ArticleLiterature Review

A Urologist's Guide to Ingredients Found in Top-Selling Nutraceuticals for Men's Sexual Health

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Abstract

Introduction: Use of supplements is common among men seeking urologic evaluation for sexual health matters. With a dizzying array of formulations available and little regulation on the dosage, purity, or ingredients found in these products, the health effects of nutraceuticals are often confusing to patients and medical practitioners alike. Aim: In this review, we set out to concisely summarize the data on ingredients found within the top-selling nutraceutical agents marketed for men's sexual health in order to provide a clinical guide for urologists. Methods: We used sales data from the most popular retail provider of men's health supplements to identify the top-selling products marketed toward improvement of men's sexual health. We summarized the available information related to the ingredients, dosage, cost, and mechanism of action for these substances and performed an extensive literature search to identify and review the current evidence available for each of the most common ingredients found in these nutraceuticals. Results: The top-selling nutraceuticals marked for men's sexual health contain a blend of multiple supplements (up to 33 in one formulation identified), the most common being ginseng, tribulus, zinc, horny goat weed, B complex vitamins/trace minerals, fenugreek, L-arginine, maca, DHEA, ginkgo, and yohimbine. The currently available medical literature evaluating the efficacy of these substances is generally of low quality. Conclusions: Despite the dearth of evidence supporting nutraceutical agents in the men's health arena, these substances are still commonly used by patients. As these products can affect the health and well-being of men presenting to a urology clinic, a familiarity with commonly used agents can help the urologist appropriately counsel their patients. Cui T, Kovell RC, Brooks DC, and Terlecki RP. A urologist's guide to ingredients found in top-selling nutraceuticals for men's sexual health. J Sex Med **;**:**-**.

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... Dietary supplements, like herbal compounds and natural products are widely accepted in society, therefore, patients with sexual dysfunction frequently search these products [10]. Negative emotional status related to shame and stigma is often present in patients with sexual dysfunction, leading them to search alone for answers, thus recurring to this type of compounds, which are easily obtainable [9,10]. ...
... Dietary supplements, like herbal compounds and natural products are widely accepted in society, therefore, patients with sexual dysfunction frequently search these products [10]. Negative emotional status related to shame and stigma is often present in patients with sexual dysfunction, leading them to search alone for answers, thus recurring to this type of compounds, which are easily obtainable [9,10]. ...
... Elevated plasma level of homocysteine has been associated to endothelial dysfunction, which is a phenomenon frequently reported in several conditions with vasculogenic erectile dysfunction presence, like diabetes mellitus, hypertension and smoking. It was demonstrated that hyperhomocysteinemia can be associated with higher risk of erectile dysfunction [26], and so, correction of vitamin B6, B12 and folate deficiencies, which regulate homocysteine levels, can improve erectile function [10]. Erectile dysfunction is commonly present in coronary artery disease and other cardiovascular diseases, with endothelial dysfunction and atherosclerosis as common factor. ...
Article
Background: Sexual dysfunction and infertility are conditions with high prevalence in general population. Nutritional factors have been reported to have impact in sexual and reproductive health. Objective: The aim of this review is to summarize the data on nutritional factors that have influence in male and female sexual and reproductive function, including nutritional status, specific foods (e.g. dairy food), nutrients and other food components and dietary supplements. Method: A literature search was performed using Cochrane Library, Medline and ScienceDirect databases without time limitations. Results: Obesity has a negative influence in male fertility, and weight loss improves male fertility. Food insufficiency is associated with increased sexual risk behaviours, more significant in women. Regarding to macronutrients and group foods, trans-fatty acids, high glycemic index food, high carbohydrate diet and high animal protein intake prejudices fertility; omega-3 and omega-6 fatty acids, low glycemic index food and low carbohydrate diet, vegetable proteins and antioxidants improves fertility. Isoflavones has a negative impact on men fertility and improves sexual health of menopausal women. Whole milk improves women fertility, but men benefit from skim milk. Concerning to dietary supplements there is weak evidence sustaining efficacy, and the most promising supplements are yohimbine, vitamin B, L-arginine and vitamin D. Conclusion: The compiled results indicate that despite the multifactorial etiology of sexual/reproductive dysfunction, nutritional factors may affect the sexual and reproductive health in both men and women. However, it is necessary further studies to clarify this association, and simultaneously improve the approach and treatment of patients with sexual and/or reproductive problems.
... • стрессоры, связанные с политическими событиями по следнего времени, нестабильным экономическим положе нием, безработицей, неуверенностью в завтрашнем дне. Следствием всех перечисленных выше стрессоров стал так называемый синдром хронической усталости: психосо матические заболевания и психические расстройства невро тического уровня, одним из самых характерных симптомов которых и является нарушение эректильной функции [5]. ...
... ЭД делится на психогенную (депрессия, проблемы в па ре, психосоциальный стресс) и органическую (нейрогенная, сосудистая, травма/заболевание полового члена, гормональ ная, лекарственная, мультифакторная). Достаточно часто встречается ЭД смешанного генеза, при которой сочетаются психогенные и органические факторы [5]. ...
... За последние 15 лет в отечественной и зарубежной на учной литературе имеется большое количество сообщений о высокой эффективности экстракта якорцов стелющихся (Tribulus terrestris) в лечении как ЭД, так и нарушения сперматогенеза экскреторного и гормонального генеза [5]. Эротизирующий эффект, как и оптимизация процессов сперматогенеза, при использовании экстракта якорцов за ключается в возможности опосредованной стимуляции клеток Лейдига фитостероловыми сапонинами. ...
Article
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Objective: to analyze the efficacy and tolerability of the use of the drug Pravenor® Forte in patients with erectile dysfunction (ED) on the background of chronic prostatitis and prostatic hyperplasia (PH). Materials and methods. The study involved 60 patients with ED who were divided into two groups. The majority of patients in both groups had chronic diseases. Patients of the main group (n = 30) received Pravenor® Forte 2 capsules per day for 30 days. Patients of the comparison group (n = 30) had ED correction without using the drug Pravenor® Forte. The diagnosis of ED was established by studying the anamnesis, objective clinical and laboratory and specialized examination. Results. Prescription of the drug Pravenor® Forte significantly increased the indices of ICEF: erection achievement - by 89.4%, erection with sexual stimulation – 68.4%, and erection adequacy - by 66.7%. Erectile function increased by 86%, satisfaction with sexual intercourse by 84%, orgasm by 79.4%, libido by 84.9%, overall satisfaction by 50%. The patients of the comparison group had no significant change in ICEF parameters. Conclusion. The drug Pravenor® Forte is effective, safe, convenient to use, which, combined with an affordable price, makes it advisable to prescribe it in ED therapy. Thanks to the multicomponent composition, Pravenor® Forte eliminates not only erectile dysfunction, but also symptoms of the inflammatory and dyshormonal genital diseases.
... This also impacts the relationship between sexual partners, including negatively affecting sexual desire and satisfaction of partners [4]. Furthermore, ED is considered an independent risk factor for the development of metabolic syndrome, cardiovascular disease and type 2 diabetes mellitus, sharing common underlying mediators, and therefore ED is considered an increased mortality risk [5][6][7]. As psychological, endocrine, immune and metabolic interactions underlie the pathogenesis [1], ED is considered a multidimensional and complex pathology [4]. ...
... Complementary and alternative medicines, including dietary supplements and herbal remedies, are increasingly being used for treatment of ED, particularly through over-the-counter and internet sources [6,13,15,16]. These can be described as 'a group of diverse medical and healthcare systems, practices, and products that are not presently considered to be part of conventional medicine' [17,18]. ...
... Up to 718 plant species are used in traditional medicine as aphrodisiacs, compounds that increase sexual arousal, libido, potency (erection) and/or sexual pleasure [13,19]. Top selling products on the market include items containing the herbs Panax ginseng (Korean ginseng), Tribulus terrestris (Tribulus), Epimedium gradiflorum (Horny goat weed), Lepidium meyenii (Maca), Ginkgo biloba (Ginkgo), Eurycoma longifolia Jack (Tongkat ali), and Pausinystalia johimbe (yohimbine), and nutraceuticals such as B complex vitamins, zinc, trace minerals, L-arginine, aspartate and dehydroepiandrosterone (DHEA) [6,15,20,21]. ...
Article
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Objectives: To systematically review and discuss the current evidence from placebo-controlled clinical trials that investigated the use of alternative medicines and herbal remedies in the management of erectile dysfunction (ED). Methods: A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-based systematic review using specific keyword combinations was conducted on the PubMed and Scopus databases. Randomised controlled trials investigating herbal medicine in at least one group and using the International Index of Erectile Function (IIEF) as an outcome in patients primarily diagnosed with ED were included for review. Results: Following the literature search, screening and eligibility analysis, a total of 42 articles were included. The 42 articles were categorised as single herb extractions (n = 14), combination herbal formula (n = 5), combination of herbal formula and non-herbal nutraceuticals (n = 7), non-herbal nutraceuticals (n = 5), acupuncture and moxibustion (n = 2), diet and nutrition (n = 3), exercise (n = 5), and topical treatments (n = 1). Based on the results, Korean ginseng, Pygnogenol and Prelox, Tribulus terrestris, Lepidium meyenii, L-arginine, acupuncture and lifestyle interventions were the more predominantly investigated treatments interventions for ED. Conclusions: Panax ginseng, Pygnogenol, Prelox and Tribulus terrestris have promising evidence as herbal products, alongside L-arginine as a nutritional supplement, for ED based on IIEF outcomes, and warrant further clinical investigation. The mechanisms of action remain unclear, but each of these appears to in part increase nitric oxide synthesis. Importantly, improved diet and exercise should be considered, particularly in patients with obesity or diabetes mellitus.
... Allerdings ist Vorsicht geboten bei über das Internet freikäu ichen und meist als natürlich angepriesenen Präparaten und Nahrungsergänzungsmitteln. Diese beinhalten häu g ungeprü e Substanzen in einer nicht de nierten Dosierung, die Sexualhormone beein ussen und mit anderen Arzneimitteln interagieren können. In einer aktuellen Studie enthielten 80 % der untersuchten Präparate nicht deklarierte PDE5i [23]. [24,25]. ...
... Kritisch zu sehen sind potenzielle Nebenwirkungen wie hypertensive Blutdruckschwankungen, vermehrtes Schwitzen, Kopfschmerzen, Angststörungen und manische Episoden, aber auch die stark variable orale Bioverfügbarkeit [27]. Das Präparat ist rezeptp ichtig und bei Patienten, die Antidepressiva oder ZNS-Stimulanzien einnehmen, kontraindiziert [23]. ...
... Allerdings zeigte eine aktuelle Studie an 100 ED-Patienten ohne vorherige erapie nach alleiniger Einnahme von 800 mg TT über einen Monat, keinen signikanten Vorteil von TT gegenüber Placebo [45]. Der fehlende Vorteil und Berichte über beträchtliche Nebenwirkungen wie Hepatonephrotoxizität bei hohen Dosierungen lassen vor der Anwendung warnen [23,46]. ...
Article
Trotz wirksamer Verfahren sind Patienten mit erektiler Dysfunktion unter Therapie häufig unzufrieden. Gründe sind unter anderem die Nebenwirkungen der einzelnen Wirkstoffe, die meist selbst zu tragenden Kosten, die Informationsflut des Internets mit seinen Versprechungen und der Verlust von Spontanität bei einer symptomatischen Therapie. Dieser Artikel stellt alternative Optionen und in den Algorithmen der täglichen Praxis oft weniger beachtete Therapieansätze vor und durchleuchtet diese anhand der aktuellen Datenlage kritisch.
... Of note, it is the most studied ingredient found in online ED supplements and the most common amino acid included in men's health supplements [45,46]. L-Arginine has the ability to increase systemic concentrations of NO when taken in supraphysiologic doses [47]. The importance of dosing was first seen in the earliest trials evaluating its efficacy. ...
... Ginseng Ginseng is one of the most extensively studied nutraceuticals in human sexual health and is the most common ingredient found in top-selling erectile dysfunction supplements [45,47]. Physiologically, it has demonstrated an ability to increase penile blood flow by increasing activity of NOS, amplifying production of NO. ...
