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. 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.)

Temporary Endoscopic Stimulation in Gastroparesis-like Syndrome

“…In prior trials temporary GES predicted improvement with permanent GES and tGES has been validated using a double-masked crossover study. 10,21 Notwithstanding these limitations, our study demonstrated that temporary endoscopic GES is an effective therapy for gastroparesis and GLS. We also demonstrated a new possible entity of GLS categorized by RGE.…”

“…Patients/insurers paid for all costs, including temporary GES implantation and gastric scintigraphy studies with consecutive patients signing a consent for the protocol. The temporary GES system used in this study has been previously described 10 and includes an FDA approved temporary cardiac pacing lead (Medtronic model 6416), and an FDA approved implantable pulse generator (Medtronic 3116). Briefly, patients undergo upper endoscopy with a standard 140 cm long endoscope with a 7F accessory channel.…”

“…Patients, regardless of gastric emptying results, then underwent implantation with tGES as previously described, 10 with patients undergoing test stimulation implantation for a period of 5 days.…”

Early Assessment of Cost-effectiveness of Gastric Electrical Stimulation for Diabetic Nausea and Vomiting

“…11 However, in another study from the same group, vomiting and nausea improved both during on and off periods. 25 In a doubleblinded, randomized crossover study among 32 patients with idiopathic GP, nausea and vomiting improved non-significantly both with the stimulator on and off, but with a trend towards more improvement with the stimulator on. However, the lack of a washout period between the on and off phases may have compromised the data in the study.…”

“…GES has proven to be superior to placebo in 4 placebocontrolled trials in patients with diabetic, post-surgical, or idiopathic recurrent nausea and/or vomiting. 11,[23][24][25][26] In a double-blinded, randomized, crossover study, symptoms and quality of life improved significantly more while the stimulator was on than when off. 11 However, in another study from the same group, vomiting and nausea improved both during on and off periods.…”