| Summary: | Prostate cancer is the most prevalent cancer in men of western nations. Major research advancements in prostate cancer diagnosis and treatment have been made over the past several decades. Unfortunately, there are no curative treatment options available for late stages of prostate cancer. Often patients with these disease states turn to alternative medicines. ESSIAC® is one of these treatments. ESSIAC® is an extract of a blend of Burdock root, Indian Rhubarb root, Slippery Elm bark and Sheep Sorrel. The intention of this study is to provide objective preclinical evidence of ESSIAC's ability to exert an anti-proliferative effect on both in vitro and in vivo prostate cancer cells and the tumors they generate. Methods: An HPLC method was developed and employed to ensure that successive commercial lots and escalating concentrations of ESSIAC® were similar in content based on the peak area produced. The extract was tested in cell culture by means of both a crystal violet cytotoxicity assay and a cell cycle analysis. The acute toxicity of the extract on healthy athymic nude mice was tested, as well as ESSIAC®'s efficacy in inhibiting subcutaneous PC-3 tumor growth. The treated tumors were analyzed for the expression levels of both Ki-67 and PCNA. Results: The HPLC analysis indicated that the within-lot variation of the extract was small with <2% RSD for most of the analyzed peaks. The between-lot variation, despite being large when considered on an absolute scale, was small when the peak areas were considered relative to the total respective peak area. No cytotoxicity was recorded with 48 hr ESSIAC® treatments. Similar results were obtained from a cell cycle analysis. Using body weight as an indicator, no toxicity was observed in the athymic nude mice using doses ranging up to 240 mg/kg QD, over 28 days. The orally dosed ESSIAC® treatment groups did not differ significantly from controls during a 28 day efficacy study. Analysis of proliferation marker expression levels confirmed the results of the efficacy study. The preclinical evaluations performed in this study suggest ESSIAC® aqueous extract has no marked anti-proliferative action on the prostate cancer models tested. === Pharmaceutical Sciences, Faculty of === Graduate
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