CASE REPORT: Oral antioxidant therapy for the treatment of primary biliarycirrhosis: A pilot study

Background: The symptoms of the chronic cholestatic liver disease primary b iliary cirrhosis (PBC), in particular fatigue and chronic pruritus, adverse ly affect quality of life and respond only poorly to treatment. Recent stud ies have suggested that oxidative stress may play a role in tissue damage i n cholestatic liver disease and may contribute to symptoms, such as fatigue . We have, therefore, examined, in an open-label pilot study, the therapeut ic effects of antioxidant medication on the biochemistry and symptomatology of PBC. Methods: Patients were randomized to 3 months treatment with a compound ant ioxidant vitamin preparation (Bio-Antox), four tablets daily (n = 11, group 1), or the combination of Bio-Quinone Q10 (100 mg) with Bio-Antox (n = 13, group 2). Biochemical and symptomatic responses were assessed at 3 months. Results: Significant improvement in both pruritus and fatigue was seen in t he patients in group 2. Mean itch visual analogue score improved from 2.4+/ -3.0 to 0.4+/-0.7 post therapy (P<0.05) while mean night itch severity scor e improved from 2.6+/-1.9 to 1.3+/-0.7 (P<0.05). Nine of 13 of these patien ts reported less fatigue, while 10/13 showed an improvement in at least one domain of their Fisk Fatigue Severity Score. No significant improvement in itch and only limited improvement in fatigue were seen in the patients in group 1. No change in biochemical parameters was seen in either group. Conclusions: Antioxidant therapy, as a combination of Bio-Antox and Bio-Qui none Q10, may improve the pruritus and fatigue of PBC. This combination of therapy should be investigated further in a double-blind, placebo-controlle d trial. (C) 1999 Blackwell Science Asia Pty Ltd.