Background/aim: It has been observed that a large number of patients with low urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH)) has been treated with a combination of tamsulosin (TAM) + Serenoa repens (SR) (TAM + SR). The aim of this study was to compare a combination TAM + SR with TAM and SR alone, to see if there was any difference in efficacy and tolerance of each in patients with LUTS/BPH.
Methods: In this prospective study patients had to have prostate volume (PV) < 50 mL, International Prostate Symptom Score (IPSS) of 7-18, Quality of Life score (QoLs) > 3, a maximal flow rate (Qmax) of 5-15 mL/s, with post voiding residual volume (PVR) < 150 mL and serum prostatic antigen (PSA) < 4 ng/mL. TAM (0.4 mg) was administered once a day, SR (320 mg) daily or SR (320 mg) + TAM (0.4 mg) daily for a median period of 6 months.
Results: A total of 297 patients were recruited, whereas 265 patients were fully available: 87 into the group TAM, 97 into the group SR and 81 into the group TAM + SR. There was no statistically significant difference between the treatment groups in the sense of demographic and other baseline parameters. No difference was found among the 3 treatment groups, neither in the major endpoint of the study in the sense of a change between baseline and final evaluation in total IPSS, obstructive and irritative subscores, improvement of QoLs, increase in Qmax, nor for the second endpoint including diminution of PV, PSA and PVR. During the treatment period 20 (23%) of the patients managed with TAM and 17 (21%) with TAM + SR had drug- treated with related adverse reactions. No adverse effect was detected in the group SR.
Conclusion: Treatment of BPH by both SR and TAM seems to be efficacious alone. None of them had superiority over another and, additionally, a combined therapy (TAM + SR) does not provide extra benefits. Furthermore, SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS/BPH.