Original articleClinical endoscopyA double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis
Section snippets
Methods
The Institutional Review Board at the University of Mississippi Medical Center approved all study protocols. An investigative device exemption was received from the Food and Drug Administration, and the study, conducted from July 2005 through October 2006, with long-term follow-up through November 2007, was registered as Clinical Trial 00432835.
Results
Table 1 provides a summary of patient baseline symptoms, demographics, and physiology for all study participants. Most study participants were female and white, had idiopathic Gp, and ranged in age from 23 to 77 years. Randomization produced a reasonably good balance among baseline inclusion characteristics. Nevertheless, the baseline vomiting score was 1.82 for group A and 2.68 for group B (differential = −0.86; 95% CI, −1.70 to −0.03; P = .043), implying some difference in the primary outcome
Discussion
The primary aim of this masked, crossover study was to measure the reduction of patient-reported GI symptoms during 72-hours of endoscopically implanted, tGES. Vomiting decreased for both stimulated and nonstimulated groups in session 1, with a larger decrease for the stimulated group (90%) than for the nonstimulated group (55%). In session 2, changes in symptoms were more moderate for both groups, leading to a nonsignificant overall treatment effect. Treatment effects appeared somewhat
Conclusion
This double-masked, randomized, crossover study showed that endoscopically placed, tGES may reduce symptoms such as vomiting and nausea. tGES may help indicate whether a patient is likely to benefit from permanent stimulation, sparing both cost and invasive surgery in patients in whom tGES does not provide relief. Unexpected difficulties that arose during the study impede our ability to make conclusive therapeutic statements; however, we did note important differences between stimulation groups
Acknowledgments
The authors thank Edy Sofer, MD, and Warren Starkebaum, PhD, for their suggestions on trial design. We also thank Greg O'Grady, MD, for his review of the manuscript. Finally, we thank the staff of the GI Division, GI Laboratory, and Department of Nuclear Medicine at the University of Mississippi Medical Center for their help with this study, and Jo Anne Fordham for her assistance with manuscript production.
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DISCLOSURE: The following author disclosed a financial relationship relevant to this publication: Dr. Abell: a licensee, consultant, and investigator for Medtronic, Inc. The other authors disclosed no financial relationships relevant to this publication. Supported in part by Medtronic, Inc. The University of Mississippi has filed an Intellectual Property claim regarding aspects of the technology used in this study.
If you would like to chat with an author of this article, you may contact Dr. Abell at [email protected].