Upper GI Tract

Transoral esophagogastric fundoplication can be an effective treatment for patients seeking to alleviate symptoms associated with gastroesophageal reflux disease, particularly in individuals with persistent regurgitation despite prior treatment with proton pump inhibitor therapy, according to the results of a new study published in the February issue of Gastroenterology (doi:10.1053/j.gastro.2014.10.009).

“Gastroesophageal reflux disease (GERD) remains one of the most common conditions for which Americans take daily medication, and PPI use has more than doubled in the last decade,” wrote lead authors Dr. John G. Hunter of Oregon Health & Science University in Portland, and Dr. Peter J. Kahrilas of Northwestern University in Chicago, and their associates. “Despite this, up to 40% of proton pump inhibitor (PPI)–dependent GERD patients have troublesome symptoms of GERD, despite PPI therapy.”

In the Randomized EsophyX vs Sham, Placebo-Controlled Transoral Fundoplication (RESPECT) trial, investigators screened 696 patients who were experiencing “troublesome regurgitation” despite daily PPI treatment. These subjects were evaluated via three validated GERD-specific symptom scales, and were either on or off PPI use at the time of trial commencement. Post trial, patients were blinded to therapy and were reassessed at intervals of 2, 12, and 26 weeks. All patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy at 66 months after the trial ended.

© nebari/Thinkstock

Regurgitation severity was based on the Montreal definition, which was used to measure efficacy of treatments given as part of the study. The Montreal definition of reflux is described by the authors as “either mucosal damage or troublesome symptoms attributable to reflux.” Those with “least troublesome” regurgitation while on PPIs “underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses.”

Eighty-seven subjects with GERD and hiatal hernias of at least 2 centimeters were randomly assigned to groups that underwent transoral fundoplication (TF) followed by placebo treatment after 6 months, while 42 subjects, who made up the control group, underwent a “sham surgery” and began regimens of once- or twice-daily omeprazole medication for 6 months.

Results showed that 67% of patients who received TF treatment experienced elimination of adverse regurgitation vs. 45% of those treated with PPI (P = .023). Control of esophageal pH also improved noticeably in patients who received TF treatment versus those who did not (9.3% vs. 6.3% on average, respectively, P < .001), but not in patients who received the “sham surgery” (8.6% preop vs. 8.9% postop on average). Fewer patients who received TF treatment recorded having “no response” after 3 months compared with those in the control group (11% vs. 36%, respectively, P = .004).

“Transoral fundoplication may fill the ‘therapeutic gap’ that exists between PPI and laparoscopic fundoplication,” wrote the authors. “Considering the virtual absence of dysphagia and bloating after TF, which may be problematic with LINX [LINX Reflux Management System], it would appear that TF is an option for patients with troublesome regurgitation, as well as for patients with troublesome GERD symptoms who wish not to take PPI over a protracted period of time.”

Several coauthors disclosed ties with the study sponsor EndoGastric Solutions of Redmond, Wash., as well as individual potential conflicts of interest.

[email protected]

Transoral esophagogastric fundoplication can be an effective treatment for patients seeking to alleviate symptoms associated with gastroesophageal reflux disease, particularly in individuals with persistent regurgitation despite prior treatment with proton pump inhibitor therapy, according to the results of a new study published in the February issue of Gastroenterology (doi:10.1053/j.gastro.2014.10.009).

“Gastroesophageal reflux disease (GERD) remains one of the most common conditions for which Americans take daily medication, and PPI use has more than doubled in the last decade,” wrote lead authors Dr. John G. Hunter of Oregon Health & Science University in Portland, and Dr. Peter J. Kahrilas of Northwestern University in Chicago, and their associates. “Despite this, up to 40% of proton pump inhibitor (PPI)–dependent GERD patients have troublesome symptoms of GERD, despite PPI therapy.”

In the Randomized EsophyX vs Sham, Placebo-Controlled Transoral Fundoplication (RESPECT) trial, investigators screened 696 patients who were experiencing “troublesome regurgitation” despite daily PPI treatment. These subjects were evaluated via three validated GERD-specific symptom scales, and were either on or off PPI use at the time of trial commencement. Post trial, patients were blinded to therapy and were reassessed at intervals of 2, 12, and 26 weeks. All patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy at 66 months after the trial ended.

© nebari/Thinkstock

Regurgitation severity was based on the Montreal definition, which was used to measure efficacy of treatments given as part of the study. The Montreal definition of reflux is described by the authors as “either mucosal damage or troublesome symptoms attributable to reflux.” Those with “least troublesome” regurgitation while on PPIs “underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses.”

Eighty-seven subjects with GERD and hiatal hernias of at least 2 centimeters were randomly assigned to groups that underwent transoral fundoplication (TF) followed by placebo treatment after 6 months, while 42 subjects, who made up the control group, underwent a “sham surgery” and began regimens of once- or twice-daily omeprazole medication for 6 months.

Results showed that 67% of patients who received TF treatment experienced elimination of adverse regurgitation vs. 45% of those treated with PPI (P = .023). Control of esophageal pH also improved noticeably in patients who received TF treatment versus those who did not (9.3% vs. 6.3% on average, respectively, P < .001), but not in patients who received the “sham surgery” (8.6% preop vs. 8.9% postop on average). Fewer patients who received TF treatment recorded having “no response” after 3 months compared with those in the control group (11% vs. 36%, respectively, P = .004).

“Transoral fundoplication may fill the ‘therapeutic gap’ that exists between PPI and laparoscopic fundoplication,” wrote the authors. “Considering the virtual absence of dysphagia and bloating after TF, which may be problematic with LINX [LINX Reflux Management System], it would appear that TF is an option for patients with troublesome regurgitation, as well as for patients with troublesome GERD symptoms who wish not to take PPI over a protracted period of time.”

Several coauthors disclosed ties with the study sponsor EndoGastric Solutions of Redmond, Wash., as well as individual potential conflicts of interest.

[email protected]

Transoral esophagogastric fundoplication can be an effective treatment for patients seeking to alleviate symptoms associated with gastroesophageal reflux disease, particularly in individuals with persistent regurgitation despite prior treatment with proton pump inhibitor therapy, according to the results of a new study published in the February issue of Gastroenterology (doi:10.1053/j.gastro.2014.10.009).

“Gastroesophageal reflux disease (GERD) remains one of the most common conditions for which Americans take daily medication, and PPI use has more than doubled in the last decade,” wrote lead authors Dr. John G. Hunter of Oregon Health & Science University in Portland, and Dr. Peter J. Kahrilas of Northwestern University in Chicago, and their associates. “Despite this, up to 40% of proton pump inhibitor (PPI)–dependent GERD patients have troublesome symptoms of GERD, despite PPI therapy.”

In the Randomized EsophyX vs Sham, Placebo-Controlled Transoral Fundoplication (RESPECT) trial, investigators screened 696 patients who were experiencing “troublesome regurgitation” despite daily PPI treatment. These subjects were evaluated via three validated GERD-specific symptom scales, and were either on or off PPI use at the time of trial commencement. Post trial, patients were blinded to therapy and were reassessed at intervals of 2, 12, and 26 weeks. All patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy at 66 months after the trial ended.

© nebari/Thinkstock

Regurgitation severity was based on the Montreal definition, which was used to measure efficacy of treatments given as part of the study. The Montreal definition of reflux is described by the authors as “either mucosal damage or troublesome symptoms attributable to reflux.” Those with “least troublesome” regurgitation while on PPIs “underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses.”

Eighty-seven subjects with GERD and hiatal hernias of at least 2 centimeters were randomly assigned to groups that underwent transoral fundoplication (TF) followed by placebo treatment after 6 months, while 42 subjects, who made up the control group, underwent a “sham surgery” and began regimens of once- or twice-daily omeprazole medication for 6 months.

Results showed that 67% of patients who received TF treatment experienced elimination of adverse regurgitation vs. 45% of those treated with PPI (P = .023). Control of esophageal pH also improved noticeably in patients who received TF treatment versus those who did not (9.3% vs. 6.3% on average, respectively, P < .001), but not in patients who received the “sham surgery” (8.6% preop vs. 8.9% postop on average). Fewer patients who received TF treatment recorded having “no response” after 3 months compared with those in the control group (11% vs. 36%, respectively, P = .004).

“Transoral fundoplication may fill the ‘therapeutic gap’ that exists between PPI and laparoscopic fundoplication,” wrote the authors. “Considering the virtual absence of dysphagia and bloating after TF, which may be problematic with LINX [LINX Reflux Management System], it would appear that TF is an option for patients with troublesome regurgitation, as well as for patients with troublesome GERD symptoms who wish not to take PPI over a protracted period of time.”

Several coauthors disclosed ties with the study sponsor EndoGastric Solutions of Redmond, Wash., as well as individual potential conflicts of interest.

[email protected]

Topical steroid therapy improved some indicators of mucosal integrity in patients with eosinophilic esophagitis, but proton pump inhibitor therapy did not, according to two studies reported in the November issue of Clinical Gastroenterology and Hepatology.

The first study found that topical fluticasone therapy at a dose of 880 mcg twice daily for 2 months helped correct esophageal spongiosis, or dilated intercellular space, in patients with eosinophilic esophagitis (EoE). Spongiosis scores for treated patients were significantly lower than for untreated patients (0.4 vs. 1.3; P = .016), said Dr. David Katzka at the Mayo Clinic in Rochester, Minn. and his associates (Clin. Gastroenterol. Hepatol. 2014 [doi:10.1016/j.cgh.2014.02.039]).

In the study, histologic analyses also showed that improved spongiosis scores in treated patients correlated with increased density of two tight junction proteins, filaggrin (P = .001) and zonula occludens-3 (P = .016), said the investigators. These proteins might help regulate antigenic penetration of the esophageal mucosa and also could permit migration of white blood cells, they said. “Loss of tight junction regulators and dilation of intercellular spaces appear to be involved in the pathophysiology of EoE and could be targets for treatment,” the researchers concluded. But they also noted that their study did not examine the same patients before and after steroid therapy and did not look at desmosomes, intercellular junctions that past research has suggested might be affected in EoE.

For the second study, Dr. Bram van Rhijn and his associates at the Academic Medical Center in the Netherlands compared endoscopies of 16 patients with dysphagia and suspected (unconfirmed) EoE with 11 controls, both at baseline and after 8 weeks of high-dose esomeprazole treatment. Esophageal mucosal integrity was “severely impaired” in patients with confirmed EoE and in those with proton pump inhibitor–responsive eosinophilia (PPRE), the researchers said (Clin. Gasteroenterol. Hepatol. 2014 [doi:10.1016/j.cgh.2014.02.037]).

In both forms of disease, molecules as large as 40,000 daltons were able to pass through the compromised esophageal mucosa, Dr. Bram van Rhijn and his associates reported. “This size is similar to the size of most plant and animal food allergens to which EoE patients are sensitized,” they added. Esophageal permeability might increase the rate of immune exposure to allergens, thereby mediating EoE and PPRE, they said.

