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Experimental drug may help those living with celiac disease
“Contamination with gluten happens during food processing, food packaging, cooking, and [because of] inadequate labeling,” Francisco Leon, MD, a consultant for Amgen and former CEO of Celimmune, said in a media briefing in advance of the annual Digestive Disease Week® (DDW). “Gluten is [also] present in unsuspected places like lipstick, toothpaste, even medicines. It is virtually impossible for celiac patients to completely avoid gluten.”
The new drug, AMG 714, works by blocking interleukin 15, a known intestinal inflammatory mediator, and lowers inflammation, resulting in fewer symptoms for patients.
In a 12-week study, patients received either 150- or 300-mg doses of subcutaneous AMG 714, or placebo. All doses of AMG 714 were administered six times over the course of the study. From weeks 2 to 12, patients were challenged with a daily dose of 2.5 grams of gluten, which is considered a high dose.
The results showed that AMG 714 significantly reduced Celiac Disease Patient Reported Outcomes at the 300-mg dose (P = .02) compared with placebo. Similarly, AMG 714 decreased Celiac Disease Gastrointestinal Symptom Rating Scale scores at the 150-mg (P = .17) and 300-mg (P = .07) doses, compared with placebo.
Dr. Leon noted that there was another subset of patients who did not receive the gluten challenge because they were shown to have intestinal atrophy – marked by the presence of flat mucosa – because of contamination in their gluten-free diets. This was measured by way of a novel stool and urine detection test. This information will be presented at DDW.
AMG 714 also improved gluten-triggered diarrhea and physician assessments, according to Dr. Leon. In fact, using the Bristol Stool Form Scale, patients who received both the 150-mg (P = .01) and 300-mg (P = .0002) doses had substantially lower rates of diarrhea, compared with placebo.
These positive results were not isolated to the Bristol Stool Form Scale scores, but extended to the Physician Global Assessment as well.
“The proportion of subjects whom physicians evaluated as clinically active at week 12 was 0 in the high dose of AMG 714 while it was 33% in the placebo group,” stated Dr. Leon.
While AMG 714 has shown promise in alleviating celiac disease symptoms for patients inadvertently exposed to gluten, it is not intended to treat exposure to high amounts of gluten.
“It is important to note that AMG 714 is intended to protect against modest contamination [with] gluten and not against the effects of regularly eaten large amounts of gluten, like bread or pasta,” Dr. Leon cautioned. “But we know that people with celiac disease are inadvertently exposed to gluten. So it is our hope that AMG 714 will allow these patients to experience fewer gluten-triggered events.”
The information presented by Dr. Leon was only a taste of what will be presented at DDW®.
“At DDW, we will show you a reduction in inflammation, and we will also show you the safety profile. There were no serious adverse events.
“We are hopeful that this will become one of the tools to combat celiac disease.”
“Contamination with gluten happens during food processing, food packaging, cooking, and [because of] inadequate labeling,” Francisco Leon, MD, a consultant for Amgen and former CEO of Celimmune, said in a media briefing in advance of the annual Digestive Disease Week® (DDW). “Gluten is [also] present in unsuspected places like lipstick, toothpaste, even medicines. It is virtually impossible for celiac patients to completely avoid gluten.”
The new drug, AMG 714, works by blocking interleukin 15, a known intestinal inflammatory mediator, and lowers inflammation, resulting in fewer symptoms for patients.
In a 12-week study, patients received either 150- or 300-mg doses of subcutaneous AMG 714, or placebo. All doses of AMG 714 were administered six times over the course of the study. From weeks 2 to 12, patients were challenged with a daily dose of 2.5 grams of gluten, which is considered a high dose.
The results showed that AMG 714 significantly reduced Celiac Disease Patient Reported Outcomes at the 300-mg dose (P = .02) compared with placebo. Similarly, AMG 714 decreased Celiac Disease Gastrointestinal Symptom Rating Scale scores at the 150-mg (P = .17) and 300-mg (P = .07) doses, compared with placebo.
Dr. Leon noted that there was another subset of patients who did not receive the gluten challenge because they were shown to have intestinal atrophy – marked by the presence of flat mucosa – because of contamination in their gluten-free diets. This was measured by way of a novel stool and urine detection test. This information will be presented at DDW.
AMG 714 also improved gluten-triggered diarrhea and physician assessments, according to Dr. Leon. In fact, using the Bristol Stool Form Scale, patients who received both the 150-mg (P = .01) and 300-mg (P = .0002) doses had substantially lower rates of diarrhea, compared with placebo.
These positive results were not isolated to the Bristol Stool Form Scale scores, but extended to the Physician Global Assessment as well.
“The proportion of subjects whom physicians evaluated as clinically active at week 12 was 0 in the high dose of AMG 714 while it was 33% in the placebo group,” stated Dr. Leon.
While AMG 714 has shown promise in alleviating celiac disease symptoms for patients inadvertently exposed to gluten, it is not intended to treat exposure to high amounts of gluten.
“It is important to note that AMG 714 is intended to protect against modest contamination [with] gluten and not against the effects of regularly eaten large amounts of gluten, like bread or pasta,” Dr. Leon cautioned. “But we know that people with celiac disease are inadvertently exposed to gluten. So it is our hope that AMG 714 will allow these patients to experience fewer gluten-triggered events.”
The information presented by Dr. Leon was only a taste of what will be presented at DDW®.
“At DDW, we will show you a reduction in inflammation, and we will also show you the safety profile. There were no serious adverse events.
“We are hopeful that this will become one of the tools to combat celiac disease.”
“Contamination with gluten happens during food processing, food packaging, cooking, and [because of] inadequate labeling,” Francisco Leon, MD, a consultant for Amgen and former CEO of Celimmune, said in a media briefing in advance of the annual Digestive Disease Week® (DDW). “Gluten is [also] present in unsuspected places like lipstick, toothpaste, even medicines. It is virtually impossible for celiac patients to completely avoid gluten.”
The new drug, AMG 714, works by blocking interleukin 15, a known intestinal inflammatory mediator, and lowers inflammation, resulting in fewer symptoms for patients.
In a 12-week study, patients received either 150- or 300-mg doses of subcutaneous AMG 714, or placebo. All doses of AMG 714 were administered six times over the course of the study. From weeks 2 to 12, patients were challenged with a daily dose of 2.5 grams of gluten, which is considered a high dose.
The results showed that AMG 714 significantly reduced Celiac Disease Patient Reported Outcomes at the 300-mg dose (P = .02) compared with placebo. Similarly, AMG 714 decreased Celiac Disease Gastrointestinal Symptom Rating Scale scores at the 150-mg (P = .17) and 300-mg (P = .07) doses, compared with placebo.
Dr. Leon noted that there was another subset of patients who did not receive the gluten challenge because they were shown to have intestinal atrophy – marked by the presence of flat mucosa – because of contamination in their gluten-free diets. This was measured by way of a novel stool and urine detection test. This information will be presented at DDW.
AMG 714 also improved gluten-triggered diarrhea and physician assessments, according to Dr. Leon. In fact, using the Bristol Stool Form Scale, patients who received both the 150-mg (P = .01) and 300-mg (P = .0002) doses had substantially lower rates of diarrhea, compared with placebo.
These positive results were not isolated to the Bristol Stool Form Scale scores, but extended to the Physician Global Assessment as well.
“The proportion of subjects whom physicians evaluated as clinically active at week 12 was 0 in the high dose of AMG 714 while it was 33% in the placebo group,” stated Dr. Leon.
While AMG 714 has shown promise in alleviating celiac disease symptoms for patients inadvertently exposed to gluten, it is not intended to treat exposure to high amounts of gluten.
“It is important to note that AMG 714 is intended to protect against modest contamination [with] gluten and not against the effects of regularly eaten large amounts of gluten, like bread or pasta,” Dr. Leon cautioned. “But we know that people with celiac disease are inadvertently exposed to gluten. So it is our hope that AMG 714 will allow these patients to experience fewer gluten-triggered events.”
The information presented by Dr. Leon was only a taste of what will be presented at DDW®.
“At DDW, we will show you a reduction in inflammation, and we will also show you the safety profile. There were no serious adverse events.
“We are hopeful that this will become one of the tools to combat celiac disease.”
REPORTING FROM DDW 2018
IBD upped Parkinson’s risk in large study
Patients with inflammatory bowel disease were about 22% more likely to develop Parkinson’s disease than were unaffected peers in a population-based cohort study spanning more than 3 decades.
The finding “strengthens the theory of a ‘gut-brain axis,’ in which the intestinal environment influences the functioning of the central nervous system and intestinal imbalance may precede Parkinson’s disease,” wrote Marie Villumsen, PhD, of Bispebjerg and Frederiksberg Hospital in Copenhagen, with her associates.
Thus, clinicians should be vigilant for parkinsonism in patients with inflammatory bowel disease (IBD), the researchers wrote on May 21 in Gut. “Although the absolute risk of Parkinson’s disease [among patients with IBD] remains low, our study points to overlapping pathogenic mechanisms which merit further investigation, as they may represent targets for future therapeutic interventions.”
Gastrointestinal dysfunction can be one of the earliest manifestations of Parkinson’s disease, the researchers noted. Both neurodegenerative disorders and IBD involve chronic inflammation, and both Crohn’s disease and Parkinson’s disease have been linked to aberrations of the LRRK2 gene, which helps regulate inflammation and clearance of alpha-sinuclein, a key component of neuronal Lewy bodies in Parkinson’s disease.
To assess whether IBD directly increases the risk of Parkinson’s disease, the investigators studied individuals from the Danish National Patient Register, which covers all hospitalizations and outpatient visits in Denmark. They matched 76,477 patients with IBD with 7.5 million unaffected individuals of the same sex and age during 1977-2014. Patients with IBD had significantly more comorbidities (P less than .001) than individuals without IBD, so the researchers also controlled for Charlson Comorbidity Index.
In the adjusted analyses, IBD significantly increased the risk of developing Parkinson’s disease among both men (hazard ratio, 1.2) and women (HR, 1.23), irrespective of follow-up time and regardless of whether patients were less than 40 years old (HR, 1.22), 40-65 years old (HR, 1.25), or older than 65 years (HR, 1.30). The association between IBD and Parkinson’s disease also held up after accounting for the possibility that early gut symptoms of Parkinson’s disease were sometimes misdiagnosed as IBD, the researchers wrote.
