|
A LOOK AT THE VIAGRA IMITATORS: HOW DO THEY MEASURE UP?
(06/30/2004) by Ellen Rapp
“Recapture the firm erections of your youth!”
“Give her the satisfaction she craves!”
“Experience the best sex of your life!”
Lines like these appear every day as spam in our e-mail inboxes, pitching products that promise to deliver strong erections. Containing various mixes of herbal ingredients, often in combination with vitamins and minerals, these formulas – and there are dozens of them – claim to promote erection by acting on the circulatory, nervous or hormone systems. Many promise additional benefits ranging from greater sexual stamina to more intense orgasms for the men who use them. Some claim to enhance non-sexual performance as well: boosting energy and well being, and even improving memory.
These products also promise to provide results safely: with few or no side effects, and without putting the user’s health at risk. Marketing strategies are geared to attract men who want to improve their erectile function with the least amount of effort and risk, and without resorting to pharmaceutical methods: namely, Viagra, Levitra or Cialis. As popular and effective as these drugs are, they have been shown to cause adverse reactions in some men who take them. Men who take nitrate-containing medications for heart conditions are advised to avoid these drugs entirely.
Sold over the counter in pharmacies and health food stores, as well as via the Internet, the herbal formulas touted for erectile dysfunction are cheaper, and easier to obtain, than pharmaceutical remedies. But are they worth buying?
Questions of Safety and Efficacy
“When discussing these products, there are really only two questions to ask,” says Drogo Montague, M.D., a urologist and director of the Center for Sexual Function at the Cleveland Clinic in Ohio. “Are they safe? And are they effective?”
When considering questions of safety and efficacy, be aware that these preparations are not classified as drugs. That means they do not have to be approved by the Food and Drug Administration, and thus don’t have to undergo the lengthy and extensive clinical trials, involving hundreds or thousands of patients for each drug tested, that are required for FDA approval.
Obviously, herbal formulas are not subjected to this kind of rigorous scientific testing. While most of these products are probably harmless, according to experts interviewed for this article, consumers who are thinking of using them should nonetheless proceed with caution and never exceed the recommended dosage.
Potential users should also be aware that “certain herbs can interact adversely with certain drugs,” says Scott Pescatore, Pharm.D., a former fellow at the University of North Carolina at Chapel Hill division of pharmacotherapy. Anyone considering an herbal product should make a list of medications and any other drugs you take, including alcohol, “and go over it with your pharmacist, to see what’s safe and what isn’t.”
Consumers should be particularly cautious when taking a product that contains yohimbine - an African plant extract said to promote sexual function by acting on nerves that affect the penis - which elevates blood pressure, and can cause dizziness and nausea in some individuals. Use common sense here: If you are experiencing adverse effects with any product, stop taking it.
An additional note: Since these preparations are not regulated, they may not contain all the ingredients advertised. Or worse, they may contain certain ingredients that aren’t advertised. According to recent news reports, Dr. Neil Fleshner of Toronto’s Princess Margaret Hospital and his colleagues bought seven products touted as herbal supplements for treating erectile dysfunction and analyzed their contents. The researchers found that two of the so-called “herbal” products contained significant levels of sildenafil, the active ingredient in Viagra, or tadalafil, the active ingredient in Cialis: both of which can be fatal if taken with heart medications containing nitrates.
How Effective Are They?
Do the supplements work? “There is little clinical evidence that any of these preparations are effective,” says Dr. Montague, who chaired a 1996 American Urological Association panel for guidelines on treating erectile dysfunction. “Some of them may serve as high-priced vitamin and mineral supplements, but beyond that, I suspect that most are useless.”
Additionally, because the products are not regulated, “there is no consistent process for evaluating what’s inside the bottle,” says Linda Banner, Ph.D., a psychologist and sex therapist with a private practice in Palo Alto, California and a researcher for Stanford Medical Center at Stanford University.
As a result, a product that claims to contain, for instance, 10 percent yohimbine may actually contain only one percent - or none at all. In fact, a recent analysis of non-drug formulas for erectile dysfunction, conducted by a New Jersey laboratory, revealed that many of these products do not contain all the ingredients listed on their label.
Are Any Worth a Try?
Despite experts’ statements that herbal products are not an effective treatment for erectile problems, many of us have seen the ads that feature glowing testimonials from satisfied customers and, with increasing frequency, physicians’ endorsements for the product. You may even know someone who takes one of these products and has nothing but good things to say.
So, how does one make a decision? “Depending on the ingredients,” says Pescatore, “certain products may be more helpful than others” (assuming that said ingredients are actually present). Listed below are three ingredients that, according to some studies, may be somewhat effective in enhancing erectile function.
However, keep in mind that studies done on an individual ingredient are not any indication that a product containing this ingredient will produce the same results. Sexual Health Network has only come across one product (see Arginmax, below) that has been clinically tested in its market-ready form, with study results published in a medical journal.
L-arginine. “Formulas that contain L-arginine probably have a better chance of helping erectile problems than those without it,” notes Linda Banner. An amino acid that naturally occurs in the body, L-arginine acts as a building block for the body’s production of nitric oxide: a substance that enhances circulation and facilitates erection by relaxing smooth muscles in the blood vessels, allowing them to become engorged with blood. The main drawback of L-arginine supplements, adds Banner, is that men generally have to take them for 30 days or more before they see any results.
Dr. Montague doubts that taking supplementary L-arginine can help erectile dysfunction patients. “Humans generally don’t have amino acid deficiencies to begin with, so I don’t see that ingesting an amino acid will make much difference.”
However, a few studies indicate there might be some benefit. A double-blind study at Tel Aviv University in Israel (reported in BJU International, February 1999) examined the effects of L-arginine supplements in men with organic erectile dysfunction. After six weeks, nine of the 29 patients taking L-arginine (and two of 17 in the placebo group) reported significant improvement in sexual function. Another study, published in the Journal of Urology (September 1997) found that long-term oral administration of L-argentine improved erectile response in aging rats.
ArginMax, a supplement containing L-arginine along with various botannical ingredients and nutrients, has undergone several physician-directed studies, published in the Hawaii Medical Journal. In one pilot study, 25 men with mild to moderate erectile dysfunction received the supplement twice a day over a four-week period. Twenty-one of the men completed the four-week regimen; of those, 89 percent said they experienced improved ability to maintain an erection during intercourse, and 75 percent reported increased satisfaction with their sex lives.
This pilot study was followed up by double-blind study of 48 men, with erectile dysfunction ranging from mild to severe, who were randomly assigned ArginMax or a placebo. After four weeks, 87.5 percent of the men in the ArginMax group reported improvement in staying erect during intercourse – compared to 22 percent in the placebo group. Seventy-five percent of those taking Arginax said they felt more satisfied with their sex lives; only 21 percent of the placebo users said the same.
None of the men in the study experienced headaches, nausea, dizziness, blood pressure alterations or any other significant side effects.
Yohimbine. A commonly listed ingredient in formulas promoting erection, the plant extract yohimbine has been shown to have some effectiveness,” says Pescatore. While some physicians say that yohimbine is useless as an erectile dysfunction remedy, others believe it is sometimes beneficial. Atlanta urologist Steven Morganstern, M.D., in his book Overcoming Impotence (Prentice Hall, 1994) declares that as many as a quarter of men with erectile dysfunction can be helped by yohimbine when it is prescribed in its synthetic, scientifically manufactured drug form. But, he cautions, consumers should be aware that the drug form of yohimbine (known as Yocan) is not the form contained in the herbal preparations, and that the latter may be “of questionable effectiveness.”
Avena sativa. A wild oat extract with a reputation as an aphrodisiac, avena sativa has not been widely researched as a treatment for erectile problems. However, the Institute for the Advanced Study of Human Sexuality, in San Francisco, conducted several studies starting in the late 1980s, testing the effects of the substance on sexual desire and function. One study involved 30 men, ages 55 to 72, who were unable to achieve an erection or had difficulty maintaining one. After two months of taking avena sativa, 19 men experienced improved erectile function, “with erection ability and sexual activity returning to pre-impotence levels,” notes the Institute. The study had no control group, so it is not known how men on placebos would have responded.
Researchers at the Institute say that avena sativa improves sexual desire and function by “freeing up” testosterone that becomes bound to compounds in the body with advancing age, rather than circulating through the bloodstream.
Dr. Montague challenges this theory. “It’s true that as men age, testosterone does bind with compounds called testosterone-binding globulins, so that there is less circulating testosterone,” he says. “But this does not happen to a magnitude that would trigger erectile dysfunction. When ED occurs, it happens for other reasons than decreased levels of testosterone in the bloodstream. We don’t see erectile dysfunction patients helped by taking androgens (male hormones), either.”
Human Growth Hormone: Erection Booster?
Another substance that has been promoted as an enhancer of erectile function and libido is human growth hormone (HGH). Secreted by the pituitary gland, human growth hormone promotes cell growth; it is responsible for the body’s development during childhood and adolescence. Levels of HGH decline as people grow older.
In the 1980s it became possible to synthesize HGH for use as a drug. Used therapeutically for treating growth hormone deficiencies in children and adults, HGH also picked up a reputation as an “anti-aging” treatment, said to increase strength and energy, reduce fat, build muscle mass, improve skin texture – and enhance sexual function and desire. With a year of growth hormone therapy costing about $10,000, using the substance in the hope of fighting the aging process became an option for high-income youth seekers.
