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

Morgia, Giuseppe; Vespasiani, Giuseppe; Pareo, Rosaria M.; Voce, S.; Madonia, Massimo; Carini, Marco; Ingrassia, A.; Terrone, Carlo; Gentile, Marcello; Carrino, Maurizio; Giannantoni, Antonella; Blefari, F.; Arnone, S.; Santelli, G; Russo, Giorgio Ivan

doi:10.1111/bju.14209

Cited by 11 publications

(10 citation statements)

References 29 publications

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“…Two trials with high RoB reported a non-significant reduction in TPV from baseline after tadalafil (-5.9%) and sildenafil (-3.9%) treatment [ 55 , 56 ]. PSA changes as reported in three trials were not significantly different from baseline (-8.6% -0%) [ 28 , 54 , 56 ]. There was no information on TZV or prostate perfusion parameters.…”

Section: Resultsmentioning

confidence: 98%

“…The SPRITE study randomized men to tadalafil 5 mg or phytotherapy [ 54 ]. No change of TPV was observed in the tadalafil arm at 6 months.…”

Section: Resultsmentioning

confidence: 99%

“…Ten trials randomized men (n = 2972) to phytotherapy versus active component [ 24 , 25 , 26 , 29 , 31 , 50 , 54 , 62 , 71 , 72 ]. Six RCTs compared Sr to an active comparator and reported non-significant changes in TPV from baseline (-7% to –2% or -2.0 ml to -0.7 ml) [ 24 , 26 , 29 , 31 , 50 , 62 ].…”

Section: Resultsmentioning

confidence: 99%

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The effect of pharmacotherapy on prostate volume, prostate perfusion and prostate-specific antigens (prostate morphometric parameters) in patients with lower urinary tract symptoms and benign prostatic obstruction. A systematic review and meta-analysis

Sakalis

Gkotsi

Charpidou

et al. 2021

Cent european J Urol

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Introduction The clinical effect of pharmacotherapy on prostate morphometric parameters is largely unknown. The sole exception is 5α-reductase inhibitors (5-ARI) that reduce prostate volume and prostate-specific antigen (PSA). This review assesses the effect of pharmacotherapy on prostate parameters effect on prostate parameters, namely total prostate volume (TPV), transitional zone volume (TZV), PSA and prostate perfusion. Material and methods We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) reporting on morphometric parameters’ changes after pharmacotherapy, as primary or secondary outcomes. The study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. RCTs’ quality was assessed by the Cochrane tool and the criteria of the Agency for Healthcare Research and Quality. The effect magnitude was expressed as standard mean difference (SMD). The study protocol was published on PROSPERO (CRD42020170172). Results Sixty-seven RCTs were included in the review and 18 in the meta-analysis. The changes after alpha-blockers are comparable to placebo. Long-term studies reporting significant changes from baseline, result from physiologic growth. Finasteride and dutasteride demonstrated large effect sizes in TPV reduction ([SMD]: -1.15 (95% CI: -1.26 to -1.04, p <0.001, and [SMD]:-0.66 (95% CI: -0.83 to -0.49, p <0.001, respectively), and similar PSA reductions. Dutasteride’s effect appears earlier (1 st vs 3 rd month), the changes reach a maximum at month 12 and are sustained thereafter. Phosphodiesterase-5 (PDE-5) inhibitors have no effect on morphometric parameters. Phytotherapy’s effect on TPV is non-significant [SMD]: 0.12 (95% CI: -0.03 to 0.27, p = 0.13). Atorvastatin reduces TPV as compared to placebo (-11.7% vs +2.5%, p <0.01). Co-administration of testosterone with dutasteride spares the prostate from the androgenic stimulation as both TPV and PSA are reduced significantly. Conclusions The 5-ARIs show large effect size in reducing TPV and PSA. Tamsulosin improves perfusion but no other effect is evident. PDE-5 inhibitors and phytotherapy do not affect morphometric parameters. Atorvastatin reduces TPV and PSA as opposed to testosterone supplementation.

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Section: Resultsmentioning

confidence: 98%

“…The SPRITE study randomized men to tadalafil 5 mg or phytotherapy [ 54 ]. No change of TPV was observed in the tadalafil arm at 6 months.…”

Section: Resultsmentioning

confidence: 99%

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The effect of pharmacotherapy on prostate volume, prostate perfusion and prostate-specific antigens (prostate morphometric parameters) in patients with lower urinary tract symptoms and benign prostatic obstruction. A systematic review and meta-analysis

