One reason for the growing popularity of herbal medicines is the perception that these compounds are safe and free of side effects. We report a case of acute hepatitis caused by Prostata (Gero Vita International), an herbal preparation used to treat prostatic hypertrophy.

A 65-year-old man with nocturia and hesitancy began taking Prostata, which had been ordered from a catalogue. Two weeks later, he developed jaundice and severe pruritus and stopped taking the medication. His abdomen was not tender, and his liver and spleen were not palpable. Biochemical findings were as follows: bilirubin level, 8.2 mg/dL; aspartate aminotransferase level, 1238 IU/L; alanine aminotransferase level, 1364 IU/L; alkaline phosphatase level, 179 IU/L (normal <108 IU/L); -glutamyl transferase level, 391 IU/L; hematocrit, 0.41; leukocyte count, 3.3 x 10³/mm³ [polymorphonuclear count, 1.6 x 10³/mm³]; lymphocyte count, 1.2 x 10³/mm³; monocyte count, 0.4 x 10³/mm³; eosinophil count, 0.1 x 10³/mm³); and platelet count, 153 000 cells/mm³. Serum total protein level was 6.3 g/dL (albumin level, 3.6 g/dL), and the carcinoembryonic antigen level was less than 2 mg/µL. Computed tomography of the abdomen revealed a normal liver, pancreas, and biliary system. Results of serologic testing were negative for hepatitis A virus IgM, hepatitis B surface antigen, cytomegalovirus IgM, and antibodies to hepatitis C virus; hepatitis C virus RNA was undetectable by polymerase chain reaction. The patient was positive for antimitochondrial antibodies (titer, 1:320) and negative for antinuclear antibodies and anti-smooth-muscle antibody. Liver enzyme levels remained abnormal for more than 3 months before completely returning to normal. Because of slow resolution of disease, liver biopsy done 2 months after presentation showed a parenchymal infiltrate of neutrophils and lymphocytes that involved the portal tracts, early bridging, and mild periportal fibrosis. No evidence showed cirrhosis, granulomas, or bile duct damage.

Prostata is a combination of zinc picolinate, pyridoxine, Lalanine, glutamic acid, apis mellifica pollen, silica, hydrangea extract, panex ginseng, serenoa serrulata, and pygeum africanum. Serenoa (saw palmetto) is presumably the most active ingredient, providing an estrogenic and antiandrogenic effect through direct stimulation of estrogen receptors and inhibition of testosterone-5--reductase [1].

Both estrogens and antiandrogens can be hepatotoxic. Estrogens interfere with bromosulfophthalein and bilirubin excretion [2], and cholestasis of pregnancy may be a manifestation of exaggerated responsiveness to cholestatic effects of high estrogen levels [3]. Fulminant hepatitis has been reported with the anti-androgenic drugs flutamide and cyproterone acetate [4]. Flutamide competitively inhibits binding of dihydrotestosterone to androgen receptors and increases plasma concentrations of estrogen and testosterone in the rat by blocking the inhibitory feedback of testosterone on production of luteinizing hormone [5]. The cholestatic hepatitis observed with flutamide is postulated to result from testosterone-mediated cholestasis.