Tolerability and toxicity of lipidosterolic extract of American dwarf palm Serenoa repens in Wistar rats: well-known extract, new insight.

BACKGROUND AND OBJECTIVES Serenoa repens extracts (SrE) have been used for centuries in the treatment of benign prostatic hyperplasia (BPH). According to recommendations that each product should be examined separately, including its tolerability and toxicity, we conducted this study in order to broaden the current cognition about tolerability and toxicity of SrE, in particular of German brand ProstamolunoR. MATERIALS AND METHODS Twenty-four adult male Wistar rats were randomly distributed into 4 groups of 6 animals. The first control group (O) received water (1 ml/kgBW) and second control group (OO) received olive oil (1 ml/kgb.w.) every day for 30 days. The third and fourth group of rats (SR5 and SR10) were treated with SrE (150 and 300 mg/kgb.w. daily) dissolved in olive oil. Tolerability and toxicity of SrE were estimated on the basis of daily monitoring of behavior, body weight gain (BWG), relative weight of liver, left kidney, prostate and left testis, and values of general biochemical parameters. Total liver proteins (TLP) and glutathione content in hepatocyte suspension were also determined. RESULTS BWG was significantly unchanged in SR5 and SR10 compared to both controls in all intervals of measurement and at the end of treatment (p > 0.05). LW/BW ratio was significantly higher in SR10 compared with O (p < 0.01). Creatinine and potassium were significantly higher in SR5 compared to O (p < 0.05), but in SR10 were significantly higher compared to both control groups (p < 0.01). TLP content was significantly higher in SR5 compared to OO (p < 0.01). The content of glutathione in homogeneous suspension of hepatocytes didn't alter significantly. CONCLUSIONS Obtained results have expanded the current state of knowledge about the tolerability and toxicity of SrE, in particular of Prostamol-unoR. For the adoption of a more precise conclusion about its tolerability and toxicity, it should be excluded possible limiting factors that we identified in this study.