 to 20% in 2019.
“From another perspective, the daily PPI dose has increased from a dose equivalent to 54 mg of omeprazole in 2013 to 104 mg in 2019,” they wrote.
The other four errors they discussed were failing to adequately consider penicillin allergies in prescription choices, failing to consider the importance of treatment compliance, repeating certain antibiotics after failures, and not checking eradication success after treatment.
Based on these findings, Dr. Nyssen and colleagues suggested that “penetration of recommendations in the participating European countries is still poor and delayed, even though some improvements from guidelines have been partially incorporated.”
According to Grigorios I. Leontiadis, MD, PhD, of McMaster University, Hamilton, Ont., who coauthored the 2017 American College of Gastroenterology H. pylori management guidelines and the Canadian Association of Gastroenterology “Toronto Consensus” in 2016, “This study is important and timely given the steadily increasing antibiotic resistance of H. pylori worldwide.”
Although Dr. Leontiadias described the results as “suboptimal,” he was partially reassured by the improvements over time, “especially following publication of the 2016 European clinical practice guidelines.” He also noted that some older clinical practice guidelines issued conditional recommendations, which could “justify the lower adherence seen in the early period of this study.”
“The unanswered question,” Dr. Leontiadias went on, “is whether the practice of gastroenterologists who volunteered to participate in this prospective registry is truly representative of how H. pylori is managed in Europe. Most likely it isn’t. Nonparticipating gastroenterologists and nongastroenterologist health care practitioners are probably less aware of and less adherent to clinical practice guidelines. This means that the actual situation in the real world is probably grimmer than what this study shows.”
William D. Chey, MD, Nostrant Collegiate Professor of Gastroenterology at the University of Michigan, Ann Arbor, considered the results “not entirely surprising, but nonetheless, noteworthy.”
Dr. Chey noted that the United States lacks a similar registry to compare real-world H. pylori management; even so, he suggested several findings that “bear reiteration” for clinicians in the United States.
“U.S. providers should consider regimens other than clarithromycin triple therapy when treating H. pylori infection,” Dr. Chey said. “Since U.S. providers do not have reliable data on H. pylori antimicrobial resistance, it is useful to ask about prior macrolide antibiotic exposure, and if a patient has received a macrolide for any reason, clarithromycin triple therapy should be avoided. Bismuth quadruple therapy remains a reliable first-line treatment option in the U.S. Another recently approved first-line treatment option is the combination of a proton pump inhibitor, rifabutin, and amoxicillin. Treatment regimens in the U.S. should be given for a minimum of 10 days and, preferably, for 14 days. Another point made by the article is that providers should be maximizing gastric acid suppression by using higher doses of proton pump inhibitors when treating H. pylori.”
Dr. Chey also noted an emerging treatment option that could soon be available. “Results from phase 3 trials in North America and Europe with the potassium-competitive acid blocker vonoprazan combined with amoxicillin, with and without clarithromycin, are expected in 2021 and may provide another novel first-line treatment option.”
Dr. Nyssen and colleagues disclosed relationships with Allergan, Mayoly, Janssen, and others. Dr. Chey is a consultant for Redhill, Phathom, and Takeda, which is developing vonoprazan. Dr. Leontiadias disclosed no conflicts of interest.
This article was updated 2/16/21.
FROM THE JOURNAL OF CLINICAL GASTROENTEROLOGY
Normal FLIP findings usually ruled out esophageal motility disorders
Most patients with normal findings on functional luminal imaging probe (FLIP) showed no clinical evidence of a major esophageal motor disorder, even when their high-resolution manometry (HRM) test results were abnormal, according to the results of a single-center retrospective cohort study.
Among 111 study participants with normal FLIP findings, 79% also showed no evidence of a major esophageal motor disorder on esophageal high-resolution manometry (HRM), wrote Alexandra J. Baumann, DO, of Northwestern University, Chicago, and associates. “Among the remaining 21% with apparent disagreement with HRM, [those] with normal FLIP panometry carried overall clinical impressions of not having a major esophageal motor disorder and subsequently were treated conservatively without the need for surgical interventions,” they reported. For patients with normal upper endoscopy and normal FLIP panometry, “the initial clinical management strategy could be directed toward addressing gastroesophageal reflux or a functional syndrome,” they wrote in Clinical Gastroenterology and Hepatology.
