Bring Back the Joy

Brides and grooms across the country are saying I do this month with the warmer weather and the upcoming summer break available for honeymoons. TheKnot.coms 2010 Real Weddings Study found 15 percent of 2010 weddings occurred in June, the most out of any month; this year cant be that different. Newlyweds arent typically thought of as needing help in the bedroom, but many may discover their love lives arent quite what they expected before they signed the marriage license, especially as the months and years go on. Kids, jobs, stress and cheeseburgers may just get in the way.

While poor sexual health isnt as physically noticeable as other conditions, such as obesity, or as easy to gauge, such as hypertension, an unhappy husband may argue its just as important, and it needs to be addressed as aggressively as other ailments to maintain overall wellness.

Not only do love, affection and sexual intimacy contribute to a healthy relationship, but they also help with your sense of well-being, said David Romeo, managing director, Nutraceuticals International.

This overall wellness is an advantage natural products have over their pharmaceutical counterparts. Western medicine often looks to testosterone replacement to treat erectile dysfunction (ED), which has been shown to compromise overall quality of life and self-esteem, and increase depression and anxiety. ED may also signal an underlying disease including diabetes, hypertension and cardiovascular disease (CVD), which natural products may also help to address.

Still, natural products have their downsides; they will most likely take weeks or even months to take effect, whereas drugs such as sildenafil (Viagra®), tadalafil (Cialis®) and vardenafil (Levitra®) are fast-acting treatments for low libido and sexual function. Of course, fast-acting also comes with its share of harmful side effects, such as increased blood pressure, heart troubles and increased risk of stroke. And, we all remember the four-hour erection warnings on television commercials.

Many consumers want to avoid these hazards as well as live more naturally overall. And, then some just dont want to bring up the topic to their family doctor if they dont have to. Many men have health issues that do not allow them to take the available prescription drugs, and so they turn to natural alternatives, said Deanne Dolnick, vice president, Next Pharmaceuticals. This is a sensitive topic, as well. If a man can go into a store or order a dietary supplement online and not have to speak to his doctor about it, dietary supplements might be the easier path to take. Women who are under a great deal of stress have found their sex drive has disappeared. If a supplement can be taken to alleviate stress instead of a prescription drug, this is usually the safer alternative.

Dolnick speaks with knowledge of consumer data. In 2008, Next polled 500 people from cities across the Untied States to find out how stress relates to sexual habits. Those who suffered more stress had significantly less sex, according to the results.

More than one-quarter (28.6 percent) of responders said they felt very stressed, giving an answer of eight, nine or 10 on a 10-point scale. Just below half (49.4 percent) indicated an average amount of stress, answering four, five, six or seven; and 22 percent felt very low stress levels (rating of one, two or three). Next also asked about sex frequency. Just over half (59 percent) of the respondents reported having sex two times per month or more, 21.8 percent had sex less than once per month and 19.2 percent never have sex.

And those who are stressed suffer in the bedroom, according to Nexts survey. Those with the least stress were significantly more likely to say they are having sex three to five times per week. Those with the most were significantly more likely to say they are having less sex than others (63.9 percent). And stress is getting worse46 percent of the adults interviewed said they are more stressed than they were a year ago.

Regardless of stress, among all respondents, 62 percent said they are not having sex often enough. However, almost one in five (19 percent) said they are very or somewhat likely to take an all-natural dietary supplement to reduce stress. Thankfully, natural remedies can help these unlucky individuals; but, unfortunately, unsafe products can  fix the immediate problem while causing long-term issues.

The Adult in Adulteration

Unhappy consumers are one thing, but angry regulators are quite another, and FDA and FTC havent been too pleased with this category as of late due companies looking for a quick buck by offering products spiked with drugs. Last Decembers warning letter from FDA Comissioner Margaret Hamburg called out sexual function supplements, along with bodybuilding and weight loss products, as having alarming adulteration problems. She said some companies within these categories market products containing the same active ingredients as FDA-approved drugs, analogs of the active ingredients in FDA-approved drugs or other compounds that do not qualify as dietary ingredients. These undeclared ingredients, she said, can pose dangers to unsuspecting consumers including strokes, acute liver injury, kidney failure, pulmonary embolisms (artery blockage in the lung) and death. In a press conference, FDA said it had, to date, recalled more than 70 sexual enhancement products tainted with drug ingredients.

