Safety evaluation of a combination, defined extract of Scutellaria baicalensis and Acacia catechu

A combined extract containing primarily baicalin from Scutellaria baicalensis and (+)-catechin from Acacia catechu used in both joint supplements and a prescription medical food was tested for safety. Cytotoxicity testing in THP-1 monocytes showed limited cell death compared to nonsteroidal anti-inflammatory drugs (NSAIDs). Acute and subchronic toxicity testing demonstrated no abnormalities in any toxicological end points examined including animal body weights, gross organ pathology and tissue histology, and blood chemistries or serology. The extract, when dosed in Fischer 344 rats, a model for gastric toxicity of NSAIDs, showed no evidence of ulceration. No mutagenicity or drug interactions were seen by AMES and cytochrome P450 enzyme inhibition, respectively. When the extract was compared with placebo after administration to a healthy human population, no changes in blood chemistry or serology were observed. Based on these findings, the combined extract with baicalin and catechin appears to possess a safety profile that justifies further testing in humans.