Viotren and other dietary supplements are being illegally marketed to treat erectile dysfunction. Some of them work, but only because they are adulterated with prescription drugs like Viagra (at up to 31 times the prescription dose). Using them can be risky.
Never tested on animals. Never tested on humans, either!
The headline reads “New $2 Sex Pill Used in China for 63 Years Finally Receives U.S. Patent.” It’s called Viotren. All the usual red flags are there. It’s a half-page ad made to look like a news story. It says a discount will be available for a short time only, so buy now. It even offers a double your money back guarantee. It makes claims not supported by evidence. They claim it restores testosterone levels in 72 hours and improves blood circulation throughout the body. In the first 30 days, “many users note an increased sense of well-being, vitality, and sexual performance.” Of course, it is “all natural” and has no side effects. You can read the ad here.Being awarded a patent does not mean the product has been proven to work. The patent is for a method of preparing the active ingredient in Viotren, tongkat ali (Eurycoma longifolia). A recent systematic review found “convincing evidence” that Eurycoma longifolia is effective for treating male sexual disorders, but 4 out of the 11 studies they reviewed found no effect. The manufacturer, The American Institute of Longevity, claims to have developed an improved formulation that is more potent and absorbed faster.The Natural Medicines Comprehensive Database rates Eurycoma longifolia as only “possibly effective for male infertility” but says there is insufficient reliable evidence to rate its effectiveness for hypogonadism. It did not consider its use for erectile dysfunction per se. They comment “Preliminary clinical research shows that taking a water-based extract of Eurycoma longifolia 200 mg daily for one month might significantly increase testosterone levels in men with low testosterone levels.” And they warn about concerns of potential contamination with lead and mercury.
Tongkat ali is the active ingredient, but there are other ingredients. I tried to find out what they were, but the only mention I could find was on a Q&A website where they said it contained Piper nigrum extract (black pepper), piperine (also black pepper), Rhodiola rosea, DIM, and tongkat ali. The Natural Medicines Comprehensive Database had no information on the use of any of these ingredients for erectile dysfunction.
The scamadviser website says the Viotren website viotren.com might be unsafe. It appears to be based in the US but there are other countries involved. The site is using an anonymous service which prevents identification of the site owner. The website had been newly registered with a short life expectancy, following the pattern used by many fraudulent and fake selling websites. I searched for viotren.com, couldn’t find it, and assumed it no longer existed. But today I checked again, and viotren.com had miraculously reappeared. It includes a list of ingredients for Viotren and Viotren Plus. It also features a single scientific study on one ingredient. Pretty slim pickings. Not even testimonials.
I tried to look up the manufacturer, The American Institute of Longevity, and found nothing but a site that said, “we do not have current ad for you today.” The American Institute of Longevity is not listed with the Better Business Bureau. I couldn’t find any information as to whether dissatisfied customers actually get twice their money back. If they do, that would be an easy way to earn some money!
This is all very strange. In all my years of researching products like this on the Internet, I have never found so little information. It makes me suspicious. What do you suppose is going on here?
The treatment of erectile dysfunction
Erectile dysfunction is caused by low blood flow to the penis, usually as a result of conditions like arteriosclerosis, high blood pressure, and high cholesterol. Viagra (sildenafil) is a prescription drug that increases blood flow to the penis. It works. The natural remedies are alleged to work by increasing testosterone levels; but increasing testosterone is useless for men with normal testosterone levels or men with low levels whose only symptom is erectile dysfunction. Viagra has a lot of side effects, warnings, and precautions. And it is expensive ($60.10 per tablet at CVS, $58.70 per tablet at Walmart pharmacy).
There are other options. Sildenafil has a number of relatives: tadalafil (Cialis), vardenafil (Levitra), and avanafil (Stendra). There is also alprostadil self-injection into the penis, alprostadil urethral suppositories, penis pumps, and penile implants. These have been tested. They work. Supplements have not been tested and shown to work.
According to a website that rated the top male-enhancing formulas, Viril-X was the best. It contains 21 powerful all-natural ingredients: Korean Ginseng, Tribulus terrestris, L-Arginine, Avena sativa (oats), Muira Puama, Maca, Orchic, Niacin, Nettles, American Ginseng, Zinc, Eleuthero, Catuaba, Kola Nut, Boron, Pumpkin seed, Ginger, Sarsaparilla, Barrenwort, L-Citrulline, and Cayenne. There is no rationale for those ingredients, and no studies to evaluate whether the mixture is effective. And interestingly, there is no overlap of ingredients with Viotren.
And then there’s low intensity extracorporeal shock wave therapy. How does it work?
The gently pulsating waves of the GAINSWave™ promote increased blood flow to the penis by opening existing blood vessels and stimulating the growth of new blood vessels. The improvement in blood flow results in stronger, harder, and more sustainable erections.
The pulsating waves also trigger a healing response that “wakes-up” dormant stem cells and growth factors in the penis. The release of these “growth factors” also leads to the creation of new blood vessels, as well as the overall rejuvenation of erectile tissue.
Maybe. I’m skeptical. It traumatizes tissue and I question whether it really activates stem cells; how could they know that? Did they measure stem cells in the penile tissue after treatment and determine that they had been activated? The systematic review concludes “Owing to the limited number and quality of the studies, more large-scale, well-designed and long-term follow-up time studies are needed to confirm our analysis.” I’ll withhold judgment for now.
Some of the natural products for erectile dysfunction do really work, but that’s because they are adulterated with prescription drugs. The FDA provides a long list of nearly 300 “sexual enhancement” products that have been found to contain sildenafil, tadalafil, vardenafil, and other analogs. And it says the list only includes a small fraction of the potentially hazardous products with hidden ingredients. They warn consumers about undeclared ingredients, unknown contaminants, risky interactions with other medications, and uncontrolled doses. One tainted product contained a whopping 31 times the prescription dose of tadalafil in combination with an antidepressant that is not approved by the FDA. That amount could potentially be fatal.
CBS News published a list of 10 products the FDA issued health warnings about this year or told manufacturers to get them off the shelves: Man Up Now, Stiff Nights, Rock Hard Weekend, Mr. Magic Male Enhancer from Don Wands, Magic Power Coffee, Duro Extend Capsules for Men, Vigor-25, Time Out Capsules, Vitalex, and Xiadafil VIP. They all contain versions of the same pharmaceutical that is in Viagra. Federal Marshals seized almost $75,000 worth of Xiadafil VIP after the manufacturer refused an FDA request to recall it. The founder of Vitalex is in a federal prison in Texas for Medicare fraud. These products all have the usual disclaimer that they are not intended to diagnose, treat, cure, or prevent any disease. But the marketing makes it clear that they are intended to treat erectile dysfunction and to replace prescription drugs. To my mind, they are in clear violation of DSHEArules and should all be removed from the market. I can’t really blame the FDA for not stopping all these crooks: they try, but they simply don’t have the manpower or budget to pursue all of them, and they try to concentrate their efforts on the things they think are most likely to harm the public.
Conclusion: Buyer beware
There are legitimate treatments for erectile dysfunction that have been tested and shown to work. The dietary supplement products are irrational mixtures of natural medicines that have not been tested and are not likely to help (unless they have been adulterated with unknown quantities of prescription drugs). Buying those products is risky. You never know what you’re getting, and you might get something harmful. Caveat emptor.
This article was originally published in the Science-Based Medicine Blog.