title: Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis.
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.
  
  
  OBJECTIVE
  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.
  
  
  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
  (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.
authors.affiliation: Department of Internal Medicine, Texas Tech University Health Sciences Center, El Paso, TX, USA.
authors.forename: R W
authors.initials: RW
authors.lastname: McCallum
authors.forename: I
authors.initials: I
authors.lastname: Sarosiek
authors.forename: H P
authors.initials: HP
authors.lastname: Parkman
authors.forename: W
authors.initials: W
authors.lastname: Snape
authors.forename: F
authors.initials: F
authors.lastname: Brody
authors.forename: J
authors.initials: J
authors.lastname: Wo
authors.forename: T
authors.initials: T
authors.lastname: Nowak
mesh_terms: D000328:Adult; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000379:methods*; D004567:Electrodes, Implanted; D005260:Female; D018589:Gastroparesis / Q000150:complications / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014839:Vomiting / Q000209:etiology / Q000628:therapy*; D055815:Young Adult
keywords: gastric stimulation; gastroparesis; idiopathic gastroparesis; nausea; vomiting
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