A Multicenter and Randomized Controlled Trial of Bicyclol in the Treatment of Statin-Induced Liver Injury.

BACKGROUND The aim of this study was to evaluate the efficacy and safety of bicyclol treatment in statin-induced liver injury. MATERIAL AND METHODS The study included 168 patients with liver injury caused by statins. Patients were randomized into two four-week treatment groups: bicyclol 25 mg three times daily or polyene phosphatidylcholine 456 mg three times daily as control. Serum biochemical indexes were compared before and after treatment. RESULTS Significant differences in alanine transaminase (ALT) levels among the three measurements before and after treatment in the two groups at different time points were observed (p<0.01). There was a significant difference (p<0.01) between two weeks and four weeks after treatment compared to the baseline period. There was a significant interaction (p=0.003) between the two groups and time factors. After two and four weeks of treatment, the ALT levels in the control group (68.20±26.31, 50.71±27.13 respectively) were higher compared to the ALT in the bicyclol group (49.33±21.39, 30.36±17.41 respectively) (p<0.01). After four weeks of treatment, the normalization rates of bicyclol and polyene phosphatidylcholine groups were 74.68% and 46.15%, respectively. The efficacy of bicyclol was significantly better than that of polyene phosphatidylcholine (p<0.05). The incidence of adverse reactions in the bicyclol and polyene phosphatidylcholine groups were 2.53% and 2.56%, respectively, with no statistically significant differences observed between the two groups (p>0.05). CONCLUSIONS These findings suggest that trends of ALT changes in the two groups were different, and the improvement of ALT was more obvious in the bicyclol group. Bicyclol is considered to be safe and effective in the treatment of statin-induced liver injury.