[Tolerance of nitrefazole in alcoholics with liver disease. A 4-week placebo-controlled double-blind study]

Liver damage is one of the most common organ manifestations of chronic alcoholism. The recovery process following abstinence should not be impaired by therapy with alcohol sensitizing drugs. In a double-blind multicentre-study (controlled against placebo) the liver tolerance of Nitrefazole which is indicated as an alcohol sensitizing agent for therapy of alcoholics, was tested during the first four weeks of a planned longterm therapy. A total of 62 patients with alcoholic liver disease--demonstrated clinically and in the laboratory--were tested. The patients received 800 mg of Nitrefazole (4 capsules a 200 mg), respectively 4 placebo capsules of identical appearance, once a week in the presence of the doctor. In both treatment groups there was a significant (p less than or equal to 0.01) decline of the previously pathologically altered laboratory values, especially concerning gamma-GT, GPT, GOT. The physical and mental condition which was additionally evaluated by the doctor improved within both treatment groups. The improvement of the liver functions due to abstinence is not delayed or impaired by Nitrefazole .