Reuters Health Information (2010-09-09): N-acetylcysteine no help in alcoholic hepatitis
N-acetylcysteine no help in alcoholic hepatitis
Last Updated: 2010-09-09 20:01:03 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Addition of the antioxidant N-acetylcysteine confers no extra benefit in patients with severe acute alcoholic hepatitis receiving enteral nutrition, Belgian researchers report in an August 18th on-line paper in the Journal of Hepatology.
Dr. Christophe Moreno of Erasme Hospital, Brussels and colleagues note that there is increasing evidence that oxidative stress is a key mechanism in alcohol-mediated hepatotoxicity. In addition, patients with alcoholic hepatitis are often malnourished.
To examine whether N-acetylcysteine along with nutritional support might be beneficial, the researchers analyzed data on 47 patients who had been randomized to intravenous N-acetylcysteine or placebo. The primary endpoint was 6-month survival.
In both groups when possible, enteral nutrition was given orally. If the patient didn't consume the expected number of calories, placement of a feeding tube was performed. Vitamin supplements were also given. Treatment lasted for 14 days.
At one month, survival was 70.2% in the N-acetylcysteine group and 83.8% in placebo patients. At 6 months, corresponding values were 62.4% and 67.1%. The authors write, however, that the study was underpowered hence the results must be interpreted with caution.
There were also no differences in outcomes including infection rate at 1 month and early biological changes.
Thus Dr. Moreno told Reuters Health by email "we demonstrated that high doses of intravenous N-acetylcysteine therapy for 14 days conferred neither survival benefits nor early biological improvement in severe acute alcoholic hepatitis patients with adequate nutritional support."
The researchers observe that an unscheduled interim analysis was conducted after only half of the initially anticipated number of patients had been included.
"In view of the results," the investigators conclude, "it was decided that there was no point in continuing the study."
J Hepatol 2010.