Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2010, 154(3):239-244 | DOI: 10.5507/bp.2010.036

THE SAFETY AND EFFICACY OF A SILYMARIN AND SELENIUM COMBINATION IN MEN AFTER RADICAL PROSTATECTOMY – A SIX MONTH PLACEBO-CONTROLLED DOUBLE-BLIND CLINICAL TRIAL

Ales Vidlar^a, Jitka Vostalova^b, Jitka Ulrichova^b, Vladimir Student^a, Milan Krajicek^c, Jana Vrbkova^d, Vilim Simanek^b

^a Department of Urology, University Hospital, Olomouc, Czech Republic

^b Department of Medical Chemistry and Biochemistry, Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic

^c Favea spol. s r.o., Koprivnice, Czech Republic

^d Department of Mathematical Analysis and Application of Mathematics, Faculty of Science, Palacky University Olomouc

Background: Silymarin, a milk thistle flavonolignan mixture, has anti-proliferative and anti-angiogenic activities in xenografts of human prostate cancer (PCa). Low dietary selenium on the other hand has been associated with increased incidence of PCa. The purpose of the current trial was to determine whether a daily administration of a silymarin and selenium (SM-Se) combination for 6 months would alter basic clinical chemistry and oxidative stress markers, and improve the quality of life score (QoL) in men after radical prostatectomy (RP).

Methods: Thirty seven participants, 2-3 months after RP, were randomly assigned to receive 570 mg of silymarin and 240 µg of selenium as selenomethionine (n = 19, SM-Se group) or placebo (n = 18, Placebo group) daily for six months. Both groups had similar clinical and demographic characteristics. Physical examination, QoL score, haematology, basic clinical chemistry and oxidative stress markers, selenium and testosterone levels, antioxidant status were evaluated at baseline, at 3 and 6 months.

Results: The six months administration of silymarin and selenium improved the QoL score, decreased low density lipoproteins (LDL) and total cholesterol and, increased serum selenium levels. The combination had no effect on blood antioxidant status and no influence on testosterone level. No adverse events were recorded. No improvement was found in the placebo group.

Conclusions: The selected combination of silymarin and selenium significantly reduced two markers of lipid metabolism known to be associated with PCa progression, LDL and total cholesterol in the blood of men after RP. This suggests that this combination may be effective in reducing PCa progression.

Keywords: Silymarin, Selenium, Prostate cancer, Radical prostatectomy, Clinical chemistry, Plasma lipoproteins, Blood cholesterol

Received: September 3, 2010; Accepted: September 13, 2010; Published: September 1, 2010  Show citation