On mucosal functional tests, both EoE and PPRE were associated with reduced transepithelial electrical resistance and lower electrical tissue impedance, most notably in patients with EoE (P less than .001 for both, compared with controls), the investigators reported. Proton pump inhibitor treatment partially reversed these changes in patients with PPRE but showed no effect for patients with EoE, they said. This finding suggests that acid reflux might play a role in PPRE, but not in EOE, they concluded.

Dr. Katzka and his associates disclosed no funding sources and reported having no conflicts of interest. Dr. Rhijn and his associates were supported by the Netherlands Organization for Scientific Research. Two of Dr. Rhijn’s coauthors reported financial relationships with AstraZeneca, Endostim, Medical Measurement Systems, Shire, and GlaxoSmithKline.

Topical steroid therapy improved some indicators of mucosal integrity in patients with eosinophilic esophagitis, but proton pump inhibitor therapy did not, according to two studies reported in the November issue of Clinical Gastroenterology and Hepatology.

The first study found that topical fluticasone therapy at a dose of 880 mcg twice daily for 2 months helped correct esophageal spongiosis, or dilated intercellular space, in patients with eosinophilic esophagitis (EoE). Spongiosis scores for treated patients were significantly lower than for untreated patients (0.4 vs. 1.3; P = .016), said Dr. David Katzka at the Mayo Clinic in Rochester, Minn. and his associates (Clin. Gastroenterol. Hepatol. 2014 [doi:10.1016/j.cgh.2014.02.039]).

In the study, histologic analyses also showed that improved spongiosis scores in treated patients correlated with increased density of two tight junction proteins, filaggrin (P = .001) and zonula occludens-3 (P = .016), said the investigators. These proteins might help regulate antigenic penetration of the esophageal mucosa and also could permit migration of white blood cells, they said. “Loss of tight junction regulators and dilation of intercellular spaces appear to be involved in the pathophysiology of EoE and could be targets for treatment,” the researchers concluded. But they also noted that their study did not examine the same patients before and after steroid therapy and did not look at desmosomes, intercellular junctions that past research has suggested might be affected in EoE.

For the second study, Dr. Bram van Rhijn and his associates at the Academic Medical Center in the Netherlands compared endoscopies of 16 patients with dysphagia and suspected (unconfirmed) EoE with 11 controls, both at baseline and after 8 weeks of high-dose esomeprazole treatment. Esophageal mucosal integrity was “severely impaired” in patients with confirmed EoE and in those with proton pump inhibitor–responsive eosinophilia (PPRE), the researchers said (Clin. Gasteroenterol. Hepatol. 2014 [doi:10.1016/j.cgh.2014.02.037]).

In both forms of disease, molecules as large as 40,000 daltons were able to pass through the compromised esophageal mucosa, Dr. Bram van Rhijn and his associates reported. “This size is similar to the size of most plant and animal food allergens to which EoE patients are sensitized,” they added. Esophageal permeability might increase the rate of immune exposure to allergens, thereby mediating EoE and PPRE, they said.

On mucosal functional tests, both EoE and PPRE were associated with reduced transepithelial electrical resistance and lower electrical tissue impedance, most notably in patients with EoE (P less than .001 for both, compared with controls), the investigators reported. Proton pump inhibitor treatment partially reversed these changes in patients with PPRE but showed no effect for patients with EoE, they said. This finding suggests that acid reflux might play a role in PPRE, but not in EOE, they concluded.

Dr. Katzka and his associates disclosed no funding sources and reported having no conflicts of interest. Dr. Rhijn and his associates were supported by the Netherlands Organization for Scientific Research. Two of Dr. Rhijn’s coauthors reported financial relationships with AstraZeneca, Endostim, Medical Measurement Systems, Shire, and GlaxoSmithKline.

Topical steroid therapy improved some indicators of mucosal integrity in patients with eosinophilic esophagitis, but proton pump inhibitor therapy did not, according to two studies reported in the November issue of Clinical Gastroenterology and Hepatology.

The first study found that topical fluticasone therapy at a dose of 880 mcg twice daily for 2 months helped correct esophageal spongiosis, or dilated intercellular space, in patients with eosinophilic esophagitis (EoE). Spongiosis scores for treated patients were significantly lower than for untreated patients (0.4 vs. 1.3; P = .016), said Dr. David Katzka at the Mayo Clinic in Rochester, Minn. and his associates (Clin. Gastroenterol. Hepatol. 2014 [doi:10.1016/j.cgh.2014.02.039]).

In the study, histologic analyses also showed that improved spongiosis scores in treated patients correlated with increased density of two tight junction proteins, filaggrin (P = .001) and zonula occludens-3 (P = .016), said the investigators. These proteins might help regulate antigenic penetration of the esophageal mucosa and also could permit migration of white blood cells, they said. “Loss of tight junction regulators and dilation of intercellular spaces appear to be involved in the pathophysiology of EoE and could be targets for treatment,” the researchers concluded. But they also noted that their study did not examine the same patients before and after steroid therapy and did not look at desmosomes, intercellular junctions that past research has suggested might be affected in EoE.

For the second study, Dr. Bram van Rhijn and his associates at the Academic Medical Center in the Netherlands compared endoscopies of 16 patients with dysphagia and suspected (unconfirmed) EoE with 11 controls, both at baseline and after 8 weeks of high-dose esomeprazole treatment. Esophageal mucosal integrity was “severely impaired” in patients with confirmed EoE and in those with proton pump inhibitor–responsive eosinophilia (PPRE), the researchers said (Clin. Gasteroenterol. Hepatol. 2014 [doi:10.1016/j.cgh.2014.02.037]).

In both forms of disease, molecules as large as 40,000 daltons were able to pass through the compromised esophageal mucosa, Dr. Bram van Rhijn and his associates reported. “This size is similar to the size of most plant and animal food allergens to which EoE patients are sensitized,” they added. Esophageal permeability might increase the rate of immune exposure to allergens, thereby mediating EoE and PPRE, they said.

On mucosal functional tests, both EoE and PPRE were associated with reduced transepithelial electrical resistance and lower electrical tissue impedance, most notably in patients with EoE (P less than .001 for both, compared with controls), the investigators reported. Proton pump inhibitor treatment partially reversed these changes in patients with PPRE but showed no effect for patients with EoE, they said. This finding suggests that acid reflux might play a role in PPRE, but not in EOE, they concluded.

Dr. Katzka and his associates disclosed no funding sources and reported having no conflicts of interest. Dr. Rhijn and his associates were supported by the Netherlands Organization for Scientific Research. Two of Dr. Rhijn’s coauthors reported financial relationships with AstraZeneca, Endostim, Medical Measurement Systems, Shire, and GlaxoSmithKline.

Combining nonsteroidal anti-inflammatory drugs with selective serotonin reuptake inhibitors increased the risk of upper gastrointestinal bleeding by up to 190% beyond the baseline risk found for NSAID monotherapy, researchers reported in the October issue of Gastroenterology.

Patients also faced excess risks of upper GI bleeding when they took corticosteroids, aldosterone antagonists, or anticoagulants together with low-dose aspirin or nonselective NSAIDs, although the effect was not seen for COX-2 inhibitors, said Dr. Gwen Masclee at Erasmus Medical Center in Rotterdam, the Netherlands and her associates.

© khuntapol / ThinkStockPhotos.com

Source: American Gastroenterological Association

The findings should help clinicians tailor treatments to minimize chances of upper gastrointestinal bleeding, particularly for elderly patients who often take multiple drugs, the investigators said (Gastroenterology 2014 [doi:10.1053/j.gastro.2014.06.007]).

The researchers analyzed 114,835 cases of upper gastrointestinal bleeding, including all gastroduodenal ulcers and hemorrhages extracted from seven electronic health record databases from the Netherlands, Italy, and Denmark. Three databases included primary care data, and four were administrative claims data, the investigators said. Cases served as their own controls, they noted.

Monotherapy with prescription nonselective NSAIDs increased the chances of an upper gastrointestinal bleed by 4.3 times, compared with not using any of the drugs studied (95% confidence interval, 4.1-4.4), the researchers said. Notably, bleeding risk from taking either nonselective NSAIDs or corticosteroids was the same, they said, adding that previous studies have yielded inconsistent findings on the topic. The incidence ratios for monotherapy with low-dose aspirin and COX-2 inhibitors were slightly lower at 3.1 (95% CI, 2.9-3.2) and 2.9 (95% CI, 2.7-3.2), respectively, they added.

Combining nonselective NSAIDs, COX-2 inhibitors, or low-dose aspirin with SSRIs led to excess risks of upper gastrointestinal bleeding of 1.6 (95% CI, 0.5-2.6), 1.9 (95% CI, 0.2-3.4), and 0.49 (–0.05-1.03), respectively, the researchers reported. "From a biological point of view, this interaction seems plausible because SSRIs decrease the serotonin level, resulting in impaired thrombocyte aggregation and an increased risk of bleeding in general," they said.

Corticosteroids combined with nonselective NSAIDs led to the greatest increases in bleeding risk, with an incidence ratio of 12.8 (95% CI, 11.1-14.7), compared with nonuse of any drug studied, and an excess risk of 5.5 (3.7-7.3), compared with NSAID use alone, said the researchers. Adding aldosterone antagonists to nonselective NSAIDs led to an excess risk of 4.46, compared with using nonselective NSAIDs alone, they reported (95% CI, 1.79-7.13).

Because the study did not capture over-the-counter NSAID prescriptions, it could have underestimated use of these drugs, the investigators said. Also, changes in health or NSAID use during the study could have created residual confounding, although sensitivity analyses did not reveal problems, they reported. They added that misclassification of some data could have led them to underestimate risks. "Finally, we did not take any carryover effect or dose of drug exposure into account, which potentially limits the generalizability concerning causality of the associations," they concluded.

Five authors reported employment or other financial support from Erasmus University Medical Center, AstraZeneca, Janssen, PHARMO Institute, and the European Medicines Agency. The other authors reported no relevant conflicts of interests.

Combining nonsteroidal anti-inflammatory drugs with selective serotonin reuptake inhibitors increased the risk of upper gastrointestinal bleeding by up to 190% beyond the baseline risk found for NSAID monotherapy, researchers reported in the October issue of Gastroenterology.

Patients also faced excess risks of upper GI bleeding when they took corticosteroids, aldosterone antagonists, or anticoagulants together with low-dose aspirin or nonselective NSAIDs, although the effect was not seen for COX-2 inhibitors, said Dr. Gwen Masclee at Erasmus Medical Center in Rotterdam, the Netherlands and her associates.

© khuntapol / ThinkStockPhotos.com

Source: American Gastroenterological Association

The findings should help clinicians tailor treatments to minimize chances of upper gastrointestinal bleeding, particularly for elderly patients who often take multiple drugs, the investigators said (Gastroenterology 2014 [doi:10.1053/j.gastro.2014.06.007]).

The researchers analyzed 114,835 cases of upper gastrointestinal bleeding, including all gastroduodenal ulcers and hemorrhages extracted from seven electronic health record databases from the Netherlands, Italy, and Denmark. Three databases included primary care data, and four were administrative claims data, the investigators said. Cases served as their own controls, they noted.

