Efficacy of a formulation containing Serenoa repens, Crocus sativus and Pinus massoniana extracts in men with concomitant LUTS and erectile dysfunction.
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BACKGROUND
The relationship between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) has received increased attention recently. This study aims to evaluate the efficacy of IDIProst® Gold, a product containing Serenoa repens, Crocus sativus and Pinus massoniana bark extract (PMBE), in improving sexual function, urinary symptoms and quality of life in patients with concomitant LUTS and ED.
METHODS
A total 140 men (mean age 48 years) were enrolled and treated in this study. All patients were administered IDIProst® Gold (Crocus sativus, PMBE, Serenoa repens) once daily for three months. At visit (T0) and after ninety days of treatment (T90), the patients were evaluated and asked to complete two self-administered questionnaires: International Prostate Symptoms Score (IPSS), International Index of Erectile Function (IIEF-5). The main outcomes were the improved IIEF-5 and IPSS scores in the 40-60 age group. The secondary outcome was the improved quality of life score among treated patients.
RESULTS
The baseline mean scores at T0 were 17.29 and 15.12 for the IPSS and IIEF-5 respectively. After three months of treatment (T90), the questionnaire results were as follows: 10.21 and 20.53 for IPSS and IIEF-5 respectively. Statistically significant differences (P<0.001) were reported between the two visits in terms of IPSS and IIEF-5 for all the groups treated, but particularly the 40-60 age group. There was also a statistically significant improvement (P<0.001) in quality of life between T0 and T90 (3.82 vs. 1.45). Compliance with the study protocol was 100%. 140 patients were enrolled out of a population of 164. No adverse events were reported.
CONCLUSIONS
Treatment once daily with IDIProst® Gold (Serenoa repens, Crocus sativus and PMBE) for three months significantly improved sexual function, urinary symptoms and quality of life in patients with concomitant LUTS and ED, especially in the 40-60 age group.