Article
Full-text available
Purpose of Review To highlight and review encouraging preliminary studies behind several alternative products and interventions for erectile dysfunction (ED). Recent Findings Alternative treatments for ED are becoming more prevalent with increased consumer interest. “Natural” products are sold online, and numerous clinics offer various off-label and investigational interventions. These alternative treatments have demonstrated varying degrees of efficacy in randomized trials and meta-analyses, but none of these interventions has robust enough evidence to be considered first-line therapy. These treatments may find a role in combination with guideline treatments or may be used in novel penile rehabilitation research protocols. Summary With growing interest in alternative treatment for men’s health, an awareness of the literature is imperative for patient counsel. Alternative treatments, like l-arginine, have a growing body of evidence for efficacy in combination with PDE5i, and low-intensity shock wave therapy and stem cell therapy continue to demonstrate encouraging outcomes in ED trials.
... Cui and colleagues have investigated the ingredients of the 30 best selling products for improving male sexual health. 74 They found up to 33 ingredients in 1 product. In this comprehensive review, the authors have tried to identify scientifically based information on the 20 most frequently used active ingredients (such as ginseng, zinc, vitamin B, L-arginine, Maca, dehydroepiandrosterone etc) of these combination products. ...
... The sobering conclusion of this work was that the scientific data on the effectiveness of the individual substances investigated were generally of low quality at that time. 74 In our investigations, we focus on only a few individual active substances for which randomized and controlled studies are available and whose presumed mechanism of action is consistent with the pathophysiology of erectile dysfunction. Certainly, further naturalzeuticals with erection promoting effects can be found in the medical literature, but detailed analysis of further substances would go beyond the scope of this overview. ...
Article
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Introduction Up to 50% of all men over 50 years of age suffer from erectile dysfunction. Since the late 1990s erectile dysfunction has been treated mostly with phosphodiesterase 5 inhibitors (PDE5I). Over the past 20 years, numerous scientific findings on the development of erectile dysfunction have been collected, which have so far received little attention in the treatment of erectile dysfunction. Objectives The objectives of this study were to review the existing medical literature on erectile dysfunction regarding physiology, pathophysiology, and especially therapeutic options beyond treatment with PDE5I and to enable a more effective and especially sustainable treatment for erectile dysfunction. Methods A literature review was performed by using PubMed from 1985 to 2020 regarding the physiology, pathophysiology, and treatment of erectile dysfunction. Results Since the end of the 1990s an enormous amount of knowledge has been gained about the physiology/pathophysiology of erection/erectile dysfunction. Based on these findings, numerous physical, drug, and holistic therapeutic options (beyond the application of PDE5I) have been developed for the treatment of erectile dysfunction. However, these are still relatively rarely used in the therapeutic concept of erectile dysfunction today. Conclusion Based on scientific findings of the last 20 years, there are numerous therapeutic approaches, including lifestyle modification, specific pelvic floor exercises, shock wave treatment, and the application of different supplements. The long-term treatment of erectile dysfunction should now go beyond the purely symptomatic use of PDE5I. W-D Beecken, M Kersting, W Kunert, et al. Thinking About Pathomechanisms and Current Treatment of Erectile Dysfunction—“The Stanley Beamish Problem.” Review, Recommendations, and Proposals. Sex Med Rev 2020;XX:XXX–XXX.
... Many DS are available on the market with various formulations, containing both nutrients and botanicals at different doses. Despite many authors demonstrating positive effects of some ingredients on semen parameters and fertility outcomes [8], many others have also shown a lack of efficacy and even potentially harmful side effects [9]. In a recent position statement, the Italian Society of Andrology and Sexual Medicine (SIAMS) summarized the state of the art on each single ingredient currently used in the andrological field. ...
... In general, there is still poor evidence in terms of large well-designed randomized and placebo-controlled trials availability, supporting the efficacy of nutraceutical products in the field of male reproductive health [54,55]. Nevertheless, these products are commonly administered to infertile patients [8,56]. Since a medical prescription is not necessary to purchase dietary supplements, subjects seeking fertility may have easy access to these products [10,57]. ...
Article
Full-text available
Dietary supplements (DS) represent a possible approach to improve sperm parameters and male fertility. A wide range of DS containing different nutrients is now available. Although many authors demonstrated benefits from some nutrients in the improvement of sperm parameters, their real effectiveness is still under debate. The aim of this study was to critically review the composition of DS using the Italian market as a sample. Active ingredients and their minimal effective daily dose (mED) on sperm parameters were identified through a literature search. Thereafter, we created a formula to classify the expected efficacy of each DS. Considering active ingredients, their concentration and the recommended daily dose, DS were scored into three classes of expected efficacy: higher, lower and none. Twenty-one DS were identified. Most of them had a large number of ingredients, frequently at doses below mED or with undemonstrated efficacy. Zinc was the most common ingredient of DS (70% of products), followed by selenium, arginine, coenzyme Q and folic acid. By applying our scoring system, 9.5% of DS fell in a higher class, 71.4% in a lower class and 19.1% in the class with no expected efficacy. DS marketed in Italy for male infertility frequently includes effective ingredients but also a large number of substances at insufficient doses or with no reported efficacy. Manufacturers and physicians should better consider the scientific evidence on effective ingredients and their doses before formulating and prescribing these products.
... The hypothesis is that these conditions, inducing an elevation of radical oxygen and nitrogen species, might impair spermatogenesis, both directly, through an alteration of a redox status, and indirectly, interfering with the hypothalamic-pituitary-testicular axis (8)(9)(10). A recent survey performed by American urologists on clinical practice in the treatment of idiopathic male infertility showed that 64.9% of caregivers use dietary supplements (DS), empirically in the face of a lack of recommendations on the guidelines for the use of these products (11). The European Food Safety Authority (EFSA) stated that "supplements aren't intended to treat or prevent diseases in humans or to modify physiological functions, but only to support specific physiological functions" (12). ...
... The European Food Safety Authority (EFSA) stated that "supplements aren't intended to treat or prevent diseases in humans or to modify physiological functions, but only to support specific physiological functions" (12). Anyway, all meta-analyses and guidelines citing the use of DS for male infertility advise to carefully evaluate the causes of infertility, as well as to accurately assess nutritional status (11,13). ...
Article
Full-text available
Content: Dietary supplements (DS) for male infertility marketed in Italy were evaluated for composition, concentration of ingredients, and recommended daily dose. A systematic review of literature identified ingredients potentially effective on sperm parameters and their minimal effective daily dose (mED). Objective: This study was conducted in order to critically evaluate the composition and efficacy of DS marketed in Italy. Design setting and participants: This was a systematic review of randomized controlled trials. Evidence acquisition: A formula allowed us to classify the expected efficacy of each DS, based on composition. Each DS was scored and included into three classes of expected efficacy: high, low, and none. Evidence synthesis: Among 24 supplements, 3 (12.5%) fall in high, 9 (37.5%) in lower, and 12 (50.0%) in no expected efficacy class. DS composition showed 36 substances, 18 with no literature on male fertility and 18 showing positive effect on sperm parameters, thus considered potentially active ingredients (PAI). All DS were mixtures of ingredients, containing from 2 to 17 different substances. Fifteen supplements (65.2%) contained at least 1 ingredient without evidence of efficacy and 21 formulations had PAI dosed below mED. Some PAI were associated to the improvement of specific sperm parameters. Conclusions: DS were usually blends of many substances that are frequently employed at negligible dose or without any evidence of efficacy on male reproduction. Some ingredients have been demonstrated to be effective on specific sperm parameters by RCTs. We report a list of ingredients with potential efficacy on specific sperm parameters, aimed to allow a tailored use of DS. Patient summary: The market of DS for male infertility offers products with potential efficacy in the improvement of sperm parameters but also many with uncertain effects. Based on current scientific literature, our study can help in the choice of DS that are more likely to be effective on specific sperm alterations, so providing the best supplementation for each patient.
... Many DS are available on the market with various formulations, containing both nutrients and botanicals at different doses. Despite many authors have demonstrated positive effects of some ingredients on semen parameters and fertility outcomes [8], many others also showed the lack of efficacy and even potentially harmful side effects [9]. In a recent position statement, the Italian Society of Andrology and Sexual Medicine (SIAMS) summarized the state of the art on each single ingredient currently used in the andrological field. ...
... Nevertheless, these products are commonly administered to infertile patients [8]. ...
Preprint
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Background: Dietary supplements (DS) represent a possible approach to improve sperm parameters and male fertility. A wide range of DS containing different nutrients is now available. Although many authors demonstrated benefits from some nutrients in male infertility, their real effectiveness is still under debate. The aim of this study was to critically review the composition of DS using the Italian market as sample. Materials & Methods: Active ingredients and their minimal effective daily dose (mFED) were identified through literature search. Thereafter, we created a formula to classify the expected efficacy of each DS. Considering active ingredients, their concentration and the recommended daily dose, DS were scored into three classes of expected efficacy: higher, lower and none. Results: Twenty-one DS were identified. Most of them had a large number of ingredients, frequently at doses below mFED or with unproven efficacy. Zinc was the most common ingredient of DS (70% of products), followed by selenium, arginine, coenzyme Q and folic acid. By applying our scoring system, 9.5% of DS fell in higher class, 71.4% in lower class and 19.1% in the class with no expected efficacy. Conclusions: DS marketed in Italy for male infertility frequently include effective ingredients but also a large number of substances at insufficient dose or with no proven efficacy. Manufacturers and physicians should better consider the scientific evidence on effective ingredients and their doses before formulating and prescribing these products.
... Plant-derived products have been used for the management of ED for a long time, and over 15% of men use natural-based therapies (2). Yohimbine, Korean ginseng, and ginkgo are popular exam-ples used as male sexual performance enhancers in traditional medicine (3). Previous clinical trials with Yohimbine demonstrated that the combination with L-arginine was effective in improving erectile function in patients with mild to moderate ED (4). ...
Article
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Cinnamomum cassia (Cinnamon) is a well-known traditional medicine with therapeutic benefits for centuries. We evaluated the effects of cinnamon essential oil (CEO) and its main component cinnamaldehyde (CA) on human corpus cavernosum (HCC) and rat CC. The essential oil of cinnamon was analyzed for the confirmation of the oil profile. HCC specimens from patients undergoing penile prosthesis surgery (age 48-69 years) were utilized for functional studies. In addition, erectile responses in anesthetized control and diabetic rats were evaluated in vivo after intracavernosal injection of CEO and CA, and rat CC strips were placed in organ baths. After precontraction with phenylephrine (10μM), relaxant responses to CEO and CA were investigated. CA (96.9%) was found as the major component. The maximum relaxation responses to CEO and CA were 96.4±3.5% and 96.0±5.0% in HCC and 97.5±5.5% and 96.8±4.8% in rat CC, respectively. There was no difference between control and diabetic rats in relaxation responses to CEO and CA. The relaxant responses obtained with essential oil and CA were not attenuated in the presence of nitric oxide synthase (NOS) inhibitor, and soluble guanylate cyclase inhibitor (sGS) in CC. In vivo, erectile responses in diabetic rats were lower than in control rats, which was restored after intracavernosal injection of CEO and CA. CEO and CA improved erectile function and relaxation of isolated strips of rat CC and HCC by a NO/cGMP-independent mechanism. Further investigations are warranted to fully elucidate the restorative effects of CEO and CA on diabetic erectile dysfunction.
... Currently, the United States market contains more than 85,000 supplement products and there are concerns about safety, quality assurance, and ingredient misidentification [4]. The evidence behind these supplements is also often conflicting and employ diverse research supports and types of evidence [4][5][6]. The estimated prevalence of hypogonadism in men aged 45 years and older in America is 39% [7]. ...
... До найбільш популярних нутрієнтів належать екстракти жень шеню, якірців сланких, йохімбе, маки, гінкго білоба, бур'яну рогової кози, пажитнику сінного, цинк, вітамін В та L аргінін. Зазвичай у дієтичних добавках (ДД) містяться різноманітні комбінації цих нутрієнтів, а їхня кількість в одній добавці може налічувати декілька десятків [4][5][6]. ...
Article
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The objective: assessment of tolerability and effect of dietary supplement (DS) Testers on the parameters of erectile function provided that within 30 days, 2 capsules per day. Patients and methods. An open study of the effectiveness and tolerability of the DS Testostam (1 capsule of 500 mg: 350 mg of the Tribulus terrestri extract / 150 mg of the Pausinystalia yohimbe extract), ingested 1 capsule twice a day for 30 days, in 30 patients aged 53±5 years with moderate erectile dysfunction (initial EF-IIEF = 18,0±0,09 points). Results. It was established that the DS Testostam clinically and statistically significantly increases the average total values of domains characterizing the erection (by 11 points), sexual desire (3 points), orgasm (6 points) and satisfaction with sexual intercourse (5 points). DS Testostam has good tolerance: 5 (16,7%) patients experienced undesirable reactions, including 2 cases of transient increase in blood pressure (less than 150/95 mm Hg) and 3 cases of stool loosening. All registered adverse events were mild and did not require the abolition of DS. Conclusion. DS Testostam can be used in urological practice to correct sexual disorders in men.
... Multiple factors may account for the relative paucity of evidence-based reports regarding effects of supplements on sexuality. First, unlike prescription medications that necessarily undergo tests for both safety and efficacy prior to their approval for the general public [2••], dietary supplement manufacturers in the USA have no obligation to demonstrate efficacy in their products under the 1994 Dietary Supplement Health and Education Act (DSHEA) [3,4], eliminating many of the requirements for validating evidence. Second, pharmaceutical companies that support research to bring patented drugs to market have little incentive to test herbal supplements, as the substance itself cannot be patented, but only the preparation and/or delivery method. ...
Article
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Purpose of Review In this update on plant-derived supplements, we provide a general introduction regarding the status and interest in phytochemicals for sexual health, indicating both progress and problems with past and current research. Recent Findings We summarize the development and current status of two well-known plant-derived supplements, using them as case studies for understanding some of the problems associated with the study of such supplements on sexual health. Summary We interpret the current situation regarding plant-derived supplements, identify common sources/journals for information about medicinal herbs for sexual health, identify supplements that are garnering increasing attention within the research community, and discuss the larger potential and pitfalls associated with this domain of research.
... Oysters are excellent aphrodisiacs, rich in taurine and zinc that have a cardioprotective effect, nerve transmission, and stimulate the male reproductive system [66,67] 27. Epimedium extract (horny goat weed) ...
Article
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Erectile dysfunction (ED) or male impotence is described as an inability to maintain penile erection primarily endothelial and neuronal dysfunction which is partly characterized by decreased production of nitric oxide (NO). Male impotence can be caused by androgen deficiency in aging men, atherosclerosis, diabetes mellitus, spinal cord injury, high level of cholesterol, hypertension, prostate surgery, prostate and heart disease, penis anatomical deformity, social and psychological conditions as unhappy marital relationship, depression, and stress. Aphrodisiac is a drink or food that arouse sexuality. It can be categorized into three groups according to their action mode as follows: increase sexual pleasure substances, increase libido substances (arousal, sexual desire), and increase sexual potency (erection effectiveness). Various extracts of medicinal plants and orally active drugs such as vardenafil, sildenafil, and tadalafil are used to increase arterial blood flow for treating (ED) in southwest Asia. Hence, this paper review focuses on medicinal plants used as aphrodisiacs for scientific validation and management of erectile dysfunction (ED).
... The global sexual-function supplement industry likely generates tens of millions, if not billions, of dollars yearly. (5)(6)(7) Despite their widespread use, dietary supplements for weight loss, muscle building, and sexual function are not medically recommended and have been shown to be ineffective in many cases (8)(9)(10) and to pose serious health risks to consumers due to adulteration with banned substances, prescription pharmaceuticals, and other dangerous chemicals. (11)(12)(13) In fact, the U.S. ...
Article
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Dietary supplements sold for weight loss (WL), muscle building (MB), and sexual function (SF) are not medically recommended. They have been shown to be ineffective in many cases and pose serious health risks to consumers due to adulteration with banned substances, prescription pharmaceuticals, and other dangerous chemicals. Yet no prior research has investigated how these products may disproportionately burden individuals and families by gender and socioeconomic position across households. We investigated household (HH) cost burden of dietary supplements sold for WL, MB, and SF in a cross-sectional study using data from 60,538 U.S. households (HH) in 2012 Nielsen/IRi National Consumer Panel, calculating annual HH expenditures on WL, MB, and SF supplements and expenditures as proportions of total annual HH income. We examined sociodemographic patterns in HH expenditures using Wald tests of mean differences across subgroups. Among HH with any expenditures on WL, MB, or SF supplements, annual HH first and ninth expenditure deciles were, respectively: WL $5.99, $145.36; MB $6.99, $141.93; and SF $4.98, $88.52. Conditional on any purchases of the products, female-male-headed HH spent more on WL supplements and male-headed HH spend more on MB and SF supplements compared to other HH types (p-values<0.01). High-income ($30,000<annual income<$100,000), compared to low-income (annual income<$30,000) HH, spent more on all three supplements types (p-values<0.01); however, proportional to income, low-income HH spent 2–4 times more than high-income HH on WL and MB supplements (p-values<0.01). Dietary supplements sold for WL, MB, and SF disproportionately burden HH by income and gender.
... A collection of dietary supplements (n = 25) containing ingredients asso- ciated with sexual enhancement20,[29][30][31][32][33]were obtained for use as matrix blanks to determine if these ingredients interfere with the assay. Thedietary supplements were purchased from 8 sources participating in a good manufacturing practice audit program managed by NSF Interna- tional or dietary supplement verification program by USP. ...
Article
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Products marketed as dietary supplements for sexual enhancement are frequently adulterated with phosphodiesterase-5 (PDE5) inhibitors, which are erectile dysfunction drugs or their analogs that can cause adverse health effects. Due to widespread adulteration, a rapid screening assay was developed to detect PDE5 inhibitors in adulterated products. The assay employs fluorescence detection and is based upon measuring inhibition of PDE5 activity, which is the pharmacological mechanism shared among the adulterants. Initially, the assay reaction scheme was established and characterized, followed by analysis of nine representative PDE5 inhibitors (IC50, 0.4–4.0 ng mL–1), demonstrating sensitive detection in matrix-free solutions. Next, dietary supplements serving as matrix blanks (n = 25) were analyzed to determine matrix interference and establish a threshold value; there were no false positives. Finally, matrix blanks were spiked with nine individual PDE5 inhibitors, along with several mixtures. All nine adulterants were successfully detected (≤ 5 % false negative rate; n = 20) at a concentration of 1.00 mg g–1, which is over five times lower than concentrations commonly encountered in adulterated products. A major distinction of the PDE5 inhibition assay is the ability to detect adulterants without prior knowledge of their chemical structures, demonstrating a broad-based detection capability that can address a continuously evolving threat of new adulterants. The PDE5 inhibition assay can analyze over 40 samples simultaneously within 15 min, involves a single incubation step and simple data analysis, all of which are advantageous for combating the widespread adulteration of sex enhancement products.
... Currently, the United States market contains more than 85,000 supplement products and there are concerns about safety, quality assurance, and ingredient misidentification [4]. The evidence behind these supplements is also often conflicting and employ diverse research supports and types of evidence [4][5][6]. The estimated prevalence of hypogonadism in men aged 45 years and older in America is 39% [7]. ...
Article
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The objective was to study available evidence for ingredients of popular over-the-counter testosterone and erectile dysfunction (ED) supplements. The top 16 male testosterone and 16 ED supplements in the USA were identified from the most popular online retailers: A1 Supplements, Amazon, Vitamin Shoppe, and Walmart. In total, 37 ingredients were identified and PUBMED online database was reviewed for randomized-controlled trials (RCT) studying their efficacy. Ingredients were categorized based on evidence quantity using an adapted version of the American Heart Association scoring system. In total, 16 ingredients from testosterone supplements and 21 from ED supplements were identified. Tribulus, Eurycoma longifolia, Zinc, L-arginine, Aspartate, Horny goat weed, and Yohimbine were most common. In all, 105 RCTs studying the identified ingredients were found. No whole supplement products have published RCT evidence. 19% of ingredients received an A grade for strong positive evidence with net positive evidence in two or more RCTs. In total, 68% received C or D grades for contradicting, negative, or lacking evidence. Overall, 69% of ingredients in testosterone supplements and 52% of ingredients in ED supplements have published RCT evidence. Many male supplements claim to improve testosterone or ED parameters; however, there is limited evidence, which should be considered when counseling patients.
... Учитывая известный фармакологический потенциал ряда признанных в мире субстанций, большая часть ком бинированных стимуляторов эрекции представлена ком позитами растительных экстрактов, биологически актив ных веществ, аминокислот, витаминов и т.д. [6]. ...
... Many cultures worldwide accept the use of natural products and herbal remedies for the improvement of male sexual health 73,74 ; however, many of these so-called "natural" products that claim to improve sexual function have been found to contain undisclosed amounts of prescription pharmaceuticals. A study testing readily available products found PDE5-I or its analogs in 81% of the samples tested, 20% of which contained >110% the highest approved dosage. ...
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Prostate cancer is one of the most prevalent cancers and the second leading cause of cancer-related deaths in men in the United States. A large number of patients undergo radiation therapy (RT) as a standard care of treatment. However, radiation therapy causes erectile dysfunction (RiED) due to late side effects after RT that significantly affects quality of life of prostate cancer patients. Within 5 years of RT, approximately 50% of patients could develop RiED. Based on the past and current research findings and number of publications from our group, the precise mechanism of RiED is under exploration in detail. Recent investigations have shown prostate RT induces significant morphologic arterial damage with aberrant alterations in internal pudendal arterial tone. Prostatic RT also reduces motor function in the cavernous nerve which may attribute to axonal degeneration may contributing to RiED. Furthermore, the advances in radiogenomics such as radiation induced somatic mutation identification, copy number variation and Genome Wide Association studies has significantly facilitated identification of biomarkers which could be used to monitoring radiation induced late toxicity and damage to the nerves. Thus, genomic and proteomic based biomarkers could greatly improve treatment and minimize arterial tissue and nerve damage. Further, advanced technologies like proton beam therapy that precisely target tumor, and significantly reduce off-target damage to vital organs and healthy tissues. In this review we summarize recent advances in RiED research and novel treatment modalities for RiED. We also discuss the possible molecular mechanism involved in the development of RiED in prostate cancer patients. Further, we discuss various readily available methods as well as novel strategies like stem cell therapies, shockwave therapy, nerve grafting with tissue engineering, and nutritional supplementations might be used to mitigate or cure sexual dysfunction following radiation treatment.
... Despite this, numbers of dietary supplements (DS) have been suggested to ameliorate sperm parameters and male fertility. Most contain a large number of ingredients, often supported by poor scientific evidence or below their minimal effective daily dose (13). Zinc is the ingredient commonly found, followed by selenium, arginine, coenzyme Q, and folic acid. ...
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Several studies suggested that male's diet affects fertility. This cross-sectional analysis from a prospective cohort study aims to explore the relation between antioxidants intake and sperm parameters in sub-fertile couples referring to a Fertility center. Socio-demographic characteristics, health history, lifestyle habits, and diet information were obtained. A semen sample was analyzed to proceed with assisted reproduction. Three hundred and twenty-three men were enrolled: 19.1% had semen volume (SV) < 1.5 mL, 31.4% sperm concentration (SC) < 15.0 mil/mL, 26.8% sperm motility < 32%, and 33.0% had total sperm count (TSC) < 39.0 mil. Higher levels of α-carotene were associated to lower risk of low SC [4th vs. 1st quartile, adjusted OR (aOR) 0.43, 95% CI 0.20–0.91) and low TSC (aOR 0.46, 95% CI 0.22–0.95). Higher intake of β-carotene was inversely associated with risk of low TSC. Lycopene intake was associated with higher risk for these conditions (aOR 2.46, 95%CI 1.01–5.98, SC), and (aOR 3.11, 95%CI 1.29–7.50, TSC). Risk of low semen volume was lower in men with higher level of vitamin D intake (aOR 0.25, 95%CI 0.09–0.66)]. Further research, especially, well-designed randomized clinical trials (RCT), is needed to understand how diet modifications may have a role in modulating male fertility and fecundability.
... A number of plants have been used as male sexual 95 performance enhancers in traditional systems of medicine 96 in different countries and different cultures [9]. Nowadays, 97 a variety of herbal extracts are highly publicized by media 98 and widely used by men with ED [10]. Such products have 99 been classified by the Dietary Supplement Health and 100 Education Act as dietary supplements [11], meaning that 101 the rigorous testing adopted for pharmaceutical drugs to 102 reach the market does not apply [11,12]. ...
Article
Purpose: Erectile dysfunction (ED) is a common condition that significantly affects quality of life and interpersonal relationships. Objective: Our objective was to perform a systematic review and meta-analysis to evaluate the efficacy of herbal dietary supplements in the treatment of ED. Materials and methods: We searched five databases to identify randomized controlled trials (RCTs) that evaluated the clinical efficacy of herbal medicines in ED. Quality was assessed and risk of bias was estimated using the Jadad score and the Cochrane risk-of-bias tool. Results: In total, 24 RCTs, including 2080 patients with ED, were identified. Among these, 12 evaluated monopreparations (five ginseng [n = 399], three saffron [n = 397], two Tribulus terrestris [n = 202], and one each Pinus pinaster [n = 21] and Lepidium meyenii [n = 50]), seven evaluated formulations (n = 544), and five investigated dietary supplements in combination with pure compounds (n = 410). Ginseng significantly improved erectile function (International Index of Erectile Function [IIEF]-5 score: 140 ginseng, 96 placebo; standardized mean difference [SMD] 0.43; 95% confidence interval [CI] 0.15-0.70; P < 0.01; I2 = 0), P. pinaster and L. meyenii showed very preliminary positive results, and saffron and T. terrestris treatment produced mixed results. Several herbal formulations were associated with a decrease of IIEF-5 or IIEF-15, although the results were preliminary. The quality of the included studies varied, with only seven having a prevalent low risk of bias. The median methodological quality Jadad score was three out of a maximum of five. Adverse events were recorded in 19 of 24 trials, with no significant differences between placebo and verum in placebo-controlled studies. Conclusions: Encouraging evidence suggests that ginseng may be an effective herbal treatment for ED. However, further, larger, and high-quality studies are required before firm conclusions can be drawn. Promising (although very preliminary) results have also been generated for some herbal formulations. Overall, more research in the field, adhering to the CONSORT statement extension for reporting trials, is justified before the use of herbal products in ED can be recommended.
Article
Erectile dysfunction (ED) is a common sexual problem affecting many men irrespective of cultures, beliefs and nationalities. While medical therapy for ED has been revolutionized by the advent of oral phosphodiesterase type 5 inhibitors and intracavernosal injection of vasoactive agents, recent technological advances such stem cell therapy, low intensity shock wave and newer generation of penile prosthesis implant offer hope to men who do not respond to conventional medical therapy. In contrast, traditional and complementary medicine (TCM) focuses on the restoration and better overall bodily regulation with the use of various herbal and animal products as well as exercises to invigorate qi (energy) in vital organs. Western medicine involves an analysis of ED symptom and underlying causes that contribute to ED, while TCM emphases the concept of holism and harmonization of body organs to achieve natural sexual life. The following article reviews our current understanding regarding the philosophical approach, and evaluates the evidence surrounding various ED therapies between mainstream Western Medicine and TCM.
Chapter
Many cultures throughout history have passed down knowledge rumored to enhance sexual performance of both men and women including sexual techniques, foods, and nutritional supplements. Sexual techniques can take the form of stimulating certain aspects of the female anatomy and sexual positions such as stimulation of the Grafenberg “G” spot. Other techniques focus on the psychological aspects of sex including synchronization of orgasms and ejaculation prolongation. Cultures around the world have imbued foods as aphrodisiacs, in addition to herbs, plants, and other dietary supplements, collectively known as nutraceuticals. Among the more common ones are pomegranates, antioxidant rich foods, omega-3, basil, cardamom, garlic, watermelon, oysters, l-arginine, caffeine, and dehydroepiandrosterone (DHEA). Herbs such as Chlorophytum borivilianum of the Indian subcontinent to Lepidium meyenii of the South American Andes have long been reported to have aphrodisiac qualities. Many of these products are rich in components that promote cardiovascular health, produce anti-inflammatory activity, cause vasodilatation and increase androgen levels—all important factors in sexual performance. This chapter reviews the various sexual enhancement techniques, foods, and nutraceuticals and the evidence to support their use.
Article
Trotz wirksamer Verfahren sind Patienten mit erektiler Dysfunktion unter Therapie häufig unzufrieden. Gründe sind unter anderem die Nebenwirkungen der einzelnen Wirkstoffe, die meist selbst zu tragenden Kosten, die Informationsflut des Internets mit seinen Versprechungen und der Verlust von Spontanität bei einer symptomatischen Therapie. Dieser Artikel stellt alternative Optionen und in den Algorithmen der täglichen Praxis oft weniger beachtete Therapieansätze vor und durchleuchtet diese anhand der aktuellen Datenlage kritisch.
Article
Introduction, The aim of this systematic review was to evaluate the current evidence for the effectiveness of ginseng, Rutin and Moringa for treating erectile dysfunction. Methods, A broad search of the Scopus, PubMed, Cochrane and Web of Science databases was performed in complicance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. The following criteria were required for articles to be included in the review: English language; observational studies (cohort studies, case control/comparative studies, single-arm studies); randomized controlled trials; non-randomized comparative studies; case series; number of participants: ≥5 for case series or ≥5 patients per group for comparative studies. The Cochrane risk of bias (RoB) assessment tool for RCTs was used to assess the risk of bias of included studies. Results, Seven full-text articles were included in this review. All studies were randomized controlled trials. No studies on Rutin and Moringa alone matched the inclusion criteria. The methodological quality of the RCTs was variable. In all studies, the group treated with ginseng reported an improvement of erectile function (EF) compared to the control groups. IIEF and IIEF-5 were used to evaluate erectile function in six studies and in four of them, the improvement of the scores in the group treated with ginseng over the control group reached the statistical significance. Conclusion, This review suggests a positive effect of ginseng on EF in men. The association of ginseng along with other nutritional components with potential beneficial effects on ED appears promising and deserves further investigation in large randomized controlled trials.
Article
Trotz wirksamer Verfahren sind Patienten mit erektiler Dysfunktion unter Therapie häufig unzufrieden. Gründe sind unter anderem die Nebenwirkungen der einzelnen Wirkstoffe, die meist selbst zu tragenden Kosten, die Informationsflut des Internets mit seinen Versprechungen und der Verlust von Spontanität bei einer symptomatischen Therapie. Dieser Artikel stellt alternative Optionen und in den Algorithmen der täglichen Praxis oft weniger beachtete Therapieansätze vor und durchleuchtet diese anhand der aktuellen Datenlage kritisch.
Article
Introduction: Testosterone-boosting supplements (T-Boosters) are prominently featured on Amazon.com, with numerous dedicated pages and claims that they "naturally" increase testosterone levels. Aim: To evaluate the highest rated and frequently reviewed T-Boosters on Amazon.com to facilitate patient counseling regarding marketing myths, T-Booster formulations, and evidence for efficacy and safety. Methods: The Amazon marketplace was queried using the key words "testosterone" + "booster," with default search settings and ranking items based on relevance. The top 5 T-Boosters identified on July 22, 2018, were reviewed based on price, ratings, reviews, manufacturer details, and ingredients. Consumer reviews were categorized using core themes in the Androgen Deficiency in the Aging Male (ADAM) questionnaire as a proxy to understand T-Booster efficacy and reanalyzed after filtration of untrustworthy comments using ReviewMeta.com, a proprietary Amazon customer review analysis software. Main outcome measures: Quantitative and qualitative evaluation of T-Boosters on Amazon.com was performed. Results: The top 5 T-Boosters had an average ± SD of 2,761 ± 5,112 reviews and a rating of 4.56 ± 0.25 stars. 19 unique ingredients were identified across these T-Boosters, and literature review revealed 191 studies involving the 10 most common ingredients, of which 19% involved human subjects, 53% animal models, 15% in vitro studies, and 12% case reports or review articles. Among 37 human studies, 30% observed an increase in T levels, 3% a decrease, 46% no effect, and 22% were indeterminate. Analysis of top customer reviews from the first 2 pages of reviews for each supplement revealed differences in the ADAM score before and after ReviewMeta.com filtration. After filtration, there was a 91% decrease in users reporting increased libido, a 59% decrease in reports of increased energy, a 93% decrease in reports of improved strength/endurance, a 60% decrease in reports of improved erections, an elimination of reports of improved work performance, a 67% decrease in reports of improved sleep, and an 89% decrease in reports of improved sports ability. Clinical implications: Our study can serve as a guide for providers to counsel patients about the efficacy of popular online T-Boosters as well as the prevalence of disingenuous reviews associated with these products on online marketplaces like Amazon.com. Strengths & limitations: Strengths include the novel approach to assess consumers' perceptions and satisfaction of T-Boosters, as well as summary information that clinicians can provide patients. Limitations include selection bias, a small number of supplements analyzed, and the proprietary nature of the Amazon review analysis software. Conclusion: T-Boosters are easily available online. Our investigation revealed that limited human studies have evaluated T-Boosters, resulting in no definitive findings of efficacy. In the absence of additional human studies, patients should be cautioned before considering T-Boosters, given the availability of highly effective therapies approved by the Food and Drug Administration. Balasubramanian A, Thirumavalavan N, Srivatsav A, et al. Testosterone Imposters: An Analysis of Popular Online Testosterone Boosting Supplements. J Sex Med 2019;16:203-212.
Article
Introduction Erectile dysfunction supplements (ED-Ss) are featured on online marketplaces like Amazon.com, with dedicated pages and claims that they naturally treat ED. However, their efficacy and safety are largely unknown, limiting the ability to counsel patients regarding their use. Aim To evaluate the highest rated and most frequently reviewed ED-Ss on Amazon.com to facilitate patient counseling regarding marketing myths, ingredient profiles, and evidence for product efficacy and safety. Methods The Amazon marketplace was queried using the key term “erectile dysfunction” with default search settings and ranking items based on relevance. The top 6 ED-S products identified on September 29, 2018, were reviewed based on price, ratings, reviews, manufacturer, and ingredients. Consumer reviews were categorized using subtopics within the International Index of Erectile Function (IIEF) questionnaire to better understand ED-S efficacy and then reanalyzed following filtration of untrustworthy comments using ReviewMeta.com, a proprietary Amazon review analysis software. Outcomes Quantitative and qualitative evaluation of ED-S products sold on Amazon.com. Results The top 6 ED-Ss had an average of 2,121 ± 1,282 reviews and a mean rating of 3.92 ± 0.42 stars. A total of 21 ingredients were identified in these ED-Ss. Ginseng, horny goat weed, L-arginine, and tongkat ali were the most popular ingredients included in the analyzed products. Our literature review identified 413 studies involving the 21 identified ingredients, of which 59 (16%) involved human subjects. Among these 69 human studies, only 12 (17%) investigated supplement ingredients individually and reported improvement in ED. Analysis of top-ranked customer reviews from the first 2 pages of reviews for each supplement revealed differences in IIEF scores before and after ReviewMeta.com filtration. After filtration, we observed a 77% decrease in reviews reporting improved erection strength, an 83% decrease in reviews reporting improved ability to maintain erection, a 90% decrease in reviews reporting increased sexual satisfaction, an 88% decrease in reviews reporting increased enjoyment with intercourse, and an 89% decrease in reviews reporting increased erection confidence. Strengths & Limitations Study strengths include a novel approach to ascertaining consumers’ perceptions and satisfaction with ED-Ss and practical summary information that clinicians can provide to patients. Limitations include selection bias, the small number of supplements analyzed, and the proprietary nature of the Amazon review analysis software. Conclusions Our investigation revealed that human studies evaluating the efficacy of ED-S ingredients are limited and have yielded no definitive findings of the effects on ED. Patients considering ED-S use should receive appropriate counseling, given the prevalence of disingenuous reviews and the ready availability of Food and Drug Administration–approved drug therapies. Balasubramanian A, Thirumavalavan N, Srivatsav A, et al. An Analysis of Popular Online Erectile Dysfunction Supplements. J Sex Med 2019;16:843–852.