Monotherapy with prescription nonselective NSAIDs increased the chances of an upper gastrointestinal bleed by 4.3 times, compared with not using any of the drugs studied (95% confidence interval, 4.1-4.4), the researchers said. Notably, bleeding risk from taking either nonselective NSAIDs or corticosteroids was the same, they said, adding that previous studies have yielded inconsistent findings on the topic. The incidence ratios for monotherapy with low-dose aspirin and COX-2 inhibitors were slightly lower at 3.1 (95% CI, 2.9-3.2) and 2.9 (95% CI, 2.7-3.2), respectively, they added.

Combining nonselective NSAIDs, COX-2 inhibitors, or low-dose aspirin with SSRIs led to excess risks of upper gastrointestinal bleeding of 1.6 (95% CI, 0.5-2.6), 1.9 (95% CI, 0.2-3.4), and 0.49 (–0.05-1.03), respectively, the researchers reported. "From a biological point of view, this interaction seems plausible because SSRIs decrease the serotonin level, resulting in impaired thrombocyte aggregation and an increased risk of bleeding in general," they said.

Corticosteroids combined with nonselective NSAIDs led to the greatest increases in bleeding risk, with an incidence ratio of 12.8 (95% CI, 11.1-14.7), compared with nonuse of any drug studied, and an excess risk of 5.5 (3.7-7.3), compared with NSAID use alone, said the researchers. Adding aldosterone antagonists to nonselective NSAIDs led to an excess risk of 4.46, compared with using nonselective NSAIDs alone, they reported (95% CI, 1.79-7.13).

Because the study did not capture over-the-counter NSAID prescriptions, it could have underestimated use of these drugs, the investigators said. Also, changes in health or NSAID use during the study could have created residual confounding, although sensitivity analyses did not reveal problems, they reported. They added that misclassification of some data could have led them to underestimate risks. "Finally, we did not take any carryover effect or dose of drug exposure into account, which potentially limits the generalizability concerning causality of the associations," they concluded.

Five authors reported employment or other financial support from Erasmus University Medical Center, AstraZeneca, Janssen, PHARMO Institute, and the European Medicines Agency. The other authors reported no relevant conflicts of interests.

Combining nonsteroidal anti-inflammatory drugs with selective serotonin reuptake inhibitors increased the risk of upper gastrointestinal bleeding by up to 190% beyond the baseline risk found for NSAID monotherapy, researchers reported in the October issue of Gastroenterology.

Patients also faced excess risks of upper GI bleeding when they took corticosteroids, aldosterone antagonists, or anticoagulants together with low-dose aspirin or nonselective NSAIDs, although the effect was not seen for COX-2 inhibitors, said Dr. Gwen Masclee at Erasmus Medical Center in Rotterdam, the Netherlands and her associates.

© khuntapol / ThinkStockPhotos.com

Source: American Gastroenterological Association

The findings should help clinicians tailor treatments to minimize chances of upper gastrointestinal bleeding, particularly for elderly patients who often take multiple drugs, the investigators said (Gastroenterology 2014 [doi:10.1053/j.gastro.2014.06.007]).

The researchers analyzed 114,835 cases of upper gastrointestinal bleeding, including all gastroduodenal ulcers and hemorrhages extracted from seven electronic health record databases from the Netherlands, Italy, and Denmark. Three databases included primary care data, and four were administrative claims data, the investigators said. Cases served as their own controls, they noted.

Monotherapy with prescription nonselective NSAIDs increased the chances of an upper gastrointestinal bleed by 4.3 times, compared with not using any of the drugs studied (95% confidence interval, 4.1-4.4), the researchers said. Notably, bleeding risk from taking either nonselective NSAIDs or corticosteroids was the same, they said, adding that previous studies have yielded inconsistent findings on the topic. The incidence ratios for monotherapy with low-dose aspirin and COX-2 inhibitors were slightly lower at 3.1 (95% CI, 2.9-3.2) and 2.9 (95% CI, 2.7-3.2), respectively, they added.

Combining nonselective NSAIDs, COX-2 inhibitors, or low-dose aspirin with SSRIs led to excess risks of upper gastrointestinal bleeding of 1.6 (95% CI, 0.5-2.6), 1.9 (95% CI, 0.2-3.4), and 0.49 (–0.05-1.03), respectively, the researchers reported. "From a biological point of view, this interaction seems plausible because SSRIs decrease the serotonin level, resulting in impaired thrombocyte aggregation and an increased risk of bleeding in general," they said.

Corticosteroids combined with nonselective NSAIDs led to the greatest increases in bleeding risk, with an incidence ratio of 12.8 (95% CI, 11.1-14.7), compared with nonuse of any drug studied, and an excess risk of 5.5 (3.7-7.3), compared with NSAID use alone, said the researchers. Adding aldosterone antagonists to nonselective NSAIDs led to an excess risk of 4.46, compared with using nonselective NSAIDs alone, they reported (95% CI, 1.79-7.13).

Because the study did not capture over-the-counter NSAID prescriptions, it could have underestimated use of these drugs, the investigators said. Also, changes in health or NSAID use during the study could have created residual confounding, although sensitivity analyses did not reveal problems, they reported. They added that misclassification of some data could have led them to underestimate risks. "Finally, we did not take any carryover effect or dose of drug exposure into account, which potentially limits the generalizability concerning causality of the associations," they concluded.

Five authors reported employment or other financial support from Erasmus University Medical Center, AstraZeneca, Janssen, PHARMO Institute, and the European Medicines Agency. The other authors reported no relevant conflicts of interests.

One highlight of the AGA Postgraduate Course was the esophageal disease session. The presentation by Dr. Michael B. Wallace summarized recent studies using advanced imaging modalities in patients with Barrett’s esophagus. Studies using chromoscopy and virtual chromoscopy techniques such as narrow-band imaging have increased the detection of dysplasia in BE patients. These are so-called red flag techniques that image large areas of mucosa to detect mucosal abnormalities suspicious for the presence of dysplasia or neoplasia.

Endomicroscopy describes the use of real-time, targeted endoscopic imaging modalities that are capable of producing histologic-like images of mucosa at depths up to 200 microns. Confocal laser endomicroscopy (CLE) uses a blue light laser (405 nm) and collimated light detection and analysis to produce 1000-fold magnified images. When used with a fluorescent contrast agent such as fluorescein or acriflavin dye, these systems produce cellular level images that are comparable to those images seen with optical microscopy. A recent study from Canto et al found that the use of CLE detected BE dysplasia at rates similar to targeted plus random biopsy protocols. Further, a multicenter study will soon begin using a tethered-capsule (nonendoscopic) form of volumetric laser endomicroscopy as a method to screen for BE.

Dr. Amitabh Chak expanded on these issues and reviewed the issues surrounding screening and surveillance of BE patients for the early detection and treatment of esophageal adenocarcinoma. This presentation suggested that necessary future improvements include cost-effective advanced imaging techniques optimized for use in clinical practice, molecular biomarker panels for prediction of which patients may progress to dysplasia and neoplasia, and high-quality intensive endoscopic surveillance for high risk BE patients.

Dr. Joe Murray’s comprehensive presentation of celiac disease described the protean clinical presentations of this disease as well as optimal use of serologic and endoscopic testing. Celiac disease is increasingly identified in middle-aged patients (median 45 years) without diarrhea. Classic malabsorption symptoms of diarrhea, weight loss, steatorrhea, and nutritional deficiencies are found in 25% of patients. Half of celiac patients will have only one symptom such as anemia, diarrhea, lactose intolerance, or weight loss. Nongastrointestinal symptoms are present in another 25% of patients such as infertility, bone disease, chronic fatigue, or abnormal liver enzyme test results.

Optimal use of serologic and endoscopic testing was reviewed, including the differential diagnosis of lymphocytic duodenosis including use of nonsteroidal anti-inflammatory agents (NSAIDs), Helicobacter pylori infection, Crohn’s disease, and Sjogren’s syndrome. Proper duodenal biopsy technique was emphasized with two forceps biopsy samples obtained from the duodenal bulb and four biopsy samples obtained from the second portion of the duodenum. Also discussed was the utility of HLA typing for DQ2/8 in patients currently using a gluten free diet, patients with negative serology results but abnormal duodenal biopsy findings, and those with negative serology results who are at increased genetic risk.

Dr. James Scheiman discussed management of the complex interaction and risks associated with the use of NSAIDs, aspirin, clopidogrel, and proton pump inhibitors in the setting of previous ulcer disease, gastrointestinal bleeding, and Helicobacter pylori infection. Results from randomized controlled studies and observational studies were the basis for the Consensus Group to recommend the use of proton pump inhibitor therapy as the GI bleeding protective strategy of choice. PPI therapy was also recommended as cost-effective treatment for aspirin-using patients, although the risks and benefits of long-term PPI treatment require patient education and individualization.

Finally, Dr. Rhonda Souza discussed eosinophilic esophagitis (EoE), a chronic immune/antigen-mediated esophageal disease characterized clinically by symptoms related to esophageal dysfunction associated with eosinophil-predominant inflammation such as dysphagia, food impaction, chest pain, heartburn, abdominal pain, and refractory reflux dyspepsia. Endoscopic features include the ringed esophagus, white specks, linear furrows and stricture. Histologic features of EoE are eosinophilia (more than 15 intraepithelial eosinophils per high power field), basal zone hyperplasia, and dilated intercellular spaces. These eosinophils are activated via T-helper 2 immune system via interleukins-4, -5 and -13. This inflammation is mediated by the dramatic upregulation involving the eotaxin-3 gene that produces a potent chemoattractant for eosinophils. Treatment of EoE usually requires the use of proton pump inhibitors based on their acid suppression, anti-oxidant and anti-inflammatory effects. The use of topical corticosteroids and endoscopic dilation for symptomatic strictures may also be necessary. Nondrug treatment approaches such as the six food elimination diet (SFED) of the most common food allergens such as milk, soy, eggs, wheat, nuts and seafood have also been successful.

Dr. Wolfsen is in the division of gastroenterology and hepatology, Mayo Clinic, Jacksonville, Fla. He moderated this session during the 2014 Digestive Diseases Week. 


One highlight of the AGA Postgraduate Course was the esophageal disease session. The presentation by Dr. Michael B. Wallace summarized recent studies using advanced imaging modalities in patients with Barrett’s esophagus. Studies using chromoscopy and virtual chromoscopy techniques such as narrow-band imaging have increased the detection of dysplasia in BE patients. These are so-called red flag techniques that image large areas of mucosa to detect mucosal abnormalities suspicious for the presence of dysplasia or neoplasia.

Endomicroscopy describes the use of real-time, targeted endoscopic imaging modalities that are capable of producing histologic-like images of mucosa at depths up to 200 microns. Confocal laser endomicroscopy (CLE) uses a blue light laser (405 nm) and collimated light detection and analysis to produce 1000-fold magnified images. When used with a fluorescent contrast agent such as fluorescein or acriflavin dye, these systems produce cellular level images that are comparable to those images seen with optical microscopy. A recent study from Canto et al found that the use of CLE detected BE dysplasia at rates similar to targeted plus random biopsy protocols. Further, a multicenter study will soon begin using a tethered-capsule (nonendoscopic) form of volumetric laser endomicroscopy as a method to screen for BE.