Interestingly, stratifying by IBD subtype showed that the statistically significant risk factor was ulcerative colitis (HR, 1.35; 95% confidence interval, 1.20-1.52), not Crohn’s disease (HR, 1.12; 95% CI, 0.89-1.40). Prior studies have found that cigarette smoking reduces the risk of both Parkinson’s disease and ulcerative colitis, the investigators noted. They called for additional studies of intestinal inflammation in Parkinson’s disease and the role of the brain-gut axis in the etiology of parkinsonism.
Parkinsonforeningen, Landsforeningen Multipel System Atrofi, and Aage og Johanne Louis-Hansens Fond provided support. The investigators declared no competing interests.
SOURCE: Villumsen M et al. Gut. 2018 May 21. doi: 10.1136/gutjnl-2017-315666.
Patients with inflammatory bowel disease were about 22% more likely to develop Parkinson’s disease than were unaffected peers in a population-based cohort study spanning more than 3 decades.
The finding “strengthens the theory of a ‘gut-brain axis,’ in which the intestinal environment influences the functioning of the central nervous system and intestinal imbalance may precede Parkinson’s disease,” wrote Marie Villumsen, PhD, of Bispebjerg and Frederiksberg Hospital in Copenhagen, with her associates.
Thus, clinicians should be vigilant for parkinsonism in patients with inflammatory bowel disease (IBD), the researchers wrote on May 21 in Gut. “Although the absolute risk of Parkinson’s disease [among patients with IBD] remains low, our study points to overlapping pathogenic mechanisms which merit further investigation, as they may represent targets for future therapeutic interventions.”
Gastrointestinal dysfunction can be one of the earliest manifestations of Parkinson’s disease, the researchers noted. Both neurodegenerative disorders and IBD involve chronic inflammation, and both Crohn’s disease and Parkinson’s disease have been linked to aberrations of the LRRK2 gene, which helps regulate inflammation and clearance of alpha-sinuclein, a key component of neuronal Lewy bodies in Parkinson’s disease.
To assess whether IBD directly increases the risk of Parkinson’s disease, the investigators studied individuals from the Danish National Patient Register, which covers all hospitalizations and outpatient visits in Denmark. They matched 76,477 patients with IBD with 7.5 million unaffected individuals of the same sex and age during 1977-2014. Patients with IBD had significantly more comorbidities (P less than .001) than individuals without IBD, so the researchers also controlled for Charlson Comorbidity Index.
In the adjusted analyses, IBD significantly increased the risk of developing Parkinson’s disease among both men (hazard ratio, 1.2) and women (HR, 1.23), irrespective of follow-up time and regardless of whether patients were less than 40 years old (HR, 1.22), 40-65 years old (HR, 1.25), or older than 65 years (HR, 1.30). The association between IBD and Parkinson’s disease also held up after accounting for the possibility that early gut symptoms of Parkinson’s disease were sometimes misdiagnosed as IBD, the researchers wrote.
Interestingly, stratifying by IBD subtype showed that the statistically significant risk factor was ulcerative colitis (HR, 1.35; 95% confidence interval, 1.20-1.52), not Crohn’s disease (HR, 1.12; 95% CI, 0.89-1.40). Prior studies have found that cigarette smoking reduces the risk of both Parkinson’s disease and ulcerative colitis, the investigators noted. They called for additional studies of intestinal inflammation in Parkinson’s disease and the role of the brain-gut axis in the etiology of parkinsonism.
Parkinsonforeningen, Landsforeningen Multipel System Atrofi, and Aage og Johanne Louis-Hansens Fond provided support. The investigators declared no competing interests.
SOURCE: Villumsen M et al. Gut. 2018 May 21. doi: 10.1136/gutjnl-2017-315666.
Patients with inflammatory bowel disease were about 22% more likely to develop Parkinson’s disease than were unaffected peers in a population-based cohort study spanning more than 3 decades.
The finding “strengthens the theory of a ‘gut-brain axis,’ in which the intestinal environment influences the functioning of the central nervous system and intestinal imbalance may precede Parkinson’s disease,” wrote Marie Villumsen, PhD, of Bispebjerg and Frederiksberg Hospital in Copenhagen, with her associates.
Thus, clinicians should be vigilant for parkinsonism in patients with inflammatory bowel disease (IBD), the researchers wrote on May 21 in Gut. “Although the absolute risk of Parkinson’s disease [among patients with IBD] remains low, our study points to overlapping pathogenic mechanisms which merit further investigation, as they may represent targets for future therapeutic interventions.”
Gastrointestinal dysfunction can be one of the earliest manifestations of Parkinson’s disease, the researchers noted. Both neurodegenerative disorders and IBD involve chronic inflammation, and both Crohn’s disease and Parkinson’s disease have been linked to aberrations of the LRRK2 gene, which helps regulate inflammation and clearance of alpha-sinuclein, a key component of neuronal Lewy bodies in Parkinson’s disease.
To assess whether IBD directly increases the risk of Parkinson’s disease, the investigators studied individuals from the Danish National Patient Register, which covers all hospitalizations and outpatient visits in Denmark. They matched 76,477 patients with IBD with 7.5 million unaffected individuals of the same sex and age during 1977-2014. Patients with IBD had significantly more comorbidities (P less than .001) than individuals without IBD, so the researchers also controlled for Charlson Comorbidity Index.
In the adjusted analyses, IBD significantly increased the risk of developing Parkinson’s disease among both men (hazard ratio, 1.2) and women (HR, 1.23), irrespective of follow-up time and regardless of whether patients were less than 40 years old (HR, 1.22), 40-65 years old (HR, 1.25), or older than 65 years (HR, 1.30). The association between IBD and Parkinson’s disease also held up after accounting for the possibility that early gut symptoms of Parkinson’s disease were sometimes misdiagnosed as IBD, the researchers wrote.
Interestingly, stratifying by IBD subtype showed that the statistically significant risk factor was ulcerative colitis (HR, 1.35; 95% confidence interval, 1.20-1.52), not Crohn’s disease (HR, 1.12; 95% CI, 0.89-1.40). Prior studies have found that cigarette smoking reduces the risk of both Parkinson’s disease and ulcerative colitis, the investigators noted. They called for additional studies of intestinal inflammation in Parkinson’s disease and the role of the brain-gut axis in the etiology of parkinsonism.
Parkinsonforeningen, Landsforeningen Multipel System Atrofi, and Aage og Johanne Louis-Hansens Fond provided support. The investigators declared no competing interests.
SOURCE: Villumsen M et al. Gut. 2018 May 21. doi: 10.1136/gutjnl-2017-315666.
FROM GUT
Key clinical point:
Major finding: After accounting for comorbidities, individuals with IBD were about 22% more likely to develop Parkinson’s disease compared with individuals without IBD (hazard ratio, 1.22; 95% confidence interval, 1.09-1.35).
Study details: A population-based cohort study of 76,477 individuals with IBD and 7.5 million unaffected persons.
Disclosures: Parkinsonforeningen, Landsforeningen Multipel System Atrofi, and Aage og Johanne Louis-Hansens Fond provided support. The investigators declared no competing interests.
Source: Villumsen M et al. Gut. 2018 May 21. doi: 10.1136/gutjnl-2017-315666.
Blood type A linked to more-severe diarrhea
Diarrhea associated with enterotoxigenic Escherichia coli (ETEC) infection is more severe among individuals with blood type A, based on data from 106 adults exposed to the agent.
The reseachers speculate that the increased severity is related, in part, to the presence of an adhesin molecule known as EtpA, which binds to the surface of the cells and combines with blood group A glycans to promote a more severe infection.
“Our studies suggest that the many ETEC strains that produce the EtpA adhesin may be particularly well equipped to preferentially infect hosts who express A blood group antigen on mucosal surfaces,” wrote Pardeep Kumar, MD, of Washington University, Saint Louis, and his colleagues.
ETEC, associated with choleralike illness, remains a major cause of infectious diarrhea in developing countries. No current vaccine offers significant protection against it, but EtpA may be useful in vaccine development. “More recently discovered virulence factors and an improved understanding of ETEC microbial pathogenesis could offer additional avenues to protect those at highest risk for severe disease and uncover novel molecular targets for future vaccine development,” the researchers said.
In a study published in the Journal of Clinical Investigation, the researchers examined blood samples from 106 adults who had participated in previous human infection model studies. The volunteers were challenged with an ETEC strain known as H10407 that was originally isolated from a case of choleralike illness.
Diarrhea was more frequent among A blood type individuals, compared with other types. Individuals with B or O blood types were significantly more likely to have no diarrhea or mild diarrhea after the E. coli challenge, compared with type A individuals (44% vs. 19%).
Overall, significantly more individuals with A or AB blood types developed moderate to severe diarrhea, compared with those with B or O blood types (81% vs. 56%). In addition, significantly more individuals with blood type A needed early initiation of antibiotic therapy, compared with those with B or O blood types (72% vs. 43%).
The study findings were limited by several factors, including the use of higher levels of bacteria to cause the infection than a typical exposure in nature. Also, the volunteers were treated with antibiotics once they met the criteria for severe diarrhea.
The researchers also noted that other blood group A lectins in addition to EtpA may not have been identified.
“While our recent studies have potentially important clinical and [vaccinological] implications, further study of the relationship between blood group, disease severity, and antigen expression could guide and inform use of these antigens in vaccines,” they wrote.
The study was supported by funds from the Enteric Vaccine Initiative of PATH, the Department of Veterans Affairs, the National Institutes of Health, and the Digestive Diseases Research Core Center at Washington University School of Medicine, St. Louis. The researchers had no financial conflicts to disclose.
SOURCE: Kumar P et al. J Clin Invest. 2018 May 17. doi: 10.1172/JCI97659.
Diarrhea associated with enterotoxigenic Escherichia coli (ETEC) infection is more severe among individuals with blood type A, based on data from 106 adults exposed to the agent.
The reseachers speculate that the increased severity is related, in part, to the presence of an adhesin molecule known as EtpA, which binds to the surface of the cells and combines with blood group A glycans to promote a more severe infection.
“Our studies suggest that the many ETEC strains that produce the EtpA adhesin may be particularly well equipped to preferentially infect hosts who express A blood group antigen on mucosal surfaces,” wrote Pardeep Kumar, MD, of Washington University, Saint Louis, and his colleagues.
ETEC, associated with choleralike illness, remains a major cause of infectious diarrhea in developing countries. No current vaccine offers significant protection against it, but EtpA may be useful in vaccine development. “More recently discovered virulence factors and an improved understanding of ETEC microbial pathogenesis could offer additional avenues to protect those at highest risk for severe disease and uncover novel molecular targets for future vaccine development,” the researchers said.
