T1029 Lack of Utility of Lactulose Breath Testing in the Irritable Bowel Syndrome (IBS)

Abstract

Background & Aims: High-frequency gastric electrical stimulation (GES) is a relatively new treatment for medically-refractory gastroparesis. A commercial device is available (Enterra, Medtronic, Minneapolis), and a number of clinical studies have been published reporting the efficacy of this treatment. A systematic review and meta-analysis was performed to evaluate the evidence for improved clinical outcome. 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 a range of clinical outcomes were evaluated. Studies of external, temporary and/or low frequency GES were excluded. Because of a paucity of controlled trials, non-controlled clinical trials were also included for analysis. Results: Of the 26 studies located, 13 were accepted for inclusion. Of these 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 [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-hour gastric emptying (5/13, mean improvement 12.7% [CI: 9.8, 15.6], p<0.0001). Weight gain following stimulation did not reach significance (3/13, 3.68kg [CI: -0.23, 7.58], p=0.07). The device removal or reimplantation rate was 8.3%, primarily due to infection (3%) or problems occurring at the site of implantation (4.9%). Conclusions This systematic review, of the best available evidence, finds significant and clinically important benefits for high-frequency GES in the treatment ofmedically-refractory gastroparesis. However, caution is necessary in interpreting the results, primarily due to the limitations of uncontrolled studies. Further controlled studies are required to confirm the clinical benefits of high-frequency GES. Results here provide strong grounds for the further development and evaluation of high-frequency GES.