bluuebunny/crossref_metadata_2025 huggingface dataset:
444 Unmet Need for Additional Resources to Support Successful Transition of Care From Pediatric to Adult Providers for the Management of Eosinophilic Gastrointestinal Diseases
Authors: Falk Gary W. , Gehman Lauren , Strobel Mary Jo
Published: October 2019

INTRODUCTION:

Eosinophilic gastrointestinal diseases (EGIDs), including eosinophilic esophagitis (EoE), are chronic conditions characterized by eosinophil infiltration into the gastrointestinal mucosa. Children and adolescents diagnosed with EGIDs typically continue to experience symptoms and require lifelong disease management. Therefore, transition to adulthood necessitates a transition from pediatric to adult healthcare providers. The aim of this study is to better understand perceived challenges, unmet needs, and utility of resources to aid in successful transition of care (TOC) for EGID patients.

METHODS:

An online survey of adolescents and young adults with EGIDs, ages 15-26 years, or their parents/caregivers, was conducted from Dec 2018 to Jan 2019. Participants were recruited through the online platforms of the American Partnership for Eosinophilic Disorders (APFED). There were no prespecified statistical analyses, as this study was intended to be descriptive only.

RESULTS:

Forty-one participants completed the survey: 7 patients and 34 parents/caregivers. Survey participants were primarily diagnosed with EoE (81%), diagnosed by a pediatric gastroenterologist (95%), and diagnosed at 5 years of age or younger (44%). Most patients (93%) planned to transition to an adult provider at some point, with ages 18-21 years the most common ages of planned TOC (51%); the remaining 7% stated they did not intend to ever transition and instead remain with their pediatric gastroenterologist indefinitely. All patients perceived potential challenges associated with TOC, with “inability to locate an adult provider” and “new provider changing my current treatment plan” cited most frequently as concerns (Table 1). All patients indicated a need for additional TOC resources, such as a list of local adult providers familiar with treating EGIDs, a designated care coordinator, and a checklist of steps to ensure smooth TOC (Table 2).

CONCLUSION:

This study identified several potential barriers to successful TOC and highlights the need for additional resources to ensure a smooth transition from pediatric to adult providers for the management of EGIDs. To alleviate concerns that TOC may result in change in treatment plan, implementation of tools that enable efficient transfer of relevant medical history and current management plan may help optimize continuity of care as patients transition into adulthood.
447 Clinical Characteristics of Secondary Achalasia Associated With a Malignancy: A 20-Year Review From a Cancer Hospital
Authors: Shafi Mehnaz A. , Bokhari Raza , Lum Phillip , Stroehlein John
Published: October 2019

INTRODUCTION:

Achalasia is an uncommon neurodegenerative disorder of esophageal motor function with an annual incidence of 1.6:100, 000. Most cases are idiopathic. Achalasia secondary to neoplasia is extremely rare, with an incidence of 1: 750,000.

AIM:

To evaluate the incidence and characteristics of achalasia in patients with a malignancy at our institution between 1999-2019.

METHODS:

Electronic medical records were retrospectively reviewed from January 1999 to May 2019 to identify patients with a diagnosis of achalasia and a malignancy. Patiets with direct tumor invasion of the distal esophagus were excluded. We identified 28 patients who had a malignancy and a diagnosis of achalasia.

RESULTS:

The median age at diagnosis of achalasia was 58 years (19-85). There were 14 (50%) male and 14 (50%) female patients. The most common associated cancer was a hematologic malignancy (N = 9, 32%: lymphoma N = 4, leukemia N = 4, myeloma N = 1), followed by breast cancer, (N = 7, 25%). Other cancers included lung, (N = 3, 11%), carcinoid tumor, (N = 2, 7%), and one each of thymoma, sarcoma, esophagus, stomach, thyroid, larynx, and prostate. The median interval between the diagnosis of cancer and achalasia was 78 months (range 2- 364). In 21 patients, the cancer preceded the diagnosis of achalasia. All patients underwent endoscopy to rule out psuedoachalasia. Where high resolution manometry was done (N = 10/28, 36%), type 2 achalasia was seen in 8/10 patients and type 1 achalasia in 2/10 patients. In seven patients, achalasia was diagnosed before the cancer. The median time interval between diagnosis of achalasia and diagnosis of a primary malignancy in these patients was 72 months (range 12-354 months). Anti-Hu antibodies were present in 2/8 patients who were checked for it, suggestive of a paraneoplastic process. Eight patients underwent endoscopic dilatations, 12 had Botulinum Toxin A injection into the lower esophageal sphincter and 6 had both procedures. 7 patients underwent a Heller myotomy. One is awaiting surgery. Response to treatment was favorable when assessed for improvement in dysphagia and eating ability for 6 months after diagnosis in 24/ 28 patients (85%).

CONCLUSION:

Malignancy associated secondary achalasia is very rare. In our population heme associated malignancy and breast cancer were the 2 cancers most commonly associated with achalasia. Patients with cancer who develop dysphagia should be screened for achalasia, as response to treatment is favorable.
450 Esophageal Motility Disorders and GERD in Patients With Pulmonary Nontuberculous Mycobacterial Infection: A Growing Medical Problem
Authors: Fass Ofer , Khan Abraham , Kamelhar David , Addrizzo-Harris Doreen , Segal Leopoldo , Knotts Rita
Published: October 2019

INTRODUCTION:

The prevalence of pulmonary infections by nontuberculous mycobacteria (NTM) is increasing worldwide. The etiology of this increase is unclear. There is evidence that gastroesophageal reflux disease (GERD) is associated with NTM infections and can increase the severity of pulmonary disease. Data regarding esophageal motility in this population is sparse. We aimed to characterize esophageal motility disturbances and GERD in patients with bronchiectatic NTM and explore its associations with pulmonary pathology and lung function.

