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Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis
Author(s) -
McCallum R. W.,
Sarosiek I.,
Parkman H. P.,
Snape W.,
Brody F.,
Wo J.,
Nowak T.
Publication year - 2013
Publication title -
neurogastroenterology and motility
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.489
H-Index - 105
eISSN - 1365-2982
pISSN - 1350-1925
DOI - 10.1111/nmo.12185
Subject(s) - gastroparesis , vomiting , medicine , crossover study , randomization , nausea , prospective cohort study , gastric emptying , gastroenterology , anesthesia , randomized controlled trial , stomach , placebo , alternative medicine , pathology
Background Gastric electrical stimulation ( GES ) is a therapeutic option for intractable symptoms of gastroparesis ( GP ). Idiopathic GP ( ID ‐ GP ) represents a subset of GP . AIMS : A 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 . Methods Thirty‐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 Results During 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.