Gastric electrical stimulation for medically refractory gastroparesis.
OBJECTIVE
This study investigated the efficacy of gastric electrical stimulation for the treatment of symptomatic gastroparesis unresponsive to standard medical therapy.


METHODS
Thirty-three patients with chronic gastroparesis (17 diabetic and 16 idiopathic) received continuous high-frequency/low-energy gastric electrical stimulation via electrodes in the muscle wall of the antrum connected to a neurostimulator in an abdominal wall pocket. After implantation, patients were randomized in a double-blind crossover design to stimulation ON or OFF for 1-month periods. The blind was then broken, and all patients were programmed to stimulation ON and evaluated at 6 and 12 months. Outcome measures were vomiting frequency, preference for ON or OFF, upper gastrointestinal tract symptoms, quality of life, gastric emptying, and adverse events.


RESULTS
In the double-blind portion of the study, self-reported vomiting frequency was significantly reduced in the ON vs. OFF period (P < 0.05) and this symptomatic improvement was consistent with the significant patient preference (P < 0.05) for the ON vs. OFF period determined before breaking the blind. In the unblinded portion of the study, vomiting frequency decreased significantly (P < 0.05) at 6 and 12 months. Scores for symptom severity and quality of life significantly improved (P < 0.05) at 6 and 12 months, whereas gastric emptying was only modestly accelerated. Five patients had their gastric electrical stimulation system explanted or revised because of infection or other complications.


CONCLUSIONS
High-frequency/low-energy gastric electrical stimulation significantly decreased vomiting frequency and gastrointestinal symptoms and improved quality of life in patients with severe gastroparesis.
Abell
Thomas
T
University of Mississippi, Jackson, Mississippi, USA.
McCallum
Richard
R
Hocking
Michael
M
Koch
Kenneth
K
Abrahamsson
Hasse
H
Leblanc
Isabelle
I
Lindberg
Greger
G
Konturek
Jan
J
Nowak
Thomas
T
Quigley
Eammon M M
EM
Tougas
Gervais
G
Starkebaum
Warren
W
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy; D005260:Female; D005746:Gastric Emptying; D018589:Gastroparesis / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged