A Prospective, Open-Label Comparison of Tamsulosin plus Serenoa repens and Bovine Colostrum versus Tamsulosin Alone in the Treatment of Benign Prostatic Hyperplasia.

Di Maida, Fabrizio; Mari, Andrea; Rubino, Roberta; Minervini, Andrea; Carini, Marco; Siena, Giampaolo

Objective: To compare the efficacy and safety of oral supplementation with Serenoa repens (SR) and bovine colostrum (BC) plus tamsulosin (TAM) versus TAM alone over 12 months in men suffering from lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Methods: Between February 2018 and February 2019, men with symptomatic BPH (IPSS ≥10) were prospectively recruited. This prospective, open-label, 12-month study included two different protocols: (1) group A, SR 320 mg/day BC 30 mg/day TAM 0.4 mg/day, and (2) group B, TAM 0.4 mg/day only. Results: Overall, 148 patients entered the study, 76 in group A and 72 in group B. At 12 months, the total IPSS had decreased by 5.5 with TAM SR BC and by 5.1 with TAM only (p = 0.21). However, when the total IPSS was divided into storage and voiding subscores, at 6 months the storage symptoms had improved significantly more with TAM SR BC (–1.6 vs. –0.9 with TAM only, p = 0.02), with the benefit persisting also at the 1-year evaluation (–1.8 vs. –0.8, p = 0.02). Moreover, the improvement in LUTS-related quality of life (QoL) was significantly different between the groups, with a mean decrease in IPSS QoL subscore of –2.5 ± 0.2 for TAM SR BC versus –1.8 ± 0.3 for TAM at 6 months (p = 0.04), and of –2.9 ± 0.4 for TAM SR BC versus –2.1 ± 0.4 for TAM at 12 months (p = 0.04). Conversely, no significant differences were found in maximal urinary flow rate (p = 0.38), postvoid residual volume (p = 0.12), prostate-specific antigen (p = 0.41), and prostate volume (p = 0.16). Conclusion: Combination treatment with SR and BC plus TAM was shown to be more effective than treatment with TAM only in improving IPSS storage and QoL subscores in BPH patients after 6 months and up to 12 months of treatment.

BENIGN prostatic hyperplasia; TAMSULOSIN; PROSTATE-specific antigen; URINARY organs; SYMPTOMS

Urologia Internationalis, 2020, Vol 104, Issue 5/6, p351

0042-1138

Academic Journal

10.1159/000503735