Dr. Amitabh Chak expanded on these issues and reviewed the issues surrounding screening and surveillance of BE patients for the early detection and treatment of esophageal adenocarcinoma. This presentation suggested that necessary future improvements include cost-effective advanced imaging techniques optimized for use in clinical practice, molecular biomarker panels for prediction of which patients may progress to dysplasia and neoplasia, and high-quality intensive endoscopic surveillance for high risk BE patients.

Dr. Joe Murray’s comprehensive presentation of celiac disease described the protean clinical presentations of this disease as well as optimal use of serologic and endoscopic testing. Celiac disease is increasingly identified in middle-aged patients (median 45 years) without diarrhea. Classic malabsorption symptoms of diarrhea, weight loss, steatorrhea, and nutritional deficiencies are found in 25% of patients. Half of celiac patients will have only one symptom such as anemia, diarrhea, lactose intolerance, or weight loss. Nongastrointestinal symptoms are present in another 25% of patients such as infertility, bone disease, chronic fatigue, or abnormal liver enzyme test results.

Optimal use of serologic and endoscopic testing was reviewed, including the differential diagnosis of lymphocytic duodenosis including use of nonsteroidal anti-inflammatory agents (NSAIDs), Helicobacter pylori infection, Crohn’s disease, and Sjogren’s syndrome. Proper duodenal biopsy technique was emphasized with two forceps biopsy samples obtained from the duodenal bulb and four biopsy samples obtained from the second portion of the duodenum. Also discussed was the utility of HLA typing for DQ2/8 in patients currently using a gluten free diet, patients with negative serology results but abnormal duodenal biopsy findings, and those with negative serology results who are at increased genetic risk.

Dr. James Scheiman discussed management of the complex interaction and risks associated with the use of NSAIDs, aspirin, clopidogrel, and proton pump inhibitors in the setting of previous ulcer disease, gastrointestinal bleeding, and Helicobacter pylori infection. Results from randomized controlled studies and observational studies were the basis for the Consensus Group to recommend the use of proton pump inhibitor therapy as the GI bleeding protective strategy of choice. PPI therapy was also recommended as cost-effective treatment for aspirin-using patients, although the risks and benefits of long-term PPI treatment require patient education and individualization.

Finally, Dr. Rhonda Souza discussed eosinophilic esophagitis (EoE), a chronic immune/antigen-mediated esophageal disease characterized clinically by symptoms related to esophageal dysfunction associated with eosinophil-predominant inflammation such as dysphagia, food impaction, chest pain, heartburn, abdominal pain, and refractory reflux dyspepsia. Endoscopic features include the ringed esophagus, white specks, linear furrows and stricture. Histologic features of EoE are eosinophilia (more than 15 intraepithelial eosinophils per high power field), basal zone hyperplasia, and dilated intercellular spaces. These eosinophils are activated via T-helper 2 immune system via interleukins-4, -5 and -13. This inflammation is mediated by the dramatic upregulation involving the eotaxin-3 gene that produces a potent chemoattractant for eosinophils. Treatment of EoE usually requires the use of proton pump inhibitors based on their acid suppression, anti-oxidant and anti-inflammatory effects. The use of topical corticosteroids and endoscopic dilation for symptomatic strictures may also be necessary. Nondrug treatment approaches such as the six food elimination diet (SFED) of the most common food allergens such as milk, soy, eggs, wheat, nuts and seafood have also been successful.

Dr. Wolfsen is in the division of gastroenterology and hepatology, Mayo Clinic, Jacksonville, Fla. He moderated this session during the 2014 Digestive Diseases Week. 


One highlight of the AGA Postgraduate Course was the esophageal disease session. The presentation by Dr. Michael B. Wallace summarized recent studies using advanced imaging modalities in patients with Barrett’s esophagus. Studies using chromoscopy and virtual chromoscopy techniques such as narrow-band imaging have increased the detection of dysplasia in BE patients. These are so-called red flag techniques that image large areas of mucosa to detect mucosal abnormalities suspicious for the presence of dysplasia or neoplasia.

Endomicroscopy describes the use of real-time, targeted endoscopic imaging modalities that are capable of producing histologic-like images of mucosa at depths up to 200 microns. Confocal laser endomicroscopy (CLE) uses a blue light laser (405 nm) and collimated light detection and analysis to produce 1000-fold magnified images. When used with a fluorescent contrast agent such as fluorescein or acriflavin dye, these systems produce cellular level images that are comparable to those images seen with optical microscopy. A recent study from Canto et al found that the use of CLE detected BE dysplasia at rates similar to targeted plus random biopsy protocols. Further, a multicenter study will soon begin using a tethered-capsule (nonendoscopic) form of volumetric laser endomicroscopy as a method to screen for BE.

Dr. Amitabh Chak expanded on these issues and reviewed the issues surrounding screening and surveillance of BE patients for the early detection and treatment of esophageal adenocarcinoma. This presentation suggested that necessary future improvements include cost-effective advanced imaging techniques optimized for use in clinical practice, molecular biomarker panels for prediction of which patients may progress to dysplasia and neoplasia, and high-quality intensive endoscopic surveillance for high risk BE patients.

Dr. Joe Murray’s comprehensive presentation of celiac disease described the protean clinical presentations of this disease as well as optimal use of serologic and endoscopic testing. Celiac disease is increasingly identified in middle-aged patients (median 45 years) without diarrhea. Classic malabsorption symptoms of diarrhea, weight loss, steatorrhea, and nutritional deficiencies are found in 25% of patients. Half of celiac patients will have only one symptom such as anemia, diarrhea, lactose intolerance, or weight loss. Nongastrointestinal symptoms are present in another 25% of patients such as infertility, bone disease, chronic fatigue, or abnormal liver enzyme test results.

Optimal use of serologic and endoscopic testing was reviewed, including the differential diagnosis of lymphocytic duodenosis including use of nonsteroidal anti-inflammatory agents (NSAIDs), Helicobacter pylori infection, Crohn’s disease, and Sjogren’s syndrome. Proper duodenal biopsy technique was emphasized with two forceps biopsy samples obtained from the duodenal bulb and four biopsy samples obtained from the second portion of the duodenum. Also discussed was the utility of HLA typing for DQ2/8 in patients currently using a gluten free diet, patients with negative serology results but abnormal duodenal biopsy findings, and those with negative serology results who are at increased genetic risk.

Dr. James Scheiman discussed management of the complex interaction and risks associated with the use of NSAIDs, aspirin, clopidogrel, and proton pump inhibitors in the setting of previous ulcer disease, gastrointestinal bleeding, and Helicobacter pylori infection. Results from randomized controlled studies and observational studies were the basis for the Consensus Group to recommend the use of proton pump inhibitor therapy as the GI bleeding protective strategy of choice. PPI therapy was also recommended as cost-effective treatment for aspirin-using patients, although the risks and benefits of long-term PPI treatment require patient education and individualization.

Finally, Dr. Rhonda Souza discussed eosinophilic esophagitis (EoE), a chronic immune/antigen-mediated esophageal disease characterized clinically by symptoms related to esophageal dysfunction associated with eosinophil-predominant inflammation such as dysphagia, food impaction, chest pain, heartburn, abdominal pain, and refractory reflux dyspepsia. Endoscopic features include the ringed esophagus, white specks, linear furrows and stricture. Histologic features of EoE are eosinophilia (more than 15 intraepithelial eosinophils per high power field), basal zone hyperplasia, and dilated intercellular spaces. These eosinophils are activated via T-helper 2 immune system via interleukins-4, -5 and -13. This inflammation is mediated by the dramatic upregulation involving the eotaxin-3 gene that produces a potent chemoattractant for eosinophils. Treatment of EoE usually requires the use of proton pump inhibitors based on their acid suppression, anti-oxidant and anti-inflammatory effects. The use of topical corticosteroids and endoscopic dilation for symptomatic strictures may also be necessary. Nondrug treatment approaches such as the six food elimination diet (SFED) of the most common food allergens such as milk, soy, eggs, wheat, nuts and seafood have also been successful.

Dr. Wolfsen is in the division of gastroenterology and hepatology, Mayo Clinic, Jacksonville, Fla. He moderated this session during the 2014 Digestive Diseases Week. 


The role of food allergy testing in the evaluation and treatment of patients with eosinophilic esophagitis is not yet clear, according to a study by Dr. Seema Sharma Aceves.

The report appears in the August issue of Clinical Gastroenterology and Hepatology (doi: org/10.1016/j.cgh.2013.09.007).

©Julián Rovagnati/Fotolia.com

Current data suggest, but do not definitively establish, that testing for food allergies is a reasonable approach for beginning to construct an elimination diet in children with EOE, but the data are inadequate to support that strategy in adults with the disorder, she said.

It is clear that food antigens function as triggers that both induce EOE in the first place and also exacerbate the condition once it is established. And removing food antigens from the diet resolves EOE, improving both endoscopic and histologic features, in more than 60% of adults and children.

But most large studies of food elimination diets have involved only children. "This type of large cohort data does not currently exist for the adult population, and smaller studies have not demonstrated success rates that mirror the pediatric data," Dr. Aceves said.

There are several reasons why an empiric elimination diet, which simply removes the six most allergenic food types from the diet, can actually be superior to testing each patient for the specific food types that trigger his or her EOE and then removing only those items from the diet.

First, simply removing these six food types – dairy, egg, soy, wheat, peanuts/tree nuts, and fish/shellfish – usually induces the same response rate as does the more complicated process of food allergy testing. It also spares patients the anxiety and discomfort of testing.

Second, testing for milk allergy notoriously yields a high rate of false-negative results.

Third, food-specific IgE can be caused by cross-reactivity with environmental allergens. For example, a patient with a respiratory allergy to grass can test positive for food allergy to wheat. In general, EOE patients are highly atopic and tend to be sensitized to multiple food and aeroallergens, she said.

And lastly, food allergy testing may reveal a food trigger but doesn’t address the need to perform endoscopy and biopsy after suspected triggers are eliminated from the diet and after they are eventually reintroduced, said Dr. Aceves of the division of allergy and immunology at Rady Children’s Hospital, San Diego.

An argument in favor of food allergy testing is that patients will not have to avoid so many foods when their own individual triggers are identified. In one study of children, those placed on an empiric elimination diet had to eliminate eight entire food groups, with numerous different foods falling under the general categories of peanuts/tree nuts and fish/shellfish. In contrast, children who eliminated only those items identified on testing had to eliminate an average of three food groups.

Food elimination diets "should be applied judiciously" because there is always the risk that patients will lose their tolerance for a food when it has been avoided for a long period of time. Sometimes patients are sensitized to a food but tolerate it because they have very low but steady exposures that allow the body to adapt to it. When that food is completely eliminated for a period of time and then reintroduced, it can trigger a severe allergic reaction and anaphylaxis.

Before reintroducing an allergenic food that has been eliminated from the diet, gastroenterologists may want to test first for a possible hypersensitivity reaction. Alternatively, the food can be reintroduced in a controlled setting such as an allergist’s office, where the staff can recognize and respond to anaphylaxis, and the necessary medications and equipment are readily available, Dr. Aceves said.

