OBJECTIVETo systematically evaluate the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsules versus diammonium glycyrrihizinate in patients with chronic viral hepatitis.

METHODSThe Chinese Biomedical Literature Database (CBM on CD-ROM) and the China Academic Journals Full-Text Database (Chinese National Knowledge Infrastructure, CNKI) were searched for randomized controlled trials (RCTs) that compared the efficacy and safety of diammonium glycyrrhizinate entetic-coated capsules versus diammonium glycyrrihizinate in treatment (less than 2 months) of chronic viral hepatitis published between 2005 and 2012. A meta-analysis was performed on the selected RCTs to determine the effects on alanine aminotransferase (ALT) normalization, serum levels of ALT, aspartate aminotransferase (AST), total bilirubin (TBil) and albumin, as well as rates of adverse reactions.

RESULTSNine RCTs, involving 687 patients, were included in the meta-analysis. Compared to the patients treated with diammonium glycyrrihizinate, the patient treated with diammonium glycyrrhizinate enteric-coated capsules had a significantly better recovery rate of ALT (relative risk (RR) =4.15, 95% confidence interval (CI):1.55 to 11.15, P less than 0.01) and significantly more robust decreases in ALT (weighted mean difference (WMD) = -32.75, 95% CI:-46.67 to-18.83, P less than 0.01) and AST (WMD = -12.70, 95% CI:-21.13 to-4.27, P less than 0.01). In contrast, the patients treated with diammonium glycyrrihizinate showed more robust improvements in the TBil level (WMD = -0.74, 95% CI:3.98 to 2.49, P =0.653) and albumin (WMD =1.03, 95% CI:-1.03 to 3.09, P =0.326), but the differences did not reach the threshold for statistical significance (P less than 0.05). Only four adverse reactions were reported, all of which were related to the lipid complex nature of the diammonium glycyrrhizin enteric-coated capsules and were mild, including dry mouth, dizziness and mild gastrointestinal discomfort and reactions.

CONCLUSIONDiammonium glycyrrhizinate enteric-coated capsules elicited superior anti-inflammatory and liver protection effects than diammonium glycyrrihizinate, and produced only mild side effects that are tolerable to the patients.