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Sex Health Supplements: Managing Expectations

By Irfan Qureshi

Published on: October 10, 2012 | Women's Health, Regulatory, Magazine

Sex health supplements may promise hyped-up benefits. What benefits can consumers realistically expect?

Maintaining vigorous sexual health is a struggle that most people go through as they age. Over time, decreased health status and chronic health conditions can have a significant impact on our ability to perform optimally from a sexual standpoint. Any number of hormonal changes, along with impacts to cardiovascular health, can severely impact sexual function. Furthermore, drugs and therapeutics that are designed to treat chronic conditions often have suppressive effects on sexual desire and erectile health in men, compounding the issue.

Since it’s common to have decreased performance with age, men often look to solutions to enhance sexual health, whether natural or synthetic. The promise of better performance, or performing as one did in more youthful years, is enticing and attractive. When it comes to performance pharmaceuticals, however, while these can be effective, the effects are often temporary and fail to address underlying factors. Beyond that, they can produce adverse effects, some of which may be serious. They are also not effective for everyone or are contraindicated with certain other medications or diseases.

Herein lies the attractiveness of natural solutions. Is it really possible to have all of the benefits of pharmaceuticals (e.g., fast-acting and efficacious) without any of the side effects? Can you really have your cake and eat it, too? In looking at the market for “natural” sexual function boosters, that’s what many players will have you believe: that their product is an all-natural solution that works faster than erectile dysfunction (ED) drugs, and without any concerns for safety. As is usually the case, when expectations are set this high, it’s often hard to live up to them.

In order to fulfill the stated promise, unscrupulous players often do unscrupulous things. Examples include the multitude of occurrences in the past few years in which FDA has found supplements in the category of men’s sexual health adulterated with ED drugs or analogs that are increasingly difficult to detect. These products are “effective” in a short period of time, but they’re also illegal and present serious safety concerns. Not only that, they taint the reputation of suppliers striving to produce truly effective and safe products, and they set expectations unbelievably high in the minds of unwitting and unknowing consumers.

The supplements industry, and particularly reputable companies in this channel, are against this dangerous practice and are constantly fighting against unrealistic expectations. As RV Venkatesh, managing director of Gencor Pacific (Anaheim, CA), an ingredient supplier marketing Testofen fenugreek extract, comments, “We are completely against the practice of natural products being spiked with synthetic drug ingredients and analogs. These products cannot be called natural products. They are adulterated drugs. People selling such products harm the reputation of the industry.”

Given this scenario, the question remains then of whether natural products can be beneficial for improving sexual health and erectile function. If so, what are the benefits that can be realistically expected?

The answer is that, when expectations are set correctly, herbs and other natural ingredients can be effective and provide significant benefits for promoting sexual health by tonifying systems and restoring optimal function. In conjunction with beneficial dietary and lifestyle practices, natural products represent an effective alternative for enhancing sexual health and performance. Many ingredients have undergone scientific investigation in this area. Select promising ingredients are highlighted below.

Sexual Health: Testofen Fenugreek Extract

Fenugreek seeds (Trigonella foenum-graecum) have a long tradition of use in Ayurveda for reducing blood sugar and blood lipids. The seeds are rich in steroidal saponins and also have been used to promote libido. Gencor’s Testofen is an extract of fenugreek standardized to 50% fenusides, components that are key to the libido-enhancing effect of fenugreek.

The research on Testofen to date suggests that the ingredient may enhance libido and sexual function by increasing the production of testosterone (including increased levels of free testosterone) by simulating the effects of testosterone in the body and by stimulating anabolic effects in muscle tissue.

In an unpublished Gencor study assessing the aphrodisiac activity in rats, three different concentrations of Testofen (5, 10, and 25 mg/kg body weight) were administered daily for 14 days. Over the study period, concentration-dependent increases in sexual function were observed in the animals. Testofen also increased serum testosterone levels and muscle mass.

In humans, Testofen has been studied both for anabolic properties and for its effect on testosterone production. An unpublished, Gencor-sponsored, double-blind, placebo-controlled, eight-week study was conducted on 60 healthy males (aged 18 to 35) who underwent resistance training for a period of one month prior to initiating treatment. Individuals were asked to supplement with Testofen (300 mg before breakfast and before dinner), or a placebo, and the primary endpoints included anabolic activity and free testosterone levels. Testofen treatment resulted in significant anabolic activity and increased free testosterone levels compared to the placebo group. Testofen also demonstrated a significant decrease in body fat compared to baseline levels.

Elizabeth Steels and colleagues in Brisbane, Australia, conducted a placebo-controlled clinical trial assessing the libido-enhancing effects of Testofen in 60 healthy males between the ages of 25 and 52 (Phytotherapy Research, 2011). In this study, a formula featuring Testofen (300 mg per dose), or a placebo, was supplemented twice daily for six weeks. The primary outcome measure was a change in scores on the DISF-SR (Derogatis Interview for Sexual Functioning), a questionnaire designed to measure the quality of sexual function. The questionnaire consists of 21 questions, split into four areas: sexual cognition/fantasy, sexual arousal, sexual behavior/experiences, and orgasm.

In addition, a serum hormone assessment was conducted, including serum testosterone levels at baseline and again at six weeks, while a quality of life assessment measured satisfaction with libido, performance, muscle strength, energy and stamina, mood, and sleep.