FLIP uses high-resolution impedance planimetry to evaluate esophageal lumen parameters, distensibility, and contractility in response to distension. Although HRM is standard for evaluating esophageal motility, false negatives and positives can result from challenges with interpreting outflow obstructions and normal lower-esophageal sphincter relaxation pressures among patients with clinical achalasia.
Hence, the researchers evaluated correlations between FLIP and HRM in 111 patients with esophageal symptoms and nonobstructive endoscopy findings who were evaluated at the Esophageal Center of Northwestern University between 2012 and 2019. Gastroenterologists performed additional studies, such as barium esophagrams, at their discretion. By study design, all patients had normal FLIP results, defined as an esophagogastric junction distensibility index above 3.0 mm2 per mm Hg and a normal contractile response (that is, normal repetitive retrograde contractions and a repetitive antegrade contraction pattern that met the Rule-of-6s). Three clinicians evaluated and reached consensus on each FLIP study. Esophageal HRM data were interpreted based on the Chicago classification system (version 3.0).
Patients with normal FLIP panometry findings “did not have a clinical impression of a major esophageal motor disorder,” the researchers reported. In all, 23 (21%) patients with normal FLIP results had discrepant (abnormal) HRM findings, most of which were false positives or equivocal.
For example, among 20 patients whose HRM suggested an esophagogastric junction outflow obstruction, 17 showed normal bolus transit on supine swallows and 16 showed normalization of integrated relaxation pressure after adjunctive maneuvers. Similarly, among 10 patients who underwent a barium esophagram, 8 showed normal emptying, 1 showed a temporary delay but no retention, and 1 had an incomplete study. “The overall clinical impression was not of an achalasia variant in any of these 20 patients with [esophagogastric junction outflow obstruction] on HRM, and thus none underwent botulinum toxin injection, pneumatic dilation, or lower-esophageal sphincter myotomy at our center,” the researchers wrote. Among 17 patients who were available for clinical follow-up, 4 underwent empiric dilation, of whom none had mucosal disruption. One patient was diagnosed with dysphagia lusoria based on cross-sectional imaging, while the rest were managed conservatively.
Similarly, among 10 patients with at least 50% ineffective swallows on HRM, 5 showed normal barium emptying and 9 were managed conservatively (the remaining patient underwent cricopharyngeal dilation for concurrent oropharyngeal dysphagia). The strong correlation between HRM and esophagrams in this study indicates that“[n]ormal findings from FLIP panometry can be used to exclude esophageal motility disorders at the time of endoscopy, possibly reducing the need for high-resolution manometry evaluation of some patients,” the investigators concluded. “However, further longitudinal studies are needed to support this approach.”
The work was supported by the Public Health Service and the American College of Gastroenterology. Dr. Baumann reported having no conflicts of interest. Four coinvestigators disclosed relevant ties to Crospon, Given Imaging, Ironwood, Medtronic, Sandhill Scientific, Torax, and other companies..
SOURCE: Baumann AJ et al. Clin Gastroenterol Hepatol 2020 Mar 20. doi: 10.1016/j.cgh.2020.03.040.
Endoscopy is often the first step in the evaluation of dysphagia and other esophageal symptoms such as chest pain. When endoscopy is negative for a cause of these esophageal symptoms and biopsies rule out eosinophilic esophagitis, an esophageal motility disorder should be excluded, and high-resolution esophageal manometry is considered the standard method for this purpose.
Functional lumen imaging probe (FLIP) panometry offers the opportunity to evaluate esophageal motor function during sedated endoscopy, and it can be easily added to the endoscopic procedure if there are no findings to explain esophageal symptoms. The prospect of establishing the presence of normal esophageal motility and ruling out a major motility disorder during endoscopy is very attractive because it would increase diagnostic efficiency while also obviating the need for an additional and potentially uncomfortable study for the patient. This study by Buamann and colleagues explores the yield of normal FLIP panometry to predict the presence of normal esophageal motility and rule out a major motility disorder. Their study showed that manometry was negative for a major motility disorder in 88 of 111 (79%) patients with normal FLIP panometry. Manometry revealed a major motility disorder in 23 patients with normal FLIP topography, mainly because of esophagogastric junction outflow obstruction (EGJOO) seen in 20 patients, along with absent contractility in 2, and distal esophageal spasm in 1. The EGJOO was for the most part not confirmed by adjunctive swallows on manometry or by esophagram, and aggressive therapies were not needed, indicating likely falsely positive EGJOO diagnosed by manometry. These are very encouraging results. If the findings are confirmed in larger prospective studies, it would be reasonable to consider modifying our paradigm for the evaluation of esophageal symptoms, and FLIP panometry could be considered as a screening tool to rule out a clinically significant major motility disorders during the initial endoscopic evaluation for esophageal symptoms.