In a study published in the Journal of Clinical Investigation, the researchers examined blood samples from 106 adults who had participated in previous human infection model studies. The volunteers were challenged with an ETEC strain known as H10407 that was originally isolated from a case of choleralike illness.
Diarrhea was more frequent among A blood type individuals, compared with other types. Individuals with B or O blood types were significantly more likely to have no diarrhea or mild diarrhea after the E. coli challenge, compared with type A individuals (44% vs. 19%).
Overall, significantly more individuals with A or AB blood types developed moderate to severe diarrhea, compared with those with B or O blood types (81% vs. 56%). In addition, significantly more individuals with blood type A needed early initiation of antibiotic therapy, compared with those with B or O blood types (72% vs. 43%).
The study findings were limited by several factors, including the use of higher levels of bacteria to cause the infection than a typical exposure in nature. Also, the volunteers were treated with antibiotics once they met the criteria for severe diarrhea.
The researchers also noted that other blood group A lectins in addition to EtpA may not have been identified.
“While our recent studies have potentially important clinical and [vaccinological] implications, further study of the relationship between blood group, disease severity, and antigen expression could guide and inform use of these antigens in vaccines,” they wrote.
The study was supported by funds from the Enteric Vaccine Initiative of PATH, the Department of Veterans Affairs, the National Institutes of Health, and the Digestive Diseases Research Core Center at Washington University School of Medicine, St. Louis. The researchers had no financial conflicts to disclose.
SOURCE: Kumar P et al. J Clin Invest. 2018 May 17. doi: 10.1172/JCI97659.
Diarrhea associated with enterotoxigenic Escherichia coli (ETEC) infection is more severe among individuals with blood type A, based on data from 106 adults exposed to the agent.
The reseachers speculate that the increased severity is related, in part, to the presence of an adhesin molecule known as EtpA, which binds to the surface of the cells and combines with blood group A glycans to promote a more severe infection.
“Our studies suggest that the many ETEC strains that produce the EtpA adhesin may be particularly well equipped to preferentially infect hosts who express A blood group antigen on mucosal surfaces,” wrote Pardeep Kumar, MD, of Washington University, Saint Louis, and his colleagues.
ETEC, associated with choleralike illness, remains a major cause of infectious diarrhea in developing countries. No current vaccine offers significant protection against it, but EtpA may be useful in vaccine development. “More recently discovered virulence factors and an improved understanding of ETEC microbial pathogenesis could offer additional avenues to protect those at highest risk for severe disease and uncover novel molecular targets for future vaccine development,” the researchers said.
In a study published in the Journal of Clinical Investigation, the researchers examined blood samples from 106 adults who had participated in previous human infection model studies. The volunteers were challenged with an ETEC strain known as H10407 that was originally isolated from a case of choleralike illness.
Diarrhea was more frequent among A blood type individuals, compared with other types. Individuals with B or O blood types were significantly more likely to have no diarrhea or mild diarrhea after the E. coli challenge, compared with type A individuals (44% vs. 19%).
Overall, significantly more individuals with A or AB blood types developed moderate to severe diarrhea, compared with those with B or O blood types (81% vs. 56%). In addition, significantly more individuals with blood type A needed early initiation of antibiotic therapy, compared with those with B or O blood types (72% vs. 43%).
The study findings were limited by several factors, including the use of higher levels of bacteria to cause the infection than a typical exposure in nature. Also, the volunteers were treated with antibiotics once they met the criteria for severe diarrhea.
The researchers also noted that other blood group A lectins in addition to EtpA may not have been identified.
“While our recent studies have potentially important clinical and [vaccinological] implications, further study of the relationship between blood group, disease severity, and antigen expression could guide and inform use of these antigens in vaccines,” they wrote.
The study was supported by funds from the Enteric Vaccine Initiative of PATH, the Department of Veterans Affairs, the National Institutes of Health, and the Digestive Diseases Research Core Center at Washington University School of Medicine, St. Louis. The researchers had no financial conflicts to disclose.
SOURCE: Kumar P et al. J Clin Invest. 2018 May 17. doi: 10.1172/JCI97659.
FROM THE JOURNAL OF CLINICAL INVESTIGATION
Key clinical point: Severe diarrhea was significantly more frequent in adults with an A blood type, compared with B or O types.
Major finding: The overall relative risk of moderate to severe diarrhea was 1.44 for A blood groups, compared with non-A blood groups.
Study details: The data come from 106 adult volunteers who had participated in previous human infection model studies.
Disclosures: The study was supported by funds from the PATH Enteric Vaccine Initiative, the Department of Veterans Affairs, the National Institutes of Health, and the Digestive Diseases Research Core Center at Washington University School of Medicine, St. Louis. The researchers had no financial conflicts to disclose.
Source: Kumar P et al. J Clin Invest. 2018 May 17; doi: 10.1172/JCI97659.
Celiac disease: Can biopsy be avoided?
LAS VEGAS – It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.
“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
Biopsy, already a tarnished standard because of issues such as interpretation, according to Dr. Murray, is being challenged in studies that examine alternate ways of making the diagnosis.
In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.
Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.
Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.
“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.
The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).
“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”
However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.
Global Academy and this news organization are owned by the same parent company.Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.
AGA offers celiac disease information for your patients in the GI Patient Center at http://ow.ly/VwJ130jN7Sx.
LAS VEGAS – It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.
“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
Biopsy, already a tarnished standard because of issues such as interpretation, according to Dr. Murray, is being challenged in studies that examine alternate ways of making the diagnosis.
In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.
Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.
Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.
“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.
The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).
“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”
However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.
Global Academy and this news organization are owned by the same parent company.Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.
AGA offers celiac disease information for your patients in the GI Patient Center at http://ow.ly/VwJ130jN7Sx.
LAS VEGAS – It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.
“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
Biopsy, already a tarnished standard because of issues such as interpretation, according to Dr. Murray, is being challenged in studies that examine alternate ways of making the diagnosis.
In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.
Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.
Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.
“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.
The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).
“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”
However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.
Global Academy and this news organization are owned by the same parent company.Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.
AGA offers celiac disease information for your patients in the GI Patient Center at http://ow.ly/VwJ130jN7Sx.
Update on AGA-Medtronic Research and Development Pilot Award in Technology
BOSTON – It’s been just a year since Bani Chander Roland, MD, FACG, was awarded the 2017 AGA-Medtronic Research and Development Pilot Award in Technology, and her team already has recruited 30 patients with irritable bowel syndrome (IBS) and small intestinal bacterial overgrowth (SIBO) for a study of the gut microbiome and functioning. Interim data from her grant will be presented at Digestive Disease Week® 2018 in June in Washington, D.C., as a poster of distinction.
Dr. Roland and her team are testing the hypothesis that IBS and SIBO result from several distinct pathophysiologic mechanisms, each of which are associated with their own distinct microbial and inflammatory profile. For the study, they are using the Wireless Motility Capsule (WMC, SmartPill) to assess alterations in gastrointestinal pathophysiology in patients with suspected IBS and SIBO – just the sort of innovative technology that the AGA Center for GI Innovation and Technology (CGIT) has fostered. They also are obtaining microflora from oropharyngeal, gastric, small bowel, and fecal samples for DNA sequencing. In addition, the team is beginning to study serum samples to test the hypothesis that patients with IBS and SIBO have increased expression of pro-inflammatory markers compared to those with only IBS; they are attempting to correlate the inflammatory markers to specific bacteria.
“IBS is a very common gastrointestinal disorder, and we’re continuing to see an increase in prevalence in Western countries, without understanding the etiology for this syndrome,” said Dr. Roland, director of gastrointestinal motility at Lenox Hill Hospital and Northwell Health System in New York. “Unfortunately, we don’t have any specific or targeted therapies for this patient population because the underlying physiological mechanisms that cause IBS are not very well understood. When we treat these patients with antibiotics, often their symptoms come right back. If we can target the causes of disease in subsets of these patients, we may be able to successfully treat them.”
“We’re very excited to see what changes in the microbiome exist in this patient population, to determine if the microbiome may be another potential area that we can target for treatment,” she added.
In data to be presented in the DDW poster, Dr. Roland’s team used the SmartPill to measure the gastrointestinal transit times, pH, and ileocecal junction pressures of patients with IBS and SIBO as compared to patients with IBS without evidence of SIBO. “Interestingly, patients who had IBS and SIBO had significantly higher contraction frequency in the stomach and small bowel compared to patients with IBS alone,” Dr. Roland said. Those with both conditions also had lower ileocecal junction pressures. “These are physiological mechanisms that have not been well understood before,” Dr. Roland said. “We have been able to begin delineating some of the underlying physiological mechanisms in this challenging patient population for the first time, using a noninvasive, wireless motility capsule.”
Dr. Roland’s team is now partnering with the hospital’s endocrinology division to compare the circulating inflammatory markers in patients with IBS and SIBO, such as TNF (tumor necrosis factor)-alpha and IL (interleukin)-6, to patients with IBS alone. They will use their data to apply for future funding.
BOSTON – It’s been just a year since Bani Chander Roland, MD, FACG, was awarded the 2017 AGA-Medtronic Research and Development Pilot Award in Technology, and her team already has recruited 30 patients with irritable bowel syndrome (IBS) and small intestinal bacterial overgrowth (SIBO) for a study of the gut microbiome and functioning. Interim data from her grant will be presented at Digestive Disease Week® 2018 in June in Washington, D.C., as a poster of distinction.
Dr. Roland and her team are testing the hypothesis that IBS and SIBO result from several distinct pathophysiologic mechanisms, each of which are associated with their own distinct microbial and inflammatory profile. For the study, they are using the Wireless Motility Capsule (WMC, SmartPill) to assess alterations in gastrointestinal pathophysiology in patients with suspected IBS and SIBO – just the sort of innovative technology that the AGA Center for GI Innovation and Technology (CGIT) has fostered. They also are obtaining microflora from oropharyngeal, gastric, small bowel, and fecal samples for DNA sequencing. In addition, the team is beginning to study serum samples to test the hypothesis that patients with IBS and SIBO have increased expression of pro-inflammatory markers compared to those with only IBS; they are attempting to correlate the inflammatory markers to specific bacteria.