Results from the study showed that Testofen had significant effects on the DISF sub-domains of sexual arousal and orgasm, along with enhancements of quality of life scores for muscle strength, energy, and well-being. Based on these findings, it seems that Testofen has benefits on physiological aspects of libido and sexual health. (Serum testosterone measurements did not change significantly from baseline to six weeks in this study.)

Sexual Health: Physta Tongkat Ali Extract

Tongkat ali (Eurycoma longifolia), or Long-Jack, is an herb used in traditional Malay medicine and other traditions of Southeast Asia for its tonifying, rejuvenating, and energy-enhancing properties. Because of its vigor-enhancing qualities, it has been used to support male sexual health. Preliminary research has found that active components of the extract enhance the synthesis of various androgens, including testosterone. (A standardized extract of this plant is marketed as Physta by Biotropics Malaysia Berhad, located in Kuala Lumpur, Malaysia.) Recent human studies are beginning to validate the potency-enhancing effect of this plant extract.

A study published in Andrologia in 2011 led by Dr. Mohd Ismail Bin Mohd Tambi of the Wellmen Clinic in Kuala Lumpur investigated the effects of 200 mg of a water-soluble extract of Tongkat ali daily for one month in 76 males suffering from late-onset hypogonadism (decreased sexual function and testosterone levels). At baseline, patients were assessed using the Aging Males’ Symptoms Ratings Scale (AMS) and serum testosterone measurements. Baseline scores showed that only 10.5% of participants had normal acceptable AMS scores, and 35.5% had normal serum testosterone. After one month of treatment, 71.7% of participants had normal AMS scores, while 90.8% had normal serum testosterone levels.

Additionally, an unpublished, double-blind, placebo-controlled trial comprising 30 heterosexual men aged 40 to 65 with reduced sexual potency conducted by Dr. Jay Udani of Medicus Research and colleagues found that a proprietary combination of Tongkat ali and Polygonum minus daily for 12 weeks significantly improved AMS scores. Significant improvements at the end of 12 weeks were noted in sexual satisfaction, erectile function, and erection hardness, indicating the effectiveness of Tongkat ali for enhancing sexual performance. (For more information on this study, visit www.phystablog.com.)

Sexual Health: Prelox, a Pycnogenol/L-Arginine Combination

Pycnogenol is a proprietary extract from French maritime pine bark. It is rich in polyphenolic compounds with powerful antioxidant effects. L-arginine is an amino acid that participates in the production of nitric oxide. Healthy nitric oxide levels can enhance circulation while supporting endothelial health.

A nutraceutical combination containing Pycnogenol and L-arginine (commercialized as Prelox) has undergone clinical studies showing support for erectile function and fertility parameters in studies dating back over a decade. More recently, Dr. Romil Stanislavov and colleagues conducted a double blind, placebo-controlled crossover trial (International Journal of Impotence Research, 2008) that included 50 men with moderate erectile dysfunction, who were recruited from patients visiting the Seminological Laboratory of the Medical University of Sofia, Bulgaria. Participants were asked to supplement with Prelox (amounting to 80 mg Pycnogenol and 3 g L-arginine aspartate), or placebo, daily for four weeks. This was followed by a four-week washout period, after which treatment was crossed over for an additional four weeks.

Improvement in the groups taking Prelox was highly significant, noted by a doubling of the IIEF score (International Index of Erectile Function). No such improvement was noted in the placebo groups. During the washout period and post-treatment periods, scores dropped; however, scores in the groups taking Prelox were still significantly higher than in those given placebo. Specific improvements included a doubling in the frequency of intercourse during treatment compared to pre-treatment periods, and improvements in orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction, and percent sexual response.

Nitric oxide activity also improved, as noted by a steep increase in eNOS (endothelial nitric oxide synthase) activity in spermatozoa. Increased nitric oxide production is thought to be the key mechanism of action for the Pycnogenol/L-arginine combination.

A further double-blind clinical study (Phytotherapy Research, 2012) was conducted by Hiromitsu Aoki and colleagues from Osaka, Japan, in which a combination of Pycnogenol (60 mg/day) and L-arginine (690 mg/day), or a placebo, was administered to Japanese men with mild to moderate ED for eight weeks. The primary outcome measure included improvements on the five-item erectile domain portion of the IIEF survey (IIEF-5).

Supplementation with the Pycnogenol/L-arginine combination improved total scores on the IIEF-5, in particular on the parameters of “hardness of erection” and “satisfaction with sexual intercourse.” Furthermore, the researchers noted a decrease in blood pressure and liver enzymes, and a slight increase in salivary testosterone levels. Based on the results, the researchers concluded that this nutritional combination appeared to be safe and effective for the treatment of mild to moderate ED in Japanese males.

Sex Health Ingredients: Rely on Research

While continued additional research in humans will serve to address the scope of function of natural ingredients for sexual health, a review of existing research makes it clear that several ingredients have potential to improve sexual and erectile function in males. What is also clear is that the benefits are not immediate, but gradual, and result from the ability of these nutritional factors to address underlying pathological issues that occur as a result of chronic disease or aging. Once function is restored through the tonifying effects of these nutraceuticals, the body and its systems can function optimally.

With these expectations in mind, consumers can feel confident that natural products are efficacious when used appropriately, and legitimate companies can promote these ingredients based on results from studies that show them to work. Creating effective and safe formulations containing natural ingredients that are supported by scientific research, setting realistic expectations in the minds of consumers who use such products, and doing away with the false hype in the marketplace will ensure that ingredients marketed in this category are used appropriately and provide desired benefits.


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