Levamisole therapy in chronic hepatitis--results of a multicentric double blind trial.

The effectiveness of levamisole in the immunmodulatory treatment of chronic hepatitis was assessed in a multicentric double blind trial. Twenty patients received in the first week 50 mg, in the second 100 mg and thereafter 150 mg, levamisole on two days every week for 6 months, 20 others received a placebo. Five patients dropped out (non-compliance 1, pregnancy 1, adverse effects 3). The diagnoses were confirmed by clinical, biochemical immunological and histological data. After 6 months 26 subjects allowed us to take a control liver biopsy. The results showed that the rate of improved, unchanged and impaired cases was not significantly different in the levamisole and placebo groups. No correlation was found between etiology, activity or histological type of chronic hepatitis, skin test reactivity (DNCB, PPD, Streptokinase) and therapeutic effect, respectively. Clinical improvement was not associated with the elimination of HBs antigen. In general levamisole was well tolerated, but we saw one case of severe agranulocytosis.