Factors that contribute to the impairment of quality of life in gastroparesis.

BACKGROUND: Understanding factors that impair quality of life (QOL) in gastroparesis is important for clinical management. AIMS: (a) Determine QOL in patients with gastroparesis; (b) Determine factors that impair QOL. METHODS: Gastroparetic patientsAQ6 underwent history and questionnaires assessing symptoms (PAGI-SYM and Rome III), QOL (SF-36v2 and PAGI-QOL), depression (Beck Depression Inventory [BDI]), and anxiety (State Trait Anxiety InventoryAQ7). KEY RESULTS: 715 gastroparesis patients (256 diabetic (DG), 459 idiopathic (IG)) were evaluated. SF-36 physical component (PC) score averaged 33.3 ± 10.5; 41% had impaired score <30. SF-36 PC scores were similar between diabetic and idiopathic gastroparesis. Impaired SF-36 PC associated with increased nausea/vomiting and upper abdominal pain subscores, acute onset of symptoms, higher number of comorbidities, use of narcotic pain medications, and irritable bowel syndrome (IBS). SF-36 mental component (MC) score averaged 38.9 ± 13.0; 26% had impaired score <30. Poor SF-36 MC associated with diabetic etiology, higher Beck depression inventory, and state anxiety scores. PAGI-QOL score averaged 2.6 ± 1.1; 50% had a score of <2.6. Low PAGI-QOL associated with higher fullness, bloating, and upper abdominal pain subscores, more depression and Trait anxiety, smoking cigarettes, need for nutritional support, progressively worsening symptoms and periodic exacerbations. CONCLUSIONS & INFERENCES: Multiple measures show poor QOL present in gastroparesis. Several areas impacted on reduced QOL: (a) Symptoms of nausea, vomiting, and abdominal pain, as well as IBS; (b) Etiology and acute onset and progressively worsening symptoms; (c) Comorbidities and psychological factors such as anxiety and depression; (d) Patient-related factors such as smoking. Targeting the modifiable factors may improve patient outcomes in gastroparesis.

Pathophysiology, Aetiology and Treatment of Gastroparesis.

Gastroparesis is characterized by delayed gastric emptying, with symptoms such as nausea, vomiting and abdominal pain, in the absence of mechanical obstruction. In most cases, it is idiopathic although diabetes mellitus is another leading cause. The physiology of gastric emptying is a complex process which is influenced by various inputs including the central nervous system, enteric nervous system and gut hormones. Developments in our understanding of gastroparesis have now demonstrated dysfunction in these systems, thus disrupting normal gastric emptying. Once mechanical obstruction is excluded, gastric scintigraphy remains the gold standard for diagnosis although wireless motility capsule and breath testing are alternative methods for diagnosis. Treatment for gastroparesis is challenging, and widely available therapies are often limited either by their poor evidence for efficacy or concerns over their long-term safety profile. Novel prokinetic agents have shown initial promise in clinical trials, and new endoscopic techniques such as gastric per-oral endoscopic myotomy are emerging. These new treatment modalities may provide an option in refractory gastroparesis with the adage of reduced morbidity compared to surgical treatments.

Marijuana Use in Patients with Symptoms of Gastroparesis: Prevalence, Patient Characteristics, and Perceived Benefit.

BACKGROUND: Marijuana may be used by some patients with gastroparesis (Gp) for its potential antiemetic, orexigenic, and pain-relieving effects. AIMS: The aim of this study was to describe the use of marijuana by patients for symptoms of Gp, assessing prevalence of use, patient characteristics, and patients' perceived benefit on their symptoms of Gp. METHODS: Patients with symptoms of Gp underwent history and physical examination, gastric emptying scintigraphy, and questionnaires assessing symptoms. Patients were asked about the current use of medications and alternative medications including marijuana. RESULTS: Fifty-nine of 506 (11.7%) patients with symptoms of Gp reported current marijuana use, being similar among patients with delayed and normal gastric emptying and similar in idiopathic and diabetic patients. Patients using marijuana were younger, more often current tobacco smokers, less likely to be a college graduate, married or have income > $50,000. Patients using marijuana had higher nausea/vomiting subscore (2.7 vs 2.1; p = 0.002), higher upper abdominal pain subscore (3.5 vs 2.9; p = 0.003), more likely to be using promethazine (37 vs 25%; p = 0.05) and dronabinol (17 vs 3%; p < 0.0001). Of patients using marijuana, 51% had been using it for more than 2 years, 47% were using this once or more per day, and 81% of marijuana users rated their benefit from marijuana as better or much better. CONCLUSIONS: A subset of patients (12%) with symptoms of Gp use marijuana. Patients with severe nausea and abdominal pain were more likely to use marijuana and perceive it to be beneficial for their symptoms. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01696747.

