title: A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis.
abstract: BACKGROUND
  Endoscopically placed, temporary gastric electrical stimulation (tGES) may relieve symptoms of gastroparesis (Gp) and predict permanent gastric electrical stimulation (GES) outcomes.
  
  
  OBJECTIVE
  To measure effects of 72 hours of temporary GES on Gp symptoms.
  
  
  METHODS
  From 2005 to 2006, we conducted a hospital-based, randomized, placebo-controlled, crossover trial of two consecutive, 4-day sessions (session 1 and session 2), enrolling 58 patients (11 males, 47 females; mean age 46 years) with GP symptom histories of three etiologies (idiopathic, 38; diabetes mellitus, 13; postsurgical, 7).
  
  
  METHODS
  72 continuous hours temporary GES was provided for group A during session 1, and for group B during session 2.
  
  
  METHODS
  Symptoms measured daily; gastric emptying, electrogastrography, and quality of life measured at baseline and session close.
  
  
  RESULTS
  In session 1, vomiting decreased in both groups, but was greater with stimulation, resulting in a day 3 difference of -1.02 (95% CI, -1.62 to -0.42; P < .001). Scores did not return to baseline during washout; on day 4, the difference persisted at -1.08 (95% CI, -1.81 to -0.35; P = .005). In session 2, vomiting slightly decreased with stimulation and slightly increased without it; at day 8, the nonactivated group had nonsignificantly greater vomiting, 0.12 (-0.68 to 0.92; P = .762). An overall treatment effect of a slight, nonsignificant daily decrease in average vomiting scores, -0.12 (-0.26 to 0.03; P = .116), was observed by pooling stimulation effects across sessions.
  
  
  CONCLUSIONS
  Missing data; potential physiological imbalances between groups.
  
  
  CONCLUSIONS
  Although overall treatment effects were not significant, differences in favor of stimulation were suggested. Barriers to observing treatment effects included a decrease in vomiting for both groups during session 1, insufficient washout, and the absence of baseline vomiting for some patients. Future studies should better define inclusion criteria, use longer washout periods, randomize by etiology and baseline physiological findings, and pursue alternative designs. (
  
  
  BACKGROUND
  00432835.).
authors.affiliation: Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA. tabell@medicine.umsmed.edu
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Abell
authors.forename: William D
authors.initials: WD
authors.lastname: Johnson
authors.forename: Archana
authors.initials: A
authors.lastname: Kedar
authors.forename: J Matthew
authors.initials: JM
authors.lastname: Runnels
authors.forename: Janelle
authors.initials: J
authors.lastname: Thompson
authors.forename: Ernest S
authors.initials: ES
authors.lastname: Weeks
authors.forename: Anil
authors.initials: A
authors.lastname: Minocha
authors.forename: Michael E
authors.initials: ME
authors.lastname: Griswold
mesh_terms: D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy; D005260:Female; D005746:Gastric Emptying; D005753:Gastric Mucosa; D018589:Gastroparesis / Q000150:complications* / Q000628:therapy*; D005773:Gastroscopy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000209:etiology; D011788:Quality of Life; D013997:Time Factors; D014839:Vomiting / Q000209:etiology*; D055815:Young Adult