Gastroenterol Res

Gastroenterology Research, ISSN 1918-2805 print, 1918-2813 online, Open Access

Article copyright, the authors; Journal compilation copyright, Gastroenterol Res and Elmer Press Inc

Journal website http://www.gastrores.org

Original Article

Volume 11, Number 5, October 2018, pages 349-354

Efficacy of Gastric Electrical Stimulation for Gastroparesis: US/European Comparison

Figure 1. The European centers (a) has a larger mean proportion of DGP patients compared to US centers (b) (59% vs. 22%) and a smaller mean proportion of IGP patients (25% vs. 72%). The figures show the number of patients (IGP, DGP, PGP) at each centre (A-H).

Figure 2. Algorithm for diagnosis and treatment of gastroparesis in US vs. Europe (European differences in bold).

**Table 1.** Data From US and European Centers
Center	Number of patients	Sex: F	Sex: M	Age	IGP	DGP	PGP	GET	Months	Change in TSS
The proportion of males to females was 1:4.2 in the US and 1:1.7 in Europe. Values for GET, months since implant, change in vomiting, and change in total symptom score (TSS) are presented as means. IGP: idiopathic gastroparesis; DGP: diabetic gastroparesis; GET: gastric emptying test; F: female; M: male.
Europe	61	38	23	41	15	36	10	100%	35	-48
US	319	258	61	42	231	71	17	75%	49	-38
Combined	380	296	84	42	246	107	27	88%	47	-38.5

Table 1. Data From US and European Centers

Center

Number of patients

Sex: F

Sex: M

Age

IGP

DGP

PGP

GET

Months

Change in TSS

The proportion of males to females was 1:4.2 in the US and 1:1.7 in Europe. Values for GET, months since implant, change in vomiting, and change in total symptom score (TSS) are presented as means. IGP: idiopathic gastroparesis; DGP: diabetic gastroparesis; GET: gastric emptying test; F: female; M: male.

Europe

100%

-48

319

258

231

75%

-38

Combined

380

296

246

107

88%

-38.5

**Table 2.** Fisher Exact Test to Determine Gender Differences in Gastroparesis Patients by Region
	Male	Female	Totals	P-value (< 0.05)
Europe	23	38	61
United States	61	258	319
Totals	84	269	380	< 0.05

Table 2. Fisher Exact Test to Determine Gender Differences in Gastroparesis Patients by Region

Male

Female

Totals

P-value (< 0.05)

Europe

United States

258

319

Totals

269

380

< 0.05

**Table 3.** Difference Between the Etiologies of Gastropathy Treated with GES by Region
	IGP	DGP	PGP	Totals	P-value (< 0.05)
Europe	15	36	10	61
United States	231	71	17	319
Totals	246	107	27	380	< 0.05

Table 3. Difference Between the Etiologies of Gastropathy Treated with GES by Region

IGP

DGP

PGP

Totals

P-value (< 0.05)

Europe

United States

231

319

Totals

246

107

380

< 0.05

**Table 4.** Metanalyses Assessing Effectiveness of Gastric Electrical Stimulation
Study title	Authors	General conclusion
NICE guidance on gastroelectrical stimulation for gastroparesis	Kong (2015) [17]	Severe diabetics with severe symptoms may benefit from therapy.
High-frequency gastric electrical stimulation for the treatment of gastroparesis: a meta-analysis	O’Grady et al (2009) [20]	Beneficial in improving symptoms in patients with gastroparesis.
Systematic review and meta-analysis: gastric electrical stimulation for gastroparesis	Levinthal et al (2017) [19]	Argues against the use of GES outside of strict clinical trials as viable treatment option.
Gastric electrical stimulation with the Enterra system: a systematic review	Lal et al (2015) [16]	GES appears to offer significant improvement in symptom control in a subset of patients.
Treatment of high-frequency gastric electrical stimulation for gastroparesis	Chu et al (2012) [18]	GES is an effective modality for treating gastroparesis refractory to less invasive treatment.

Table 4. Metanalyses Assessing Effectiveness of Gastric Electrical Stimulation

Study title

Authors

General conclusion

NICE guidance on gastroelectrical stimulation for gastroparesis

Kong (2015) [17]

Severe diabetics with severe symptoms may benefit from therapy.

