, Volume 21, Issue 11, pp 765-773

Ademetionine 1,4 Butanedisulphonate vs Traditional Chinese Medicine for the Treatment of Hepatocellular Jaundice Complicating Chronic Viral Hepatitis

Purchase on Springer.com

$49.95 / €39.95 / £34.95*

Rent the article at a discount

Rent now

* Final gross prices may vary according to local VAT.

Get Access

Abstract

Objectives

To compare the efficacy of ademetionine 1,4-butanedisulphonate (Ade-SD4) versus a traditional Chinese remedy (TCR) against biochemical markers of hepatocellular jaundice and major signs and symptoms of chronic liver disease.

Methods

In this multicentre, parallel-group, open-label study, patients (aged 14 to 65 years) with chronic viral hepatitis and hepatocellular jaundice (serum bilirubin >2 × upper limit of normal) were randomised to receive either Ade-SD4 (equivalent to ademetionine 1g) 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 by 30ml orally for a further 4 weeks plus six tablets of Tanshinone, a Salvia miltiorrhiza derivative, once daily throughout the 8-week study). Treatment efficacy was signified by reductions in serum bilirubin to <50% of baseline 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 < 0.01). There were significantly more bilirubin responders to Ade-SD4 than to TCR at 28 and 56 days (p < 0.0001). Ade-SD4 was superior to TCR in reducing serum transaminases and alkaline phosphatase, and in improving general discomfort and fatigue (p ≤ 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 symptomatic treatment of chronic viral hepatitis complicated by hepatocellular jaundice.