Gastroparesis Cardinal Symptom Index Score Research Articles

Prevalence of Cardiovascular Autonomic Neuropathy and Gastroparesis Symptoms among Adults with Type 2 Diabetes Who Attend a Primary Health Care Center

Introduction: Cardiovascular autonomic neuropathy (CAN) and gastroparesis are two forms of diabetic autonomic neuropathy that could affect the quality of life of the patients and carry significant morbidity and mortality outcomes. This study aimed to estimate the prevalence and risk factors of both CAN and gastroparesis symptoms (GPS) among patients with type 2 diabetes (T2D). Methods: A cross-sectional study was conducted among 347 adults (≥ 18 years) with T2D from April 1- December 15, 2017. CAN was defined by the presence of any of the followings: resting tachycardia (RT); resting heart rate > 100 bpm, orthostatic hypotension OH (a fall in systolic blood pressure (SBP) by ≥ 20 mmHg or a fall in diastolic blood pressure by ≥ 10 mmHg within 3 minutes of standing) or prolonged corrected QT interval (QTc) in the electrocardiogram (> 0.47 seconds in females, and > 0.45 seconds in males). The GPS were assessed using a validated questionnaire: Gastroparesis Cardinal Symptom Index (GCSI). GCSI score ≥ 1.9 signified definite GPS. Results: The mean age was 55.6 ± 10 years. The mean HbA1c and T2D duration was 8 ± 1.6% and 10.6 ± 6.9 years, respectively. CAN was present in 15.6%: 2.9% with OH, 5.8% with RT and 8.4% with prolonged QTc. Antihypertensive agents (anti-HTN), body mass index (BMI), SBP, triglycerides and HbA1c were significantly higher in patients with CAN, P<0.05. Prolonged T2D duration (OR= 1.07, 95% CI 1-1.14; p= 0.04) and anti-HTN (OR= 5.2, 95% CI 1.2-23; p= 0.03) were independently associated with CAN. GPS were present in 3.2% and were significantly associated with higher BMI, P<0.05. Metformin use emerged as the single significant independent predictor of the presence of at least one GPS (OR= 5.2, 95% CI 1.8- 14.7; p= 0.002). Conclusion: The prevalence of CAN among T2D subjects was 15.5%. Prolonged T2D duration and anti-HTN emerged as significant predictors of CAN. The prevalence of GPS was 3.2% and was independently associated with metformin use. Disclosure L. AlOlaiwi: None. T. Alharbi: None. A. Tourkmani: None.

Gastric Peroral Endoscopic Pyloromyotomy Reduces Symptoms, Increases Quality of Life, and Reduces Health Care Use For Patients With Gastroparesis

Gastric peroral endoscopic pyloromyotomy (GPOEM) is becoming a promising treatment option for patients with refractory gastroparesis. We aimed to systematically assess the efficacy of GPOEM and its effects on health care use. We performed a retrospective study on 30 patients with refractory gastroparesis who underwent GPOEM from June 2015 through July 2017 at a tertiary center. We compared outcomes with those of 7 patients with refractory gastroparesis who did not undergo the procedure (controls). The primary outcomes were patient-reported reductions in symptoms, based on the gastroparesis cardinal symptom index (GCSI), and increases in 8 aspects of quality of life, based on Short Form 36 (SF-36) scores. Data were collected on the day of the procedure (baseline) and at 1 month, 6 months, 12 months, and 18 months afterward. Secondary outcomes included visits to the emergency department or hospitalization for gastroparesis-related symptoms. GPOEM was technically successful in all patients and significantly reduced GCSI scores in repeated-measure analysis of variance (F2.044, 38.838= 22.319; P < .0005). The mean score at baseline was 3.5 ± 0.6, at 1 month after GPOEM was 1.8 ± 1.0 (P < .0005), at 6 months after was 1.9 ± 1.2 (P < .0005), at 12 months after was 2.6 ± 1.5 (P < .026), and at 18 months after was 2.1 ± 1.3 (P < .016). GPOEM was associated with improved quality of life: 77.8%, 76.5%, and 70% of patients had significant increases in SF-36 scores, compared with baseline, at 1 month, 6 months, and 12 months after GPOEM, respectively (F1.71,18.83= 14.16; P < .0005). Compared with controls, patients who underwent GPOEM had significant reductions in GCSI, after we controlled for baseline score and duration of the disease (F1,31= 9.001; P= .005). Patients who received GPOEM had significant reductions in number of emergency department visits (from 2.2 ± 3.1 times/mo at baseline to 0.3 ± 0.8 times/mo; P= .003) and hospitalizations (from 1.7 ± 2 times/mo at baseline to 0.2 ± 0.4 times/mo; P= .0002). In a retrospective study of patients who underwent GPOEM for refractory gastroparesis, we found the procedure significantly improved symptoms, increased quality of life, and reduced health care use related to gastroparesis.

Islet Cell Associated Autoantibodies and C-Peptide Levels in Patients with Diabetes and Symptoms of Gastroparesis.

