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Granisetron transdermal system (GTS; Sancuso®), a patch delivering a 5-HT3 receptor antagonist, has been shown to improve nausea and vomiting in gastroparesis. Recent FDA guidance on gastroparesis suggests daily scoring of symptoms to show efficacy. Aim: Determine the efficacy and onset of therapeutic response of GTS in improving specific symptoms and overall symptoms of gastroparesis in patients with gastroparesis using a daily symptom diary for gastroparesis. Methods: Symptomatic patients with diabetic or idiopathic gastroparesis with nausea and/or vomiting were enrolled. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) captured severity of symptoms at baseline for one week and during two weeks of treatment with GTS. Key Results: 14 patients (age 41.5±17 years; 13 females) with refractory gastroparesis (5 idiopathic, 9 diabetic) participated in this open label study. Nausea, early satiety, postprandial fullness, abdominal pain, GCSI-DD composite score, and overall symptom severity significantly improved (p

Gastric electric stimulation (GES) is used to treat patients with refractory gastroparesis symptoms. However, the effectiveness of GES in clinical practice and the effect of GES on specific symptoms of gastroparesis are not well delineated. To determine the effectiveness of GES for treatment for refractory symptoms of gastroparesis, the improvement in specific symptoms of gastroparesis, and clinical factors impacting on outcome. Enterra GES was used to treat refractory gastroparesis symptoms. Patients filled out a symptom severity questionnaire (PAGI-SYM) prior to insertion. At each follow-up visit, the patient filled out PAGI-SYM and assessed their therapeutic response using the Clinical Patient Grading Assessment Scale (CPGAS). One hundred and fifty-one patients (120 females) with refractory gastroparesis (72 diabetic, 73 idiopathic, 6 other) underwent GES. Of the 138 with follow-up (1.4 ± 1.0 years), the average CPGAS was 2.4 ± 0.3 (SEM): 104 patients (75 %) improved (CPGAS > 0) and 34 (25 %) did not (CPGAS ≤ 0). Sixty patients (43 %) were at least moderately improved (CPGAS score ≥4). Clinical improvement was seen in both diabetic and idiopathic patients with the CPGAS in diabetic patients (3.5 ± 0.3) higher in idiopathic patients (1.5 ± 0.5; p

Common symptoms of gastroparesis include nausea, vomiting, early satiety, postprandial fullness, and upper abdominal pain. Domperidone is used for treatment of gastroparesis. Daily symptom scoring may help document efficacy. Aim To determine the effectiveness of domperidone for gastroparesis symptoms using the gastroparesis cardinal symptom index-daily diary (GCSI-DD) and to determine which symptoms improve and when with domperidone treatment. Methods Symptomatic patients with diabetic or idiopathic gastroparesis were enrolled. Gastric emptying was performed using 4 hour scintigraphy. GCSI-DD recorded symptoms at baseline and during six weeks of treatment with domperidone 10 mg TID. GCSI-DD records severity of nausea, early satiety, postprandial fullness, upper abdominal pain, overall gastroparesis symptoms on a scale of 0 (no symptom) to 4 (very severe) and records the number of vomiting episodes per day. Results Thirty-four patients with gastroparesis (5 diabetic, 29 idiopathic) participated in this open label study. Treatment duration averaged 36.9 ± 7.6 days. Improvement in overall gastroparesis symptoms occurred on day 3 of treatment and maintained during the treatment. Early satiety, postprandial fullness, and overall symptom severity significantly improved from baseline to the final week of treatment (P

Background The aims of this study were to describe the histology in gastroparesis, specifically to relate histopathology to etiology of gastroparesis (idiopathic and diabetic gastroparesis), gastric emptying, and clinical response to gastric electric stimulation. Methods Full thickness gastric body sections obtained during insertion of gastric stimulator in gastroparetics were stained with Hematoxylin & Eosin, Masson Trichrome and immunohistochemical stains for Neuron-Specific Enolase and c-Kit. Key Results In all, 145 gastroparetics (71 diabetics, 71 idiopathic, 2 post-surgical, and 1 chronic intestinal pseudo-obstruction) had full thickness gastric body biopsies. A lymphocytic infiltrate was seen in the intermyenteric plexus in 22 diabetic and 23 idiopathic gastroparesis patients. Fibrosis was present in the inner circular layer in 13 diabetic and 15 idiopathics and in the outer longitudinal layer in 46 diabetic and 51 idiopathics. Diabetic gastroparesis had less ganglion cells (3.27±1.82 vs 4.81±2.81/hpf; P

Treatment of gastroparesis (GP) often requires long-term adherence to dietary modifications and medications. Patient beliefs on internal (self) and external (others) control of their health and patient empowerment (self activation) have been shown in other chronic diseases to impact disease presentation and outcome. AIMS: 1) Compare health locus of control and patient activation in patients with diabetic (DG) and idiopathic (IG) gastroparesis; and 2) Compare health locus of control and patient activation measure in patients with delayed gastric emptying to patients with similar symptoms but normal gastric emptying.METHODS: This prospective study evaluated patients from June 2014 to October 2014 referred for refractory symptoms of gastroparesis. Patients completed Patient Assessment of Upper GI Symptoms (PAGI-SYM), Multidimensional Health Locus of Control (MHLOC), and Patient Activation Measure (PAM-13). MHLOC measures three localizations of health control: "internality" (belief that health status depends only on personal decision and behaviors); "chance externality" (belief that health status is determined by chance, fate or luck), and "powerful others externality" (conviction that health depends on powerful people such as doctors, family members or close friends). RESULTS: 40 patients with refractory gastroparesis symptoms were evaluated. Of the 31 patients with delayed GES, 8 were diabetic and 19 idiopathic. Patient activation scores were similar between normal GES vs delayed GES (61.1±14.9 [SD] vs 57.9±12.1) and DG vs IG (58.6±12.7 vs 58.4±12) (Table 1). These activation scores translate to patient's beginning to take action to self-manage their own disease (Level 3). Abdominal pain was negatively correlated to PAM scores in patients with delayed gastric emptying (r=-0.30; p=0.09). When evaluating localization of health control, "powerful others externality" was higher in patients with delayed GES compared to normal emptying (3.4±0.9 vs 2.9±0.7; p=0.16) and DG compared to IG (3.9±0.9 vs 3.2±0.9; p= 0.11) (Table 2). The other localizations such as "internality" and "chance externality" were similar when comparing patients with normal GES to delayed GES and DG to IG. DISCUSSION: This study investigates the role of internal and external control and patient activation in patients with gastroparesis. Our study suggests higher abdominal pain severity scores were related to lower activation levels. Furthermore, patients with delayed gastric emptying tend to have higher scores for "powerful others externality" compared to patients with normal gastric emptying. Within the subset of GP, patients with DG had higher scores for "powerful others externality". These results suggest a reliance of patients with gastroparesis, especially diabetic patients and those with abdominal pain, on "powerful others" (including physicians), rather than themselves. Table 1. Patient Activation Measure in patients with normal GES vs delayed GES and diabetic GP vs idiopathic GP