Abstract
To compare the efficacy of ademetionine 1, 4-butanedisulphonate (Ade-SD/4) versus a traditional Chinese remedy (TCR) in patients with hepatocellular jaundice associated with acute viral hepatitis. 253 patients were enrolled and 148 completed the study. In this randomised, open-label, multicentre, parallel-group study, patients (aged 14 to 65 years) with elevated serum bilirubin levels (>2 × upper limit of normal) received either Ade-SD4 (ademetionine 1g) intravenously once daily for 2 weeks then oral Ade-SD4 (ademetionine 0.5g) twice daily for 4 weeks, or TCR (Capillarin, a herbal derivative, 30ml intravenously once daily for 2 weeks, then oral Capillarin 30ml for 4 weeks plus six tablets of Tanshinone, a Salvia miltiorrhiza derivative, once daily throughout the 6 weeks). Treatment efficacy was evaluated by changes in serum bilirubin (total and conjugated) and transaminases, fatigue and jaundice after 7, 14, 28 and 42 days. Both Ade-SD4 (n = 132) and TCR (n = 121) significantly improved serum transaminases, albumin, alkaline phosphatase, γ-glutamyl transferase and total bile acids; improvements in serum total and conjugated bilirubin and alanine amino transferase (ALT) were significantly greater with Ade-SD4 than with TCR. After 7 days of treatment, median total bilirubin was 2.23 mg/dl in Ade-SD4-treated patients vs 3.08 mg/dl in TCR-treated patients (p = 0.0001), while conjugated bilirubin and ALT were, respectively, 0.97 vs 1.5 mg/dl (p = 0.0001) and 116 vs 162 U/L (p = 0.0006). At day 7, the proportion of serum total and conjugated bilirubin responders was significantly higher in the Ade-SD4 group (69 and 73%, respectively) than in the TCR group (50 and 54%, respectively; p ≤ 0.004). Significant differences in favour of Ade-SD4 were observed for jaundice (p = 0.01), fatigue (p = 0.004), general discomfort (p = 0.05), urinary discoloration (p = 0.02), nausea (p = 0.01), anorexia (p = 0.001), and patient (p = 0.01) and physician (p = 0.05) assessments of treatment efficacy. Both treatments were well tolerated and no serious adverse effects were reported. Ade-SD4 is significantly more effective than TCR in reducing the severity and duration of hepatocellular jaundice associated with acute viral hepatitis.
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