A study conducted by researchers at Johann Wolfgang Goethe University in Frankfurt, Germany found that high doses of ursodeoxycholic acid (UDCA), suggested by some studies to have a beneficial effect on nonalcoholic steatohepatitis (NASH), does not improve overall histology in these patients. Full findings of this study are published in the August issue of Hepatology, a journal of the American Association for the Study of Liver Diseases (AASLD).
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NASH ranks as one of the major causes of cirrhosis in America, behind hepatitis C and alcoholic liver disease. Liver transplantation is the only treatment for advanced cirrhosis with liver failure, and transplantation is increasingly performed in people with NASH. Currently, there are no specific therapies for NASH.
Small, open label clinical studies have shown that UDCA positively influenced liver function tests and liver histology in NASH patients, but a two-year prospective double-blind trial with 166 patients at the dosage of 13mg/kg body weight per day failed to confirm these results. To determine if the dosage of UDCA may have been too low and a reduction of body weight could have contributed to the results, the German research team initiated a multicenter, placebo-controlled double-blind trial with a high dose of UDCA and without weight-lowering diet.
A UDCA dose of 23-28 mg/kg body weight or placebo was administered daily in three divided doses to 147 randomized patients of both sexes, aged 18 years and older. No special diet was recommended and the body weight of the patients remained constant during the study period. The total treatment time for each patient was 18 months. The primary objective was improvement of liver histology by at least 3 points. Secondary criteria were single histological variables and liver biochemistry.
Pre- and post-treatment liver biopsies
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