A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis

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. Design, Setting, and Patients: 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). Intervention: 72 continuous hours temporary GES was provided for group A during session 1, and for group B during session 2. Main Outcome Measurements: 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. Limitations: 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. (Clinical trial registration number: 00432835.)