Evidence map›Paper›PMID 23895180›Full record

Trial reportNeurogastroenterology and motility2013

Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis.

R W McCallum, I Sarosiek, H P Parkman, W Snape, F Brody, J Wo, T Nowak

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neurogastroenterology and motility, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05039424 (A Randomized, Sham-controlled Trial), which is not on this map. Cited by 54 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 1 pooled it
4.9field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05039424 naactive not recruitingnot on this mapstarted 2022, after this paper: background citation

A Randomized, Sham-controlled Trial: Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms (EMPTIES)

TypeinterventionalSponsorMatthew AllemangRan2022 to 2027Enrolled100ConditionsGastroparesisArmsEndoscopic per-oral pyloromyotomy (POP), Diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 1 synthesis or guideline pooled it, 110 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Methods and Techniques for Closed-Loop Gastrointestinal Pacing.Neurogastroenterology and motility · 2026
    Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Reconsideration of the Gastroparetic Syndrome.Current gastroenterology reports · 2023
    Review
  14. Gastroparesis: Myths, Misconceptions, and Management.Clinical and experimental gastroenterology · 2023
    Review
  15. Article
  16. Review
  17. POEM, GPOEM, and ZPOEM.Digestive diseases and sciences · 2022
    Review
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

R W McCallumDepartment of Internal Medicine, Texas Tech University Health Sciences Center, El Paso, TX, USA.
I Sarosiek
H P Parkman
W Snape
F Brody
J Wo
T Nowak
Indiana University IndianapolisTexas Tech University · USCalifornia Pacific Medical Center · USTemple University · USWashington University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGastric electrical stimulation (GES) is a therapeutic option for intractable symptoms of gastroparesis (GP). Idiopathic GP (ID-GP) represents a subset of GP.

aimsA prospective, multicenter, double-blinded, randomized, crossover study to evaluate the safety and efficacy of Enterra GES in the treatment of chronic vomiting in ID-GP.

methodsThirty-two ID-GP subjects (mean age 39; 81% F, mean 7.7 years of GP) were implanted with GES. The stimulator was turned ON for 1½ months followed by double-blind randomization to consecutive 3-month crossover periods with the device either ON or OFF. ON stimulation was followed in unblinded fashion for another 4.5 months. Twenty-five subjects completed the crossover phase and 21 finished 1 year of follow-up. KEY

resultsDuring the unblinded ON period, there was a reduction in weekly vomiting frequency (WVF) from baseline (61.2%, P < 0.001). There was a non-significant reduction in WVF between ON vs OFF periods (the primary outcome) with median reduction of 17% (P > 0.10). Seventy-five percent of patients preferred the ON vs OFF period (P = 0.021). At 1 year, WVF remained decreased (median reduction = 87%, P < 0.001), accompanied by improvements in GP symptoms, gastric emptying and days of hospitalization (P < 0.05). CONCLUSIONS & INFERENCES: (i) In this prospective study of Enterra GES for ID-GP, there was a reduction in vomiting during the initial ON period; (ii) The double-blind 3-month periods showed a non-significant reduction in vomiting in the ON vs OFF period, the primary outcome variable; (iii) At 12 months with ON stimulation, there was a sustained decrease in vomiting and days of hospitalizations.

Indexed as

AdultCross-Over StudiesDouble-Blind MethodElectric Stimulation TherapyElectrodes, ImplantedFemaleGastroparesisHumansMaleMiddle AgedTreatment OutcomeVomitingYoung Adultgastric stimulationgastroparesisidiopathic gastroparesisnauseavomiting

Identifiers

PMID23895180
PMCPMC4274014
OpenAlexW2097142381

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.