[摘要]:A double-blind parallel group comparison design clinical study was conducted in Japanese patients with mild to moderate erectile dysfunction to investigate the efficacy of a supplement containing Pycnogenol (R) and L-arginine. Subjects were instructed to take a supplement (Pycnogenol (R) 60mg/day, l-arginine 690mg/day and aspartic acid 552mg/day) or an identical placebo for 8weeks, and the results were assessed using the five-item erectile domain (IIEF-5) of the International Index of Erectile Function. Additionally, blood biochemistry, urinalysis and salivary testosterone were measured. Eight weeks of supplement intake improved the total score of the IIEF-5. In particular, a marked improvement was observed in hardness of erection and satisfaction with sexual intercourse. A decrease in blood pressure, aspartate transaminase and -glutamyl transpeptidase (-GTP), and a slight increase in salivary testosterone were observed in the supplement group. No adverse reactions were observed during the study period. In conclusion, Pycnogenol (R) in combination with l-arginine as a dietary supplement is effective and safe in Japanese patients with mild to moderate erectile dysfunction. Copyright (C) 2011 John Wiley & Sons, Ltd.