Rifaximin treatment in patients with severe alcoholic hepatitis: A multicenter, randomized controlled, open-label, pilot trial
Introduction and Objectives: The short-term mortality of severe alcoholic-associated hepatitis (SAH) is high, but there are no effective treatments to improve short-term mortality other than corticosteroids. This study investigated the effects of adding rifaximin to standard treatment in patients wi...
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Elsevier
2025-01-01
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| Series: | Annals of Hepatology |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1665268124005325 |
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| author | Do Seon Song Jin Mo Yang Young Kul Jung Hyung Joon Yim Hee Yeon Kim Chang Wook Kim Soon Sun Kim Jae Youn Cheong Hae Lim Lee Sung Won Lee Jeong-Ju Yoo Sang Gyune Kim Young Seok Kim |
| author_facet | Do Seon Song Jin Mo Yang Young Kul Jung Hyung Joon Yim Hee Yeon Kim Chang Wook Kim Soon Sun Kim Jae Youn Cheong Hae Lim Lee Sung Won Lee Jeong-Ju Yoo Sang Gyune Kim Young Seok Kim |
| author_sort | Do Seon Song |
| collection | DOAJ |
| description | Introduction and Objectives: The short-term mortality of severe alcoholic-associated hepatitis (SAH) is high, but there are no effective treatments to improve short-term mortality other than corticosteroids. This study investigated the effects of adding rifaximin to standard treatment in patients with SAH. Material and Methods: In this randomized controlled open-label trial, patients with SAH (Maddrey's discriminant function≥32) were randomized to the rifaximin or control group. Patients were simultaneously treated with corticosteroid or pentoxifylline as standard treatment for 4 weeks. Randomization was stratified by SAH treatment. Results: A total of 50 patients were enrolled in this study (29 in the control group and 21 in the rifaximin group). The mean Model for End-stage Liver Disease (MELD) scores were 24.4 and 27.5 in the control and rifaximin groups, respectively (P = 0.106). There were no significant differences in 6-month Liver Transplantation (LT)-free survival rate between the two groups (P = 0.502). When stratified by SAH treatment, there was no significant difference in 6-month LT-free survival rate between the control and rifaximin treatment groups (P = 0.186 in the corticosteroid group and P = 0.548 in the pentoxifylline group). There were no significant differences in the occurrence of liver-related complications between the two groups (all Ps>0.05). The MELD score was the only independent factor for 6-month LT-free survival (hazard ratio 1.188, 95 % confidence interval 1.094-1.289, P<0.001), and rifaximin was not. Conclusions: In patients with SAH, adding rifaximin to corticosteroid or pentoxifylline had no survival benefit and no preventive effect on the development of liver-related complications. The MELD score was the only significant factor for short-term mortality. Clinical trial registration: The study was registered on ClinicalTrials.gov (number: NCT02485106). |
| format | Article |
| id | doaj-art-1bd03a4fa4304b359840bf359b243e46 |
| institution | Kabale University |
| issn | 1665-2681 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Annals of Hepatology |
| spelling | doaj-art-1bd03a4fa4304b359840bf359b243e462025-01-31T05:10:58ZengElsevierAnnals of Hepatology1665-26812025-01-01301101749Rifaximin treatment in patients with severe alcoholic hepatitis: A multicenter, randomized controlled, open-label, pilot trialDo Seon Song0Jin Mo Yang1Young Kul Jung2Hyung Joon Yim3Hee Yeon Kim4Chang Wook Kim5Soon Sun Kim6Jae Youn Cheong7Hae Lim Lee8Sung Won Lee9Jeong-Ju Yoo10Sang Gyune Kim11Young Seok Kim12Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea, Seoul, South KoreaDepartment of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea, Seoul, South KoreaDepartment of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, South Korea; Corresponding author.Department of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, South KoreaDepartment of Internal Medicine, Uijeongbu St. Mary's Hospital, The Catholic University of Korea, Seoul, South KoreaDepartment of Internal Medicine, Uijeongbu St. Mary's Hospital, The Catholic University of Korea, Seoul, South KoreaDepartment of Internal Medicine, Ajou University School of Medicine, Suwon, South KoreaDepartment of Internal Medicine, Ajou University School of Medicine, Suwon, South KoreaDepartment of Internal Medicine, Bucheon St. Mary's Hospital, The Catholic University of Korea, Seoul, South KoreaDepartment of Internal Medicine, Bucheon St. Mary's Hospital, The Catholic University of Korea, Seoul, South KoreaDepartment of Internal Medicine, Bucheon Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Bucheon, South KoreaDepartment of Internal Medicine, Bucheon Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Bucheon, South KoreaDepartment of Internal Medicine, Bucheon Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Bucheon, South KoreaIntroduction and Objectives: The short-term mortality of severe alcoholic-associated hepatitis (SAH) is high, but there are no effective treatments to improve short-term mortality other than corticosteroids. This study investigated the effects of adding rifaximin to standard treatment in patients with SAH. Material and Methods: In this randomized controlled open-label trial, patients with SAH (Maddrey's discriminant function≥32) were randomized to the rifaximin or control group. Patients were simultaneously treated with corticosteroid or pentoxifylline as standard treatment for 4 weeks. Randomization was stratified by SAH treatment. Results: A total of 50 patients were enrolled in this study (29 in the control group and 21 in the rifaximin group). The mean Model for End-stage Liver Disease (MELD) scores were 24.4 and 27.5 in the control and rifaximin groups, respectively (P = 0.106). There were no significant differences in 6-month Liver Transplantation (LT)-free survival rate between the two groups (P = 0.502). When stratified by SAH treatment, there was no significant difference in 6-month LT-free survival rate between the control and rifaximin treatment groups (P = 0.186 in the corticosteroid group and P = 0.548 in the pentoxifylline group). There were no significant differences in the occurrence of liver-related complications between the two groups (all Ps>0.05). The MELD score was the only independent factor for 6-month LT-free survival (hazard ratio 1.188, 95 % confidence interval 1.094-1.289, P<0.001), and rifaximin was not. Conclusions: In patients with SAH, adding rifaximin to corticosteroid or pentoxifylline had no survival benefit and no preventive effect on the development of liver-related complications. The MELD score was the only significant factor for short-term mortality. Clinical trial registration: The study was registered on ClinicalTrials.gov (number: NCT02485106).http://www.sciencedirect.com/science/article/pii/S1665268124005325RifaximinGut microbiomeEndotoxinSAH, severe alcohol-associated hepatitis |
| spellingShingle | Do Seon Song Jin Mo Yang Young Kul Jung Hyung Joon Yim Hee Yeon Kim Chang Wook Kim Soon Sun Kim Jae Youn Cheong Hae Lim Lee Sung Won Lee Jeong-Ju Yoo Sang Gyune Kim Young Seok Kim Rifaximin treatment in patients with severe alcoholic hepatitis: A multicenter, randomized controlled, open-label, pilot trial Annals of Hepatology Rifaximin Gut microbiome Endotoxin SAH, severe alcohol-associated hepatitis |
| title | Rifaximin treatment in patients with severe alcoholic hepatitis: A multicenter, randomized controlled, open-label, pilot trial |
| title_full | Rifaximin treatment in patients with severe alcoholic hepatitis: A multicenter, randomized controlled, open-label, pilot trial |
| title_fullStr | Rifaximin treatment in patients with severe alcoholic hepatitis: A multicenter, randomized controlled, open-label, pilot trial |
| title_full_unstemmed | Rifaximin treatment in patients with severe alcoholic hepatitis: A multicenter, randomized controlled, open-label, pilot trial |
| title_short | Rifaximin treatment in patients with severe alcoholic hepatitis: A multicenter, randomized controlled, open-label, pilot trial |
| title_sort | rifaximin treatment in patients with severe alcoholic hepatitis a multicenter randomized controlled open label pilot trial |
| topic | Rifaximin Gut microbiome Endotoxin SAH, severe alcohol-associated hepatitis |
| url | http://www.sciencedirect.com/science/article/pii/S1665268124005325 |
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