Gastroenterology

Gastroenterology

Volume 125, Issue 2, August 2003, Pages 421-428
Gastroenterology

Clinical-alimentary tract
Gastric electrical stimulation for medically refractory gastroparesis

https://doi.org/10.1016/S0016-5085(03)00878-3Get rights and content

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.

Section snippets

Materials and methods

The Worldwide Antivomiting Electrical Stimulation Study, was conducted at 11 centers in the United States, Canada, and Europe in compliance with all applicable regulations of each country. Approval was obtained from the institutional review board or ethical committee of each center, and patients gave their written, informed consent before entering the trial.

Baseline demographics

Thirty-three patients from 11 centers (17 diabetic [9 male and 8 female] and 16 female idiopathic patients) from 19 to 65 years old were enrolled. The number of patients enrolled at each center varied from 1 to 13. These patients were highly symptomatic, with a median weekly vomiting frequency of 17.3 episodes per week and with mean vomiting and nausea severity scores of 3.3 and 3.5, respectively; had delayed gastric emptying at 2 and 4 hours; and met all entry criteria. Most were receiving

Discussion

The results of phase I, the double-blind study period, showed a consistently positive outcome for the combined group (significantly decreased vomiting frequency and preference for stimulation ON). The results of phase I were less compelling when each patient subgroup was examined separately (i.e., there was no significant different in vomiting frequency in either the diabetic or idiopathic subgroup and no significant difference in ON/OFF preference in the diabetic subgroup). Several factors may

Acknowledgements

The authors would like to acknowledge the following individuals who supported this study: G. Voeller, M.D., P. Eaton, R.N., and R. Werkman (University of Tennessee); Theresa Cutts, Ph.D. (University of Tennessee); Lesa Gann (University of Arkansas); C. Sninsky, M.D., and S. Fitz William, R.N. (University of Florida); R. Delcore, M.D., J. Forster, M.D., Z. Lin, M.S., G. Raju, M.D., and I. Sarosiek, M.D. (University of Kansas); G. Kaufman, M.D., L. Xu, M.D., and S. Bingaman, R.N. (Penn State

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  • Cited by (0)

    Supported in part by Medtronic, Inc., Portions of the study were presented in abstract form at the American Gastroenterological Association meetings in 2001 and 2002.

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