S. repens is safe in its application .
We suggest that strong placebo effect , potentially influenced by positive patients ' expectation on S. repens , shapes both the clinical practice outcomes and the findings of clinical trials .
Hitherto , the totality of evidence continues to suggest that S. repens is a prudent therapeutic option as part of the naturopathic treatment for LUTS/BPH .
OBJECTIVES Benign prostatic hyperplasia ( BPH ) commonly affects men above 40 years old .
The progression of BPH is often accompanied with lower urinary tract symptoms ( LUTS ) that can significantly affect the quality of life of the patients .
Serenoa repens ( saw palmetto ) is a popular herbal remedy indicated for LUTS/BPH .
We review ed the current research on the efficacy of S. repens on LUTS/BPH as a monotherapy as well as combination therapies .
RESULTS The latest evidence , based largely on the Cochrane review , suggests that S. repens is not superior to placebo in treating LUTS/BPH as a monotherapy , even at double and triple doses .
Initial clinical trials on treatment of LUTS/BPH using S. repens with lycopene and selenium , as well as S. repens with Urtica Dioica , have shown positive results .
Effects of Serenoa repens, selenium and lycopene (Profluss®) on chronic inflammation associated with benign prostatic hyperplasia: results of "FLOG" (Flogosis and Profluss in Prostatic and Genital Disease), a multicentre Italian study.
OBJECTIVE To evaluate the efficacy of Profluss ® on prostatic chronic inflammation ( PCI ) . MATERIAL S AND METHODS We prospect ively enrolled 168 subjects affected by LUTS due to bladder outlet obstruction su bmi tted to 12 cores prostatic biopsy for suspected prostate cancer + 2 cores collected for PCI valuation . First group consisted of 108 subjects , with histological diagnosis of PCI associated with BPH and high grade PIN and /or ASAP , r and omly assigned to 1:1 ratio to  daily Profluss ®  ( group I ) for 6 months or to control group ( group Ic ) . Second group consisted of 60 subjects , with histological diagnosis of BPH , r and omly assigned to 1:1 ratio to daily Profluss ® + a-blockers treatment ( group II ) for 3 months or to control group ( group IIc ) . After 6 months first group underwent 24 cores prostatic re-biopsy + 2 cores for PCI while after 3 months second group underwent two-cores prostatic for PCI . Specimens were evaluated for changes in inflammation parameters and for density of T-cells ( CD3 , CD8 ) , B-cells ( CD20 ) and macrophages ( CD68 ) . RESULTS At follow-up there were statistical significant reductions of extension and grading of flogosis , mean values of CD20 , CD3 , CD68 and mean PSA value in group I compared to Ic , while extension and grading of flogosis in group II were inferior to IIc but not statistical significant . A statistically significant reduction in the density of CD20 , CD3 , CD68 , CD8 was demonstrated in group II in respect to control IIc . CONCLUSIONS Serenoa repens+Selenium+Lycopene may have an anti-inflammatory activity that could be of interest in the treatment of PCI in BPH and /or PIN/ASAP patients
S. repens is safe in its application .
We suggest that strong placebo effect , potentially influenced by positive patients ' expectation on S. repens , shapes both the clinical practice outcomes and the findings of clinical trials .
Hitherto , the totality of evidence continues to suggest that S. repens is a prudent therapeutic option as part of the naturopathic treatment for LUTS/BPH .
OBJECTIVES Benign prostatic hyperplasia ( BPH ) commonly affects men above 40 years old .
The progression of BPH is often accompanied with lower urinary tract symptoms ( LUTS ) that can significantly affect the quality of life of the patients .
Serenoa repens ( saw palmetto ) is a popular herbal remedy indicated for LUTS/BPH .
We review ed the current research on the efficacy of S. repens on LUTS/BPH as a monotherapy as well as combination therapies .
RESULTS The latest evidence , based largely on the Cochrane review , suggests that S. repens is not superior to placebo in treating LUTS/BPH as a monotherapy , even at double and triple doses .
Initial clinical trials on treatment of LUTS/BPH using S. repens with lycopene and selenium , as well as S. repens with Urtica Dioica , have shown positive results .