Nitric oxide, Prenorex and drug regulation in China

Though the Chinese regime regulates the press more heavily than any other countries, it is incompetent when it comes to things that affect lives directly – drug, environment, food, etc. There are more snake oils in China than all combined from other countries.  It is the semi-lawless Wild West for Chinese capitalist in these fields.

Taking advantage of Chinese people’s favorable perception of Western products, especially American products, savvy marketers make all kinds of links to the US for their products. Prenorex is a classic example.

Here are the claims that link Prenorex, a nitric oxide (NO) supplement, with the US:

1. The efficacy of the drug was discovered by a US Nobel laureate – Louis Ignarro, a professor at the UCLA School of Medicine.
2. The product is manufactured by a US company – Healthway.
3. The product has been approved by the FDA of the US.

Here are the problems of the claims:

1. NO has been confirmed to have various physiological functions, but NO cannot be taken directly because it is unstable and potentially toxic. Ignarro promotes his 3-part program: supplements, nutrition and fitness.  As for supplements, he advocates L-citrulline and L-arginine.  Both amino acids can be obtained from various stores.  He invented a mixture of the supplements named Nite-works that is not what sold in China.
2. Healthway is a US company, but it has been set up by a Chinese and targets the Chinese market almost exclusively.  It is essentially a Chinese company that happens to be in the US.
3. The FDA has never approved any NO products for adult use.  NO has been approved only for neonates to treat pulmonary hypertension.  The “FDA approval certificate” shown on the product website is actually a processed food registration in the state of California which has nothing to do with the FDA.  The FDA approval claim sounds like an outright deceit.

It is not clear at all what Prenorex is exactly.  The promotion website only says it is a NO product.  It cannot be pure NO which is a colorless gas at room temperature, and it can be toxic if administered directly. If it is a simple mixture of L-arginine and L-citrulline, there should be information regarding its composition. Prenorex is treated as a food supplement in the US, and has not been validated by any clinical studies.  Without knowing Prenorex’s composition,  its users are gambling with their health and money.

Even the efficacy and long-term safety of Nite-works, the invention of Nobel laureate Dr. Ignarro, is debatable. If Nite-works is so effective in fighting so many diseases, why has its manufacturer not conducted a clinical trial? Viagra, another NO product that has a very narrow indication – erectile dysfunction, has been validated by clinical trials, hence produced a huge amount of profit.  If the benefits of Nite-works are so profound and certain, there should be every reason for its manufacturer to sponsor clinical trials.

I have no doubt about the acute effects of NO supplements, but I am yet to see evidence showing it is safe and beneficial for long term use.

The primary physiological effect of NO is vasodilatation which leads to many other benefits one of which is alleviating hypertension.   When the blood pulsatility, measured by the difference between systolic pressure and diastolic pressure, is high, it indicates possible hardening of blood vessels. In this case, NO supplements can be very useful in making blood vessels more elastic. However, hypertension can happen even without blood vessel hardening.

Let us try to understand the hypertension in layman’s terms first.  The easiest way to understand the vascular system related to blood pressure is treating it as a balloon filled with blood.  If the balloon hardens, the blood pressure will increase, and vice versa. If the balloon is filled with more blood, the blood pressure will rise too. Actually, adjusting the volume of blood is the primary mechanism of maintaining a stable blood pressure in our body.  The organ responsible for adjusting the blood volume is the kidney. Our kidney has a set-point for blood pressure. When the blood pressure is higher than the set-point, it reduces the blood volume by excreting more urine.  This is why the most frequently used drugs for hypertension are diuretics.  They essentially work on the kidney to change the set-point. How does NO affect this set-point remains to be clarified, especially, for long term.

NO is produced naturally in our body.  Our body has all kinds of feedback loop. NO supplements could well reduce our body’s natural NO reduction, and such reduction could be permanent. This may make the withdrawal of NO supplements dangerous. In other words, users may become dependent on NO supplements.

There are simply too many questions remaining to be answered for NO supplements’ long term consumption.

Ignarro advocates his 3-part program:(NO supplements, nutrition and fitness.  The nutrition and fitness parts of Ignarro's 3-part program are common sense and safe, so we should try to follow them.