Navigation Links
High doses of ursodeoxycholic acid ineffective for NASH patients
Date:7/20/2010

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󈝻mg/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 systemsno 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."


'/>"/>

Contact: Dawn Peters
healthnews@wiley.com
781-388-8408
Wiley-Blackwell
Source:Eurekalert

Related medicine news :

1. ASTRO publishes supplement on protecting cancer patients by reducing radiation doses, side effects
2. Children with food allergies should carry 2 doses of emergency medicine
3. Botox reduces wrinkles even in less frequent doses
4. High doses of antioxidant supplements induce stem cell genetic abnormalities
5. Organic Clothing – Is Your Clothing Delivering Death in Small Doses?
6. Cumulative Radiation Doses Seen in Cardiac Imaging
7. Yearly Chlamydia Screening May Be Ineffective for Some
8. Glucosamine Ineffective for Lower Back Pain Linked to Arthritis
9. ICU Patients at Risk for Rare Heart Rhythm Problem
10. Young patients with chronic illnesses find relief in acupuncture
11. For Some Breast Cancer Patients, Shorter Radiation Works Well
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating to ... of individuals in the United States and Canada wear eyeglasses. Once considered to be ... vision and make a fashion statement. Even celebrities use glasses as a way of ...
(Date:6/26/2016)... , ... June 26, 2016 , ... On June 10-11, ... of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, ... the city’s history as home to some of the world’s leading providers of cereal ...
(Date:6/26/2016)... , ... June 26, 2016 , ... PawPaws brand ... new product that was developed to enhance the health of felines. The formula is ... The two main herbs in the PawPaws Cat Kidney Support Supplement Soft ...
(Date:6/26/2016)... Lake Orion, Clarkston, Michigan (PRWEB) , ... June ... ... direction with respect to fertility once they have been diagnosed with endometriosis. These ... tolerable intercourse but they also require a comprehensive approach that can help for ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, ... Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. ... skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Research and Markets has announced the addition of the ... to 2022" report to their offering. ... financial data derived from varied research sources to present unique ... on the market during the next five years, including a ... markets, regional and country level analysis. The report provides a ...
(Date:6/23/2016)... , June 23, 2016 Research and ... News Issue 52" report to their offering. ... influenza treatment creates a favourable commercial environment for MedImmune to ... patient base that will serve to drive considerable growth for ... would serve to cap sales considerably, but development is still ...
(Date:6/23/2016)... Calif. , June 23, 2016 ... CST on Thursday, July 7, 2016 , , , , ... ) , , , , EXPERT PANELISTS:  , , ... Naik; Senior Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar ... The global pharmaceutical industry is witnessing an exceptional ...
Breaking Medicine Technology: