Liverubin (standardized silymarin) in the supplementary management of functional, temporary hepatic damage. A pilot, registry, study.

Aim: Mild, temporary hepatic failure (MTHF) may be completely asymptomatic or cause minimal signs and symptoms. This common clinical problem is very diffuse and, in case of repeated episodes may cause a chronic impairment in liver function. The aim of this registry was to evaluate the evolution of MTHF in subjects using Liverubin (a new standardized Silymarin preparation) over a 4-week period.

Methods: Patients with MTHF were observed in a registry study. In all subjects viral hepatitis markers were negative at inclusion. Different possible causes of MTHF had been considered, documented or excluded. The role of alcohol was mainly as a "facilitator" and not definitely determinant as a single factor in causing the MTHF episode. The registry included patients with MTHF characterized by: decreased albumin levels; increased total bilirubin; altered hepatic functions enzymes; increased oxidative stress. Two management groups were created: a. standard management (SM) only; b: SM and Liverubin; 25 Liverubin patients and 23 SM subjects completed the registry. The average follow-up period was 32.2;1.3 days in the supplement group and 32.1;2 days in controls.

Results: The distribution of symptoms and ultrasound results were comparable. Most symptoms observed at inclusion were disappeared or attenuated at 4 weeks in both groups. At inclusion, the values in the two groups were comparable. The increase in albumin levels was significantly (P<0.05 at 4 weeks) faster and the final values were higher in the Liverubin group. Total bilirubin was reduced in the supplement group better than in controls (P<0.05). Direct bilirubin values improved more in the supplement group at 4 weeks (P<0.05). The decrease of ALT-SGPT and AST-ASAT was more evident in the supplement group (P<0.05). Improvement in controls was more limited. Alkaline phosphatase value was normalized at 4 weeks in Liverubin patients; values decreased less in controls (P<0.05). Gamma GT decreased and were normal at 4 weeks with Liverubin. ESR was decreased in both groups (significantly more in the Liverubin group: P<0.05). There was a less important decrease in controls without normalization at 4 weeks. The white cell count was also better at 4 weeks in the supplement group; P<0.05). Plasma free radicals were significantly elevated in both groups at inclusion. A more significant decrease in the supplement group was observed at 4 weeks. Persisting, elevated values were seen in controls (P<0.05 in comparison with normal range). Platelets values improved in the Liverubin group (P<0.05) better than in controls. All other blood tests values (including hematocrit, renal function tests) were within the normal range at inclusion and at 4 weeks in both groups. Hepatitis markers were negative at inclusion and at 4 weeks. Compliance. Ninety-six percent of the Liverubin capsules were correctly used. Safety and tolerability were optimal (no side effect was registered).

Conclusion: In conclusion, data from this pilot, registry study indicate a significant activity of Liverubin associated with a very good safety profile, in patients with temporary hepatic failure. The recovery of hepatic function is faster and more effective with Liverubin compared to the best "standard" management.