G.E.S.

Therapy in Drug Refractory Severe Gastroparesis:

Summary of appended literature.

Ideopathic Gastroparesis is a little understood progressive neuromuscular condition

that causes paralysis of the stomach in sufferers. Gastroelectrical stimulation is an
option for the treatment of patients with chronic, intractable (drug-refractory) nausea
and vomiting secondary to gastroparesis. Other options include the palliative
procedures of jejunostomy tube for feeding, gastrostomy tube for stomach
decompression, and pyloroplasty to improve or facilitate gastric emptying.
Electrical stimulation is delivered via an implanted system that consists of a
neurostimulator and two leads. Under general anaesthetic, the stimulating electrode of
each intramuscular lead is fixed to the muscle of the lower stomach. The connector
end of each lead is then attached to the neurostimulator, which is placed in a small
pocket in the abdominal wall via a surgical incision. When the neurostimulator is
turned on, electrical impulses are delivered. A programmer can adjust the rate and
amplitude of stimulation1.
G.E.S therapy is indicated only in severely Gastroparetic patients who have
previously been found to be refractory to conventional pharmacological therapy.
Whilst data is not available on the size of this population in the UK it is estimated in
Ontario to have an annual frequency of between 20 and 150 in a population of 14
million2. This population suffer from frequent vomiting, nausea, early satiety,
declining nutritional status and an increased risk of gastric pseudo-obstruction. As
will be discussed later this has an enormous impact on HRQOL and leads to
significantly increased mortality3.
A number of studies in the 1990s demonstrated the effectiveness of G.E.S. in
increasing gastric emptying in canine models4. These were followed by a number of
small scale studies which demonstrated symptomatic improvement and increased
gastric emptying in humans5. A 2003 double blind study of 33 patients showed
highly significant reduction in vomiting frequency when the implanted G.E.S device
was on versus similar periods during which it was turned off. In an unblinded long
term follow up the same study demonstrated ongoing reduction in symptom severity
at six and twelve months but only a modest improvement in gastric emptying6. The

Details from: http://guidance.nice.org.uk/IPG103

A simple extrapolation suggests a total UK annual frequency of 87 to 653 although higher diabetes
rates in North America mean that a direct correlation is likely to exaggerate UK frequency.
3
BMJ 1995;310:1331-1332 (20 May)., Also Aaron, X et al Anesthesiology 2001; 95:A476 and
http://digestivedistress.com/pdf/alberta_briefing.pdf.
4
For example Bellahsene BE et Al., Acceleration of gastric emptying with electrical stimulation in a
canine model of gastroparesis. Am. J. Physiol, 1992; 262: G826-G834. Also Familoni BO et al.,
Efficacy of electrical stimulation in frequencies higher than basal rate in canine stomach. Dig Dis Sci
1997;42:892-897.
5
For example McCallum RW et al., Gastric pacing improves emptying and symptoms inpatients with
gastroparesis. Gastroenterology 1998;114:456-461. Also Forster J et al Gastric pacing is a new surgical
treatment for gastroparesis. Am J, Surg 2001;182:676-681.
6
Thomas Abell et al., Gastric electrical stimulation for medically refractory gastroparesis
Gastroenterology 2003;125:421-428.
2

authors of this study note that the relationship between decrease in symptoms and
gastric emptying rates is not clearly associated7.
Considering the small size of the relevant population and high levels of co-morbidity
there is now a significant body of literature which demonstrates long term
symptomatic improvement with GES therapy. A longer term study of 55 patients in
Texas showed that total symptom scores declined by 62.5% at three year follow up.
Further, the same study showed a sustained decline in the use of medications,
hospitalization days and nutritional support at 3 years.8
A 2005 study which compared GES with standard pharmacological therapy in a
study of 18 patients found significant improvement in healthcare resource utilization
in the GES arm at 12, 24 and 36 months9. The same study showed increased mortality
in the non-GES arm as well as reduced costs and improved HRQOL beyond three
years in the GES group. According to one study overall costs are reduced by GES
therapy within three years in comparison with the total healthcare costs in a group
managed conventionally10.
Gastroparesis is a debilitating condition that is widely accepted to have a significant
HRQOL impact. There are now a number of studies that show significant and
sustained improvements in HRQOL in patients treated with GES versus conventional
therapy11. Numerous studies have also shown decreased hospitalization, drug usage
and a decline in overall costs of patients treated with GES12.

Thomas Abell et al., Gastric electrical stimulation for medically refractory gastroparesis.
Gastroenterology 2003;125:427.
8
Lin Z et al., Symptom responses, long term outcomes and adverse events beyond three years of high
frequency gastric electrical stimulation for gastroparesis. Neurogastroenterol Motil 2006;18:18-27.
9
Cutts TF et al., Is gastric electrical stimulation superior to standard pharmacologic therapy in
improving GI symptoms, healthcare resources, and long term healthcare benefits? Neurogastroenterol
Motil 2005;17:35-43.
10
Cutts TF et al., Is gastric electrical stimulation superior to standard pharmacologic therapy in
improving GI symptoms, healthcare resources, and long term healthcare benefits? Neurogastroenterol
Motil 2005;17:35-43.
11

For example Zhiyue Lin et al., Chronic gastric electric stimulation for gastroparesis reduces the use
of prokinetic and/or antiemetic medications and the need for hospitalizations. Dig Dis Sci
2005;50:1328-1334. Also Cutts TF et al., Is gastric electrical stimulation superior to standard
pharmacologic therapy in improving GI symptoms, healthcare resources, and long term healthcare
benefits? Neurogastroenterol Motil 2005;17:35-43. Thomas Abell et al., Gastric electrical stimulation
for medically refractory gastroparesis Gastroenterology 2003;125:421-428. Lin Z et al., Symptom
responses, long term outcomes and adverse events beyond three years of high frequency gastric
electrical stimulation for gastroparesis. Neurogastroenterol Motil 2006;18:18-27. Z Lin et al.,
Treatment of diabetic gastroparesis by high frequency gastric electrical stimulation. Diabetes Care
2004;27:1071-1076. Jameson Forster et al., Further experience with gastric stimulation to treat drug
refractory paresis. Am J Surg 2003;186:690-695.
12
See especially Also Cutts TF et al., Is gastric electrical stimulation superior to standard
pharmacologic therapy in improving GI symptoms, healthcare resources, and long term healthcare
benefits? Neurogastroenterol Motil 2005;17:35-43. And Zhiyue Lin et al., Chronic gastric electric
stimulation for gastroparesis reduces the use of prokinetic and/or antiemetic medications and the need
for hospitalizations. Dig Dis Sci 2005;50:1328-1334.

Whilst improvements in gastric emptying have not been shown to correlate closely
with symptom control a number of studies have shown significant improvements in
the nutritional status of patients during GES therapy13.
Safety data presented by the manufacturer suggests that GES implantation carries
similar levels of risk to other procedures involving laparotomy or laparoscopy14.
Conclusions
In summary, GES has been shown to provide an effective long term therapy that
reduces vomiting and nausea in gastroparetic patients. Consequently, it has a
significant positive impact on HRQOL and reduces the need for hospitalization. As a
result a number of studies have found that it is a cost effective therapeutic option.
Under NICE IPG 103 the procedure is authorised for use within the NHS and has
recently been funded by a number of PCTs and SHBs including Tayside, Dumfries
and Galloway, Lothian, Liverpool, Stoke and Essex.
Prepared by Richard Hankins Ph.D., Cert Clin Res. 27/8/07.

13

For example Jameson Forster et al., Further experience with gastric stimulation to treat drug
refractory paresis. Am J Surg 2003;186:690-695. And Richard McCallum et al., Clinical response to
gastric electrical stimulation in patients with postsurgical gastroparesis. Clin Gastroenterol Hepatol
2005;3:49-54.
14
Karolina Minda, Enterra Therapy Gastric Eectrical Stimulation for gastroparesis, European
reimbursement master file, November 2004.