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Randomized Controlled Trial
. 2020 Jul 3;20(1):86.
doi: 10.1186/s12894-020-00648-9.

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

H V Sudeep  1   2 , Jestin V Thomas  3 , K Shyamprasad  4
Affiliations
Randomized Controlled Trial

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

H V Sudeep et al. BMC Urol. .

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.

Trial registration: CTRI/2018/12/016724 dated 19/12/2018 prospectively registered. URL: http://ctri.nic.in/Clinicaltrials/advsearch.php.

Keywords: Androgen deficiency; Benign prostate hyperplasia; Safety; Saw palmetto oil; β-Sitosterol.

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Conflict of interest statement

We have read and understood the BMC policy on declaration of interests and declare that there are no conflicts of interest.

Figures

Fig. 1
Fig. 1
LCMS chromatograms of reference compound β-sitosterol (95%) (a), SPO (b) and VISPO (c)
Fig. 2
Fig. 2
Subject participant flow chart
Fig. 3
Fig. 3
Mean change in SF-12 score of the study participants. The changes from baseline (visit 1) to the end of treatment (visit 3) in SF-12 total score (a), physical health composite (PCS-12) score and mental health composite (MCS-12) score (b) . The values are represented as mean ± SD (n = 33 in each group). The data were analysed by one way ANOVA followed by Scheffe test. ***p < 0.001 vs. placebo
See this image and copyright information in PMC

References

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