METHODS:

We conducted a retrospective review of all patients with a confirmed diagnosis of bronchiectatic NTM at a single center who underwent high resolution esophageal manometry (HRM) between November 2014 and March 2018. Chicago Classification 3.0 was used to characterize HRM findings. Combined multichannel intraluminal impedance-pH (pH-MII) was utilized to assess reflux burden. Statistical relationships between proportions and percentages were evaluated by Fisher’s exact test. Linear regression was utilized to assess associations with pulmonary function testing.

RESULTS:

A total of 32 patients underwent HRM, of which 27 underwent pH-MII. The mean age of all was 70 (SD 10), mean body mass index was 23.4 (SD 6.1), 78% were female, and 44% had a smoking history. The mean lower esophageal sphincter (LES) resting and residual pressures (mmHg) were 36.12 (SD 17.12) and 11 (SD 8.37), respectively. HRM motility disorders included 38% ineffective esophageal motility, 38% normal esophageal motility, 19% esophagogastric outflow obstruction, and 6% jackhammer esophagus. Significant evidence of GERD on pH testing was seen in 12 patients (44%). pH testing showed similar upright and supine reflux burdens of 7.6% and 7.4% respectively. On endoscopy, 2 patients (6.25%) had Barrett’s esophagus. No statistically-significant correlations were found between BMI, gender, mycobacterial organism, imaging characteristics, pulmonary function, HRM diagnosis or presence of significant reflux.

CONCLUSION:

Esophageal motility is frequently abnormal among patients with NTM. NTM patients also have a high prevalence of GERD, including supine GERD, and Barrett’s esophagus, which is far greater than the general population. Consideration should be given to screening for BE among patients with NTM related bronchiectasis. Larger studies are warranted to further characterize esophageal physiology in these patients and the potential impact on pulmonary pathology.
454 Usefulness of Linked Color Imaging in Reflux Esophagitis
Authors: Takeda Tsutomu , Asaoka Daisuke , Nagahara Akihito
Published: October 2019

INTRODUCTION:

Barrett's esophagus and esophageal adenocarcinoma are increasing because of rising prevalence of gastro esophageal reflux disease. Accurate diagnosis of reflux esophagitis is important in daily clinical practice. Linked Color Imaging (LCI) was newly developed for image-enhanced endoscopy that makes easy to recognize differences in mucosal color. Therefore, we investigated the visibility of LCI in reflux esophagitis compared with white light imaging (WLI).

METHODS:

Consecutive patients who underwent esophagogastroduodenoscopy using WLI, LCI between April 2017 and March 2018 in our hospital were selected retrospectively. 5 endoscopists compared WLI images with LCI of 109 images obtained from 109 patients. Physicians assessed visibility as follows: 5 (improved), 4 (somewhat improved), 3 (equivalent), 2 (somewhat decreased), 1 (decreased). Scores were totaled and defined more than 20 points as improved visibility, 10-20 points as equivalent to white light, less than 10 points as decreased visibility. Inter-rater reliability (Intra-class Correlation Coefficient: ICC) was also evaluated. Images were objectively evaluated based on L* a* b* color values and color differences (ΔE*) between normal esophageal mucosa and reflux esophagitis in a CIELAB color space system.

RESULTS:

Improved visibility compared with WLI achieved for All: 29.4% (32/109), LA-M: 21.3% (13/61), LA-A: 41.2% (14/34), LA-B: 50.0% (5/10), LA-C: 0%, LA-D: 0%. Decreased visibility was not detected in LCI. ICC of LCI compared with WLI was 0.470 and inter-rater reliability is moderate. The color difference (ΔE*) revealed WLI: 22.8 ± 7.0, LCI: 33.5 ± 8.4 and statistically significant difference between WLI and LCI was observed (P < 0.001).

CONCLUSION:

LCI improves visibility of reflux esophagitis compared with WLI especially for LA-M, A, B when evaluated both subjectively and objectively. LCI enables the clear visualization of reflux esophagitis and provides better contrasting images between normal esophageal mucosa and reflux esophagitis.
459 The Effect of Rebamipide in Patients With Gastroesophageal Reflux Disease, Including Non-Erosive Reflux Disease: A Multi-Center, Randomized, Single-Blind, Placebo-Controlled Study (RENERD Study)
Authors: Lee Jun Su , Kwon Hyeonwoo , Kim Seongmin , Cho Byungha , Choi Jongwook , Yoon Soon Man , Kim Hyoung Woo , Kim Ki Bae
Published: October 2019

INTRODUCTION:

Gastroesophageal reflux disease (GERD) is a chronic and frequently relapsing disease. The etiology of non-erosive reflux disease (NERD) remains unclear, but it has been reported to manifest histologic changes such as dilated intercellular spaces (DIS) and inflammatory cells infiltration in the esophageal mucosa. In this study, we investigated the effect of rebamipide, a mucosal protective agent, in the recurrence of symptoms in GERD patients during proton pump inhibitor (PPI) and also examined histologic changes in the esophageal mucosa of NERD patients.

METHODS:

A total of 139 patients with GERD including 50 patients with NERD were enrolled in this study and were treated randomly with either PPI plus rebamipide (rebamipide group) or PPI plus placebo (placebo group) during 8 weeks. We compared the change of symptom score at 8 weeks in both groups using a GERD questionnaire. In addition, we analyzed histologic findings such as DIS, inflammatory cells infiltration, and basal cell hyperplasia in the esophageal mucosa of NERD patients, and we compared the histologic changes at 8 weeks in both groups.

