Gastric Electrical Stimulation With Enterra Therapy Improves Symptoms From Diabetic Gastroparesis in a Prospective Study

BACKGROUND & AIMS Gastric electrical stimulation (GES) treats refractory gastroparesis by delivering electric cur rent, via electrodes, to gastric smooth muscle Enterra therapy (Medtronic, Inc, Minneapolis, MN) uses an implantable neuro stimulator with a high frequency, low energy output We per formed a controlled, multicenter, prospective study to evaluate the safety and efficacy of Enterra therapy in patients with chronic intractable nausea and vomiting from diabetic gastroparesis (DGP) METHODS Patients with refractory DGP (n = SS, mean age, 38 y, 66% female, 5 9 years of DGP) were given implants of the Enterra gastric stimulation system After surgery, all patients had the stimulator turned on for 6 weeks and then they randomly were assigned to groups that had consecutive 3 month, cross over periods with the device on or off After this period, the device was turned on in all patients and they were followed up, unblinded, for 45 months RESULTS The median reduction in weekly vomiting frequency (WVF) at 6 weeks, compared with baseline, was 57% (P < 001) There was no difference in WVF between patients who had the device turned on or off during the cross over period (median reduction, 0%, P = 215) At 1 year, the WVF of all patients was significantly lower than baseline values (median reduction, 67 8%, P < 00 L) Patients also had significant improvements in total symptom score, gastric emptying, quality of life, and median days in the hospital CONCLUSIONS In patients with intractable DGP, 6 weeks of GES therapy with Enterra significantly reduced vomiting and gastroparetic symptoms Patient. had improvements in subjective and objective parameters with chronic stimulation after 12 months of GES, compared with baseline