Gastroparesis syndromes: Response to electrical stimulation.

BACKGROUND AND AIMS: Factors underlying gastroparesis are not well defined, nor is the mechanism of action of gastric electrical stimulation (GES). We hypothesized that GES acts via several mechanisms related to underlying disordered pathophysiology. METHODS: We studied 43 consecutive eligible patients with gastroparetic symptoms, previously evaluated by two methods in each of five core areas: inflammatory, autonomic, enteric, electrophysiologic, and hormonal; and also categorized by GI symptoms, metabolic status, illness quantification, and gastric physiology. We then studied 41 patients who underwent temporary GES for 5-7 days. Thirty-six of those patients were implanted and 30 were followed up at 6 months after permanent GES. RESULTS: In previous but separately reported work, patients had similar GI symptoms regardless of baseline gastric emptying or diabetic/idiopathic status and all patients demonstrated abnormalities in each of the five areas studied. After GES, patients showed early and late effects of electrical stimulation with changes noted in multiple areas, categorized by improvement status. CONCLUSION: Patients with symptoms of gastroparesis have multiple abnormalities, including systemic inflammation and disordered hormonal status. GES affects many of these abnormalities. We conclude electrical stimulation improves symptoms and physiology with (a) an early and sustained anti-emetic effect; (b) an early and durable gastric prokinetic effect in delayed emptying patients; (c) an early anti-arrhythmic effect that continues over time; (d) a late autonomic effect; (e) a late hormonal effect; (f) an early anti-inflammatory effect that persists; and (g) an early and sustained improvement in health-related quality of life. This study is registered with Clinicaltrials.gov under study # NCT03178370 (https://clinicaltrials.gov/ct2/show/NCT03178370).

The willingness of patients with gastroparesis to take risks with medications.

BACKGROUND: Gastroparesis has a significant negative impact on patients' quality of life. Only one medication is approved for gastroparesis and it is associated with a significant risk of side effects. AIM: To assess the willingness of patients to take risks associated with medications to treat gastroparesis symptoms. METHODS: We developed a questionnaire to assess medication risk-taking behaviour in patients identified as having documented gastroparesis (consistent symptoms, normal upper endoscopy, delayed gastric emptying). The survey assessed demographics, symptoms, medication use, anxiety, depression and impulsivity. A standard reference gamble evaluated respondents' willingness to take medication risks. RESULTS: Two hundred seven questionnaires were mailed to patients, 103 questionnaires were completed. Seventy-six percent were female; the mean age was 48 years; average duration of gastroparesis symptoms was 10 years. Self-reported symptom severity was severe in 52% and moderate in 32%. Gastroparesis patients reported that they would accept a median 13.4% risk of sudden death to cure their symptoms using a hypothetical medication. Self-reported gastroparesis symptom severity and Gastroparesis Cardinal Symptom Index scores correlated significantly with increased willingness to take risks associated with medications to treat gastroparesis, while anxiety was negatively associated. CONCLUSIONS: Gastroparesis patients are willing to accept markedly high risks with a hypothetical medication to cure their symptoms. Patients with severe gastroparesis symptoms and higher Gastroparesis Cardinal Symptom Index scores were more willing to take these risks. This study, the first to quantify gastroparesis patients' willingness to accept medication associated risks, should help clinicians through the complex maze of gastroparesis therapies and their associated risks and benefits.

Peroral endoscopic pyloromyotomy is efficacious and safe for refractory gastroparesis: prospective trial with assessment of pyloric function.

BACKGROUND: Gastroparesis is a functional disorder with a variety of symptoms that is characterized by delayed gastric emptying in the absence of mechanical obstruction. A recent series of retrospective studies has demonstrated that peroral endoscopic pyloromyotomy (G-POEM) is a promising endoscopic procedure for treating patients with refractory gastroparesis. The aim of this prospective study was to evaluate the feasibility, safety, and efficacy of G-POEM. METHODS: 20 patients with refractory gastroparesis (10 diabetic and 10 nondiabetic) were prospectively included in the trial. Patients were treated by G-POEM after evaluation of pyloric function using an endoscopic functional luminal imaging probe. Clinical responses were evaluated using the Gastroparesis Cardinal Symptom Index (GCSI), and quality of life was assessed using the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life scale and the Gastrointestinal Quality of Life Index scores. Gastric emptying was measured using 4-hour scintigraphy before G-POEM and at 3 months. RESULTS: Feasibility of the procedure was 100 %. Compared with baseline values, G-POEM significantly improved symptoms (GCSI: 1.3 vs. 3.5; P < 0.001), quality of life, and gastric emptying (T½: 100 vs. 345 minutes, P < 0.001; %H2: 56.0 % vs. 81.5 %, P < 0.001; %H4: 15.0 % vs. 57.5 %, P = 0.003) at 3 months. The clinical success of G-POEM using the functional imaging probe inflated to 50 mL had specificity of 100 % and sensitivity of 72.2 % (P = 0.04; 95 % confidence interval 0.51 - 0.94; area under the curve 0.72) at a distensibility threshold of 9.2 mm2/mmHg. CONCLUSION: G-POEM was efficacious and safe for treating refractory gastroparesis, especially in patients with low pyloric distensibility.

Opioid Use and Potency Are Associated With Clinical Features, Quality of Life, and Use of Resources in Patients With Gastroparesis.

BACKGROUND & AIMS: Many patients with gastroparesis are prescribed opioids for pain control, but indications for opioid prescriptions and the relationship of opioid use to gastroparesis manifestations are undefined. We characterized associations of use of potent vs weaker opioids and presentations of diabetic and idiopathic gastroparesis. METHODS: We collected data on symptoms, gastric emptying, quality of life, and health care resource use from 583 patients with gastroparesis (>10% 4-h scintigraphic retention) from the National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Consortium, from January 2007 through November 2016. Patients completed medical questionnaires that included questions about opioid use. The opioid(s) were categorized for potency relative to oral morphine. Symptom severities were quantified by Patient Assessment of Upper Gastrointestinal Disorders Symptoms questionnaires. Subgroup analyses compared patients on potent vs weaker opioids and opioid effects in diabetic vs idiopathic etiologies. RESULTS: Forty-one percent of patients were taking opioids; 82% of these took potent agents (morphine, hydrocodone, oxycodone, methadone, hydromorphone, buprenorphine, or fentanyl). Abdominal pain was the reason for prescription for 61% of patients taking opioids. Mean scores for gastroparesis, nausea/vomiting, bloating/distention, abdominal pain, and constipation scores were higher in opioid users (P ≤ .05). Opioid use was associated with greater levels of gastric retention, worse quality of life, increased hospitalization, and increased use of antiemetic and pain modulator medications compared with nonusers (P ≤ .03). Use of potent opioids was associated with worse gastroparesis, nausea/vomiting, upper abdominal pain, and quality-of-life scores, and more hospitalizations compared with weaker opioids (tapentadol, tramadol, codeine, or propoxyphene) (P ≤ .05). Opioid use was associated with larger increases in gastric retention in patients with idiopathic vs diabetic gastroparesis (P = .008). CONCLUSIONS: Opioid use is prevalent among patients with diabetic or idiopathic gastroparesis, and is associated with worse symptoms, delays in gastric emptying, and lower quality of life, as well as greater use of resources. Potent opioids are associated with larger effects than weaker agents. These findings form a basis for studies to characterize adverse outcomes of opioid use in patients with gastroparesis and to help identify those who might benefit from interventions to prevent opioid overuse.

Functional Dyspepsia: Clinical Symptoms, Psychological Findings, and GCSI Scores.

BACKGROUND: The GCSI questionnaire measures symptoms of gastroparesis (GP). Symptoms of FD overlap with GP. The ability of the GCSI to discriminate FD from GP is unknown. AIMS: By prospectively evaluating functional dyspepsia (FD) patients, we aimed to evaluate the ability of the Gastroparesis Cardinal Symptom Index (GCSI) to: (1) distinguish FD from GP; (2) predict symptom severity, anxiety, and depression; (3) correlate symptoms with gastric emptying. METHODS: FD patients (Rome III criteria) were identified, and upper endoscopy and gastric emptying scan (GES) data recorded. A total of 254 patients were mailed a questionnaire evaluating demographics, FD symptoms, mental well-being; the GCSI was included. RESULTS: One hundred and twenty-three patients responded; of them, 75% were women and mean age was 49 (15 SD) years. 44.7% were categorized as postprandial distress subtype (PDS), 34.1% were epigastric pain subtype (EPS), and 21.1% were mixed type. The mean GCSI score was 2.02 (1.1 SD), slightly lower than historical GP controls (2.26-2.56). Mixed EPS-PDS subtype had the lowest GCSI scores (1.79; 0.91 SD). Bloating was the highest GCSI subscore (2.70; 1.53 SD), followed by fullness (2.31; 1.39 SD) and nausea (1.08; 1.19 SD). The GCSI total score did not correlate with anxiety and depression scores or with 4-h gastric emptying. CONCLUSIONS: In this population of FD patients, GCSI scores were slightly lower than historical gastroparesis control patients, although within the reported range. These results suggest that the GCSI cannot accurately distinguish FD patients from GP patients. A more specific questionnaire is needed to aid in the diagnosis and management of these distinct gastrointestinal disorders.

Exploring Symptom Severity, Illness Perceptions, Coping Styles, and Well-Being in Gastroparesis Patients Using the Common Sense Model.

AIMS: This study aimed to examine the relationships between gastroparesis symptom severity, illness perceptions, coping styles, quality of life (QoL), and psychological distress in patients with gastroparesis, guided by the common sense model. METHODS: One hundred and seventy-nine adults with gastroparesis (165 females, 14 males; mean age 41.82 years) completed an online questionnaire. The Gastroparesis Cardinal Symptom Index was used to measure gastroparesis symptom severity, QoL was explored using the PAGI-QOL, illness perceptions were measured using the Brief Illness Perception Questionnaire, the Carver Brief COPE scale assessed coping styles, and psychological distress was investigated using the DASS21. RESULTS: Structural equation modeling resulted in a final model with excellent fit. Gastroparesis symptom severity directly influenced illness perceptions (ß = .52, p < .001) and QoL (ß = .30, p < .001). Illness perceptions directly influenced maladaptive coping (ß = - .64, p < .001), psychological distress (ß = - .32, p < .001), and QoL (ß = .30, p = .01). Maladaptive coping directly influenced psychological distress (ß = .62, p < .001), which in turn had a direct influence on QoL (ß = - .38, p < .001). CONCLUSIONS: The final model showed that the influence of gastroparesis symptom severity on psychological distress was fully mediated by illness perceptions, while the influence on QoL was partially mediated by illness perceptions. The study provides guidance for the development of psychological interventions targeted toward improving mediating psychological factors.

Gastroparesis: Quality of Life and Health Care Utilization.

BACKGROUND AND AIMS: Gastroparesis (GP) patients suffer from recurrent symptoms of nausea, vomiting, early satiety, and abdominal pain. The impact of GP on quality of life (QoL), health care utilization and daily activities is not well understood. MATERIALS AND METHODS: Part 1: 398 adult patients (≥18 y) with documented GP (symptoms >6 mo) were surveyed to assess QoL and pain using the Short Form 36 and McGill pain questionnaires. Part 2: 491 adult GP patients were surveyed to evaluate employment status, work and daily activities, medication use, physician visits, diagnostic testing, emergency room visits, and hospitalizations related to their GP symptoms. Both protocols received Institutional Review Board approval. RESULTS: Part 1: 250 fully evaluable surveys were returned (63%). The mean age was 46.8 years (range, 18 to 84 y); 78% were women. Mean Short Form 36 scores for mental health (56.9) and social functioning (68.1) were analogous to scores for patients with serious chronic medical disorders and depression. Pain scores were lower in patients with idiopathic GP compared with diabetic GP. Part 2: 228 evaluable surveys were analyzed (58.3% response rate). The mean age was 49.6 (19 to 86 y); 77.2% were women. GP symptoms reduced daily activities in 67.5% and lowered annual income in 28.5%. In total, 11% were disabled due to GP symptoms. CONCLUSIONS: GP reduces patients' QoL and places a significant financial burden on the health care system. Treatment strategies for GP patients should be broad based and incorporate pain management, psychological evaluation and management, and strategies to improve overall well-being with a return to work and daily activities.

A longitudinal study on patients with diabetes and symptoms of gastroparesis - associations with impaired quality of life and increased depressive and anxiety symptoms.

AIMS: To examine patient reported outcomes (PRO) in patients previously assessed for diabetic gastroparesis, and to investigate how symptoms of gastroparesis evolve over time. In addition, to further evaluate outcomes in those with versus without diabetic gastroparesis at baseline. METHODS: Thirty-four patients with diabetes and gastrointestinal (GI) symptoms, diagnosed with or without diabetic gastroparesis in 2011-2013, were included in this follow-up study. PRO were measured with the Patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM), 36-Item Short Form Survey (SF-36), Patient assessment of upper gastrointestinal disorders-quality of life (PAGI-QOL) and Hospital Anxiety and Depression Scale (HADS). Demographic factors and clinical variables were also recorded. RESULTS: Participants diagnosed with gastroparesis had improved glycemic control (p=0.04) and less GI symptoms (p=0.001), after a follow-up time of 3.2years (mean). Both groups reported severely impaired quality of life (QoL). In total 47% reported symptoms of anxiety, 38% symptoms of depression (scores≥8). GI symptom severity or other PRO could not differentiate between the two groups. CONCLUSIONS: Patients diagnosed with diabetic gastroparesis, as well as those with gastroparesis symptoms - but normal gastric emptying, suffer from severely impaired QoL and a high burden of anxiety and depressive symptoms.

Exploring the Diabetic Gastroparesis Patient Experience: Patient Exit Interviews.

INTRODUCTION: To improve understanding of the diabetic gastroparesis (DGP) patient experience and inform the patient-reported outcome measurement strategy for future trials in DGP, qualitative interviews were conducted with participants in a phase 2 clinical trial of a novel DGP treatment. METHODS: Trial participants were invited to participate in interviews at both the pretreatment visit (PTV) and the end-of-treatment visit (EOTV). The interviews were conducted by experienced qualitative researchers and followed a semistructured interview guide. The PTV interviews focused on patients' DGP symptoms and the impact of DGP on their lives, and the EOTV interviews focused on any symptom changes patients experienced during the trial. RESULTS: Of 90 enrolled trial participants, 78 (86.7%) opted to participate in the interview study. Bloating, stomach fullness, upper abdominal pain, vomiting, constipation, and heartburn or reflux were each reported spontaneously by a majority of the 73 PTV interview participants with evaluable data. These patients commonly reported bloating (n = 20), upper abdominal pain (n = 12), and nausea (n = 11) as their most bothersome DGP symptom. Of 51 EOTV interview participants, 44 (86.3%) reported improvement in at least one DGP symptom either spontaneously or when asked about specific symptoms reported during their PTV interview. CONCLUSION: Bloating, abdominal pain, nausea, constipation, stomach fullness, vomiting, and heartburn were frequently reported by patients as the most bothersome and important-to-treat symptoms. These results support the assessment of these symptoms in future DGP clinical trials, whether for symptom improvement or worsening. FUNDING: Ironwood Pharmaceuticals. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02289846.

Psychological controversies in gastroparesis: A systematic review.

AIM: To systematically review literature addressing three key psychologically-oriented controversies associated with gastroparesis. METHODS: A comprehensive search of PubMed, CINAHL, and PsycINFO databases was performed to identify literature addressing the relationship between gastroparesis and psychological factors. Two researchers independently screened all references. Inclusion criteria were: an adult sample of gastroparesis patients, a quantitative methodology, and at least one of the following: (1) evaluation of the prevalence of psychopathology; (2) an outcome measure of anxiety, depression, or quality of life; and (3) evidence of a psychological intervention. Case studies, review articles, and publications in languages other than English were excluded from the current review. RESULTS: Prevalence of psychopathology was evaluated by three studies (n = 378), which found that combined anxiety/depression was present in 24% of the gastroparesis cohort, severe anxiety in 12.4%, depression in 21.8%-23%, and somatization in 50%. Level of anxiety and depression was included as an outcome measure in six studies (n = 1408), and while limited research made it difficult to determine the level of anxiety and depression in the cohort, a clear positive relationship with gastroparesis symptom severity was evident. Quality of life was included as an outcome measure in 11 studies (n = 2076), with gastroparesis patients reporting lower quality of life than population norms, and a negative relationship between quality of life and symptom severity. One study assessed the use of a psychological intervention for gastroparesis patients (n = 120) and found that depression and gastric function were improved in patients who received psychological intervention, however the study had considerable methodological limitations. CONCLUSION: Gastroparesis is associated with significant psychological distress and poor quality of life. Recommendations for future studies and the development of psychological interventions are provided.

Exploration of the psychosocial issues associated with gastroparesis: a qualitative investigation.

AIMS AND OBJECTIVES: To build on the understanding of how individuals experience gastroparesis, how gastroparesis impacts on their lives and how they adapt to living with gastroparesis. BACKGROUND: Gastroparesis is a neurogastroenterological disorder associated with increased psychological distress and reduced quality of life. Research shows that gastroparesis poses a significant burden across many facets of life; however, less is known about how individuals cope and adapt to living with the condition. DESIGN: The study employed an interpretive phenomenological approach with semistructured interviews and thematic analysis. METHODS: Ten gastroparesis patients were interviewed over the telephone (n = 8), Skype (n = 1) or face-to-face (n = 1). All interviews were audio-recorded and transcribed. RESULTS: Key themes identified: (1) frustration, (2) identity and (3) coping and adaptation. Gastroparesis patients experience significant frustration around their diagnostic journey, being misunderstood and the burden of living with the illness. Patients differed in how they identified with the illness, and this appeared to be associated with adaptation and whether they remained socially engaged. CONCLUSIONS: Gastroparesis is associated with significant frustration and burden; however, some patients adapt to living with the condition more effectively than others. Identity appears to play an important role in this relationship. Support aimed at fostering a health-focused and resilient identity may assist gastroparesis patients in adaptation. RELEVANCE TO CLINICAL PRACTICE: The findings of this study can help nurses and other healthcare professionals better understand the experience of living with gastroparesis and the factors that help patients best adapt to living with the condition. Nurses can help promote resilience in patients by discussing the importance of being health-focused rather than illness-focused. Nurses can also support patients by helping them problem-solve issues that may arise around social eating and remaining socially engaged.

Twenty-five years of advocacy for patients with gastroparesis: support group therapy and patient reported outcome tool development.

BACKGROUND: Gastroparesis (Gp) is a poorly understood chronic gastrointestinal medical condition for which patient reported outcomes (PRO) are lacking. Previously developed symptoms scoring has been used for several decades. Using symptoms scores as a basis for documentation, 12 years of support/focus group patient feedback from the nearly 1000 attendees were integrated with medical care and recommendations for treatment were developed. Early attenders of the support group were compared with non-attendees for illness acuity, disability, and duration and number of office phone calls. METHODS: Patients cared for in an academic medical practice were assessed for patient-derived PRO symptoms, coupled with standardized Health Related Quality of Life (HRQOL) measures. Based on factors identified by the patients via support/focus groups, a diagnostic and prognostic tool was developed. RESULTS: The new tool utilized PRO symptoms and included provider assessments of medical illnesses as well as resource utilization. This 'post PRO' tool has been applied in a variety of settings for patients with the symptoms of Gp over the last two decades. The 'pre-PRO' factors from the support/focus groups were compared to the PRO measures as well as the 'post-PRO' scale to assess their usefulness. Using methods that combine chart data, including electronic medical records (EMR), with PRO symptoms may have design implications for PRO assessment. The resultant scales, as part of a new tool, can allow for sharing of PRO derived scores in a chronic gastrointestinal (GI), illness with different practitioners. CONCLUSIONS: These newly-derived scales offer a potentially useful tool for clinical decision-making, tailoring treatment to patient subgroups and engaging both patients and their families and caregivers in more active partnerships with providers to improve health outcomes.

The impact of gastroparesis on diabetes control: Patient perceptions.

UNLABELLED: The impact of gastroparesis on diabetes management and control from the patient perspective has not been well characterized. The aim of this study was to identify patient perceptions regarding the impact of gastroparesis on managing their diabetes. METHODS: Patients with diabetes being referred for gastroparesis were enrolled in this prospective study. Gastroparetic symptom severity was assessed with the Patient Assessment of Upper GI Symptoms (PAGI-SYM). A questionnaire examined the impact of gastroparesis on diabetes related symptoms and control. RESULTS: 54 diabetic gastroparesis patients (36 T1DM, 18 T2DM) participated. Duration of diabetes averaged 17.4±1.4years and gastroparetic symptoms 5.1±1.1years. Patients rated their most severe symptoms as postprandial fullness, early satiety, and nausea. Two thirds of diabetic subjects identified that since their diagnosis of gastroparesis, their diabetes was more difficult to control (44 of 54 patients) and that extra time and effort were required for care of their diabetes (45 of 54). Patients with T1DM, compared to those with T2DM, more often expressed that since developing gastroparesis, their blood sugars have been higher, they have had more frequent episodes of hypoglycemia, and they found that their gastroparetic symptoms worsened if blood sugars were too high. CONCLUSIONS: Gastroparesis has a significant impact on patients' perceived ability to self-manage and control their diabetes. T1DM patients, in particular, associate their gastroparesis with episodes of hyper- and hypo-glycemia, and find their gastroparetic symptoms worsen with poor control. Future research should focus on strategies to support self-management of patients with diabetic gastroparesis.

Structural changes in gastric glial cells and delayed gastric emptying as responses to early life stress and acute adulthood stress in rats.

AIM: Enteric glial cells (EGCs) modulate colonic motility in a maternal separation model. We aimed to investigate structural changes in gastric EGC and gastric emptying as responses to maternal separation and acute adulthood stress in rats to elucidate the pathophysiological roles of gastric EGC. MAIN METHODS: As a chronic stress, we subjected male Wistar rats to 3h of maternal separation during postnatal days 2-14. As an acute adulthood stress (7weeks of age), we used the 8-h water-immersion method. We morphologically evaluated gastric EGCs using whole-mount longitudinal muscle-myenteric plexus preparations. We analyzed gastric emptying by the phenol red method. KEY FINDING: The area of EGC processes that apparently overlapped with neurons increased according to stress intensity (acute stress, 10.4%; maternal separation, 10.2%; maternal separation plus acute stress, 26.6%; control, 5.0%). Ratios of morphologically changed leaf-like processes to the total processes were 8.1%, acute stress; 10.3%, maternal separation; 4.0%, control. Ratio dramatically increased in the combined stress group (20.5%, p=0.026 vs. control). The mean bulging head area of leaf-like processes in the combined stress group was greater by 6.4µm(2) (control, 2.4µm(2); p=0.042). Gastric emptying in the maternal separation group was gradually delayed (104.1% at 7weeks, 66.7% at 17weeks, and 48.5% at 48weeks; p<0.05, respectively). Gastric emptying in the combined stress group tended to be delayed at 17weeks (45.7% vs. 81% in controls, p=0.066). SIGNIFICANCE: Gastric EGCs exhibited structural changes according to stress intensity, which may be associated with stress-induced dysfunction of the stomach.

Prospective evaluation of gastric neurostimulation for diabetic gastroparesis in Canada.

BACKGROUND: The efficacy of gastric neurostimulation therapy for diabetic gastroparesis (GP) in a 'real-life' Canadian setting has not been assessed. AIMS: To assess changes in health-related quality of life (QoL), weekly vomiting frequency (WVF), total symptom score (TSS) and health care utilization 12 months before and after gastric neurostimulator implantation in a diabetic GP cohort. METHODS: Medication-refractory diabetic GP patients (n=7, four female, mean age 42 years) were prospectively recruited from 2008 to 2012. QoL scores were self-administered and obtained at baseline, 24 and 48 weeks postimplantion. WVF and TSS were assessed similarly. Health care usage, measured as hospitalization frequency and medication cost, was obtained six and 12 months before and after implant. Changes from baseline to six and 12 months for all outcomes were compared. RESULTS: The mean ( ± SD) QoL according to EuroQol was significantly better at 24 weeks after the baseline measurement (baseline 29 ± 5, 24 weeks 52 ± 7; P = 0.03). The mean improvement in TSS was significantly better at one year postintervention (baseline score 35 ± 5 versus 12 months 27 ± 3; P = 0.03). Changes in Short-Form 36 Health Survey and WVF were not significant. Days of GP-related hospitalization were highly variable but decreased from a median of 71 days (range 0 to 227 days) to 29 days (range two to 334 days) one year before and after surgery, respectively (P = 0.735). Outpatient medication costs did not decrease to a significant extent. CONCLUSION: Gastric neurostimulation for diabetic GP appeared to show some beneficial palliative effects overall in the present small open-label series, but the effect is highly variable among patients, and placebo effect cannot be ruled out.