Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study

The study evaluated the efficacy and tolerability of two combination treatments for 136 men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia. Over 6 months, patients were treated with Tamsulosin combined with either the hexanic extract of Serenoa repens (HESr) or a 5-alpha-reductase inhibitor (5ARI). Both treatments showed similar improvements in urinary symptoms and quality of life, with mean IPSS score improvements of 7.7 and 6.7 points for TAM + 5ARI and TAM + HESr, respectively. However, the TAM + HESr group experienced fewer adverse effects, particularly those affecting sexual function, reported by 10.3% of patients compared to 26.5% in the TAM + 5ARI group. This indicated that TAM + HESr was as effective as TAM + 5ARI but had better tolerability.