“IBS is a very common gastrointestinal disorder, and we’re continuing to see an increase in prevalence in Western countries, without understanding the etiology for this syndrome,” said Dr. Roland, director of gastrointestinal motility at Lenox Hill Hospital and Northwell Health System in New York. “Unfortunately, we don’t have any specific or targeted therapies for this patient population because the underlying physiological mechanisms that cause IBS are not very well understood. When we treat these patients with antibiotics, often their symptoms come right back. If we can target the causes of disease in subsets of these patients, we may be able to successfully treat them.”
“We’re very excited to see what changes in the microbiome exist in this patient population, to determine if the microbiome may be another potential area that we can target for treatment,” she added.
In data to be presented in the DDW poster, Dr. Roland’s team used the SmartPill to measure the gastrointestinal transit times, pH, and ileocecal junction pressures of patients with IBS and SIBO as compared to patients with IBS without evidence of SIBO. “Interestingly, patients who had IBS and SIBO had significantly higher contraction frequency in the stomach and small bowel compared to patients with IBS alone,” Dr. Roland said. Those with both conditions also had lower ileocecal junction pressures. “These are physiological mechanisms that have not been well understood before,” Dr. Roland said. “We have been able to begin delineating some of the underlying physiological mechanisms in this challenging patient population for the first time, using a noninvasive, wireless motility capsule.”
Dr. Roland’s team is now partnering with the hospital’s endocrinology division to compare the circulating inflammatory markers in patients with IBS and SIBO, such as TNF (tumor necrosis factor)-alpha and IL (interleukin)-6, to patients with IBS alone. They will use their data to apply for future funding.
BOSTON – It’s been just a year since Bani Chander Roland, MD, FACG, was awarded the 2017 AGA-Medtronic Research and Development Pilot Award in Technology, and her team already has recruited 30 patients with irritable bowel syndrome (IBS) and small intestinal bacterial overgrowth (SIBO) for a study of the gut microbiome and functioning. Interim data from her grant will be presented at Digestive Disease Week® 2018 in June in Washington, D.C., as a poster of distinction.
Dr. Roland and her team are testing the hypothesis that IBS and SIBO result from several distinct pathophysiologic mechanisms, each of which are associated with their own distinct microbial and inflammatory profile. For the study, they are using the Wireless Motility Capsule (WMC, SmartPill) to assess alterations in gastrointestinal pathophysiology in patients with suspected IBS and SIBO – just the sort of innovative technology that the AGA Center for GI Innovation and Technology (CGIT) has fostered. They also are obtaining microflora from oropharyngeal, gastric, small bowel, and fecal samples for DNA sequencing. In addition, the team is beginning to study serum samples to test the hypothesis that patients with IBS and SIBO have increased expression of pro-inflammatory markers compared to those with only IBS; they are attempting to correlate the inflammatory markers to specific bacteria.
“IBS is a very common gastrointestinal disorder, and we’re continuing to see an increase in prevalence in Western countries, without understanding the etiology for this syndrome,” said Dr. Roland, director of gastrointestinal motility at Lenox Hill Hospital and Northwell Health System in New York. “Unfortunately, we don’t have any specific or targeted therapies for this patient population because the underlying physiological mechanisms that cause IBS are not very well understood. When we treat these patients with antibiotics, often their symptoms come right back. If we can target the causes of disease in subsets of these patients, we may be able to successfully treat them.”
“We’re very excited to see what changes in the microbiome exist in this patient population, to determine if the microbiome may be another potential area that we can target for treatment,” she added.
In data to be presented in the DDW poster, Dr. Roland’s team used the SmartPill to measure the gastrointestinal transit times, pH, and ileocecal junction pressures of patients with IBS and SIBO as compared to patients with IBS without evidence of SIBO. “Interestingly, patients who had IBS and SIBO had significantly higher contraction frequency in the stomach and small bowel compared to patients with IBS alone,” Dr. Roland said. Those with both conditions also had lower ileocecal junction pressures. “These are physiological mechanisms that have not been well understood before,” Dr. Roland said. “We have been able to begin delineating some of the underlying physiological mechanisms in this challenging patient population for the first time, using a noninvasive, wireless motility capsule.”
Dr. Roland’s team is now partnering with the hospital’s endocrinology division to compare the circulating inflammatory markers in patients with IBS and SIBO, such as TNF (tumor necrosis factor)-alpha and IL (interleukin)-6, to patients with IBS alone. They will use their data to apply for future funding.
2018 AGA TECH SUMMIT
Constipation on opioids? Follow these three steps to ID the true cause
LAS VEGAS – To appropriately manage patients on opioids who develop constipation, one of the most important distinctions to make is whether the condition was caused by the pain treatment or was just exacerbated by it, according to Darren M. Brenner, MD.
Because of the rampant use of opioids, the answer to that question is increasingly relevant to clinical practice, said Dr. Brenner, associate professor of medicine (gastroenterology and hepatology) and surgery at Northwestern University, Chicago.
Dr. Brenner described a concise algorithm (Curr Gastroenterol Rep. 2017 Mar;19[3]:12) for discerning these patient groups; he codeveloped the algorithm with meeting cochair Brooks D. Cash, MD, chief of the division of gastroenterology, hepatology, and nutrition at the University of Texas, Houston.
Step 1 in the algorithm is simply to ask patients whether they are constipated. “You should ask all of your patients who are on opioids if they have this problem,” Dr. Brenner said. “A significant percentage of individuals using opioids will develop constipation.”
According to the results of studies that Dr. Brenner summarized, up to 80% of patients taking opioids for chronic, noncancer pain will develop opioid-induced constipation, and more than 90% of opioid-taking patients with advanced illness will need laxatives.
Given this prevalence, clinicians might want to be skeptical when patients on opioids reply “no” when asked whether they are constipated.
“From my own clinical experience, you will miss a third of your population that has constipation,” Dr. Brenner said, noting that some patients will instead think of their condition in terms of incomplete evacuation or decreased stool frequency.
Step 2 of the algorithm, therefore, is to assess for signs and symptoms of functional constipation in all patients, regardless of whether they report the condition.
The recently published Rome IV diagnostic criteria included a new category for opioid-induced constipation. According to the new definition, opioid-induced constipation must include new or worsening symptoms, such as fewer than three solid bowel movements per week, and straining, blockage sensation, or manual maneuvers on at least 25% of bowel movements, among other symptoms listed in the report.
If patients do have constipation meeting these criteria, then step 3 of the algorithm is to determine whether the symptoms were present prior to taking opioids.
If onset of constipation is related to the start of opioid treatment, options may include prescribing peripherally acting mu-opioid receptor antagonists (PAMORAs). By contrast, onset unrelated to the start of opioids, also known as opioid-exacerbated constipation, may require treatment according to the underlying cause. For example, slow-transit constipation may respond to laxatives, while evacuation disorders may be treated with surgery, biofeedback, or physical therapy.
The hardest group to identify, according to Dr. Brenner, is individuals whose symptoms were so minor that they didn’t even realize they had constipation symptoms prior to opioids.
Because treatment protocols for opioid-induced and opioid-exacerbated constipation are so different, “we must tease these people out,” Dr. Brenner said.
Global Academy and this news organization are owned by the same parent company.
Dr. Brenner reported disclosures related to Allergan, Daiichi Sankyo, Ironwood Pharmaceuticals, Prius Medical, Salix Pharmaceuticals, Synergy Pharmaceuticals, Shionogi, and others.
LAS VEGAS – To appropriately manage patients on opioids who develop constipation, one of the most important distinctions to make is whether the condition was caused by the pain treatment or was just exacerbated by it, according to Darren M. Brenner, MD.
Because of the rampant use of opioids, the answer to that question is increasingly relevant to clinical practice, said Dr. Brenner, associate professor of medicine (gastroenterology and hepatology) and surgery at Northwestern University, Chicago.
Dr. Brenner described a concise algorithm (Curr Gastroenterol Rep. 2017 Mar;19[3]:12) for discerning these patient groups; he codeveloped the algorithm with meeting cochair Brooks D. Cash, MD, chief of the division of gastroenterology, hepatology, and nutrition at the University of Texas, Houston.
Step 1 in the algorithm is simply to ask patients whether they are constipated. “You should ask all of your patients who are on opioids if they have this problem,” Dr. Brenner said. “A significant percentage of individuals using opioids will develop constipation.”
According to the results of studies that Dr. Brenner summarized, up to 80% of patients taking opioids for chronic, noncancer pain will develop opioid-induced constipation, and more than 90% of opioid-taking patients with advanced illness will need laxatives.
Given this prevalence, clinicians might want to be skeptical when patients on opioids reply “no” when asked whether they are constipated.
“From my own clinical experience, you will miss a third of your population that has constipation,” Dr. Brenner said, noting that some patients will instead think of their condition in terms of incomplete evacuation or decreased stool frequency.
Step 2 of the algorithm, therefore, is to assess for signs and symptoms of functional constipation in all patients, regardless of whether they report the condition.
The recently published Rome IV diagnostic criteria included a new category for opioid-induced constipation. According to the new definition, opioid-induced constipation must include new or worsening symptoms, such as fewer than three solid bowel movements per week, and straining, blockage sensation, or manual maneuvers on at least 25% of bowel movements, among other symptoms listed in the report.
If patients do have constipation meeting these criteria, then step 3 of the algorithm is to determine whether the symptoms were present prior to taking opioids.
If onset of constipation is related to the start of opioid treatment, options may include prescribing peripherally acting mu-opioid receptor antagonists (PAMORAs). By contrast, onset unrelated to the start of opioids, also known as opioid-exacerbated constipation, may require treatment according to the underlying cause. For example, slow-transit constipation may respond to laxatives, while evacuation disorders may be treated with surgery, biofeedback, or physical therapy.
The hardest group to identify, according to Dr. Brenner, is individuals whose symptoms were so minor that they didn’t even realize they had constipation symptoms prior to opioids.
Because treatment protocols for opioid-induced and opioid-exacerbated constipation are so different, “we must tease these people out,” Dr. Brenner said.
Global Academy and this news organization are owned by the same parent company.
Dr. Brenner reported disclosures related to Allergan, Daiichi Sankyo, Ironwood Pharmaceuticals, Prius Medical, Salix Pharmaceuticals, Synergy Pharmaceuticals, Shionogi, and others.
LAS VEGAS – To appropriately manage patients on opioids who develop constipation, one of the most important distinctions to make is whether the condition was caused by the pain treatment or was just exacerbated by it, according to Darren M. Brenner, MD.
