{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,1,15]],"date-time":"2024-01-15T18:34:44Z","timestamp":1705343684758},"reference-count":59,"publisher":"Consilium Medicum","issue":"8","license":[{"start":{"date-parts":[[2019,8,15]],"date-time":"2019-08-15T00:00:00Z","timestamp":1565827200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-sa\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Terapevticheskii arkhiv"],"abstract":"<jats:p>Alcoholic hepatitis (AH) is a form of alcoholic liver disease. Glucocorticosteroids (GCS) are used as anti - inflammatory drugs for people with alcoholic hepatitis. Aim. To assess the benefits and harms of GCS in people with AH. Material and methods. We identified trials through electronic searches in Cochrane Hepato-Biliary's (CHB) Controlled Trials Register, CENTRAL, MEDLINE, Embase, LILACS, and Science Citation Index Expanded. We considered for inclusion randomised clinical trials (RCTs) assessing GCS versus placebo\/no intervention in adult participants with AH. We allowed co - interventions in the trial groups if they were similar. We followed Cochrane methodology, CHB Group methodology using Review Manager 5 and Trial Sequential Analysis(TSA) to perform meta - analysis (M-A), assessed bias risk of the trials, certainty of evidence using GRADE. Results and discussion. Sixteen trials fulfilled the inclusion criteria. Fifteen trials provided data for analysis (927 participants received GCS, 934 - placebo\/no intervention). The GCS were administered to adult participants at different stages of AH orally or parenterally for a median of 28 days. There was no evidence of effect of GCCs on our primary outcomes all - cause mortality up to 3 months following randomisation (RR 0.90, 95% CI 0.70-1.15; n=1861), on health - related quality of life (MD - 0.04 points; 95% CI -0.11-0.03; n=377; trial = 1) (EQ-5D-3L scale), on the occurrence of serious adverse events during treatment (RR 1.05, 95% CI 0.85-1.29; n=1861). We found no evidence of a difference between the intervention groups. The risk of bias was high in all the trials except one. The certainty of evidence was very low or low. One of the trials seems to be not industry - funded. Conclusion. We found no evidence of a difference between GCS and placebo or no intervention on all - cause mortality, health - related quality of life, and serious adverse events during treatment. We cannot exclude increases in adverse events and cannot rule out significant benefits and harms of GCSs. Future trials ought to report depersonalised individual participant data.<\/jats:p>","DOI":"10.26442\/00403660.2019.08.000354","type":"journal-article","created":{"date-parts":[[2019,9,7]],"date-time":"2019-09-07T21:59:22Z","timestamp":1567893562000},"page":"52-66","source":"Crossref","is-referenced-by-count":4,"title":["Glucocorticosteroids for people with alcoholic hepatitis (Cochrane review)"],"prefix":"10.26442","volume":"91","author":[{"given":"Chavdar S","family":"Pavlov","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daria L","family":"Varganova","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giovanni","family":"Casazza","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emmanuel","family":"Tsochatzis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dimitrinka","family":"Nikolova","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Gluud","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"18344","published-online":{"date-parts":[[2019,8,15]]},"reference":[{"key":"ref1","unstructured":"WHO. Global status report: Alcohol and health, 2018. Available from: https:\/\/www.who.int\/substance_abuse\/publications\/global_alcohol_report\/gsr_2018\/en\/ (\u0421\u0441\u044b\u043b\u043a\u0430 \u0430\u043a\u0442\u0438\u0432\u043d\u0430 \u043d\u0430 19.04.2019)."},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2018.03.018"},{"key":"ref3","unstructured":"WHO. Global status report: Alcohol and health, 2014. Available from: http:\/\/www.who.int\/substance_abuse\/publications\/ global_alcohol_report\/en\/ (\u0421\u0441\u044b\u043b\u043a\u0430 \u0430\u043a\u0442\u0438\u0432\u043d\u0430 \u043d\u0430 21.03.2019)."},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2011.09.024"},{"key":"ref5","doi-asserted-by":"crossref","unstructured":"Maddrey W.C, Boitnott J.K, Bedine M.S, Weber F.L. Jr, Mezey E, White R.I. Jr. Corticosteroid therapy of alcoholic hepatitis. Gastroenterology. 1978;75(2):193-9.","DOI":"10.1016\/0016-5085(78)90401-8"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1002\/hep.20503"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2004.050781"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2008.02104.x"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-110-9-685"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2005.11.039"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23258"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.22416\/1382-4376-2017-27-6-20-40"},{"key":"ref13","unstructured":"www.lillemodel.com"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1002\/hep.21607"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1016\/j.cld.2004.11.001"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1136\/gut.37.1.113"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2008.03685.x"},{"key":"ref18","unstructured":"Reynolds T.B, Benhamou J.P, Blake J, Naccarato R, Orrego H. Treatment of acute alcoholic hepatitis. Gastroenterol Int. 1989;2(4):208-16."},{"key":"ref19","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-113-4-299"},{"key":"ref20","unstructured":"Daures J-P, Peray P, Bories P, Blanc P, Yousfi A, Michel H, et al. Steroid therapy in acute alcoholic hepatitis: a pooled estimate based on published randomized controlled trials [Place de la corticotherapie dans le traitement des h\u00e9patites alcooliques aigu\u00ebs. R\u00e9sultants d'une m\u00e9ta - analyse]. Gastroenterologie Clinique et Biologique. 1991;51:223-8."},{"key":"ref21","doi-asserted-by":"crossref","unstructured":"Christensen E, Gluud C. Glucocorticosteroids are not effective in alcoholic hepatitis. Am J Gastroenterol. 1999;94(10)(3065):66.","DOI":"10.1111\/j.1572-0241.1999.03065.x"},{"key":"ref22","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2010.224097"},{"key":"ref23","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2018.05.011"},{"key":"ref24","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD001511.pub3"},{"key":"ref25","doi-asserted-by":"publisher","DOI":"10.1002\/14651858"},{"key":"ref26","unstructured":"International Conference on Harmonisation Expert Working Group. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH harmonised tripartite guideline. Guideline for good clinical practice CFR & ICH Guidelines. Vol. 1. Philadelphia (PA): Barnett International\/PAREXEL, 1997."},{"key":"ref27","unstructured":"Higgins J.P.T, Altman D.G, Sterne J.A.C (eds). Chapter 8: Assessing risk of bias in included studies. In: Higgins J.P.T, Green S (eds). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from: handbook.cochrane.org"},{"key":"ref28","unstructured":"Gluud C, Nikolova D, Klingenberg S.L. Cochrane Hepato-Biliary Group. About Cochrane (Cochrane Review Groups (CRGs)) 2017, Issue 2. Art. No.: LIVER 2017."},{"key":"ref29","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-14-120"},{"key":"ref30","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1186"},{"key":"ref31","unstructured":"GRADE [Computer program]. Available from: http:\/\/www.gradeworkinggroup.org\/"},{"key":"ref32","unstructured":"Review Manager (RevMan) [Computer program]. Version 5.3. Copenhagen: The Nordic Cochrane Centre, the Cochrane Collaboration; 2014. Available from: https:\/\/community.cochrane.org\/help\/tools-and-software\/revman-5. Accessed Sep 9, 2018."