Other substances have been marketed, at lower cost, as HGH releasers, claiming to increase the amount of the hormone circulating in the bloodstream. While there have been anecdotal accounts of supplemental HGH leading to improved sexual function, there are no published clinical studies confirming this. A 1990 study in the New England Journal of Medicine of 12 men (aged 61 to 81) who received growth hormone injections over a six-month period did find that the men experienced decreases in fat tissue and increases in muscle mass. However, an accompanying editorial cautioned that the long-range effects of giving HGH to healthy adults were unknown.
Nonetheless, response to the article spurred the practice of “anti-aging medicine” that included the use of HGH. And as Internet use soared, Web sites and e-mail spam became venues for pitching growth hormone products.
The New England Journal of Medicine’s editor-in-chief, Jeffrey Drazen, wrote an editorial in response to the marketing phenomenon. Commenting that many advertisements for HGH products “refer to statements made in our pages as evidence of the value of these products,” Drazen discouraged readers from purchasing such products.
He wrote: “Although the findings of the (1990) study were biologically interesting… it was clear that the results were not sufficient to serve as a basis for treatment recommendation.…. If people are induced to buy (these products) on the basis of research published in the Journal, they are being misled.”
The Placebo Effect
Since many cases of erectile dysfunction do have a psychological component, it is entirely possible that some men who respond to herbal and other alternative remedies are experiencing what is known as the “placebo effect.” This occurs when a patient responds positively to a placebo (inactive substance) because they believe that it will be effective: in short, the power of mind over body.
The placebo effect is fairly common. Studies on yohimbine for erectile dysfunction, for example, generally show that about 30 percent of patients receiving placebo report improvement.
Even in “many clinical trials, including those for Viagra, the response rate of the placebo group tends to range from 20 to 40 percent,” says Ira Sharlip, M.D. A urologist at Pan Pacific Urology in San Francisco, Sharlip is also assistant clinical professor of urology at the University of California at San Francisco, and secretary of the International Society for Sexual Medicine.
The late sex therapist Bernie Zilbergeld, Ph.D., in his book The New Male Sexuality, (Bantam, 1999), described the placebo effect as follows:
“If I lined up a hundred men with erection problems and had them all drink a cup of organic camel urine daily for a week, at least ten or twenty would probably report that their erection problems had vanished. While this is not sufficient to demonstrate that camel urine is a reliable cure for erection problems, those who benefited won’t care.”
Zilbergeld makes a good point: If you believe that a particular substance or method will help you, and it does, then you don’t have a problem. “But if it doesn’t, or if it does but then stops working, try something with more scientific backing.”
Use Your Common Sense
A consumer can easily be overwhelmed by the scores of non-FDA approved products that claim to reverse erectile problems. In addition to the ingredients outlined above, they may contain any of the following botanicals: ginseng, gingko biloba, saw palmetto, muira puama (from the South American rain forest), Chinese herbs, and more, as well as vitamins and minerals. They may claim to work by increasing circulation, enhancing nervous system activity, or boosting the body’s natural production of testosterone.
If you should decide to try an herbal remedy, it’s best to avoid those that make “particularly outlandish claims,” says Dr. Montague. For instance: Products that claim to give you the sexual response of 18-year-old; to increase sperm production along with enhancing erection, or as one Chinese herbal remedy promises, to “improve physique” and cure “spiritual lassitude” as well as boost sexual function, should be regarded warily. Says Dr. Montague “Unfortunately, this is an unregulated area and people who market these products are free to say whatever they want. My advice is, Buyer beware.”
And don’t assume that a physician’s name appearing in an advertisement is any guarantee of a superior product. “I know of a doctor, a member of the American Urological Association, who endorses a product and happens to own the company that makes it,” says Dr. Sharlip.
There are also instances in which “a physician’s name is used even though he has no relation with the product advertised,” adds Sharlip. “He may have done research on a compound similar to the product or one of its ingredients, so the company will use his name in their ad. This type of thing should be controlled by the government in some manner, but because these products don’t require government approval, it isn’t.”
For example, a brochure for one of these products said that scientists at Stanford University had tested yohimbine, the product’s primary ingredient, in laboratory rats - and found that the rats’ mating activity doubled within 15 minutes of receiving the substance. The brochure heralded this research as “the Super Sex Breakthrough of 1999!” However, the Sexual Health Network, conducting telephone and online research to follow up the brochure’s claims, was unable to find any record of the study that was said to have taken place. Nor did Sexual Health Network uncover any directory listing at Stanford University for Dr. John Clark, the scientist said to have led the research.
Ultimately, it is up to the individual whether or not he wants to experiment with these products. Keep in mind that these are not FDA-approved substances, and that experimentation is at one’s own risk. Before taking any of these supplements, be sure to consult a physician or pharmacist in order to avoid adverse drug interactions.
Our advice: Don’t expect miracles. If something sounds too good to be true, it probably is. And if you are taking a product that is not helping you, then stop taking it - and talk to your physician about other options for treating erectile dysfunction.
This article appears in the following topics:
|