Some diagnostic tools that have recently become available for food allergy testing but have not yet been systematically assessed for identifying food triggers in EOE may eventually prove useful. These include peptide microarrays that gauge the repertoire of IgE in patient serum, component-resolved diagnostic testing that assesses which epitopes within a food antigen are recognized by patient serum, and assays that analyze either the release or the activation of basophils in the periphery.

Finally, the recent finding that food-specific, CD4-positive, IL-5-producing T cells can be found in the peripheral blood is intriguing, Dr. Aceves said. If these cells are found to exist in the esophagus as well, then assays for such peripheral T cells might also function as markers for EOE food triggers.

This work was supported by the National Institute of Allergy and Infectious Diseases. Dr. Aceves reported no financial conflicts of interest.

The role of food allergy testing in the evaluation and treatment of patients with eosinophilic esophagitis is not yet clear, according to a study by Dr. Seema Sharma Aceves.

The report appears in the August issue of Clinical Gastroenterology and Hepatology (doi: org/10.1016/j.cgh.2013.09.007).

©Julián Rovagnati/Fotolia.com

Current data suggest, but do not definitively establish, that testing for food allergies is a reasonable approach for beginning to construct an elimination diet in children with EOE, but the data are inadequate to support that strategy in adults with the disorder, she said.

It is clear that food antigens function as triggers that both induce EOE in the first place and also exacerbate the condition once it is established. And removing food antigens from the diet resolves EOE, improving both endoscopic and histologic features, in more than 60% of adults and children.

But most large studies of food elimination diets have involved only children. "This type of large cohort data does not currently exist for the adult population, and smaller studies have not demonstrated success rates that mirror the pediatric data," Dr. Aceves said.

There are several reasons why an empiric elimination diet, which simply removes the six most allergenic food types from the diet, can actually be superior to testing each patient for the specific food types that trigger his or her EOE and then removing only those items from the diet.

First, simply removing these six food types – dairy, egg, soy, wheat, peanuts/tree nuts, and fish/shellfish – usually induces the same response rate as does the more complicated process of food allergy testing. It also spares patients the anxiety and discomfort of testing.

Second, testing for milk allergy notoriously yields a high rate of false-negative results.

Third, food-specific IgE can be caused by cross-reactivity with environmental allergens. For example, a patient with a respiratory allergy to grass can test positive for food allergy to wheat. In general, EOE patients are highly atopic and tend to be sensitized to multiple food and aeroallergens, she said.

And lastly, food allergy testing may reveal a food trigger but doesn’t address the need to perform endoscopy and biopsy after suspected triggers are eliminated from the diet and after they are eventually reintroduced, said Dr. Aceves of the division of allergy and immunology at Rady Children’s Hospital, San Diego.

An argument in favor of food allergy testing is that patients will not have to avoid so many foods when their own individual triggers are identified. In one study of children, those placed on an empiric elimination diet had to eliminate eight entire food groups, with numerous different foods falling under the general categories of peanuts/tree nuts and fish/shellfish. In contrast, children who eliminated only those items identified on testing had to eliminate an average of three food groups.

Food elimination diets "should be applied judiciously" because there is always the risk that patients will lose their tolerance for a food when it has been avoided for a long period of time. Sometimes patients are sensitized to a food but tolerate it because they have very low but steady exposures that allow the body to adapt to it. When that food is completely eliminated for a period of time and then reintroduced, it can trigger a severe allergic reaction and anaphylaxis.

Before reintroducing an allergenic food that has been eliminated from the diet, gastroenterologists may want to test first for a possible hypersensitivity reaction. Alternatively, the food can be reintroduced in a controlled setting such as an allergist’s office, where the staff can recognize and respond to anaphylaxis, and the necessary medications and equipment are readily available, Dr. Aceves said.

Some diagnostic tools that have recently become available for food allergy testing but have not yet been systematically assessed for identifying food triggers in EOE may eventually prove useful. These include peptide microarrays that gauge the repertoire of IgE in patient serum, component-resolved diagnostic testing that assesses which epitopes within a food antigen are recognized by patient serum, and assays that analyze either the release or the activation of basophils in the periphery.

Finally, the recent finding that food-specific, CD4-positive, IL-5-producing T cells can be found in the peripheral blood is intriguing, Dr. Aceves said. If these cells are found to exist in the esophagus as well, then assays for such peripheral T cells might also function as markers for EOE food triggers.

This work was supported by the National Institute of Allergy and Infectious Diseases. Dr. Aceves reported no financial conflicts of interest.

The role of food allergy testing in the evaluation and treatment of patients with eosinophilic esophagitis is not yet clear, according to a study by Dr. Seema Sharma Aceves.

The report appears in the August issue of Clinical Gastroenterology and Hepatology (doi: org/10.1016/j.cgh.2013.09.007).

©Julián Rovagnati/Fotolia.com

Current data suggest, but do not definitively establish, that testing for food allergies is a reasonable approach for beginning to construct an elimination diet in children with EOE, but the data are inadequate to support that strategy in adults with the disorder, she said.

It is clear that food antigens function as triggers that both induce EOE in the first place and also exacerbate the condition once it is established. And removing food antigens from the diet resolves EOE, improving both endoscopic and histologic features, in more than 60% of adults and children.

But most large studies of food elimination diets have involved only children. "This type of large cohort data does not currently exist for the adult population, and smaller studies have not demonstrated success rates that mirror the pediatric data," Dr. Aceves said.

There are several reasons why an empiric elimination diet, which simply removes the six most allergenic food types from the diet, can actually be superior to testing each patient for the specific food types that trigger his or her EOE and then removing only those items from the diet.

First, simply removing these six food types – dairy, egg, soy, wheat, peanuts/tree nuts, and fish/shellfish – usually induces the same response rate as does the more complicated process of food allergy testing. It also spares patients the anxiety and discomfort of testing.

Second, testing for milk allergy notoriously yields a high rate of false-negative results.

Third, food-specific IgE can be caused by cross-reactivity with environmental allergens. For example, a patient with a respiratory allergy to grass can test positive for food allergy to wheat. In general, EOE patients are highly atopic and tend to be sensitized to multiple food and aeroallergens, she said.

And lastly, food allergy testing may reveal a food trigger but doesn’t address the need to perform endoscopy and biopsy after suspected triggers are eliminated from the diet and after they are eventually reintroduced, said Dr. Aceves of the division of allergy and immunology at Rady Children’s Hospital, San Diego.

An argument in favor of food allergy testing is that patients will not have to avoid so many foods when their own individual triggers are identified. In one study of children, those placed on an empiric elimination diet had to eliminate eight entire food groups, with numerous different foods falling under the general categories of peanuts/tree nuts and fish/shellfish. In contrast, children who eliminated only those items identified on testing had to eliminate an average of three food groups.

Food elimination diets "should be applied judiciously" because there is always the risk that patients will lose their tolerance for a food when it has been avoided for a long period of time. Sometimes patients are sensitized to a food but tolerate it because they have very low but steady exposures that allow the body to adapt to it. When that food is completely eliminated for a period of time and then reintroduced, it can trigger a severe allergic reaction and anaphylaxis.

Before reintroducing an allergenic food that has been eliminated from the diet, gastroenterologists may want to test first for a possible hypersensitivity reaction. Alternatively, the food can be reintroduced in a controlled setting such as an allergist’s office, where the staff can recognize and respond to anaphylaxis, and the necessary medications and equipment are readily available, Dr. Aceves said.

Some diagnostic tools that have recently become available for food allergy testing but have not yet been systematically assessed for identifying food triggers in EOE may eventually prove useful. These include peptide microarrays that gauge the repertoire of IgE in patient serum, component-resolved diagnostic testing that assesses which epitopes within a food antigen are recognized by patient serum, and assays that analyze either the release or the activation of basophils in the periphery.

Finally, the recent finding that food-specific, CD4-positive, IL-5-producing T cells can be found in the peripheral blood is intriguing, Dr. Aceves said. If these cells are found to exist in the esophagus as well, then assays for such peripheral T cells might also function as markers for EOE food triggers.

This work was supported by the National Institute of Allergy and Infectious Diseases. Dr. Aceves reported no financial conflicts of interest.

Proton pump inhibitors affect the size, relative acidity, and position of the acid pocket in gastroesophageal reflux patients, reported Dr. Wout O. Rohof and his colleagues.

"If one accepts that the acid pocket is still the source of the refluxate during PPI use, therapeutic strategies directly intervening with the acid pocket possibly may prove effective in preventing persistent symptoms on PPI," they wrote in the July issue of Clinical Gastroenterology and Hepatology News (doi.org/10.1016/j.cgh.2014.04.003-).

© nebari/Thinkstock

"This insight is of great importance because in approximately 30% of patients PPI therapy fails to resolve symptoms, either partially or completely," they added.

Dr. Rohof of the Academic Medical Center in Amsterdam and his colleagues looked at 36 patients with gastroesophageal reflux disease (GERD) confirmed by the presence of esophagitis on endoscopy and/or impedance-pH-metry with an acid exposure of more than 4.5%, plus usual GERD symptoms.

Eighteen patients were on PPIs; the remainder had been off PPIs for at least 1 week prior to the study; eight PPI cohort patients used omeprazole, five used pantoprazole, and five used esomeprazole, with dosages varying from 20 mg (one patient), to 40 mg (eight patients), to 40 mg twice daily (nine patients).

All patients were fed a standardized meal of orange juice and pancakes; afterward, concurrent scintigraphy, high-resolution manometry, and pH-impedance recordings were acquired for 105 minutes.

At the study’s conclusion, the acid pocket – a floating pool of acid on top of ingested food, visualized on scintigraphy after patients were injected with a radioisotope – was aspirated for analysis of its pH level.

The authors found that overall, while the total number of reflux episodes was similar for both PPI and non-PPI cohorts (15 vs. 14; P = .81), "As expected, the number of acid reflux episodes was lower on PPI (4.5 vs. 2.0; P = .04)."

Only two patients in the entire cohort did not demonstrate an acid pocket on scintigraphy; both were taking PPIs.

Of the remaining patients, the size of the acid pocket was significantly less among PPI patients than their counterparts (10 cm² vs. 15 cm²; P less than .01).

Moreover, when the acid pocket was aspirated at the conclusion of the study through the manometry catheter, the pH of the aspirated acid pocket fluid was significantly higher among PPI patients, compared with those not taking the drug (3.9 vs.0.9; P less than .001).

Finally, the investigators looked at the location of the acid pocket, which has also been shown to correlate with reflux episodes.

Their data showed that PPI patients were more likely to have the pocket located below the level of the diaphragm (60%), compared with patients not on PPI therapy (40%; P = .04).

This was especially important since pockets at this level correlated with only a 7% and 15% risk of acidic reflux events in PPI and non-PPI patients, respectively; in comparison, pockets in the hiatus and higher were associated with much greater rates of acidic reflux for both PPI and non-PPI patients, though the rates were lower among the former.

The authors disclosed no conflicts of interest or outside funding.

Proton pump inhibitors affect the size, relative acidity, and position of the acid pocket in gastroesophageal reflux patients, reported Dr. Wout O. Rohof and his colleagues.