Indeed, numerous companies have voluntarily recalled products due to adulteration/contamination (BEST Enhancer from AVNS Inc. in April 2011, STUD Capsules for Men and XOX for Men from Kanec USA in 2010, ProLatis in August 2010, Duro Extend Capsules for Men from Intelli Health Products in December 2010, Vialipro from Good Health Inc. in July 2010, etc.). Most of these unapproved drugs contained sulfoaildenafil or sildenafil, FDA-approved drugs used in the treatment of male ED. These drugs can interact with nitrates found in other pharmaceuticals and lower blood pressure to dangerous levels. FDA has also issued warnings to consumers (Vigor-25 in November 2010, Time Out Capsules in August 2010, etc.) for misbranded products containing sulfoaildenafil or sildenafil.

Voluntary recalls usually accompany FDA warnings. FDAs October 2011 warning letter to Kanec USA for STUD Capsules for Men and XOX also noted product labeling positioned the two products as drugs, not dietary supplements. Further, FDA listed several violations of GMP (good manufacturing practice) standards, including a lack of testing procedures, lack of batch records and no quality control unit for oversight of components. Others, such as ProLatis, faced the same situation: FDA sent it a warning letter four months after its recall citing product claims that arent structure/function in nature, making them unapproved drugs. FDA even seized boxes of an herb-based drug product (Stiff Nights from Impulsaria LLC) for containing sulfoaildenafil in June 2010.

The industrys self-regulatory bodies have also been active. In October 2010, The Electronic Retailing Self-Regulation Program (ERSP) recommended Leading Edge Marketing Inc. modify or discontinue certain advertising claims for its VigRX line of male enhancement products.

The problem with adulteration in this area is huge because pharmaceutical ingredients are well-known to work, therefore its an easy cheat to add a small amount of those ingredients, said Jay Udani, M.D., CEO, Medicus Research LLC, and assistant clinical professor, UCLA School of Medicine. My hunch is that adulteration is more common than contamination because people know what theyre doing. He noted increased regulatory enforcement is a good thing because it prompts unscrupulous companies to leave the market.

However, these recalls and FDA warnings can shed a negative light on the entire industry. The nutrition industry continues to be portrayed by mainstream media as an unregulated industry, said Chase Hagerman, business development and marketing manager, Chemi Nutra. It is important to ensure ingredients are well researched and have no adverse effects before they are taken to market.

While exact numbers are hard to come by, articles that have appeared in The New York Times, Wall Street Journal, ABC News, CBC/Radio Canada and others have surely made consumers question the validity of all products within this category.

Safety is of top concern to FDA, consumers and companies within this market, at least the companies that are truly trying to help those with sexual issues. The best way to prove safety in the sex health market is like all other categoriestesting. Proper TLC evaluation of herbs ensures you are using the right plant, said medicine hunter Chris Kilham, scientific advisory board member, EuroPharma. Safety testing looks at heavy metals, bacteria, yeast, fungus, pesticides and certain other toxins. These technologies are popular among good companies because they ensure the delivery of consistent, safe products. To do this requires everything from basic lab setups to sophisticated instrumentation like HPLC and GC Mass Spectrometry, and talented people who know how to use all of it.

After safety, consumers want efficacy, but marketers should help set appropriate expectations; natural products wont work like pharmaceutical drugs, and they arent supposed to. Natural products are designed to address sexual health problems, its true, but they often dont zero in to fix only one specific problem. As consumers take products that work, they will find they improve general health as well; or, is it the improvement of general health that allows healthy sex to resume?

Physical sexual performance is only one part of sexuality, Hagerman said. Emotional, mental and social well-being also play a critical role in human sexuality. I predict more products will emerge that address sexual function through a holistic approach. This is especially true for women, where research shows that libido is more complicated than a simple physical problem.

Indeed, sex hormones affect nearly every major function in the body. Estrogen affects cognitive function, bone health, mood stability, cardiovascular health and skin health; progesterone helps regulate the immune system, sleep and anxiety; and testosterone plays a role in heart health, insulin sensitivity and muscle strength. The sex hormone precursor dehydroepiandrosterone (DHEA) and pregnenolone also play a role in brain function and muscle strength.

