High-frequency/low-energy gastric electrical stimulation significantly decreases vomiting and gastrointestinal symptoms in patients with gastroparesis.
“The results of a clinical study have definitively demonstrated the promise of gastric electrical stimulation for patients whose lives are seriously affected by one of the world’s most tragic diseases,” lead author Thomas Abell, from the University of Mississippi School of Medicine in Jackson, says in a news release. “Gastric electrical stimulation is an important treatment option for patients with gastroparesis who no longer respond to standard medication.”
Of 33 patients with chronic gastroparesis enrolled at 11 U.S., European, and Canadian medical centers, 17 had diabetic and 16 idiopathic gastroparesis. All received Enterra therapy, consisting of continuous high-frequency/low-energy gastric electrical stimulation delivered via electrodes in the muscle wall of the antrum connected to a neurostimulator in an abdominal wall pocket.
After electrode implantation, patients were randomized in a double-blind crossover design to receive stimulation or no stimulation each for one month. All patients then received continuous stimulation and were re-evaluated at six and 12 months.
During the double-blind portion of the study, self-reported vomiting frequency was 50% lower during periods of stimulation than during periods of no stimulation (P < .05), and patients preferred periods of stimulation to periods of no stimulation (P < .05).
At six and 12 months, vomiting frequency decreased (P < .05), scores for symptom severity and quality of life improved (P < .05), and gastric emptying was modestly accelerated. Scores comparing quality of life before and after receiving Enterra therapy showed reductions in bodily pain and improvements in physical functioning, general health, vitality, and social functioning. Symptom improvement was more consistent in the diabetic than in the idiopathic subgroup.
Infection or other complications led to explanation or revision of the gastric electrical stimulation system in five patients.
“The symptoms of gastroparesis are so severe that these patients become debilitated. Enterra therapy provides new hope for these young patients — 20 to 65 years old — by returning them to their functional personal and professional lives,” says coauthor Richard McCallum, from the University of Kansas School of Medicine in Kansas City. “It is the most impressive long-term result for gastroparesis that I have seen during the 25 years I have studied gastroenterology.”
The investigators suggest that 25% to 50% of patients referred for treatment of gastroparesis refractory to conventional medical therapy may be candidates for Enterra therapy. They recommend that future studies include a postoperative recovery time of one to three months before randomization and that electrical stimulation in placebo-controlled studies be extended to at least three months.
Medtronic, Inc., helped support this study. Gastroenterology. 2003;125:421-428
“Diabetes in Control 10,000 Step Study 30 Million Steps and 15,000 Miles Later”
Because of the Diabetes In Control Study, more than 8500 patients have started the Step Program.
Have a program for your office. Click Here