Gastric electrical stimulation for medically refractory gastroparesis

Thomas Abell, Richard W. McCallum, Michael Hocking, Kenneth Koch, Hasse Abrahamsson, Isabelle Leblanc, Greger Lindberg, Jan Konturek, Thomas Nowak, Eammon M M Quigley, Gervais Tougas, Warren Starkebaum

Research output: Contribution to journalArticle

389 Citations (Scopus)

Abstract

Background & Aims: This study investigated the efficacy of gastric electrical stimulation for the treatment of symptomatic gastroparesis unresponsive to standard medical therapy. Methods: Thirty-three patients with chronic gastroparesis (17 diabetic and 16 idiopathic) received continuous high-frequency/low-energy gastric electrical stimulation via electrodes in the muscle wall of the antrum connected to a neurostimulator in an abdominal wall pocket. After implantation, patients were randomized in a double-blind crossover design to stimulation ON or OFF for 1-month periods. The blind was then broken, and all patients were programmed to stimulation ON and evaluated at 6 and 12 months. Outcome measures were vomiting frequency, preference for ON or OFF, upper gastrointestinal tract symptoms, quality of life, gastric emptying, and adverse events. Results: In the double-blind portion of the study, self-reported vomiting frequency was significantly reduced in the ON vs. OFF period (P <0.05) and this symptomatic improvement was consistent with the significant patient preference (P <0.05) for the ON vs. OFF period determined before breaking the blind. In the unblinded portion of the study, vomiting frequency decreased significantly (P <0.05) at 6 and 12 months. Scores for symptom severity and quality of life significantly improved (P <0.05) at 6 and 12 months, whereas gastric emptying was only modestly accelerated. Five patients had their gastric electrical stimulation system explanted or revised because of infection or other complications. Conclusions: High-frequency/low-energy gastric electrical stimulation significantly decreased vomiting frequency and gastrointestinal symptoms and improved quality of life in patients with severe gastroparesis.

Original languageEnglish (US)
Pages (from-to)421-428
Number of pages8
JournalGastroenterology
Volume125
Issue number2
DOIs
StatePublished - Aug 1 2003

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Gastroparesis
Electric Stimulation
Stomach
Vomiting
Gastric Emptying
Quality of Life
Upper Gastrointestinal Tract
Patient Preference
Abdominal Wall
Double-Blind Method
Cross-Over Studies
Electrodes
Outcome Assessment (Health Care)
Muscles
Therapeutics
Infection

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Abell, T., McCallum, R. W., Hocking, M., Koch, K., Abrahamsson, H., Leblanc, I., ... Starkebaum, W. (2003). Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology, 125(2), 421-428. https://doi.org/10.1016/S0016-5085(03)00878-3

Gastric electrical stimulation for medically refractory gastroparesis. / Abell, Thomas; McCallum, Richard W.; Hocking, Michael; Koch, Kenneth; Abrahamsson, Hasse; Leblanc, Isabelle; Lindberg, Greger; Konturek, Jan; Nowak, Thomas; Quigley, Eammon M M; Tougas, Gervais; Starkebaum, Warren.

In: Gastroenterology, Vol. 125, No. 2, 01.08.2003, p. 421-428.

Research output: Contribution to journalArticle

Abell, T, McCallum, RW, Hocking, M, Koch, K, Abrahamsson, H, Leblanc, I, Lindberg, G, Konturek, J, Nowak, T, Quigley, EMM, Tougas, G & Starkebaum, W 2003, 'Gastric electrical stimulation for medically refractory gastroparesis', Gastroenterology, vol. 125, no. 2, pp. 421-428. https://doi.org/10.1016/S0016-5085(03)00878-3
Abell T, McCallum RW, Hocking M, Koch K, Abrahamsson H, Leblanc I et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. 2003 Aug 1;125(2):421-428. https://doi.org/10.1016/S0016-5085(03)00878-3
Abell, Thomas ; McCallum, Richard W. ; Hocking, Michael ; Koch, Kenneth ; Abrahamsson, Hasse ; Leblanc, Isabelle ; Lindberg, Greger ; Konturek, Jan ; Nowak, Thomas ; Quigley, Eammon M M ; Tougas, Gervais ; Starkebaum, Warren. / Gastric electrical stimulation for medically refractory gastroparesis. In: Gastroenterology. 2003 ; Vol. 125, No. 2. pp. 421-428.
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AU - Lindberg, Greger

AU - Konturek, Jan

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N2 - Background & Aims: This study investigated the efficacy of gastric electrical stimulation for the treatment of symptomatic gastroparesis unresponsive to standard medical therapy. Methods: Thirty-three patients with chronic gastroparesis (17 diabetic and 16 idiopathic) received continuous high-frequency/low-energy gastric electrical stimulation via electrodes in the muscle wall of the antrum connected to a neurostimulator in an abdominal wall pocket. After implantation, patients were randomized in a double-blind crossover design to stimulation ON or OFF for 1-month periods. The blind was then broken, and all patients were programmed to stimulation ON and evaluated at 6 and 12 months. Outcome measures were vomiting frequency, preference for ON or OFF, upper gastrointestinal tract symptoms, quality of life, gastric emptying, and adverse events. Results: In the double-blind portion of the study, self-reported vomiting frequency was significantly reduced in the ON vs. OFF period (P <0.05) and this symptomatic improvement was consistent with the significant patient preference (P <0.05) for the ON vs. OFF period determined before breaking the blind. In the unblinded portion of the study, vomiting frequency decreased significantly (P <0.05) at 6 and 12 months. Scores for symptom severity and quality of life significantly improved (P <0.05) at 6 and 12 months, whereas gastric emptying was only modestly accelerated. Five patients had their gastric electrical stimulation system explanted or revised because of infection or other complications. Conclusions: High-frequency/low-energy gastric electrical stimulation significantly decreased vomiting frequency and gastrointestinal symptoms and improved quality of life in patients with severe gastroparesis.

AB - Background & Aims: This study investigated the efficacy of gastric electrical stimulation for the treatment of symptomatic gastroparesis unresponsive to standard medical therapy. Methods: Thirty-three patients with chronic gastroparesis (17 diabetic and 16 idiopathic) received continuous high-frequency/low-energy gastric electrical stimulation via electrodes in the muscle wall of the antrum connected to a neurostimulator in an abdominal wall pocket. After implantation, patients were randomized in a double-blind crossover design to stimulation ON or OFF for 1-month periods. The blind was then broken, and all patients were programmed to stimulation ON and evaluated at 6 and 12 months. Outcome measures were vomiting frequency, preference for ON or OFF, upper gastrointestinal tract symptoms, quality of life, gastric emptying, and adverse events. Results: In the double-blind portion of the study, self-reported vomiting frequency was significantly reduced in the ON vs. OFF period (P <0.05) and this symptomatic improvement was consistent with the significant patient preference (P <0.05) for the ON vs. OFF period determined before breaking the blind. In the unblinded portion of the study, vomiting frequency decreased significantly (P <0.05) at 6 and 12 months. Scores for symptom severity and quality of life significantly improved (P <0.05) at 6 and 12 months, whereas gastric emptying was only modestly accelerated. Five patients had their gastric electrical stimulation system explanted or revised because of infection or other complications. Conclusions: High-frequency/low-energy gastric electrical stimulation significantly decreased vomiting frequency and gastrointestinal symptoms and improved quality of life in patients with severe gastroparesis.

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