Natural relief from the discomfort of prostate related symptoms.

Product Overview

General Description of Prostaphil™

™ is a combination of water-soluble and a lipid-soluble fractions prepared from a defined set of different pollen sources. The main ingredient being rye pollen. The pollens are dried, freed from impurities and then mixed in a specific ratio. This mixture subsequently is processed in two steps at low temperature to produce the hydrophilic and lipophilic extracts, which are, respectively, light yellowish and dark greenish brown powders. These fractions are standardized according to proprietary amino acid and phytosterol content profiles and then combined to produce the final product.

The properties of this non-allergenic and non-toxic pollen extract composition were first discovered more than forty years ago and presented in journal articles beginning in 1960. This pollen extract compostion, although not well-known in the United States, has been extensively researched in Europe and in Japan. Originally, its therapeutic usage was as a general tonic in geriatrics, pediatrics and for convalescent patients to increase immune capacity, to combat chronic infections, to speed recovery and the healing of wounds, to improve metabolic functioning and to reduce inflammation. In Europe, this pollen extract composition is still prescribed to provide these benefits.

Scientific data (in vivo experimental data) shows that this pollen extract composition possesses powerful antioxidant properties and that it can serve to protect the liver and certain other tissues from pathological changes associated with exposure to ethionine, carbon tetrachloride, galactosamine, cadmium and similar toxins. Under experimental conditions, this pollen extract composition lowered serum lipids in animal models and modified the lipid deposition in the major arteries.

In addition, pollen extracts have been found in clinical studies to be particularly beneficial in cases of prostatitis, prostatodynia, benign prostatic hyperplasia (BPH) and non-specific urethritis. Compounds found in the rye pollen source have been shown in vitro to inhibit prostate cancer and stromal cell growth. ™ has a calming effect upon spasms in the musculature of the smooth muscles of the urethra and bladder neck. It improves the contractility of the bladder and reduces inflammation arising from a variety of sources. Because it exerts a broad effect upon the tissues of the urethra and the bladder, ™ offers benefits to women as well as to men.

Chemical Composition

™ is a complex natural product which as been freed from antigens and any potential contaminants. Excepting vitamin B12, it contains the known vitamins, minerals and trace minerals, numerous carbohydrates and free fatty acids, twenty-one amino acids (including the essential amino acids), naturally-occurring waxes, and various sterols and sterol esters. All components are of vegetable origin.

The special active components found within ™ are known to include beta sitosterol, diamines and derivatives of feruloylputrescine (FP), the cyclic hydroxamic acid identified as 2,4-dihydroxy-2H-1,4-benzoxazin-3(4H)-one (DIBOA), and secalosides A and B. Both water- and acetone-derived extracts of several of the individual pollens have been tested and been shown to possess distinctive benefits such that the ™ mixture has a broader general usage than would be true of an extract derived from any one of the individual pollens.

Pharmacology / Mechanisms of Action

With regard to its benefits to the prostate, ™ possesses as many as eight distinct mechanisms of action. These proposed mechanisms, presented only in outline here, are derived from both in vivo and in vitro experimental data, including data derived from tests with human subjects.

1. Relaxes Smooth Muscles

2. Improves Bladder Contractility

3. Inhibits Prostate Epithelial and Stromal Cell Growth

4. Inhibits Arachidonic Acid Cascade / Is an Anti-inflammatory and an Antioxidant

5. Inhibits the Formation of Dihydrotestosterone (DHT) via Inhibition of 5-alpha-Reductase Activity

6. Reduces the Binding of Dihydrotestosterone to Its Prostate Cell Receptor Site

7. In In Vitro Tests Has Been Found To Inhibit Prostate Cancer by Inducing the Death of Cancerous Cells

8. Reduces the Effects of Cadmium, a Suspected Inducer of Prostatic Hyperplasia

Book Cover, The Prostate Cure From the book "The Prostate Cure":

Throughout The Prostate Cure, we will present information for a number of studies on well-know procedures used to treat BPH (benign prostatic hyperplasia, or enlargement of the prostate) and on the studies that have accumulated using Cernitin/™. We think the data speaks for itself, but to help you evaluate that information on your own, we want to leave the topic of BPH for a moment and explain some of the rudiments of medical research and what is involved in various types of studies.

When a new medical product is developed, it may first be tested in the laboratory on animals, animal tissue, or human tissue (often removed during surgery) to determine its effectiveness. As you will see in Chapter 4, laboratory research was done many times on rates for Cernitin/™ to determine the actual contents of the products and what components of Cernitine/™ were doing what.