Because of the rampant use of opioids, the answer to that question is increasingly relevant to clinical practice, said Dr. Brenner, associate professor of medicine (gastroenterology and hepatology) and surgery at Northwestern University, Chicago.
Dr. Brenner described a concise algorithm (Curr Gastroenterol Rep. 2017 Mar;19[3]:12) for discerning these patient groups; he codeveloped the algorithm with meeting cochair Brooks D. Cash, MD, chief of the division of gastroenterology, hepatology, and nutrition at the University of Texas, Houston.
Step 1 in the algorithm is simply to ask patients whether they are constipated. “You should ask all of your patients who are on opioids if they have this problem,” Dr. Brenner said. “A significant percentage of individuals using opioids will develop constipation.”
According to the results of studies that Dr. Brenner summarized, up to 80% of patients taking opioids for chronic, noncancer pain will develop opioid-induced constipation, and more than 90% of opioid-taking patients with advanced illness will need laxatives.
Given this prevalence, clinicians might want to be skeptical when patients on opioids reply “no” when asked whether they are constipated.
“From my own clinical experience, you will miss a third of your population that has constipation,” Dr. Brenner said, noting that some patients will instead think of their condition in terms of incomplete evacuation or decreased stool frequency.
Step 2 of the algorithm, therefore, is to assess for signs and symptoms of functional constipation in all patients, regardless of whether they report the condition.
The recently published Rome IV diagnostic criteria included a new category for opioid-induced constipation. According to the new definition, opioid-induced constipation must include new or worsening symptoms, such as fewer than three solid bowel movements per week, and straining, blockage sensation, or manual maneuvers on at least 25% of bowel movements, among other symptoms listed in the report.
If patients do have constipation meeting these criteria, then step 3 of the algorithm is to determine whether the symptoms were present prior to taking opioids.
If onset of constipation is related to the start of opioid treatment, options may include prescribing peripherally acting mu-opioid receptor antagonists (PAMORAs). By contrast, onset unrelated to the start of opioids, also known as opioid-exacerbated constipation, may require treatment according to the underlying cause. For example, slow-transit constipation may respond to laxatives, while evacuation disorders may be treated with surgery, biofeedback, or physical therapy.
The hardest group to identify, according to Dr. Brenner, is individuals whose symptoms were so minor that they didn’t even realize they had constipation symptoms prior to opioids.
Because treatment protocols for opioid-induced and opioid-exacerbated constipation are so different, “we must tease these people out,” Dr. Brenner said.
Global Academy and this news organization are owned by the same parent company.
Dr. Brenner reported disclosures related to Allergan, Daiichi Sankyo, Ironwood Pharmaceuticals, Prius Medical, Salix Pharmaceuticals, Synergy Pharmaceuticals, Shionogi, and others.
EXPERT ANALYSIS FROM PERSPECTIVES IN DIGESTIVE DISEASES
Spine fracture risk may be increased in IBD patients
Moreover, fracture risk appears to be higher among IBD patients using steroids, according to a report published in the Journal of Clinical Gastroenterology by Yuga Komaki, MD, of the Inflammatory Bowel Disease Center, University of Chicago, and coauthors.
“Further studies addressing the differential risk among Crohn’s disease and ulcerative colitis are needed, but strict surveillance and prevention of spine fractures are indicated in IBD,” wrote Dr. Komaki and associates.
The systematic review and meta-analysis by Dr. Komaki and colleagues was based on 10 studies comprising 470,541 patients with IBD for whom the risk of fracture was reported.
“It is of importance to identify the risk of fractures, as it will increase patient morbidity, disability, and mortality,” the authors wrote. “However, it is often overlooked in the management of IBD.”
Results of the analysis by this group of researchers showed that there was no significant difference in fracture risk overall between IBD patients and controls (odds ratio, 1.08; 95% confidence interval, 0.72-1.62; P = .70).
By contrast, the OR for spine fractures was significantly elevated (OR, 2.21; 95% CI, 1.39-3.50; P less than .0001), while risk of hip, rib, and wrist fractures were not, Dr. Komaki and coauthors said in their report.
Steroids were more often being used in the treatment of IBD patients who had fractures than in patients with no fractures, though the finding did not quite reach statistical significance (OR, 1.47; 95% CI, 0.99-2.20; P = .057).
Prior studies of fracture risk in IBD have shown “controversial results,” according to Dr. Komaki and colleagues. Some of those studies suggest an increased risk of fractures, whereas others suggest the risk is not different from what is seen in the general population.
“Individual studies may be underpowered to detect any risk,” they said in the report.
Steroids have been shown to increase risk of spine and rib fracture, but whether those earlier studies apply in IBD is unclear, they noted.
While the present meta-analysis sheds light on fracture risk in IBD patients, further meta-analyses may be needed to specifically look at cohorts of patients with Crohn’s disease and ulcerative colitis.
In this study, the investigators did find that spine fracture risk was significantly elevated in patients with Crohn’s disease, and was trending toward significance for ulcerative colitis patients. They cautioned that those results were based on a limited amount of patient data.
Dr. Komaki reported that he had no disclosures related to the reported study. One study coauthor reported disclosures related to AbbVie and Celltrion.
SOURCE: Komaki Y et al. J Clin Gastroenterol. 2018 Apr 18. 2018 Apr 18. doi: 10.1097/MCG.0000000000001031.
Moreover, fracture risk appears to be higher among IBD patients using steroids, according to a report published in the Journal of Clinical Gastroenterology by Yuga Komaki, MD, of the Inflammatory Bowel Disease Center, University of Chicago, and coauthors.
“Further studies addressing the differential risk among Crohn’s disease and ulcerative colitis are needed, but strict surveillance and prevention of spine fractures are indicated in IBD,” wrote Dr. Komaki and associates.
The systematic review and meta-analysis by Dr. Komaki and colleagues was based on 10 studies comprising 470,541 patients with IBD for whom the risk of fracture was reported.
“It is of importance to identify the risk of fractures, as it will increase patient morbidity, disability, and mortality,” the authors wrote. “However, it is often overlooked in the management of IBD.”
Results of the analysis by this group of researchers showed that there was no significant difference in fracture risk overall between IBD patients and controls (odds ratio, 1.08; 95% confidence interval, 0.72-1.62; P = .70).
By contrast, the OR for spine fractures was significantly elevated (OR, 2.21; 95% CI, 1.39-3.50; P less than .0001), while risk of hip, rib, and wrist fractures were not, Dr. Komaki and coauthors said in their report.
Steroids were more often being used in the treatment of IBD patients who had fractures than in patients with no fractures, though the finding did not quite reach statistical significance (OR, 1.47; 95% CI, 0.99-2.20; P = .057).
Prior studies of fracture risk in IBD have shown “controversial results,” according to Dr. Komaki and colleagues. Some of those studies suggest an increased risk of fractures, whereas others suggest the risk is not different from what is seen in the general population.
“Individual studies may be underpowered to detect any risk,” they said in the report.
Steroids have been shown to increase risk of spine and rib fracture, but whether those earlier studies apply in IBD is unclear, they noted.
While the present meta-analysis sheds light on fracture risk in IBD patients, further meta-analyses may be needed to specifically look at cohorts of patients with Crohn’s disease and ulcerative colitis.
In this study, the investigators did find that spine fracture risk was significantly elevated in patients with Crohn’s disease, and was trending toward significance for ulcerative colitis patients. They cautioned that those results were based on a limited amount of patient data.
Dr. Komaki reported that he had no disclosures related to the reported study. One study coauthor reported disclosures related to AbbVie and Celltrion.
SOURCE: Komaki Y et al. J Clin Gastroenterol. 2018 Apr 18. 2018 Apr 18. doi: 10.1097/MCG.0000000000001031.
Moreover, fracture risk appears to be higher among IBD patients using steroids, according to a report published in the Journal of Clinical Gastroenterology by Yuga Komaki, MD, of the Inflammatory Bowel Disease Center, University of Chicago, and coauthors.
“Further studies addressing the differential risk among Crohn’s disease and ulcerative colitis are needed, but strict surveillance and prevention of spine fractures are indicated in IBD,” wrote Dr. Komaki and associates.
The systematic review and meta-analysis by Dr. Komaki and colleagues was based on 10 studies comprising 470,541 patients with IBD for whom the risk of fracture was reported.
“It is of importance to identify the risk of fractures, as it will increase patient morbidity, disability, and mortality,” the authors wrote. “However, it is often overlooked in the management of IBD.”
Results of the analysis by this group of researchers showed that there was no significant difference in fracture risk overall between IBD patients and controls (odds ratio, 1.08; 95% confidence interval, 0.72-1.62; P = .70).
By contrast, the OR for spine fractures was significantly elevated (OR, 2.21; 95% CI, 1.39-3.50; P less than .0001), while risk of hip, rib, and wrist fractures were not, Dr. Komaki and coauthors said in their report.
Steroids were more often being used in the treatment of IBD patients who had fractures than in patients with no fractures, though the finding did not quite reach statistical significance (OR, 1.47; 95% CI, 0.99-2.20; P = .057).
Prior studies of fracture risk in IBD have shown “controversial results,” according to Dr. Komaki and colleagues. Some of those studies suggest an increased risk of fractures, whereas others suggest the risk is not different from what is seen in the general population.
“Individual studies may be underpowered to detect any risk,” they said in the report.
Steroids have been shown to increase risk of spine and rib fracture, but whether those earlier studies apply in IBD is unclear, they noted.
While the present meta-analysis sheds light on fracture risk in IBD patients, further meta-analyses may be needed to specifically look at cohorts of patients with Crohn’s disease and ulcerative colitis.
In this study, the investigators did find that spine fracture risk was significantly elevated in patients with Crohn’s disease, and was trending toward significance for ulcerative colitis patients. They cautioned that those results were based on a limited amount of patient data.
Dr. Komaki reported that he had no disclosures related to the reported study. One study coauthor reported disclosures related to AbbVie and Celltrion.
SOURCE: Komaki Y et al. J Clin Gastroenterol. 2018 Apr 18. 2018 Apr 18. doi: 10.1097/MCG.0000000000001031.
FROM THE JOURNAL OF CLINICAL GASTROENTEROLOGY
Key clinical point: Patients with inflammatory bowel disease may be at increased risk of fractures in the spine.
Major finding: The odds ratio for spine fractures was 2.21 (95% CI, 1.39-3.50; P less than .0001).
Study details: A systematic review and meta-analysis of 10 studies including 470,541 patients.