Individuals with diabetes are at increased risk for complications, including gastroparesis. Type 1 diabetes mellitus (T1DM) is an autoimmune disorder resulting in decreased beta-cell function. Glutamic acid decarboxylase-65 antibody (GADA) is the most commonly used test to assess autoimmunity while C-peptide level is used to assess beta-cell function. Patients with type 2 diabetes mellitus (T2DM), who are GADA positive, are labeled latent autoimmune diabetes in adults (LADA). To characterize patients with T1 and T2DM who have symptoms of gastroparesis using GADA and C-peptide levels and to look for association with the presence of gastroparesis and its symptom severity. 113 T1DM and 90 T2DM patients with symptoms suggestive of gastroparesis were studied. Symptom severity was assessed using Gastroparesis Cardinal Symptom Index (GCSI). Serum samples were analyzed for GADA and C-peptide. Delayed gastric emptying was present in 91 (81%) of T1DM and 60 (67%) of T2DM patients (p = 0.04). GADA was present in 13% of T2DM subjects [10% in delayed gastric emptying and 20% in normal gastric emptying (p = 0.2)]. Gastric retention and GCSI scores were mostly similar in GADA positive and negative T2DM patients. GADA was present in 45% of T1DM subjects [46% in delayed gastric emptying and 41% in normal gastric emptying (p = 0.81)]. Low C-peptide levels were seen in 79% T1DM patients and 8% T2DM. All seven T2DM patients with low C-peptide were taking insulin compared to 52% of T2DM with normal C-peptide. GADA was present in 13% while low C-peptide was seen in 8% of our T2DM patients with symptoms of gastroparesis. Neither did correlate with degree of delayed gastric emptying or symptom severity. NCT01696747.

Procedural Characteristics and Relation to Clinical Outcomes in Gastric Peroral Endoscopic Pyloromyotomy (GPOEM) for Refractory Gastroparesis

Introduction: Refractory gastroparesis has shown encouraging response to the emerging gastric peroral endoscopic pyloromyotomy (GPOEM) procedure. GPOEM is technically similar to POEM for achalasia; however, the focus is on pyloromyotomy for improved stomach emptying. This study assesses procedural characteristics of GPOEM and the relation to clinical outcomes in patients with refractory gastroparesis. Methods: This study was a case-control retrospective analysis of 14 total patients who underwent GPOEM from June 2015 to July 2016 for refractory gastroparesis. Seven patients were grouped based on failed clinical response to the procedure, as defined by: (1) less than 20% decrease in Gastroparesis Cardinal Symptom Index (GCSI) score after one month, (2) gastric retention at 4 hours failed to decreased by 50% during gastric emptying study, or (3) Short Form 36 score did not increase by 25% overall or by more than 50% in three or more individual categories. We compared these seven patients with seven pre-procedural GCSI-matched patients who achieved improvement based on the above criteria. Procedural parameters, including timing of procedure, i.e. performed during the first 10 cases within first six months or learning curve period, participation of an advanced endoscopy fellow/trainee, and the length of myotomy, were compared between the two groups using bivariate analysis. Results: Age, gender, and race were matched between the two groups. The average pre-GPOEM GCSI score for non-responders was 31.7 ± 5.1 and for responders was 32.0 ± 4.7 (p=0.36). Number of the procedures performed during the learning curve period was not significantly different between the two groups (p=0.17) and none of the seven patients who failed to respond to GPOEM underwent their procedure during this period. An advanced endoscopy fellow/trainee participated in all 14 cases. Mean myotomy length was longer for non-responders (2.92 ± 0.19 cm) compared with 2.71 ± 0.39 cm for responders but did not reach statistical significance (p=0.07). Conclusion: It does not appear that timing of GPOEM, in terms of being performed within the learning curve period, or participation of a trainee significantly affects outcomes. There may be an association of increasing myotomy length and lack of clinical improvement following the procedure, however, this trend did not reach statistical significance. We suspect that antral contractility, and thus stomach emptying, may be adversely affected by longer myotomy length.Table: Table. Procedural Characteristics of Included Cases

Effect of Intravenous Fluids and Analgesia on Dysmotility in Patients With Acute Pancreatitis: A Prospective Cohort Study.

Analgesia and intravenous fluid resuscitation are cornerstones of initial patient management in acute pancreatitis (AP). The aim was to investigate the effect of intravenous fluids and analgesia on gastrointestinal motility in the early course of AP. Gastrointestinal dysmotility was assessed using the Gastroparesis Cardinal Symptom Index (GCSI). One-way analysis of variance and analysis of covariance were conducted, adjusting for age, sex, body mass index, severity of AP, preexisting diabetes mellitus, and time from first symptom onset to hospital admission. A total of 108 patients with AP were prospectively enrolled. Opioid analgesia, when compared with nonopioid analgesia, was significantly associated with increase in total GCSI score in both unadjusted and adjusted analyses. There was no significant difference between aggressive and nonaggressive fluid resuscitation in both unadjusted and adjusted analyses. A combination of opioids and any intravenous fluids was associated with a significantly increased total GCSI score compared with opioids and no intravenous fluids in both unadjusted and adjusted analyses. Duration of symptoms was the confounder that significantly affected 6 of 9 studied associations. Intravenous fluids and analgesia significantly affect motility independent of severity and other covariates. Guidelines on prudent use of opioids and fluids in AP need to be developed, particularly taking into account duration of symptoms from onset to hospitalization.

