Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double‐blinded randomized study between single or combination therapy (PROCOMB trial)

Abstract

BACKGROUND. Phytotherapy has been used to treat patients with lower urinary tract symptoms (LUTS). We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens (SeR), Lycopene (Ly), and Selenium (Se) þ tamsulosin versus single therapies. METHODS. PROCOMB trial (ISRCTN78639965) was a randomized double-blinded, doubledummy multicenter study of 225 patients between 55 and 80 years old, PSA 4 ng/ml, IPSS !12, prostate volume 60 cc, Qmax 15 ml/sec, postvoid residual urine (PVR) <150 ml. Participants were randomized group A (SeR-Se-Ly), group B (tamsulosin 0.4 mg), group C (SeR-Se-Ly þ tamsulosin 0.4 mg). The primary endpoints of the study were the reduction of IPSS, PVR, and increase of Qmax in group C versus monotherapy groups. RESULTS. The decrease for combination therapy was significantly greater versus group A (P < 0.05) and group B (P < 0.01) for IPSS and versus group A (P < 0.01) for PVR from baseline This study has been designed and conducted independently. Konpharma provided support for this study. Data collection and management and all statistical analyses were performed and retained by data manager (R.A.). The corresponding author and other co-authors interpreted the data and participated in the preparation, review and approval of the manuscript. to 6 months. A greater decrease in IPSS was observed for Group C versus group A (P < 0.01) and increase in Qmax versus group B (P < 0.01), from 6 months to 12 months. At one year, the changes of IPSS and Qmax were greater for Group C versus monotherapies (each comparison <0.05). The proportions of men with a decrease of at least three points (each comparison P < 0.05) and decrease of 25% for IPSS (each comparison P < 0.01) were greater for Group C. CONCLUSION. SeR-Se-Ly þ tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS.

Survivin and NAIP in Human Benign Prostatic Hyperplasia: Protective Role of the Association of Serenoa repens, Lycopene and Selenium from the Randomized Clinical Study

“…However, although current guidelines cannot make any specific recommendation on phytotherapy for the treatment of male LUTS because of product heterogeneity, limited regulatory framework, and the methodological limitations of published trials, recently a short-term study on the combination of plant extracts with tamsulosin was published with promising results [21]. We have recently demonstrated that the combined treatment with Ser-Se-Ly and tamsulosin was more effective than single therapies (Ser-Se-Ly or tamsulosin) in improving IPSS and increasing Qmax in patients with LUTS at 12 months [20]. The combined treatment with Ser and tamsulosin was more effective than tamsulosin monotherapy in reducing storage symptoms; but IPSS, voiding subscore, QoL, Qmax, PVR, PSA, and prostate volume were unchanged [20].…”

“…We have recently demonstrated that the combined treatment with Ser-Se-Ly and tamsulosin was more effective than single therapies (Ser-Se-Ly or tamsulosin) in improving IPSS and increasing Qmax in patients with LUTS at 12 months [20]. The combined treatment with Ser and tamsulosin was more effective than tamsulosin monotherapy in reducing storage symptoms; but IPSS, voiding subscore, QoL, Qmax, PVR, PSA, and prostate volume were unchanged [20]. …”

“…In this way, a therapeutic activity has been obtained in BPH [18]. Furthermore, triple Ser-Se-Ly combination was shown to be more effective than Ser alone in the recovery of apoptosis, reducing prostatic growth [19,20]. In light of this background, we aimed to evaluate the effects of the association of Ser-Se-Ly on IAPs in men with BPH.…”

Serenoa repens + selenium + lycopene vs tadalafil 5 mg for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction: a Phase IV, non‐inferiority, open‐label, clinical study (SPRITE study)

“…Recently, two clinical trials have reported promising clinical efficacy of the SeR and tamsulosin in combination for the treatment of LUTS, as reported by the latest guidelines of the EAU [8]. Previously, the PROCOMB study showed that combined treatment with SeR-Se-Ly and tamsulosin was more effective than single monotherapy in improving the IPSS and Q max after 12 months of follow-up [11]. In another study, Ryu et al [22] reported that the combination of SeRs and tamsulosin (0.2 mg) was more effective than tamsulosin monotherapy in reducing storage symptoms.…”

Surgical management of benign prostatic hyperplasia

“…Pacijentima kojima njihovi simptomi ne predstavljaju veliki problem možemo ponuditi aktivno nadziranje uz savjetovanje o promjeni životnih navika [5][6] . Uz to opcionalna je nadaleko raširena i prisutna fitoterapija 7 . Kod pacijenata kojima ti simptomi predstavljaju veći problem u terapiju ćemo uvesti jedan od lijekova iz lepeze koja nam je danas dostupna za liječenje simptoma donjeg mokraćnog sustava, a to su: α-blokatori, inhibitori 5-α reduktaze, antagonisti muskarinskih receptora, inhibitori 5 fosfodiesteraze te β-3 agonisti 4 .…”