"If one accepts that the acid pocket is still the source of the refluxate during PPI use, therapeutic strategies directly intervening with the acid pocket possibly may prove effective in preventing persistent symptoms on PPI," they wrote in the July issue of Clinical Gastroenterology and Hepatology News (doi.org/10.1016/j.cgh.2014.04.003-).

© nebari/Thinkstock

"This insight is of great importance because in approximately 30% of patients PPI therapy fails to resolve symptoms, either partially or completely," they added.

Dr. Rohof of the Academic Medical Center in Amsterdam and his colleagues looked at 36 patients with gastroesophageal reflux disease (GERD) confirmed by the presence of esophagitis on endoscopy and/or impedance-pH-metry with an acid exposure of more than 4.5%, plus usual GERD symptoms.

Eighteen patients were on PPIs; the remainder had been off PPIs for at least 1 week prior to the study; eight PPI cohort patients used omeprazole, five used pantoprazole, and five used esomeprazole, with dosages varying from 20 mg (one patient), to 40 mg (eight patients), to 40 mg twice daily (nine patients).

All patients were fed a standardized meal of orange juice and pancakes; afterward, concurrent scintigraphy, high-resolution manometry, and pH-impedance recordings were acquired for 105 minutes.

At the study’s conclusion, the acid pocket – a floating pool of acid on top of ingested food, visualized on scintigraphy after patients were injected with a radioisotope – was aspirated for analysis of its pH level.

The authors found that overall, while the total number of reflux episodes was similar for both PPI and non-PPI cohorts (15 vs. 14; P = .81), "As expected, the number of acid reflux episodes was lower on PPI (4.5 vs. 2.0; P = .04)."

Only two patients in the entire cohort did not demonstrate an acid pocket on scintigraphy; both were taking PPIs.

Of the remaining patients, the size of the acid pocket was significantly less among PPI patients than their counterparts (10 cm² vs. 15 cm²; P less than .01).

Moreover, when the acid pocket was aspirated at the conclusion of the study through the manometry catheter, the pH of the aspirated acid pocket fluid was significantly higher among PPI patients, compared with those not taking the drug (3.9 vs.0.9; P less than .001).

Finally, the investigators looked at the location of the acid pocket, which has also been shown to correlate with reflux episodes.

Their data showed that PPI patients were more likely to have the pocket located below the level of the diaphragm (60%), compared with patients not on PPI therapy (40%; P = .04).

This was especially important since pockets at this level correlated with only a 7% and 15% risk of acidic reflux events in PPI and non-PPI patients, respectively; in comparison, pockets in the hiatus and higher were associated with much greater rates of acidic reflux for both PPI and non-PPI patients, though the rates were lower among the former.

The authors disclosed no conflicts of interest or outside funding.

Proton pump inhibitors affect the size, relative acidity, and position of the acid pocket in gastroesophageal reflux patients, reported Dr. Wout O. Rohof and his colleagues.

"If one accepts that the acid pocket is still the source of the refluxate during PPI use, therapeutic strategies directly intervening with the acid pocket possibly may prove effective in preventing persistent symptoms on PPI," they wrote in the July issue of Clinical Gastroenterology and Hepatology News (doi.org/10.1016/j.cgh.2014.04.003-).

© nebari/Thinkstock

"This insight is of great importance because in approximately 30% of patients PPI therapy fails to resolve symptoms, either partially or completely," they added.

Dr. Rohof of the Academic Medical Center in Amsterdam and his colleagues looked at 36 patients with gastroesophageal reflux disease (GERD) confirmed by the presence of esophagitis on endoscopy and/or impedance-pH-metry with an acid exposure of more than 4.5%, plus usual GERD symptoms.

Eighteen patients were on PPIs; the remainder had been off PPIs for at least 1 week prior to the study; eight PPI cohort patients used omeprazole, five used pantoprazole, and five used esomeprazole, with dosages varying from 20 mg (one patient), to 40 mg (eight patients), to 40 mg twice daily (nine patients).

All patients were fed a standardized meal of orange juice and pancakes; afterward, concurrent scintigraphy, high-resolution manometry, and pH-impedance recordings were acquired for 105 minutes.

At the study’s conclusion, the acid pocket – a floating pool of acid on top of ingested food, visualized on scintigraphy after patients were injected with a radioisotope – was aspirated for analysis of its pH level.

The authors found that overall, while the total number of reflux episodes was similar for both PPI and non-PPI cohorts (15 vs. 14; P = .81), "As expected, the number of acid reflux episodes was lower on PPI (4.5 vs. 2.0; P = .04)."

Only two patients in the entire cohort did not demonstrate an acid pocket on scintigraphy; both were taking PPIs.

Of the remaining patients, the size of the acid pocket was significantly less among PPI patients than their counterparts (10 cm² vs. 15 cm²; P less than .01).

Moreover, when the acid pocket was aspirated at the conclusion of the study through the manometry catheter, the pH of the aspirated acid pocket fluid was significantly higher among PPI patients, compared with those not taking the drug (3.9 vs.0.9; P less than .001).

Finally, the investigators looked at the location of the acid pocket, which has also been shown to correlate with reflux episodes.

Their data showed that PPI patients were more likely to have the pocket located below the level of the diaphragm (60%), compared with patients not on PPI therapy (40%; P = .04).

This was especially important since pockets at this level correlated with only a 7% and 15% risk of acidic reflux events in PPI and non-PPI patients, respectively; in comparison, pockets in the hiatus and higher were associated with much greater rates of acidic reflux for both PPI and non-PPI patients, though the rates were lower among the former.

The authors disclosed no conflicts of interest or outside funding.

CHICAGO – The prevalence of erosive esophagitis and Barrett’s esophagus is comparable in individuals regardless of whether they have gastroesophageal reflux symptoms, according to a population-based study.

"These results directly challenge the established GERD-based Barrett’s esophagus screening paradigm and provide strong rationale for using central obesity in Caucasian males with or without symptomatic GERD as criteria for Barrett’s esophagus screening," Dr. Nicholas R. Crews said at the annual Digestive Disease Week.

"In this study, waist-hip ratio was our surrogate marker for central obesity. It’s easily obtainable and usable in clinical practice," noted Dr. Crews of the Mayo Clinic in Rochester, Minn.

Barrett’s esophagus is the precursor lesion and principal risk factor for esophageal adenocarcinoma, a malignancy whose incidence in the United States and other developed nations is increasing at an alarming rate. Improved methods of screening for esophageal adenocarcinoma are sorely needed, he added.

Dr. Crews presented a study in which a representative sample of Olmsted County, Minn., residents over age 50 with no history of endoscopy were randomized to screening for Barrett’s esophagus by one of three methods: sedated endoscopy in the GI suite, unsedated transnasal endoscopy in the clinic, or unsedated transnasal endoscopy in a Mayo mobile research van.

Participants’ mean age was 70 years, 46% were men, 206 of the 209 were white, and only one-third of subjects had GERD symptoms.

The prevalence of esophagitis grades A-C proved to be 32% in the symptomatic GERD group and similar at 29% in those without GERD symptoms. Similarly, Barrett’s esophagus was identified in 8.7% of the symptomatic GERD group and 7.9% of subjects without GERD symptoms. Dysplasia was present in 1.4% of each group. The mean length of the esophageal segment with Barrett’s esophagus was 2.4 cm in patients with GERD symptoms and not significantly different in those who were asymptomatic.

Three risk factors proved significant as predictors of esophageal injury as defined by esophagitis or Barrett’s esophagus: male sex, central obesity as defined by a waist-hip ratio greater than 0.9, and consumption of more than two alcoholic drinks per day. Age, smoking status, and body mass index were not predictive.

The mean waist-to-hip ratio was 0.89 in screened subjects with no esophagitis or Barrett’s esophagus, 0.91 in those with positive endoscopic findings and symptomatic gastroesophageal reflux, and 0.95 in those with positive findings who were asymptomatic.

Audience members expressed skepticism about the notion of routinely screening for Barrett’s esophagus in individuals with central obesity in an era of an unprecedented obesity epidemic.

For example, Dr. Joel E. Richter, who described himself as "an anti-Barrett’s person," commented that he believes gastroenterologists are already overdiagnosing and overtreating the condition, needlessly alarming many patients.

In women, particularly, it’s increasingly clear that Barrett’s esophagus only rarely develops into esophageal adenocarcinoma, he said.

"Others have said that women with Barrett’s esophagus are as likely to get esophageal cancer as men are to get breast cancer," commented Dr. Richter, professor of internal medicine and director of the center for swallowing disorders at the University of South Florida, Tampa.

Another audience member told Dr. Crews, "I totally agree with you that we miss most people with Barrett’s by our current screening process. The problem is, it’s unclear whether it’s important or not to find them. To extrapolate from your study and say that anyone with central obesity ought to be screened for [Barrett’s esophagus] is a little strong, I think."

"It’s very controversial," Dr. Crews agreed. "It’s something we continue to struggle with."

He reported having no relevant financial conflicts.

[email protected]

CHICAGO – The prevalence of erosive esophagitis and Barrett’s esophagus is comparable in individuals regardless of whether they have gastroesophageal reflux symptoms, according to a population-based study.

"These results directly challenge the established GERD-based Barrett’s esophagus screening paradigm and provide strong rationale for using central obesity in Caucasian males with or without symptomatic GERD as criteria for Barrett’s esophagus screening," Dr. Nicholas R. Crews said at the annual Digestive Disease Week.

"In this study, waist-hip ratio was our surrogate marker for central obesity. It’s easily obtainable and usable in clinical practice," noted Dr. Crews of the Mayo Clinic in Rochester, Minn.

Barrett’s esophagus is the precursor lesion and principal risk factor for esophageal adenocarcinoma, a malignancy whose incidence in the United States and other developed nations is increasing at an alarming rate. Improved methods of screening for esophageal adenocarcinoma are sorely needed, he added.

Dr. Crews presented a study in which a representative sample of Olmsted County, Minn., residents over age 50 with no history of endoscopy were randomized to screening for Barrett’s esophagus by one of three methods: sedated endoscopy in the GI suite, unsedated transnasal endoscopy in the clinic, or unsedated transnasal endoscopy in a Mayo mobile research van.

Participants’ mean age was 70 years, 46% were men, 206 of the 209 were white, and only one-third of subjects had GERD symptoms.

The prevalence of esophagitis grades A-C proved to be 32% in the symptomatic GERD group and similar at 29% in those without GERD symptoms. Similarly, Barrett’s esophagus was identified in 8.7% of the symptomatic GERD group and 7.9% of subjects without GERD symptoms. Dysplasia was present in 1.4% of each group. The mean length of the esophageal segment with Barrett’s esophagus was 2.4 cm in patients with GERD symptoms and not significantly different in those who were asymptomatic.

Three risk factors proved significant as predictors of esophageal injury as defined by esophagitis or Barrett’s esophagus: male sex, central obesity as defined by a waist-hip ratio greater than 0.9, and consumption of more than two alcoholic drinks per day. Age, smoking status, and body mass index were not predictive.

