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Abstract
A Double-Blind Placebo-Controlled Study on the Effects of ArginMax, a Natural Nutritional
Supplement for Enhancement of Male Sexual Function.
Thomas Ito, MD, Assistant Professor of Urology (University of Hawaii School of Medicine) Kaye Kawahara, MD Associate Professor of Medicine (University of Hawaii School of Medicine), Director of Bone Marrow Transplantation (Saint Francis Medical Center), Director of Cancer Research (Queen's Medical Center) Anurag Das, MD FACS, Assistant Professor of Surgery, Department of Urology, (Albany Medical College) Contact: Thomas Ito, M.D., 1010 S. King Street, Suite 218B, Honolulu, Hawaii, 96814, Purpose: To evaluate the role of a natural nutritional supplement to enhance male sexual function as
a follow-up to a previously published pilot study examining the effects of ArginMax on sexual health.
Materials and Methods: Seventy-three (73) subjects participated in the study with twenty-five (25)
subjects participating in the pilot arm, and forty-eight (48) subjects participating in the double-blind
placebo-controlled arm of the study. This abstract will review the double-blind placebo-controlled
study.
Forty-three (48) study participants, ages 31-73, enrolled through a urology clinic were evaluated over a 4-week period. Subjects were enrolled consecutively with participation open to all individuals diagnosed with mild, moderate, to severe erectile dysfunction of varying etiology. The study instrument was the International Index of Erectile Function (I.I.E.F.), a validated instrument with multidimensional scale for assessment of erectile function used in the evaluation of Viagra (sildenafil citrate). Upon enrollment, subjects were randomly assigned active or placebo in a double-blind fashion resulting in twenty-four (24) subjects placed on active and twenty-four (24) subjects placed on placebo. The age of the ArginMax group ranged from 41 to 73, the age of the placebo group ranged from 31 to 73. The average age of the ArginMax group was 60.5, the average age of the placebo group was 61.0. There were 4 diabetic participants in the ArginMax group, and 3 diabetic participants in the placebo group. There were 7 participants with hypertension in the ArginMax group, and 8 participants with hypertension in the placebo group. ArginMax is a proprietary nutritional supplement which incorporates a standardized combination of ginkgo biloba (24% flavone glycosides, 6% terpene lactones), Korean ginseng (Panax Ginseng-30% ginsenosides), American ginseng (Panax Quinquefolius- 5% ginsenosides), L-arginine (precursor to nitric oxide), along with vitamins B6, B12, folate, thiamin, riboflavin, niacin, biotin, pantothenic acid, antioxidant vitamins A, C, E, selenium, and Zinc. Results: 87.5% of subjects in the ArginMax group reported improvement in ability to maintain an
erection during intercourse, while 22.2% reported improvement in the placebo group. 75.0% of
subjects in the ArginMax group reported improvement in satisfaction with their overall sex life, while
20.8% reported improvement in the placebo group. No headaches, nausea, vomiting, stomach upset,
visual disturbance, blood pressure alterations, dizziness, or other significant side effects were noted in
either group.
Discussion: The results of this double-blind placebo-controlled study are consistent with the findings
of the ArginMax pilot study where twenty-five (25) men with mild to moderate erectile dysfunction
were placed on a four week course of ArginMax. In the pilot study, 88.9% of the participants
improved in ability to maintain an erection during intercourse, and 75% improved in their satisfaction
with overall sex life.
Nitric oxide (NO) is central to smooth muscle relaxation, vascular dilatation, and the regulation of circulation and erection. L-arginine, a naturally occurring amino acid, is the precursor of nitric oxide. Supplementation with L-arginine provides the substrate for nitric oxide production by endothelial cells. The conversion of L-arginine to nitric oxide is mediated by an enzyme, nitric oxide synthase (NOS). Certain botanical extracts with a long history of use in traditional medicine have been observed to facilitate the conversion of L-arginine into nitric oxide. One observed mechanism for increase in nitric oxide production in endothelial cells is stimulation of the NOS enzyme activity by ginsenosides—a primary active class of ingredient extracted from ginseng. Ginkgo biloba has a well established role in facilitating micro-vascular circulation with evidence suggesting that it may directly promote smooth muscle relaxation in the corpus cavernosum via its action on the nitric oxide pathway. Hence, the presence of a highly specific combination of these natural botanical extracts and L-arginine, the precursor of N.O., promotes the production of nitric oxide which serves to optimize circulation and erection. The proposed mechanism of action of ArginMax is through up-regulation of the L-arginine/nitric oxide pathway. Conclusion: The roThe The le of nutritional supplements for sexual health is an infrequently
discussed yet extremely important subject matter. Nutritional supplementation can play a major role in
sexual health. It is critical to recognize that as consumers develop an ever increasing interest in a
wellness oriented approach towards healthcare, the role of nutritional supplementation for one of the
most important biological functions of life—sexual health—be addressed. After all, if we take a
calcium supplement for our bones, and a vitamin E supplement for our heart, why not a nutritional
supplement for our sexual health?
This arena will be further evaluated via the continuation of the current study as part of a large-scale multi-center study of ArginMax. Review of the Medical Literature
The following is a review of selective scientific literature pertaining to ArginMax ingredients. It is well established that nitric oxide (NO) is the key mediator for the up-regulation of cGMP which in turn mediates erectile function.1 L-arginine is the precursor of nitric oxide. The conversion of L-arginine to nitric oxide is mediated by nitric oxide synthase (NOS). Increasing tissue L-arginine levels results in the increase of NO and cGMP.2, 3 Supplementation with L-arginine has been shown to be play a role in restoring endothelial-derived nitric oxide production in many disorders in which endothelial-derived nitric oxide is reduced or impaired, including impairment resulting from diabetes and hypercholesterolemia.4,5,6,7,8 Studies also point to the role of L-arginine as not only a substrate for NOS in the up-regulation of cGMP, but also acts to reduce cell-mediated breakdown of nitric oxide.9 The efficacy of Korean ginseng (Panax Ginseng) in treating erectile dysfunction was recently demonstrated in a randomized controlled clinical trial involving a total of 90 patients studied over 3 months, 30 each receiving placebo, trazadone, or ginseng.10 Ginseng was the most efficacious treatment with improvements measured in erectile parameters such as girth, libido, and patient satisfaction. Frequency of intercourse, ejaculations, and erections did not differ among groups. In a controlled study with 66 patients, Panax ginseng was demonstrated to increase spermatozoa count and motility in 66 patients with fertility problems. 11 Ginsenosides (the primary active component of ginseng) have been shown to increase NO production in endothelial cells.12,13.14 One observed mechanism for increase in NO production is up-regulation of NOS activity by ginsenosides.14 The effects of ginsenosides on NO production has implications for improved sexual function, and may partly account for the aphrodisiac effect of Panax ginseng used in traditional Chinese medicine. Ginkgo biloba is well established to facilitate microvascular circulation15 which may physiologically lead to improvement of erections. In addition to ginkgo biloba's ability to facilitate microvascular circulation, potentially benefiting erectile function through enhanced vascular blood flow, there is evidence that ginkgo biloba extract may also directly elucidate smooth muscle relaxation in the corpus cavernosum, likely via effects on the nitric oxide pathway. 16,17 B-complex vitamins are important to the activity of hundreds of enzymes and in energy metabolism. Low levels of circulating folate and vitamin B6 confer an increased risk of peripheral vascular disease,18 leading to potential reduction of erectile function. Zinc is a fundamental mineral in the maintenance of human reproductive function. Low levels of serum zinc has been shown to cause sexual dysfunction and associated with infertility in males.19,20 Zinc deficiency during growth periods result in lack of gonadal development in males.21,22 Zinc deficiency leads to depletion of testosterone and inhibition of spermatogenesis.23 Zinc is also thought to help extend the functional life span of ejaculated spermatozoa.23 Selenium has a key influence on spermatozoa numbers and motility. It is an essential element in normal spermatozoa development. Selenium is incorporated in the sperm mitochondria capsule and may thus affect the behavior and function of the spermazoon.24 It has been shown that dietary supplementation with selenium-vitamin E statistically significantly increases sperm motility, percent live, and percent normal spermatozoa.25 It is well established that one of the key roles of seminal plasma is the protection of spermatozoa against reactive oxygen species.26 In a study of 101 patients seeking consultation for infertility and 15 fertile donors, a strong inverse relationship was found between total reactive antioxidant potential in seminal plasma and infertility.26 A pilot clinical study was undertaken to preliminarily evaluate the role of a combinatorial nutritional product which incorporates the previously discussed key ingredients for optimization of nitric oxide production and enhancement of sexual function. In the pilot study, 32,33,34,35 twenty-five study participants were consecutively enrolled through a urology clinic with participation open to all individuals diagnosed with mild to moderate erectile dysfunction of varying etiology. The study instrument was the International Index of Erectile Function (IIEF). Following the completion of the study, 88.9% of the subjects experienced improvement in ability to maintain an erection during intercourse, and 75.0% experienced improvement in satisfaction with their overall sex life.32,33,34,35 The results of the pilot clinical study indicate that an expansion of the study to a larger population with a double-blind placebo-controlled protocol is the logical next step in exploring the sexual function benefits of ArginMax, and the basis for the present study.36,37 Bibliography
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