Featured Research

from universities, journals, and other organizations

High doses of ursodeoxycholic acid ineffective for NASH patients, study suggests

Date:
July 20, 2010
Source:
Wiley-Blackwell
Summary:
High doses of ursodeoxycholic acid, suggested by some studies to have a beneficial effect on nonalcoholic steatohepatitis (NASH), does not improve overall histology in NASH patients, according to new research.

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 13-15mg/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 from each patient were evaluated according to a modified Brunt score (including steatosis, hepatocellular ballooning, lobular inflammation, and portal/lobular fibrosis) as well as the nonalcoholic fatty liver disease activity score (NAS). Using the modified Brunt score, 185 patients with histologically proven NASH were randomized (intention to treat: ITT), 147 were treated per protocol (PP). Using the NAS, 137 patients were confirmed as having NASH, 48 were borderline NASH, and 1 was not NASH.

The results were the same for both scoring systems -- no significant improvement in overall histology was detected. Of the single variables, only lobular inflammation improved using both the modified Brunt and NAS scores. In subgroup analyses, significant improvement of lobular inflammation was also observed in males, patients less than 50 years of age, slightly overweight patients, in patients with hypertension and an increased histology score. The fibrosis scores did not change.

"Our study has shown that the high dose of 23 to 28 mg UDCA/kg body weight per day, over a treatment time of 18 months, was unable to improve liver histology and overall liver function when compared to placebo and thus confirms the results of an earlier study using a lower dose over a period of 24 months," concluded study leader Dr. Ulrich F.H. Leuschner.

"Previous investigations may have shown positive results, because, first of all, in most of the studies the number of patients was too small, treatment time was too short, or a control group was missing," he explains. "Secondly, the positive effect of UDCA on the suggested pathogenetic mechanisms has been shown in only a few investigations with a small number of experimental animals and in few patients. Finally, the anticipation of an effect of UDCA in NASH probably depends on an incorrect assumption. Up to now positive effects of UDCA have only been observed in primary biliary cirrhosis, but NASH does not present with features of biliary liver diseases."


Story Source:

The above story is based on materials provided by Wiley-Blackwell. Note: Materials may be edited for content and length.


Journal Reference:

  1. Leuschner et al. High-dose ursodeoxycholic acid therapy for nonalcoholic steatohepatitis: a double-blind, randomized, placebo-controlled trial. Hepatology, 2010; DOI: 10.1002/hep.23727

Cite This Page:

Wiley-Blackwell. "High doses of ursodeoxycholic acid ineffective for NASH patients, study suggests." ScienceDaily. ScienceDaily, 20 July 2010. <www.sciencedaily.com/releases/2010/07/100720162310.htm>.
Wiley-Blackwell. (2010, July 20). High doses of ursodeoxycholic acid ineffective for NASH patients, study suggests. ScienceDaily. Retrieved April 20, 2014 from www.sciencedaily.com/releases/2010/07/100720162310.htm
Wiley-Blackwell. "High doses of ursodeoxycholic acid ineffective for NASH patients, study suggests." ScienceDaily. www.sciencedaily.com/releases/2010/07/100720162310.htm (accessed April 20, 2014).

Share This



More Health & Medicine News

Sunday, April 20, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Nine-Month-Old Baby Can't Open His Mouth

Nine-Month-Old Baby Can't Open His Mouth

Newsy (Apr. 19, 2014) Nine-month-old Wyatt Scott was born with a rare disorder called congenital trismus, which prevents him from opening his mouth. Video provided by Newsy
Powered by NewsLook.com
'Holy Grail' Of Weight Loss? New Find Could Be It

'Holy Grail' Of Weight Loss? New Find Could Be It

Newsy (Apr. 18, 2014) In a potential breakthrough for future obesity treatments, scientists have used MRI scans to pinpoint brown fat in a living adult for the first time. Video provided by Newsy
Powered by NewsLook.com
Little Progress Made In Fighting Food Poisoning, CDC Says

Little Progress Made In Fighting Food Poisoning, CDC Says

Newsy (Apr. 18, 2014) A new report shows rates of two foodborne infections increased in the U.S. in recent years, while salmonella actually dropped 9 percent. Video provided by Newsy
Powered by NewsLook.com
Scientists Create Stem Cells From Adult Skin Cells

Scientists Create Stem Cells From Adult Skin Cells

Newsy (Apr. 17, 2014) The breakthrough could mean a cure for some serious diseases and even the possibility of human cloning, but it's all still a way off. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins