Journal of hepatology
-
Journal of hepatology · Aug 2007
Randomized Controlled TrialA randomized trial of antioxidant therapy alone or with corticosteroids in acute alcoholic hepatitis.
Oxidative stress is putatively involved in the pathogenesis of alcohol-induced liver injury. This trial was devised to determine whether antioxidant therapy, alone or as an adjunct to corticosteroids, improved survival in patients with acute alcoholic hepatitis. ⋯ Antioxidant therapy, alone or in combination with corticosteroids, does not improve 6-month survival in severe alcoholic hepatitis.
-
Journal of hepatology · May 2007
ReviewMethodology of superiority vs. equivalence trials and non-inferiority trials.
The randomized clinical trial (RCT) is generally accepted as the best method of comparing effects of therapies. Most often the aim of an RCT is to show that a new therapy is superior to an established therapy or placebo, i.e. they are planned and performed as superiority trials. Sometimes the aim of an RCT is just to show that a new therapy is not superior but equivalent to or not inferior to an established therapy, i.e. they are planned and performed as equivalence trials or non-inferiority trials. ⋯ This paper reviews the methodology of these types of trials with special reference to differences in respect to planning, performance, analysis and reporting of the trial. In this context the relevant basal statistical concepts are reviewed. Some of the important points are illustrated by examples.
-
Journal of hepatology · May 2007
Endotoxemia contributes to the immune paralysis in patients with cirrhosis.
Immune paralysis, defined as decreased HLA-DR expression on monocytes and indicated immune dysfunctions, was found in sepsis, severe acute pancreatitis and acute liver failure. However, the relationship between HLA-DR expression and cirrhosis is unclear. ⋯ Child-Pugh class C cirrhotic patients suffer from down-regulation of HLA-DR expression. Endotoxemia, possibly mediated by IL-10, contributes to this HLA-DR down-regulation.
-
Journal of hepatology · Apr 2007
ReviewHepatology may have problems with putative surrogate outcome measures.
A surrogate outcome measure is a laboratory measurement, a physical sign, or another intermediate substitute that is able to predict an intervention's effect on a clinically meaningful outcome. A clinical outcome detects how a patient feels, functions, or survives. Surrogate outcome measures occur faster or more often, are cheaper, and/or are less invasively achieved than the clinical outcome. ⋯ In hepatology a number of putative surrogate outcomes are used both in clinical research and in clinical practice without having been properly validated. Sustained virological response to interferons and ribavirin in patients with chronic hepatitis C, serum bilirubin concentration following ursodeoxycholic acid or immunosuppressants for patients with primary biliary cirrhosis, and nutritional outcomes following artificial nutrition for liver patients may not be valid surrogates for morbidity or mortality. The challenge is to develop reliable surrogates, both to facilitate the development of new interventions and to ensure our patients and us that these interventions are effective clinically.
-
Journal of hepatology · Jan 2007
Editorial Comment ReviewIn the new area of noninvasive markers of hepatocellular carcinoma.