Although the combined administration of glycyrrhizin (SNMC) and ursodeoxycholic acid (UDCA) is usually used for intractable patients with active HCV-associated chronic hepatitis (HCV-CH) or cirrhosis (LC), there are many cases that do not respond to this combination therapy. In this study, we examined the effects of adding Juzen-taiho-to (TJ-48) to lower the serum alanine aminotransferase (s-ALT=s-GPT) levels in such cases. Methods: The average s-ALT levels for 6 months were compared before and after 7.5g of Juzen-taiho-to was added to the combined therapy of SNMC and UDCA for 9 HCV-CH and 12 HCV-LC patients. In some cases, the effectiveness of the therapy over 12 months was also evaluated. Results: In the HCV-CH cases s-ALT levels were significantly decreased in 3 of 9 (33%) cases in 6 months (about 30 INU in average). In the HCV-LC cases, s-ALT levels were significantly decreased in 5 of 12 (42%) cases in 6 months (more than 40 INU in average). There were some patients whose s-ALT levels decreased significantly after 6 months. As to the improvement of clinical symptoms, general fatigability improved in 12 out of 20 cases (60%) and anorexia improved in 10 out of 19 cases (53%). Conclusions: Juzen-taiho-to (TJ-48, 7.5g daily) added to the combined therapy of SNMC and UDCA may be an effective therapy for intractable cases of active HCV-CH or LC.

Although glycyrrhizin (SNMC), and ursodeoxycholic acid (UDCA), alone or in combination have been administered in patients with active HCV-associated chronic hepatitis (HCV-CH) or liver cirrhosis (HCV-LC), there are many patients who do not respond well to these anti-inflammatory treatments. In this study, we examined retrospectively the possibility for juzentaihoto to alleviate inflammation in such patients. We calculated average ALT levels every 6 months for all 67 patients. If we assume an improvement in average serum ALT levels of more than 25% after juzentaihoto administration to be significantly effective, as compared with average ALT levels before juzentaihoto administration, 23 out of 40 patients (57.5%) showed significant improvement within one year. In the 32 patients with HCV-associated liver disease who were treated with combination SNMC and UDCA therapy, and whose average ALT levels did not decline to less than 80 IU/L, 18 (56.3%) showed significant improvement when juzentaihoto was added. Juzentaihoto was effective in 62.5% of patients with CH, and 54.2% of those with LC. Moreover, juzentaihoto was effective in 41.2% of male, and 69.6% of female patients. And in about 40% of patients, average ALT levels lowered increasingly over time, out to 2 years. Juzentaihoto may be an effective anti-inflammatory agent for intractable cases of active HCV-CH, or HCV-LC.