Disclosures: One study author reported disclosures related to AbbVie and Celltrion.
Source: Komaki Y et al. J Clin Gastroenterol. 2018 Apr 18. doi: 10.1097/MCG.0000000000001031.
One in seven Americans had fecal incontinence
One in seven respondents to a national survey reported a history of fecal incontinence, including one-third within the preceding week, investigators reported.
“Fecal incontinence [FI] is age-related and more prevalent among individuals with inflammatory bowel disease, celiac disease, irritable bowel syndrome, or diabetes than people without these disorders. Proactive screening for FI among these groups is warranted,” Stacy B. Menees, MD, and her associates wrote in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2018.01.062).
Accurately determining the prevalence of FI is difficult because patients are reluctant to disclose symptoms and physicians often do not ask. In one study of HMO enrollees, about a third of patients had a history of FI but fewer than 3% had a medical diagnosis. In other studies, the prevalence of FI has ranged from 2% to 21%. Population aging fuels the need to narrow these estimates because FI becomes more common with age, the investigators noted.
Accordingly, in October 2015, they used a mobile app called MyGIHealth to survey nearly 72,000 individuals about fecal incontinence and other GI symptoms. The survey took about 15 minutes to complete, in return for which respondents could receive cash, shop online, or donate to charity. The investigators assessed FI severity by analyzing responses to the National Institutes of Health FI Patient Reported Outcomes Measurement Information System questionnaire.
Of the 10,033 respondents reporting a history of fecal incontinence (14.4%), 33.3% had experienced at least one episode in the past week. About a third of individuals with FI said it interfered with their daily activities. “Increasing age and concomitant diarrhea and constipation were associated with increased odds [of] FI,” the researchers wrote. Compared with individuals aged 18-24 years, the odds of having ever experienced FI rose by 29% among those aged 25-45 years, by 72% among those aged 45-64 years, and by 118% among persons aged 65 years and older.
Self-reported FI also was significantly more common among individuals with Crohn’s disease (41%), ulcerative colitis (37%), celiac disease (34%), irritable bowel syndrome (13%), or diabetes (13%) than it was among persons without these conditions. Corresponding odds ratios ranged from about 1.5 (diabetes) to 2.8 (celiac disease).
For individuals reporting FI within the past week, greater severity (based on their responses to the NIH FI Patient Reported Outcomes Measurement Information System questionnaire) significantly correlated with being non-Hispanic black (P = .03) or Latino (P = .02) and with having Crohn’s disease (P less than .001), celiac disease (P less than .001), diabetes (P = .04), human immunodeficiency syndrome (P = .001), or chronic idiopathic constipation (P less than .001). “Our study is the first to find differences among racial/ethnic groups regarding FI severity,” the researchers noted. They did not speculate on reasons for the finding, but stressed the importance of screening for FI and screening patients with FI for serious GI diseases.
Ironwood Pharmaceuticals funded the National GI Survey, but the investigators received no funding for this study. Three coinvestigators reported ties to Ironwood Pharmaceuticals and My Total Health.
SOURCE: Menees SB et al. Gastroenterology. 2018 Feb 3. doi: 10.1053/j.gastro.2018.01.062.
Fecal incontinence (FI) is a common problem associated with significant social anxiety and decreased quality of life for patients who experience it. Unfortunately, patients are not always forthcoming regarding their symptoms, and physicians often fail to inquire directly about incontinence symptoms.
Previous studies have shown the prevalence of FI to vary widely across different populations. Using novel technology through a mobile app, researchers at the University of Michigan, Ann Arbor, and Cedars-Sinai Medical Center, Los Angeles, have been able to perform the largest population-based study of community-dwelling Americans. They confirmed that FI is indeed a common problem experienced across the spectrum of age, sex, race, and socioeconomic status and interferes with the daily activities of more than one-third of those who experience it.
This study supports previous findings of an age-related increase in FI, with the highest prevalence in patients over age 65 years. Interestingly, males were more likely than female to have experienced FI within the past week, but not more likely to have ever experienced FI. While FI is often thought of as a primarily female problem (related to past obstetrical injury), it is important to remember that it likely affects both sexes equally.
Other significant risk factors include diabetes and gastrointestinal disorders. This study also confirms prior population-based findings that patients with chronic constipation are more likely to suffer FI. Finally, this study also identified risk factors associated with FI symptom severity including diabetes, HIV/AIDS, Crohn’s disease, celiac disease, and chronic constipation. This is also the first study to show differences between racial/ethnic groups, suggesting higher FI symptom scores in Latinos and African-Americans.
The strengths of this study include its size and the anonymity provided by an internet-based survey regarding a potentially embarrassing topic; however, it also may have led to the potential exclusion of older individuals or those without regular internet access.
In summary, I believe this is an important study which confirms that FI is a common among Americans while helping to identify potential risk factors for the presence and severity of FI. I am hopeful that with increased awareness, health care providers will become more prudent in screening their patients for FI, particularly in these higher-risk populations.
Stephanie A. McAbee, MD, is an assistant professor of medicine in the division of gastroenterology, hepatology, and nutrition at Vanderbilt University Medical Center, Nashville, Tenn. She has no conflicts of interest.
Fecal incontinence (FI) is a common problem associated with significant social anxiety and decreased quality of life for patients who experience it. Unfortunately, patients are not always forthcoming regarding their symptoms, and physicians often fail to inquire directly about incontinence symptoms.
Previous studies have shown the prevalence of FI to vary widely across different populations. Using novel technology through a mobile app, researchers at the University of Michigan, Ann Arbor, and Cedars-Sinai Medical Center, Los Angeles, have been able to perform the largest population-based study of community-dwelling Americans. They confirmed that FI is indeed a common problem experienced across the spectrum of age, sex, race, and socioeconomic status and interferes with the daily activities of more than one-third of those who experience it.
This study supports previous findings of an age-related increase in FI, with the highest prevalence in patients over age 65 years. Interestingly, males were more likely than female to have experienced FI within the past week, but not more likely to have ever experienced FI. While FI is often thought of as a primarily female problem (related to past obstetrical injury), it is important to remember that it likely affects both sexes equally.
Other significant risk factors include diabetes and gastrointestinal disorders. This study also confirms prior population-based findings that patients with chronic constipation are more likely to suffer FI. Finally, this study also identified risk factors associated with FI symptom severity including diabetes, HIV/AIDS, Crohn’s disease, celiac disease, and chronic constipation. This is also the first study to show differences between racial/ethnic groups, suggesting higher FI symptom scores in Latinos and African-Americans.
The strengths of this study include its size and the anonymity provided by an internet-based survey regarding a potentially embarrassing topic; however, it also may have led to the potential exclusion of older individuals or those without regular internet access.
In summary, I believe this is an important study which confirms that FI is a common among Americans while helping to identify potential risk factors for the presence and severity of FI. I am hopeful that with increased awareness, health care providers will become more prudent in screening their patients for FI, particularly in these higher-risk populations.
Stephanie A. McAbee, MD, is an assistant professor of medicine in the division of gastroenterology, hepatology, and nutrition at Vanderbilt University Medical Center, Nashville, Tenn. She has no conflicts of interest.
Fecal incontinence (FI) is a common problem associated with significant social anxiety and decreased quality of life for patients who experience it. Unfortunately, patients are not always forthcoming regarding their symptoms, and physicians often fail to inquire directly about incontinence symptoms.
Previous studies have shown the prevalence of FI to vary widely across different populations. Using novel technology through a mobile app, researchers at the University of Michigan, Ann Arbor, and Cedars-Sinai Medical Center, Los Angeles, have been able to perform the largest population-based study of community-dwelling Americans. They confirmed that FI is indeed a common problem experienced across the spectrum of age, sex, race, and socioeconomic status and interferes with the daily activities of more than one-third of those who experience it.
This study supports previous findings of an age-related increase in FI, with the highest prevalence in patients over age 65 years. Interestingly, males were more likely than female to have experienced FI within the past week, but not more likely to have ever experienced FI. While FI is often thought of as a primarily female problem (related to past obstetrical injury), it is important to remember that it likely affects both sexes equally.
Other significant risk factors include diabetes and gastrointestinal disorders. This study also confirms prior population-based findings that patients with chronic constipation are more likely to suffer FI. Finally, this study also identified risk factors associated with FI symptom severity including diabetes, HIV/AIDS, Crohn’s disease, celiac disease, and chronic constipation. This is also the first study to show differences between racial/ethnic groups, suggesting higher FI symptom scores in Latinos and African-Americans.
The strengths of this study include its size and the anonymity provided by an internet-based survey regarding a potentially embarrassing topic; however, it also may have led to the potential exclusion of older individuals or those without regular internet access.
In summary, I believe this is an important study which confirms that FI is a common among Americans while helping to identify potential risk factors for the presence and severity of FI. I am hopeful that with increased awareness, health care providers will become more prudent in screening their patients for FI, particularly in these higher-risk populations.
Stephanie A. McAbee, MD, is an assistant professor of medicine in the division of gastroenterology, hepatology, and nutrition at Vanderbilt University Medical Center, Nashville, Tenn. She has no conflicts of interest.
One in seven respondents to a national survey reported a history of fecal incontinence, including one-third within the preceding week, investigators reported.
“Fecal incontinence [FI] is age-related and more prevalent among individuals with inflammatory bowel disease, celiac disease, irritable bowel syndrome, or diabetes than people without these disorders. Proactive screening for FI among these groups is warranted,” Stacy B. Menees, MD, and her associates wrote in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2018.01.062).
Accurately determining the prevalence of FI is difficult because patients are reluctant to disclose symptoms and physicians often do not ask. In one study of HMO enrollees, about a third of patients had a history of FI but fewer than 3% had a medical diagnosis. In other studies, the prevalence of FI has ranged from 2% to 21%. Population aging fuels the need to narrow these estimates because FI becomes more common with age, the investigators noted.
Accordingly, in October 2015, they used a mobile app called MyGIHealth to survey nearly 72,000 individuals about fecal incontinence and other GI symptoms. The survey took about 15 minutes to complete, in return for which respondents could receive cash, shop online, or donate to charity. The investigators assessed FI severity by analyzing responses to the National Institutes of Health FI Patient Reported Outcomes Measurement Information System questionnaire.
