Ademetionine 1,4 butanedisulphonate vs traditional Chinese medicine for the treatment of hepatocellular jaundice complicating chronic viral hepatitis

Objectives: To compare the efficacy of ademetionine 1,4-butanedisulphonate (Ade-SD4) versus a traditional Chinese remedy (TCR) against biochemical mar kers of hepatocellular jaundice and major signs and symptoms of chronic liv er disease. Methods: In this multicentre, parallel-group, open-label study, patients (a ged 14 to 65 years) with chronic viral hepatitis and hepatocellular jaundic e (serum bilirubin >2 x upper limit of normal) were randomised to receive e ither Ade-SD4 (equivalent to ademetionine 1 g) intravenously once daily for 4 weeks followed by 0.5g orally twice daily for 4 weeks or TCR (Capillarin , a herbal derivative, 30ml intravenously once daily for 4 weeks followed b y 30ml orally for a further 4 weeks plus six tablets of Tanshinone, a Salvi a miltiorrhiza derivative, once daily throughout the 8-week study). Treatme nt efficacy was signified by reductions in serum bilirubin to <50% of basel ine and serum transaminases to twice the upper limit of normal. Results: A total of 289 patients received Ade-SD4 (n = 141) or TCR (n = 148 ). Ade-SD4 reduced serum bilirubin levels significantly more than TCR at 14 , 28, 42 and 56 days (p < 0.0 1). There were significantly more bilirubin r esponders to Ade-SD4 than to TCR at 28 and 56 days (p < 0.0001). Ade-SD4 wa s superior to TCR in reducing serum transaminases and alkaline phosphatase, and in improving general discomfort and fatigue (p <less than or equal to> 0.05). Both treatments were well tolerated and no serious adverse effects were reported. Conclusion: Ade-SD4 is well tolerated and more effective than TCR for the s ymptomatic treatment of chronic viral hepatitis complicated by hepatocellul ar jaundice.