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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.

Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis