Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis

• Published in: Neurogastroenterology and motility Vol. 25; no. 10; pp. 815 - e636
• Main Authors: McCallum, R. W., Sarosiek, I., Parkman, H. P., Snape, W., Brody, F., Wo, J., Nowak, T.
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.10.2013; BlackWell Publishing Ltd
• Subjects: Adult; Cross-Over Studies; Double-Blind Method; Electric Stimulation Therapy - methods; Electrodes, Implanted; Female; gastric stimulation; gastroparesis; Gastroparesis - complications; Gastroparesis - therapy; Humans; idiopathic gastroparesis; Male; Middle Aged; nausea; Original; Treatment Outcome; vomiting; Vomiting - etiology; Vomiting - therapy; Young Adult; idiopathic gastroparesis; gastric stimulation; gastroparesis; nausea; vomiting
• ISSN: 1350-1925; 1365-2982
• DOI: 10.1111/nmo.12185

Background Gastric electrical stimulation (GES) is a therapeutic option for intractable symptoms of gastroparesis (GP). Idiopathic GP (ID‐GP) represents a subset of GP. AIMS: 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. Key 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 & Inferences (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.