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GAZZETTA MEDICA ITALIANA ARCHIVIO PER LE SCIENZE MEDICHE
A Journal on Internal Medicine and Pharmacology
Indexed/Abstracted in: BIOSIS Previews, EMBASE, Scopus, Emerging Sources Citation Index
Gazzetta Medica Italiana Archivio per le Scienze Mediche 2016 October;175(10):413-20
Efficacy and tolerability of Roystonea regia (D-004) and saw palmetto lipid extracts in men with symptomatic benign prostatic hyperplasia: a 24 weeks study
Raul GUZMÁN 1, Jose ILLNAIT 2, Rosa MAS 2, Lilia FERNÁNDEZ 2, Manuel PEDROSO 1, Julio FERNÁNDEZ 2, Daisy CARBAJAL 2, Sarahi MENDOZA 2, Jilma MENA 1, Ana T. RODRÍGUEZ 1, Zunilda RODRIGUEZ 1, Yolanda CRUZ 3, Marbelis CAMPOS 3, Pablo REYES 4, Dalmer RUIZ 4
1 Urological Department, Dr. Salvador Allende Hospital, Havana, Cuba; 2 Centre of Natural Products, National Centre for Scientific Research, Havana, Cuba; 3 Clinical Laboratory, Medical Surgical Research Centre, Havana, Cuba; 4 Software and Database Group, National Centre for Scientific Research, Havana, Cuba
BACKGROUND: To compare the effects of Roystonea regia (D-004) and saw palmetto (SP) fruit lipid extracts, administered for 24 weeks, on lower urinary tract symptoms (LUTS) of men with benign prostatic hyperplasia (BPH).
METHODS: One hundred (100) eligible patients with mild to moderate BPH were double-blindly randomised to D-004 or SP (320 mg/day both) capsules for 24 weeks. Decrease in the International Prostate Symptoms Score (IPSS) was the primary outcome. Secondary outcomes included reductions of prostate size and post-voiding residual volume.
RESULTS: After 2 months on therapy, D-004 and SP lowered (P<0.00001 for both) mean IPSS by 5.34 and 5.44 units versus baseline, respectively. This effect increased over the study. Between baseline and 24 weeks, mean IPSS scores decreased from 12.38 to 3.68 points (-8.7 points; 95% CI, -7.78 to -9.62) with D-004 and from 12.70 to 3.94 points (-8.8 points; 95% CI, -7.64 to -9.80) with SP, without differences between groups. The post-voiding residual volume decreased significantly (P<0.05) by 49.6% (D-004) and 54.5% (SP) versus baseline. D-004, not SP, reduced significantly (P<0.05), but modestly, the prostate size (9.1%). No significant differences between groups were found. There were seven withdrawals (2 from D-004 and 5 from SP), one of them (SP) being due to an adverse experience (dermatitis).
CONCLUSIONS: D-004 (320 mg/day) was shown to be as effective as SP (320 mg/day) in reducing LUTS in BPH patients after 24 weeks of treatment, being well tolerated (RPCEC00000138).