A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis

Ratziu, Vlad; Lédinghen, Victor de; Oberti, Frédéric; Mathurin, Philippe; Wartelle-Bladou, Claire; Renou, Christophe; Sogni, Philippe; Maynard, Marianne; Larrey, Dominique; Serfaty, Lawrence; Bonnefont‐Rousselot, Dominique; Bastard, Jean‐Philippe; Rivière, Marc; Spénard, Jean

doi:10.1016/j.jhep.2010.08.030

Cited by 292 publications

(196 citation statements)

References 59 publications

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“…(Strength -1, Quality -B) 22. Until further data supporting its effectiveness become available, vitamin E is not recommended to treat NASH in diabetic patients, NAFLD without liver biopsy, NASH cirrhosis, or cryptogenic cirrhosis (Strength -1, Quality -C) Ursodeoxycholic acid (UDCA), Omega-3 fatty acids, and Miscellaneous Agents Several studies 126,[137][138][139][140] investigated UDCA (conventional and high doses) to improve aminotransferases and steatosis in patients with NAFLD and liver histology in patients with NASH. All but one study 139 have been proof-of-concept studies with small numbers of participants and/or surrogate endpoints.…”

Section: Vitamin Ementioning

confidence: 99%

The diagnosis and management of non-alcoholic fatty liver disease: Practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association

et al. 2012

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Section: Vitamin Ementioning

confidence: 99%

The diagnosis and management of non-alcoholic fatty liver disease: Practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association

et al. 2012

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“…Seven RCTs (639 participants, 21% diabetic; three RCTs with post-treatment histology, five RCTs with a low risk of bias) evaluated UDCA in NAFLD (ESM Table 5) [82][83][84][85][86][87][88].…”

Section: Ursodeoxycholic Acid (Udca)mentioning

confidence: 99%

Impact of current treatments on liver disease, glucose metabolism and cardiovascular risk in non-alcoholic fatty liver disease (NAFLD): a systematic review and meta-analysis of randomised trials

et al. 2012

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Aims/hypothesis Non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum ranging from simple steatosis to non-alcoholic steatohepatitis (NASH): NAFLD causes an increased risk of cardiovascular disease, diabetes and liverrelated complications (the latter confined to NASH). The effect of proposed treatments on liver disease, glucose metabolism and cardiovascular risk in NAFLD is unknown. We reviewed the evidence for the management of liver disease and cardiometabolic risk in NAFLD. Methods Publications through November 2011 were systematically reviewed by two authors. Outcomes evaluated though standard methods were: histological/radiological/biochemical features of NAFLD, variables of glucose metabolism and cardiovascular risk factors. Seventy-eight randomised trials were included (38 in NASH, 40 in NAFLD): 41% assessed post-treatment histology, 71% assessed glucose metabolism and 88% assessed cardiovascular risk factors. Lifestyle intervention, thiazolidinediones, metformin and antioxidants were most extensively evaluated. Results Lifestyle-induced weight loss was safe and improved cardio-metabolic risk profile; a weight loss ≥7% improved histological disease activity, but was achieved by <50%

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“…A meta-analysis also revealed that UDCA induced only modest improvement in serum ALT, but overall improvement was not observed [86]. In 2011, an RCT for high dose UDCA treatment of NASH was published, and the results were very negative [87]. On the basis of these studies, conventional dosing of UDCA is not recommended for the treatment of NAFLD/NASH.…”

Section: Metformin Cq: Are Biguanides Effective For Patients With Nafmentioning

confidence: 99%

Evidence-based clinical practice guidelines for nonalcoholic fatty liver disease/nonalcoholic steatohepatitis

et al. 2015

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Nonalcoholic fatty liver disease (NAFLD) is currently the most common cause of chronic liver disease in industrialized countries worldwide, and has become a serious public health issue not only in Western countries but also in many Asian countries including Japan. Within the wide spectrum of NAFLD, nonalcoholic steatohepatitis (NASH) is a progressive form of disease, which often develops into liver cirrhosis and increases the risk of hepatocellular carcinoma. In turn, a large proportion of NAFLD/NASH is the liver manifestation of metabolic syndrome, suggesting that NAFLD/NASH plays a key role in the pathogenesis of systemic atherosclerotic diseases. Currently, a definite diagnosis of NASH requires liver biopsy, though various noninvasive measures are under development. The mainstays of prevention and treatment of NAFLD/NASH include dietary restriction and exercise; however, pharmacological approaches are often necessary.Currently, vitamin E and thiazolidinedione derivatives are the most evidence-based therapeutic options, although the clinical evidence for long-term efficacy and safety is limited. This practice guideline for NAFLD/NASH, established by the Japanese Society of Gastroenterology in cooperation with The Japan Society of Hepatology, covers lines of clinical evidence reported internationally in the period starting from 1983 to January 2012, and each clinical question was evaluated using the GRADE system. Based on the primary release of the full version in Japanese, this English summary provides the core essentials of this clinical practice guideline comprising the definition, diagnosis, and current therapeutic recommendations for NAFLD/NASH in Japan.

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A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis

Cited by 292 publications

References 59 publications

The diagnosis and management of non-alcoholic fatty liver disease: Practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association

The diagnosis and management of non-alcoholic fatty liver disease: Practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association

Impact of current treatments on liver disease, glucose metabolism and cardiovascular risk in non-alcoholic fatty liver disease (NAFLD): a systematic review and meta-analysis of randomised trials

Evidence-based clinical practice guidelines for nonalcoholic fatty liver disease/nonalcoholic steatohepatitis

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