High-frequency gastric electrical stimulation for the treatment of gastroparesis: a meta-analysis

O’Grady et al (2009) [20]

Beneficial in improving symptoms in patients with gastroparesis.

Systematic review and meta-analysis: gastric electrical stimulation for gastroparesis

Levinthal et al (2017) [19]

Argues against the use of GES outside of strict clinical trials as viable treatment option.

Gastric electrical stimulation with the Enterra system: a systematic review

Lal et al (2015) [16]

GES appears to offer significant improvement in symptom control in a subset of patients.

Treatment of high-frequency gastric electrical stimulation for gastroparesis

Chu et al (2012) [18]

GES is an effective modality for treating gastroparesis refractory to less invasive treatment.

**Table 5.** Controlled Trials Assessing Effectiveness of Gastric Electrical Stimulation
Study title	Authors	General conclusion
A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis	Abell et al (2011) [23]	Temporary GES may improve symptoms such as vomiting.
Gastric electrical stimulation is associated with improvement in pancreatic exocrine function in humans	Luo et al (2004) [25]	GES had noted effects on autonomic control, improvement in exocrine pancreatic enzyme release, and improvement in GI symptoms.
Gastric electrical stimulation for medically refractory gastroparesis	Abell et al (2003) [22]	GES set to high-frequency/low-energy decreased vomiting frequency and GI symptoms.
Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis	McCallum et al (2013) [26]	GES implanted with ON stimulation was shown to decrease vomiting symptoms and days of hospitalizations.
Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study	McCallum et al (2010) [27]	GES for 6 weeks significantly reduced vomiting and gastroparetic symptoms for diabetic gastroparesis.
Effectiveness of gastric electrical stimulation in gastroparesis: results from a large prospectively collected database of a national gastroparesis registry	Abell et al (2015) [24]	Patients treated with GES had clinically significant improvement in gastroparesis symptoms.
Gastric electrical stimulation (GES) for refractory vomiting: results of a prospective multicenter double-blinded randomized controlled cross-over trial	Ducrotte et al (2017) [21]	GES was associated with significant reduction of symptoms in both diabetic and non diabetic gastroparesis patients.
Is gastric electrical stimulation superior to standard pharmacologic therapy in improving GI symptoms, healthcare resources, and long-term healthcare benefits?	Cutts et al (2005) [28]	GES was found to be more effective in improving long-term GI symptoms, decreased costs, and less use of healthcare resources than intensive medical therapy.

Table 5. Controlled Trials Assessing Effectiveness of Gastric Electrical Stimulation

Study title

Authors

General conclusion

A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis

Abell et al (2011) [23]

Temporary GES may improve symptoms such as vomiting.

Gastric electrical stimulation is associated with improvement in pancreatic exocrine function in humans

Luo et al (2004) [25]

GES had noted effects on autonomic control, improvement in exocrine pancreatic enzyme release, and improvement in GI symptoms.

Gastric electrical stimulation for medically refractory gastroparesis

Abell et al (2003) [22]

GES set to high-frequency/low-energy decreased vomiting frequency and GI symptoms.

Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis

McCallum et al (2013) [26]

GES implanted with ON stimulation was shown to decrease vomiting symptoms and days of hospitalizations.

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

McCallum et al (2010) [27]

GES for 6 weeks significantly reduced vomiting and gastroparetic symptoms for diabetic gastroparesis.

Effectiveness of gastric electrical stimulation in gastroparesis: results from a large prospectively collected database of a national gastroparesis registry

Abell et al (2015) [24]

Patients treated with GES had clinically significant improvement in gastroparesis symptoms.

Gastric electrical stimulation (GES) for refractory vomiting: results of a prospective multicenter double-blinded randomized controlled cross-over trial

Ducrotte et al (2017) [21]

GES was associated with significant reduction of symptoms in both diabetic and non diabetic gastroparesis patients.

Is gastric electrical stimulation superior to standard pharmacologic therapy in improving GI symptoms, healthcare resources, and long-term healthcare benefits?

Cutts et al (2005) [28]

GES was found to be more effective in improving long-term GI symptoms, decreased costs, and less use of healthcare resources than intensive medical therapy.