Health Canada is advising consumers not to use Dr. Life and Chong Cao Ju Wang due to concerns about possible side-effects.

Dr. Life and Chong Cao Ju Wang are promoted for the treatment of erectile dysfunction.

Reason for Warning

The Hong Kong Department of Health warned consumers not to buy or use Dr. Life or Chong Cao Ju Wang because they were found to contain undeclared pharmaceutical ingredients. Dr. Life was found to contain an unauthorised substance with a structure similar to tadalafil (aminotadalafil) while Chong Cao Ju Wang was found to contain sildenafil.

Tadalafil and sildenafil are prescription drugs used in the treatment of erectile dysfunction, and should only be used under the supervision of a health care practitioner.

Possible Side-Effects

Unsupervised use of tadalafil or sildenafil by patients with heart disease can result in serious cardiovascular side-effects such as sudden cardiac death, heart attack, stroke, hypertension, chest pain and abnormal heartbeat. Additionally, use of tadalafil or sildenafil may be associated with other side-effects including temporary vision loss, seizure, prolonged erection, headache, flushing, nasal congestion and abdominal pain. Products containing tadalafil or sildenafil should not be used by individuals taking any type of nitrate drug (e.g., nitroglycerine) due to the risk of developing potentially life-threatening low blood pressure.

Over many years Hackett reports regularly seeing patients referred with erectile dysfunction after a heart attack, only to hear that they had developed erectile dysfunction two to three years before – a warning sign ignored by their general practitioners.

It is well known that erectile dysfunction (a symptom of vascular disease in the smaller arteries) doubles the risk of heart disease, a risk equivalent to being a moderate smoker or having an immediate family history of heart disease. Erectile dysfunction in type 2 diabetes has been shown to be a better predictor of the risk of heart disease than high blood pressure or high cholesterol.

But despite this considerable evidence erectile dysfunction is still treated as a recreational or “lifestyle issue” rather than a predictor of a serious health problem, says Hackett.

The UK government has pledged to reduce the death rate from coronary heart disease and stroke and related diseases in people under 75 by at least 40% by 2010, yet there is no screening for erectile dysfunction in patients with diabetes or heart disease, he says.

“Continuing to ignore these issues on the basis that cardiologists feel uncomfortable mentioning the word ‘erection’ to their patients or that they may have to deal with the management of a positive response, is no longer acceptable and possibly, based on current evidence, clinically negligent”, he concludes.

Online Internet shopping today offers many benefits. You can research a product in the privacy of your own home and purchase most anything by clicking a mouse. But should we be allowed to buy prescription drugs via the Internet, bypassing a traditional office visit or conversation with a physician? In the August issue of Mayo Clinic Proceedings, researchers from Utah and several colleagues compare the relative safety of two systems — an online prescribing service versus traditional physician consultation – for patients seeking medication to treat erectile dysfunction.

Online prescribing, also called e-medicine prescribing, is relatively new in the United States. Patient demand for these services appears to be growing, but the researchers acknowledge that the health care industry “has appropriately raised serious concerns about the safety of prescribing over the Internet.” In 2002, the state of Utah signed a contract with an Internet prescribing service to prescribe erectile dysfunction drugs called PDE-5 inhibitors. Erectile dysfunction (ED) is the inability of a man to maintain a firm erection long enough to have sex.

The researchers randomly selected 1,000 patient medical records from patients seeking ED treatment from Jan. 1, 2001 to Dec. 31, 2005. Half (500) of these patients used the online prescriber (the e-medicine group), and 500 consulted a physician (the traditional medicine group) for treatment.

Using statistical analyses, the researchers compared the safety of both approaches — e-medicine versus traditional medicine — in treating patients who have ED. The safety comparisons looked at a number of criteria, including prescription appropriateness, how often the prescribers used a diagnostic tool called the International Index of Erectile Questions (IIEQs) and the level of patient education provided by prescribers.

Evaluating both systems for these safety criteria, the researchers concluded that the e-medicine system “outperformed the traditional system in most of the safety variables tested.” One area the e-medicine system appeared to excel was patient education. The authors noted that 100 percent of the e-medicine clients received written manufacturer product information, and 75.2 percent of e-medicine clients received tailored electronic messages. In comparison, study data showed that no medication instructions were recorded for 51.8 percent of patients who received prescriptions via a traditional physician consultation.

“Innovation, technology and current medical practice all factor into the outcome of this study,” note the authors. “Application of an expert interview system specifically targeted to erectile dysfunction along with a continuous platform for patient client-physician communications make this particular Internet system comparable to traditional medical practice.”

The researchers acknowledge that additional research is needed to confirm these results. They also recommend that state regulatory agencies “consider using the regulatory model of oversight protections implemented by the state of Utah to license Internet prescribing companies.”

The research involved forty two (42) men diagnosed with erectile dysfunction and various other conditions such as high blood pressure, high cholesterol, diabetes and removal of the prostate. The average age was 55. All trial participants had previously failed on Viagra, Levitra or Cialis type tablets.

Test results were documented using various methodologies such as penile buckling pressures, RigiScans (an instrument that documents penile rigidity) and Erection Hardness Scores (EHS). All test participants experienced some degree of tumescence or increased blood flow and 17 of the patients or 40%, experienced erections sufficient for penetration during sexual intercourse.

Typically, trimix compound in liquid form requires refrigeration and the patient must use a needle to self inject. TriMix gel does not require refrigeration and does not use a needle. It allows the patient to carry the medicine on his person at room temperature. More importantly, an ED patient would not have to use a needle to self inject before sexual intercourse.

Dr. Marmar stated, "Among a group of men who previously failed to achieve erections on Viagra, Levitra and Cialis type tablets, TriMix-gel demonstrated statistically significant greater Erection Hardness Scores. TriMix gel may offer ED patients an elegant alternative to penile injection."

The study, published online in the Journal of Sexual Medicine, was performed on eighteen rats with age related erectile dysfunction. The cream, when applied topically, delivers drugs to treat erectile dysfunction in a controlled release fashion that eliminates the potential side effects when erectile dysfunction drugs are delivered systemically.

The researchers treated three groups of rats – one group received the topical nanoparticles erectile treatment with encapsulated nitric oxide. A second group received nanoparticles encapsulated with nitric oxide, plus an experimental erectile dysfunction drug called sialorphin. Sialorphin acts differently than PDE5 inhibitors currently on the market such as Viagra and Cialis. The third group was given the topical erectile dysfunction cream plus tadalafil (Cialis).

The nanoparticle, nitric oxide system, applied topically, combined with either sialorphin or tadalafil, significantly improved erectile dysfunction in five out of seven rats treated. Developer of the topical erectile dysfunction treatment and study co-author Joel M. Friedman, M.D., PhDs says, "Most of the animals, nearly 90 percent, showed a response to treatment with the nanoparticles.”

It only took thirty minutes for the rats to respond to the treatment says senior author Kelvin P. Davies, Ph.D., associate professor of urology at Einstein. “In both rats and humans, it can take 30 minutes to one hour for oral ED medications to take effect."

Using a topical treatment for erectile dysfunction could prove safer for men with existing heart disease, and could also provide a more effective treatment for diabetics who have high rates of erectile dysfunction. So far, the erectile dysfunction cream looks safe. The scientists found no signs of systemic toxicity, local inflammation, or other undesirable side effects.

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