efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating BPH and androgen deficiency

[madman]

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



Abstract

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.







Conclusion

The present study provides first ever clinical evidence on the improved efficacy of saw palmetto oil due to the enriched content of β-sitosterol. This comparative study clearly recommends the use of a phytosterol-enriched saw palmetto oil as a functional ingredient in dietary supplements for effective management of symptomatic BPH.

 

[madman]

 

[broker]

Do they sell saw palmetta oil in a capsule? This study seems promising.
is this what you would call a credible / legitimate study?
another important question: is saw palmetto extract better than saw palmetto oil or visa versa?
how is saw palmetto oil taken? Do you drink it?

 

[madman]

Do they sell saw palmetta oil in a capsule? This study seems promising.
is this what you would call a credible / legitimate study?
another important question: is saw palmetto extract better than saw palmetto oil or visa versa?
how is saw palmetto oil taken? Do you drink it?

Study design

This study was conducted in compliance with ICH-GCP (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use –Good Clinical Practice) guidelines and Helsinki Declaration Standards. This clinical study adheres to the CONSORT guidelines. The study was performed at Aman Hospital and Research Center, Vadodara, India. The trial was designed as a double-blind, placebo-controlled, single centered study including 99 male subjects randomized to three treatment arms: VISPO, SPO, and placebo, on 1:1:1 ratio (n = 33 in each group). Block randomization was implemented for groupwise allocation of subjects wherein the participants received an xx-digit randomization number. The investigator and subjects were blinded of the interventions. The study medications were dispensed by the unblinded pharmacist at the site.




Background

Growing interest in the use of functional foods and dietary supplements for healthcare management has led to the availability of natural products in the market. However, development of nutraceuticals requires supportive evidence of efficacy and tolerability that must be clearly demonstrated with clinical trials [1]. Serenoa repens (saw palmetto) is one of the most studied plants for the treatment of lower urinary tract diseases (LUTS), especially mild to moderate prostatic diseases. Major bioactive principles attributing to the medicinal use of saw palmetto oil are the phytosterols and fatty acids. Explored mechanisms of action for saw palmetto oil includes inhibition of 5α-reductase, cyclooxygenase (COX) and 5-lipoxygenase (LOX). In addition, it exhibits antiproliferative effect on prostatic epithelial cells and antiestrogenic activity [2]. Thus, the candidature of saw palmetto preparations as alternative medicine to treat benign prostate hyperplasia has been the subject of clinical research.


Phytoconstituents such as sterols, fatty acids and vitamin E together contribute to the efficacy of SP extract in mitigating the BPH complications [9, 10]. Conventionally SP oil contains 0.2–0.3% β-sitosterol in addition to fatty acids. Here we have used a 3% β-sitosterol containing SP oil for the clinical evaluation of therapeutic potential, alongside comparing with the conventional SP oil in a placebo-controlled trial. Previously we have demonstrated the improved efficacy of β-sitosterol enriched SP oil as compared to the conventional oil in testosterone-induced BPH model rats [11]. Here we have provided the first ever clinical evidence on the improved efficacy of β-sitosterol-enriched SP extract superior to the conventional SP.


Methods

Investigational product
The investigational product was a standardized saw palmetto extract containing 3% β-sitosterol (VISPO™). VISPO and the conventional saw palmetto oil (SPO, 0.2% β-sitosterol) were prepared in-house from the berries (Florida, USA) using the supercritical fluid extraction method. The higher percentage of β-sitosterol in VISPO was achieved by column chromatography. The βsitosterol content was quantified using LCMS analysis (Fig. 1). The extracts were then formulated into powder form with maltodextrin as excipient and filled in capsules (500 mg in weight). Each capsule contained 200 mg of extract. Placebo capsules consisted of maltodextrin only.








The product used in the study contains (standardized saw palmetto extract containing 3% β-sitosterol (VISPO™) that was formulated into a powder.

Most supplements on the market use conventional saw palmetto oil (SPO, 0.2% β-sitosterol) and the capsules are filled with extracts in powder form with added fillers or extracts in powder form mixed with food-grade oils such as pumpkin seed.

VISPO™ is the only product on the market which contains 3% β-sitosterol.

 

[madman]

 

[madman]

Benign prostatic hyperplasia: the mature man’s problem

An innovative saw palmetto extract from Vidya Herbs, said to be more efficient than traditional saw palmetto extracts, restores the virility and self-confidence of mature men, reports Dr David Daguet, Scientific Director

www.nutraceuticalbusinessreview.com

.



An innovative saw palmetto extract: Vi-spo

Vidya Herbs has developed a solvent-free beta-sitosterol-enriched (3%) saw palmetto extract. It is obtained from non-GMO Serenoa repens berries that are cultivated without pesticides using a 100% green CO2-SC extraction process and chromatographic purification.

 

[mqsymth]

These were pretty small guys that they tested. 61kg=134 lbs and 158.94cm=62.5 inches=5' 2"

 

[TucsonJJ]

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



Abstract

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.







Conclusion

The present study provides first ever clinical evidence on the improved efficacy of saw palmetto oil due to the enriched content of β-sitosterol. This comparative study clearly recommends the use of a phytosterol-enriched saw palmetto oil as a functional ingredient in dietary supplements for effective management of symptomatic BPH.

I wonder if flax seed oil would work too? It supposedly has lots of phytosterols... I never had much luck with saw palmetto exstract or whole herb... but never tried the oil, or enriched oil... is it readily available?

 

[Joe Sixpack]

Sounds promising. But I believe the product works by blocking the conversion of testosterone into DHT. Thus it would seem to be a "natural" version of finasteride. With all the problems that finasteride can cause, I'd be a little leery of using this product.

 

[TucsonJJ]

Sounds promising. But I believe the product works by blocking the conversion of testosterone into DHT. Thus it would seem to be a "natural" version of finasteride. With all the problems that finasteride can cause, I'd be a little leery of using this product.

I think Saw Palmetto is pretty safe in any form... it didn't work for me... I get bad side effects from finisteride... so I will try Nizoral 2% shampoo 3-4x/week and hope...

 

[DorianGray]

Benign prostatic hyperplasia: the mature man’s problem

An innovative saw palmetto extract from Vidya Herbs, said to be more efficient than traditional saw palmetto extracts, restores the virility and self-confidence of mature men, reports Dr David Daguet, Scientific Director

www.nutraceuticalbusinessreview.com

.



An innovative saw palmetto extract: Vi-spo

Vidya Herbs has developed a solvent-free beta-sitosterol-enriched (3%) saw palmetto extract. It is obtained from non-GMO Serenoa repens berries that are cultivated without pesticides using a 100% green CO2-SC extraction process and chromatographic purification.

Unable to find any retail sources for this specific product. If anyone runs across a source, please post.