Early Assessment of Cost-effectiveness of Gastric Electrical Stimulation for Diabetic Nausea and Vomiting

Klinge, Mette Winther; Rask, Peter; Mortensen, Lene; Lassen, Kathrine; Ejskjær, Niels; Ehlers, Lars Holger; Krogh, Klaus

doi:10.5056/jnm16179

Cited by 8 publications

(8 citation statements)

References 36 publications

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“…Gastric symptoms in diabetes may be caused—at least in part—by vagal neuropathy, and therefore, there is a theoretical background to use a neuromodulation treatment option and this is the rationale for gastric pacing. Several studies have shown that the method may be effective to alleviate nausea and vomiting and is cost-effective [ 95 ]. However, most studies have been small and suffered from methodological problems (i.e., no sham arm), and recent guidelines have not recommended this modality outside protocol studies [ 96 ].…”

Section: Clinical Managementmentioning

confidence: 99%

Diabetic Enteropathy: From Molecule to Mechanism-Based Treatment

Meldgaard

Olesen

Farmer

et al. 2018

Journal of Diabetes Research

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The incidence of the micro- and macrovascular complications of diabetes is rising, mirroring the increase in the worldwide prevalence. Arguably, the most common microvascular complication is neuropathy, leading to deleterious changes in both the structure and function of neurons. Amongst the various neuropathies with the highest symptom burden are those associated with alterations in the enteric nervous system, referred to as diabetic enteropathy. The primary aim of this review is to provide a contemporaneous summary of pathophysiology of diabetic enteropathy thereby allowing a “molecule to mechanism” approach to treatment, which will include 4 distinct aspects. Firstly, the aim is to provide an overview of the diabetes-induced structural remodelling, biochemical dysfunction, immune-mediated alterations, and inflammatory properties of the enteric nervous system and associated structures. Secondly, the aim is to provide a synopsis of the clinical relevance of diabetic enteropathy. Thirdly, the aim is to discuss the various patient-reported outcome measures and the objective modalities for evaluating dysmotility, and finally, the aim is to outline the clinical management and different treatment options that are available. Given the burden of disease that diabetic enteropathy causes, earlier recognition is needed allowing prompt investigation and intervention, which may lead to improvements in quality of life for sufferers.

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Section: Clinical Managementmentioning

confidence: 99%

Diabetic Enteropathy: From Molecule to Mechanism-Based Treatment

Meldgaard

Olesen

Farmer

et al. 2018

Journal of Diabetes Research

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“…Quality-adjusted life years improved after GES and was cost-effective after 24 months. 34 In conclusion, our results suggest that gastric electrical stimulation is an effective therapy in the long-term in approximately half of the patients with medically refractory nausea and vomiting. Other long-term prospective studies are however warranted to confirm these findings.…”

Section: In Fact Several Open Studies Conducted In Gastroparetic Patmentioning

confidence: 53%

“…In fact, several open studies conducted in gastroparetic patients have reported a short‐term improvement, 8,17‐33 but very few studies have reported GES efficacy over the medium‐ or long‐term 12,14,34‐38 . In addition, none of these studies evaluated efficacy on patient with medically refractory nausea and vomiting without gastroparesis.…”

Section: Discussionmentioning

confidence: 99%

“…Several studies have shown that the method may be effective to alleviate nausea and vomiting and is cost‐effective. In a previous study conducted by Klinge et al, 34 surgical implantation was performed to 33 patients with diabetic gastroparesis without mortality or major complications. Six months after surgery, 78% of the respondents had at least 50% reduction in time with nausea and 48% had at least 50% reduction in days with vomiting.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy of gastric electrical stimulation in intractable nausea and vomiting at 10 years: A retrospective analysis of prospectively collected data

Hedjoudje

Huet

Leroi

et al. 2020

Neurogastroenterology Motil

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Background: Gastric electrical simulation has been shown to relieve nausea and vomiting in medically refractory patients. Efficacy of gastric electrical stimulation has been reported mostly in short-term studies, but none has evaluated its efficacy beyond 10 years after implantation. Methods: Patients implanted at our center for medically refractory severe and chronic nausea and/or vomiting were evaluated before and over 10 years after implantation using symptomatic scale and quality of life (GIQLI) score. Improvement was defined as a reduction of more than 50% in vomiting frequency. Key Results: A total of 50 patients were implanted from January 1998 to December 2009. Among them, 7 were explanted due to a lack of efficacy and/or side effects, 2 died, and 4 were lost to follow-up. Mean follow-up was 10.5 ± 3.7 years. In intention-to-treat analysis, 27/50 (54%) patients reported an improvement. Beyond 10 years, an improvement in early satiety (3.05 vs 1.76, <0.001), bloating (2.51 vs 1.70, P = .012), nausea (2.46 vs 1.35, P = .001), and vomiting (3.35 vs 1.49 P < .001) scores were observed. Quality of life improved over 10 years (GIQLI score: 69.7 vs. 86.4, P = .005) and body mass index (BMI: 23.4 vs. 26.2 kg/m 2 ; P = .048). Conclusions and Inferences: Gastric electrical simulation is effective in the long-term in patients with medically refractory nausea and vomiting, with an efficacy of 54% at 10 years on an intention-to-treat analysis. Other long-term observational studies are warranted to confirm these results.

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“…Gastric electrical stimulation (GES), which utilizes electrodes and a pulse generator to electrically stimulate the gastric tissues, can effectively mitigate the symptoms of gastroparesis. [3][4][5][6] In clinical studies on patients with gastroparesis, GES was observed to significantly improve gastrointestinal symptoms, especially nausea and vomiting, and reduce hospitalization and use of medication, thereby enhancing the patients' quality of life. However, devices that are currently in clinical use require invasive procedures to be performed under general anesthesia.…”

Section: Introductionmentioning

confidence: 99%

Minimally Invasive Gastric Electrical Stimulation Using a Newly Developed Wireless Gastrostimulator: A Pilot Animal Study

Kim

Chun

et al. 2020

J Neurogastroenterol Motil

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Background/Aims Gastric electrical stimulation (GES) is a feasible modality for the treatment of gastroparesis; however, the presently available device requires invasive surgical implantation for long-term stimulation and repeated surgical procedure after a period of time. This study is aimed at developing a wireless miniature GES device and testing its endoscopic insertion in animal models. Methods Endoscopic gastric implantation of the GES device was performed on 5 healthy weaner pigs under general anesthesia. We created an endoscopic submucosal pocket and inserted the gastro-electrical stimulator. In vivo gastric slow waves were recorded and measured during electrical stimulation. A multi-channel recorder, called an electrogastrogram, was used to record the gastric myoelectrical activity in the study. Results The gastric slow waves on the electrogastrogram were more consistent with GES on the gastric tissues compared to no stimulation. The frequency-to-amplitude ratio was also significantly altered after the electrical stimulation. Conclusions GES is feasible with our minimally invasive wireless device. This technique has the potential to increase utilization of GES as a treatment alternative.

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Early Assessment of Cost-effectiveness of Gastric Electrical Stimulation for Diabetic Nausea and Vomiting

Cited by 8 publications

References 36 publications

Diabetic Enteropathy: From Molecule to Mechanism-Based Treatment

Diabetic Enteropathy: From Molecule to Mechanism-Based Treatment

Efficacy of gastric electrical stimulation in intractable nausea and vomiting at 10 years: A retrospective analysis of prospectively collected data

Minimally Invasive Gastric Electrical Stimulation Using a Newly Developed Wireless Gastrostimulator: A Pilot Animal Study

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