Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis

R W McCallum, I Sarosiek, H P Parkman, W Snape, F Brody, J Wo, T Nowak, R W McCallum, I Sarosiek, H P Parkman, W Snape, F Brody, J Wo, T Nowak

Abstract

Background: Gastric electrical stimulation (GES) is a therapeutic option for intractable symptoms of gastroparesis (GP). Idiopathic GP (ID-GP) represents a subset of GP.

Aims: A prospective, multicenter, double-blinded, randomized, crossover study to evaluate the safety and efficacy of Enterra GES in the treatment of chronic vomiting in ID-GP.

Methods: Thirty-two ID-GP subjects (mean age 39; 81% F, mean 7.7 years of GP) were implanted with GES. The stimulator was turned ON for 1½ months followed by double-blind randomization to consecutive 3-month crossover periods with the device either ON or OFF. ON stimulation was followed in unblinded fashion for another 4.5 months. Twenty-five subjects completed the crossover phase and 21 finished 1 year of follow-up.

Key results: During the unblinded ON period, there was a reduction in weekly vomiting frequency (WVF) from baseline (61.2%, P < 0.001). There was a non-significant reduction in WVF between ON vs OFF periods (the primary outcome) with median reduction of 17% (P > 0.10). Seventy-five percent of patients preferred the ON vs OFF period (P = 0.021). At 1 year, WVF remained decreased (median reduction = 87%, P < 0.001), accompanied by improvements in GP symptoms, gastric emptying and days of hospitalization (P < 0.05).

Conclusions & inferences: (i) In this prospective study of Enterra GES for ID-GP, there was a reduction in vomiting during the initial ON period; (ii) The double-blind 3-month periods showed a non-significant reduction in vomiting in the ON vs OFF period, the primary outcome variable; (iii) At 12 months with ON stimulation, there was a sustained decrease in vomiting and days of hospitalizations.

Keywords: gastric stimulation; gastroparesis; idiopathic gastroparesis; nausea; vomiting.

© 2013 The Authors. Neurogastroenterology & Motility published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Subject disposition.
Figure 3
Figure 3
Weekly vomiting frequency at baseline and follow-ups.

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