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Use of Natural Products to
Treat Benign Prostatic Hyperplasia (BPH) and Chronic Non-Bacterial Prostatitis: Emphasis
on Cernitin
by Harry G. Preuss, MD FACN CNS
Many males throughout the world, both young and
old, suffer severely from the ravages of cardiovascular disorders and cancers, but another
important area of specific concern receiving less attention involves a small gland of the
reproductive tract called the prostate.1 The prostate is very important for a
number of health reasons. Malignancy of this gland is recognized as the most common cancer
among men (1 out of 10) and, unfortunately, is the second most fatal. It has been
estimated that over 300,000 men will develop prostate cancer in the coming year, and more
than 40,000 will succumb to it. It is important to note that the prostate gland is also
the origin of an even more widespread problem benign prostatic hyperplasia (BPH).
The morbidity from benign prostatic hyperplasia surpasses that of prostatic cancer
nearly 60% of men over the age of 40 have an enlarged prostate, and the incidence
increases to over 80% by the age of 80.2,3,4,5 Over $1 billion dollars are
spent each year on treatment for prostatic enlargement.
The major function of the prostate, a gland
associated with the male reproductive system, is to produce and discharge a viscous
alkaline liquid that provides a major portion of the seminal fluid. This gland is made up
of both muscular and glandular tissue. It produces semen to carry sperm in the ejaculate.
Sperm are protected, at least to some extent, and can survive longer after ejaculation
because of the environment afforded by the presence of prostatic fluid. Prostatic fluid
also contains prostaglandins, which are fatty acids that, similar to hormones, affect
smooth muscle fibers and blood vessel walls.
Although the prostate plays no direct role in the
functioning of the male urinary system, many urinary perturbations occur when it expands
via growth due to its location at the outlet of the bladder.1,6 The prostate is
located in front of the rectum and below the urinary bladder. Importantly, it surrounds
the urethra, a tube which carries urine from the bladder to the tip of the penis for
expulsion. The gland is the size of a pea at birth and grows slowly until puberty. Driven
by sex hormones, the prostate grows at a faster pace. During the 20s and 30s, the gland is
characteristically the size of a walnut, weighing roughly one ounce. Around age 45, cells
in the prostate multiply once more causing the gland to grow up to 10 times the normal
adult size.7
Common symptoms of obstructive BPH include (1) a
weak urinary stream, (2) a sense of incomplete bladder emptying, (3) difficulty initiating
urination, (4) frequent urination (especially at night when it is referred to as
nocturia), (5) urgency (difficulty postponing urination), and (6) interruption of the
stream (stopping and starting). The typical sufferer usually becomes aware of the problem
when the urge to urinate becomes more frequent than expected. The person suffering with
BPH rarely can sit through a movie or concert he is the one that requests the aisle
seat on an airplane in order not to disturb his fellow passengers by his frequent sojourns
to the restroom. At night, trips to the bathroom caused by nocturia steadily increase, so
that there is a definite impingement on sleep. Accordingly, any experiencing of such
urinary frequency should lead to suspicion of the disorder. In view of the rising life
expectancy of the male population, knowledge of the means with the best risk/benefits
ratio to treat BPH in its various stages will become even more important.
In the past, treatment options for prostate
enlargement focused on surgery. Over the last few years, prescription drugs have been used
to initiate therapy against BPH in its early stages. One highly recognized group of agents
works chiefly to inhibit the activity of 5-alpha reductase (finasterides). Another group
works to relax the muscle tissue of the prostate and thus relieve the pressure around the
urethra (alpha blockers). Unfortunately, surgery and pharmaceuticals used to treat BPH
carry a high cost and the added risk of potentially debilitating side effects. In recent
years, emphasis has been placed upon the use of natural compounds to ameliorate the
symptoms of BPH and chronic non-bacterial prostatitis. The attractiveness of natural
compounds, for the most part, lies in their fewer serious side effects compared to drugs.
In many cases, natural products work similar to many pharmaceuticals used to treat BPH.
Some plant extracts not only lower the rate of DHT formation like finasterides, but block
the ability of DHT to bind to cells, preventing the action of hormone. They may also relax
the musculature involved in urination similar to alpha blockers. In addition, they may
prevent severe inflammatory responses similar to drug inhibitors of the prostaglandin
cascade (COX 2 inhibitors).
