Comparative Effects of Roystonea Regia (D-004) and Saw Palmetto Lipid Extracts On Blood Oxidative Variables in Men with Benign Prostate Hyperplasia (BPH)
Journal Title: IOSR Journal of Pharmacy (IOSRPHR) - Year 2013, Vol 3, Issue 7
Abstract
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) capsulesfor 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
Authors and Affiliations
Raúl Guzmán Rosa Mas , Julio Fernández Lisete Borrero,
Keywords
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