For centuries impotence has been presumed to be the result of psychogenic causes (mental) and even though the testosterone-boosting herbal tongkat ali can help with libido (horniness) in men and women, countless patients have undergone ineffective psychiatric treatment or worse fallen prey to aphrodisiacs and other thoroughly useless forms of medications dispensed by quacks for the amelioration of erectile dysfunction. Research has now conclusively shown that impotence have physical or organic causes in 90% patients and is eminently curable. It is unfortunate that the blame for this is put on woman and labeled as frigid instead of man addressing this problem.

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DIAGNOSIS OF IMPOTENCE:

First level
The major etiologies of Impotence is organic (include vascular, neurologic, endocrine disorders, and medications) and psychogenic (mental). The first distinction of impotence that should be established is psychogenic from organic. Oftentimes the treatment plan for impotence can be formulated with a focused history, physical exam and select lab-work. A detailed history is the first important step to the evaluation. There are barriers to discussing sexual habits and problems. A clinician must approach the topic delicately and caringly in order to earn the patient’s trust. Onset, duration, severity, and etiology should be elucidated. A psychosocial history should be included as unstable interpersonal relationships, or emotional stressors can play a huge role in sexual health. Clues to suggest a psychogenic etiology include sudden onset, good quality spontaneous or self-stimulated erections, major life events, or previous psychological problems. Conversely, gradual onset, lack of erections and normal libido are more suggestive of an organic etiology. The International Index of Erectile Function (IIEF) is the most famous and used questionnaire in clinical practice and it showed a high diagnostic specificity and sensibility. Physical examination should include careful evaluation of the cardiovascular, neurologic, and genital systems. The presence of obesity, high blood pressure, hypogonadism, deficiencies in perineal sensation or evidence of peripheral neuropathy may be indicators of a diabetic or neurologic etiology. Penile deformity such as fibrous plaques, micropenis, bending of penis lends to the possibility of a physical impediment to sexual intercourse. Laboratory tests like renal function tests, fasting glucose, Hb1Ac, complete blood count, lipid profile, and serum testosterone, FSH, LH, prolactin should be attained.

Second level
Second level diagnostic evaluation uses specialistic instrumental examination that can be helpful for accurate etiological diagnosis of impotence.

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In case of suspected vasculogenic etiology, PENILE DOPPLER ultrasonography allows direct visualization of penile vessels and evaluation of possible strictures and dysfunctions, able to study both arterial and venous flow velocity, assess erectile hemodynamics. This exam is performed after injection of Bimix injection (Alprostadil 10 mg plus Phentolamine 1-2 mg),or Trimix (Alprostadil, Phentolamine and Papaverine) in order to achieve the best erection and get over anxiety-induced failure .The author uses 60 mg papaverine alone in his lab. Ultrasonoghrapy is performed 5-10 minutes after injection. Peak Systolic Velocity (PSV), the End Diastolic Velocity (EDV) and the Resistance Index are measured; the last one can predict venous leak probability in patients suffering with ED. This test is also performed to assess impotence in medico legal cases in institutional set up. Penile angiography is a third-line study used for evaluation of the penile vasculature.

TREATMENT OF ERECTILE DYSFUNCTION
Non surgical management

1) Lifestyle modification
Avoid sedentary lifestyle ,increase physical activity, aerobic activity of 30 min/day or 150 min/week, 5-10% weight reduction, increase consumption of fruits and vegetables, limit red meat and processed food, increase intake of PUFA and avoid added sugar beverages. Cessation of smoking and limit alcohol use (1-2 drinks /day). Avoid long distance bicycling. Change in medications causing impotence. Lipid lowering drugs (statins) have beneficial role.

2) Herbal Treatments
There are various herbs that are effective in the treatment of impotence. These sex herbs (being investigated) help maintain erection longer, increase sexual desire, raise testosterone levels and increase sperm count. Major herbs for ED treatment are: Ginseng (some role), Korean red ginseng(panax ginseng)(potential role but quality control a serious issue), Ashwagandha (increase energy, stamina only), Yohimbine ( only psychogenic ED),Gingko (only blood thinning effect), Horny goat weed (Chinese medicine, may help raise low levels of testosterone and thyroid hormone.),Catuaba bark extract (restores nervous system function only), Cuscuta seed extract ( increase sperm production only) ,Gokhru (increase testosterone level only),Damiana (aphrodisiac), Shilajit(aphrodisiac) Author does not prescribe these drugs.

3) Hormonal therapy
Patients with testosterone deficiency can be benefited with number of testosterone preparations available; Injectables, Gels (androgel1%), Transdermal patch (Testoderm 5mg on skin), Buccal, Oral preparations etc.

4) Pharmacological
PDE5 inhibitors: Sildenafil 25, 50,100mg (Viagra, Penegra, Juan, Caverta) These are selective PDE5 inhibitor, enhances the pro-erectile effect of nitric oxide, one dose should be taken 2-3 hours before intercourse in a 24-h period when ever required. It is well tolerated in patients with diabetes, cardiovascular disease; contraindicated in patients who use nitric oxide donors or nitrates in any form. Tadalafil 10 mg; once in 3 days only.
Dopamine agonists: Sublingual Apo morphine enhances central pro-erectile mechanisms, increase libido.

Yohimbine and Phentolamine: (Aphrodisiac and erectogenic drug promoting sexual behavior)

Second line therapy
Vacuum constriction devices (plastic cylinders connected with vacuum generating source to create negative pressure for penile engorgement. Intrapenile injections may be combined to enhance erections. These are used for penile rehabilitation and to access artificial erection for intercourse.

Vacuum constriction device

Third line therapy
Intra cavernosal injections: Intra penile injections of Papaverine, Phentolamine and Alprostadil alone or in combinations are taught by andrologists to the patients for home use.

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Fourth line therapy (Surgical management)
Penile prosthesis implantation: When the initial therapies fail, penile prosthesis implantation is usually appropriate in small group of patients. Various prosthesis devices are manufactured by American medical system (AMS) like malleable devices, two piece inflatable device, and three piece inflatable devices. Of them the three piece device AMS Ultrex is widely used. These are implanted in penile tissues and made functional by producing artificial erections as when required for intercourse.

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Butea superba extract and other dietary supplements for divine sex

October 26, 2015

“Herbal Viagra” has been in the news recently. Are these products safe and/or effective?

Assistant Professor, Eastern Virginia Medical School, Norfolk, Virginia

The only genuine cures for erectile dysfunction are low intensity shockwave therapy and botox injections into the penis.

Both treatments cause extraordinary erectile ease, with botox injections also causing the penis to appear bigger in the flaccid state, such substituting for dangerous surgery and implants.

Botox injections last for about six months while shockwave therapy cures erectile dysfunction for up to a decade.

Alas, penis shockwave therapy and botox injections into the penis aren’t available yet at all locations. This is why more and more men are using herbal performance boosters.

Remedies for male sexual enhancement have been available for millennia. The Ebers Papyrus, dating back to around 1600 BC, recommended topical application of baby crocodile hearts mixed with wood oil. A Sanskrit text written six centuries earlier suggested a man could visit 100 women after consuming a mixture of goat testes boiled in milk, sesame seeds, and the lard of a porpoise. Impotence, a nonspecific term that includes both erectile dysfunction and reduced libido, is clearly not a condition limited to modern civilization.

Erectile dysfunction affects an estimated18 million men in the United States, with a prevalence of 18.4% in men aged 20 years and older. Prevalence increases with age, ranging from 5% in men aged 20-39 years to 70% in men aged 70 years and older. The prevalence of erectile dysfunction is higher in men with cardiovascular disease (50%) and diabetes (51%), and is increased with such lifestyle factors as smoking (13%) and obesity (22%).

Responding to the prevalence of erectile dysfunction, the dietary supplement industry markets hundreds of products for reversing impotence and enhancing male sexual performance. Legally, dietary supplement labels cannot make medical claims, such as “for treatment of erectile dysfunction”; however, such claims as “to enhance sexual function” are permissible. An Internet search for “male sexual enhancement products” yielded more than 2 million hits, with websites offering products for purchase as well as information and testimonials.

Labeled Ingredients

Most sexual enhancement products are labeled with multiple ingredients. Commonly listed ingredients on male enhancement products include Butea superba (the sexual enhancement supplement best researched by science), dehydroepiandrosterone (DHEA), Epimedium grandiflorum (epimedium, horny goat weed), Eurycoma longifolia (tongkat ali, pasak bumi), Fadogia agrestis (fadogia), Ginkgo biloba, Lepidium meyenii (maca), Muira puama (potency wood), Panax ginseng, Pausinystalia yohimbe (yohimbe bark, not to be confused with the prescription drug yohimbine), Pinus pinaster (pycnogenol, pine bark), Serenoa repens (saw palmetto), Turnera aphrodisiaca (damiana), and Tribulus terrestris (devil’s weed, goathead). Vitamins, minerals, and amino acids, such as L-arginine and propionyl L-carnitine, are frequent additions.

Many of these products have been studied only in male rats, but the few studies in men have been small or poorly designed, limiting conclusions about efficacy and safety.