A number of natural products have been recognized
as having some therapeutics use for prostate problems. The natural product most used for
prostate problems is saw palmetto.8,9,10,11,12,13 A number of clinical studies
have substantiated the efficacy of saw palmetto usage in treating BPH.14,15,16,17,18,19
Pygeum africanum contains phytosterols which have been purported to have
anti-inflammatory properties.20 When 263 German men were tested with Pygeum
africanum, urinary symptoms improved in 66% compared to 31% in the placebo group.
Occasional gastrointestinal upset seems to be the major adverse side effect. Less work has
been performed using the stinging nettle (Urtica dioica) to ameliorate BPH.21,22
Of late, much attention has been focused on beta-sitosterol.23 Beta-sitosterol
is a phytopharmacological agent containing many phytosterols. In a randomized,
double-blind study reported in the Lancet,24 200 patients with symptoms
of BPH from eight private urological practices were treated for six months with either 20
mg of beta-sitosterol or placebo. At the end of six months, modified Boyarsky scores25
decreased significantly in the beta-sitosterol-treated group compared to placebo.
Reduction took place in prostatic volume, the quality of life score improved, the peak
urine flow increased, and the mean voiding time and urinary volume retention also improved
from the initial scores in the sterol group, whereas no changes were noted in the placebo
group. Importantly, no severe adverse reactions were attributed to beta-sitosterol.
Compared to other natural products, a defined
flower pollen extract called "Cernitin" has received less recognition in the USA
as a therapeutic agent for prostate perturbations.26 Ironically, it may be the
best natural product for this condition yet recognized. In 1950, a beekeeper in a tiny
Swedish village found a way to collect pollen artificially.27 Initially, the
flower pollen was used as a prophylactic agent against infections. Later the extraction
process was modified so that the active pollen was released and was non-allergenic. Oily
Cernitin GBX and water soluble Cernitin T60 are
important extracts of a mixture of three different pollen strains: timothy, maize, and
rye. Found in the pollen are peptides, carbohydrates, fatty acids, vitamins, minerals,
nucleic acids, and enzymes. Whatever the original hypothesis concerning overall health,
Cernitin proved specifically useful in treating BPH.28
Many types of clinical trials of all varieties
examining the therapeutic benefits of Cernitin on prostate
perturbations, including randomized, multi-center, double-blinded, and placebo-controlled,
have been published. The most significant investigations have been performed in Europe
(Germany, Britain, Switzerland) and Japan. End points for examination have included both
subjective (various questionnaires and history of symptom amelioration) and objective
(flow rates, residual urine volumes, estimation of prostate size, and concentration of
prostate specific antigen [PSA evaluation]) criteria. The overall trend in all these
trials, both open and blinded, was to show an improvement in the symptoms and signs of BPH
and chronic prostatitis, whether subjective and/or objective criteria were used. Brief
descriptions of some clinical investigations are listed below:
- Using pollen extract, Leander29
found a 60-80% improvement over placebo in symptoms of obstruction, probably through
elimination of inflammatory edema.
- In 1967, Ohkoshi, Kawamura and
Nagakubo of Keio University, reported impressive results in 30 patients with prostatitis
and/or urethritis.30 Examining 14 patients receiving cernitin, it was found
that treatment was successful in 10, slightly effective in three, and ineffective in only
one case.
- Takeuchi31 investigated both
subjective and objective effects of Cernitin on 25 men with BPH. There was a 50% improvement of nocturnal
micturition.
- Inada, et al., reported favorable
effects in 12 patients suffering from prostatic hypertrophy.32 They reported
that five cases had "effective" results, five showed "slightly
effective" results and two reported "ineffective" results.
- In 1986, a field study of 2,289
patients being treated by 170 urologists was undertaken.33 Improvement of
symptoms was reported in 64-82%, in contrast to a low rate of adverse reaction found only
in 2.9% of cases.
- Brauer34 compared the effects of
Cernitin and beta-sitosterol in 39 patients. A significant
reduction in circulating levels of PSA with Cernitin therapy indicated a reduction of cell lesions in BPH. In contrast,
no such change occurred with beta-sitosterol treatment. Although flower pollen extract
proved superior to beta-sitosterol in many respects, the mean values for residual volume
fell under 15 ml for both at the end of the treatment.