RESULTS:

After 8 weeks, the mean decreases in the total symptom score in the rebamipide group were greater than those in the placebo group in GERD patients, but not statistically significant (-4.4 ± 2.7 vs. -3.9 ± 3.1, P = 0.382). However, the proportion of at least a 50% decrease in the total symptom score in the rebamipide group was significantly higher than that in the placebo group (74.1% vs. 51.7%, P = 0.020). With regard to histologic changes in NERD patients, the severity of DIS in the rebamipide group was significantly improved compared to that in the placebo group after 8 weeks (P = 0.024), and also the lymphocytes counts were more decreased in the rebamipide group compared to the placebo group (P = 0.026).

CONCLUSION:

Rebamipide, a mucosal protective agent, might be helpful in attenuating the recurrence of symptoms in GERD patients. It could also improve histologic abnormalities in the esophageal mucosa of NERD patients.
463 The Prevalence and Epidemiology of Achalasia in the USA: A Population-Based Study
Authors: Khoudari George , Saleh Mohannad Abou , Sarmini Muhammad Talal , Parikh Malav P. , Vega Kenneth J. , Sanaka Madhusudhan R.
Published: October 2019

INTRODUCTION:

Achalasia is a rare and benign neurodegenerative disorder characterized by failure of relaxation of the lower esophageal sphincter (LES) and loss of peristalsis in the distal esophagus. A substantial increase has been reported in the number of hospitalizations for achalasia and its associated costs over the last few decades and the etiology is still unknown. Epidemiological studies of this disease have been limited by small sample size. We aim to investigate further the epidemiology of achalasia using a large database.

METHODS:

We used a commercial database (Explorys Inc, Cleveland, OH), which includes electronic health record data from 26 major integrated US healthcare systems. We identified all patients aged 18 and older who were diagnosed with achalasia, over the last five years based on Systematized Nomenclature Of Medicine – Clinical Terms (SNOMED-CT) and evaluated the prevalence of Achalasia among all the patients in this database. We also performed univariate analysis to describe age-, race-, and gender-based distributions and to identify potential risk factors.

RESULTS:

Of the 36,750,450 individuals in the database, we identified 19,840 individuals with achalasia with an overall prevalence of 0.05%. Individuals with achalasia were more likely to be females, senior adults (age > 65), Caucasians, (P < 0.0001 to all) compared to patients without achalasia. Similarly, patients with achalasia were more likely to have gastroesophageal reflux disease (GERD), Barrett's esophagus, eosinophilic esophagitis, esophageal neoplasms, autoimmune disease, diabetes mellitus type 2, amyloidosis, sarcoidosis, and hypoadrenalism, (P < 0.0001 to all). Additionally, patients with achalasia were more likely to be obese, smokers, and drink alcohol (P < 0.0001 to all). Table 1 represents the odds ratio (OR) for all factors.

CONCLUSION:

This is one of the largest epidemiological studies investigating the prevalence and epidemiology of achalasia. The estimated prevalence rate of achalasia was 0.05%. Patients with achalasia were more likely to be females, senior adults (age >65), Caucasians, smokers, and obese. Further studies are needed to confirm these findings.
465 A Pharmacokinetic Bridging Study to Compare the Bioavailability of Budesonide Between Budesonide Oral Suspension and ENTOCORT EC in Healthy Subjects
Authors: Song Ivy , Finkelman Richard , Lan Lan
Published: October 2019

INTRODUCTION:

Budesonide oral suspension (BOS; TAK-721) is a viscous formulation of budesonide that is in development for the treatment of eosinophilic esophagitis in adults and adolescents. BOS was granted Breakthrough Designation by the FDA and is currently being evaluated in phase 3 trials. Several budesonide products are approved in the US for other indications, including ENTOCORT EC for mild to moderate active Crohn's disease; thus, the safety of budesonide has been evaluated extensively. The present study compared the bioavailability of BOS with ENTOCORT EC, aiming to provide the pharmacokinetic (PK) bridge to the safety data of ENTOCORT EC.

METHODS:

Healthy adults (n=22) were enrolled in an open-label, single-center, crossover study. Subjects received two treatments in a randomized sequence with a 48 h washout period between treatments: a single oral dose of BOS 2 mg and a single oral dose of ENTOCORT EC 9 mg. Serial blood samples were collected in each treatment period to determine plasma budesonide concentrations. PK parameters were calculated by non-compartmental analysis and compared between treatments using a mixed effects model with sequence and treatment as fixed effects and subject within sequence as a random effect.

RESULTS:

Plasma budesonide concentrations showed a faster absorption from BOS compared with ENTOCORT EC. Peak plasma concentrations were achieved ∼1.5 h post-dose for BOS and ∼4 h post-dose for ENTOCORT EC. Systemic exposure to budesonide after a single dose of BOS 2 mg was lower than that observed after a single dose of ENTOCORT EC 9 mg: the geometric mean AUC0-t, AUC0-inf and Cmax of budesonide after BOS 2 mg were 33.6%, 32.9% and 71.1% of those after ENTOCORT EC 9 mg, respectively.

