Bicyclol for chronic hepatitis C.

backgroundBicyclol 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.

objectivesTo study the benefits and harms of bicyclol for patients with chronic hepatitis C. SEARCH STRATEGY: 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. SELECTION CRITERIA: 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. DATA COLLECTION AND ANALYSIS: 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. MAIN

resultsThe 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). AUTHORS'

conclusionsOnly 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.