Effects of Roystonea Regia (D-004) and Saw Palmetto Lipid Extracts in Men with Symptomatic benign Prostatic Hyperplasia
Journal Title: IOSR Journal of Pharmacy (IOSRPHR) - Year 2013, Vol 3, Issue 6
Abstract
Background: Benign prostatic hyperplasia (BPH), common among elderly men, often causes lower urinary tract symptoms (LUTS). BPH/LUTS pharmacological therapies include 5-reductase inhibitors, 1-adrenoreceptors blockers and phytotherapies, like saw palmetto (SP) lipid extracts. D-004, a lipid extract of Roystonea regia fruits, reduced experimental prostate hyperplasia in rodents and the International Prostate Symptoms Score (IPSS) as effectively as SP in a pilot trial in men with BPH. Objective: To compare the effects of D-004 and SP in the treatment of men with symptomatic BPH.Methods: Sixty-one patients with moderate BPH were double-blindly randomised to D-004 or SP (320 mg/day both) capsules for 4 months. Decrease on IPSS was the primary efficacy variable. Effects on prostate size, residual volume post-voiding and serum prostate specific antigen (PSA) were secondary outcomes.Results: After 2 months on therapy, D-004 and SP decreased (p<0.05) mean IPSS values by 2.1 units versus baseline (15.8% and 16.0% decreases, respectively). This effect increased at study completion, when IPSS decreased by 4.8 (36.0%) with D-004 and by 4.5 units (34.1%) with SP (p<0.0001 in both cases), without differences between groups. Both treatments did not modify prostate size, residual volume post-voiding.Treatment with SP, not with D-004, increased (p<0.05) serum PSA. Two SP-treated patients withdrew from the study, one due to an adverse experience (hemorrhagic stroke). One D-004- and 2 SP-treated patients experienced adverse experiences. Conclusions: D-004 (320 mg/day) for 4 months was as effective as SP (320 mg/day) for decreasing LUTS in men with moderate BPH, and well tolerated. Further studies should confirm these results.
Authors and Affiliations
Raúl Guzmán, ,
Keywords
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