Prospective observational study on the efficacy and tolerability of a complex of phytochemicals versus dutasteride in the treatment of Lower Urinary Tract Symptomps due to Benign Prostatic Hyperplasia.

Introduction: The aim of our study was to treat 2 similar groups of patients suffering from BPH: one group with a complex based on phycocyanin, PEA and selenium; the other group with dutasteride. So the effectiveness of these treatments was checked, especially regarding the improvement of LUTS and the reduction of PSA and prostate volume.

Materials and methods: We included 104 patients in the study. All patients aged between 50 and 70 years, PSA values between 4 and 10 ng/ml, prostate volume calculated by transrectal ultrasound between 50 and 70 cc, flowmetry with maximum flow value greater than or equal to 10 ml/s, no suspicious nodules on DRE, no suspicious lesions on MRI (PI-RADS 1-2), negative previous prostatic biopsies or never bioptied, moreover absence of diabetes mellitus or chronic renal failure (blood creatinine >2 mg/dl). We considered: -Group A of 54 men who used the complex; -Group B of 50 patients treated with dutasteride. Then we controlled all patients 6 months after starting therapy, considering the following parameters: PSA, prostate volume, flowmetry.

Results: Our results showed that both dutasteride and complex decreased PSA levels (both had a p<0.0001), with a more significant contribution of dutasteride (mean decrease of -2.743 ng/ml vs -0.971 ng/ml). Uroflowmetry also improved with both ( p<0.0001) with a mean increase in maximum flow of urine of + 3.03 ml/min for the former and + 13.02 ml/min for the latter. Lastly, dutasteride proved to be highly effective on reducing the prostate volume on TRUS (- 22.14 ml, p<0.0001) compared to Ficoxpea, which showed a mean decrease of - 10.04 ml (p<0.0001). Moreover the consistent reduction in prostate volume obtained through the use of dutasteride proved to be more intense than the one obtained by using the complex even in statistical analysis (p<0.0001).

Conclusions: Both Ficoxpea and Dutasteride showed reduction of PSA values after 6 months of treatment. The complex based on phycocyanin, PEA and selenium showed a statistically significant improvement in urinary flow, while dutasteride acts more on the volume of the prostate. However, the natural complex is a product with good efficacy on the phlogistic component and does not have the side effects of dutasteride (e.g. gynecomastia, reduced libido). Therefore, we believe it can be used by a large part of the population, in order to reduce LUTS and PSA and improve urinary flow, without side effects.