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Clinical Applications

Pollen extracts in combination (providing the same composition as ™ ) have been the subject of double-blinded placebo-controlled studies; double-blinded parallel studies vis- -vis beta-sitosterol, Paraprost (mixture of the amino acids L-glutamic acid, L-alanine, glycine) and Tadenan (Pygeum africanum extract); open-field multi-center studies, etc. It also has been the subject of numerous animal studies designed to elucidate its mechanisms of action. Typically, between 60% and 90% of subjects have reported improvements within 1 to 3 months, depending upon the severity of their conditions at the start of the studies. Pollen extract clinically has proven to be useful in the treatment of prostatitis, prostatodynia, benign prostatic hyperplasia (BPH), and non-specific urethritis.

In direct comparisons, the pollen extract composition has outperformed beta-sitosterol, Paraprost (mixture of the amino acids L-glutamic acid, L-alanine, glycine) and Tadenan (Pygeum africanum extract). Although beta-sitosterol is found in the oil-soluble fraction, the results found with the pollen extracts go far beyond those reported with beta-sitosterol. The overall results of clinical trials involving BPH have been as good as or superior to those reported with any other phyto-pharmaceutical remedy. Pollen extracts, moreover, unlike other natural remedies, can boast a record of success against prostatitis, prostatodynia and other urogenito-tract conditions.

As can be seen in Figures 1 and 2 (adapted from [15]), pollen extracts, when used with subjects experiencing moderate sypmtomatic BPH for three months, provided significant relief in all of the following categories of complaints: urgency/discomfort, dysuria, nocturia, incomplete voiding, prolonged voiding, delayed voiding, intermittency and post-voiding dribbling. After three months, the overall clinical efficacy was 85%.

More dramatic still, pollen extracts have a pronounced beneficial effect when used long-term. As the second figure shows, both prostatic volume (confirmed via transrectal ultrasonography and digital examination) and residual urine volume declined remarkably with continued treatment, confirming the results found in experimental animal studies in which the weight of the ventral and dorsal lobes of the prostate decreased with treatment with pollen extract. These results were stable in the 28 subjects who were followed for one year, which further indicates that the benefits were not merely placebo. A decline in prostate volume has been reported in several of the clinical studies, but this reduction in prostate size appears to be significant only with usage which continues beyond one or two months. Another study found a significant decrease in prostate volume with four months of treatment.

Figure 1 shows the results found with 79 patients with mild to moderate symptomatic BPH. These patients ranged from 62 to 89 years of age, with a mean age of 68. Pollen extract was given to these subjects at the rate of 126 mg three times per day for 12 weeks. Urgency or discomfort improved by 76.9%; dysuria, by 71.4%; nocturia, by 56.8%; incomplete emptying, by 66.2%; prolonged voiding, by 64.1%; delayed voiding, by 62.2%; intermittency, by 60.6%, and postvoid dribbling, by 42.7%.

Figure 1: Three Month Results (Clinical Therapeutics 1995; 17,1:82-87)
Symptom Improvement Diagram

The long term follow-up of 28 patients who had responded well in the short term examined the results of treatment with pollen extract for more than one year. There was a significant decrease in prostate volume, a significant increase in maximum flow rate(MFR) and significant decreases in symptom scores and residual urine volume.

Figure 2: Year-Long Follow-Up (Clinical Therapeutics 1995; 17,1:82-87)
12 Month Study Diagram

Usage

Both the hydrophilic and the lipophilic extracts are active, but against different, if overlapping ranges of causative and symptomatic elements. For this reason, the ™ combination includes 60 mg of the water-soluble extract for each 3 mg of the oil-soluble fraction. It has been determined that there is a definite dose response relationship with this roduct. At 63 mg actives per dosage form, it is recommended to take 6 tablets per day (either 2 tablets three times per day between meals or 3 tablets taken upon arising and upon retiring on an empty stomach) for one to three months or until relief is obtained. Once relief is obtained, maintenance is usually 1 to 2 tablets per day, although it may be advantageous to continue at a higher dosage level of 4 tablets/day (2 tablets taken morning and evening on an empty stomach). Long-term usage leads to additional benefits which differ in kind from those found with short-term usage.

Toxicity

™ is considered to have no toxicity with either acute or chronic administration. The LD50 in mice and rats is greater than 16 grams/kilogram of body weight, which suggests that acute toxicity in the average (70 kg) human would require the ingestion of more than one kilogram of ™ . In clinical trials, pollen extracts have been extremely well-tolerated. In most trials no side effects of any kind have been reported. Rare mild temporary gastro-intestinal tract upset was reported in one large open-field trial with 2,289 patients (in approximately 2.5% of the subjects, which is a level roughly equal to that typically found with placebo).