A literature review in Germany noted that Legalon is the best documented agent for the treatment of toxic liver impairment (Morazzani and Bombardelli, 1995). These authors also reviewed studies which suggest future use in dermatological and cosmetic products, based on a number of activities including promoting healing at wound sites, improved burn healing, and counteracting skin degeneration and aging via anti-inflammatory and free radical scavenging mechanisms. A more recent review concluded that despite some flaws in methodology of some of the clinical studies, Legalon® has not demonstrated adverse side effects and it "may be effective in improving the clinical courses of both acute and chronic viral, drug- and toxin-induced and alcoholic hepatitis" (Flora et al., 1998).

Because the well-documented antioxidant activity of silymarin has been shown to prevent lipoperoxidative hepatic damage by xenobiotic compounds (e.g., alcohol and certain pharmaceutical drugs), researchers attempted to determine whether milk thistle would be helpful for patients being administered psychotropic drugs. In a double-blind, placebo-controlled study, the efficacy of silymarin was evaluated in patients receiving psychotropic drugs as long-term therapy (Palasciano et al., 1994). Sixty women in the psychiatric ward of an Italian hospital were selected for the trial, all having been treated with either phenothiazines and/or butyrophenones for at least five years. They were randomly divided into four groups, with the silymarin patients receiving 800 mg a day for 90 days. Results showed that 800 mg/day of silymarin may be useful in the treatment of some instances of lipoperoxidative hepatic damage, such as the damage that may occur during long-term treatment with the psychotropic drugs.

Milk thistle extract has become increasingly popular in the United States as a dietary supplement for people with livers compromised by alcohol or exposure to toxic chemicals. Based on the increasing number of clinical studies indicating its safety and suggesting efficacy, consumers are also using this preparation as a means to ensure proper liver function and to assist in "detoxification" measures. Given this phytomedicine"s well established safety and its reasonable documentation of efficacy, future clinical use of milk thistle extract should be explored as an adjunct therapy in chemotherapy to help offset the effects of powerful and potentially hepatotoxic conventional drugs.

U.S. pharmacopeial grade milk thistle consists of the dried ripe fruit of S. marianum with its pappus removed. It must contain not less than 2% of silymarin, calculated as silybin, as determined by a USP spectrophotometric assay method. Botanical identification must be confirmed by thin-layer chromatography (TLC) and macroscopic and microscopic examinations (USP 24–NF 19, 1999). German pharmacopeial grade milk thistle also consists of the ripe fruit with the pappus removed. However, it must contain not less than 1.5% silymarin, calculated as silybin with reference to the dried drug. Total silymarin must be determined by a liquid chromatagraphic method (DAB method V.6.20.4). Botanical identity must be confirmed by TLC, macroscopic and microscopic examinations, and organoleptic evaluations. For example, the seed husk should have a bitter taste while the seed has an oleaginous taste, and it may not smell or taste rancid (DAB, 1997). The German Homeopathic Pharmacopoeia monograph requires that it contain not less than 1% of silymarin, calculated as silybin (GHP, 1993).