Summary of articles and clinical support for Physician Approved™ supplements.

For centuries, saw palmetto berries have been used in patients with prostate and urinary problems. Analysis of saw palmetto and other plant-derived prostate treatments reveals the common ingredient phytosterols. In particular, beta-sitosterol.

In Europe, very powerful extracts of the above mentioned herbs are sold by prescription only and are very expensive. These are all standardized according to their phytosterol content. In France, the prescription form of this substance is called "Permixon". In German, this is sold as "Harzol", "Tadenan", Cernilton" and Azuprostat". A large number of studies have looked at the effectiveness of beta-sitosterol in the treatment of prostate problems.

In one study, for instance, in European Urology (vol 21, pg 309-14, 1992) Di Silverio and colleagues showed that very powerful saw palmetto extracts were very effective in treating benign prostate hypertrophy. They hypothesized that this was due to the phytosterols inhibiting the nuclear estrogen receptors of the prostate gland as well as strongly inhibiting the conversion of testosterone into dihydortestosterone by inhibiting 5-alpha-reductase. This is the identical mechanism of the American prescription drug Proscar, although the native activity of the plant-derived product is less.

In the British Journal of Clinical Pharmacology (vol 18, p 461-2, 1984) Champault and colleagues used Permixon to treat BPH with veIy good success. The phytosterols acted as anti-androgens to prevent the formation of DHT (dihydrotestosterone) and inhibit 5-alpha-reductase. Night urination was dramatically reduced, urine flow rate was greatly improved and the bladder residual urine was reduced.

In the British journal Pharmacy (vol 79, p 327, 1983) Briley showed that the betasitosterol in Permixon inhibited DHT by antiandrogenic action.

InMed Sci. Res. (Vol 16, p 1067-68, 1988), Malini et al used pure beta-sitosterol to reduce the weight of the dorsolateral prostate, It is important to note they used 350 mg per 70 kg human equivalent. This also lowered the fructose concentration of the prostate which is basic to growth of this gland.

Klippel et al in a 13 center placebo-controlled study evaluated pure beta-sitosterol complex. Using the intenational prostate symptom score, they proved the benefit of beta-sitosterol for BPH. (British Journal of Urology vol. 80, p. 427-32, 19973.

Perhaps the clearest study of the effectiveness of beta-sitosterol on BPH was done in the journal Lancet (vol. 345, p 1529-1532, 1995). Berges et al found that pure beta-sitosterol complex, was the herbal constituent in saw palmetto and other herbs responsible for prostate health.

In the British J. of Urology (vol 78, p 325-35, 1996), Buck et al produced an extensive review article entitled "Phytotherapy for Prostate". In the article, they discuss several European prescription extracts of phytosterols. They report on the 5-alpha-reductase inhibition, lack of side effects and androgen blocking effects.

In Current Therapeutic Research (vol. 55, p.776-85, 1994) Braeckman et al found dramatic improvements of BPH symptoms in only 45 days. They used Prostaserene, a saw palmetto prescription extract from Belgium with high phytosterol content.

In trials in the Journal of the National Cancer Institute (March 18, 1998; 90(6):416-417), Vitamin E was shown to reduce prostate cancer rates. A 20% reduction in prostate cancer rate was reported in men consuming diets high in Iycopene, the active ingredient in tomato-based foods (J.National Cancer Institute, December, 1995; 87(23): 1767-1776 ).

In the June 1996 Edition of Family Practice News, a reduction in prostate cancer incidence was observed in subjects taking selenium. Dr. William Fair, Chief of Urologic Surgery at Memorial Sloan-Kettering, is currently conducting a prostate cancer nutrition intervention study to evaluate the apparent added benefit of low fat diet and soy products in combination with selenium.

Dr. Donald Lamm documented a beneficial effect of garlic (Allium sativum) on bladder cancer in an animal study reported in the journal Cancer, May 15, 1997, 79(10): 1987-94. Isoflavonoids were found in higher concentrations in the prostates of men from countries with low prostate cancer incidence, as reported in lathe Prostate by Morton et al, 1997; 32: 122-28.

Isoflavonoids, Saw Palmetto, garlic extract, Vitamin E, Selenium, Zinc, and lycopene have been combined in Physician Approved™ to provide men with a single supplement which can benefit prostate health. As outlined in the citations above, phytomedication, combined with a low fat diet rich in soy products, appears to aid in prostate cancer prevention as well as in the treatment of symptoms from benign prostate hypertrophy. Our brochure however does not state or imply any direct benefit for prostate cancer despite the compelling evidence listed above. Also, informational material distributed in physician's offices, complies with FDA requirements and contains the requisite disclaimer for non-prescription dietary products.