Assessing β-Sitosterol Levels in Dietary Supplements for Benign Prostatic Hyperplasia: Implications for Therapeutic Efficacy.

Introduction Benign prostatic hyperplasia (BPH) is a prevalent condition among aging men that affects their life quality due to urinary symptoms. Current pharmacologic treatments, often lead to sexual dysfunction, so dietary supplements (DS) containing plant-based compounds such as β-sitosterol (SIT) are preferred. DS are highly accessible and widely used, but poorly regulated, so often patients are victims of fraud. The use of DS to treat BPH symptoms is questionable, and this may be due not to the efficacity of the active compound but to the quality of commonly available DS. Aim This study aimed to assess the concentration of SIT in DS available on the market and evaluate whether the concentration of the active compound at the recommended dosage is sufficient to elicit beneficial effects in BPH. Method An HPLC-UV method based on direct saponification and acid hydrolysis was developed for the quantification of free and conjugated SIT in DS. The concentration of SIT in various DS was determined and compared with the one declared on the label. Results The chromatographic analysis confirmed the presence of SIT in all the DS but also showed a considerable variability of SIT content among DS, with only one product meeting the necessary concentration to bring potential benefits in BPH. Conclusion The study highlights inconsistencies in SIT content among DS and the importance of DS containing a standardized extract of SIT. Quality control measures are imperative to ensure that consumers receive effective and safe SIT-based DS to manage BPH symptoms. Further research is needed to establish standardized dosages and to evaluate their long-term efficacy and safety.