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

Thomas L. Abell, Goro Yamada, Richard W. McCallum, Mark L. Van Natta, James Tonascia, Henry P. Parkman, Kenneth L. Koch, Irene Sarosiek, Gianrico Farrugia, Madhusudan Grover, William Hasler, Linda Nguyen, William Snape, Braden Kuo, Robert Shulman, Frank A. Hamilton, Pankaj J. Pasricha

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Article numbere13714
JournalNeurogastroenterology and Motility
DOIs
StateAccepted/In press - Jan 1 2019

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Gastroparesis
Electric Stimulation
Registries
Stomach
Databases
Nausea
Propensity Score
Multicenter Studies
Vomiting
Observational Studies

Keywords

  • abdominal Pain
  • gastric electrical stimulation
  • gastroparesis
  • nausea
  • vomiting

ASJC Scopus subject areas

  • Physiology
  • Endocrine and Autonomic Systems
  • Gastroenterology

Cite this

Effectiveness of gastric electrical stimulation in gastroparesis : Results from a large prospectively collected database of national gastroparesis registries. / Abell, Thomas L.; Yamada, Goro; McCallum, Richard W.; Van Natta, Mark L.; Tonascia, James; Parkman, Henry P.; Koch, Kenneth L.; Sarosiek, Irene; Farrugia, Gianrico; Grover, Madhusudan; Hasler, William; Nguyen, Linda; Snape, William; Kuo, Braden; Shulman, Robert; Hamilton, Frank A.; Pasricha, Pankaj J.

In: Neurogastroenterology and Motility, 01.01.2019.

Research output: Contribution to journalArticle

Abell, TL, Yamada, G, McCallum, RW, Van Natta, ML, Tonascia, J, Parkman, HP, Koch, KL, Sarosiek, I, Farrugia, G, Grover, M, Hasler, W, Nguyen, L, Snape, W, Kuo, B, Shulman, R, Hamilton, FA & Pasricha, PJ 2019, 'Effectiveness of gastric electrical stimulation in gastroparesis: Results from a large prospectively collected database of national gastroparesis registries', Neurogastroenterology and Motility. https://doi.org/10.1111/nmo.13714
Abell, Thomas L. ; Yamada, Goro ; McCallum, Richard W. ; Van Natta, Mark L. ; Tonascia, James ; Parkman, Henry P. ; Koch, Kenneth L. ; Sarosiek, Irene ; Farrugia, Gianrico ; Grover, Madhusudan ; Hasler, William ; Nguyen, Linda ; Snape, William ; Kuo, Braden ; Shulman, Robert ; Hamilton, Frank A. ; Pasricha, Pankaj J. / Effectiveness of gastric electrical stimulation in gastroparesis : Results from a large prospectively collected database of national gastroparesis registries. In: Neurogastroenterology and Motility. 2019.
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abstract = "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.",
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T1 - Effectiveness of gastric electrical stimulation in gastroparesis

T2 - Results from a large prospectively collected database of national gastroparesis registries

AU - Abell, Thomas L.

AU - Yamada, Goro

AU - McCallum, Richard W.

AU - Van Natta, Mark L.

AU - Tonascia, James

AU - Parkman, Henry P.

AU - Koch, Kenneth L.

AU - Sarosiek, Irene

AU - Farrugia, Gianrico

AU - Grover, Madhusudan

AU - Hasler, William

AU - Nguyen, Linda

AU - Snape, William

AU - Kuo, Braden

AU - Shulman, Robert

AU - Hamilton, Frank A.

AU - Pasricha, Pankaj J.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

KW - abdominal Pain

KW - gastric electrical stimulation

KW - gastroparesis

KW - nausea

KW - vomiting

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