Article
Aphrodisiacs, libido or erection-enhancing supplements are widely available on the internet. The beneficial effects are controversial. Forensic toxicologists should be aware of the potential toxicities of these products because they could be given in cases of drug-facilitated sexual assault. This article presents a case report in which the defendant claimed to have administered an aphrodisiac to several women who showed strong symptoms of intoxication after consumption in an alcoholic drink. A literature research was carried out for potential substances sold in these aphrodisiac products. Synthetic substances as well as products of herbal or animal origin can be the ingredients. The main products that could cause intensive side effects and intoxication are phosphodiesterase V inhibitors (declared or undeclared on packaging), yohimbine, steroid hormones, flibanserin, gamma-hydroxybutyric acid, Tribulus terrestris, Bufo Toad, Spanish fly or Horny Goat Weed. All other products used as aphrodisiacs and described herein show less potential side effects or no studies on side effects in humans were carried out.
Article
Introduction Erectile dysfunction (ED) is the inability to attain or sustain an erection for sexual intercourse. Affected men endorse difficulties with intimacy and feelings of guilt and shame. Although medical treatments are available, patients are reluctant to discuss ED with physicians and often use dietary supplements to attempt to treat their ED. As such, there is a need to better understand the effects of ingredients used in nutraceuticals for ED treatment. Objectives To summarize the literature on the efficacy and safety of the most common ingredients used in ED supplements. Methods 10 of the most common ingredients in ED supplements were reviewed using PubMed-indexed literature to assess their efficacy and safety in treating ED. Key findings were summarized to include historical use, active ingredients, prior animal studies, human studies, and toxicity. Results Nutraceuticals used in ED treatment include a variety of ingredients. Although L-arginine is a safe supplement with clinical data supporting improved erectile function, limited data exist on the efficacy of other ingredients in the treatment of ED. Conclusion Despite the growing use of supplements for treatment of sexual dysfunction, ED supplements remain poorly studied, with limited data demonstrating efficacy of individual ingredients. Further study is required to definitively determine the efficacy of nutraceuticals in ED treatment. Srivatsav A, Balasubramanian A, Pathak UI, et al. Efficacy and Safety of Common Ingredients in Aphrodisiacs Used for Erectile Dysfunction: A Review. J Sex Med 2020;XX:XXX–XXX.
Article
Introduction Efforts to understand and unlock the body's potential for regeneration have increased dramatically in recent years. So-called “biohacking” hopes to improve functionality and reverse disease processes. Objectives This review will seek to summarize the available data for the use of platelet-rich plasma, cellular therapies, and other novel therapeutics within sexual medicine. Methods The PubMed database search was performed using the keywords “Stem cell therapy in Erectile dysfunction (ED)”, “Gene therapy in ED”, “Novel therapeutics for ED”, and “Biohacking”. Popular news articles for regulation of stem cell therapy were reviewed. Results Research efforts have managed to produce an array of novel therapeutics, including stem cell therapy and platelet-rich plasma. Although the use of these items has been largely focused within specialties other than urology, applications involving sexual medicine have been documented and appear to be increasing. Conclusion Despite evidence of these technologies being adopted within clinical practices as revenue-generators, quality data to support efficacy are quite limited. Matz EL, Scarberry K, Terlecki R, Platelet-Rich Plasma and Cellular Therapies for Sexual Medicine and Beyond. Sex Med Rev 2020;XX:XXX–XXX.
Article
Erectile dysfunction affects an increasing number of men. The mainstays of management include oral medications, local erectogenic agents, and surgical placement of prosthetic devices. Newer technologies such as stem cell and gene therapy have been investigated as a means to restore spontaneous erectile capacity. Mesenchymal stem cells are thought to produce a local immunomodulatory and pro-repair milieu at the area of injury or needed repair. Gene therapy involves targeting the erectogenic pathway to augment factors involved in producing a natural erection. Such therapies are considered experimental and should be used in the setting of a clinical trial with appropriate oversight.
Chapter
Erectile dysfunction (ED) is defined as an inability to achieve or maintain penile erection sufficiently enough for sexual performance. Sexual function involves an interplay between psychological, vascular, neurological, endocrine functions; thus the various etiologies of ED can be divided into psychosocial or organic causes. Current mainstays of treatment for ED are centered around enhancing levels of nitric oxide at the nerve terminal with pharmacologic agents such as phosphodiesterase inhibitors, followed by more invasive therapies such as intracavernosal injections and penile prosthesis. The market for supplements for ED has been growing in popularity and has warranted further investigation into mechanisms of action and efficacy. This chapter discusses several supplements that have been marketed as therapies for ED, their efficacies in clinical trials, as well as their mechanism of action on the biochemical level, safety profiles, and adverse effects.
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Viele Männer stehen noch immer auf natürliche Mittel gegen sexuelle Beschwerden. Nicht selten enthalten diese aber auch PDE-5-Hemmer — in weitgehend unkontrollierter Form und Dosierung.
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Erectile dysfunction (ED) worsens in patients with diabetes mellitus (DM) despite good control of blood glucose level with insulin. Recent studies imply that diabetic vascular stresses (e.g. oxidative stress) persist in spite of glucose normalization, which is defined as metabolic memory. Studies suggest that the interaction between advanced glycation end products (AGEs) and their receptor (RAGE) mediates the development of metabolic memory. To investigate the effects of the antioxidant icariside II plus insulin on erectile function in streptozotocin (STZ)- induced type 1 diabetic rats. Fifty 8-week-old Sprague-Dawley rats were randomly distributed into five groups: normal control, diabetic, insulin-treated diabetic, icariside II-treated diabetic, and insulin plus icariside II-treated diabetic. Diabetes was induced by a single intraperitoneal injection of STZ. Eight weeks after induction of diabetes, icariside II was administered by gastric lavage once a day (5 mg/kg) for 6 weeks; and 2-6 units of intermediate-acting insulin were given to maintain normal glycemia for 6 weeks. The main outcome measures were the ratio of intracavernous pressure (ICP) to mean arterial pressure (MAP); histology of penile endothelial cells and smooth muscle cells; neural nitric oxide synthase, AGEs and RAGE expression; malondialdehyde concentration; superoxide dismutase activity; and apoptosis index. Diabetic rats demonstrated a significantly lower ICP/MAP ratio, reduced penile endothelial cells, reduced smooth muscle cells, increased AGEs and RAGE, and increased apoptosis. Insulin and icariside II monotherapy partially restored erectile function and histological changes. However, the combination therapy group showed significantly better erectile parameters, cytological components and biochemistry, similar to those in the normal control group. These results suggest that, although insulin can effectively control glycemic levels, it does not completely alter the pathological changes in erectile tissues. Better efficacy could be expected with tight glycemic control plus the antioxidant icariside II. The proposed combination therapy might have the potential to eliminate metabolic memory by down-regulating the AGEs-RAGE-oxidative stress axis. © 2015 The Authors. Journal of Cellular and Molecular Medicine published by John Wiley & Sons Ltd and Foundation for Cellular and Molecular Medicine.
Article
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Herbal and nutritional supplements are more and more popular in the western population. One of them is an extract of an exotic plant, named Tribulus terrestris (TT). TT is a component of several supplements that are available over-the-counter and widely recommended, generally as enhancers of human vitality. TT is touted as a testosterone booster and remedy for impaired erectile function; therefore, it is targeted at physically active men, including male athletes. Based on the scientific literature describing the results of clinical trials, this review attempted to verify information on marketing TT with particular reference to the needs of athletes. It was found that there are few reliable data on the usefulness of TT in competitive sport. In humans, a TT extract used alone without additional components does not improve androgenic status or physical performance among athletes. The results of a few studies have showed that the combination of TT with other pharmacological components increases testosterone levels, but it was not discovered which components of the mixture contributed to that effect. TT contains several organic compounds including alkaloids and steroidal glycosides, of which pharmacological action in humans is not completely explained. One anti-doping study reported an incident with a TT supplement contaminated by a banned steroid. Toxicological studies regarding TT have been carried out on animals only, however, one accidental poisoning of a man was described. The Australian Institute of Sport does not recommend athletes' usage of TT. So far, the published data concerning TT do not provide strong evidence for either usefulness or safe usage in sport.
Article
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Introduction: The use of unlicensed food and herbal supplements to enhance sexual functions is drastically increasing. This phenomenon, combined with the availability of these products over the Internet, represents a challenge from a clinical and a public health perspective. Methods: A comprehensive multilingual assessment of websites, drug fora, and other online resources was carried out between February and July 2013 with exploratory qualitative searches including 203 websites. Additional searches were conducted using the Global Public Health Intelligence Network (GPHIN). Once the active constitutes of the products were identified, a comprehensive literature search was carried out using PsycInfo and PubMed. Results: The most common sexual enhancement products available on the Internet were identified. Their active ingredients included yohimbine, maca, horny goat weed and Ginkgo biloba. These four substances were reported with the occurrence of adverse events and the induction of psychological symptoms, such as mood changes, anxiety, and hallucinations as well as addictive behaviours. Conclusions: Uncontrolled availability of sexual enhancement products that contain potentially harmful substances is a major public health concern. The possible impact on population health, particularly among subjects with psychiatric disorders, usually at risk for sexual dysfunction, may be significant. This new trend needs to be extensively studied and monitored.
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Selenium (Se) is an essential element involved in normal gonadal development, gametogenesis, and fertilization. Molecular studies show that the gonads actively take up and store Se, most of which is incorporated in the glutathione peroxidase enzymes. We provide a systematic review of the original molecular studies, prospective observational data and randomized controlled trials on the role of Se in reproductive function conducted in the past 30 years. A critical appraisal of these findings suggests that Se supplementation produces a bell-shaped response curve, with negative effects observed for both low and high concentrations. The few available clinical trials support the use of Se supplementation (<200 μg/d) to improve male infertility, although their pre-treatment assessment of Se levels in enrolled subjects is inconsistent and their quality and size are insufficient to enable general recommendations. In females, a putative role in oocyte maturation and fertilization is suggested, but no large controlled trials have yet been performed. The role of Se supplementation on pregnancy outcomes is promising, and ongoing studies and meta-analysis should soon enable proper recommendations to be suggested. How best to assess Se in terms of cut-off value, sample type (serum, semen, other fluids) and the specific outcome of interest remains to be clarified. In the meantime, assessment of serum Se levels followed by low-dose replacement therapy when necessary is a reasonable approach to improve male idiopathic infertility and gestational outcome.
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Several reports have promoted the root-derived Korean red ginseng (KRG; Panax ginseng) as alternative treatment for erectile dysfunction (ED), and ginsenosides are known to be the principal active ingredients of ginseng. Recent studies showed that ginseng berries produce more ginsenosides than KRG; thus, we investigated the ability of the Korean ginseng berry extract GB0710 to relax the penile corpus cavernosum smooth muscle (CCSM) in this study. As a comparative control, the results were compared to those obtained using KRG. In addition, possible mechanisms of action for GB0710 were investigated. While KRG and GB0710 both displayed dose-dependent relaxation effects on precontracted rabbit CCSM in vitro, GB0710 was shown to be more potent than KRG. The GB0710-induced relaxation could be partially reduced by removing the endothelium. In addition, pre-treatment with several nitric oxide (NO) inhibitors significantly inhibited the relaxation of muscle strips. Furthermore, administration of GB0710 increased intracavernosal pressure (ICP) in a rat in vivo model in both a dose- and duration-dependent manner. Intracellular NO production in human microvascular endothelial cells could be induced by GB0710 and inhibited by N(G)-monomethyl-L-arginine. In conclusion, GB0710 had a greater relaxation effect on rabbit CCSM than did KRG extract, and increased ICP in a rat model in both a dose- and a duration-dependent manner. This relaxing effect might be mediated by NO production.Asian Journal of Andrology advance online publication, 27 May 2013; doi:10.1038/aja.2013.49.
