Aim of this review is to evaluate the pharmacological efficacy and safety of Serenoa repens extracts in managing lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH). Using PubMed, Web of Science, and the Cochrane database, we identified studies published until November 2023 reporting effect of Serenoa repens extracts on LUTS and BPH. All studies were included in the literature search. The most relevant studies were selected to identify the effects of different extracts of serenoa repens in terms of pharmacology, efficacy and safety. Hexanic extract of Serenoa repens (HESr), presents important anti-inflammatory, antiproliferative, and antiandrogenic activities proven through various in vitro, in vivo, and clinical trials. The current phytotherapeutic landscape is very heterogeneous and limited by the lack of a regulatory framework for herbal substances. There is a clear disparity in the qualitative and quantitative composition of extracts due to varied extractive processes, affecting the therapeutic efficacy. Several studies (prospective randomized clinical trials) demonstrated the clinical efficacy of HESr compared to placebo and other pharmacological treatments. Particularly, HESr improves nocturia and Qmax. Other extraction techniques, such as alcoholic and CO<inf>2</inf> need further RCT to better define their efficacy. The review identifies the critical role of Serenoa repens extract in managing LUTS in patients with BPH. Particularly the evidence suggests significant in vitro and in vivo differences in terms of inflammation reduction, symptoms relief and flow improvement depending on the extraction technique.
Minerva urology and nephrology. 2026 Apr [Epub]
Cosimo DE Nunzio, Riccardo Lombardo, Antonio Franco, Beatrice Turchi, Antonio Cicione, Mauro Gacci, Stavros Gravas
Department of Urology, Sapienza University of Rome, Rome, Italy., Department of Urology, Sapienza University of Rome, Rome, Italy - ., Unit of Urological Robotic Surgery and Renal Transplantation, Careggi Hospital, University of Florence, Florence, Italy., Department of Urology, Medical School, University of Cyprus, Nicosia, Cyprus.