Gastric electrical stimulation with enterra therapy improves symptoms from diabetic gastroparesis in a prospective study

Richard W. McCallum, William Snape, Fredrick Brody, John Wo, Henry P. Parkman, Thomas Nowak

Research output: Contribution to journalArticle

105 Citations (Scopus)

Abstract

Background & Aims: Gastric electrical stimulation (GES) treats refractory gastroparesis by delivering electric current, via electrodes, to gastric smooth muscle. Enterra therapy (Medtronic, Inc, Minneapolis, MN) uses an implantable neurostimulator with a high-frequency, low-energy output. We performed a controlled, multicenter, prospective study to evaluate the safety and efficacy of Enterra therapy in patients with chronic intractable nausea and vomiting from diabetic gastroparesis (DGP). Methods: Patients with refractory DGP (n = 55; mean age, 38 y; 66% female, 5.9 years of DGP) were given implants of the Enterra gastric stimulation system. After surgery, all patients had the stimulator turned on for 6 weeks and then they randomly were assigned to groups that had consecutive 3-month, cross-over periods with the device on or off. After this period, the device was turned on in all patients and they were followed up, unblinded, for 4.5 months. Results: The median reduction in weekly vomiting frequency (WVF) at 6 weeks, compared with baseline, was 57% (P <.001). There was no difference in WVF between patients who had the device turned on or off during the cross-over period (median reduction, 0%; P = .215). At 1 year, the WVF of all patients was significantly lower than baseline values (median reduction, 67.8%; P <.001). Patients also had significant improvements in total symptom score, gastric emptying, quality of life, and median days in the hospital. Conclusions: In patients with intractable DGP, 6 weeks of GES therapy with Enterra significantly reduced vomiting and gastroparetic symptoms. Patients had improvements in subjective and objective parameters with chronic stimulation after 12 months of GES, compared with baseline.

Original languageEnglish (US)
JournalClinical Gastroenterology and Hepatology
Volume8
Issue number11
DOIs
StatePublished - Nov 2010
Externally publishedYes

Fingerprint

Gastroparesis
Electric Stimulation
Stomach
Prospective Studies
Vomiting
Therapeutics
Equipment and Supplies
Implantable Neurostimulators
Electric Stimulation Therapy
Gastric Emptying
Nausea
Multicenter Studies
Smooth Muscle
Electrodes
Quality of Life
Safety

Keywords

  • Enterra Therapy
  • Gastric Electrical Stimulation
  • Gastroparesis

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

Cite this

Gastric electrical stimulation with enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. / McCallum, Richard W.; Snape, William; Brody, Fredrick; Wo, John; Parkman, Henry P.; Nowak, Thomas.

In: Clinical Gastroenterology and Hepatology, Vol. 8, No. 11, 11.2010.

Research output: Contribution to journalArticle

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