Christophe Moreno1, Pierre Deltenre2, Christelle Senterre3, Alexandre Louvet4, Thierry Gustot5, Boris Bastens6, Axel Hittelet7, Marie-Astrid Piquet8, Wim Laleman9, Hans Orlent10, Luc Lasser11, Thomas Sersté12, Peter Starkel13, Xavier De Koninck14, Sergio Negrin Dastis15, Jean Delwaide16, Isabelle Colle17, Chantal de Galocsy18, Sven Francque19, Philippe Langlet20, Virginie Putzeys21, Hendrik Reynaert22, Delphine Degré5, Eric Trépo5. 1. Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Cliniques Universitaires de Bruxelles Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium; Laboratory of Experimental Gastroenterology, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: Christophe.Moreno@erasme.ulb.ac.be. 2. Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Cliniques Universitaires de Bruxelles Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium; Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Service d'Hépato-Gastroentérologie, Hôpital de Jolimont, Haine-Saint-Paul, Belgium. 3. Research Center of Epidemiology, Biostatistics and Clinical Research, School of Public Health, Université Libre de Bruxelles, Brussels, Belgium. 4. Service des Maladies de l'Appareil Digestif, Hôpital Huriez, Lille, France. 5. Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Cliniques Universitaires de Bruxelles Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium; Laboratory of Experimental Gastroenterology, Université Libre de Bruxelles, Brussels, Belgium. 6. Department of Gastroenterology, Hôpital Saint-Joseph, Liège, Belgium. 7. Department of Gastroenterology, Hôpital Ambroise Paré, Mons, Belgium. 8. Service d'Hépatogastroentérologie, Centre Hositalier Unive de Caen, Caen, France. 9. Department of Liver and Biliopancreatic Disorders, University Hospitals Leuven, Katholieke Universiteit Leuven, Leuven, Belgium. 10. Department of Gastroenterology and Hepatology, Academisch Ziekenhuis Sint Jan, Brugge, Belgium. 11. Department of Hepatogastroenterology, Centre Hositalier Unive Brugmann, Brussels, Belgium. 12. Department of Hepatogastroenterology, Centre Hositalier Unive Saint-Pierre, Brussels, Belgium. 13. Department of Gastroenterology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium. 14. Department of Gastroenterology, Hôpital Saint-Pierre, Ottignies, Belgium. 15. Department of Gastroenterology, Hôpital Saint-Joseph, Warquignies, Belgium. 16. Department of Hepatogastroenterology, Centre Hositalier Unive Sart Tilman, University of Liège, Liège, Belgium. 17. Department of Hepatogastroenterology, Ghent University Hospital, Ghent, Belgium. 18. Department of Gastroenterology, Hôpitaux Iris Sud, Brussels, Belgium. 19. Department of Gastroenterology and Hepatology, University Hospital Antwerp, Edegem, Belgium. 20. Department of Gastroenterology, Centre Hospitalier Interrégional Edith Cavell, Brussels, Belgium. 21. Department of Gastroenterology, CHR La Citadelle, Liège, Belgium. 22. Department of Hepatogastroenterology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Abstract
BACKGROUND & AIMS:Severe alcoholic hepatitis (AH) is a life-threatening disease for which adequate oral nutritional support is recommended. We performed a randomized controlled trial to determine whether the combination of corticosteroid and intensive enteral nutrition therapy is more effective than corticosteroid therapy alone in patients with severe AH. METHODS: We enrolled 136 heavy consumers of alcohol (age, 18-75 y) with recent onset of jaundice and biopsy-proven severe AH in our study, performed at 18 hospitals in Belgium and 2 in France, from February 2010 through February 2013. Subjects were assigned randomly (1:1) to groups that received either intensive enteral nutrition plus methylprednisolone or conventional nutrition plus methylprednisolone (controls). In the intensive enteral nutrition group, enteral nutrition was given via feeding tube for 14 days. The primary end point was patient survival for 6 months. RESULTS: In an intention-to-treat analysis, we found no significant difference between groups in 6-month cumulative mortality: 44.4% of patients died in the intensive enteral nutrition group (95% confidence interval [CI], 32.2%-55.9%) and 52.1% of controls died (95% CI, 39.4%-63.4%) (P = .406). The enteral feeding tube was withdrawn prematurely from 48.5% of patients, and serious adverse events considered to be related to enteral nutrition occurred in 5 patients. Regardless of group, a greater proportion of patients with a daily calorie intake less than 21.5 kcal/kg/day died (65.8%; 95% CI, 48.8-78.4) than patients with a higher intake of calories (33.1%; 95% CI, 23.1%-43.4%) (P < .001). CONCLUSIONS: In a randomized trial of patients with severe AH treated withcorticosteroids, we found that intensive enteral nutrition was difficult to implement and did not increase survival. However, low daily energy intake was associated with greater mortality, so adequate nutritional intake should be a main goal for treatment. ClinicalTrials.gov number: NCT01801332.
RCT Entities:
BACKGROUND & AIMS:Severe alcoholic hepatitis (AH) is a life-threatening disease for which adequate oral nutritional support is recommended. We performed a randomized controlled trial to determine whether the combination of corticosteroid and intensive enteral nutrition therapy is more effective than corticosteroid therapy alone in patients with severe AH. METHODS: We enrolled 136 heavy consumers of alcohol (age, 18-75 y) with recent onset of jaundice and biopsy-proven severe AH in our study, performed at 18 hospitals in Belgium and 2 in France, from February 2010 through February 2013. Subjects were assigned randomly (1:1) to groups that received either intensive enteral nutrition plus methylprednisolone or conventional nutrition plus methylprednisolone (controls). In the intensive enteral nutrition group, enteral nutrition was given via feeding tube for 14 days. The primary end point was patient survival for 6 months. RESULTS: In an intention-to-treat analysis, we found no significant difference between groups in 6-month cumulative mortality: 44.4% of patients died in the intensive enteral nutrition group (95% confidence interval [CI], 32.2%-55.9%) and 52.1% of controls died (95% CI, 39.4%-63.4%) (P = .406). The enteral feeding tube was withdrawn prematurely from 48.5% of patients, and serious adverse events considered to be related to enteral nutrition occurred in 5 patients. Regardless of group, a greater proportion of patients with a daily calorie intake less than 21.5 kcal/kg/day died (65.8%; 95% CI, 48.8-78.4) than patients with a higher intake of calories (33.1%; 95% CI, 23.1%-43.4%) (P < .001). CONCLUSIONS: In a randomized trial of patients with severe AH treated with corticosteroids, we found that intensive enteral nutrition was difficult to implement and did not increase survival. However, low daily energy intake was associated with greater mortality, so adequate nutritional intake should be a main goal for treatment. ClinicalTrials.gov number: NCT01801332.
Authors: Mathias Plauth; William Bernal; Srinivasan Dasarathy; Manuela Merli; Lindsay D Plank; Tatjana Schütz; Stephan C Bischoff Journal: Clin Nutr Date: 2019-01-16 Impact factor: 7.324