As noted by Next Pharmaceuticals study, stress plays a role in healthy sexual function. Chronic stress elevates levels of the hormone cortisol; high cortisol levels decrease DHEA, which, in turn, decreases sex hormones. This can not only lead to problems in the bedroom, but other health issues.

Therefore, many ingredients in this category offer multiple effects within the body; but, no matter what they are, companies need to be clear to consumers about what those effects are. Simply put by SiSiti Nooruhani Ibrahim, director of marketing and customer service at Biotropics: Consumers deserve products that contain what the label says they contain, in the amounts as labeled and do what they claim to do. Consumers also deserve products that are backed by research that shows that they work.

Bedroom Botanicals

Consumed for multiple health benefits, including sexual function, plants seem to dominate this category. Maca (Lepidium meyenii) is one herb thats seen an explosion of interest, with help from CNN appearances by Kilham. Elizabeth Cohen, CNNs senior medical correspondent, joined Kilham on air for a visit to an outdoor market in Peru in 2010 where maca is sold in many forms, including maca muffins. Cohen asked Kilham what would happen if she took a scoop of maca powder, threw it in a smoothie and drank it every morning. Sexually? It might cause Chinese New Years fireworks in your pants," he said.

But, maca can benefit more than that. Maca has been deemed by ancient Peruvians as a highly nutritious, energy-instilling food, Romeo said. It has been used as a remedy to enhance strength, stamina, libido and for its aphrodisiac properties. It is believed that this herb has the ability to boost fertility and help treat sexual function in both men and women.

Its not all talk, however. 2008 research has shown benefits of maca, including reducing psychological symptoms, such as anxiety and depression, and lowering measures of sexual dysfunction in postmenopausal women.¹ In male rats, maca increased sperm production and sperm count after seven days of oral administration in a different 2008 study.² And a 2009 review from Peru reported randomized clinical trials have shown maca has favorable effects on energy and mood, may decrease anxiety and may improve sexual desire.³ The review also noted maca has also been shown to improve sperm production, sperm motility and semen volume.

The benefits are certainly driving sales, as Steve Siegel, vice president, said this herb is Ecuadorian Rainforests best-selling ingredient.

Tongkat ali (Eurycoma longifolia), a medicinal plant from southeast Asiathat has been traditionally used for its anti-malarial, anti-diabetic, antimicrobial and aphrodisiac effects, helped male rats significantly increased the leavator ani muscle (classic tissue model for the study of hormone-muscle interactions) when compared with the control, according to a 2001 study in Malaysia.⁴ Researchers concluded, Hence, the pro-androgenic effect as shown by this study further supported the traditional use of this plant as an aphrodisiac. And in 2003, the same researchers found it enhanced the sexual qualities of middle-aged male rats by decreasing their hesitation time to start intercourse when compared to controls.⁵ However, safety questions still loom. A 2010 review noted toxicity and safety evaluation studies have been pursued, but said a major gap still exists in providing scientific base for commercial use and clearance of tongkat ali products with regard to consumer's safety.⁶

Annie Eng, president of HP Ingredients, added increased saliva free testosterone levels, increased fat free mass, decreased body fat, increased arm circumference, increased muscle strength, increased anabolic state, reduced catabolic state, reduced cortisol levels, increased testosterone levels and faster recovery to the list of health benefits of Eurycoma longifolia. She added HP offers LJ100 Eurycoma longifolia extract, which is standardized to 22-percent eurypeptides and 40-percent glyco saponins, which is patented for the treatment of ED.

And, Ibrahim said men who took Biotropics patented form of tongkat ali, PhysTA, reported significant improvements in sexual performance and satisfaction across several parameters when compared to the placebo in a 12-week, randomized, double blind, placebo-controlled unpublished study.

From India, fenugreek (Trigonella foenum-graecum) also has an effect on the libido, especially for men. An extract from fenugreek seeds standardized for a special matrix of saponin glycosides called fenusides (as Testofen from Gencor) has been studied in recent animal and human trials. In February 2001, it demonstrated a significant positive effect on physiological aspects of male libido, and researchers said it may assist to maintain normal healthy testosterone levels.⁷ In the randomized study of 60 healthy males without ED, Testofen significantly increased sexual arousal and orgasm. It also had a positive effect on quality of life in self-reported satisfaction with muscle strength, energy and well-being. In 2010, Testofen increased muscle mass in castrated rats without affecting testosterone levels, and researchers said this anabolic activity has the potential to aid men as they enter andropause, an age-related conditions associated with the loss of libido, loss of muscle mass and decreased testosterone production.⁸

Other herbs have also been promoted for their sexual health benefits. Guarana (Paullinia cupana) is one for instance. The botanical has a history of being used as an energy enhancer, thus, manufacturers have taken this and applied it to their sexual health products, Siegel said.

