Comparative Effects of Roystonea Regia (D-004) and Saw Palmetto Lipid Extracts On Blood Oxidative Variables in Men with Benign Prostate Hyperplasia (BPH)

Abstract

Background: Lipid extracts of Roystonea regia (D-004) and saw palmetto (SP) fruits have been shown to prevent experimentally-induced prostate hyperplasia in rodents, and to produce antioxidant effects in experimental and clinical studies. OBJECTIVE: To compare the effects of D-004 and SP extracts on the International Prostate Symptoms Score (IPSS) and plasma oxidative variables in men with benign prostate hyperplasia (BPH) METHODS: This randomized, double-blind study was conducted in patients with moderate BPH. Forty-eight eligible subjects (average age: 65 years) were randomised to D-004 (320 mg/day) or SP (320 mg/day) capsules for 8 weeks. Decrease on IPSS was the primary efficacy variable. Oxidative markers were secondary outcomes. Data were analysed as per Intention to treat. RESULTS: D-004 and SP significantly decreased mean IPSS values by 33.9% (p<0.0001) and 24.4% (p<0.001), respectively, as compared to baseline. D-004 (p<0.0001) reduced plasma malondialdehyde (MDA) (32.6%), protein-linked carbonyl groups (CG) (25.2%) and increased (p<0.0001) catalase (CAT) activity. SP treatment lowered (p<0.0001) MDA (28.2%), CG (23.4%) and raised (p<0.0001) CAT activity. Effects on oxidative variables were similar in both groups. D-004, not SP, significantly lowered (p<0.05) prostate specific antigen (PSA) values. Both treatments were well tolerated. Only 2 SP-treated patients withdrew from the study. No adverse experiences were reported. CONCLUSIONS. Treatment with D-004 or SP (320 mg/day) for 8 weeks decreased significantly IPSS values in patients with moderate BPH, the effect of D-004 being the better, but further studies should confirm this result. Both treatments favourably and similarly modified plasma MDA (lipid peroxidation marker), GC (protein oxidation marker) and CAT activity.