Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Cross-Over Trial.

Abstract

BACKGROUND & AIMS\nThere have been conflicting results from trials of gastric electrical stimulation (GES) for treatment of refractory vomiting, associated or not with gastroparesis. We performed a large, multicenter, randomized, double-blind trial with cross-over to study the efficacy of GES in patients with refractory vomiting, with or without gastroparesis.\n\n\nMETHODS\nFor 4 months, we assessed symptoms in 172 patients (66% women; mean age 45±12 years; 133 with gastroparesis) with chronic (more than 12 months) of refractory vomiting (idiopathic, associated with a type 1 or 2 diabetes, or post-surgical). A gastric electrical stimulation device was implanted and left unactivated until subjects were randomly assigned, in a double-blind manner, to groups that received 4 months stimulation parameters (14 Hz, 5 mA, pulses of 330 μsec) or no stimulation (controls); 149 patients then crossed over to the other group for 4 months. Patients were examined at the end of each 4-months period (at 5 and 9 months after implantation). Primary end-points were the vomiting score ranging from 0 (daily vomiting) to 4 (no vomiting) and the quality of life, assessed by the GIQLI scoring system. Secondary endpoints were changes in other digestive symptoms, nutritional status, gastric emptying, and control of diabetes.\n\n\nRESULTS\nDuring both phases of the cross-over study, vomiting scores were higher in the group with the device on (median score, 2) than the control group (median score, 1; P<.001), in diabetic and non-diabetic patients. Vomiting scores increased significantly when the device was on in patients with delayed (P<.01) or normal gastric emptying (P=.05). Gastric emptying was not accelerated during the on period compared with the off period. Having the GES turned on was not associated with increased quality of life.\n\n\nCONCLUSIONS\nIn a randomized cross-over study, we found GES to reduce the frequency of refractory vomiting in patients with and without diabetes, although it did not accelerate gastric emptying or increase of quality of life. Clinicaltrials.gov no: NCT00903799.