Romeo noted the Ayurvedic herbs Akarkara (Anacyclus pyrethrum) and Tribulus terrestris can also be added to sexual health formulas. Akarkara has been considered a tonic used in remedies since ancient times, to aid the nervous system, he said. It has been reported to motivate intimate urges as well as assist in premature ejaculation and impotency in males.  He added, T. terrestris is now being promoted as a booster for the purpose of increasing sex drive. The extract is claimed to increase the body's natural testosterone levels and thereby improve male sexual performance and help build muscle. It is also used as an aphrodisiac, diuretic and nervine in Ayurveda and in Unani, another medical system of India.

Botanicals, with their complementary effects, have also been combined to help reduce the negative effects of stress, and thus, improve sex lives. Relora, a proprietary combination of Magnolia officinalis and Phellodendron amurense extracts from Next Pharmaceuticals reduced stress levels in healthy, overweight premenopausal females who eat more in response to stress.⁹ Relora also prevented weight gain for obese women who eat in response to stress as compared to placebo in a 2006 study where researchers supposed the combination reduced cortisol levels.¹⁰ An unpublished study on Relora found two weeks of supplementation in subjects with mild to moderate stress caused a significant increase in salivary DHEA and a significant decrease in morning salivary cortisol levels with all 10 of the subjects responding to the treatment. Given that stress causes a lack of sex hormones, Next Pharmaceuticals reasons Relora can address sexual health issues as well. Obesity can also cause sexual health problems, as a study in the May/June 2011 issue of Journal of Sex and Marital Therapy reported increasing ones body mass index (BMI) was associated with decreasing sexual functioning for arousal and behavior.¹¹ In fact, that study found obese womens sexual functioning scores were below those of a group of cancer survivors.

Produced by the Body

Botanicals dominate the market, but nutrients found in body cells have also shown to boost human sexuality. Phosphatidylserine (PS), for instance, has been shown to suppress the release of cortisol in stressful situations. PS is a phospholipid component found in cell membranes. While Hagerman said Chemi Nutra doesnt actively pursue the sexual health category, its SerinAid® PS and its AlphaSize® alpha-glyceryl phosphoryl choline (Alpha-GPC) can aid in sexual function by helping to maintain healthy hormone levels. Research shows supplementation with SerinAid PS boosts testosterone and suppresses cortisol, a stress hormone that has close ties to inhibiting libido, he said. A-GPC is a nutrient that occurs naturally in the human body, where it is involved in a multitude of biochemical functions. And, according to Chemi Nutra literature, A-GPC increases acetylcholine (AC), a neurotransmitter that enhances the secretion of human growth hormone (HGH). Thus, supplementation with A-GPC can boost HGH, which may boost vitality.

The amino acid L-carnitine carries fatty acids to the mitochondria to be broken down for energy, and this includes the mitochondria of sperm cells. A 2007 systematic review from China reported administration of L-carnitine may be effective in improving pregnancy rates and sperm kinetic features in patients affected by male infertility; however, the researchers said the exact efficacy of carnitine on male infertility needed to be confirmed by further research.¹² And, one placebo-controlled, double blind, crossover trial from 2003 of 100 infertile men (aged 20 to 40 years), found 2 g/d of L-carnitine therapy or placebo increased semen quality, especially in groups with lower baseline levels.¹³

Lonzas Carnipure L-Carnitine plays an important role in sexual health, said Kevin Owen, Ph.D., NAFTA head of technical marketing and scientific affairs, Lonza. Since it is widely accepted that reproductive efficiency is highest for individuals with good nutritional status and health, and since this supplement has a role in supporting sperm health, supplementation with Carnipure may be recommended to males interested in promoting their reproductive health.

