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BACKGROUND:Bicyclol is a novel synthetic 'anti-hepatitis' drug, used in China forchronic hepatitis B. Until now, systematic reviews of bicyclol therapy have notbeen performed. OBJECTIVES: To study the benefits and harms of bicyclol forpatients with chronic hepatitis B. SEARCH STRATEGY: We searched The CochraneHepato-Biliary Group Controlled Trials Register (July 2005), The CochraneCentral Register of Controlled Trials in The Cochrane Library (Issue 2, 2005),MEDLINE (1950 to July 2005), EMBASE (1980 to July 2005), Science Citation IndexExpanded (1945 to July 2005), The Chinese Biomedical Database (1994 to August2005), VIP Chinese Science and Technique Journals Database (1994 to August2005), and China National Infrastructure (CNKI)(1994 to August 2005). We alsocontacted manufacturers and researchers in the field. SELECTION CRITERIA:Randomised clinical trials with bicyclol versus no intervention, placebo, orother interventions were included, irrespective of blinding, publicationstatus, or language. DATA COLLECTION AND ANALYSIS: The primary outcome measureswere mortality (total and liver-related) and liver-related morbidity (eg,cirrhosis and carcinoma). Secondary outcome measures were viral response andliver histology. MAIN RESULTS: The search identified one randomised clinicaltrial comparing bicyclol with bifendate (biphenyldicarboxylate) for patientswith hepatitis B. The follow-up was three months. There was no evidence thatbicyclol was superior to bifendate for loss of HBeAg (RR 1.38, 95% CI 0.95 to2.00), seroconversion of HBeAg to HBeAb (RR 1.44, 95% CI 0.90 to 2.29), loss ofHBV DNA (RR 1.19, 95%CI 0.93 to 1.53), or number of patients with normalisedalanine aminotransferase and aspartate aminotransferase activity (RR 0.88, 95%CI 0.70 to 1.11 and RR 0.97, 95% CI 0.79 to 1.20, respectively). AUTHORS'CONCLUSIONS: Only one randomised clinical trial has examined the potentialbenefit of bicyclol for patients with chronic hepatitis B. 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 toexamine the possible benefits and harms associated with bicyclol. Bicyclol canonly be recommended for use in randomised trials. Leggi l'articolo: è full text!