- In a double-blind, placebo-controlled study
performed in 1988 in collaboration with six practicing urologists, Becker and Ebeling
examined 48 patients taking Cernitin
and compared them with an
equal number of patients receiving placebo over a 12-week interval.35 The
results showed that there was a significant improvement using Cernitin
compared to placebo of nocturia, i.e., 69% vs. 37% (p < 0.005).
Not only the sensation of residual urine but the actual volume of residual urine was
significantly reduced by flower pollen extract. Mild nausea was reported in one patient.
- In a follow-up, open study emanating from
the above double-blinded study, 92 patients, all receiving cernitin, were evaluated.36
There was a marked improvement in nocturia and residual urine volume. Differences between
Cernitin and placebo groups during the initial, double-blind
phase were balanced out after the switch from the placebo to cernitin.
- In an open trial using the defined Cernitin pollen extract on 15 patients with chronic prostatitis or
prostadynia, Buck and his colleagues reported that 13 obtained either complete and lasting
relief of symptoms or marked improvement only two patients failed to respond.37
- In a paper appearing one year later, Buck,
et al., performed a larger study on 57 patients with outflow obstruction due to BPH.38
This was a double-blind, placebo-controlled trial to evaluate the effect of a six-month
course of pollen extract on symptomatology. The overall subjective improvement with the
defined Cernitin pollen extract of 69% more than doubled that of the
placebo group (30%). The investigators reported a significant decrease in residual urine
with Cernitin and in the antero-posterior diameter of the prostate
by ultrasound assessment.
- Rugendorff, et al.,39
performed a prospective, case-controlled, open trial to treat chronic prostatitis and
prostadynia. In 90 patients who were treated for six months, freedom of symptoms and
normalization of the palpation finding were obtained in 50-70% of patients without
complicating factors.
- Braun and Peyer40 in a
1993 double blind, placebo-controlled investigation on 44 patients with Grade I and II BPH
assessed the validity of treatment with flower pollen extract on subjective and objective
parameters. They found by using questionnaires, echography, and laboratory analysis of PSA
that flower pollen extract had a clear benefit over placebo. In 25 patients receiving
verum compared to 19 receiving placebo, there was a significant reduction in the mean
number of both diurnal and nocturnal micturitions with flower pollen extract (p <
0.05). Using ultrasonic measures, the mean volume of the prostate decreased significantly
more in the verum group (-29% vs -8.8%, p < 0.05). More reduction in residual urine
volume and PSA levels were noted in the verum group.
- An open post-marketing observation study in
which 208 doctors participated investigated the efficacy and tolerability of Cernitin
in the treatment of BPH stage I-II according to Aiken.41
One thousand seven hundred ninety-eight patients were treated for 24 weeks. Improvements
in all irritative symptoms in 50-80% was noted, and residual urine volume improved.
Adverse effects were noted in 15 patients (0.8%). The perturbations were mainly
gastrointestinal symptoms, and termination of treatment because of adverse effects were
seen only in four patients.
- In a Japanese study published 1995, 79
patients were treated with Cernitin
pollen extract.42
At a dosage of 126 mg tid, symptom scores based on a modified Boyarsky rating scale,25
uroflowmetry, prostate volume, and residual volume were measured. Urine maximum flow
increased significantly from 9.3 ml/s to 11 ml/s, while residual urine volume decreased
significantly from 54.2 ml to less than 30.0 ml. When 28 patients who had received
treatment for one year were examined, a mean decrease of prostatic volume of 26.5 cm3
was found.
We undertook a randomized, placebo-controlled,
double-blind study using a combined treatment of cernitin, saw palmetto, vitamin E and
beta-sitosterol.43 Patients were enrolled from 3 urological practices in the
USA. One hundred forty-four subjects were randomized for study. Of those, 17 subjects
eventually withdrew, leaving 70 patients in the nutraceutical group and 57 in the placebo
group to complete the study. Patients received either placebo or the combined natural
products for 3 months. Evaluations were performed via the AUA Symptom Index scores,
urinary flow rates, PSA measurements, and residual bladder volumes. Nocturia showed a
markedly significant decrease in severity in patients receiving the combined natural
products compared to those taking placebo (p < 0.001). Daytime frequency was also
lessened significantly (p < 0.04). When the average individual total AUA Symptom Index
score in the verum group was compared to that in the placebo group, the difference proved
highly significant (p < 0.014). PSA measurements, maximal and verage urinary flow
rates, and residual volumes showed no statistically significant differences.