},{"key":"ref33","unstructured":"TSA - Trial Sequential Analysis [Computer program]. Version 0.9 Beta. Copenhagen: Copenhagen Trial Unit, 2011. Available from: www.ctu.dk\/tsa\/downloads.aspx"},{"key":"ref34","doi-asserted-by":"publisher","DOI":"10.1186\/s12874-017-0315-7"},{"key":"ref35","unstructured":"Thorlund K, Engstr\u00f8m J, Wetterslev J, Brok J, Imberger G, Gluud C. User manual for Trial Sequential Analysis (TSA). Available from: ctu.dk\/tsa\/files\/tsa_manual.pdf"},{"key":"ref36","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2007.10.007"},{"key":"ref37","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyn188"},{"key":"ref38","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyn179"},{"key":"ref39","doi-asserted-by":"publisher","DOI":"10.2147\/\u0421LEP.S9242"},{"key":"ref40","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-74-3-311"},{"key":"ref41","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM197106172842404"},{"key":"ref42","doi-asserted-by":"crossref","unstructured":"Blitzer B.L, Mutchnick M.G, Joshi P.H, Phillips M.M, Fessel J.M, Conn H.O. Adrenocorticosteroid therapy in alcoholic hepatitis. A prospective, double - blind randomized study. Dig Dis. 1977;22(6):477-84.","DOI":"10.1007\/BF01072499"},{"key":"ref43","doi-asserted-by":"crossref","unstructured":"Mendenhall C.L, Goldberg S. Risk factors and therapy in alcoholic hepatitis (AH). Gastroenterology. 1977;72(5):1100.","DOI":"10.1016\/S0016-5085(77)80139-X"},{"key":"ref44","doi-asserted-by":"publisher","DOI":"10.1053\/jhep.2000.8627"},{"key":"ref45","unstructured":"Shumaker J.B, Resnick R.H, Galambos J.T, Makopour H, Iber F.L. A controlled trial of 6-methylprednisolone in acute alcoholic hepatitis. With a note on published results in encephalopathic patients. Am J Gastroenterol. 1978;69(4):443-9."},{"key":"ref46","doi-asserted-by":"crossref","unstructured":"Depew W, Boyer T, Omata M, Redeker A, Reynolds T. Double - blind controlled trial of prednisolone therapy in patients with severe acute alcoholic hepatitis and spontaneous encephalopathy. Gastroenterology. 1980;78(3):524-9.","DOI":"10.1016\/0016-5085(80)90867-7"},{"key":"ref47","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199202203260802"},{"key":"ref48","doi-asserted-by":"publisher","DOI":"10.4103\/2141-9248.141562"},{"key":"ref49","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1412278"},{"key":"ref50","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-79-5-625"},{"key":"ref51","doi-asserted-by":"publisher","DOI":"10.1136\/gut.23.1.75"},{"key":"ref52","unstructured":"Bories P, Guedj J.Y, Mirouze D, Yousfi A, Michel H. Prednisolone treatment of alcoholic hepatitis: forty - five patients [Traitement de l'hepatite alcoolique aigue par la prednisolone. Quarante - cinq malades]. La Presse Medicale. 1987;16:769-72."},{"key":"ref53","unstructured":"Richardet J.P, Dehoux M, Mal F, Roulot D, Labadie H, Pol S, et al. Influence of corticosteroids (CS) on plasma cytokines concentrations in patients with severe alcoholic hepatitis (HA): results of a randomized study. J Hepatol. 1993;18:S75."},{"key":"ref54","doi-asserted-by":"crossref","unstructured":"Lesesne H.R, Bozymski E.M, Fallon H.J. Treatment of alcoholic hepatitis with encephalopathy. Comparison of prednisolone with caloric supplements. Gastroenterology. 1978;74(2 Pt 1):169-73.","DOI":"10.1016\/0016-5085(78)90790-4"},{"key":"ref55","doi-asserted-by":"publisher","DOI":"10.1053\/jhep.2000.8627"},{"key":"ref56","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2380"},{"key":"ref57","doi-asserted-by":"crossref","unstructured":"Student. The probable error of a mean. Biometrika. 1908;6(1):1-25.","DOI":"10.1093\/biomet\/6.1.1"},{"key":"ref58","doi-asserted-by":"publisher","DOI":"10.1002\/14651858"},{"key":"ref59","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-3-201302050-00583"}],"container-title":["Terapevticheskii arkhiv"],"original-title":[],"link":[{"URL":"https:\/\/ter-arkhiv.ru\/0040-3660\/article\/viewFile\/33614\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ter-arkhiv.ru\/0040-3660\/article\/viewFile\/33614\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,10,13]],"date-time":"2021-10-13T21:33:23Z","timestamp":1634160803000},"score":1,"resource":{"primary":{"URL":"https:\/\/ter-arkhiv.ru\/0040-3660\/article\/view\/33614"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,8,15]]},"references-count":59,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2019,8,15]]}},"URL":"https:\/\/doi.org\/10.26442\/00403660.2019.08.000354","relation":{},"ISSN":["2309-5342","0040-3660"],"issn-type":[{"value":"2309-5342","type":"electronic"},{"value":"0040-3660","type":"print"}],"subject":[],"published":{"date-parts":[[2019,8,15]]}}}