A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis - 27/08/11
Reprint requests: Thomas L. Abell, MD, Division of Digestive Diseases, University of Mississippi Medical Center, Jackson, MS 39216Riassunto |
Background |
Endoscopically placed, temporary gastric electrical stimulation (tGES) may relieve symptoms of gastroparesis (Gp) and predict permanent gastric electrical stimulation (GES) outcomes.
Objective |
To measure effects of 72 hours of temporary GES on Gp symptoms.
Design, Setting, and Patients |
From 2005 to 2006, we conducted a hospital-based, randomized, placebo-controlled, crossover trial of two consecutive, 4-day sessions (session 1 and session 2), enrolling 58 patients (11 males, 47 females; mean age 46 years) with GP symptom histories of three etiologies (idiopathic, 38; diabetes mellitus, 13; postsurgical, 7).
Intervention |
72 continuous hours temporary GES was provided for group A during session 1, and for group B during session 2.
Main Outcome Measurements |
Symptoms measured daily; gastric emptying, electrogastrography, and quality of life measured at baseline and session close.
Results |
In session 1, vomiting decreased in both groups, but was greater with stimulation, resulting in a day 3 difference of −1.02 (95% CI, −1.62 to −0.42; P < .001). Scores did not return to baseline during washout; on day 4, the difference persisted at −1.08 (95% CI, −1.81 to −0.35; P = .005). In session 2, vomiting slightly decreased with stimulation and slightly increased without it; at day 8, the nonactivated group had nonsignificantly greater vomiting, 0.12 (−0.68 to 0.92; P = .762). An overall treatment effect of a slight, nonsignificant daily decrease in average vomiting scores, −0.12 (−0.26 to 0.03; P = .116), was observed by pooling stimulation effects across sessions.
Limitations |
Missing data; potential physiological imbalances between groups.
Conclusions |
Although overall treatment effects were not significant, differences in favor of stimulation were suggested. Barriers to observing treatment effects included a decrease in vomiting for both groups during session 1, insufficient washout, and the absence of baseline vomiting for some patients. Future studies should better define inclusion criteria, use longer washout periods, randomize by etiology and baseline physiological findings, and pursue alternative designs. (Clinical trial registration number: 00432835.)
Il testo completo di questo articolo è disponibile in PDF.Abbreviations : EGG, Gp, GES, GET, tGES
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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. |
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| If you would like to chat with an author of this article, you may contact Dr. Abell at tabell@medicine.umsmed.edu. |
Vol 74 - N° 3
P. 496 - settembre 2011 Ritorno al numero
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