Per oral endoscopic pyloromyotomy for refractory gastroparesis: initial results from a single institution.

Gastroparesis is a debilitating disease characterized by delayed gastric emptying in the absence of mechanical obstruction. A new intramural technique, per oral endoscopic pyloromyotomy (POP), has been proposed as an alternative to surgical pyloroplasty for the management of medical refractory gastroparesis. Herein, we detail the short-term results of POP at our institution. POP was first performed at our institution in January 2016. All patients undergoing POP for management of gastroparesis from January 2016 through January 2017 were prospectively followed. All patients underwent a 4-h, non-extrapolated gastric emptying scintigraphy study and were asked to rate their symptoms using the Gastroparesis Cardinal Symptom Index (GCSI) at their pre-procedure visit and at 3months post-procedure. A total of 47 patients underwent POP during the defined study period. Twenty-seven (57.4%) patients had idiopathic gastroparesis, 12 (25.6%) had diabetic gastroparesis, and eight (17.0%) had post-surgical gastroparesis. Forty-one (87.2%) patients had at least one previous intervention (i.e., enteral feeding tube, gastric pacer, botox injection) for their gastroparesis symptoms. All patients had evidence of gastroparesis on pre-procedure gastric emptying studies. The average length of hospital stay was 1day. One patient died within 30-days of their index procedure which was unrelated to the procedure itself. The average pre-procedure percentage of retained food at 4h was 37% compared to an average post-procedure percentage of 20% (p<0.03). The average pre-procedure GCSI score was 4.6 compared to an average post-procedure GCSI of 3.3 (p<0.001). POP is a safe and feasible endoscopic intervention for medical refractory gastroparesis. Additional follow-up is required to determine the long-term success of this approach in alleviating gastroparesis symptoms.

The Association Between Fasting C-peptide and Gastrointestinal Symptoms of Gastroparesis in Type 2 Diabetic Patients.

Background/AimsThe relationship between C-peptide levels and gastrointestinal (GI) symptoms in type 2 diabetic patients is not clear. The purpose of this study is to examine the association between fasting C-peptide and GI symptoms of gastroparesis in type 2 diabetic patients.MethodsWe recruited 333 type 2 diabetic patients into the present study. All patients filled out questionnaires of gastroparesis cardinal symptom index (GCSI) to evaluate GI symptoms. Hospital anxiety and depression scale were adopted to define anxiety and depression. Patients with GCSI scores ≥ 1.9 were regarded as having symptoms of gastroparesis.ResultsIn our study, 71 (21.3%) type 2 diabetic patients had GCSI scores ≥ 1.9. In comparison to patients with scores < 1.9, those with scores ≥ 1.9 had significantly lower fasting c-peptide levels (1.49 ng/mL vs 1.94 ng/mL, P < 0.001), higher prevalence of depression (40.9% vs 18.3%, P < 0.001) and anxiety (28.2% vs 13.0%, P = 0.002). Multivariate logistic regression revealed that fasting C-peptide was still significantly associated with symptoms of gastroparesis (odds ratio, 0.67; 95% confidence intervals, 0.48–0.94; P = 0.021), even after adjustments for age, sex, body mass index, HbA1c, current smoking and drinking status, anxiety, and depression. Furthermore, linear regressions showed that fasting C-peptide was independently and negatively related to GCSI scores (standardized regression coefficient, −0.29; P < 0.001) in patients with at least one GI symptom.ConclusionGI symptoms of diabetic gastroparesis affect approximately 20% of type 2 diabetes patients and are associated with lower fasting C-peptide levels independent of depression and anxiety status.

Electroacupuncture combined with mosapride alleviates symptoms in diabetic patients with gastroparesis.

The present study compared the clinical effectiveness of electroacupuncture (EA), monotherapy and combination therapy involving the administration of EA and mosapride in diabetic patients with severe or mild symptoms suggestive of gastroparesis. A total of 56 patients with type 2 diabetes who had symptoms suggestive of gastroparesis for >3 months were divided into two groups according to the Gastroparesis Cardinal Symptom Index (GCSI) score, including 33 in the mild group (GCSI score <3.5) and 23 in the severe group (GCSI score ≥3.5). Initially, all patients received EA monotherapy for 14 days. An effective response was defined as a reduction of the overall baseline GCSI score by >25% after treatment. The non-responding patients then received a combination treatment with EA and mosapride. Gastric emptying was assessed by the 13C-octanoic acid breath test at the beginning and end of each treatment session. Two patients in the severe group dropped out of the study during the initial treatment session. The results revealed that 34 early-responding patients (30 from the mild group and 4 from the severe group) treated with EA monotherapy, and 20 non-early-responding patients receiving combination therapy with EA and mosapride showed clinically significant improvements. Analysis of data from the mild subgroup demonstrated that EA treatment specifically improved symptoms of nausea, vomiting, stomach fullness, excessive fullness and bloating. There was no statistically significant difference in the gastric half-emptying time among patients prior to and after EA monotherapy. These preliminary results suggested that EA may be an option for improving mild symptoms in patients with diabetic gastroparesis, whereas combination therapy involving EA and pharmaceutics is required in patients with severe symptoms.

Abdominal paracentesis drainage improves tolerance of enteral nutrition in acute pancreatitis: a randomized controlled trial

Objective: The objective of this study is to determine whether abdominal paracentesis drainage (APD) could improve the administration of enteral nutrition (EN) in acute pancreatitis.Methods: Between January 2015 and April 2016, a total of 161 acute pancreatitis patients were enrolled and randomly assigned to either the APD group or the non-APD group. Several indexes associated with the administration of EN, including the gastroparesis cardinal symptom index (GCSI), the incidence of gastrointestinal adverse events, and the clinical outcomes, were recorded.Results: The mean GCSI scores were 13.6 ± 2.1 before randomization and 7.1 ± 2.3 after a week in the APD group. These scores were 13.9 ± 2.4 and 9.7 ± 1.9 in the non-APD group. The incidences of gastrointestinal adverse events in the two groups were similar (p > .05), except for diarrhea. However, the patients in the APD group spent less time achieving the nutrition target (25 per kilogram of body weight per day) and fully tolerated the oral diet (p < .05). Additionally, the clinical outcomes of the APD group were better compared with those of the non-APD group.Conclusion: APD can improve the administration of EN in acute pancreatitis. Given the positive effect of EN on clinical outcomes, this phenomenon possibly explains why APD could improve the clinical outcomes of acute pancreatitis patients in some aspects.

Nomogram for predicting oral feeding intolerance in patients with acute pancreatitis

ObjectivesOral feeding intolerance (OFI) is a common complication of acute pancreatitis that leads to prolonged hospitalization, increased use of hospital resources, and impaired quality of life. However, there are no clinically useful predictors of OFI. The aims of this study were to determine whether gastrointestinal dysmotility is associated with the development of OFI, and whether the gastroparesis cardinal symptom index (GCSI) can be used as a predictive tool in a clinical setting. MethodsThis was a prospective cohort study. The primary outcome was the development of OFI. Daily GCSI total score and subscores (nausea/vomiting, early satiety, and bloating) were recorded. Univariate and multivariate binary logistic regression analyses were conducted, adjusting for age, etiology of pancreatitis, severity, diabetes status, and time from symptom onset to hospital admission. ResultsThe study included 217 consecutive adult patients with acute pancreatitis. Multivariate analyses showed significant associations between OFI occurrence and the total GCSI score on day 2 of hospital admission (odds ratio [OR], 1.42; 95% confidence interval [CI], 1.02–2.00), the highest total GCSI score (OR, 1.38; 95% CI, 1.03–1.86), the day 2 nausea/vomiting subscore (OR, 1.40; 95% CI, 1.04–1.89), the day 2 bloating subscore (OR, 1.25; 95% CI, 1.01–1.54), and the highest bloating subscore (OR, 1.32; 95% CI, 1.08–1.63). ConclusionsGastrointestinal dysmotility is associated with the development of OFI and the GCSI has potential as a clinically useful predictive tool in the setting of acute pancreatitis. The developed nomogram holds promise but needs to be validated externally.

Effect of Nasogastric Tube Feeding vs Nil per Os on Dysmotility in Acute Pancreatitis: Results of a Randomized Controlled Trial.

Evidence from animal studies suggests that gastrointestinal motility is impaired in acute pancreatitis. Enteral nutrition, and more specifically nasogastric tube feeding, has emerged as a key treatment modality in patients with acute pancreatitis, but its effect on motility has not been investigated in this setting. The aim was to validate the Gastroparesis Cardinal Symptom Index (GCSI) in patients with acute pancreatitis and determine the effect of nasogastric tube feeding on GCSI. The study design was a randomized controlled trial. Patients were allocated to nasogastric tube feeding or nil per os within 24 hours of hospital admission. GCSI data from before randomization to 72 hours after randomization were analyzed. The test-retest reliability analysis was used to calculate Cronbach's α. Seventeen patients were randomized to nasogastric tube feeding and 18 to nil per os. Overall, the total GCSI score significantly decreased over the study (F = 8.537; P = .001) but was not significantly different between the 2 study groups during hospitalization (F = 1.159; P = .322). However, patients on nasogastric tube feeding did show improved appetite compared with nil per os (F = 3.526; P = .036). The GCSI was found to be a reliable tool in the setting of acute pancreatitis (Cronbach's α = 0.852). Nasogastric tube feeding does not appear to affect dysmotility symptoms in acute pancreatitis as measured by the GCSI, although appetite improved. Use of the simple, noninvasive, and inexpensive GCSI tool to evaluate motility is recommended in future clinical trials in pancreatology.

Outcomes and Factors Associated With Reduced Symptoms in Patients With Gastroparesis

Gastroparesis is a chronic clinical syndrome characterized by delayed gastric emptying. However, little is known about patient outcomes or factors associated with reduction of symptoms. We studied adult patients with gastroparesis (of diabetic or idiopathic type) enrolled in the National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium Gastroparesis Registry, seen every 16 weeks and treated according to the standard of care with prescribed medications or other therapies at 7 tertiary care centers. Characteristics associated with reduced symptoms, based on a decrease of 1 or more in the gastroparesis cardinal symptom index (GCSI) score after 48 weeks of care, were determined from logistic regression models. Data were collected from patients for up to 4 years (median, 2.1 y). Of 262 patients, 28% had reductions in GCSI scores of 1 or more at 48 weeks. However, there were no significant reductions in GCSI score from weeks 48 through 192. Factors independently associated with reduced symptoms at 48 weeks included male sex, age 50 years and older, initial infectious prodrome, antidepressant use, and 4-hour gastric retention greater than 20%. Factors associated with no reduction in symptoms included overweight or obesity, a history of smoking, use of pain modulators, moderate to severe abdominal pain, a severe gastroesophageal reflex, and moderate to severe depression. Over a median follow-up period of 2.1 years, 28% of patients treated for gastroparesis at centers of expertise had reductions in GCSI scores of 1 or greater, regardless of diabetes. These findings indicate the chronic nature of gastroparesis. We identified factors associated with reduced symptoms that might be used to guide treatment. ClinicalTrials.gov no: NCT00398801.

OC-069 Non-invasive afferent vagus nerve stimulation (nvns) using gammacore (gc) in patients with treatment refractory gastroparesis awaiting enterra gastric neurostimulation

Introduction High frequency, low energy gastric neurostimulation (EnterraTM) is indicated for compassionate treatment of patients with refractory gastroparesis. Symptom improvement is reported in 50–60% of patients but not accompanied by improved gastric emptying. It is likely that gastric neurostimulation affects the gut-brain axis influencing autonomic afferents.1GammaCore (electroCore, LLC) is a non-invasive, afferent selective vagus nerve stimulator (nVNS) used for the treatment of migraine and cluster headache.2We report the first use of gammaCore (gC) in patients with refractory gastroparesis. Method 35 consecutive patients with intractable gastroparesis were invited to undergo a course of gC whilst awaiting funding for Enterra. The gC device delivers its stimulus to afferent vagus fibres as they cross the neck adjacent to the carotid arteries and it is programmed to deliver doses of 120 s. Patients were trained to deliver 2 doses (240 secs) to the left and right vagus nerve respectively. This dosing regimen was self-administered 8 hly (12 doses/day) for 2 weeks, increasing in week 3 to 3 doses 8 hly (18 doses/day). Patients were asked to grade their symptoms daily using the 9 item Gastroparesis Cardinal Symptom Index (GCSI) with a 5 point Likert scale. The GCSI was completed for 2 weeks prior and throughout the treatment period. At the end of the treatment period, the mean aggregated GSCI score at baseline was compared with the score of the final week of treatment. Clinically meaningful improvement was defined as a GCSI Likert scale reduction of ≥1. Results Twenty-three of the 35 patients (65.7%) used the gC as instructed and completed the diary. At 3 weeks, 8 patients (35%) had a ≥1 reduction in the aggregated GSCI score. Two patients who continued stimulation for more than three weeks had a delayed response, giving a total response rate of 43%. The response was evident within 1 week of commencing treatment in 8/10 responders (80%) and there was symptom recurrence within a week of stopping treatment in all the responders. There were no significant adverse events. Conclusion In this group of patients with treatment refractory gastroparesis, 1/3 failed to engage with short term nVNS. In compliant patients,43% recorded a fall of ≥1 in their aggregated GCSI score. As gC stimulates afferent vagus fibres, it is likely that the response is mediated at the level of the gut-brain axis. In refractory gastroparesis, gC might offer a new approach to symptom control. The dosing and duration of nVNS required to obtain an optimal response deserves further consideration. Disclosure of interest None Declared. References McCallum RW, et al. Neurogastroenterol Motil. 2010;22(2):161–7 Goadsby P, et al. Cephalgia 2014;34(12):986–93

PTU-174 Can gastroparesis cardinal symptom index (GCSI) sub-scores and total score predict delayed gastric emptying?

Introduction The Gastroparesis Cardinal Symptom Index (GCSI) is a validated tool for monitoring treatment induced changes in the symptoms of gastroparesis. For diagnosis, a gastric emptying scintigraphy (GES) study must be done to demonstrate the delayed gastric emptying (DGE) that separates gastroparesis from its functional differentials. Previous studies noted associations between GES results and GCSI values but these were not sufficiently predictive to allow reliable diagnosis. This study aimed to corroborate these findings. If GCSI could be proved to be predictive of DGE, it may allow for less GES studies, especially as part of follow up, resulting in reduced costs and less radiation exposure for the patient. Method Forty one patients with symptoms suggestive of gastroparesis were identified at clinic. Patients filled out the GCSI questionnaire and underwent a GES study as part of standard investigation of their symptoms. Linear regressions were used to identify if the GCSI sub-scores or the total GCSI score were predictive of% gastric retention across all imaging times. Mann-Whitney U tests were used to identify any significant differences between the distributions of the GCSI components in those with DGE and those without. Both tests were done for the whole population, then for the three main aetiologies (idiopathic, diabetes mellitus, post-surgical). Results For the whole population, regression analysis identified three components as positive predictors at 2 hrs (total GCSI score, post-prandial fullness and bloating sub-scores). The R2values were all ≤0.16 and the only significant Mann-Whitney U test was for the total GCSI score. For idiopathic cases there was only one significant positive predictor, again at 2 hrs (total GCSI score, R2= 0.244). There were significant differences in the distributions of the average score and the nausea and vomiting sub-score. Post-operative cases had five significant negative predictors: nausea and vomiting sub-score (R2= 0.389) at ½ hr; nausea and vomiting sub-score (R2= 0.547), total GCSI score (R2= 0.428), bloating sub-score (R2= 0.364) at 1 hr; nausea and vomiting sub-score at 4 hrs (R2= 0.468). All of these components had associated significant Mann-Whitney U tests. There were no significant Mann-Whitney U tests in the diabetic cohort, but there were three significant positive predictors: bloating sub-score at 1 hr (R2= 0.577) and 2 hrs (R2= 0.590), post-prandial fullness sub-score at 2 hrs (R2= 0.612). Conclusion All GCSI components studied were associated with significant linear regression findings but their individual predictive power tends to be poor. Thus, it is unlikely the GCSI components in isolation would be clinically useful as diagnostic predictors of gastroparesis. This concurs with the conclusions of previous studies in this field. Disclosure of interest None Declared.

The short-term effects of acupuncture on patients with diabetic gastroparesis: a randomised crossover study.

Acupuncture may improve gastrointestinal symptoms in patients with various disorders, but its efficacy in diabetic gastroparesis is unclear. To evaluate the short-term effects of acupuncture on gastric emptying and gastroparesis symptoms in patients with diabetic gastroparesis. In a single-blind controlled crossover trial, 25 patients with diabetic gastroparesis were randomly assigned to undergo 1 week of real acupuncture (RA) treatment followed by 1 week of sham acupuncture (SA) treatment, or vice versa, with a washout of 1 month in between. Before and after each intervention, gastric retention, the Gastroparesis Cardinal Symptom Index (GCSI), fasting blood glucose (FBG) and HbA1c levels were measured. 21 patients completed the study. Compared with SA treatment, RA treatment was associated with significantly greater reductions in gastric retention at 2 h (-11.1±7.0%; 95% CI -13.6% to -6.2%; p<0.01) and at 4 h (-5.0±2.8%; 95% CI -6.0% to -0.2%; p=0.04) and in GCSI score (-8.0±3.4; 95% CI -8.4 to -2.8; p<0.01). There were no significant differences in FBG and HbA1c levels between RA and SA treatments. In patients with diabetic gastroparesis, 1 week of short-term manual acupuncture reduces gastric retention and improves gastroparesis symptoms.

Su1427 Gastric Electrical Stimulation of the Antrum Evokes Compound Cervical Vagal Nerve Action Potentials in Rodents

Purpose: Patients with diabetic or idiopathic gastroparesis have delayed gastric emptying (GE) time. Velusetrag (VEL) is an oral, once-daily, investigational, highly-selective 5-HT4 agonist that has demonstrated prokinetic effects in the lower gastrointestinal tract in subjects with chronic idiopathic constipation. The current study evaluated VEL prokinetic effects in the upper gastrointestinal tract by assessing GE time in both diabetic and idiopathic gastroparesis subjects. Methods: Subjects with gastroparesis were screened for increased GE time (t1/2 > 160 mins), symptoms consistent with gastroparesis for ≥3 months, Gastroparesis Cardinal Symptom Index score between 2-4 inclusive, and HbA1c < 10% (diabetics). Subjects were randomized in an incomplete block, 3-period, cross-over design to 3 of 4 treatments, VEL 5-, 15and 30-mg and placebo stratified for diabetic or idiopathic gastroparesis. In all 3 treatment periods, subjects performed a 6-hr 13C-octanoate breath test of GE time on Day -1 (baseline) and after the 7th dose. Efficacy was assessed by the change from baseline in GE t1/2. All efficacy endpoints were evaluated using mixed-effect models with a covariate for baseline GE. Results: 34 subjects were randomized; n=26 (placebo), 26 (VEL 5-mg), 25 (VEL 15-mg), and 25 (VEL 30-mg). The study populationwas 68% female, 82%Caucasian, and 53% diabetic, with mean (SD) age of 46 (10.3) yrs and baseline GE t1/2 mean (SD) [range]: 206 min (91.1) [107-640]. The proportion of subjects with at least a 20% reduction in GE t1/2 was 5% for placebo and 26%, 20%, 52% for VEL 5-, 15-, and 30-mg respectively. Statistical significance was observed in the 30-mg dose group (p=0.002). The mean (SD) change from baseline of GE t1/2 was -13 (14.9) mins for placebo and -35 (14.6), -34 (15.5), and -52 (15.2) mins for VEL 5-, 15-, and 30-mg, respectively. Similar treatment effects were observed with VEL in both diabetic and idiopathic subjects. A pre-specified analysis of subjects with delayed GE time at baseline (GE between 180-350 mins excluding relatively normal and extremely abnormal GE times) revealed a placebo-adjusted mean (SD) reduction [% improvement] from baseline in VEL-treated subjects of -76 (41.9) [-33%], -73 (50.4) [28%] and -85 (40.9) [-37%] mins for VEL 5-, 15and 30-mg, respectively. All doses of VEL were generally well tolerated. The most common adverse events were diarrhea (n=16) and headache (n=6). No on-treatment serious adverse events were observed. Conclusions: Velusetrag treatment was generally well tolerated and resulted in a statistically significant improvement in GE time at the 30 mg dose in subjects with diabetic or idiopathic gastroparesis. Future studies will assess the translation of these pharmacodynamics effects into symptomatic improvement.

Upper gastrointestinal symptoms in medical professionals: a higher burden?

Gastroesophageal reflux disease (GERD) and dyspepsia cause significant healthcare resource utilization and greatly affect quality of life; therefore, a tendency exists to self-treat in lieu of formal diagnosis. Although their prevalence is established in the general population, their prevalence in physicians remains unknown. Our aim was to estimate the prevalence of GERD and dyspepsia symptoms in a sample of medical professionals by level of training. An anonymous, computer-based questionnaire was distributed to medical students, residents/fellows, and attending physicians at our institution. The survey included symptom-based questions for GERD (Reflux Disease Questionnaire); quality-of-life questionnaire for dyspepsia (Nepean Dyspepsia Index [NDI]), and the Gastroparesis Cardinal Symptom Index (GCSI). We calculated scores based on the validated system from each questionnaire and used appropriate statistical analysis to evaluate associations between symptomatology and training level (medical students, residents/fellows, and attending physicians). Overall, there were 327 respondents (155 medical students, 127 residents/fellows, 45 attending physicians), of whom 52% were women, 56% were white non-Hispanic, 19% were Hispanic, and 74% were born in the United States/Canada. A total of 21% reported previously diagnosed GERD/dyspepsia, and 42% reported previously or currently using a medication for GERD/dyspepsia, with significantly higher use of proton pump inhibitors in attending physicians than in medical students and residents/fellows (P < 0.01). Higher median total scores for the NDI (P = 0.01) and GCSI (P < 0.01) in medical students exist compared with residents/fellows and attending physicians, with no significant differences for the Reflux Disease Questionnaire among groups. Although the prevalence of diagnosed GERD/dyspepsia in our sample was comparable to the general population, medication use was higher. Self-treatment with prescription medications increased with training. Median NDI and GCSI scores were inversely related to training level, which may reflect self-treatment in medical professionals with advanced training. Further study of GERD/dyspepsia in medical professionals is warranted.

Upper Gastrointestinal Symptoms in Medical Professionals: A Higher Burden?

Introduction: Gastroesophageal reflux diseases (GERD) and dyspepsia cause significant healthcare resource utilization and greatly impact quality of life (QOL); therefore, a tendency exists to self-treat in lieu of formal diagnosis. While its prevalence is established in the general population, that of GERD and dyspepsia in physicians remains unknown. Our goal was to estimate the prevalence of GERD and dyspepsia symptomatology and disease characteristics in a sample of medical professionals by level of training. Methods: An anonymous, computer-based questionnaire was distributed to medical students (MS), residents/fellows (RES), and attendings (ATT) at our institution. The survey included symptom-based questions for GERD (RDQ: reflux disease questionnaire. Am J Gastroenterol. 2012;107:1354-60); QOL questionnaire for dyspepsia (NDI: nepean dyspepsia index. Aliment Pharmacol Ther. 2001;15:207-16), and GCSI (gastroparesis cardinal symptom index. Aliment Pharmacol Ther. 2003;18:141-50). We calculated scores based on the validated system from each questionnaire, and used appropriate statistical analysis to evaluate associations between symptomatology and training level (MS, RES, ATT). IRB approval was obtained. Results: Three hundred twenty-seven respondents (155 MS, 127 RES, 45 ATT), 52% women, 56% white non-Hispanic, 19% Hispanic, and 74% U.S./Canadian, participated. Twenty-one percent reported previously diagnosed GERD/dyspepsia, while 42% reported previously or currently using a medication for GERD/dyspepsia, with significantly higher use of PPIs in ATT than MS/RES (p<0.01). Higher median total scores for the NDI (p=0.01) and GCSI (p<0.01) in MS exist compared to RES/ATT, with no significant differences for the RDQ amongst groups (Tables 1-2).TableConclusion: While the prevalence of diagnosed GERD/dyspepsia in our sample was comparable to the general population, medication use was higher. Self-treatment with prescription medications significantly increased with level of training. Median NDI and GCSI scores were inversely related to training level, which may reflect the results of self-treatment in advanced medical professionals. Further study of GERD/dyspepsia in medical professionals is warranted to enable effective diagnosis, improve healthcare resource utilization and their QOL.

Combination of symptoms, syndrome and disease: treatment of refractory diabetic gastroparesis.

To assess effect of combination of symptoms, syndrome and disease on treatment of diabetic gastroparesis with severe nausea and vomiting. Professor Tong Xiaolin's clinical electronic medical records of patients who were treated between January 1, 2006 and October 1, 2012 were used as a database. Patients who met the inclusion criteria were enrolled. General information (name, sex and age), symptoms and blood glucose levels were obtained from the clinic electronic medical record, which was supplemented by a telephone interview. The patient-rated Gastroparesis Cardinal Symptom Index (GCSI) was used to evaluate the severity of the symptoms of gastroparesis. The effects of the treatment were assessed by the change in the severity of the symptoms of gastroparesis and the change in blood glucose between the baseline levels and the post-treatment levels at 1, 2, 4, 8 and 12 wk. Forty-five patients had a mean GCSI nausea and vomiting severity score of 4.21 ± 0.67 and a total GCSI score of 2.77 ± 0.63 before treatment. There was a significant improvement in the nausea and vomiting score at every return visit compared with the baseline score (1 wk: 3.02 ± 1.04 vs 4.18 ± 0.71, P < 0.001; 2 wk: 2.32 ± 1.25 vs 4.16 ± 0.73, P < 0.001; 4 wk: 2.12 ± 1.26 vs 4.12 ± 0.73, P < 0.001; 8 wk: 1.79 ± 1.09 vs 4.24 ± 0.77, P < 0.001; 12 wk: 0.69 ± 0.92 vs 4.25 ± 0.70, P < 0.001). Twenty-five of the 45 patients had complete resolution of vomiting during the observation period (mean time to resolution was 37.9 ± 27.3 d). The postprandial fullness and early satiety subscale, bloating subscale and total GCSI scores were also improved. Finally, the blood glucose levels improved after treatment, although the change was not significant. Use of the combination of symptoms, syndrome and disease to treat diabetic gastroparesis with refractory nausea and vomiting may be a new treatment option.

Effect of Nortriptyline on Symptoms of Idiopathic Gastroparesis

Gastroparesis remains a challenging syndrome to manage, with few effective treatments and a lack of rigorously controlled trials. Tricyclic antidepressants are often used to treat refractory symptoms of nausea, vomiting, and abdominal pain. Evidence from well-designed studies for this use is lacking. To determine whether treatment with nortriptyline results in symptomatic improvement in patients with idiopathic gastroparesis. The NORIG (Nortriptyline for Idiopathic Gastroparesis) trial, a 15-week multicenter, parallel-group, placebo-controlled, double-masked, randomized clinical trial from the National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium (GpCRC), comparing nortriptyline with placebo for symptomatic relief in idiopathic gastroparesis. One hundred thirty patients with idiopathic gastroparesis were enrolled between March 2009 and June 2012 at 7 US academic medical centers. Patient follow-up was completed in October 2012. Inclusion criteria included delayed gastric emptying and moderate to severe symptom scores using the Gastroparesis Cardinal Symptom Index (GCSI). INTERVENTIONS Nortriptyline vs placebo. Study drug dose was increased at 3-week intervals (10, 25, 50, 75 mg) up to 75 mg at 12 weeks. The primary outcome measure of symptomatic improvement was a decrease from the patient's baseline GCSI score of at least 50% on 2 consecutive 3-week GCSI assessments during 15 weeks of treatment. The primary symptomatic improvement outcome did not differ between 65 patients randomized to nortriptyline vs 65 patients randomized to placebo: 15 (23% [95% CI, 14%-35%]) in the nortriptyline group vs 14 (21% [95% CI, 12%-34%]) in the placebo group (P = .86). Treatment was stopped more often in the nortriptyline group (19 [29% {95% CI, 19%-42%}]) than in the placebo group (6 [9%] {95% CI, 3%-19%}]) (P = .007), but numbers of adverse events were not different (27 [95% CI, 18-39] vs 28 [95% CI, 19-40]) (P = .89). Among patients with idiopathic gastroparesis, the use of nortriptyline compared with placebo for 15 weeks did not result in improvement in overall symptoms. These findings do not support the use of nortriptyline for idiopathic gastroparesis. clinicaltrials.gov Identifier: NCT00765895.