Sakalis

Gkotsi

Charpidou

et al. 2021

Cent european J Urol

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“…Conversely, no significative differences between the two groups emerged at the 3rd month voiding subscore assessment (p = 0.06) while a statistically significant improvement at 6-month evaluation (6 [IQR: 3-9] vs. 9 [IQR: 6-11], p = 0.03) in the treatment group was recorded. Table 3 A significative improvement in Qmax (16.7 mL/s [IQR: [13][14][15][16][17][18][19]] vs. 11.3 mL/s [IQR: 10-15], p = 0.001) and Qave (14.2 mL/s [IQR: [10][11][12][13][14][15][16] vs. 12 mL/s [IQR 10-14], p = 0.05) were found at 6-month evaluation in the treatment group as compared to the control group. In terms of PVR, significant differences were detected at each follow up visit with the most relevant reduction of median PVR at 6-month assessment (102 cc [IQR: 91-116] vs. 127 cc [IQR: 98-139], p = 0.02), (Figure 4).…”

Section: Resultsmentioning

confidence: 99%

“…In addition, the different kinds of extraction still limit the correct interpretation of the available data [17]. Currently, SeR represents the most commonly used phytotherapeutic compound for BPH management [18] and the only one actually recommended for well-established use by the Committee on Herbal Medicinal Products (HMPC). Its effectiveness in prostate size reduction and urinary frequency improvement was also confirmed by two systematic reviews and meta-analyses [10,19].…”

Section: Discussionmentioning

confidence: 99%

Impact of the Treatment of Serenoa repens, Solanum lycopersicum, Lycopene and Bromelain in Combination with Alfuzosin for Benign Prostatic Hyperplasia. Results from a Match-Paired Comparison Analysis

Lambertini

Maida

Tellini

et al. 2021

Uro

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Background: Phytotherapeutic agents aroused an increasing interest either as alternative or in addition to conventional therapy in the management of BPH. The aim of the article was to evaluate the clinical and functional changes after add-on treatment with Serenoa repens associated with Solanum lycopersicum, lycopene and bromelain in patients with BPH presenting with mild to moderate LUTS and previously treated only with Alfuzosin over a 6–12 months period. Materials and methods: Between January and July 2019, patients with symptomatic BPH already on treatment with Alfuzosin (Al) 10 mg for at least 6–12-month were enrolled at three academic referral centres, included in a prospective treatment group, and managed with a combination treatment of Al and 6-month daily oral single-tablet supplementation of Serenoa repens and Solanum lycopersicum + lycopene + bromelain (SeR + SL + Ly + Br). A retrospective control group with comparable baseline characteristics was obtained by performing a propensity score matching from a database of 434 patients managed with Alfuzosin 10 mg/day only over a 6–12 months period between March 2015 and December 2018. IPSS, QoL questionnaires, voiding diary assessment, postvoid residual volume (PVR), maximal (Qmax) and average (Qave) urinary flow rates were evaluated at baseline in the treatment group at the moment of patient accrual, in the control group after 6-month of treatment with alfuzosin, and thereafter at 3 and 6 months in both groups. Results: Overall, 250 patients entered the study (n = 125 treatment group; n = 125 control group). Total IPSS score significantly decreased at 6-month assessment from baseline in the treatment vs control group (17 [IQR: 12–20] vs 12 [IQR: 9–14], p = 0.02) with a significative storage symptoms improvement detected both at 3- (p = 0.03) and 6-month evaluation (p = 0.001). PVR significantly improved at each follow-up visit with the most relevant reduction at 6-month assessment (125 cc vs. 102 cc; p = 0.02). Moreover, a significative improvement in LUTS-related quality of life (QoL) was recorded at 3- and 6-month assessment with a median decrease of −1 and −2 (p = 0.05 and p = 0.001 respectively) from baseline. Conclusions: Combination treatment with AB and SeR + SL + Ly + Br led to meaningful improvements in LUTS severity compared to AB as monotherapy, after a 6-month treatment period in men with mild to moderate LUTS/BPH.

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Serenoa repens for the treatment of lower urinary tract symptoms due to benign prostatic enlargement

Franco

Trivisonno

Sgarbossa

et al. 2023

Cochrane Database of Systematic Reviews

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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)

Abstract: We have shown that treatment with SeR-Se-Ly was not inferior to tadalafil 5 mg for improving IPSS and Q in men with LUTS.

Cited by 11 publications

References 29 publications

The effect of pharmacotherapy on prostate volume, prostate perfusion and prostate-specific antigens (prostate morphometric parameters) in patients with lower urinary tract symptoms and benign prostatic obstruction. A systematic review and meta-analysis

The effect of pharmacotherapy on prostate volume, prostate perfusion and prostate-specific antigens (prostate morphometric parameters) in patients with lower urinary tract symptoms and benign prostatic obstruction. A systematic review and meta-analysis

Impact of the Treatment of Serenoa repens, Solanum lycopersicum, Lycopene and Bromelain in Combination with Alfuzosin for Benign Prostatic Hyperplasia. Results from a Match-Paired Comparison Analysis

Serenoa repens for the treatment of lower urinary tract symptoms due to benign prostatic enlargement

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