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CHICAGO – Esophageal dilation combined with standard medical management of eosinophilic esophagitis doesn’t provide added benefit over medication alone in terms of dysphagia relief, according to a randomized, blinded clinical trial.
"In our group of patients with moderate endoscopic findings and without severe stricturing disease, esophageal dilation does not appear to be a necessary additional treatment strategy," Dr. Robert T. Kavitt stated at the annual Digestive Disease Week.
The study involved 31 patients newly diagnosed with eosinophilic esophagitis and baseline moderate to severe difficulty in swallowing. They were randomized to dilation or no dilation at initial endoscopy. Then all patients received standard medical management with 440 mcg of swallowed fluticasone b.i.d. and dexlansoprazole at 60 mg/day for 2 months. Patients were blinded as to their dilation status, as were the physicians who rated their change in dysphagia scores during follow-up.
Both groups experienced robust albeit equal reductions in overall dysphagia scores upon assessment at 30 and 60 days after endoscopy. At baseline, dysphagia scores averaged 6-6.5 on a 0-9 scale, indicative of moderate to severe dysphagia. At follow-up, scores in both groups had dropped to an average of 3 or less, reported Dr. Kavitt of the University of Chicago.
Complete resolution of dysphagia, defined as a dysphagia score of 0, occurred in only 23% of the dilation group and 57% of the no-dilation controls, which was not a statistically significant difference. The looser standard of "significant improvement" – meaning a dysphagia score of 3 or less – was met by 92% of the dilation group and 86% of controls.
Two patients in the dilation group and one control reported odynophagia.
Patients in the dilation group were dilated to the endpoint of mucosal tear. Three-quarters of the patients were dilated to a maximum size of 50 French or larger.
Baseline endoscopic scores assessing strictures, fissures, rings, and other abnormalities were in the moderate range on a 0-13 severity scale, so the study finding of a lack of benefit for dilation as part of an initial treatment strategy in eosinophilic esophagitis may not extend to the minority of patients having truly severe stricturing disease, according to Dr. Kavitt.
He noted that, before this study, the role of dilation in the treatment of eosinophilic esophagitis was a matter of divergent expert opinion unsupported by randomized trial evidence. The 2013 American College of Gastroenterology guidelines state that "the role of dilation as a primary monotherapy of eosinophilic esophagitis is still controversial and should be individualized."
Later during the meeting, in his state-of-the-art lecture on changing therapeutic concepts in eosinophilic esophagitis, Dr. Ikuo Hirano cited Dr. Kavitt’s randomized trial in support of his argument against dilation as primary therapy.
"Dilation does nothing to address the underlying inflammatory response that’s causing strictures to form," noted Dr. Hirano, professor of medicine at Northwestern University, Chicago. "I believe that dilation is inappropriate therapy for children and adults with a predominantly inflammatory phenotype of disease."
Medication and diet therapies not only relieve the symptoms of eosinophilic esophagitis, he continued, they also improve the histopathology.
Dilation entails considerable pain as well as a risk of perforation. Recent reassuring safety data regarding dilation for eosinophilic esophagitis come from specialized esophageal centers with an unusual amount of experience with the procedure, the gastroenterologist said.
Dr. Kavitt reported having no financial conflicts of interest with regard to the randomized trial, which was supported by institutional funds. Dr. Hirano serves as a consultant to Meritage Pharma, Receptos, and Aptalis.
This is the first prospective examination of the role of esophageal dilation in eosinophilic esophagitis (EoE). The symptom-based outcomes suggest that dilation is not necessary for the initial therapy of EoE. The improvement in dysphagia was equivalent in patients treated with dilation combined with medical therapy, compared with those treated with medical therapy alone.
 |
| Dr. Ikuo Hirano |
Moreover, while all patients randomized to dilation had dysphagia, not all had endoscopically identified esophageal strictures. One would not expect therapeutic gain for esophageal dilation in the absence of an identifiable stricture. Furthermore, randomized controlled trials of medical therapy for EoE have identified a surprisingly high placebo-response rate for the outcome of dysphagia that may have made demonstration of the benefits of dilation difficult to detect, especially in patients with mild disease severity. Symptom improvement in dysphagia may occur in response to modifications in eating habits such as meticulous mastication or avoidance of highly textured foods.
Finally, the inability to discern a difference in treatment groups may reflect the use of a nonvalidated dysphagia severity assessment instrument.
Despite these shortcomings, the results support current guideline recommendations that dilation should target aspects of esophageal remodeling in EoE that are not amenable to currently available medical or diet therapies.
The data, however, do not exclude an important therapeutic benefit of esophageal dilation in EoE. The study excluded patients with significant strictures that could not be traversed with a standard adult endoscope. The findings, therefore, would not apply to EoE patients with substantial fibrostenosis.
In this study, medical therapy was highly effective at relieving symptoms, but prior studies have shown that symptoms recur in almost all patients following cessation of medications.
Dilation, on the other hand, is generally safe and provides long-lasting relief of dysphagia in adults, even in the absence of medical or diet therapy. Additional prospective studies are needed to define the most appropriate patient subgroups that would benefit from dilation.
Dr. Ikuo Hirano is professor of medicine in the division of gastroenterology at Northwestern University's Feinberg School of Medicine in Chicago. He serves as a consultant to Meritage Pharma, Receptos, and Aptalis.
This is the first prospective examination of the role of esophageal dilation in eosinophilic esophagitis (EoE). The symptom-based outcomes suggest that dilation is not necessary for the initial therapy of EoE. The improvement in dysphagia was equivalent in patients treated with dilation combined with medical therapy, compared with those treated with medical therapy alone.
|
| Dr. Ikuo Hirano |
Moreover, while all patients randomized to dilation had dysphagia, not all had endoscopically identified esophageal strictures. One would not expect therapeutic gain for esophageal dilation in the absence of an identifiable stricture. Furthermore, randomized controlled trials of medical therapy for EoE have identified a surprisingly high placebo-response rate for the outcome of dysphagia that may have made demonstration of the benefits of dilation difficult to detect, especially in patients with mild disease severity. Symptom improvement in dysphagia may occur in response to modifications in eating habits such as meticulous mastication or avoidance of highly textured foods.
Finally, the inability to discern a difference in treatment groups may reflect the use of a nonvalidated dysphagia severity assessment instrument.
Despite these shortcomings, the results support current guideline recommendations that dilation should target aspects of esophageal remodeling in EoE that are not amenable to currently available medical or diet therapies.
The data, however, do not exclude an important therapeutic benefit of esophageal dilation in EoE. The study excluded patients with significant strictures that could not be traversed with a standard adult endoscope. The findings, therefore, would not apply to EoE patients with substantial fibrostenosis.
In this study, medical therapy was highly effective at relieving symptoms, but prior studies have shown that symptoms recur in almost all patients following cessation of medications.
Dilation, on the other hand, is generally safe and provides long-lasting relief of dysphagia in adults, even in the absence of medical or diet therapy. Additional prospective studies are needed to define the most appropriate patient subgroups that would benefit from dilation.
Dr. Ikuo Hirano is professor of medicine in the division of gastroenterology at Northwestern University's Feinberg School of Medicine in Chicago. He serves as a consultant to Meritage Pharma, Receptos, and Aptalis.
This is the first prospective examination of the role of esophageal dilation in eosinophilic esophagitis (EoE). The symptom-based outcomes suggest that dilation is not necessary for the initial therapy of EoE. The improvement in dysphagia was equivalent in patients treated with dilation combined with medical therapy, compared with those treated with medical therapy alone.
|
| Dr. Ikuo Hirano |
Moreover, while all patients randomized to dilation had dysphagia, not all had endoscopically identified esophageal strictures. One would not expect therapeutic gain for esophageal dilation in the absence of an identifiable stricture. Furthermore, randomized controlled trials of medical therapy for EoE have identified a surprisingly high placebo-response rate for the outcome of dysphagia that may have made demonstration of the benefits of dilation difficult to detect, especially in patients with mild disease severity. Symptom improvement in dysphagia may occur in response to modifications in eating habits such as meticulous mastication or avoidance of highly textured foods.
Finally, the inability to discern a difference in treatment groups may reflect the use of a nonvalidated dysphagia severity assessment instrument.
Despite these shortcomings, the results support current guideline recommendations that dilation should target aspects of esophageal remodeling in EoE that are not amenable to currently available medical or diet therapies.