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Intestinal microbiota metabolism of choline and phosphatidylcholine produces trimethylamine (TMA), which is further metabolized to a proatherogenic species, trimethylamine-N-oxide (TMAO). We demonstrate here that metabolism by intestinal microbiota of dietary l-carnitine, a trimethylamine abundant in red meat, also produces TMAO and accelerates atherosclerosis in mice. Omnivorous human subjects produced more TMAO than did vegans or vegetarians following ingestion of l-carnitine through a microbiota-dependent mechanism. The presence of specific bacterial taxa in human feces was associated with both plasma TMAO concentration and dietary status. Plasma l-carnitine levels in subjects undergoing cardiac evaluation (n = 2,595) predicted increased risks for both prevalent cardiovascular disease (CVD) and incident major adverse cardiac events (myocardial infarction, stroke or death), but only among subjects with concurrently high TMAO levels. Chronic dietary l-carnitine supplementation in mice altered cecal microbial composition, markedly enhanced synthesis of TMA and TMAO, and increased atherosclerosis, but this did not occur if intestinal microbiota was concurrently suppressed. In mice with an intact intestinal microbiota, dietary supplementation with TMAO or either carnitine or choline reduced in vivo reverse cholesterol transport. Intestinal microbiota may thus contribute to the well-established link between high levels of red meat consumption and CVD risk.
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Polyneuropathy in dry beriberi is known to be associated with vitamin B1 (thiamine) deficiency. Chronic alcoholism and prolonged nutritional deficiency may also result in peripheral neuropathy due to thiamine deficiency. However, while somatic erectile dysfunction is ohn caused by neurogenic abnormalities, to our knowledge no previous report describes the relationship of erectile dysfunction to thiamine deficiency and the role of this vitamin in the treatment of neurogenic impotence. We report on a man with an uncommon form of neurogenic impotence in whom serum pyruvate was elevated and vitamin B supplementation resulted in cure. CASE REPORT A 65-year-old man with a history of chronic alcoholism had erectile dysfunction 1 year in duration as well as symptoms of retrograde ejaculation and a weak stream. He was a nonsmoker and not on medication. Physical examination showed normal external genitalia and scrotal contents. Rectal examination demonstrated a normal prostate. The bulbocavernoSUB reflex was palpable and the pinprick sense was normal. Laboratory studies revealed normal electrolytes, creatinine, liver enzymes, glucose and testosterone but elevated serum pyruvate (106 pmolA., normal 34 to 100). Free uroflowmetry demonstrated a maximum flow rate of 6.4 ml. per second with voiding time 106 seconds and an interrupted curve (see figure). Pharmacological duplex scan showed normal peak flow velocity (29 cm. per second) before and after the administration of 25 mg. papaverine intracorporeally. Peak flow velocity greater than 25 cc per second and resistance index of 1 are considered normal vasculogenic function. Neurophysiological evaluation revealed normal bulbocavernosus reflex (35 msec.) and somatosensory evoked potentials
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Introduction: Several cases of adulteration of dietary supplements with tadalafil, sildenafil, and vardenafil, or their unapproved analogues have been reported worldwide. Mainly, the presence of the latter represents a serious health risk to consumers as their efficacy and toxic effects have not been assessed and may result in unpredictable adverse effects. Aim: To investigate the suspected adulteration with synthetic phosphodiesterase type 5 (PDE-5) inhibitors in a dietary supplement marketed in Argentina for the treatment of erectile dysfunction (ED). Methods: The content of the capsules of the dietary supplement (sample A) was analyzed by thin layer chromatography (TLC) and high-performance liquid chromatography (HPLC) diode-array detection. From the organic extract of sample A, a major compound was purified by column chromatography (CC). The isolated compound was identified by proton nuclear magnetic resonance (1H NMR) and carbon NMR (13C NMR), heteronuclear single quantum coherence, distortionless enhancement by polarization transfer (DEPT 135), electrospray ionization mass spectrometry, and ultraviolet, and infrared (Fourier transform infrared spectroscopy) spectroscopy. Main outcome measure: Proof of adulteration of herbal products with synthetic PDE-5 inhibitors. Results: By TLC and HPLC analysis, a major compound was detected in sample A organic extract. The purification of this extract by CC led to the isolation of a pure compound which was identified according to its spectral data as (6R,12aR)-2-amino-6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydropyrazino [1',2':1,6] pyrido [3,4-b] indole-1,4-dione or aminotadalafil. Conclusions: An unapproved PDE-5 inhibitor analogue, which was identified as aminotadalafil, has been detected in a dietary supplement. This study represents the first report in Latin America and one of the few independent studies of an adulteration with an unapproved PDE-5 inhibitor of an herbal product for ED treatment.
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Acute tubular necrosis (ATN), especially from toxic injury is frequently accompanied by tubular casts and crystals. Myeloma casts, myoglobin, red blood cell and granular casts are well described. However, bile casts in tubules are rarely seen. We describe a case of Tribulus terrestris toxicity in a young healthy male, presenting with severe hyperbilirubinemia followed by acute renal failure and bile containing casts in the tubules. Tribulus terrestris is an herb often used by athletes as a nutritional supplement for performance enhancement. Although it is thought to be relatively safe, serious side effects have been reported before. Our aim is to increase awareness of the potential toxicities of performance enhancing herbal medications. These are often sold over-the-counter and therefore casually used, especially by young healthy individuals. Beneficial effects are controversial. Under-reporting by patients and infrequent documentation by health-care providers can delay diagnosis. We elaborately describe the kidney biopsy findings in Tribulus terrestris toxicity, and also provide a concise overview of the spectrum of tubular casts and their staining patterns, found in various kidney diseases.
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Americans spend more than $32 billion a year on dietary supplements, which do not require premarketing approval before they reach store shelves. Under current law, the FDA must identify and remove dangerous supplements only after they have caused harm. Epidemiologists at the Centers for Disease Control and Prevention (CDC) recently confirmed what an astute liver-transplant surgeon in Honolulu already suspected: OxyElite Pro, a popular over-the-counter supplement, was responsible for a cluster of cases of severe hepatitis and liver failure.(1) Although patients began to develop severe hepatitis in May 2013, the Food and Drug Administration (FDA), whose job it is to remove dangerous supplements from store shelves, did not learn of the cases until mid-September, 4 months later. By February 2014, the CDC had linked 97 cases, resulting in 47 hospitalizations, three liver transplantations, and one death, to OxyElite Pro. . . .
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Objectives To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels. Design and methods Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way. Results The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914). Conclusions At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total testosterone.
Article
ABSTRACT Tribulus terrestris (TT) is a dicotyledonous herbal plant of the Zygophyllaceae family. In ancient medicine, extracts of the aerial parts and fruits have been used for its diuretic, tonic, and aphrodisiac properties. Today, TT is widely used by athletes and bodybuilders based on the belief, fueled by claims in marketing information, that it can enhance testosterone concentrations. To assess TT's effect on testosterone levels in human and animals, an electronic literature search out using seven databases and the patent database up to August 2013 was carried out. Randomized control trials, which included healthy human subjects ingesting TT as sole or combined supplement, along with animal studies with TT as a sole treatment across a number of species were included. Eleven studies met the inclusion criteria, including one patent application. The results showed that trials varied in duration, dosage and supplementation with TT as sole or combined treatment, rendering meta-analysis impossible. A limited number of animal studies displayed a significant increase in serum testosterone levels after TT administration, but this effect was only noted in humans when TT was part of a combined supplement administration. Literature available for the effectiveness of TT on enhancing testosterone concentrations is limited. Evidence to date suggests that TT is ineffective for increasing testosterone levels in humans, thus marketing claims are unsubstantiated. The nitric oxide release effect of TT may offer a plausible explanation for the observed physiological responses to TT supplementation, independent of the testosterone level.
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The quantity of adulterated sex supplements sold in the United States is staggering. One Utah manufacturer produced more than 1 million capsules a month of pharmaceutically tainted sexual enhancement supplements, which netted the company over $2 million in 3 years.⁵ Some men may choose these products to avoid the inconvenience, embarrassment, and cost of a visit to a physician. Other consumers may have contraindications to prescription PDE-5 inhibitors, such as sildenafil citrate (Viagra; Pfizer) or tadalafil (Cialis; Lilly USA), and turn to natural products because they perceive them to be safer alternatives to treating sexual troubles. In the United States, these sexual enhancement products are sold as dietary supplements and are legally permitted to make claims such as “enhances sexual performance” without evidence of efficacy or safety.⁶ To garner repeat customers, many manufacturers clandestinely add prescription medications to their products. But the US sales represent only a small fraction of the global market for adulterated pills—one study in Singapore found that 77% of “natural” sex supplements collected from informal markets contained undeclared pharmaceuticals.⁷ Even more concerning, more than half of the adulterated products contained greater than therapeutic dosages of the pharmaceutical adulterants.⁷
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Many products labeled “herbal” or “all natural” (herbal/natural) that claim to enhance sexual performance and imply use for the treatment of erectile dysfunction (ED) are marketed as over-the-counter (OTC) dietary supplements. However, adulteration with undeclared phosphodiesterase type 5 (PDE5) inhibitors appears widespread. To assess the availability, cost, origin, categorical content, and adulteration with PDE5 inhibitors of purported herbal/natural OTC dietary supplements claiming to naturally enhance sexual performance. Pfizer Global Security coordinated sample collection (all from convenience stores and filling stations in two U.S. metropolitan areas except for seven from U.S. Customs seizures) and liquid chromatography/mass spectrometry examination. Adulteration with synthetic PDE5 inhibitors. Ninety-one samples labeled as 58 distinct products and priced from $2.99 to $17.99 were evaluated. Origin/manufacture was claimed as United States (n = 62), apparently Asian (n = 15), and not clearly identified (n = 14). Although no sample claimed to include synthetic substances, 74 (81%) contained PDE5-inhibitor pharmaceutical ingredients, including tadalafil and/or sildenafil (n = 40, of which 18 contained >110% of the highest approved drug product strength) or PDE5-inhibitor analogs (n = 34). Pronounced heterogeneity of contents between samples within individual products indicated minimal quality control during manufacture. Labeling was inadequate (e.g., lacking lot number and/or expiry date) for 17 products (23 samples) and inconsistent between samples within a given product (e.g., in manufacturer, lot number, and/or expiry date) for seven of 17 products having multiple samples. Only 14 samples warned against concomitant nitrate use. Ethical pharmaceutical companies are concerned for an unsuspecting public when their products are counterfeited, mislabeled, and illegally offered for sale in an unsafe manner. Because of the dangers of adulteration with synthetic PDE5 inhibitors, absent safety warnings, and lack of quality or consistent manufacture, men with ED unknowingly risk their health by using OTC herbal/natural products that claim to enhance sexual performance. Campbell N, Clark JP, Stecher VJ, Thomas JW, Callanan AC, Donnelly BF, Goldstein I, and Kaminetsky JC. Adulteration of purported herbal and natural sexual performance enhancement dietary supplements with synthetic phosphodiesterase type 5 inhibitors. J Sex Med 2013;10:1842–1849.
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Icariin is the major active ingredient in Herba epimedii which is a commonly used Chinese herbal medicine for the treatment of osteoporosis. The present study aims to evaluate the osteoprotective effect of Icariin in glucocorticoid-induced osteoporosis in vivo and investigate the effect of Icariin on glucocorticoid-induced osteocyte apoptosis in vitro. A total of 48 female Sprague-Dawley rats were used. Glucocorticoid-induced osteoporosis was induced by daily injections of dexamethasone (0.1 mg/kg, daily, s.c.) for 60 days, whereas sham animals were injected daily with vehicle. At the end of the osteoporosis development period, osteoporotic rats were randomized to receive: vehicle (n = 8), Icariin (5,125 mg/kg, i.g.; n = 8), or alendronate (0.03 mg/kg, s.c.; n = 8) for 12 weeks. Sham animals were treated with vehicle for 12 weeks. At the beginning and at the end of treatments, animals were examined for bone mineral density. Serum bone-alkaline phosphatase and carboxy-terminal collagen cross links were measured. Primary osteocytes were isolated, and apoptosis was determined by trypan-blue assay. Interaction between Icariin and estrogen receptor and prosurvival signaling pathways activated by Icariin were also investigated. Icariin showed a comparable efficacy with alendronate in increasing bone mass. Icariin significantly increased bone-alkaline phosphatase (bone formation marker) and reduced carboxy-terminal collagen cross links (bone resorption marker). In vitro studies demonstrated that Icariin significantly prevented GC-induced apoptosis in osteocytes by activating ERK signaling via estrogen receptor. Our results suggest that Icariin might exert osteoprotective effect by maintaining osteocyte viability, thereby, regulating bone remodeling. Furthermore, our study provides preclinical evidence for the efficacy of Icariin for management of Glucocorticoid-induced osteoporosis.
Article
Introduction Phosphodiesterase type 5 inhibitors PDE5Is are less effective in diabetic men with erectile dysfunction (ED); however, the effect of combination therapy with folic acid and PDE5Is in these patients has not been investigated. Aim To evaluate the efficacy and safety of combination therapy with folic acid and tadalafil for the management of ED in men with type 2 diabetes mellitus. Methods Eighty‐three patients with type 2 diabetes mellitus and ED were included in this randomized double‐blind clinical trial. They were randomly divided into two groups. Group A was treated with tadalafil 10 mg every other day plus folic acid 5 mg daily and group B received tadalafil 10 mg every other day plus placebo daily for 3 months. The mean International Index of Erectile Function (IIEF) scores before and after treatment in each groups were recorded. Men with diagnosis of psychological ED, spinal cord injury, or who used folic acid in the past 3 months and patients with any contradiction for use of PDE5Is were excluded. Main Outcomes Measures The cross tabulation and independent t‐test were used to evaluate the difference between baseline characteristic of the patients in the two groups. Wilcoxon signed‐ranks test and Mann–Whitney U‐test were used to evaluate the IIEF score and also its changes before and after treatment in the two groups. Results The mean IIEF scores before and after treatment were 11.65 ± 2.67 and 16.80 ± 4.03 in group A (P < 0.001) and 12.70 ± 2.31 and 14.37 ± 2.17 in group B (P < 0.001), respectively. The difference of mean IIEF score after treatment between the two groups was significant (16.80 ± 4.03 vs. 14.37 ± 2.17 in groups A and B, respectively) (P = 0.002). Also, the mean IIEF score was significantly increased in group A as compared with group B (5.14 ± 3.84 vs. 1.68 ± 0.99 in groups A and B, respectively) (P < 0.001). Both folic acid and tadalafil were well tolerated by all the patients. Conclusion Sexual function in diabetic patients with ED treated with the combination of tadalafil and folic acid improved significantly as compared with the placebo group. The use of folic acid and tadalafil is safe.
Article
Dyslipidemia is closely related to erectile dysfunction (ED). Evidence has shown that the lipid-lowering agent, 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor (statins), can improve erectile function. However, information about the potential role of another class of lipid-lowering agent, niacin, is unknown. To assess the effect of niacin alone on erectile function in patients suffering from both ED and dyslipidemia. A single center prospective randomized placebo-controlled parallel-group trial was conducted. One hundred sixty male patients with ED and dyslipidemia were randomized in a one-to-one ratio to receive up to 1,500 mg oral niacin daily or placebo for 12 weeks. The primary outcome measure was the improvement in erectile function as assessed by question 3 and question 4 of the International Index of Erectile Function (IIEF Q3 and Q4). Secondary outcome measurements included the total IIEF score, IIEF-erectile function domain, and Sexual Health Inventory for Men (SHIM) score. From the overall analysis, the niacin group showed a significant increase in both IIEF-Q3 scores (0.53 ± 1.18, P < 0.001) and IIEF-Q4 scores (0.35 ± 1.17, P = 0.013) compared with baseline values. The placebo group also showed a significant increase in IIEF-Q3 scores (0.30 ± 1.16, P = 0.040) but not IIEF-Q4 scores (0.24 ± 1.13, P = 0.084). However, when patients were stratified according to the baseline severity of ED, the patients with moderate and severe ED who received niacin showed a significant improvement in IIEF-Q3 scores (0.56 ± 0.96 [P = 0.037] and 1.03 ± 1.20 [P < 0.001], respectively) and IIEF-Q4 scores (0.56 ± 1.03 [P = 0.048] and 0.84 ± 1.05 [P < 0.001], respectively] compared with baseline values, but not for the placebo group. The improvement in IIEF-EF domain score for severe and moderate ED patients in the niacin group were 5.28 ± 5.94 (P < 0.001) and 3.31 ± 4.54 (P = 0.014) and in the placebo group were 2.65 ± 5.63 (P < 0.041) and 2.74 ± 5.59 (P = 0.027), respectively. There was no significant improvement in erectile function for patients with mild and mild-to-moderate ED for both groups. For patients not receiving statins treatment, there was a significant improvement in IIEF-Q3 scores (0.47 ± 1.16 [P = 0.004]) for the niacin group, but not for the placebo group. Niacin alone can improve the erectile function in patients suffering from moderate to severe ED and dyslipidemia.
Article
The aim of the clinical study was to evaluate the effect of Testofen, a standardized Trigonella foenum-graecum (Fenugreek) extract and mineral formulation, on male libido (sexual drive, urge or desire) in a double blind randomized placebo controlled study. The study recruited 60 healthy males aged between 25 and 52, without erectile dysfunction and randomized to an oral dose (two tablets per day) of the active treatment (600 mg Testofen per day) or placebo for 6 weeks. The primary outcome measure was the DISF-SR (male) self-administered QOL total score and the four domain scores. The secondary outcome was specific quality of life parameters. Testofen had an overall positive effect on physiological aspects of libido. In particular, there was a significant increase in the subdomains of sexual arousal and orgasm. Testofen had a positive effect on QOL in self-reported satisfaction with muscle strength, energy and well-being but did not have an effect on mood or sleep. Serum prolactin and testosterone levels remained within the reference range. It was concluded that Testofen demonstrated a significant positive effect on physiological aspects of libido and may assist to maintain normal healthy testosterone levels. Copyright © 2011 John Wiley & Sons, Ltd.
Article
To test the efficacy and safety of oral L-citrulline supplementation in improving erection hardness in patients with mild erectile dysfunction (ED). L-arginine supplementation improves nitric oxide-mediated vasodilation and endothelial function; however, oral administration has been hampered by extensive presystemic metabolism. In contrast, L-citrulline escapes presystemic metabolism and is converted to L-arginine, thus setting the rationale for oral L-citrulline supplementation as a donor for the L-arginine/nitric oxide pathway of penile erection. In the present single-blind study, men with mild ED (erection hardness score of 3) received a placebo for 1 month and L-citrulline, 1.5 g/d, for another month. The erection hardness score, number of intercourses per month, treatment satisfaction, and adverse events were recorded. A total of 24 patients, mean age 56.5 ± 9.8 years, were entered and concluded the study without adverse events. The improvement in the erection hardness score from 3 (mild ED) to 4 (normal erectile function) occurred in 2 (8.3%) of the 24 men when taking placebo and 12 (50%) of the 24 men when taking L-citrulline (P < .01). The mean number of intercourses per month increased from 1.37 ± 0.93 at baseline to 1.53 ± 1.00 at the end of the placebo phase (P = .57) and 2.3 ± 1.37 at the end of the treatment phase (P < .01). All patients reporting an erection hardness score improvement from 3 to 4 reported being very satisfied. Although less effective than phosphodiesterase type-5 enzyme inhibitors, at least in the short term, L-citrulline supplementation has been proved to be safe and psychologically well accepted by patients. Its role as an alternative treatment for mild to moderate ED, particularly in patients with a psychologically fear of phosphodiesterase type-5 enzyme inhibitors, deserves further research.
Article
Sexual dysfunction is very common in patients with chronic kidney disease (CKD), but treatment options are limited. The benefits and harms of existing interventions for treatment of sexual dysfunction were assessed in patients with CKD. MEDLINE (1966 to December 2008), EMBASE (1980 to December 2008), and the Cochrane Trial Registry (Issue 4 2008) were searched for parallel and crossover randomized and quasi-randomized trials. Treatment effects were summarized as mean differences (MD) or standardized mean difference (SMD) with 95% confidence intervals (CI) using a random effects model. Fourteen trials (328 patients) were included. Phosphodiesterase-5 inhibitors (PDE5i) compared with placebo significantly increased the overall International Index of Erectile Function-5 (IIEF-5) score (three trials, 101 patients, MD 1.81, 95% CI 1.51 to 2.10), all of its individual domains, and the complete 15-item IIEF-5 (two trials, 80 patients, MD 10.64, 95% CI 5.32 to 15.96). End-of-treatment testosterone levels were not significantly increased by addition of zinc to dialysate (two trials, 22 patients, SMD 0.19 ng/dl, 95% CI -2.12 to 2.50), but oral zinc improved end-of-treatment testosterone levels. There was no difference in plasma luteinizing and follicle-stimulating hormone level at the end of the study period with zinc therapy. PDE5i and zinc are promising interventions for treating sexual dysfunction in CKD. Evidence supporting their routine use in CKD patients is limited. There is an unmet need for studying interventions for male and female sexual dysfunction in CKD considering the significant disease burden.
Article
Epimedium species (aka horny goat weed) have been utilized for the treatment of erectile dysfunction in Traditional Chinese Medicine for many years. Icariin (ICA) is the active moiety of Epimedium species. To evaluate the penile hemodynamic and tissue effects of ICA in cavernous nerve injured rats. We also studied the in vitro effects of ICA on cultured pelvic ganglia. Rats were subjected to cavernous nerve injury and subsequently treated for 4 weeks with daily gavage feedings of a placebo solution of normal saline and Dimethyl sulfoxide (DMSO) vs. ICA dissolved in DMSO at doses of 1, 5, and 10 mg/kg. A separate group underwent a single dose of ICA 10 mg/kg 2 hours prior to functional testing. Functional testing with cavernous nerve stimulation and real-time assessment of intracavernous pressure (ICP) was performed at 4 weeks. After functional testing, penile tissue was procured for immunohistochemistry and molecular studies. In separate experiments, pelvic ganglia were excised from healthy rats and cultured in the presence of ICA, sildenafil, or placebo culture media. Ratio of ICP and area under the curve (AUC) to mean arterial pressure (MAP) during cavernous nerve stimulation of subject rodents. We also assayed tissue expression of neuronal nitric oxide synthase (nNOS), eNOS: endothelial nitric oxide synthase (eNOS), calponin, and apoptosis via immunohistochemistry and Western blot. Serum testosterone and luteinizing hormone (LH) were assayed using enzyme-linked immunosorbant assay (ELISA). Differential length of neurite outgrowth was assessed in cultured pelvic ganglia. Rats treated with low-dose ICA demonstrated significantly higher ICP/MAP and AUC/MAP ratios compared with control and single-dose ICA animals. Immunohistochemistry and Western blot were revealing of significantly greater positivity for nNOS and calponin in penile tissues of all rats treated with ICA. ICA led to significantly greater neurite length in cultured specimens of pelvic ganglia. ICA may have neurotrophic effects in addition to known phosphodiesterase type 5 inhibiting effects.
Article
In recent years, there has been increasing interest in the use of herbs and supplements as an alternative to drugs used for the treatment of erectile dysfunction, in order to enhance sexual performance. Over the years, adverse events associated with the consumption of natural health products for sexual enhancement and the treatment of erectile dysfunction have been reported. The objective of this work was to assess the safety and quality of 175 sexual enhancement health products seized from makeshift stalls in red-light districts of Singapore. Seven raids were conducted by the Health Sciences Authority, Singapore, in two red-light districts in February and March 2008. 175 sexual enhancement health products seized from makeshift stalls were extracted with methanol and screened for Western drug adulterants using high performance liquid chromatography and gas chromatography-mass spectrometry. The labels and claims of the products were also evaluated. Of the 175 products evaluated, 134 (77%) were found to be adulterated with Western drugs or their analogues. Most of these 134 samples (123 [92%]) were found to be adulterated with sildenafil. The extent of adulteration of these illegal health products with Western drugs, including synthetic phosphodiesterase type 5 enzyme (PDE-5) inhibitors, and the risks of consuming such illegal sexual enhancement products are discussed in this study. Because of the scope of the raids, sildenafil was the most common adulterant found. In addition, some products were found to contain high contents of sildenafil (>100 mg) and high contents of the antidiabetic drug, glibenclamide (glyburide). The resultant severe hypoglycaemia has led to ten fatalities. The presence of Western drug adulterants and their analogues in illegal sexual enhancement products seized from red-light districts in Singapore, and their often misleading labels and claims, put the health of consumers at risk. To safeguard public health, greater public awareness of the danger of consuming such illegal products and the lack of quality control of these illegal sexual enhancement health products is important.