CONCLUSION:

ENTOCORT EC 9 mg once daily (qd) is approved for induction treatment of Crohn's disease. The proposed clinical dosing regimen for BOS for induction treatment of eosinophilic esophagitis is 2 mg twice daily (bid). When taking into account the different dosing frequencies, the daily AUC and the Cmax of budesonide from BOS 2 mg bid at steady state are estimated to be 67% and 71% of those from ENTOCORT EC 9 mg qd, respectively. These results provide PK bridging data to compare BOS 2 mg bid to ENTOCORT EC with respect to safety information.
466 Avoidant/Restrictive Food Intake Disorder (ARFID) Among Adult Gastroenterology Behavioral Health Patients: Comparison of ARFID vs. Non-ARFID Patients
Authors: Harer Kimberly N. , Jagielski Christina , Chey William D. , Riehl Megan
Published: October 2019

INTRODUCTION:

Avoidant/Restrictive Food Intake Disorder (ARFID) is a feeding disorder characterized by avoidance or restriction of food associated with weight loss, nutritional deficiency, dependence on tube feeds/oral supplements, or significant psychosocial impairment. Emerging evidence has shown 6-19% of gastroenterology (GI) patients have concurrent ARFID; however, these patients have not been characterized.

METHODS:

Retrospective analysis of 223 adult GI patients seen by a gastroenterologist and GI psychologist at a tertiary care center from 2016 to 2018. ARFID diagnosis was based on chart review by a gastroenterologist and GI psychologist for evidence of DSM-5 ARFID criteria. Demographic, clinical, and questionnaire data were recorded.

RESULTS:

Of 223 patients, 28 (12.6%) met criteria for ARFID. Concern for ARFID was raised in 0% of cases. There was no difference between ARFID and non-ARFID patient gender, age, educational level, GI diagnosis, GI symptom severity, mean BMI, or frequency of nutrition referral (Table 1). ARFID patients were less likely to be using a psychotropic medication (17.9% vs 50%, P < 0.01). There was no difference in eating disorder history (ARFID 3.6% vs non-ARFID 8.7%, P = 0.12). On the IBS-QOL questionnaire, ARFID patients reported more severe food avoidance concerns, more frustration with not being able to eat what they wanted, and less severe body image concerns (all P< 0.5). Following completion of GI-directed psychological therapies, IBS-QOL scores improved less in ARFID patients (Table 2). There was no difference between groups in Brief Symptoms Inventory scores or sleep quality scores (Table 3).

CONCLUSION:

This is the first study comparing ARFID vs non-ARFID adult GI behavioral health patients. Of 223 patients, 12.6% met ARFID criteria. ARFID and non-ARFID patients were clinically indistinguishable based on age, gender, BMI, GI diagnosis, or GI symptom severity. Although ARFID is often associated by gastroenterologists with underlying psychiatric or eating disorders, ARFID patients were less likely to be using psychotropic agents, reported lower body image concerns, and reported increased frustration with not being able to eat than non-ARFID patients. ARFID patients had decreased improvement in post-behavioral health therapy IBS-QOL scores. This data demonstrates the need to appropriately screen patients for ARFID and raises concern regarding the need utilize a multidisciplinary treatment approach that takes into account GI, psychological, and nutritional needs.
470 Nutritional Deficiencies in Irritable Bowel Syndrome: A North American Population-Based Study
Authors: Hujoel Isabel A.
Published: October 2019

INTRODUCTION:

Irritable bowel syndrome (IBS) is common, affecting 12% of the population. However, the quality of evidence in support of current medical interventions has been rated as very low, and the majority of those with IBS report their symptoms as being unchanged or worsened over time. Diet is thought to play a significant role in IBS, and there is increasing focus on the therapeutic benefit of diet and supplementation. This study aims to compare dietary composition and serologic markers of nutritional status in those with and without IBS to determine potential targets for therapeutic supplementation.

METHODS:

All 17 national surveys between 1959 and 2019 were screened and only one, the Second National Health and Nutrition Examination Survey (NHANES II) (1976-1980), provided comprehensive data on IBS. We performed a cross-sectional analysis of serology and dietary composition of 12,295 individuals, aged 18 to 74 in NHANES II. Dietary composition was drawn from dietary recall questionnaires, and the diagnosis of IBS was based on self-reporting.

RESULTS:

Individuals with IBS had significantly higher copper-zinc ratios (1.70 versus 1.55, P = 0.048) and were more likely to have ratios above 1.8 (odds ratio 1.79, 95% confidence interval 1.02-3.13), suggestive of an underlying zinc deficiency. This deficiency may be due to their avoidance of milk, which was the largest source of dietary zinc in the study population. While they were significantly more likely to report dietary avoidances, they had no other serologic evidence of nutritional deficiencies. Additionally, dietary recall showed that they consumed significantly more daily calories (P = 0.02), were more likely to take vitamin supplements (P = 0.003) and that their macro and micronutrient intake was not significantly different.

CONCLUSION:

The findings suggest that individuals with IBS should be screened for zinc deficiency. Zinc deficiency may perpetuate the underlying pathophysiology of IBS and may contribute to the associated psychiatric conditions through zinc's role in the immune system, “brain-gut” axis, and gastrointestinal barrier integrity. This suggests that zinc supplementation may be a potential therapy both to mitigate underlying pathology as well as improve symptoms. Our findings should be confirmed in future studies, and the association of copper-zinc ratios with symptom severity, and the response of symptoms to supplementation could be investigated.
471 Investigating the Tissue Distribution of [14C]-Prucalopride Following a Single Oral Dose in Rats
Authors: Lou Zhen , Welty Devin
Published: October 2019

INTRODUCTION:

Prucalopride is a selective, high-affinity agonist of the 5-hydroxytryptamine-4 (5-HT4) receptor and is indicated for the treatment of adult patients with chronic constipation. In humans, prucalopride is rapidly absorbed and extensively distributed, reaching maximum plasma concentration 2–3 h after a 2 mg oral dose. We report three studies investigating tissue distribution of prucalopride in rats.

