Philippe Ducrotte1, Benoit Coffin2, Bruno Bonaz3, Sébastien Fontaine4, Stanislas Bruley Des Varannes5, Frank Zerbib6, Robert Caiazzo7, Jean Charles Grimaud8, Francois Mion9, Samy Hadjadj10, Paul Elie Valensi11, Lucine Vuitton12, Guillaume Charpentier13, Alain Ropert14, Romain Altwegg15, Philippe Pouderoux16, Etienne Dorval17, Michel Dapoigny18, Henri Duboc2, Pierre Yves Benhamou3, Aurelie Schmidt19, Nathalie Donnadieu1, Guillaume Gourcerol20, Bruno Guerci21. 1. Rouen University Hospital-Inserm UMR 1073/Inserm CIC-CRB 1404, Rouen, France. 2. Paris-HP Louis Mourier Hospital, Colombes, France. 3. Grenoble University Hospital, Grenoble, France. 4. Toulouse University Hospital, Toulouse, France. 5. Nantes University Hospital, Nantes, France. 6. Department of Gastroenterology, Hepatology, and Digestive Oncology, Bordeaux University Hospital, Bordeaux, France. 7. Lille University Hospital, Lille, France. 8. Marseille University Hospital, Marseille, France. 9. Lyon Hôpital E. Herriot, Lyon, France. 10. Poitiers University Hospital, Poitiers, France. 11. Paris-HP Jean Verdier Hospital, Bondy, France. 12. Besancon University Hospital, Besancon, France. 13. Corbeil-Essonnes Central Hospital, Corbeil-Essonnes, France. 14. Rennes University Hospital, Rennes, France. 15. Montpellier University Hospital-Lapeyronie, Montpellier, France. 16. Nimes University Hospital, Nimes, France. 17. Tours University Hospital, Tours, France. 18. Clermont-Ferrand University Hospital, Clermont Ferrand, France. 19. Steve Consultants, Oullins, France. 20. Rouen University Hospital-Inserm UMR 1073/Inserm CIC-CRB 1404, Rouen, France. Electronic address: guillaume.gourcerol@chu-rouen.fr. 21. Nancy University Hospital, Nancy, France.
Abstract
BACKGROUND & AIMS: There have been conflicting results from trials of gastric electrical stimulation (GES) for treatment of refractory vomiting, associated or not with gastroparesis. We performed a large, multicenter, randomized, double-blind trial with crossover to study the efficacy of GES in patients with refractory vomiting, with or without gastroparesis. METHODS: For 4 months, we assessed symptoms in 172 patients (66% women; mean age ± standard deviation, 45 ± 12 years; 133 with gastroparesis) with chronic (>12 months) of refractory vomiting (idiopathic, associated with a type 1 or 2 diabetes, or postsurgical). A GES device was implanted and left unactivated until patients were randomly assigned, in a double-blind manner, to groups that received 4 months of stimulation parameters (14 Hz, 5 mA, pulses of 330 μs) or no stimulation (control); 149 patients then crossed over to the other group for 4 months. Patients were examined at the end of each 4-month period (at 5 and 9 months after implantation). Primary endpoints were vomiting score, ranging from 0 (daily vomiting) to 4 (no vomiting), and the quality of life, assessed by the Gastrointestinal Quality of Life Index scoring system. Secondary endpoints were changes in other digestive symptoms, nutritional status, gastric emptying, and control of diabetes. RESULTS: During both phases of the crossover study, vomiting scores were higher in the group with the device on (median score, 2) than the control group (median score, 1; P < .001), in diabetic and nondiabetic patients. Vomiting scores increased significantly when the device was ON in patients with delayed (P < .01) or normal gastric emptying (P = .05). Gastric emptying was not accelerated during the ON period compared with the OFF period. Having the GES turned on was not associated with increased quality of life. CONCLUSIONS: In a randomized crossover study, we found that GES reduced the frequency of refractory vomiting in patients with and without diabetes, although it did not accelerate gastric emptying or increase of quality of life. Clinicaltrials.gov, Number: NCT00903799.
RCT Entities:
BACKGROUND & AIMS: There have been conflicting results from trials of gastric electrical stimulation (GES) for treatment of refractory vomiting, associated or not with gastroparesis. We performed a large, multicenter, randomized, double-blind trial with crossover to study the efficacy of GES in patients with refractory vomiting, with or without gastroparesis. METHODS: For 4 months, we assessed symptoms in 172 patients (66% women; mean age ± standard deviation, 45 ± 12 years; 133 with gastroparesis) with chronic (>12 months) of refractory vomiting (idiopathic, associated with a type 1 or 2 diabetes, or postsurgical). A GES device was implanted and left unactivated until patients were randomly assigned, in a double-blind manner, to groups that received 4 months of stimulation parameters (14 Hz, 5 mA, pulses of 330 μs) or no stimulation (control); 149 patients then crossed over to the other group for 4 months. Patients were examined at the end of each 4-month period (at 5 and 9 months after implantation). Primary endpoints were vomiting score, ranging from 0 (daily vomiting) to 4 (no vomiting), and the quality of life, assessed by the Gastrointestinal Quality of Life Index scoring system. Secondary endpoints were changes in other digestive symptoms, nutritional status, gastric emptying, and control of diabetes. RESULTS: During both phases of the crossover study, vomiting scores were higher in the group with the device on (median score, 2) than the control group (median score, 1; P < .001), in diabetic and nondiabetic patients. Vomiting scores increased significantly when the device was ON in patients with delayed (P < .01) or normal gastric emptying (P = .05). Gastric emptying was not accelerated during the ON period compared with the OFF period. Having the GES turned on was not associated with increased quality of life. CONCLUSIONS: In a randomized crossover study, we found that GES reduced the frequency of refractory vomiting in patients with and without diabetes, although it did not accelerate gastric emptying or increase of quality of life. Clinicaltrials.gov, Number: NCT00903799.
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