Article
Supplemental administration of androgens has been advocated for men with sexual dysfunction (SD) and hypoandrogenism. The preponderance of evidence indicates that most delivery forms of testosterone (T) are effective but the role of dehydroepiandrosterone (DHEA) is controversial. A placebo-controlled, randomized trial of oral androgen (T versus DHEA) supplementation was carried out to determine their efficacy. Eighty-six men with SD and decreased levels of serum T and/or DHEA, participated in a study receiving oral T undecanoate (OTU) (n = 29) 80 mg twice daily, DHEA (n = 28) 50 mg twice daily, or placebo (n = 29). Outcomes included evaluation of sexual performance by the International Index of Erectile Function (IIEF), the Androgen Deficiency in the Aging Male (ADAM), Aging Male Symtom Scale (AMS), and Global Assessment Questionnaire (GAQ) questionnaires. Biochemical evaluations included measurement of T and DHEA, prolactin, gonadotropins, and PSA. Seventy-nine men completed the study. There were no significant differences in outcomes as assessed by four different instruments: the ADAM, IIEF, AMS, and GAQ in regard to sexual interest or erectile function. Biochemically, a significant increase in serum DHEA between baseline and final visit was documented in the group receiving DHEA. The levels of T, on the other hand, increased insignificantly between entry and final visit in the T cohort. No biochemical changes were observed in the placebo group. Levels of PSA remained stable in all three groups. This study did not suggest a clinical benefit of OTU or DHEA supplementation in men with hypoandrogenism and SD. The recommended dose of OTU may have been inadequate or poorly absorbed. Increased doses or an alternative T delivery form may result in a different response.
Article
Maca (Lepidium meyenii Walp) is consumed both as a sports supplement by strength and endurance athletes, and as a natural stimulant to enhance sexual drive. However, whether or not the postulated benefits of maca consumption are of scientific merit is not yet known. The aim of the study was therefore to investigate the effect of 14 days maca supplementation on endurance performance and sexual desire in trained male cyclists. Eight participants each completed a 40 km cycling time trial before and after 14 days supplementation with both maca extract (ME) and placebo, in a randomised cross-over design. Subjects also completed a sexual desire inventory during each visit. ME administration significantly improved 40 km cycling time performance compared to the baseline test (P=0.01), but not compared to the placebo trial after supplementation (P>0.05). ME administration significantly improved the self-rated sexual desire score compared to the baseline test (P=0.01), and compared to the placebo trial after supplementation (P=0.03). 14 days ME supplementation improved 40 km cycling time trial performance and sexual desire in trained male cyclists. These promising results encourage long-term clinical studies involving more volunteers, to further evaluate the efficacy of ME in athletes and normal individuals and also to explore its possible mechanisms of action.
Article
Lepidium meyenii (Maca) is a cultivated root belonging to the brassica family used in the Andean region for its supposed aphrodisiac properties. We carried out a double-blind clinical trial on 50 Caucasian men affected by mild erectile dysfunction (ED), randomised to treatment with Maca dry extract, 2400 mg, or placebo. The treatment effect on ED and subjective well-being was tested administrating before and after 12 weeks the International Index of Erectile Function (IIEF-5) and the Satisfaction Profile (SAT-P). After 12 weeks of treatment, both Maca- and placebo-treated patients experienced a significant increase in IIEF-5 score (P < 0.05 for both). However, patients taking Maca experienced a more significant increase than those taking placebo (1.6 +/- 1.1 versus 0.5 +/- 0.6, P < 0.001). Both Maca- and placebo-treated subjects experienced a significant improvement in psychological performance-related SAT-P score, but the Maca group higher than that of placebo group (+9 +/- 6 versus +6 +/- 5, P < 0.05). However, only Maca-treated patients experienced a significant improvement in physical and social performance-related SAT-P score compared with the baseline (+7 +/- 6 and +7 +/- 6, both P < 0.05). In conclusion, our data support a small but significant effect of Maca supplementation on subjective perception of general and sexual well-being in adult patients with mild ED.
Article
To examine the estrogenic and androgenic activity of Lepidium meyenii (Maca) and its effect on the hormonal profile and symptoms in postmenopausal women. Fourteen postmenopausal women completed a randomized, double-blind, placebo-controlled, crossover trial. They received 3.5 g/day of powered Maca for 6 weeks and matching placebo for 6 weeks, in either order, over a total of 12 weeks. At baseline and weeks 6 and 12 blood samples were collected for the measurement of estradiol, follicle-stimulating hormone, luteinizing hormone, and sex hormone-binding globulin, and the women completed the Greene Climacteric Scale to assess the severity of menopausal symptoms. In addition, aqueous and methanolic Maca extracts were tested for androgenic and estrogenic activity using a yeast-based hormone-dependent reporter assay. No differences were seen in serum concentrations of estradiol, follicle-stimulating hormone, luteinizing hormone, and sex hormone-binding globulin between baseline, Maca treatment, and placebo (P > 0.05). The Greene Climacteric Scale revealed a significant reduction in scores in the areas of psychological symptoms, including the subscales for anxiety and depression and sexual dysfunction after Maca consumption compared with both baseline and placebo (P < 0.05). These findings did not correlate with androgenic or alpha-estrogenic activity present in the Maca as no physiologically significant activity was observed in yeast-based assays employing up to 4 mg/mL Maca extract (equivalent to 200 mg/mL Maca). Preliminary findings show that Lepidium meyenii (Maca) (3.5 g/d) reduces psychological symptoms, including anxiety and depression, and lowers measures of sexual dysfunction in postmenopausal women independent of estrogenic and androgenic activity.
Article
Korean red ginseng (unskinned Panax ginseng before it is steamed or otherwise heated and subsequently dried) is one of the most widely used herbal remedies. This systematic review evaluates the current evidence for the effectiveness of red ginseng for treating erectile dysfunction. Systematic searches were conducted on 20 electronic databases without language restrictions. Hand-searches included conference proceedings and our files. All randomized clinical studies (RCT) of red ginseng as a treatment of erectile dysfunction were considered for inclusion. Methodological quality was assessed using the Jadad score. Seven RCTs met all the inclusion criteria. Their methodological quality was low on average. Six of the included RCTs compared the therapeutic efficacy of red ginseng with placebo. The meta-analysis of these data showed a significant effect (n = 349, risk ratio, 2.40; 95% CI of 1.65, 3.51, p < 0.00001, heterogeneity: tau(2) = 0.05, chi(2) = 6.42, p = 0.27, I(2) = 22%). Subgroup analyses also showed beneficial effects of red ginseng in psychogenic erectile dysfunction (n = 135, risk ratio, 2.05; 95% CI of 1.33, 3.16, p = 0.001, heterogeneity: chi(2) = 0.08, p = 0.96, I(2) = 0%). Collectively these RCTs provide suggestive evidence for the effectiveness of red ginseng in the treatment of erectile dysfunction. However, the total number of RCTs included in the analysis, the total sample size and the methodological quality of the primary studies were too low to draw definitive conclusions. Thus more rigorous studies are necessary.
Article
To evaluate the hypothesis that endocrine profiles change with aging independently of specific disease states, we examined the age trends of 17 major sex hormones, metabolites, and related serum proteins in 2 large groups of adult males drawn from the Massachusetts Male Aging Study, a population-based cross-sectional survey of men aged 39-70 yr conducted in 1986-89. Group 1 consisted of 415 men who were free of obesity, alcoholism, all prescription medication, prostate problems, and chronic illness (cancer, coronary heart disease, hypertension, diabetes, and ulcer). Group 2 consisted of 1294 men who reported 1 or more of the above conditions. Each age trend was satisfactorily described by a constant percent change per yr between ages 39-70 yr. Free testosterone declined by 1.2%/yr, and albumin-bound testosterone by 1.0%/yr. Sex hormone-binding globulin (SHBG), the major serum carrier of testosterone, increased by 1.2%/yr, with the net effect that total serum testosterone declined more slowly (0.4%/yr) than the free or albumin-bound pools alone. Among the major androgens and metabolites, androstane-3 alpha,17 beta-diol (androstanediol; 0.8%/yr) and androstanediol glucuronide (0.6%/yr) declined less rapidly than free testosterone, while 5 alpha-dihydrotestosterone remained essentially constant between ages 39-70 yr. Androstenedione declined at 1.3%/yr, a rate comparable to that of free testosterone, while the adrenal androgen dehydroepiandrosterone (3.1%/yr) and its sulfate (2.2%/yr) declined 2-3 times more rapidly. The levels of testosterone, SHBG, and several androgen metabolites followed a parallel course in groups 1 and 2, remaining consistently 10-15% lower in group 2 across the age range of the study. Subgroup analyses suggested that obese subjects might be responsible for much of the group difference in androgen level. Serum concentrations of estrogens and cortisol did not change significantly with age or differ between groups. Of the pituitary gonadotropins, FSH increased at 1.9%/yr, LH increased at 1.3%/yr, and PRL declined at 0.4%/yr, with no significant difference between groups 1 and 2.(ABSTRACT TRUNCATED AT 400 WORDS)
Article
A double-blind, partial crossover study on the therapeutic effect of yohimbine hydrochloride on erectile dysfunction was done in 82 sexually impotent patients. All patients underwent a multifactorial evaluation, including determination of penile brachial blood pressure index, cavernosography, sacral evoked response, testosterone and prolactin determination, Derogatis sexual dysfunction inventory and daytime arousal test. After 1 month of treatment with a maximum of 42.0 mg. oral yohimbine hydrochloride daily 14 per cent of the patients experienced restoration of full and sustained erections, 20 per cent reported a partial response to the therapy and 65 per cent reported no improvement. Three patients reported a positive placebo effect. Maximum effect takes 2 to 3 weeks to manifest itself. Yohimbine was active in some patients with arterial insufficiency and a unilateral sacral reflex arc lesion, and in 1 with low serum testosterone levels. The 34 per cent response is encouraging, particularly in a Veterans Administration population presenting with a high incidence of diabetes and vascular pathological conditions not found in regular office patients. Only few and benign side effects were recorded, which makes this medication worth an attempt, often as a first line of treatment even at a dose of 8 tablets.
Article
A pilot study was conducted to assess the effect of the alpha-adrenergic antagonist, yohimbine, in a group of patients with organic impotence. The results suggest that the drug may be beneficial in selected cases but the number of satisfactory results is inferior to previous reports. The need for controlled trials is emphasized.
Article
We provide current, normative data on the prevalence of impotence, and its physiological and psychosocial correlates in a general population using results from the Massachusetts Male Aging Study. The Massachusetts Male Aging Study was a community based, random sample observational survey of noninstitutionalized men 40 to 70 years old conducted from 1987 to 1989 in cities and towns near Boston, Massachusetts. Blood samples, physiological measures, socio-demographic variables, psychological indexes, and information on health status, medications, smoking and lifestyle were collected by trained interviewers in the subject's home. A self-administered sexual activity questionnaire was used to characterize erectile potency. The combined prevalence of minimal, moderate and complete impotence was 52%. The prevalence of complete impotence tripled from 5 to 15% between subject ages 40 and 70 years. Subject age was the variable most strongly associated with impotence. After adjustment for age, a higher probability of impotence was directly correlated with heart disease, hypertension, diabetes, associated medications, and indexes of anger and depression, and inversely correlated with serum dehydroepiandrosterone, high density lipoprotein cholesterol and an index of dominant personality. Cigarette smoking was associated with a greater probability of complete impotence in men with heart disease and hypertension. We conclude that impotence is a major health concern in light of the high prevalence, is strongly associated with age, has multiple determinants, including some risk factors for vascular disease, and may be due partly to modifiable para-aging phenomena.
Article
Ginkgo biloba (Ginkgoaceae) is an ancient Chinese tree which has been cultivated and held sacred for its health-promoting properties. There is substantial experimental evidence to support the view that Ginkgo biloba extracts have neuroprotective properties under conditions such as hypoxia/ischemia, seizure activity and peripheral nerve damage. Research on the biochemical effects of Ginkgo biloba extracts is still at a very early stage. One of the components of Ginkgo biloba, ginkgolide B, is a potent platelet-activating factor (PAF) antagonist. Although the terpene fraction of Ginkgo biloba, which contains the ginkgolides, may contribute to the neuroprotective properties of the Ginkgo biloba leaf, it is also likely that the flavonoid fraction, containing free radical scavengers, is important in this respect. Taken together, the evidence suggests that Ginkgo biloba extracts are worthy of further investigation as potential neuroprotectant agents.