[Treatment of chronic hepatitis C by bicyclum, a randomized double-blind placebo controlled trial].
To evaluate the efficacy and safety of bicyclum, a China made new hepatocyte protecting agent, in the treatment of chronic hepatitis C (CHC).
                Thirty-nine CHC patients matched demographically and clinically were randomized into two groups: bicyclum group (group A, n = 20) and placebo/bicyclum crossovergroup (group B, n = 19). Bicyclum 75mg/d or placebo was administered to these two groups respectively for 3 months. Then the patients in group A received bicyclum for further 3 months and were observed for 3 months after the treatment discontinued; and the patients in group B received bicyclum 75mg/d for six months and were observed for 3 months after the treatment discontinued. Investigation items included clinical manifestations,liver function, serum HCV RNA and anti-HCV.
                In group A, the serum ALT was 120 +/- 43 U/L before treatment and was 57 +/- 32 U/L after treatment ( P < 0.01) In group B the baseline serum ALT was 126 U/L +/- 48 U/L. After the placebo administration the serum ALT was 127 U/L +/- 97 U/L (P > 0.05) and the clinical feature showed no improvement. After bicyclum treatment for 6 months, the serum ALT in group B was 68 +/- 45 U/L, significantly lower than that before bicyclum treatment ( P < 0.01) and clinical symptoms improved. The overall ALT normalization response rate were 64.1% and 48.7% at the end of bicyclum treatment and 3 months after the treatment discontinued respectively for the total 39 patients. The serum HCV-RNA became negative in 5 and 2 patients at end of treatment and 3 months after the treatment discontinued. Adverse drug reactions were mild and uncommon. Mild dizziness occurred in 1 patient in each group.
                Bicyclum is effective in improving ALT and clinical manifestations of CHC patients. It is safe and well tolerated and shows few adverse reactions.
Only one randomised clinical trial has examined bicyclol for patients with chronic hepatitis C. This small, short-term trial found no evidence to support or refute its use. Large, randomised, double-blind clinical trials with long-term follow-up are needed to examine the possible benefits and harms associated with bicyclol. Bicyclol can only be recommended for use in randomised trials.