ABSTRACT
Background: chronic liver disease is a major cause of mortality and morbidity in Egypt. D.D.B. was found to improve the abnormal liver function tests in those patients. Since then it has been used in the management of chronic liver disease, yet clinical improvement and changes in the biochemical and pathological examination are still considered study questions
Objectives: to evaluate the efficacy and side effects of D.D.B. compared to Silymarine in wells compensated patients with chronic HCV infection
Method: the study population included 50 patients with compensated chronic HCV infection subdivided into two groups 25 patients each. One group received D.D.B. for 48 weeks and the other received Sily-marine for the same period of time. Each patient was subjected to assessment of the liver function tests, virological studies, abdominal ultrasound, isotope liver scan, liver biopsy and rectal snip before starting the treatment. Further evaluation was performed by repeating the liver function tests every 3 months, the abdominal ultrasound every 6 months, the rest of the tests and the liver biopsy were repeated after one year i.e. at the end of treatment
Results: sustained normalization of ALT level and transient normalization of the AST level was found in the DDB group. No significant effect on the. HCV RNA, level was detected after one year of D.D.B. therapy; in none of the patients did the HCV RNA become undetectable. The liver-splenic ratio in the iso-topic studies showed significant decrease after one-year therapy with D.D.B. The grade of inflammation was unchanged in 10 cases, worse in 11 cases and better in 3 cases while fibrosis was unchanged in 22 cases and worse in 2 cases. No major side effects were observed in either group of patients
Conclusion: DDB has no antiviral effect in patients with chronic HCV infection. It does not show a histological benefit [neither in terms of degree of necroinflammation nor stage of fibrosis] after 1 year of treatment and when compared to Silymarin. On the other hand it improves some biochemical parameters [ALT] as well as the general well being of the patients. It has no major side effects