METHODS:

A single oral dose of 14C-labelled prucalopride at 5mg base-equivalent(eq)/kg was administered to 30 SPF Wistar rats (5 males, seven groups of 3 non-pregnant females and 4 pregnant females [dose administered on day 18 of gestation]). Total radioactivity (TR) in various tissues was measured up to 96h. In females, the area under the TR concentration curve for up to 8h (AUC0–8h) and the AUC0–8h tissue:plasma ratio was calculated. The tissue concentration of unchanged drug (UD) was measured up to 48 h.

RESULTS:

The highest mean TR for all rats was detected in the pancreas (8.9µg-eq/g within 30 min of dosing; below the limit of detection [LOD] after 24 h), the liver (12.5 µg-eq/g within 20 min; 0.3 µg-eq/g after 96 h) and the small intestine (15.6µg-eq/g within 30 min; below the LOD after 24 h). The highest mean concentration of UD in non-pregnant females was detected in the small intestine (10.1 µg-eq/g within 20 min; below the LOD after 24 h). The lowest mean TR was detected in the brain, in males (0.12 µg-eq/g within 30 min), non-pregnant females (0.21 µg-eq/g within 1 h) and pregnant females (0.21 µg-eq/g within 30 min). TR in the brain was below the LOD within 2, 24 and 8 h of dosing, respectively. In non-pregnant females, the highest AUC0–8h and AUC0–8h tissue:plasma ratios of TR were observed in the small intestine (75.3 and 31.3, respectively); the lowest values were observed in the brain (0.85 and 0.35, respectively). Findings were similar for UD. In pregnant females the highest AUC0–8h and AUC0–8h tissue:plasma ratios of TR were observed in rectal (mucosa) and salivary gland tissue (122 and 20.5, respectively, for both); the lowest values were observed in the brain (0.33 and 0.17 [AUC0–2h], respectively).

CONCLUSION:

After a single oral dose of prucalopride, high concentrations were detected in the pancreas, liver and small intestine, and very low concentrations in the brain (∼0.05% of the dose in non-pregnant female rats). Mean concentrations of TR and UD in the brain were below the LOD within 24h of dosing, suggesting prucalopride is not unduly retained in the brain.
475 The Fragility Index of the Randomized Trials for Irritable Bowel Syndrome With Constipation
Authors: Takakura Will , Rezaie Ali
Published: October 2019

INTRODUCTION:

In the age of frequentist analyses and standardized threshold P-values (<0.05); fragility index (FI), the minimum number of patients that needs to change from “non-responder” to “responder” for the P-value to become >0.05, has been suggested to aid our interpretation of the robustness of the “positive” large randomized control trials (RCTs) (Walsh, M. et al. JCE 2014). This number allows the reader to quickly know the number of patients that the study relies on for its significance, hence a higher index suggests a higher confidence in the results. Based on all available RCTs, we aimed to calculate the FI of medications that are approved by Food and Drug Association (FDA) for (Irritable bowel syndrome with constipation) IBS-C.

METHODS:

Data from 13 double-blind RCTs on linaclotide, plecanatide, lubiprostone and tegaserod were analyzed. FI was calculated by converting the number of “non-responders” in a dichotomized data to a “responders” to get a P-value > 0.05 by using the Fisher's exact test. We calculated the FI for the FDA endpoint if it was reported, otherwise the dichotomized endpoint evaluating its efficacy was used. A similar calculation was done for diarrhea as the most common side effect in RCTs on IBS-C in each respective study by converting those without diarrhea to those with diarrhea to calculate its FI.

RESULTS:

All 13 studies had a positive FI except for Johanson et al. studying lubiprostone since the study itself reported a nonsignificant outcome, as well as Novick at al. studying tegaserod (Table 1). The FI for diarrhea was positive for those in linaclotide and 2 studies for plecanatide and tegaserod but not in lubiprostone. The median (mean) FI for efficacy was 27 (28.5), 13 (17.7), 2 (2), and 6 (11) events and the median (mean) FI for diarrhea was 31.5 (29.3), 2 (3), 0 (0), and 8 (5.7) events for linaclotide, plecanatide, lubiprostone and tegaserod respectively. Linear regression showed a significant positive correlation between FI for efficacy and diarrhea with R2 = 0.54 (P = 0.004) (Figure 1).

CONCLUSION:

Median FI is appropriately positive for RCTs assessing IBS-C on medications currently approved by FDA. We recommend considering the addition of FI, as a simple and useful tool, in future systematic reviews to assist in appropriate and optimal decision making in patient care.
477 Abdominal Herniation and Gastrointestinal Symptoms in Patients With Loey Dietz Syndrome and Vascular Ehlers Danlos Syndrome
Authors: Wang Xiao Jing , Babameto Mary , Babovic-Vuksanovic Dusica , Camilleri Michael
Published: October 2019

INTRODUCTION:

Loey Dietz syndrome (LDS) is an autosomal dominant disorder caused by a mutation in TGFBR1- or TGFBR2. LDS is characterized by distinctive facies, tortuous arteries and aortic aneurysms predisposition to eosinophilic allergic disorders including eosinophilic esophagitis and gastritis, and other systemic findings including inflammatory bowel disease. Patients with vascular Ehlers Danlos Syndrome (vEDS) have deficiency in type III collagen and have similar vascular laxity and concomitant GI manifestations. This connective tissue vulnerability contributes to increased post-operative wound dehiscence and development of hernias. Our aim was to summarize abdominal wall and GI tract manifestations in these two rare vascular disorders at a tertiary referral center.

