This systematic review assessed the potential effectiveness and safety of Serenoa repens (saw palmetto) for benign prostatic disorders, mainly benign prostatic hyperplasia and associated lower urinary tract symptoms. Following PRISMA guidance (PROSPERO: CRD420251032255), we searched PubMed, Cochrane and ScienceDirect for human studies from January 2020 to May 2025. Sixteen studies (>3000 participants) met criteria, including randomized trials, observational cohorts, a post hoc analysis, an open-label comparative study and a pharmacovigilance analysis. Overall, S. repens was associated with improvements in symptom severity (International Prostate Symptom Score) in several trials, with variable effects on urinary flow, post-void residual volume, and patient-reported quality of life. Signals of benefit appeared more consistently with hexanic lipidosterolic extracts and β-sitosterol-enriched preparations, and some real-world and head-to-head comparisons suggested outcomes comparable to alpha-blockers with fewer adverse events. Combination therapy, especially with the addition of alpha-blockers, showed larger symptom reductions in select populations, particularly with more pronounced baseline symptoms or prostatic inflammation. However, heterogeneity in extract formulations, dosing, study design, and outcome reporting limited cross-study comparability. Safety findings were generally favourable, with mostly mild gastrointestinal events and fewer sexual adverse effects than reported for conventional pharmacotherapies. Taken together, recent evidence supports S. repens as a potentially useful, well-tolerated option for benign prostatic hyperplasia-related symptoms - especially in certain formulations and as part of combination strategies - whilst underscoring the need for standardized, adequately powered trials to clarify which patients benefit most, optimal dosing, and durability of effects.
Benign prostatic disorders (BPDs) are non-malignant diseases commonly found in ageing men. They include benign prostatic hyperplasia (BPH; where the prostate is enlarged) and prostatitis (where the prostate is inflamed). These diseases present symptoms that impair the quality of life of the affected men. They include increased urinary frequency and urgency during the day and exacerbated during the night. The total harm that these illnesses cause around the world is high and continues to rise. Current clinical treatments for BPDs range from lifestyle changes (for example, reducing caffeine and fluid intake, promoting exercise) to various pharmacological treatments and, in more severe cases, surgical procedures. Among the drugs that have beneficial effects on BPDs, there are two different groups: synthetic and natural drugs. Alpha-blockers and 5-alpha-reductase inhibitors are the most used synthetic drugs; however, although these drugs are effective, most men abandon the treatment because they have marked sexual side effects. Natural drugs include a variety of phytotherapeutic agents, with Serenoa repens being the most widely used. However, a standardized formulation or ideal dosage have not yet been established. This study determines whether Serenoa repens formulations can benefit men with BPDs in reducing their symptoms. The authors reviewed articles from several studies where Serenoa repens was used in the treatment of BPDs, either alone or in combination with other treatments. The evaluated clinical studies were published within the past 5 years in renowned international journals, and the authors revised these articles in a systematic way (with a scientific and rigorous method to summarize the evidence in the most impartial and complete way). The authors evaluated the efficacy and safety of Serenoa repens formulations, aiming to register the following parameters: symptom relief, objective urinary measures (for example, peak flow, prostate volume), and tolerability. Overall, treatment of BPDs with Serenoa repens was associated with improvements in symptom severity in most of the studies. Several studies show that Serenoa repens offers similar benefits to synthetic drugs but with a lower risk of adverse events. Combination therapy using Serenoa repens along with alpha-blockers showed several advantages. First, the beneficial effects of alpha-blockers are known to be brief, and the addition of Serenoa repens seems to prolong their duration. Second, combination therapy has shown larger symptom reductions. Finally, as Serenoa repens has been associated with significantly lower sexual side effects, it has been shown that, when administered in combination with an alpha-blocker, it can counteract those side effects — this advantage will make men more predisposed to adhering to treatment. Taken together, this review supports Serenoa repens as a potentially useful, well-tolerated option for the treatment of BPD-related symptoms, especially in combination with alpha-blockers. This review makes it clear that it is worth the effort to standardize drug formulations and dosages. Doing so would benefit patients and enable greater comparability between studies, which in turn would lead to stronger conclusions.
Drugs in context. 2026 May 13*** epublish ***
Iván Schwartzmann, Anna Redondo, Alba Farré, Paula Izquierdo, Enver Moncada, María Montlleó, Yesica Quiroz, Alberto Breda, Joan Palou, Javier Ponce de León
Fundació Puigvert, Barcelona, Spain.