Delivery

For now, it seems consumers prefer capsules and tablets for delivery of their sexual health ingredients, be they natural or pharmaceutical. As noted by Siegel, Sexual health supplements (capsules and tablets) are the most popular method. These natural products often mimic pharmaceutical products (Viagra for example), which are very popular.

Kilham said history shows Americans like pills and capsules. Other dosage forms remain at the periphery of the market, he said. Yet, other dosage forms, such as fluid elixirs and edible products, could be not only highly effective, but novel and fun. Still, the market really seems to want pills. Innovative product releases mostly have to do with clever marketing and great labels. The marketing materials that stop you in your tracks, and the labels that make you pick up the bottles are innovative.

Eng said oral strip delivery systems are always an option, and Hagerman said women may be interested in cosmeceutical delivery forms such as creams, but he sees little interest from men in this area. He also said food and beverages may be helpful for those who have difficulty swallowing pills. Yet, Udani said he has not seen sexual performance ingredients in foods.

But, one never knows how consumer interest will change. In fact, in December 2010, The Food Channel®, in conjunction with CultureWaves, the International Food Futurists and Mintel International, predicted eating for sex would be one of the top ten food trends for 2011. And Hagerman noted Chemi Nutras AlphaSize and SerinAid have GRAS (generally recognized as safe) status and are just waiting to be introduced in foods for the sexual health market.

While Eng noted sales may have decreased slightly due to the economic slowdown, sex will always sell. Once FDA and FTC can weed out some of the bad apples, consumer trust should rise with their libidos. New ingredients and technologies are always on the horizon to help safely address sexual healthright along with general health issues. According to Kilham, Our customers are eager for safe, effective products. Let's deliver those, and make a great contribution to human health. This is completely within our ability.

References for  "Bring Back the Joy"

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2.       Yucra S et al. Effect of different fractions from hydroalcoholic extract of Black Maca (Lepidium meyenii) on testicular function in adult male rats. Fertil Steril. 2008 May;89(5 Suppl):1461-7.

3.       Gonzales GF, Gonzales C, Gonzales-Castañeda C. Lepidium meyenii (Maca): a plant from the highlands of Peru--from tradition to science. Forsch Komplementmed. 2009 Dec;16(6):373-80.

4.       Ang HH, Cheang HS. Effects of Eurycoma longifolia jack on laevator ani muscle in both uncastrated and testosterone-stimulated castrated intact male rats. Arch Pharm Res. 2001 Oct;24(5):437-40.

5.       Ang HH, Ngai TH, Tan TH. Effects of Eurycoma longifolia Jack on sexual qualities in middle aged male rats. Phytomedicine. 2003;10(6-7):590-3.

6.       Bhat R, Karim AA. Tongkat Ali (Eurycoma longifolia Jack): a review on its ethnobotany and pharmacological importance. Fitoterapia. 2010 Oct;81(7):669-79

7.       Steels E, Rao A, Vitetta L. Physiological Aspects of Male Libido Enhanced by Standardized Trigonella foenum-graecum Extract and Mineral Formulation. Phytother Res. 2011 Feb 10. doi: 10.1002/ptr.3360

8.       Aswar U, Bodhankar SL, Mohan V, Thakurdesai PA. Effect of furostanol glycosides from Trigonella foenum-graecum on the reproductive system of male albino rats. Phytother Res. 2010 Oct;24(10):1482-8.

9.       Kalman DS. "Effect of a proprietary Magnolia and Phellodendron extract on stress levels in healthy women: a pilot, double-blind, placebo-controlled clinical trial." Nutr J. 2008 Apr 21;7:11.

10.   Garrison R, Chambliss WG. Effect of a proprietary Magnolia and Phellodendron extract on weight management: a pilot, double-blind, placebo-controlled clinical trial. Altern Ther Health Med. 2006 Jan-Feb;12(1):50-4.

11.   Ostbye T, et al. Sexual functioning in obese adults enrolling in a weight loss study. J Sex Marital Ther. 2011 May;37(3):224-35.

12.   Zhou X, Liu F, Zhai S. Effect of L-carnitine and/or L-acetyl-carnitine in nutrition treatment for male infertility: a systematic review. Asia Pac J Clin Nutr. 2007;16 Suppl 1:383-90

13.   Lenzi A, et al. Use of carnitine therapy in selected cases of male factor infertility: a double-blind crossover trial. Fertil Steril. 2003 Feb;79(2):292-300.