BPH Study

Randomized, Open-label Study Comparison of Peenuts® and a Patented European BPH formula Versus the Signs and Symptoms of Prostate Disease Specifically Targeting Non-Bacterial Prostatitis (2004-2005)

Author – Ronald E. Wheeler, M.D.

Background for the Study

Prostate nutritional products are common worldwide, with most products claiming benefit to prostate health based on improvement in urinary symptoms consistent with Benign Prostatic Hyperplasia (BPH). The BPH formula used in this study, patented in Europe and the United States, is associated with symptoms relevant to BPH while Peenuts® is patented in the United States in association with signs and symptoms of Prostatitis. Historically, almost 50% of men have BPH related urinary symptoms by age 50 years while virtually all men with at age 50 with urinary symptoms and a PSA of ≥ 1.0 ng/ml have prostatitis.

Symptoms attributed to BPH are categorized as static or dynamic consistent with obstructive symptoms (Incomplete Emptying, Intermittency of Stream, Stream Size, and/or the need to Strain to Void) or irritative symptoms (Frequency, Urgency, and/or Nocturia), respectively. Obstructive symptoms are generally identified with Prostate enlargement (BPH) while irritative symptoms are commonly associated with Prostatitis or inflammation. Notwithstanding the above, there is considerable crossover of signs and symptoms from one disease to another. As recognized in the patent of the BPH formula, the urinating symptoms common to BPH may also be consistent with the disease process of Prostatitis. Not uncommonly, any impediment to urinary outflow from the bladder (proximally) to the tip of the urethra (distally) may produce these same symptoms. To state further, in addition to BPH and Prostatitis, other diseases or conditions associated with urinary symptoms include but are not limited to bladder inflammation/infection including Interstitial Cystitis, Prostate inflammation/infection, urethral or bladder stones, urethral stricture (narrowing) and/or bladder neck hypertrophy.

On the other hand, the number of white blood cells in the Expressed Prostatic Secretion (EPS) has no significant corollary to BPH. To state further, while voiding symptoms do not accurately reflect any specific disease with 100% sensitivity, the Expressed Prostatic Secretion (EPS) is a disease marker that accurately identifies the presence of inflammation (Prostatitis) 100% of the time when the white blood cell count is greater than or equal to 10 WBCs per high power field (400X).

The inability to identify the requisite number of white blood cells does not preclude the presence and/or evolution of the disease but the diagnosis becomes less certain. The EPS may be routinely obtained at the time of digital Prostate examination and massage. Validation for the diagnosis is clinically assured in the presence of a normal urinalysis preceding the EPS. The work of Stamey, Meares, and others confirm these facts.

Based on the above, it is reasonable to conclude that the Expressed Prostatic Secretion is the only legitimate biological marker that can be used to identify benefit of any product, concept or formula versus Prostatitis.

Description of Study

12 men were recruited to this study based on qualifications that included either a Prostate Specific Antigen (PSA) in excess of 1.0 ng/ml or significant urinary symptoms. To qualify, men were required to present with a normal urinalysis, precluding the possibility that either PSA level or symptoms of urination were falsely elevated in association with a urinary tract infection. Additionally, all men denied the previous or concurrent use of prostate formulations. None of the men were under the care of a physician at the time of the study and denied personal knowledge for the presence of BPH, Prostatitis, or Prostate Cancer. The 12 men were randomized in accordance with study standards to receive either the BPH formula or Peenuts® in an open label protocol. Product ingredients and amounts were determined and manufactured in accordance with the respective patents. Men were asked to take the product in accordance with standard instructions. Men were placed on the respective products for a period of minimally 4 months. All participants signed a consent form with agreement to participate willingly. An Independent Review Board was not required to sanction or monitor the study as both products are concurrently available to the public. Nonetheless, men were asked to contact the Prostatitis & Prostate Cancer Center in the event of questions or concerns. All testing was initiated and carried out by the staff of the Prostatitis and Prostate Cancer Center under the auspices of Ronald E. Wheeler, M.D., (Urologist).

All men received a qualifying urinalysis, PSA, and International Prostate Symptom Score Index (IPSS-Index) as well as a battery of tests intended to evaluate and distinguish the parameters of prostate disease consistent with either BPH or Prostatitis. In addition to the above mentioned tests, all men received a Uroflow (measures urine volume over time), a Post Void Residual Ultrasound (identifies an amount of urine that remains in the bladder immediately after the Uroflow), and a physical examination focusing on the male Genito-Urinary system. Specifically, the Prostate exam was performed confirming a lack of Prostate Cancer and/or suspicious nodules, organ atypia, or asymmetry. Men subsequently had a Prostate massage in the standard fashion yielding a secretion at the tip of the Urethra. There was no difficulty obtaining 3-4 spontaneous drops of secretion during this procedure. The secretion was gathered on a glass slide and evaluated microscopically under 400X once the cover slip was placed with a subsequent evaluation of minimally 30 fields of view. The examination failed to identify any bacteria or yeast, but all patients exhibited white blood cells in excess of 10 WBCs per high power field consistent with the diagnosis of non-bacterial Prostatitis. In addition to evaluating the EPS for Prostatitis, associated with the number (range) of white blood cells, all specimens noted secretory granules, oval fat bodies, crystals, and scattered red blood cells.

Enclosed in this report are documents that reflect the intensity and complexity of this evaluation including the Pre-Nutritional Assessment as well as the Post-Nutritional Assessment of comparative data tables associated with age, PSA, IPSS-Index, Uroflow (total bladder volume and voided volume), Post Void Residual, and Expressed Prostatic Secretion. Additionally, the work sheets on all patients are included to allow the reviewer to easily correlate the data points studied. The names in this study were not redacted as this assists the integrity of the validation process. For this reason, this document is confidential and only indicated for the purpose intended by the review person or panel and must not be disseminated.

Analysis of Results

In a small study conducted over a limited time frame, it is often difficult to find points of clinical or scientific relevance that allow for profound commentary. Despite this criticism, there was benefit identified with both formulas versus signs and symptoms of Benign Prostatic Hyperplasia (BPH). Most notably, the BPH formula improved the Peak Flow and Average Flow modestly when compared to Peenuts®. Importantly, while the participants improved these clinical Uroflow parameters, the men generally failed to appreciate the clinical benefit as noted through the IPSS-Index scores. Comparatively speaking, Peenuts® demonstrated an improvement in urinating symptoms in this pre-qualified Prostatitis population as well as improvement in the Uroflow parameters of average flow and peak flow. In this case, it may have been that the patients selected for the study were better candidates to demonstrate Prostatitis rather than BPH.

To state further, the Peenuts® formula excelled versus Prostatitis as evidenced by the quantification of the Expressed Prostatic Secretion (EPS). The finding for the reduction in the EPS by 68.2 % matches closely with the 66% recorded in the US Patent application process. Additionally, the 73% reduction in EPS noted in a Prospective Study evaluating the benefit of diet and nutrition on Prostate Cancer Patients continues to show the clustering of data relevant to inflammation resolution with the Peenuts® formula. By comparison, while the BPH formula failed to impact the number of white blood cells, the rise in white blood cells evidenced in this group, in my opinion, merely reflects an exacerbation of inflammation common to the disease process rather than speaking to a lack of significant benefit of the BPH formula to Prostatitis. Notwithstanding the inability to improve the EPS, an equally plausible interpretation could be that men would need to take this formula for a period of time in excess of 4 months to identify benefit or in fact, the product was never intended to impact prostatitis beyond symptom improvement.

Conclusion

In a Randomized Open Label Study in excess of 4 months, data showed unequivocally the benefit of Peenuts® to make an impact on the signs and symptoms of prostatitis. The BPH formula, conversely, better known for its benefit versus the signs and symptoms of BPH, failed to demonstrate convincingly any ability to alter the EPS, as the diagnostic marker for prostatitis. To state further, while urinating symptoms are common to BPH and Prostatitis, the symptom complex is not sensitive enough to identify either disease with absolute certainty. While this study does not deprecate in any way the merits of the BPH formula, it clearly suggests that Peenuts® is effective versus the disease process of Prostatitis and that the additional ingredients contained in the Peenuts® formula are integral and synergistic to the disease resolution process.

Formulas

Patented BPH Formula Ingredients: Pumpkin Seed, Zinc, Saw Palmetto, Pygeum, Vitamin E

Patented Prostatitis formula (Peenuts®) Ingredients: Pumpkin Seed, Zinc, Saw Palmetto, Pygeum, Vitamin E, Vitamin C, Selenium, Echinacea, Nettle, Vitamin B 6, Ginkgo Biloba, Garlic, Glycine, Alanine, Glutamic Acid

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