UP-02.034 Multicentre Study on the Efficacy and Tolerability of Permixon® in Patients with Chronic Benign Prostate Conditions Associated with Inflammation

Giulianelli, R.; Pecoraro, Stefano; Sepe, Giuseppe Salvatore; Leonardi, Rosario; Gentile, Barbara Cristina; Albanesi, L.; Brunori, S.; Mavilla, L.; Pisanti, F.; Giannella, R.; Morello, P; Tuzzolo, D.; Coscione, M.; Galasso, F; D'angelo, T.; Ferravante, P.; Morelli, Emilio; Miragliuolo, Antonio

doi:10.1016/j.urology.2011.07.852

Cited by 12 publications

(16 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Saw palmetto (SP) has been clinically tested either alone or in combination with other alpha-blockers and 5α-reductase inhibitors . Guilianelli et al demonstrated in a multicentre clinical trial that the use of SP extract for 6 months showed significant improvement in International Prostate Symptom (IPSS) score and uroflowmetry in subjects with BPH [3]. Sinescu et al have reported the long-term efficacy of SP extract in improving the LUTS, urinary flow, erectile dysfunction and quality of life (QoL) [4].…”

Section: Introductionmentioning

confidence: 99%

A double blind, placebo-controlled randomized comparative study on the efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating benign prostate hyperplasia and androgen deficiency

Sudeep¹,

Thomas²,

Shyamprasad³

2020

BMC Urol

View full text Add to dashboard Cite

Background: The present clinical trial was conducted to evaluate the efficacy and tolerability of a standardized saw palmetto oil containing 3% β-sitosterol in the treatment of benign prostate hyperplasia (BPH) and androgen deficiency. Methods: Subjects aged 40-65 years with symptomatic BPH were randomized to 12-week double-blind treatment with 500 mg doses of β-sitosterol enriched saw palmetto oil, conventional saw palmetto oil and placebo orally in the form of capsules (n = 33 in each group). BPH severity was determined using the International Prostate Symptom Score (IPSS), uroflowmetry, serum measurement of prostate specific antigen (PSA), testosterone and 5α-reductase. During the trial, the androgen deficiency was evaluated using Aging Male Symptoms (AMS) scale, the Androgen Deficiency in the Aging Male (ADAM) questionnaire, serum levels of free testosterone. Results: Subjects treated with β-sitosterol enriched saw palmetto oil showed significant decrease in IPSS, AMS and ADAM scores along with reduced postvoiding residual volume (p < 0.001), PSA (p < 0.01) and 5α-reductase from baseline to end of 12-week treatment as compared to placebo. There was also a significant increment in the maximum and average urine flow rate (p < 0.001), and serum free testosterone level of subjects treated with enriched saw palmetto oil as compared to placebo. Conclusion: This study demonstrates the efficacy of β-sitosterol enriched saw palmetto oil superior to conventional oil thus extending the scope of effective BPH and androgen deficiency treatment with improved quality of life through the intake of functional ingredients.

show abstract

Section: Introductionmentioning

confidence: 99%

A double blind, placebo-controlled randomized comparative study on the efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating benign prostate hyperplasia and androgen deficiency

Sudeep¹,

Thomas²,

Shyamprasad³

2020

BMC Urol

View full text Add to dashboard Cite

show abstract

“…The investigators concluded that treatment for 6 months with the hexane extract of SP in routine clinical practice gave rise to a statistically significant improvement in peak flow rate and the International Prostate Symptom Score, National Institutes of Health Chronic Prostatitis Symptom Index, and International Index of Erectile Function 5 questionnaire scores, reflecting not only an improvement in urinary symptoms but also an overall improvement in patients’ quality of life. 27 …”

Section: Discussionmentioning

confidence: 99%

Determination of the potency of a novel saw palmetto supercritical CO2 extract (SPSE) for 5α-reductase isoform II inhibition using a cell-free in vitro test system

