P.O. Box 144345 Austin, TX 78714-4345 512.926.4900 Fax: 512.926.2345 www.herbalgram.

org

HerbClip
Mariann Garner-Wizard David Levine

Shari Henson Heather S Oliff, PhD

Amy Keller, PhD Risa Schulman, PhD Managing Editor Lori Glenn

Executive Editor Mark Blumenthal

Consulting Editors Dennis Awang, PhD, Thomas Brendler, Francis Brinker, ND, Mark Dreher, Steven Foster, Risa Schulman, PhD Assistant Editor Tamarind Reaves

File: French Maritime Pine (Pinus pinaster) Bark Pycnogenol L-arginine Erectile Dysfunction HC 071131-434 Date: October 14, 2011 RE: Pycnogenol and L-arginine Supplement Improves Erectile Dysfunction Aoki H, Nagao J, Ueda T, et al. Clinical assessment of a supplement of Pycnogenol and Larginine in Japanese patients with mild to moderate erectile dysfunction. Phytother Res. 2011; [epub ahead of print]. doi:10.1002/ptr.3462. Erectile dysfunction (ED) occurs in one-fourth of adult males in Japan. In clinical studies of Europeans and Americans, Prelox, the proprietary, patented combination of L-arginine aspartate and French maritime pine (Pinus pinaster) bark extract Pycnogenol (Horphag Research; Geneva, Switzerland), has improved mild to moderate ED.1,2 However, say these authors, no one has reported on the use of a Pycnogenol and L-arginine supplement for ED in Asians in general or in Japanese patients specifically. Because of this, the authors conducted a small, double-blind, parallel group study to investigate the ED-improving action of a supplement containing Pycnogenol, L-arginine, and aspartic acid in Japanese men with mild to moderate ED. Pycnogenol is a concentrate of polyphenols, mainly procyanidins. Reportedly, it improves ED by activating endothelial nitric oxide synthase (e-NOS), which increases nitric oxide production and thereby promotes vasodilation. Reports also suggest that the combination of Pycnogenol and L-arginine may increase testosterone concentration, possibly secondary to increased sexual activity. The 24 subjects for this study were selected from outpatients at the Akihabara Medical Clinic in Japan who had mild to moderate ED. The subjects were divided into the study herb supplement group (n=12) and the placebo group (n=12) to obtain a comparable average body mass index (BMI) for each group. Those with a BMI 35 were excluded. One subject in the placebo group was unable to continue the study. Used in the study was the supplement Edicare (Kobayashi Pharmaceutical Co., Ltd.; Osaka, Japan), which contains 10 mg of Pycnogenol, 115 mg of L-arginine, and 92 mg of aspartic acid per tablet. The placebo tablet, also manufactured by Kobayashi Pharmaceutical Co., Ltd., contained the same excipients as the study supplement plus 6.0 mg per tablet of red rice malt powder for coloring. The subjects in both groups were asked to take 6 tablets daily for 8 weeks and to record their supplement intake in a diary.

The International Index of Erectile Function (IIEF-5) was used for assessment at baseline and at 4 and 8 weeks. Also at those time points, the subjects provided blood, urine, and saliva samples; were asked about their general health; and were examined by a physician. Height, body weight, BMI, blood pressure, and pulse rate were recorded. The authors report that the total IIEF-5 score increased in 67% (8/12) of subjects in the supplement group and in 36% (4/11) of the placebo group. Examining the intragroup change, the authors note that the scores for question 2 (When you had erections with sexual stimulation, how often were your erections hard enough for penetration?) significantly improved in the supplement group after 8 weeks (P<0.05). Also noted was a significant improvement (P<0.05) in the supplement group compared with placebo group scores on question 5 (When you attempted sexual intercourse, how often was it satisfactory to you?). A nonsignificant trend of improved total IIEF-5 scores was present in the supplement group (P<0.1). No significant improvements in scores or similar trends were observed in the placebo group. The improved erectile function reported in the supplement group was less than reported in other studies on the effects of the combination of Pycnogenol and L-arginine, partly because of the smaller dose of these agents used in this study, say the authors. The mean salivary testosterone concentrations showed a trend of increase (P<0.1) in the supplement group at 4 and 8 weeks. A similar increase in salivary testosterone has been reported previously with the use of Pycnogenol and L-arginine; the specific mechanism is unclear. Further investigation is needed. No changes in salivary testosterone were observed in the placebo group during the study. Slight but significant improvements in blood glucose and the liver enzymes aspartate aminotransferase and -glutamyl transpeptidase were noted in the supplement group. A statistically significant decrease in diastolic blood pressure was noted in the supplement group (from 76.6 10.2 mm Hg to 71.4 10.1 mm Hg). Urinalysis remained unchanged in both groups at 4 and 8 weeks. No adverse reactions were observed in this study. The results of this study demonstrate that consumption of a supplement of Pycnogenol, Larginine, and aspartic acid for 8 weeks significantly improved IIEF-5 scores related to the hardness of erection and sexual intercourse satisfaction. Shari Henson
References 1 Henson S. Mild cases of declining erectile quality may improve with a patented complex formulation of Pycnogenol and L-arginine aspartate. HerbClip. January 31, 2011 (No. 101035-417). Austin, TX: American Botanical Council. Review of Prelox for improvement of erectile quality by Lamm S. European Endocrinology. 2009;5(1):70-74.
2

Miner E. Moderate improvement of erectile dysfunction with Pycnogenol and L-arginine formula. HerbClip. November 30, 2010 (No. 081011-413). Austin, TX: American Botanical Council. Review of Investigation of a complex plant extract for mild to moderate erectile dysfunction in a randomized, double-blind, placebocontrolled, parallel-arm study by Ledda A, Belcaro G, Cesarone MR, Dugall M, Schnlau F. BJU Int. Oct 2010;106(7):1030-1033. The American Botanical Council has chosen not to reprint the original article.

The American Botanical Council provides this review as an educational service. By providing this service, ABC does not warrant that the data is accurate and correct, nor does distribution of the article constitute any endorsement of the information contained or of the views of the authors. ABC does not authorize the copying or use of the original articles. Reproduction of the reviews is allowed on a limited basis for students, colleagues, employees and/or members. Other uses and distribution require prior approval from ABC.