Confusion Between Powder Capsule and Extract Softgel Forms Can Result in Significant Under-dosing Relative to Clinical Trial Results
ORLANDO, Fla., Aug. 10, 2010 — Today, Valensa International (Eustis, FL USA) sent communications to thought leaders, marketers and retailers of saw palmetto cautioning them about widespread improper use of the leading botanical ingredient in support of prostate health. The potential for improper use stems from consumers confusing clinically unproven powdered saw palmetto capsules containing saw palmetto berry powder with similar-sized capsules containing clinically proven oil extract. The communication cited a series of clinical trials that show that a daily dose of 320 milligrams of saw palmetto oil extract mitigated the common effects of benign prostatic hyperplasia (BPH) in middle-aged and elderly men who were suffering from frequent urination and other common manifestations of BPH. Saw palmetto oil extract is the only form of the product used in every successful saw palmetto BPH clinical trial to date. Saw palmetto powders are usually sold in 320 to 500 mg capsules that mimic their oil extract counterparts in size. These powder-form products contain only about 10-12% of the oil extract that has been studied in all of the successful clinical trials. At this rate, users would need to consume between 7 and 10 capsules a day to ingest the 320 mg oil extract dose supported by the trials. Typically, dosage recommendations for these powder-form products are only 1 capsule per day. It is estimated that 50% of the sales of saw palmetto in the United States are related to these powder-form products. Powder-form saw palmetto is virtually unknown in Europe, where the botanical is regulated as a drug in some countries and sold as a supplement in other countries.
According to Dr. Rudi E. Moerck, President & CEO of Valensa, there is a great potential for consumers to miss out on the benefits of saw palmetto extract supplementation if they follow the recommended dosage levels with the powder-form products. "There is a solid body of evidence based on a number of clinical trials that show the 320 mg per day dosage of pure saw palmetto oil extract offers support to men experiencing the common effects of BPH. There have been no studies done on similar levels of the powder-form products," he said. "Just because both product forms start with saw palmetto berries, it doesn't mean they are equivalent when it comes to achieving the result we expect from saw palmetto oil extracts. Both a car and a bicycle can get you from Chicago to St. Louis – I just wouldn't recommend the bicycle to anyone I cared about. At the end of the day, we should be recommending the oil extract form of the product for supporting prostate health, because the science says it works and it is easier and less expensive for consumers to get the levels required," he said.
Powder Versus Extract: What's the Difference?
Saw palmetto berries (Serenoa repens), which grow wild in Florida and other parts of the Southeastern United States, have been harvested and extracted for use for mitigation of the effects of BPH in the USA since about 1872. Berries are typically harvested from August to October each year. Powder products are made by drying and then crushing and grinding the green whole berries. On the other hand, extracts are made using a variety of processes that remove the oil from the saw palmetto berry, leaving an inert berry mass, which is then discarded. The berries used for oil extracts are typically the more mature berries because they have high oil content and are more economical to extract. In the United States, most saw palmetto extracts are made using safe, super-critical CO2 extraction.
The components of saw palmetto that are interesting to scientists break down into four groups: free fatty acids, phytosterols (plant sterols), free fatty alcohols and monoglycerides. The United States Pharmacopeia (USP) has developed a set of minimum standards for saw palmetto as a nutraceutical supplement based on total fatty acids, fatty acid profile, total fatty alcohols and phytosterol levels (U.S. Pharmacopeia Saw Palmetto Extract. USP 26 – NF 21 First Supplement. 2003. p.3024-25). Very high-efficiency saw palmetto extraction methods – such as supercritical CO2 – yield higher levels of these important compounds. With powder-form products, the oils are held inside the inert berry mass, and subsequently, they have substantially lower amounts of the relevant compounds. Laboratory analysis shows that saw palmetto powders contain between 10 and 12 percent oil, while the high-quality extracts contain 100%.
The Science – and Business – of Prostate Health
Recent head-to-head clinical trial results in Europe again confirmed that herbal saw palmetto extract is as effective as prostate health drugs like finasteride and dutasteride in blocking the critical enzyme that leads to BPH. These and similar results in earlier trials, including another popular drug, tamsulosin, confirm that saw palmetto is the nutraceutical of choice in supporting prostate health. Also, in these trials, saw palmetto had none of the side effects observed for the registered drugs. In all cases, these clinical trials have been conducted using a saw palmetto oil extract and not a powder-form product.*
Typically, conditions related to benign prostatic hyperplasia begin to develop in men in their late 40s. These include urinary hesitancy, frequent urination, dysuria (painful urination), increased risk of urinary tract infections, and urinary retention. Today, more than 70% of men over 50 exhibit symptoms of BPH. This percentage will grow substantially as they age, with studies showing 90% of men in their 70s and 80s affected by BPH. Today, more than 1 million instances of BPH are reported in the USA and Europe each year. This number will rise as the baby boomer population ages.
As a nutraceutical, saw palmetto extract is one of the most trusted products in the market today and has been available on the US market as an extract since the 1870s. It is the #3 nutraceutical supplement by sales volume in the United States. In the United States, consumer saw palmetto sales are approximately $200 million. Around the rest of the world, sales are roughly $500 million – for a global market size of around $700 million.
Moerck says he does not have a problem with the powder-form product per se, but with the dosage recommendations made by marketers and retailers that fall short of the levels suggested by clinical trials. "Saw palmetto has been used safely and effectively for decades. The powder-form product is probably fine if you take eight to ten capsules or tablets a day – even if that is a pain in the neck and expensive," he said. "However, if men only use one 320 mg dose of powdered-form product – there is no proof that it will have any impact on the effects of BPH at all. As people who work in the nutritional supplement market, we are doing a disservice to our customers when we make these casual recommendations that are not based on science – and perhaps more importantly, we aren't helping give men the relief that they so desperately need," he added.
*For information on clinical trials conducted with saw palmetto extract, contact Valensa or visit http://www.valensa.com. An excellent source of information on saw palmetto can be found via the American Botanical Council at http://www.herbalgram.org.
For further information, contact:
Dr. Rudi E. Moerck, President
Voice: 210-632-0695
Fax: 352-483-2095
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