Background & aims: High-frequency gastric electrical stimulation (GES) is a relatively new treatment for medically refractory gastroparesis. There have been a number of clinical studies based on the use of a high-frequency stimulator (Enterra, Medtronic, Minneapolis, MN). A meta-analysis was performed to evaluate evidence for improved clinical outcome with this device.
Methods: A literature search of major medical databases was performed for the period January 1992 to August 2008. Clinical studies involving an implanted high-frequency GES device were included and reported a range of clinical outcomes. Studies of external, temporary, and/or low-frequency GES were excluded.
Results: Of 13 included studies, 12 lacked controls and only one was blinded and randomized. Following GES, patients reported improvements in total symptom severity score (3/13 studies, mean difference 6.52 [confidence interval--CI: 1.32, 11.73]; P = 0.01), vomiting severity score (4/13, 1.45 [CI: 0.99, 1.91]; P < 0.0001), nausea severity score (4/13, 1.69 [CI: 1.26, 2.12]; P < 0.0001), SF-36 physical composite score (4/13, 8.05 [CI: 5.01, 11.10]; P < 0.0001), SF-36 mental composite score (4/13, 8.16 [CI: 4.85, 11.47]; P < 0.0001), requirement for enteral or parenteral nutrition (8/13, OR 5.53 [CI: 2.75, 11.13]; P < 0.001), and 4-h gastric emptying (5/13, 12.7% [CI: 9.8, 15.6]; P < 0.0001). Weight gain did not reach significance (3/13, 3.68 kg [CI: -0.23, 7.58]; P = 0.07). The device removal or reimplantation rate was 8.3%.
Conclusions: Results show substantial benefits for high-frequency GES in the treatment of gastroparesis. However, caution is necessary in interpreting the results, primarily because of the limitations of uncontrolled studies. Further controlled studies are required to confirm the clinical benefits of high-frequency GES.