bicyclol and Hepatitis-C--Chronic

Chronic viral hepatitis B and C are diseases worldwide. At present, the number of effective and safe drugs for treatment of HBV and HCV is still limited. In order to develop novel anti-viral hepatitis drug, a number of analogues of the active component schizandrin C from Fructus Schiznadrae, a Chinese herb used in the therapy of viral hepatitis, were synthesized. Bicyclol, one of the analogues, was demonstrated to have actions of anti-hepatitis virus replication in duck hepatitis model and 2.2.15 cell line, anti-experimental liver injury induced by hepatotoxins such as CCl4, acetaminophen and ConA, and anti-liver fibrosis in rats and mice. The active mechanism of bicyclol might be anti-apoptosis of hepatocytes through multiple signaling pathways mainly inducing the expressions of hepatic heat shock proteins (HSP27 and HSP70), molecular chaperons. Clinical trial was performed by double blind, randomized and positive control or placebo method in multi-medical centers in China. Patients received bicyclol 25mg thrice daily for six months, then stopped treatment and followed up for 3 months. Oral administration of bicyclol normalized the elevated serum transaminases (ALT, AST) by approximately 50% in chronic viral hepatitis B and C, and also showed certain level of inhibiting HBV and HCV replication. No noticeable adverse reaction has been observed. In combination therapy of bicyclol with interferon alpha, lamivudine and adefovir dipivoxil in HBV or HCV, bicyclol may potentiate the anti-viral efficacy and reduce YMDD mutant and side effects. In 2004 China FDA issued license to manufacture bicyclol. Since then bicyclol has been widely used to treat chronic HBV and HCV in China.

Topics: Animals; Antiviral Agents; Biphenyl Compounds; Hepatitis B, Chronic; Hepatitis C, Chronic; Humans; Molecular Structure

Bicyclol is a novel synthetic 'anti-hepatitis' drug, used in China for chronic hepatitis C. Until now, systematic reviews on bicyclol therapy have not been performed.. To study the benefits and harms of bicyclol for patients with chronic hepatitis C.. We searched The Cochrane Hepato-Biliary Group Controlled Trials Register (July 2005), the Cochrane Central Register of Controlled Trials in The Cochrane Library (Issue 2, 2005), MEDLINE (1994 to July 2005), EMBASE (1994 to July 2005), Science Citation Index Expanded (1994 to July 2005), The Chinese Biomedical Database (1994 to August 2005), Chinese Journals Full-article Database (1994 to August 2005), VIP Chinese Science and Technique Journals Database (1994 to August 2005), and China National Infrastructure (CNKI) (1994 to August 2005). We also contacted manufacturers and researchers in the field.. Randomised clinical trials on bicyclol versus no intervention, placebo, or other interventions in patients with chronic hepatitis C were included, irrespective of blinding, publication status, or language.. The primary outcome measures were total and liver-related mortality and liver-related morbidity (eg, cirrhosis and carcinoma). Secondary outcome measures were viral response and liver histology.. The search identified one randomised clinical trial comparing bicyclol with placebo for 39 patients with chronic hepatitis C. The follow-up was three months. In the trial, there was no evidence that bicyclol was superior to placebo for clearance of HCV RNA (RR 3.80, 95% CI 0.47 to 31.0) and anti-HCV antibodies, but bicyclol was associated with statistically significant decrease in alanine aminotransferase activity at 12-th week after treatment (WMD -69 IU/L, 95% CI -115 to -24).. 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.

Topics: Biphenyl Compounds; Hepatitis C, Chronic; Humans

To evaluate treatment effectiveness and safety of bicyclo tablets in children with chronic hepatitis B or C.. A randomized controlled trial was conducted in 148 children with chronic hepatitis B or C for evaluating safety, tolerability, and efficacy of treatment with bicyclo tablets or Hugan tablets. Children in therapy group were treated with bicyclo tablets and control group treated with Hugan tablets.. (1) ALT and AST level decreased more prominently in therapy group than in control group (P<0.01). (2) Bicyclo was more effective than Hugan tablets (P<0.01). (3) Symptoms were ameliorated more prominently in bicyclo group than in control group (P<0.01). (4) Both groups had no significant adverse events.. Satisfactory therapeutic effect and safety were obtained with bicyclo tablets in children with chronic hepatitis B or C.

Topics: Adolescent; Biphenyl Compounds; Child; Child, Preschool; Hepatitis B, Chronic; Hepatitis C, Chronic; Humans; Tablets; Treatment Outcome