Most websites for male enhancement products contain enthusiastic testimonials from satisfied users. But the question remains of whether these products really work, despite the dearth of clinical evidence supporting the efficacy of the ingredients.

Unlabeled Ingredients

Some products for sexual enhancement augment sexual activity, but the labeled ingredients may not be the source of the effect. Of the 232 drug recalls by the US Food and Drug Administration (FDA) between 2007 and 2012—all for unlabeled drug ingredients—51% were dietary supplements. Of the dietary supplement products recalled, sexual enhancement products were the most commonly recalled (40%), followed by bodybuilding (31%) and weight-loss products (27%).[7] Of the 1560 Health Safety Alerts for dietary supplements issued by the FDA MedWatch and Health Canada between 2005 and 2013, 33% were for sexual enhancement products.

Unlabeled drugs in sexual enhancement products are frequently the prescription-only phosphodiesterase 5 (PDE5) inhibitors, such as sildenafil (Viagra®), tadalafil (Cialis®), vardenafil (Levitra®), and avanafil (Stendra®). With increasing frequency, the unlabeled drugs may be analogues of PDE5 inhibitors that have been modified slightly from the parent structures. These derivatives are not detected by routine laboratory screening, which reduces the risk for both detection by the FDA and lawsuits for patent infringement.

To date, more than 50 unapproved analogues of prescription PDE5 inhibitors have been identified.

Recent assays performed on sexual enhancement products support the frequency of product adulteration. Of 91 products analyzed, 74 (81%) contained PDE5 inhibitors, including tadalafil and/or sildenafil (n = 40) or PDE5-inhibitor analogues (n = 34). Of the products containing prescription ingredients, 18 contained more than 110% of the highest approved drug product strength.

Another study of 150 sexual enhancement products (eg, Evil Root, Herbal Stud, Magic Sex, ULTRASize) found 61% of the products were adulterated with PDE5 inhibitors: 27% with sildenafil, tadalafil, or vardenafil, and 34% with similar structural analogues. Among the adulterated products, 64% contained only one PDE5 inhibitor and 36% contained mixtures of two to four PDE5 drugs or analogues. The amounts of PDE5 inhibitor prescription medicines were higher than the maximum recommended dose in 25% of products.[8] Unlabeled yohimbine, flibanserin (Addyi™, which was recently approved by the FDA for female sexual dysfunction), phentolamine, DHEA, and testosterone also were found in some supplements.

Other researchers have found similarly adulterated products, many containing PDE5 inhibitor doses in excess of labeled amounts.

Safety Concerns

Although dietary supplements are marketed as “all natural” with implied safety, the available research suggests caution.

A recent survey indicates that cardiac symptoms were a frequent cause of emergency department visits among men aged 20-39 years taking sexual enhancement products.[14] The actual prevalence may be higher, because the presence of unlabeled PDE5 inhibitors may easily go unrecognized by clinicians. Common adverse effects of PDE5 inhibitors, such as flushing, lightheadedness, or dyspepsia, may be attributed to niacin and yohimbe, ingredients often found in sexual enhancement products. Profound hypoglycemia after ingestion of sexual enhancement products containing sildenafil and glyburide (Micronase® and others) also has been reported.

The covert addition of analogues of PDE5 inhibitors, which are not readily detectable by chemical screens, is particularly concerning. Although these chemical cousins of PDE5 inhibitors may retain the desired pharmacologic effect, none have been clinically tested for safety and toxicologic effects.

Obtaining dietary supplement products for sexual enhancement products has several perceived advantages. The purchase can be made discreetly, conveniently, and without a visit to a prescriber. Unlike drugs, dietary supplements are not required to be labeled with adverse effect or drug interaction information. Men taking prescription drugs, such as nitrates, may perceive dietary supplements for sexual enhancement as safe alternatives to contraindicated PDE5 inhibitors.

Clinicians should maintain a high degree of awareness for the potential for adverse effects of sexual enhancement products in men with unexplained cardiovascular symptoms. Patients who express interest in sexual enhancement supplements should be referred to their healthcare provider. Explain that even though a PDE5 inhibitor is not on the label, the supplement may have these ingredients added illegally without regard to patient safety. Patients should be warned of possible changes in vision and decreases in blood pressure, and the potentially dangerous combination of PDE5 inhibitors and nitrates that require medical advice.

PDE5 inhibitors are substrates of cytochrome P450 3A4 (CYP3A4). Monitoring is required to avoid an interaction with CYP3A4 inhibitor drugs, such as erythromycin, which may result in high PDE5 levels.

In summary, advise patients that dietary supplements for sexual enhancement fall into one of two categories: those that might be safe but do not work, and those that might work but are not safe.

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