Scientific Data on AFFIRM ingredients

Thank you for your interest in AFFIRM, the official nitric oxide booster for GAINSwave shockwave therapy.  This is Dr. Judson Brandeis board-certified urologist and chief medical officer of AFFIRM science.  I am also the director of clinical excellence for GAINSwave.  AFFIRM is an all-natural tablet consisting of L citrulline Muira Puama, red Beet root and Panax or Asian ginseng.  During GAINSwave shockwave therapy, patients are instructed to take a loading dose of 2 pills twice a day for the first six weeks of treatment.  After six weeks; I recommend that patients take two pills once a day.  The tablets can be taken with or without food but preferably with food and water.  It takes several weeks in most cases for the nutritional supplement to begin to improve blood flow, but many patients respond earlier in the course of treatment.  The purpose of this webinar is to educate our prescribing physicians and loyal customers.  I will present the data behind the all natural ingredients in AFFIRM.

The word Citrulline derives from the Latin word for watermelon.  It is found in watermelon rind, so it is virtually impossible to get sufficient amounts through your diet.  Citrulline increases nitric oxide levels which then boosts blood flow to the penis which in turn improves erectile function.  Because citrulline boosts nitric oxide, it may have been an antiplatelet effect which means it acts as a weak blood thinner so be careful when combining it with other blood thinning drugs.  However, I am not aware of any case reports of significant bleeding.  It also may cause a slight reduction in blood pressure.  If you are on other blood pressure medications or high doses of Viagra or other PDE 5 inhibitors, please check with your doctor.  You also need to have adequate kidney function for this product to work properly because kidneys facilitate the conversion of L citrulline into nitric oxide by way of L-arginine.  From a functional perspective, combining L citrulline with Viagra and other PDE 5 inhibitors should be synergistic.

It is better to take L-citrulline then to take L-arginine.  The liver metabolizes L-arginine The metabolites can significantly decrease your blood pressure.  The kidney converts L citrulline into L-arginine.  Arginine interacts with nitric oxide synthase which produces  L-citrulline and a molecule of nitric oxide.  The citrulline is then recycled back into arginine where it becomes available again to become a nitric oxide donor.  Nitric oxide then initiates a chain reaction which results in vasodilation.

This article appeared in the journal Urology in 2011.  Twenty-four patients were given L-citrulline 1500 mg/day for a month.  There was a statistically significant improvement in erectile hardness and an increase in the frequency of intercourse.  The researchers concluded that although citrulline alone was less effective than PDE 5 inhibitors, L-citrulline supplementation was safe and well accepted by the patients. 

The second article out of Japan appeared in the Journal of Sexual Medicine.  It looked at L-citrulline and Transresveratrol supplementation in combination with PDE 5 inhibitors.  What they found was that a combination of L-citrulline and Transresveratrol is effective for erectile dysfunction treatment in men taking PDE 5 inhibitors, and that the supplement may augment the effects of PDE 5 inhibition.

The second ingredient in AFIRM is red beet extract, known to be a natural means of increasing nitric oxide and manage hypertension.  The endurance sports community has endorsed red beet root extract as a way to improve athletic performance.  Beet root is known to be rich in antioxidants which protect cells from oxidative injury to DNA, lipids and protein structures.

The following is an overview of bioactive compounds isolated from Beet Root.   The compounds that are important to us are nitrates which boost nitric oxide and betalains which are strong antioxidants that protect against oxidative injury and injury from oxygen free radicals.

There is an excellent review article in Nutrients in 2015 on the potential benefits of red beet root supplementation and health and disease.

Figure 3 shows the excellent free radical antioxidant properties of beets, second only to pomegranate juice.

The study concludes that the powerful antioxidant, anti-inflammatory and vascular protective effects altered by beet root and its constituents have been demonstrated by several in vitro and in vivo human and animal studies.  Hence it’s increasing popularity as a nutritional approach to help manage cardiovascular disease and cancer.  In human studies beet root supplementation has been reported to reduce blood pressure, decrease inflammation, avoid oxidative stress, preserve endothelial function and restore cerebrovascular hemodynamics.  Furthermore, although beyond the scope of this review, several studies have now established beet root supplementation as an effective means of enhancing athletic performance. 

The third ingredient in AFFIRM is Muira Puama, commonly known as potency wood.  It is a small tree that is native to the Brazilian Amazon rain forest.  The benefits of treating impotence with Muira Puama have been studied in human trials in France.  These studies showed that Muira Puama was effective in improving libido and treating erectile dysfunction.  In one study of 262 male patients, 62% of the patients reported that the extract of Muira Puama had a dynamic effect and 51% of patients with erectile dysfunction felt that Muira Puama was beneficial.  The second study indicated Muira Puama could enhance libido, increase the frequency of intercourse and improve the ability to maintain an erection.

Korean Red ginseng has also been investigated extensively.  In Korea there is even a journal of ginseng research where you can find the following monograph.  Ginseng has been traditionally used for thousands of years in Asian countries as a therapeutic agent for a variety of diseases and its effects have been well documented by researchers.  Raw ginseng refers to freshly harvested ginseng.  Red ginseng is manufactured by steaming the fresh ginseng without peeling the roots and then drying it. 

The Korean food and drug administration has approved claims for the immunity improvement, fatigue relief, blood circulation improvement, memory enhancement, and anti-oxidation properties.

A review article on using red ginseng for treating erectile dysfunction published in 2008 in the British Journal of clinical pharmacology concluded that the randomized controlled trials suggested evidence for the effectiveness of red ginseng in the treatment of erectile dysfunction.  However, the total number of randomized control trials included in the analysis, the small sample size and the methodology of the primary studies were too low to draw definitive conclusions.

AFFIRM was utilized in a study in combination with GAINSwave shockwave therapy for treating erectile dysfunction.  The results show significant improvement in erectile function from the combination of the two.  There were no side effects from AFFIRM.  Research is ongoing.  I presented this data at the Sexual medicine Society of North America meeting in Miami in 2018.

AFFIRM is comprised of L citrulline, red beet extract, Muira Puama and Asian ginseng.  There is substantial but not conclusive evidence for benefits of these supplement ingredients.  Additional studies are necessary but can be challenging to perform because people’s diets vary significantly and erectile function can be challenging to measure.  AFFIRM science continues to research the benefits of AFFIRM on erectile dysfunction and 10% of the profits of AFFIRM go towards research on erectile dysfunction.  If you would like to order AFFIRM, you can do so at AFFirmscience.com.  If you have any questions about the content of this webinar, please contact our chief medical officer Dr. Brandeis at cmo@afirmscience.com.


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