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.)
Background: Drug-refractory gastroparesis has previously been without acceptable alternative therapies. Although gastric electrical stimulation has been used for over a decade, no long-term multicenter data exist. Methods: We studied 214 consecutive drug-refractory patients with the symptoms of gastroparesis (146 idiopathic, 45 diabetic, 23 after surgery) who consented to participate in a variety of clinical research and clinical protocols at three centers from January 1992 through January 2005, resulting in 156 patients implanted with a gastric electrical stimulation device and the other 58 patients serving as controls. The patients were stratified into three groups: (1) consented but never permanently implanted; (2) implanted with permanent device, and (3) consented while awaiting a permanent device. The patients were followed over time for gastrointestinal symptoms, solid gastric emptying, health-related quality of life, survival, device retention, and complications. Demographics, descriptive statistics, and t tests were used for comparison between baseline and latest follow-up. Results: At latest follow-up, median 4 years for 5,568 patient months, most patients implanted (135 of 156) were alive with intact devices, significantly reduced gastrointestinal symptoms, and improved health-related quality of life, with evidence of improved gastric emptying, and 90% of the patients had a response in at least 1 of 3 main symptoms. Most patients explanted, usually for pocket infections, were later reimplanted successfully. There were no deaths directly related to the device. Conclusion: Based on this sample of patients, implanted with gastric electrical stimulation devices at three centers and followed for up toward a decade, gastric electrical stimulation for drug-refractory gastroparesis is both safe and effective.
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