Of the 10,033 respondents reporting a history of fecal incontinence (14.4%), 33.3% had experienced at least one episode in the past week. About a third of individuals with FI said it interfered with their daily activities. “Increasing age and concomitant diarrhea and constipation were associated with increased odds [of] FI,” the researchers wrote. Compared with individuals aged 18-24 years, the odds of having ever experienced FI rose by 29% among those aged 25-45 years, by 72% among those aged 45-64 years, and by 118% among persons aged 65 years and older.
Self-reported FI also was significantly more common among individuals with Crohn’s disease (41%), ulcerative colitis (37%), celiac disease (34%), irritable bowel syndrome (13%), or diabetes (13%) than it was among persons without these conditions. Corresponding odds ratios ranged from about 1.5 (diabetes) to 2.8 (celiac disease).
For individuals reporting FI within the past week, greater severity (based on their responses to the NIH FI Patient Reported Outcomes Measurement Information System questionnaire) significantly correlated with being non-Hispanic black (P = .03) or Latino (P = .02) and with having Crohn’s disease (P less than .001), celiac disease (P less than .001), diabetes (P = .04), human immunodeficiency syndrome (P = .001), or chronic idiopathic constipation (P less than .001). “Our study is the first to find differences among racial/ethnic groups regarding FI severity,” the researchers noted. They did not speculate on reasons for the finding, but stressed the importance of screening for FI and screening patients with FI for serious GI diseases.
Ironwood Pharmaceuticals funded the National GI Survey, but the investigators received no funding for this study. Three coinvestigators reported ties to Ironwood Pharmaceuticals and My Total Health.
SOURCE: Menees SB et al. Gastroenterology. 2018 Feb 3. doi: 10.1053/j.gastro.2018.01.062.
One in seven respondents to a national survey reported a history of fecal incontinence, including one-third within the preceding week, investigators reported.
“Fecal incontinence [FI] is age-related and more prevalent among individuals with inflammatory bowel disease, celiac disease, irritable bowel syndrome, or diabetes than people without these disorders. Proactive screening for FI among these groups is warranted,” Stacy B. Menees, MD, and her associates wrote in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2018.01.062).
Accurately determining the prevalence of FI is difficult because patients are reluctant to disclose symptoms and physicians often do not ask. In one study of HMO enrollees, about a third of patients had a history of FI but fewer than 3% had a medical diagnosis. In other studies, the prevalence of FI has ranged from 2% to 21%. Population aging fuels the need to narrow these estimates because FI becomes more common with age, the investigators noted.
Accordingly, in October 2015, they used a mobile app called MyGIHealth to survey nearly 72,000 individuals about fecal incontinence and other GI symptoms. The survey took about 15 minutes to complete, in return for which respondents could receive cash, shop online, or donate to charity. The investigators assessed FI severity by analyzing responses to the National Institutes of Health FI Patient Reported Outcomes Measurement Information System questionnaire.
Of the 10,033 respondents reporting a history of fecal incontinence (14.4%), 33.3% had experienced at least one episode in the past week. About a third of individuals with FI said it interfered with their daily activities. “Increasing age and concomitant diarrhea and constipation were associated with increased odds [of] FI,” the researchers wrote. Compared with individuals aged 18-24 years, the odds of having ever experienced FI rose by 29% among those aged 25-45 years, by 72% among those aged 45-64 years, and by 118% among persons aged 65 years and older.
Self-reported FI also was significantly more common among individuals with Crohn’s disease (41%), ulcerative colitis (37%), celiac disease (34%), irritable bowel syndrome (13%), or diabetes (13%) than it was among persons without these conditions. Corresponding odds ratios ranged from about 1.5 (diabetes) to 2.8 (celiac disease).
For individuals reporting FI within the past week, greater severity (based on their responses to the NIH FI Patient Reported Outcomes Measurement Information System questionnaire) significantly correlated with being non-Hispanic black (P = .03) or Latino (P = .02) and with having Crohn’s disease (P less than .001), celiac disease (P less than .001), diabetes (P = .04), human immunodeficiency syndrome (P = .001), or chronic idiopathic constipation (P less than .001). “Our study is the first to find differences among racial/ethnic groups regarding FI severity,” the researchers noted. They did not speculate on reasons for the finding, but stressed the importance of screening for FI and screening patients with FI for serious GI diseases.
Ironwood Pharmaceuticals funded the National GI Survey, but the investigators received no funding for this study. Three coinvestigators reported ties to Ironwood Pharmaceuticals and My Total Health.
SOURCE: Menees SB et al. Gastroenterology. 2018 Feb 3. doi: 10.1053/j.gastro.2018.01.062.
FROM GASTROENTEROLOGY
Key clinical point: One in seven (14%) individuals had experienced fecal incontinence (FI), one-third within the past week.
Major finding: Self-reported FI was significantly more common among individuals with Crohn’s disease (41%), ulcerative colitis (37%), celiac disease (34%), irritable bowel syndrome (13%), or diabetes (13%) than among individuals without these diagnoses.
Study details: Analysis of 71,812 responses to the National GI Survey, conducted in October 2015.
Disclosures: Although Ironwood Pharmaceuticals funded the National GI Survey, the investigators received no funding for this study. Three coinvestigators reported ties to Ironwood Pharmaceuticals and My Total Health.
Source: Menees SB et al. Gastroenterology. 2018 Feb 3. doi: 10.1053/j.gastro.2018.01.062.
New study establishes IBD severity index
Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648).
The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.
The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.
Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course.
A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.
A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity.
A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.
The exercise first had participants decide which hypothetical patient profiles met their evaluation criteria; it then showed them two final profiles and asked which was the more severe case. Survey length depended on the consistency of participants’ responses, with those lacking consistency being given more tasks to complete, Dr. Siegel and his colleagues reported.
Respondents completed the exercise three times: first independently without discussion, then after discussion in a group setting with an automated response system, and finally, independently following group discussion.
Disease severity indexes were created on a 100-point scale, and average part-worth utility scores were used to determine minimum and maximum scores for each attribute, with zero representing the absence of a symptom.
This analysis “helps redefine overall disease severity for IBD,” the authors wrote. Once validated, the indexes will offer “both further research opportunities and a practical tool by which to classify overall disease severity of patients and offer appropriate treatment without relying on present symptoms alone,” they added.
Dr. Siegel and his colleagues noted that future studies should focus on prospective validation of the disease indexes in different patient populations, as well as conducting a conjoint analysis with patients.
“We expect this work to begin to address a change in how we think about patients with IBD and how to identify those at the higher end of the risk spectrum so that appropriate intensive treatment can be initiated and optimized in an efficient, precise, and cost-effective manner,” they concluded.
The study was funded by AbbVie and Tillotts Pharma. The authors disclosed financial relationships with numerous additional pharmaceutical companies.
SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.
AGA patient education materials can help your IBD patients better understand and manage their disease. Learn more at www.gastro.org/IBD
Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648).
The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.
The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.
Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course.
A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.
A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity.
A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.
The exercise first had participants decide which hypothetical patient profiles met their evaluation criteria; it then showed them two final profiles and asked which was the more severe case. Survey length depended on the consistency of participants’ responses, with those lacking consistency being given more tasks to complete, Dr. Siegel and his colleagues reported.
Respondents completed the exercise three times: first independently without discussion, then after discussion in a group setting with an automated response system, and finally, independently following group discussion.
Disease severity indexes were created on a 100-point scale, and average part-worth utility scores were used to determine minimum and maximum scores for each attribute, with zero representing the absence of a symptom.
This analysis “helps redefine overall disease severity for IBD,” the authors wrote. Once validated, the indexes will offer “both further research opportunities and a practical tool by which to classify overall disease severity of patients and offer appropriate treatment without relying on present symptoms alone,” they added.
Dr. Siegel and his colleagues noted that future studies should focus on prospective validation of the disease indexes in different patient populations, as well as conducting a conjoint analysis with patients.
“We expect this work to begin to address a change in how we think about patients with IBD and how to identify those at the higher end of the risk spectrum so that appropriate intensive treatment can be initiated and optimized in an efficient, precise, and cost-effective manner,” they concluded.
The study was funded by AbbVie and Tillotts Pharma. The authors disclosed financial relationships with numerous additional pharmaceutical companies.
SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.
AGA patient education materials can help your IBD patients better understand and manage their disease. Learn more at www.gastro.org/IBD
Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648).
The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.
The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.
Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course.
A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.
A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity.
A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.
The exercise first had participants decide which hypothetical patient profiles met their evaluation criteria; it then showed them two final profiles and asked which was the more severe case. Survey length depended on the consistency of participants’ responses, with those lacking consistency being given more tasks to complete, Dr. Siegel and his colleagues reported.
Respondents completed the exercise three times: first independently without discussion, then after discussion in a group setting with an automated response system, and finally, independently following group discussion.
Disease severity indexes were created on a 100-point scale, and average part-worth utility scores were used to determine minimum and maximum scores for each attribute, with zero representing the absence of a symptom.
This analysis “helps redefine overall disease severity for IBD,” the authors wrote. Once validated, the indexes will offer “both further research opportunities and a practical tool by which to classify overall disease severity of patients and offer appropriate treatment without relying on present symptoms alone,” they added.
Dr. Siegel and his colleagues noted that future studies should focus on prospective validation of the disease indexes in different patient populations, as well as conducting a conjoint analysis with patients.
“We expect this work to begin to address a change in how we think about patients with IBD and how to identify those at the higher end of the risk spectrum so that appropriate intensive treatment can be initiated and optimized in an efficient, precise, and cost-effective manner,” they concluded.
The study was funded by AbbVie and Tillotts Pharma. The authors disclosed financial relationships with numerous additional pharmaceutical companies.
SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.
AGA patient education materials can help your IBD patients better understand and manage their disease. Learn more at www.gastro.org/IBD
FROM GUT
AGA Clinical Practice Update: Incorporating psychological care in the management of chronic digestive diseases
This burden includes digestive symptoms and disease severity, as well as patients’ ability to cope with them. Chronic digestive diseases, such as irritable bowel syndrome, gastroesophageal reflux disease, and inflammatory bowel diseases, cannot be disentangled from their psychosocial context. In this regard, the role of gastroenterologists in promoting best practices for the assessment and referral of patients across the spectrum of disease to brain-gut psychotherapies is crucial.
A review by Laurie Keefer, PhD, AGAF, and her coauthors, published in the April issue of Gastroenterology, provided a clinical update on the structure and efficacy of two major classes of psychogastroenterology – cognitive-behavioral therapy (CBT) and gut-directed hypnotherapy (HYP). The review discussed the effects of these therapies on GI symptoms and the patients’ ability to improve coping, resilience, and self-regulation. The review also provided a framework to understand the scientific rationale and best practices associated with incorporating brain-gut psychotherapies into routine GI care. Furthermore, it presented recommendations on how to address psychological issues and make effective referrals in routine practice.
Previous studies had highlighted that the burden of chronic digestive diseases is amplified by psychosocial factors, including poor coping, depression, and poor social support. Mental health professionals specializing in psychogastroenterology integrate the use of brain-gut psychotherapies into GI practice settings, which may help reduce health care utilization and symptom burden.
The article contains best practice advice based on a review of the literature, including existing systematic reviews and expert opinions. These best practices include the following:
- Gastroenterologists routinely should assess health-related quality of life, symptom-specific anxieties, early-life adversity, and functional impairment related to a patient’s digestive complaints.
- Gastroenterologists should master patient-friendly language to help explain the brain-gut pathway and how this pathway can become dysregulated by any number of factors, the psychosocial risks perpetuating and maintaining factors of GI diseases, and why the gastroenterologist is referring a patient to a mental health provider.
- Gastroenterologists should know the structure and core features of the most effective brain-gut psychotherapies.
- Gastroenterologists should establish a direct referral and ongoing communication pathway with one or two qualified mental health providers and assure patients that he/she will remain a part of the care team.
- Gastroenterologists should familiarize themselves with one or two neuromodulators that can be used to augment behavioral therapies when necessary.
Patient education about the referral to a mental health provider is difficult and requires attention to detail and fostering a good physician-patient relationship. It is important to help patients understand why they are being referred to a psychologist for a gastrointestinal complaint and that their physical symptoms are not being discounted. Failure to properly explain the reason for referral may lead to poor follow-through and even lead the patient to seek care with another provider.
In order to foster widespread integration of these services, research and clinical gaps need to be addressed. Research gaps include the lack of prospective trials that compare the relative effectiveness of brain-gut psychotherapies with each other and/or with that of psychotropic medications. Other promising brain-gut therapies, such as mindfulness meditation or acceptance-based approaches, lack sufficient research to be included in clinical practice. Limited evidence supports the effect of psychotherapies have in accelerating or enhancing the efficacy of pharmacologic therapies and on improving disease course or inflammation in conditions such as Crohn’s and ulcerative colitis.
Clinical gaps include the need for better coverage for these therapies by insurance – many providers are out of network or do not accept insurance, although Medicare and commercial insurance plans often cover the cost of services in network. Health psychologists can be reimbursed for health and behavior codes for treating these conditions (CPTs 96150/96152), but there are restrictions on which other types of professionals can use them. Ongoing research is focusing on the cost-effectiveness of these therapies, although some highly effective therapies may be short term and have a one-time total cost of $1,000-$2,000 paid out of pocket. There is a growing need to expand remote, online, or digitally based brain-gut therapies with more trained health care providers that could offset overhead and other therapy costs.
SOURCE: Keefer L et al. Gastroenterology. doi: 10.1053/j.gastro.2018.01.045.
This burden includes digestive symptoms and disease severity, as well as patients’ ability to cope with them. Chronic digestive diseases, such as irritable bowel syndrome, gastroesophageal reflux disease, and inflammatory bowel diseases, cannot be disentangled from their psychosocial context. In this regard, the role of gastroenterologists in promoting best practices for the assessment and referral of patients across the spectrum of disease to brain-gut psychotherapies is crucial.
A review by Laurie Keefer, PhD, AGAF, and her coauthors, published in the April issue of Gastroenterology, provided a clinical update on the structure and efficacy of two major classes of psychogastroenterology – cognitive-behavioral therapy (CBT) and gut-directed hypnotherapy (HYP). The review discussed the effects of these therapies on GI symptoms and the patients’ ability to improve coping, resilience, and self-regulation. The review also provided a framework to understand the scientific rationale and best practices associated with incorporating brain-gut psychotherapies into routine GI care. Furthermore, it presented recommendations on how to address psychological issues and make effective referrals in routine practice.
Previous studies had highlighted that the burden of chronic digestive diseases is amplified by psychosocial factors, including poor coping, depression, and poor social support. Mental health professionals specializing in psychogastroenterology integrate the use of brain-gut psychotherapies into GI practice settings, which may help reduce health care utilization and symptom burden.
The article contains best practice advice based on a review of the literature, including existing systematic reviews and expert opinions. These best practices include the following:
- Gastroenterologists routinely should assess health-related quality of life, symptom-specific anxieties, early-life adversity, and functional impairment related to a patient’s digestive complaints.
- Gastroenterologists should master patient-friendly language to help explain the brain-gut pathway and how this pathway can become dysregulated by any number of factors, the psychosocial risks perpetuating and maintaining factors of GI diseases, and why the gastroenterologist is referring a patient to a mental health provider.
- Gastroenterologists should know the structure and core features of the most effective brain-gut psychotherapies.
- Gastroenterologists should establish a direct referral and ongoing communication pathway with one or two qualified mental health providers and assure patients that he/she will remain a part of the care team.
- Gastroenterologists should familiarize themselves with one or two neuromodulators that can be used to augment behavioral therapies when necessary.
Patient education about the referral to a mental health provider is difficult and requires attention to detail and fostering a good physician-patient relationship. It is important to help patients understand why they are being referred to a psychologist for a gastrointestinal complaint and that their physical symptoms are not being discounted. Failure to properly explain the reason for referral may lead to poor follow-through and even lead the patient to seek care with another provider.
In order to foster widespread integration of these services, research and clinical gaps need to be addressed. Research gaps include the lack of prospective trials that compare the relative effectiveness of brain-gut psychotherapies with each other and/or with that of psychotropic medications. Other promising brain-gut therapies, such as mindfulness meditation or acceptance-based approaches, lack sufficient research to be included in clinical practice. Limited evidence supports the effect of psychotherapies have in accelerating or enhancing the efficacy of pharmacologic therapies and on improving disease course or inflammation in conditions such as Crohn’s and ulcerative colitis.
Clinical gaps include the need for better coverage for these therapies by insurance – many providers are out of network or do not accept insurance, although Medicare and commercial insurance plans often cover the cost of services in network. Health psychologists can be reimbursed for health and behavior codes for treating these conditions (CPTs 96150/96152), but there are restrictions on which other types of professionals can use them. Ongoing research is focusing on the cost-effectiveness of these therapies, although some highly effective therapies may be short term and have a one-time total cost of $1,000-$2,000 paid out of pocket. There is a growing need to expand remote, online, or digitally based brain-gut therapies with more trained health care providers that could offset overhead and other therapy costs.
SOURCE: Keefer L et al. Gastroenterology. doi: 10.1053/j.gastro.2018.01.045.
This burden includes digestive symptoms and disease severity, as well as patients’ ability to cope with them. Chronic digestive diseases, such as irritable bowel syndrome, gastroesophageal reflux disease, and inflammatory bowel diseases, cannot be disentangled from their psychosocial context. In this regard, the role of gastroenterologists in promoting best practices for the assessment and referral of patients across the spectrum of disease to brain-gut psychotherapies is crucial.
A review by Laurie Keefer, PhD, AGAF, and her coauthors, published in the April issue of Gastroenterology, provided a clinical update on the structure and efficacy of two major classes of psychogastroenterology – cognitive-behavioral therapy (CBT) and gut-directed hypnotherapy (HYP). The review discussed the effects of these therapies on GI symptoms and the patients’ ability to improve coping, resilience, and self-regulation. The review also provided a framework to understand the scientific rationale and best practices associated with incorporating brain-gut psychotherapies into routine GI care. Furthermore, it presented recommendations on how to address psychological issues and make effective referrals in routine practice.
Previous studies had highlighted that the burden of chronic digestive diseases is amplified by psychosocial factors, including poor coping, depression, and poor social support. Mental health professionals specializing in psychogastroenterology integrate the use of brain-gut psychotherapies into GI practice settings, which may help reduce health care utilization and symptom burden.
The article contains best practice advice based on a review of the literature, including existing systematic reviews and expert opinions. These best practices include the following:
- Gastroenterologists routinely should assess health-related quality of life, symptom-specific anxieties, early-life adversity, and functional impairment related to a patient’s digestive complaints.
- Gastroenterologists should master patient-friendly language to help explain the brain-gut pathway and how this pathway can become dysregulated by any number of factors, the psychosocial risks perpetuating and maintaining factors of GI diseases, and why the gastroenterologist is referring a patient to a mental health provider.
- Gastroenterologists should know the structure and core features of the most effective brain-gut psychotherapies.
- Gastroenterologists should establish a direct referral and ongoing communication pathway with one or two qualified mental health providers and assure patients that he/she will remain a part of the care team.
- Gastroenterologists should familiarize themselves with one or two neuromodulators that can be used to augment behavioral therapies when necessary.
Patient education about the referral to a mental health provider is difficult and requires attention to detail and fostering a good physician-patient relationship. It is important to help patients understand why they are being referred to a psychologist for a gastrointestinal complaint and that their physical symptoms are not being discounted. Failure to properly explain the reason for referral may lead to poor follow-through and even lead the patient to seek care with another provider.
In order to foster widespread integration of these services, research and clinical gaps need to be addressed. Research gaps include the lack of prospective trials that compare the relative effectiveness of brain-gut psychotherapies with each other and/or with that of psychotropic medications. Other promising brain-gut therapies, such as mindfulness meditation or acceptance-based approaches, lack sufficient research to be included in clinical practice. Limited evidence supports the effect of psychotherapies have in accelerating or enhancing the efficacy of pharmacologic therapies and on improving disease course or inflammation in conditions such as Crohn’s and ulcerative colitis.
Clinical gaps include the need for better coverage for these therapies by insurance – many providers are out of network or do not accept insurance, although Medicare and commercial insurance plans often cover the cost of services in network. Health psychologists can be reimbursed for health and behavior codes for treating these conditions (CPTs 96150/96152), but there are restrictions on which other types of professionals can use them. Ongoing research is focusing on the cost-effectiveness of these therapies, although some highly effective therapies may be short term and have a one-time total cost of $1,000-$2,000 paid out of pocket. There is a growing need to expand remote, online, or digitally based brain-gut therapies with more trained health care providers that could offset overhead and other therapy costs.
SOURCE: Keefer L et al. Gastroenterology. doi: 10.1053/j.gastro.2018.01.045.
FROM GASTROENTEROLOGY