METHODS:

Data were collected via Advanced Cohort Explorer (ACE) application at Mayo Clinic. A chart review was undertaken on patients with a confirmed diagnosis of vEDS or LDS seen at Mayo Clinic in Rochester from 1994 to 2018. Diagnoses were confirmed by genetic testing and/or clinical review through the specialized medical genetics clinic. Information was extracted on vascular complications of disease, prevalence of abdominal hernias, and gastrointestinal symptoms. The study was reviewed and exempted by the Mayo Clinic IRB.

RESULTS:

We identified and reviewed records of 50 vEDS and 13 LDS patients; data are summarized in Tables 1 and 2. Patients were similar in age at diagnosis and gender distribution. Hernias were present in similar proportions of patients with vEDS and LDS, although ventral hernias were more frequent and the hernias were more likely to be post-operative in vEDS than in LDS. LDS patients had more aneurysms (58% vEDS vs. 76.9% LDS, P = 0.02) with higher proportion requiring arterial repair (32.7% vEDS vs. 69.2% LDS, P = 0.03). Co-morbidities more prevalent in LDS than vEDS were autonomic dysfunction, psychopathology and allergy. We did not note increase in symptoms suggestive of eosinophilic esophagitis/gastritis in the LDS patients. GI symptoms were prevalent in both disorders and largely similar, except for diarrhea and constipation which were both significantly more prevalent in LDS patients.

CONCLUSION/DISCUSSION:

While vEDS and LDS are both connective tissue disorders with propensity for GI symptoms, abdominal hernias and aneurysm formation, the risk of arterial rupture and co-morbidity of autonomic dysfunction, psychopathology and allergy are greater in LDS than vEDS.
482 Prevalence and Predictors of Symptom Complexes Commonly Seen in Acute Hepatic Porphyria in the General Population
Authors: Lakhoo Krutika , Almario Christopher , Ko John J. , Wei Alex , Meninger Stephen , Spiegel Brennan
Published: October 2019

INTRODUCTION:

Acute hepatic porphyria (AHP), a family of rare genetic disorders, can present with life-threatening attacks with a predominant symptom of abdominal pain. Literature states that patients with AHP have been misdiagnosed with other conditions such as irritable bowel syndrome, functional abdominal pain, and endometriosis, among others. We aimed to determine the prevalence and predictors of symptom complexes commonly seen in AHP among community-dwelling adults in the US.

METHODS:

We partnered with Cint, an online survey research firm, to recruit a representative sample of US adults aged ≥18 y with abdominal pain. We asked if they had recurrent episodes of excruciating belly pain lasting ≥1 day with any of these co-occurring symptoms: urine color change to dark red/brown; skin blisters on sun-exposed areas; peripheral (e.g., muscle weakness, extremity pain), central (e.g., depression, seizures), or autonomic (e.g., tachycardia, hypertension) nervous system manifestations. Multivariable logistic regression models were used to adjust for confounding.

RESULTS:

24,932 individuals accessed the survey, with 10,300 (41.3%) reporting abdominal pain (Table 1). Of those with abdominal pain, 23.4% had symptoms consistent with AHP (≥2 episodes of excruciating abdominal pain and ≥2 concomitant symptoms). Those with AHP-like symptoms experienced the following: autonomic (97.7%), central (96.5%), and peripheral (58.8%) nervous system manifestations; urine color change (21.9%); and skin blisters (6.6%). Most (90.9%) sought medical care for their symptoms: emergency room (57.6%), doctor's office (52.1%); urgent care facility (29.4%); clinic/health center (19.1%); hospital admission (18.4%). Table 2 shows results of the regression analysis on presence of AHP-like symptoms. Younger individuals, Latinos, those who identified as other race, and those with a usual source of care, comorbidities, lower locus of control, more severe pain, and worse physical health were more likely to have AHP-like symptoms.

CONCLUSION:

In this population-based survey, 1 of 4 individuals with prior abdominal pain had symptoms consistent with AHP manifestations. Although AHP prevalence is very low, clinicians should ask those experiencing multiple episodes of severe abdominal pain about concomitant neurologic, psychiatric, skin, and urologic symptoms. This practice may prompt earlier testing for AHP, decreasing the delay to diagnosis and improving outcomes.
488 National Trends and Outcomes of Irritable Bowel Syndrome Presenting to Emergency Departments: Results From the Nationwide Emergency Department Sample (NEDS) Database
Authors: Tariq Tooba , Sieloff Martin , Irfan Furqan
Published: October 2019

INTRODUCTION:

Irritable bowel syndrome (IBS) is a chronically relapsing disease that causes gastrointestinal discomfort with diarrhea and/or constipation in a large group of Americans. Estimates of IBS disease burden in emergency departments (ED) are lacking. We sought to investigate IBS emergency department visits nationally, patient demographics and hospitalization trends from 2009-2014 using Nationwide Emergency Department Sample (NEDS) database.

METHODS:

The Nationwide Emergency Department Sample database was used to extract data from 2009 to 2014 for patients who visited the ED with a primary diagnosis of irritable bowel syndrome. International Classification of Diseases (ICD-9-CM) were used to identify patients; Irritable bowel syndrome (ICD-9-CM: 564.1). The 2009-2014 NEDS data was used to study the incidence of ED visits, patient/hospital factors, inpatient charges, length of hospitalization and discharge from hospital to home.