The data, however, do not exclude an important therapeutic benefit of esophageal dilation in EoE. The study excluded patients with significant strictures that could not be traversed with a standard adult endoscope. The findings, therefore, would not apply to EoE patients with substantial fibrostenosis.
In this study, medical therapy was highly effective at relieving symptoms, but prior studies have shown that symptoms recur in almost all patients following cessation of medications.
Dilation, on the other hand, is generally safe and provides long-lasting relief of dysphagia in adults, even in the absence of medical or diet therapy. Additional prospective studies are needed to define the most appropriate patient subgroups that would benefit from dilation.
Dr. Ikuo Hirano is professor of medicine in the division of gastroenterology at Northwestern University's Feinberg School of Medicine in Chicago. He serves as a consultant to Meritage Pharma, Receptos, and Aptalis.
CHICAGO – Esophageal dilation combined with standard medical management of eosinophilic esophagitis doesn’t provide added benefit over medication alone in terms of dysphagia relief, according to a randomized, blinded clinical trial.
"In our group of patients with moderate endoscopic findings and without severe stricturing disease, esophageal dilation does not appear to be a necessary additional treatment strategy," Dr. Robert T. Kavitt stated at the annual Digestive Disease Week.
The study involved 31 patients newly diagnosed with eosinophilic esophagitis and baseline moderate to severe difficulty in swallowing. They were randomized to dilation or no dilation at initial endoscopy. Then all patients received standard medical management with 440 mcg of swallowed fluticasone b.i.d. and dexlansoprazole at 60 mg/day for 2 months. Patients were blinded as to their dilation status, as were the physicians who rated their change in dysphagia scores during follow-up.
Both groups experienced robust albeit equal reductions in overall dysphagia scores upon assessment at 30 and 60 days after endoscopy. At baseline, dysphagia scores averaged 6-6.5 on a 0-9 scale, indicative of moderate to severe dysphagia. At follow-up, scores in both groups had dropped to an average of 3 or less, reported Dr. Kavitt of the University of Chicago.
Complete resolution of dysphagia, defined as a dysphagia score of 0, occurred in only 23% of the dilation group and 57% of the no-dilation controls, which was not a statistically significant difference. The looser standard of "significant improvement" – meaning a dysphagia score of 3 or less – was met by 92% of the dilation group and 86% of controls.
Two patients in the dilation group and one control reported odynophagia.
Patients in the dilation group were dilated to the endpoint of mucosal tear. Three-quarters of the patients were dilated to a maximum size of 50 French or larger.
Baseline endoscopic scores assessing strictures, fissures, rings, and other abnormalities were in the moderate range on a 0-13 severity scale, so the study finding of a lack of benefit for dilation as part of an initial treatment strategy in eosinophilic esophagitis may not extend to the minority of patients having truly severe stricturing disease, according to Dr. Kavitt.
He noted that, before this study, the role of dilation in the treatment of eosinophilic esophagitis was a matter of divergent expert opinion unsupported by randomized trial evidence. The 2013 American College of Gastroenterology guidelines state that "the role of dilation as a primary monotherapy of eosinophilic esophagitis is still controversial and should be individualized."
Later during the meeting, in his state-of-the-art lecture on changing therapeutic concepts in eosinophilic esophagitis, Dr. Ikuo Hirano cited Dr. Kavitt’s randomized trial in support of his argument against dilation as primary therapy.
"Dilation does nothing to address the underlying inflammatory response that’s causing strictures to form," noted Dr. Hirano, professor of medicine at Northwestern University, Chicago. "I believe that dilation is inappropriate therapy for children and adults with a predominantly inflammatory phenotype of disease."
Medication and diet therapies not only relieve the symptoms of eosinophilic esophagitis, he continued, they also improve the histopathology.
Dilation entails considerable pain as well as a risk of perforation. Recent reassuring safety data regarding dilation for eosinophilic esophagitis come from specialized esophageal centers with an unusual amount of experience with the procedure, the gastroenterologist said.
Dr. Kavitt reported having no financial conflicts of interest with regard to the randomized trial, which was supported by institutional funds. Dr. Hirano serves as a consultant to Meritage Pharma, Receptos, and Aptalis.