Greenlaw¹,

Pais²,

Rull³

et al. 2016

RRU

View full text Add to dashboard Cite

BackgroundThe nicotinamide adenine dinucleotide phosphate-dependent membrane protein 5α-reductase catalyses the conversion of testosterone to the most potent androgen – 5α-dihydrotestosterone. Two 5α-reductase isoenzymes are expressed in humans: type I and type II. The latter is found primarily in prostate tissue. Saw palmetto extract (SPE) has been used extensively in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH). The pharmacological effects of SPE include the inhibition of 5α-reductase, as well as anti-inflammatory and antiproliferative effects. Clinical studies of SPE have been inconclusive – some have shown significant results, and others have not – possibly the result of varying bioactivities of the SPEs used in the studies.PurposeTo determine the in vitro potency in a cell-free test system of a novel SP supercritical CO2 extract (SPSE), an inhibitor of the 5α-reductase isoenzyme type II.Materials and methodsThe inhibitory potency of SPSE was compared to that of finasteride, an approved 5α-reductase inhibitor, on the basis of the enzymatic conversion of the substrate androstenedione to the 5α-reduced product 5α-androstanedione.ResultsBy concentration-dependent inhibition of 5α-reductase type II in vitro (half-maximal inhibitory concentration 3.58±0.05 μg/mL), SPSE demonstrated competitive binding toward the active site of the enzyme. Finasteride, the approved 5α-reductase inhibitor tested as positive control, led to 63%–75% inhibition of 5α-reductase type II.ConclusionSPSE effectively inhibits the enzyme that has been linked to BPH, and the amount of extract required for activity is comparatively low. It can be confirmed from the results of this study that SPSE has bioactivity that promotes prostate health at a level that is superior to that of many other phytotherapeutic extracts. The bioactivity of SPSE corresponds favorably to that reported for the hexane extract used in a large number of positive BPH clinical trials, as well as to finasteride, the established standard of therapy among prescription drugs. Future in vitro and clinical trials involving SPEs would be useful for elucidating their comparative differences, as well as appropriate patient selection for their use.

show abstract

Section: Anti-inflammatory Effectmentioning

confidence: 99%

“…The effect of the hexanic extract of Serenoa repens (HESr) on measures of inflammation was evaluated in two controlled studies [2,77]. In the Giulianelli 2012 open-label multicenter study, men with prostate diseases with associated inflammation showed significant improvement after six months in urinary flow rate, IPSS, and chronic prostatitis symptoms [77]. In Latil 2015 [2], men with moderate-to-severe LUTS were evaluated with biomarkers of chronic prostatic inflammation in an international, randomized, doubleblind study comparing HESr at 320 mg/d vs. tamsulosin at 0.4 mg/d.…”

Section: Anti-inflammatory Effectmentioning

confidence: 99%

<i>Serenoa repens</i> (Saw Palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part II

Strum¹

2021

Preprint

View full text Add to dashboard Cite

Part I of this 3-part series provided the groundwork for understanding the role of a standardized lipidosterolic extract of Serenoa repens (LSESr) in the treatment of LUTS. It documented that a treatment having a high therapeutic index (i.e., a ratio of benefit to adverse reactions) is a critical need in the demographic context of a rapidly growing elder population. Part I described the clinical symptomatology of LUTS and how it is quantified. A critique of the reports from four authoritative bodies: the European Scientific Cooperative on Phytotherapy (ESCOP), Cochrane 2012, the European Medicines Agency (EMA), and the AUA (American Urological Association) was presented. The foundation above then fine-tuned our search to require (a) consistent evaluability criteria, (b) the quantification of clinical findings, (c) the need to focus on studies employing a standardized LSESr product meeting the fatty acid profile set forth by the European Medicines Agency (EMA) and the US Pharmacopeia and (d) a global assessment of scientific investigations published in all languages and not limited to only English. Part II details the following “new” findings when LSESr vs. LUTS is examined with the above constraints.

show abstract

UP-02.034 Multicentre Study on the Efficacy and Tolerability of Permixon® in Patients with Chronic Benign Prostate Conditions Associated with Inflammation

Cited by 12 publications

References 0 publications

A double blind, placebo-controlled randomized comparative study on the efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating benign prostate hyperplasia and androgen deficiency

A double blind, placebo-controlled randomized comparative study on the efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating benign prostate hyperplasia and androgen deficiency

Determination of the potency of a novel saw palmetto supercritical CO2 extract (SPSE) for 5α-reductase isoform II inhibition using a cell-free in vitro test system

<i>Serenoa repens</i> (Saw Palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part II

Contact Info

Product

Resources

About

UP-02.034 Multicentre Study on the Efficacy and Tolerability of Permixon® in Patients with Chronic Benign Prostate Conditions Associated with Inflammation

Cited by 12 publications

References 0 publications

A double blind, placebo-controlled randomized comparative study on the efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating benign prostate hyperplasia and androgen deficiency

A double blind, placebo-controlled randomized comparative study on the efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating benign prostate hyperplasia and androgen deficiency

Determination of the potency of a novel saw palmetto supercritical CO2 extract (SPSE) for 5&alpha;-reductase isoform II inhibition using a cell-free in vitro test system

<i>Serenoa repens</i> (Saw Palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part II

Contact Info

Product

Resources

About

Determination of the potency of a novel saw palmetto supercritical CO2 extract (SPSE) for 5α-reductase isoform II inhibition using a cell-free in vitro test system