RESULTS:

There were 189,210 (0.02%) ED visits identified with a diagnosis of IBS among a total of 795,980,104 ED visits between 2009-2014 in the NEDS database. Most patients were female (n = 143247.6, 75.8%) with a mean age of 42.4 years. The rate of ED visits decreased from 10.2 per 100,000 in 2009, to 9.4 per 100,000 in 2014 (decrease of 8%; z = -1.691, P = 0.091). The majority of patients had private insurance (n = 68687, 36.3%) followed by Medicare (n = 43272, 22.9%) and Medicaid (n = 41737, 22.1%). Uninsured patients presenting with IBS to the ED constituted 15% (n = 28392) of the study population. Patients presented with IBS in far greater numbers to urban EDs (n = 150148, 79.4%) compared to rural EDs (n = 39062, 20.6%). Most were discharged from the ED (n = 134616.9, 71.1%) while 28.9% (n = 54593.5) patients were admitted. Hospitalized patients had a decrease in mean length of stay from 3.64 days in 2009 to 3.53 days in 2014; however, the mean inpatient charges increased from $20,823 in 2009 to $27,649 in 2014 (increase of 32.8%).

CONCLUSION:

Irritable bowel syndrome emergency department visits remained relatively constant between 2009 and 2014 while nearly 30% of patients were admitted. Despite unchanged hospital length of stay, hospitalization costs appear to be increasing. Better outpatient management of irritable bowel syndrome is needed to avoid emergency department visits and rising inpatient costs.
490 High-Resolution Electrogastrogram Identifies Disturbed Gastric Slow Waves and Dysautonomia in Subjects With Dumping Syndrome
Authors: Kabadi Alisha , Coleman Todd P. , Greenwald Holly S. , Kunkel David C.
Published: October 2019

INTRODUCTION:

Rapid gastric emptying is the sine qua non of Dumping Syndrome (DS), which can arise from multiple etiologies including gastric surgery and diabetes mellitus. The relationship between DS and gastric myoelectric activity is unknown, but dysautonomia may play a role. We sought to characterize features of gastric slow waves and autonomic indices among subjects with DS using the ambulatory high-resolution electrogastrogram (HR-EGG).

METHODS:

Eleven subjects completed 24-hour ambulatory HR-EGG. Fasting abdominal computed tomography scan was utilized for stomach localization and placement of the ambulatory HR-EGG array, consisting of 10 skin mounted electrodes. Subjects were divided into two groups: DS (4F, age 53.2 ± 9.3, BMI 31.7 ± 11, 79-93% gastric emptying at 1 hour on scintigraphy, two diabetics, one prior gastric surgery, one gastrointestinal amyloidosis) and healthy age-matched controls (4M/3F, age 47.6 ± 28, BMI 24.5 ± 3.7). All subjects completed the PAGI-SYM foregut symptom questionnaire and a diary capturing all meals and sleep/wake times.

RESULTS:

Subjects with DS had significantly higher mean PAGI-SYM foregut symptom severity scores (1.9 ± 1.0 vs 0.1 ± 0.1; P = 0.0007). HR-EGG showed that DS subjects had a significantly lower slow wave speed (4.6 vs 5.9 ± 0.4; P = 0.0003) and higher post-prandial power change (11 vs 3.5 ± 3.6; P = 0.002) compared to healthy controls. The global percent stomach activity throughout the 24-hour ambulatory recordings was not different between groups. DS subjects trended towards higher post-prandial area under the curve EGG activity at both the 1-hour (261.9 ± 360.7 vs 172.9 ± 137.5) and 4-hour marks (1108.8 ± 1589.4 vs 656.3 ± 442.2). In addition, subjects with DS had significantly lower heart rate variability than controls: RMSDD (39.9 ± 9.7 vs 58.1 ± 7.8) and SDNN (12.6 ± 4.2 vs 23.7 ± 3.2); no differences were noted in mean heart rate (Table 1).

CONCLUSION:

Ambulatory HR-EGG clearly identifies that there are spatial abnormalities of the gastric slow wave present among subjects with DS. Moreover, reduced heart rate variability - a marker of autonomic dysfunction - was observed among subjects with DS. These findings suggest that gastric dysrhythmias and autonomic disturbances should be given important consideration in the pathogenesis of Dumping Syndrome.
500 Assessing the Impact of a National Small-Group CME Activity on Management of Patients With IBS
Authors: Salinas Gregory D. , Saenz Thomas , Cash Brooks D.
Published: October 2019

INTRODUCTION:

Rapid advances in understanding of and available therapies for IBS have created a significant educational need among practicing clinicians. Our aim was to determine the effectiveness of a CME activity discussing IBS on clinical performance.

METHODS:

In 2018, a national educational initiative focusing on the management of IBS was led by the Gi Health Foundation (GiHF) IBS Centers of Educational Expertise and complemented by educational resources on the GiHF's educational portal. The initiative consisted of 50 small group CME discussions and one on-line module. The target audience consisted of community-based gastroenterologists and healthcare professionals who provide care for patients with IBS. To assess the effectiveness of the initiative, a series of case vignette-based surveys were provided to a sample of learners at least 30 days after attending the education (Aug-Oct 18). Learner decisions were compared to a demographically similar nonlearner control group of clinicians collected in the same timeframe. Analyses were conducted to compare the two groups and to understand specific and overall educational effect.

RESULTS:

The education had a total of 401 learners; 236 of those were eligible for the outcomes study based on demographic criteria (MD/NP/PA role, currently managing patients with IBS). A sample of 52 learners were collected and matched to a control group of 52 nonlearners. Comparing their performance and decision-making choices, learners were 42% (effect size 0.68) more likely than nonlearners to provide evidence-based care. Performance improvements were seen in aspects of diagnosis and patient management, including confirming IBS-D diagnosis, selecting appropriate initial IBS-D management, and selecting appropriate management for recurrent IBS-D. A linear regression analysis was conducted to determine whether the effect was due to education participation or another confounding demographic variable. We found that when all demographic variables (clinician age, degree, specialty, patient load, etc.) are equal, participation in education is the primary driver of performance change in this sample.