CHICAGO – Esophageal dilation combined with standard medical management of eosinophilic esophagitis doesn’t provide added benefit over medication alone in terms of dysphagia relief, according to a randomized, blinded clinical trial.
"In our group of patients with moderate endoscopic findings and without severe stricturing disease, esophageal dilation does not appear to be a necessary additional treatment strategy," Dr. Robert T. Kavitt stated at the annual Digestive Disease Week.
The study involved 31 patients newly diagnosed with eosinophilic esophagitis and baseline moderate to severe difficulty in swallowing. They were randomized to dilation or no dilation at initial endoscopy. Then all patients received standard medical management with 440 mcg of swallowed fluticasone b.i.d. and dexlansoprazole at 60 mg/day for 2 months. Patients were blinded as to their dilation status, as were the physicians who rated their change in dysphagia scores during follow-up.
Both groups experienced robust albeit equal reductions in overall dysphagia scores upon assessment at 30 and 60 days after endoscopy. At baseline, dysphagia scores averaged 6-6.5 on a 0-9 scale, indicative of moderate to severe dysphagia. At follow-up, scores in both groups had dropped to an average of 3 or less, reported Dr. Kavitt of the University of Chicago.
Complete resolution of dysphagia, defined as a dysphagia score of 0, occurred in only 23% of the dilation group and 57% of the no-dilation controls, which was not a statistically significant difference. The looser standard of "significant improvement" – meaning a dysphagia score of 3 or less – was met by 92% of the dilation group and 86% of controls.
Two patients in the dilation group and one control reported odynophagia.
Patients in the dilation group were dilated to the endpoint of mucosal tear. Three-quarters of the patients were dilated to a maximum size of 50 French or larger.
Baseline endoscopic scores assessing strictures, fissures, rings, and other abnormalities were in the moderate range on a 0-13 severity scale, so the study finding of a lack of benefit for dilation as part of an initial treatment strategy in eosinophilic esophagitis may not extend to the minority of patients having truly severe stricturing disease, according to Dr. Kavitt.
He noted that, before this study, the role of dilation in the treatment of eosinophilic esophagitis was a matter of divergent expert opinion unsupported by randomized trial evidence. The 2013 American College of Gastroenterology guidelines state that "the role of dilation as a primary monotherapy of eosinophilic esophagitis is still controversial and should be individualized."
Later during the meeting, in his state-of-the-art lecture on changing therapeutic concepts in eosinophilic esophagitis, Dr. Ikuo Hirano cited Dr. Kavitt’s randomized trial in support of his argument against dilation as primary therapy.
"Dilation does nothing to address the underlying inflammatory response that’s causing strictures to form," noted Dr. Hirano, professor of medicine at Northwestern University, Chicago. "I believe that dilation is inappropriate therapy for children and adults with a predominantly inflammatory phenotype of disease."
Medication and diet therapies not only relieve the symptoms of eosinophilic esophagitis, he continued, they also improve the histopathology.
Dilation entails considerable pain as well as a risk of perforation. Recent reassuring safety data regarding dilation for eosinophilic esophagitis come from specialized esophageal centers with an unusual amount of experience with the procedure, the gastroenterologist said.
Dr. Kavitt reported having no financial conflicts of interest with regard to the randomized trial, which was supported by institutional funds. Dr. Hirano serves as a consultant to Meritage Pharma, Receptos, and Aptalis.
AT DDW 2014
Key clinical point: Dilation offers no added benefit over medication alone in relieving dysphagia symptoms in eosinophilic esophagitis.
Major finding: Significant improvement in dysphagia symptoms was documented 30 and 60 days post endoscopy in 92% of eosinophilic esophagitis patients who underwent dilation plus medical therapy and in 86% who got medication alone.
Data source: This was a randomized trial involving 31 patients newly diagnosed with eosinophilic esophagitis who were assigned to dilation or no dilation at initial endoscopy, after which all participants received 2 months of medical therapy with a swallowed corticosteroid and a proton pump inhibitor. Patients as well as the physicians who rated their dysphagia symptoms 30 and 60 days post endoscopy were blinded as to dilation status.
Disclosures: Dr. Kavitt reported having no financial conflicts regarding this study, which was supported by institutional funds. Dr. Hirano serves as a consultant to Meritage Pharma, Receptos, and Aptalis.