The major mechanism behind the beneficial action of
Cernitin is believed to be inhibition of edema formation and
prevention of inflammation in the prostate. Inflammation of the prostate can cause edema
of the interstitial tissue surrounding the acini and ducts of the glands leading to poor
drainage. This, in turn, creates difficulty in voiding, dysuria, frequency, and nocturia
symptoms which have been shown to improve with flower-pollen extract usage. In
addition, pollen extract has been reported to reduce prostatic volume and residual volume,
and improves voiding difficulties and urinary flow rates of patients with BPH. Obviously,
pain may be due to such processes and will remit if these perturbations are overcome. It
is believed that the anticongestive action is based upon the inhibition of prostaglandin
and leukotriene biosynthesis. It has been noted that the activities of 5-lipoxygenase and
cyclo-oxygenase enzymes are markedly reduced and the arachidonic cascade is interrupted.28
Additional pharmacological effects reported for the pollen
are: inhibition of prostate cell growth in animals, influences on contractility of bladder
and urethral smooth muscle, as well as diaphragms of animals, and influences on metabolism
of dihydrotestosterone.28 In conclusion, the combined mechanisms behind the
effects of Cernitin pollen extract will go a long way to
ensure overall prostate health.
About the Author
Dr. Preuss is a graduate of Cornell Medical School in
New York City, trained for three years in internal medicine at Vanderbilt University
Medical Center, spent two years as a fellow in renal physiology at Cornell University
Medical Center, and two more years in clinical and research training in nephrology at
Georgetown University Medical Center. He then worked as an Assistant and Associate
(tenured) Professor at the University of Pittsburgh Medical Center for five years. He
returned to Georgetown and became a Professor of Medicine and Pathology (tenured). His
bibliography includes over 150 peer-reviewed research papers, 110 miscellaneous items such
as requested articles, book chapters, etc. and over 170 abstracts. Dr. Preuss has edited
or co-edited four books and two symposia published in well-established journals. He is the
co-author of The Prostate Cure. He was a special research fellow of the NIH in 1966
and an Established Investigator of the American Heart Association between 1967-1972. In
1976, Dr. Preuss was elected to membership in the American Society of Clinical
Investigations, a prestigious research group. He has had numerous grants from the NIH and
completed a recent one for the US Department of Agriculture. He is currently an advisory
editor for six journals. His previous appointments included four years on the Advisory
Council for the National Institute on Aging and was their representative to the Advisory
Council of the then director of the NIH (Wyngaarden). He was appointed by the Secretary of
Health, Education and Welfare and became a member of the Advisory Council for the Office
of Alternative Medicine of the NIH. He was appointed by the National Research Council for
Health of Meridian, Idaho, to be their director. He has been a member of many other peer
research review committees for the NIH and American Heart Association and was recently
appointed to the advisory council of the National Cholesterol Education Program at the
NHLBI. Dr. Preuss has been invited as a featured speaker at many meetings and has
participated in discussions concerning nutrition on audio and video tapes, as well as live
television. Dr. Preuss is a Fellow of the American College of Nutrition (ACN), former
chairman of the Hypertension Council of the ACN, and is now Past President of the ACN
after a brief stint on their board of directors, three years as secretary/treasurer and
three years as Vice President, President-Elect and President. Dr. Preuss is a member of
the board of directors for the American Preventive Medical Association and is on the
medical advisory board of Advocare, Inc., of Dallas, Texas, and the Alzheimers
Prevention Foundation. He is a consultant for Novartis Pharmaceuticals (Summit, New
Jersey), Alternet Health Technologies (Los Angeles, California), and InterHealth
Neutraceuticals (Concord, California). Dr. Preuss wrote the nutrition section for the
Encyclopedia Americana and was recently certified as a Certified Nutrition Specialist. He
is now Co-Chairman of the Internal Review Board, which reviews all clinical protocols at
Georgetown University Medical Center.
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Article appeared in:
June 2000 Original Internist
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