Enterra for gastroparesis

To the editor: Gastric stimulation with the Enterra device (Medtronic, Minneapolis, MN) has been advocated as an effective therapy in patients with diabetic or idiopathic gastroparesis. To date, however, there are no published controlled data providing evidence of its value over placebo. In fact, the data submitted to the U.S. Food and Drug Administration to gain its Humanitarian Device Exemption showed similar reductions in nausea and vomiting scores whether the device was in the "on" or "off" mode (1).