The mean waist-to-hip ratio was 0.89 in screened subjects with no esophagitis or Barrett’s esophagus, 0.91 in those with positive endoscopic findings and symptomatic gastroesophageal reflux, and 0.95 in those with positive findings who were asymptomatic.

Audience members expressed skepticism about the notion of routinely screening for Barrett’s esophagus in individuals with central obesity in an era of an unprecedented obesity epidemic.

For example, Dr. Joel E. Richter, who described himself as "an anti-Barrett’s person," commented that he believes gastroenterologists are already overdiagnosing and overtreating the condition, needlessly alarming many patients.

In women, particularly, it’s increasingly clear that Barrett’s esophagus only rarely develops into esophageal adenocarcinoma, he said.

"Others have said that women with Barrett’s esophagus are as likely to get esophageal cancer as men are to get breast cancer," commented Dr. Richter, professor of internal medicine and director of the center for swallowing disorders at the University of South Florida, Tampa.

Another audience member told Dr. Crews, "I totally agree with you that we miss most people with Barrett’s by our current screening process. The problem is, it’s unclear whether it’s important or not to find them. To extrapolate from your study and say that anyone with central obesity ought to be screened for [Barrett’s esophagus] is a little strong, I think."

"It’s very controversial," Dr. Crews agreed. "It’s something we continue to struggle with."

He reported having no relevant financial conflicts.

[email protected]

CHICAGO – The prevalence of erosive esophagitis and Barrett’s esophagus is comparable in individuals regardless of whether they have gastroesophageal reflux symptoms, according to a population-based study.

"These results directly challenge the established GERD-based Barrett’s esophagus screening paradigm and provide strong rationale for using central obesity in Caucasian males with or without symptomatic GERD as criteria for Barrett’s esophagus screening," Dr. Nicholas R. Crews said at the annual Digestive Disease Week.

"In this study, waist-hip ratio was our surrogate marker for central obesity. It’s easily obtainable and usable in clinical practice," noted Dr. Crews of the Mayo Clinic in Rochester, Minn.

Barrett’s esophagus is the precursor lesion and principal risk factor for esophageal adenocarcinoma, a malignancy whose incidence in the United States and other developed nations is increasing at an alarming rate. Improved methods of screening for esophageal adenocarcinoma are sorely needed, he added.

Dr. Crews presented a study in which a representative sample of Olmsted County, Minn., residents over age 50 with no history of endoscopy were randomized to screening for Barrett’s esophagus by one of three methods: sedated endoscopy in the GI suite, unsedated transnasal endoscopy in the clinic, or unsedated transnasal endoscopy in a Mayo mobile research van.

Participants’ mean age was 70 years, 46% were men, 206 of the 209 were white, and only one-third of subjects had GERD symptoms.

The prevalence of esophagitis grades A-C proved to be 32% in the symptomatic GERD group and similar at 29% in those without GERD symptoms. Similarly, Barrett’s esophagus was identified in 8.7% of the symptomatic GERD group and 7.9% of subjects without GERD symptoms. Dysplasia was present in 1.4% of each group. The mean length of the esophageal segment with Barrett’s esophagus was 2.4 cm in patients with GERD symptoms and not significantly different in those who were asymptomatic.

Three risk factors proved significant as predictors of esophageal injury as defined by esophagitis or Barrett’s esophagus: male sex, central obesity as defined by a waist-hip ratio greater than 0.9, and consumption of more than two alcoholic drinks per day. Age, smoking status, and body mass index were not predictive.

The mean waist-to-hip ratio was 0.89 in screened subjects with no esophagitis or Barrett’s esophagus, 0.91 in those with positive endoscopic findings and symptomatic gastroesophageal reflux, and 0.95 in those with positive findings who were asymptomatic.

Audience members expressed skepticism about the notion of routinely screening for Barrett’s esophagus in individuals with central obesity in an era of an unprecedented obesity epidemic.

For example, Dr. Joel E. Richter, who described himself as "an anti-Barrett’s person," commented that he believes gastroenterologists are already overdiagnosing and overtreating the condition, needlessly alarming many patients.

In women, particularly, it’s increasingly clear that Barrett’s esophagus only rarely develops into esophageal adenocarcinoma, he said.

"Others have said that women with Barrett’s esophagus are as likely to get esophageal cancer as men are to get breast cancer," commented Dr. Richter, professor of internal medicine and director of the center for swallowing disorders at the University of South Florida, Tampa.

Another audience member told Dr. Crews, "I totally agree with you that we miss most people with Barrett’s by our current screening process. The problem is, it’s unclear whether it’s important or not to find them. To extrapolate from your study and say that anyone with central obesity ought to be screened for [Barrett’s esophagus] is a little strong, I think."

"It’s very controversial," Dr. Crews agreed. "It’s something we continue to struggle with."

He reported having no relevant financial conflicts.

[email protected]

CHICAGO – A novel, externally worn device for the treatment of extraesophageal reflux proved effective, safe, and well tolerated in a multicenter clinical trial.

"Given the poor response to PPI [proton-pump inhibitors] therapy in many patients with extraesophageal reflux, this device may be an alternative form of treating this difficult disorder," Dr. Michael F. Vaezi said in a presentation of the study findings at the annual Digestive Disease Week.

Extraesophageal reflux (EER) affects more than 15 million Americans. The cost of care is estimated to be in excess of $50 billion annually, most of which goes for PPIs, which are overused and generally not effective in treating this common disorder, observed Dr. Vaezi, professor of medicine at Vanderbilt University, Nashville, Tenn.

EER is caused by reflux of gastroduodenal contents into the laryngopharynx, resulting in a range of symptoms including chronic cough, postnasal drip, throat clearing, hoarseness, and a sensation of a lump in the throat.

The investigational device, known as the Reza-Band, is an individually fitted upper esophageal sphincter assist device to be worn at bedtime. It is designed to apply slight pressure to the cricoid cartilage area sufficient to increase the intraluminal pressure of the upper esophageal sphincter to 20 mm Hg. In earlier studies, this modest increase in pressure eliminated pharyngeal reflux without affecting normal activities such as swallowing and belching.

Dr. Vaezi reported on 47 patients with EER treated with the upper esophageal assist device at four medical centers. Their mean age was 50 years, with an average body mass index of 26.1 kg/m². Three-quarters of patients were on PPI therapy, which they felt to be ineffective.

The primary study endpoint was the change in Reflux Symptom Index scores from baseline through week 4 of nighttime use of the assist device. The median score improved from 27 at baseline to 14 at week 2 and 12 at week 4. That translated to a mean 54% reduction. A total of 86% of subjects were deemed to have experienced treatment success as defined by at least a 25% improvement in their symptom score; 30% of participants showed a greater than 75% improvement.

Treatment side effects were few, mild, and brief, consisting chiefly of skin irritation from the device’s Velcro strap. No one withdrew from the study.

The Reza-Band device was developed by gastroenterologists at the Medical College of Wisconsin, Milwaukee. Dr. Vaezi said he and his coinvestigators decided to formally investigate the device because "we were intrigued and impressed by the fact that it has helped so many patients."

"For me, it’s a welcome development," Dr. Vaezi added. "Just anecdotally, many patients in the study wanted to know how they could purchase this device. It’s really welcome in an area [in which] we don’t have many therapeutic options."

Still, he noted, it’s probably a good idea for device users to continue to keep a couple of bricks under the head of the bed, in accord with standard medical advice.

Future plans include a sham-controlled study designed to assess the device’s true benefit over placebo therapy; this will be an important study because EER is known to have a substantial placebo response rate, he continued. Also, plans are afoot for a safety study assessing whether the device has any clinically meaningful impact upon intraocular pressure.

The study was supported by Somna Therapeutics, which is developing the device. Dr. Vaezi reported having no financial relationship with the company.

[email protected]

CHICAGO – A novel, externally worn device for the treatment of extraesophageal reflux proved effective, safe, and well tolerated in a multicenter clinical trial.

"Given the poor response to PPI [proton-pump inhibitors] therapy in many patients with extraesophageal reflux, this device may be an alternative form of treating this difficult disorder," Dr. Michael F. Vaezi said in a presentation of the study findings at the annual Digestive Disease Week.

Extraesophageal reflux (EER) affects more than 15 million Americans. The cost of care is estimated to be in excess of $50 billion annually, most of which goes for PPIs, which are overused and generally not effective in treating this common disorder, observed Dr. Vaezi, professor of medicine at Vanderbilt University, Nashville, Tenn.

EER is caused by reflux of gastroduodenal contents into the laryngopharynx, resulting in a range of symptoms including chronic cough, postnasal drip, throat clearing, hoarseness, and a sensation of a lump in the throat.

The investigational device, known as the Reza-Band, is an individually fitted upper esophageal sphincter assist device to be worn at bedtime. It is designed to apply slight pressure to the cricoid cartilage area sufficient to increase the intraluminal pressure of the upper esophageal sphincter to 20 mm Hg. In earlier studies, this modest increase in pressure eliminated pharyngeal reflux without affecting normal activities such as swallowing and belching.

Dr. Vaezi reported on 47 patients with EER treated with the upper esophageal assist device at four medical centers. Their mean age was 50 years, with an average body mass index of 26.1 kg/m². Three-quarters of patients were on PPI therapy, which they felt to be ineffective.

The primary study endpoint was the change in Reflux Symptom Index scores from baseline through week 4 of nighttime use of the assist device. The median score improved from 27 at baseline to 14 at week 2 and 12 at week 4. That translated to a mean 54% reduction. A total of 86% of subjects were deemed to have experienced treatment success as defined by at least a 25% improvement in their symptom score; 30% of participants showed a greater than 75% improvement.

Treatment side effects were few, mild, and brief, consisting chiefly of skin irritation from the device’s Velcro strap. No one withdrew from the study.

The Reza-Band device was developed by gastroenterologists at the Medical College of Wisconsin, Milwaukee. Dr. Vaezi said he and his coinvestigators decided to formally investigate the device because "we were intrigued and impressed by the fact that it has helped so many patients."

"For me, it’s a welcome development," Dr. Vaezi added. "Just anecdotally, many patients in the study wanted to know how they could purchase this device. It’s really welcome in an area [in which] we don’t have many therapeutic options."

Still, he noted, it’s probably a good idea for device users to continue to keep a couple of bricks under the head of the bed, in accord with standard medical advice.

Future plans include a sham-controlled study designed to assess the device’s true benefit over placebo therapy; this will be an important study because EER is known to have a substantial placebo response rate, he continued. Also, plans are afoot for a safety study assessing whether the device has any clinically meaningful impact upon intraocular pressure.

The study was supported by Somna Therapeutics, which is developing the device. Dr. Vaezi reported having no financial relationship with the company.

[email protected]

CHICAGO – A novel, externally worn device for the treatment of extraesophageal reflux proved effective, safe, and well tolerated in a multicenter clinical trial.

"Given the poor response to PPI [proton-pump inhibitors] therapy in many patients with extraesophageal reflux, this device may be an alternative form of treating this difficult disorder," Dr. Michael F. Vaezi said in a presentation of the study findings at the annual Digestive Disease Week.

Extraesophageal reflux (EER) affects more than 15 million Americans. The cost of care is estimated to be in excess of $50 billion annually, most of which goes for PPIs, which are overused and generally not effective in treating this common disorder, observed Dr. Vaezi, professor of medicine at Vanderbilt University, Nashville, Tenn.

EER is caused by reflux of gastroduodenal contents into the laryngopharynx, resulting in a range of symptoms including chronic cough, postnasal drip, throat clearing, hoarseness, and a sensation of a lump in the throat.

The investigational device, known as the Reza-Band, is an individually fitted upper esophageal sphincter assist device to be worn at bedtime. It is designed to apply slight pressure to the cricoid cartilage area sufficient to increase the intraluminal pressure of the upper esophageal sphincter to 20 mm Hg. In earlier studies, this modest increase in pressure eliminated pharyngeal reflux without affecting normal activities such as swallowing and belching.

Dr. Vaezi reported on 47 patients with EER treated with the upper esophageal assist device at four medical centers. Their mean age was 50 years, with an average body mass index of 26.1 kg/m². Three-quarters of patients were on PPI therapy, which they felt to be ineffective.

The primary study endpoint was the change in Reflux Symptom Index scores from baseline through week 4 of nighttime use of the assist device. The median score improved from 27 at baseline to 14 at week 2 and 12 at week 4. That translated to a mean 54% reduction. A total of 86% of subjects were deemed to have experienced treatment success as defined by at least a 25% improvement in their symptom score; 30% of participants showed a greater than 75% improvement.

Treatment side effects were few, mild, and brief, consisting chiefly of skin irritation from the device’s Velcro strap. No one withdrew from the study.

The Reza-Band device was developed by gastroenterologists at the Medical College of Wisconsin, Milwaukee. Dr. Vaezi said he and his coinvestigators decided to formally investigate the device because "we were intrigued and impressed by the fact that it has helped so many patients."

"For me, it’s a welcome development," Dr. Vaezi added. "Just anecdotally, many patients in the study wanted to know how they could purchase this device. It’s really welcome in an area [in which] we don’t have many therapeutic options."

Still, he noted, it’s probably a good idea for device users to continue to keep a couple of bricks under the head of the bed, in accord with standard medical advice.

Future plans include a sham-controlled study designed to assess the device’s true benefit over placebo therapy; this will be an important study because EER is known to have a substantial placebo response rate, he continued. Also, plans are afoot for a safety study assessing whether the device has any clinically meaningful impact upon intraocular pressure.

The study was supported by Somna Therapeutics, which is developing the device. Dr. Vaezi reported having no financial relationship with the company.

[email protected]

An elemental diet was more than 90% effective in inducing histologic remission in eosinophilic esophagitis patients, reported Dr. Ángel Arias and colleagues in the June issue of Gastroenterology.

The Six Food Elimination Diet was also highly efficacious, reinforcing the idea that dietary modification "should be considered as a first-line therapy in both children and adults affected by this disease," wrote the investigators (doi:10.1053/j.gastro.2014.02.006).

Dr. Arias of the Complejo Hospitalario La Mancha Centro, in Alcázar de San Juan, Spain, searched the MEDLINE, EMBASE, and SCOPUS databases for studies performed prior to June 2013 investigating the efficacy of dietary interventions in eosinophilic esophagitis (EoE).

Abstracts and other relevant material from conferences including Digestive Disease Week, the American College of Gastroenterology meeting, and European Gastroenterology Week were also included.

Overall, 33 studies were included, 23 of which were full articles with the remainder being abstracts; there were a total of 1,128 children and 189 adults included in the analysis.

Of the 13 studies that assessed the efficacy of exclusive feeding with an amino acid–based elemental diet (involving 411 children and 18 adults), 90.8% of patients achieved histologic remission of EoE, defined as fewer than 15 eosinophils per high-power field on esophageal biopsy (95% confidence interval, 84.7%-95.5%).

The next best diet, the Six Food Elimination Diet (SFED), offered a 72.1% efficacy rate (95% CI, 65.8%-78.1%) across 75 children and 122 adults and was "the only one assessed in more adults than children."

On the other hand, the strategy of eliminating foods that gave a positive result in skin allergy tests was assessed in 14 studies (594 children and 32 adults), and demonstrated an overall efficacy of just 45.5% (95% CI, 35.4%-55.7%).

Other less-studied diets included gluten-free and cow’s milk elimination diets, both of which seemed to result in histologic remission (58.7% and 68.2%, respectively).

However, "because studies assessing these dietary treatments are still scarce, making conclusions from them can be risky," wrote the authors.

"For example, although the overall efficacy of a gluten-free diet in achieving histologic remission of EoE was 58.7%, the remission rate ranged from 23.1% to 85.6%," they reported.

"Despite its obvious success, the multiple drawbacks of elemental diets, which include the need to avoid all table food, its unpleasant taste, and high cost, and the psychological effects produced by the social limitations that this diet entails, have probably contributed to the fact that this dietary intervention has been restricted almost exclusively to pediatric patients," commented Dr. Arias.

"In fact, no research on adults was available until 2013, with the reported remission rates being comparable with those documented in children."

On the other hand, the relatively high efficacy of the SFED diet, which avoids many of the disadvantages of the elemental diet, seems to make this the best choice for "children and motivated adult patients," added the researchers.

Future studies and meta-analyses should address whether diet adherence results in changes in esophageal fibrosis as well as quality of life issues brought on by diet adherence.

The authors disclosed no relevant financial conflicts.

[email protected]

An elemental diet was more than 90% effective in inducing histologic remission in eosinophilic esophagitis patients, reported Dr. Ángel Arias and colleagues in the June issue of Gastroenterology.

The Six Food Elimination Diet was also highly efficacious, reinforcing the idea that dietary modification "should be considered as a first-line therapy in both children and adults affected by this disease," wrote the investigators (doi:10.1053/j.gastro.2014.02.006).

Dr. Arias of the Complejo Hospitalario La Mancha Centro, in Alcázar de San Juan, Spain, searched the MEDLINE, EMBASE, and SCOPUS databases for studies performed prior to June 2013 investigating the efficacy of dietary interventions in eosinophilic esophagitis (EoE).

Abstracts and other relevant material from conferences including Digestive Disease Week, the American College of Gastroenterology meeting, and European Gastroenterology Week were also included.

Overall, 33 studies were included, 23 of which were full articles with the remainder being abstracts; there were a total of 1,128 children and 189 adults included in the analysis.

Of the 13 studies that assessed the efficacy of exclusive feeding with an amino acid–based elemental diet (involving 411 children and 18 adults), 90.8% of patients achieved histologic remission of EoE, defined as fewer than 15 eosinophils per high-power field on esophageal biopsy (95% confidence interval, 84.7%-95.5%).

The next best diet, the Six Food Elimination Diet (SFED), offered a 72.1% efficacy rate (95% CI, 65.8%-78.1%) across 75 children and 122 adults and was "the only one assessed in more adults than children."

On the other hand, the strategy of eliminating foods that gave a positive result in skin allergy tests was assessed in 14 studies (594 children and 32 adults), and demonstrated an overall efficacy of just 45.5% (95% CI, 35.4%-55.7%).

Other less-studied diets included gluten-free and cow’s milk elimination diets, both of which seemed to result in histologic remission (58.7% and 68.2%, respectively).

However, "because studies assessing these dietary treatments are still scarce, making conclusions from them can be risky," wrote the authors.

"For example, although the overall efficacy of a gluten-free diet in achieving histologic remission of EoE was 58.7%, the remission rate ranged from 23.1% to 85.6%," they reported.

"Despite its obvious success, the multiple drawbacks of elemental diets, which include the need to avoid all table food, its unpleasant taste, and high cost, and the psychological effects produced by the social limitations that this diet entails, have probably contributed to the fact that this dietary intervention has been restricted almost exclusively to pediatric patients," commented Dr. Arias.

"In fact, no research on adults was available until 2013, with the reported remission rates being comparable with those documented in children."

On the other hand, the relatively high efficacy of the SFED diet, which avoids many of the disadvantages of the elemental diet, seems to make this the best choice for "children and motivated adult patients," added the researchers.

Future studies and meta-analyses should address whether diet adherence results in changes in esophageal fibrosis as well as quality of life issues brought on by diet adherence.

The authors disclosed no relevant financial conflicts.

[email protected]

An elemental diet was more than 90% effective in inducing histologic remission in eosinophilic esophagitis patients, reported Dr. Ángel Arias and colleagues in the June issue of Gastroenterology.

The Six Food Elimination Diet was also highly efficacious, reinforcing the idea that dietary modification "should be considered as a first-line therapy in both children and adults affected by this disease," wrote the investigators (doi:10.1053/j.gastro.2014.02.006).

Dr. Arias of the Complejo Hospitalario La Mancha Centro, in Alcázar de San Juan, Spain, searched the MEDLINE, EMBASE, and SCOPUS databases for studies performed prior to June 2013 investigating the efficacy of dietary interventions in eosinophilic esophagitis (EoE).

Abstracts and other relevant material from conferences including Digestive Disease Week, the American College of Gastroenterology meeting, and European Gastroenterology Week were also included.

Overall, 33 studies were included, 23 of which were full articles with the remainder being abstracts; there were a total of 1,128 children and 189 adults included in the analysis.

Of the 13 studies that assessed the efficacy of exclusive feeding with an amino acid–based elemental diet (involving 411 children and 18 adults), 90.8% of patients achieved histologic remission of EoE, defined as fewer than 15 eosinophils per high-power field on esophageal biopsy (95% confidence interval, 84.7%-95.5%).

The next best diet, the Six Food Elimination Diet (SFED), offered a 72.1% efficacy rate (95% CI, 65.8%-78.1%) across 75 children and 122 adults and was "the only one assessed in more adults than children."

On the other hand, the strategy of eliminating foods that gave a positive result in skin allergy tests was assessed in 14 studies (594 children and 32 adults), and demonstrated an overall efficacy of just 45.5% (95% CI, 35.4%-55.7%).

Other less-studied diets included gluten-free and cow’s milk elimination diets, both of which seemed to result in histologic remission (58.7% and 68.2%, respectively).

However, "because studies assessing these dietary treatments are still scarce, making conclusions from them can be risky," wrote the authors.

"For example, although the overall efficacy of a gluten-free diet in achieving histologic remission of EoE was 58.7%, the remission rate ranged from 23.1% to 85.6%," they reported.

"Despite its obvious success, the multiple drawbacks of elemental diets, which include the need to avoid all table food, its unpleasant taste, and high cost, and the psychological effects produced by the social limitations that this diet entails, have probably contributed to the fact that this dietary intervention has been restricted almost exclusively to pediatric patients," commented Dr. Arias.

"In fact, no research on adults was available until 2013, with the reported remission rates being comparable with those documented in children."

On the other hand, the relatively high efficacy of the SFED diet, which avoids many of the disadvantages of the elemental diet, seems to make this the best choice for "children and motivated adult patients," added the researchers.

Future studies and meta-analyses should address whether diet adherence results in changes in esophageal fibrosis as well as quality of life issues brought on by diet adherence.

The authors disclosed no relevant financial conflicts.

[email protected]