Marcelo F. Vela, MD, MSCR, AGAF, is professor of medicine, director of Esophageal Disorders, and program director of Esophageal Fellowship in the division of gastroenterology and hepatology at Mayo Clinic Arizona in Scottsdale. He reports being a consultant for Medtronic and receiving research support from Diversatek.
Endoscopy is often the first step in the evaluation of dysphagia and other esophageal symptoms such as chest pain. When endoscopy is negative for a cause of these esophageal symptoms and biopsies rule out eosinophilic esophagitis, an esophageal motility disorder should be excluded, and high-resolution esophageal manometry is considered the standard method for this purpose.
Functional lumen imaging probe (FLIP) panometry offers the opportunity to evaluate esophageal motor function during sedated endoscopy, and it can be easily added to the endoscopic procedure if there are no findings to explain esophageal symptoms. The prospect of establishing the presence of normal esophageal motility and ruling out a major motility disorder during endoscopy is very attractive because it would increase diagnostic efficiency while also obviating the need for an additional and potentially uncomfortable study for the patient. This study by Buamann and colleagues explores the yield of normal FLIP panometry to predict the presence of normal esophageal motility and rule out a major motility disorder. Their study showed that manometry was negative for a major motility disorder in 88 of 111 (79%) patients with normal FLIP panometry. Manometry revealed a major motility disorder in 23 patients with normal FLIP topography, mainly because of esophagogastric junction outflow obstruction (EGJOO) seen in 20 patients, along with absent contractility in 2, and distal esophageal spasm in 1. The EGJOO was for the most part not confirmed by adjunctive swallows on manometry or by esophagram, and aggressive therapies were not needed, indicating likely falsely positive EGJOO diagnosed by manometry. These are very encouraging results. If the findings are confirmed in larger prospective studies, it would be reasonable to consider modifying our paradigm for the evaluation of esophageal symptoms, and FLIP panometry could be considered as a screening tool to rule out a clinically significant major motility disorders during the initial endoscopic evaluation for esophageal symptoms.
Marcelo F. Vela, MD, MSCR, AGAF, is professor of medicine, director of Esophageal Disorders, and program director of Esophageal Fellowship in the division of gastroenterology and hepatology at Mayo Clinic Arizona in Scottsdale. He reports being a consultant for Medtronic and receiving research support from Diversatek.
Endoscopy is often the first step in the evaluation of dysphagia and other esophageal symptoms such as chest pain. When endoscopy is negative for a cause of these esophageal symptoms and biopsies rule out eosinophilic esophagitis, an esophageal motility disorder should be excluded, and high-resolution esophageal manometry is considered the standard method for this purpose.
Functional lumen imaging probe (FLIP) panometry offers the opportunity to evaluate esophageal motor function during sedated endoscopy, and it can be easily added to the endoscopic procedure if there are no findings to explain esophageal symptoms. The prospect of establishing the presence of normal esophageal motility and ruling out a major motility disorder during endoscopy is very attractive because it would increase diagnostic efficiency while also obviating the need for an additional and potentially uncomfortable study for the patient. This study by Buamann and colleagues explores the yield of normal FLIP panometry to predict the presence of normal esophageal motility and rule out a major motility disorder. Their study showed that manometry was negative for a major motility disorder in 88 of 111 (79%) patients with normal FLIP panometry. Manometry revealed a major motility disorder in 23 patients with normal FLIP topography, mainly because of esophagogastric junction outflow obstruction (EGJOO) seen in 20 patients, along with absent contractility in 2, and distal esophageal spasm in 1. The EGJOO was for the most part not confirmed by adjunctive swallows on manometry or by esophagram, and aggressive therapies were not needed, indicating likely falsely positive EGJOO diagnosed by manometry. These are very encouraging results. If the findings are confirmed in larger prospective studies, it would be reasonable to consider modifying our paradigm for the evaluation of esophageal symptoms, and FLIP panometry could be considered as a screening tool to rule out a clinically significant major motility disorders during the initial endoscopic evaluation for esophageal symptoms.