CONCLUSION:

This educational series had significant impact on lasting physician performance and indicated areas of need for future education, such as treatment choice of for a patient with IBS-C, timing of colonoscopies, managing psychosocial aspects of care, determining next steps in a patient not responding to rifaximin, and strategies to promote patient adherence.
502 Translumbosacral Anorectal Magnetic Stimulation (TAMS): Novel Anorectal Neurophysiology Test, Normative Values, and Effects of Gender
Authors: Yan Yun , Xiang Xuelian , Sharma Amol , Herekar Anam , Parr Rachael , Rao Satish
Published: October 2019

INTRODUCTION:

Although anal electromyography and pudental nerve latency have been used for assessment of anal neuropathy, neither test is used routinely in clinical practice, because of significant deficiencies with each test and were not endorsed by AGA. Also neither test comprehensively assesses the entire nerves from their origin in spinal cord to anal innervation. Truslumbosacral Anorectal Magnetic Stimulation (TAMS) is a novel, non-invasive test for identifying anorectal neuropathy. It evaluates the neuronal integrity of lumbar and sacral plexus nerves from their origin in spinal cord to their innervation in the rectum and anus by measuring the latencies of motor evoked potentials (MEPs). Our aim was to determine the normal values for TAMS in healthy subjects and evaluate the effects of gender.

METHODS:

Healthy subjects underwent bilateral translumbar and transacral magnetic stimulation using a 90 mm magnetic coil (Magstim, UK). Motor evoked potentials (MEPs) were recorded simultaneously from the rectum and anus using two pairs of bipolar ring electrodes. The 8 MEP latencies from each healthy subject were measured (mean ± SEM) and gender differences compared.

RESULTS:

Forth-eight healthy subjects (18-59) years, F/M = 32/16) were evaluated. The mean latency of all 8 MEPs, and in men and women are summarized in Table 1. Although there are small differences in MEP latencies between individual sites, overall there were no differences between the lumbar and sacral nerve latencies or between the right or left side or between the anal and rectal sites (Table 1). Also there were no differences in MEP latencies between men and women for any of the 8 sites. Age is not significantly associated with the anal or rectal MEP latencies (r = 0.09 to 0.326), except weak association for right sacro-rectal MEP (r = 0.386), P = 0.009).

CONCLUSION:

This study provides normative values for the bilateral lumbar and sacral-anorectal MEPs in healthy subjects. Neither gender nor age appear to influence the rectal and anal MEP latencies. These data will provide the basis for comparing the novel TAMS test findings in patients with those from suspected anorectal or pelvic neuropathy.
503 Small Intestinal Bacterial Overgrowth (SIBO) in Functional Dyspepsia (FD): Does Dyspeptic Symptom Pattern Make a Difference?
Authors: Nojkov Borko , Baker Jason , Watts Lydia , Lee Allen , Chey William D. , Saad Richard
Published: October 2019

INTRODUCTION:

FD is a common gastrointestinal disorder with poorly understood pathophysiology. Patients with FD and SIBO frequently overlap symptomatically. The prevalence of SIBO in patients with FD is not well studied, particularly in relation to the predominant FD symptom profile. We aimed to evaluate the prevalence of SIBO diagnosed by glucose breath test (GBT) in patients with FD and compare the SIBO prevalence in FD subtypes - Postprandial Distress Syndrome (PDS), Epigastric Pain Syndrome (EPS) or both (PDS+EPS).

METHODS:

Retrospective, tertiary center, study of patients fulfilling Rome criteria for FD, who completed GBT (2018-2019). Demographics, history, medications, and GBT findings were reviewed. Patients with documented structural disease (eg. neoplasm) were excluded. GI symptoms (including mid upper abdominal pain or burning, early satiety and postprandial fullness) were prospectively collected from all patients at the time of their GBT. Based on these responses, patients were classified into: 1. FD-PDS, 2. FD-EPS and 3. FD-PDS+EPS. A priori variables associated with SIBO were analyzed including: presence of diabetes, GERD, and gastroparesis; history of small bowel surgery or gastric bypass; use of opioids or proton pump inhibitors. Prior to GBT, patients had low carbohydrate diet (2 days), no antibiotics (30 days) and no tobacco (12 hrs). Positive GBT for SIBO was defined by ≥20 ppm H2 increase over basal within 90 min and/or ≥10 ppm CH4 increase at any time. Statistical methods included chi-square and t test.

RESULTS:

737 consecutive patients were studied (mean age=51.6±17.6 years, 70% female, 88% Caucasian, mean BMI=28.4±7.1). No differences in demographic or a priori SIBO-associated variables were found between the 3 subgroups of FD patients (P = NS). 31.4% of patients fulfilling criteria for FD had a GBT positive for SIBO. Individual gas (H2, CH4, or both) excretion responsible for a positive glucose HBT in each of the FD subgroups is shown on Table 1. There was no statistically significant difference in the prevalence of SIBO (by either H2, CH4 or both) between the three FD patient subtypes. There was borderline significant difference for slower H2 peak depicting a positive GBT in FD-PDS compared to FD-EPS and FD-EPS+PDS (83.8 vs. 70.7 vs. 65.7 minutes, P = 0.05).

CONCLUSION:

SIBO diagnosed by GBT is common in patients with FD regardless of the predominant symptomatic pattern. The prevalence of SIBO was similar in the three FD subtypes.