Background/a ims. A double-blinded trial eval uating silymarin, an herbal supplement for
liver di sease, to prevent complications of chronic hepatitis C virus infection has not been
done. •
Subjects. One hundred and seventy-seven consenting residents of an Egyptian village with
chronic hepatitis C virus were randomly assigned to receive either silymarin or
multivitamin supplements.
Methods. Participants had baseline and fo llow-up clinical, ultrasound, blood tests and
quality-of-life assessments. Community nurses visited weekly to ascertain compliance,
distribute supplements and record adverse effects.
Results. At 12 months almost all of 141 remaining subjects reported feeling better,
although symptoms and quality-of- Iife scores did not differ between the silymarin and
multivitamin groups. Both the silymarin and vitamins were tolerated equally well; and
>95% of supplements were taken by >95% of subjects. One in each group had no
detectable hepatitis C virus antibodies while two in the silymarin group and three receiving
multivitamins had un4etectable hepatitis C virus R.NA. Serum alan ine aminotransferase
elevations did not differ between groups. Serum hepatic fibrosis marker, hyaluronic acid
and YKL-40, and abdominal ul trasound results were simi lar in both groups and may have
progressed slightly at 12 months.
Conclusions. The recommended dose of silymarin can be safely taken for 1 year and improves
symptoms and general well-being, but has no effect upon hepatitis C virus virenn ia, serum AL T,
or serum and ultrasound markers for hepatic fibrosis. More prolonged evaluation and a higher dose
may be. required to ascertain whether milk thistle supplements prevent complications of chronic
hepatitis C virus.