Marcelo F. Vela, MD, MSCR, AGAF, is professor of medicine, director of Esophageal Disorders, and program director of Esophageal Fellowship in the division of gastroenterology and hepatology at Mayo Clinic Arizona in Scottsdale. He reports being a consultant for Medtronic and receiving research support from Diversatek.
Most patients with normal findings on functional luminal imaging probe (FLIP) showed no clinical evidence of a major esophageal motor disorder, even when their high-resolution manometry (HRM) test results were abnormal, according to the results of a single-center retrospective cohort study.
Among 111 study participants with normal FLIP findings, 79% also showed no evidence of a major esophageal motor disorder on esophageal high-resolution manometry (HRM), wrote Alexandra J. Baumann, DO, of Northwestern University, Chicago, and associates. “Among the remaining 21% with apparent disagreement with HRM, [those] with normal FLIP panometry carried overall clinical impressions of not having a major esophageal motor disorder and subsequently were treated conservatively without the need for surgical interventions,” they reported. For patients with normal upper endoscopy and normal FLIP panometry, “the initial clinical management strategy could be directed toward addressing gastroesophageal reflux or a functional syndrome,” they wrote in Clinical Gastroenterology and Hepatology.
FLIP uses high-resolution impedance planimetry to evaluate esophageal lumen parameters, distensibility, and contractility in response to distension. Although HRM is standard for evaluating esophageal motility, false negatives and positives can result from challenges with interpreting outflow obstructions and normal lower-esophageal sphincter relaxation pressures among patients with clinical achalasia.
Hence, the researchers evaluated correlations between FLIP and HRM in 111 patients with esophageal symptoms and nonobstructive endoscopy findings who were evaluated at the Esophageal Center of Northwestern University between 2012 and 2019. Gastroenterologists performed additional studies, such as barium esophagrams, at their discretion. By study design, all patients had normal FLIP results, defined as an esophagogastric junction distensibility index above 3.0 mm2 per mm Hg and a normal contractile response (that is, normal repetitive retrograde contractions and a repetitive antegrade contraction pattern that met the Rule-of-6s). Three clinicians evaluated and reached consensus on each FLIP study. Esophageal HRM data were interpreted based on the Chicago classification system (version 3.0).
Patients with normal FLIP panometry findings “did not have a clinical impression of a major esophageal motor disorder,” the researchers reported. In all, 23 (21%) patients with normal FLIP results had discrepant (abnormal) HRM findings, most of which were false positives or equivocal.
For example, among 20 patients whose HRM suggested an esophagogastric junction outflow obstruction, 17 showed normal bolus transit on supine swallows and 16 showed normalization of integrated relaxation pressure after adjunctive maneuvers. Similarly, among 10 patients who underwent a barium esophagram, 8 showed normal emptying, 1 showed a temporary delay but no retention, and 1 had an incomplete study. “The overall clinical impression was not of an achalasia variant in any of these 20 patients with [esophagogastric junction outflow obstruction] on HRM, and thus none underwent botulinum toxin injection, pneumatic dilation, or lower-esophageal sphincter myotomy at our center,” the researchers wrote. Among 17 patients who were available for clinical follow-up, 4 underwent empiric dilation, of whom none had mucosal disruption. One patient was diagnosed with dysphagia lusoria based on cross-sectional imaging, while the rest were managed conservatively.
Similarly, among 10 patients with at least 50% ineffective swallows on HRM, 5 showed normal barium emptying and 9 were managed conservatively (the remaining patient underwent cricopharyngeal dilation for concurrent oropharyngeal dysphagia). The strong correlation between HRM and esophagrams in this study indicates that“[n]ormal findings from FLIP panometry can be used to exclude esophageal motility disorders at the time of endoscopy, possibly reducing the need for high-resolution manometry evaluation of some patients,” the investigators concluded. “However, further longitudinal studies are needed to support this approach.”
The work was supported by the Public Health Service and the American College of Gastroenterology. Dr. Baumann reported having no conflicts of interest. Four coinvestigators disclosed relevant ties to Crospon, Given Imaging, Ironwood, Medtronic, Sandhill Scientific, Torax, and other companies..
SOURCE: Baumann AJ et al. Clin Gastroenterol Hepatol 2020 Mar 20. doi: 10.1016/j.cgh.2020.03.040.
Most patients with normal findings on functional luminal imaging probe (FLIP) showed no clinical evidence of a major esophageal motor disorder, even when their high-resolution manometry (HRM) test results were abnormal, according to the results of a single-center retrospective cohort study.
Among 111 study participants with normal FLIP findings, 79% also showed no evidence of a major esophageal motor disorder on esophageal high-resolution manometry (HRM), wrote Alexandra J. Baumann, DO, of Northwestern University, Chicago, and associates. “Among the remaining 21% with apparent disagreement with HRM, [those] with normal FLIP panometry carried overall clinical impressions of not having a major esophageal motor disorder and subsequently were treated conservatively without the need for surgical interventions,” they reported. For patients with normal upper endoscopy and normal FLIP panometry, “the initial clinical management strategy could be directed toward addressing gastroesophageal reflux or a functional syndrome,” they wrote in Clinical Gastroenterology and Hepatology.
FLIP uses high-resolution impedance planimetry to evaluate esophageal lumen parameters, distensibility, and contractility in response to distension. Although HRM is standard for evaluating esophageal motility, false negatives and positives can result from challenges with interpreting outflow obstructions and normal lower-esophageal sphincter relaxation pressures among patients with clinical achalasia.
Hence, the researchers evaluated correlations between FLIP and HRM in 111 patients with esophageal symptoms and nonobstructive endoscopy findings who were evaluated at the Esophageal Center of Northwestern University between 2012 and 2019. Gastroenterologists performed additional studies, such as barium esophagrams, at their discretion. By study design, all patients had normal FLIP results, defined as an esophagogastric junction distensibility index above 3.0 mm2 per mm Hg and a normal contractile response (that is, normal repetitive retrograde contractions and a repetitive antegrade contraction pattern that met the Rule-of-6s). Three clinicians evaluated and reached consensus on each FLIP study. Esophageal HRM data were interpreted based on the Chicago classification system (version 3.0).
Patients with normal FLIP panometry findings “did not have a clinical impression of a major esophageal motor disorder,” the researchers reported. In all, 23 (21%) patients with normal FLIP results had discrepant (abnormal) HRM findings, most of which were false positives or equivocal.
For example, among 20 patients whose HRM suggested an esophagogastric junction outflow obstruction, 17 showed normal bolus transit on supine swallows and 16 showed normalization of integrated relaxation pressure after adjunctive maneuvers. Similarly, among 10 patients who underwent a barium esophagram, 8 showed normal emptying, 1 showed a temporary delay but no retention, and 1 had an incomplete study. “The overall clinical impression was not of an achalasia variant in any of these 20 patients with [esophagogastric junction outflow obstruction] on HRM, and thus none underwent botulinum toxin injection, pneumatic dilation, or lower-esophageal sphincter myotomy at our center,” the researchers wrote. Among 17 patients who were available for clinical follow-up, 4 underwent empiric dilation, of whom none had mucosal disruption. One patient was diagnosed with dysphagia lusoria based on cross-sectional imaging, while the rest were managed conservatively.
Similarly, among 10 patients with at least 50% ineffective swallows on HRM, 5 showed normal barium emptying and 9 were managed conservatively (the remaining patient underwent cricopharyngeal dilation for concurrent oropharyngeal dysphagia). The strong correlation between HRM and esophagrams in this study indicates that“[n]ormal findings from FLIP panometry can be used to exclude esophageal motility disorders at the time of endoscopy, possibly reducing the need for high-resolution manometry evaluation of some patients,” the investigators concluded. “However, further longitudinal studies are needed to support this approach.”
The work was supported by the Public Health Service and the American College of Gastroenterology. Dr. Baumann reported having no conflicts of interest. Four coinvestigators disclosed relevant ties to Crospon, Given Imaging, Ironwood, Medtronic, Sandhill Scientific, Torax, and other companies..
SOURCE: Baumann AJ et al. Clin Gastroenterol Hepatol 2020 Mar 20. doi: 10.1016/j.cgh.2020.03.040.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY