Neurostimulation of the Gastrointestinal Tract: Review of Recent Developments

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Background Gastric electrical stimulation (GES) for treating gastroparesis symptoms is controversial. Methods We studied 319 idiopathic or diabetic gastroparesis symptom patients from the Gastroparesis Clinical Research Consortium (GpCRC) observational studies: 238 without GES and 81 with GES. We assessed the effects of GES using change in GCSI total score and nausea/vomiting subscales between baseline and 48 weeks. We used propensity score methods to control for imbalances in patient characteristics between comparison groups. Key Results GES patients were clinically worse (40% severe vs. 18% for non‐GES; P < .001); worse PAGI‐QOL (2.2. vs. 2.6; P = .003); and worse GCSI total scores (3.5 vs. 2.8; P < .001). We observed improvements in 48‐week GCSI total scores for GES vs. non‐GES: improvement by ≥ 1‐point (RR = 1.63; 95% CI = (1.14, 2.33); P = .01) and change from enrollment (difference = −0.5 (−0.8, −0.3); P < .001). When adjusting for patient characteristics, symptom scores were smaller and not statistically significant: improvement by ≥ 1‐point (RR = 1.29 (0.88, 1.90); P = .20) and change from the enrollment (difference = −0.3 (−0.6, 0.0); P = .07). Of the individual items, the nausea improved by ≥ 1 point (RR = 1.31 (1.03, 1.67); P = .04). Patients with GCSI score ≥ 3.0 tended to improve more than those with score < 3.0. (Adjusted P = 0.02). Conclusions and Inferences This multicenter study of gastroparesis patients found significant improvements in gastroparesis symptoms among GES patients. Accounting for imbalances in patient characteristics, only nausea remained significant. Patients with greater symptoms at baseline improved more after GES. A much larger sample of patients is needed to fully evaluate symptomatic responses and to identify patients likely to respond to GES.

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Effectiveness of gastric electrical stimulation in gastroparesis: Results from a large prospectively collected database of national gastroparesis registries

Abell

Yamada

McCallum

et al. 2019

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“…181 Neuromodulation via gastric electrical stimulation (GES) uses high frequency, low amplitude current that is delivered as a pulse after gastric surgical implantation. 182 This method is effective for refractory nausea and vomiting associated with gastroparesis in both children and adults. [183][184][185][186][187][188] These studies show variable effects on gastric emptying rates.…”

Section: Treatmentmentioning

confidence: 99%

Update on pediatric gastroparesis: A review of the published literature and recommendations for future research

Kovacic

Elfar

Rosen

et al. 2019

Background Due to scarcity of scientific literature on pediatric gastroparesis, there is a need to summarize current evidence and identify areas requiring further research. The aim of this study was to provide an evidence‐based review of the available literature on the prevalence, pathogenesis, clinical presentation, diagnosis, treatment, and outcomes of pediatric gastroparesis. Methods A search of the literature was performed using the Preferred Reporting Items for Systematic Reviews and Meta‐analyses guidelines with the following databases: PubMed, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, and Web of Science. Two independent reviewers screened abstracts for eligibility. Key Results Our search yielded 1085 original publications, 135 of which met inclusion criteria. Most articles were of retrospective study design. Only 12 randomized controlled trials were identified, all of which were in infants. The prevalence of pediatric gastroparesis is unknown. Gastroparesis may be suspected based on clinical symptoms although these are often non‐specific. The 4‐hour nuclear scintigraphy scan remains gold standard for diagnosis despite lack of pediatric normative comparison data. Therapeutic approaches include dietary modifications, prokinetic drugs, and postpyloric enteral tube feeds. For refractory cases, intrapyloric botulinum toxin and surgical interventions such as gastric electrical stimulation may be warranted. Most interventions still lack rigorous supportive data. Conclusions Diagnosis and treatment of pediatric gastroparesis are challenging due to paucity of published evidence. Larger and more rigorous clinical trials are necessary to improve outcomes.

Section: Discussionmentioning

confidence: 99%

“…Discussion of subgroup profiling of hormonal and cytokine data showed some differences between patient diagnostic groups and subgroups, as was the analysis of comorbidities by all patients and by subgroups. 10,20,21 Regarding effects of GES on metabolic control, a recent study done by Lebovitz in type II DM patients who were treated with GES In addition, a high-frequency/low-energy GES treatment regimen in DM Gp patients showed a significant lowering of HbA1c from 8.5% to 6.5% over a period of 1 year. 25 Thus, the exact mechanism of HbA1c reduction after GES therapy is yet to be fully explained; we could speculate that an increase in GLP-1 post-GES might be one of the reasons for improved glycemic control with long-term GES.…”

Section: Anatomic-mucosal Neuronal Density Vs Full-thickness Biopsymentioning

confidence: 99%

Gastroparesis syndromes: Response to electrical stimulation

Abell

Kedar

Stocker

et al. 2019

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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).