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 .
Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial).
BACKGROUND Phytotherapy has been used to treat patients with lower urinary tract symptoms ( LUTS ) . We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens ( SeR ) , Lycopene ( Ly ) , and Selenium ( Se ) + tamsulosin versus single therapies . METHODS PROCOMB trial ( IS RCT N78639965 ) was a r and omized double-blinded , double-dummy multicenter study of 225 patients between 55 and 80 years old , PSA ≤ 4 ng/ml , IPSS ≥12 , prostate volume ≤60 cc , Qmax ≤15 ml/sec , postvoid residual urine ( PVR ) < 150 ml . Participants were r and omized group A ( SeR-Se-Ly ) , group B ( tamsulosin 0.4 mg ) , group C ( SeR-Se-Ly + tamsulosin 0.4 mg ) . The primary endpoints of the study were the reduction of IPSS , PVR , and increase of Qmax in group C versus monotherapy groups . RESULTS The decrease for combination therapy was significantly greater versus group A ( P < 0.05 ) and group B ( P < 0.01 ) for IPSS and versus group A ( P < 0.01 ) for PVR from baseline to 6 months . A greater decrease in IPSS was observed for Group C versus group A ( P < 0.01 ) and increase in Qmax versus group B ( P < 0.01 ) , from 6 months to 12 months . At one year , the changes of IPSS and Qmax were greater for Group C versus monotherapies ( each comparison < 0.05 ) . The proportions of men with a decrease of at least three points ( each comparison P < 0.05 ) and decrease of 25 % for IPSS ( each comparison P < 0.01 ) were greater for Group C. CONCLUSION SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS
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 .