The purpose of this letter is to alert physicians and the general public
to the potential implications regarding the detection and treatment of
prostate cancer involved with the use of an alternative supplement sold
in health food stores called saw palmetto. Prostate cancer is the most
commonly diagnosed cancer in American men. In 1996, an estimated 317,100
new cases of prostate cancer, and 41,400 deaths from prostate cancer
will be found, among men in the United States. It is the second most
common cause of death in men older than 55. Early detection is the most
important factor for cure! We are detecting prostate cancer within the
past decade with increasing frequency, and many patients with this
condition are receiving such treatments as radical prostatectomy and
radiation therapy for cure.
Although refinements in PSA-based testing have contributed substantially
to the increased detection rate of prostate cancer, the incidence of
disease was increasing dramatically even before the detection of PSA was
possible. Self medication for prostate disorders has increased
throughout the US and the rest of the world. Saw palmetto in particular
raises concerns for urologists regarding their ability to diagnose and
treat prostate cancer. I have seen many patients who have placed
themselves on this herb. Its use is advised in advertisements and other
marketing for treatment and prevention of benign prostatic hyperplasia
(BPH), prostatitis, and "urinary difficulty" in men.
The extract comes from the berries of the palm tree saw palmetto
(Serenoa Repens, Serenoa Serrulata), which is indigenous in the Atlantic
southeast coast of North America from South Carolina to Florida and
native to the West Indies.The plant grows six to 10 feet tall, with a
crown of large spiny-leaves that form a circular, fan-shaped outline.
The berries are deep red-brown or black and are oblong and about one
inch long. The extract from these berries is cheap and easy to purchase.
Word has been spread via direct marketing, as well as by advertisements
in magazines and throughout the Internet. Reports, mostly in the
European literature, suggest that use of saw palmetto can decrease the
size of the prostate and improve urinary symptoms (dose dependent) after
months of use.[1] No "well done" long-term, double-blind,
placebo-controlled studies of saw palmetto have been done to date.[2]
Although saw palmetto does not affect certain hormonal levels, there is
clinical evidence, however, to suggest that its mechanism of action is
similar to that of the commonly prescribed prostate drug finasteride
(Proscar). For example, several animal studies[3, 4] suggest that saw
palmetto has a similar effect on competitively inhibiting the binding of
dihydrotestosterone (DHT) and blocking the conversion of testosterone to
DHT, via its inhibition of 5-alpha reductase.
Saw palmetto's primary therapeutic action is to inhibit 5-alpha
reductase in forming DHT and to a lesser extent, 3-alpha reductase, and
to block the action of DHT to receptors on prostate cells via
3-ketosteroid reductase. Research has also shown an anti-inflammatory[5]
and antiestrogenic[3, 6,7] effect of Serenoa Repens. Use of saw palmetto
in >patients with BPH results in reduction in the size of the
prostate.[5 ] With finasteride, however, studies have shown that 6 to 12
months of >treatment with 5 mg of finasteride daily can reduce prostate
volume, DHT, and prostate-specific antigen (PSA) levels by 50
percent.[8] Therefore, any patient placed on finasteride must have a
baseline PSA and digital rectal examination.The mechanism of action
mimics the pharmacologic action of finasteride, which has recently been
documented to be of little physiologic value compared with a placebo or
alpha blockers.[9] The purified extract of saw palmetto contains 85% to
95% fatty acids and sterols. Unfortunately, there are many forms of this
extract on the market, containing additives and many combinations of
other herbs, vitamins, and minerals. Consequently the consumer does not
know exactly what he is purchasing. Saw palmetto has been used in Europe
for more than 20 years. Research there, however, has included clinical
studies showing its clinical urologic effects versus a placebo. [10]
Only one study measured the PSA levels prematurely after 3months "the
treatment did not significantly alter PSA concentrations in these
patients."[13] However 5-alpha reductase inhibitors will reduce the PSA
levels by average of 50% after 6-12 months of use, invalidating this
study on PSA. Consequently of most significance is the lack of well
planned "long term clinical studies" concerning the effects of saw
palmetto on "lowering the PSA" levels after 6-12 months! Any
interference with PSA makes this test useless as a diagnostic tool for
prostate cancer.
The use of saw palmetto is not regulated by the FDA (its use falls under
the guidelines for food supplements). In my own clinical practice, I
have seen many patients on saw palmetto who were embarrassed to bring
this to my attention. I have also noticed a dramatic drop in PSA levels
when patients have been on this herb for many months, making my clinical
diagnostic determination of prostate cancer more complex. Any 5-alpha
reductase inhibitor--whether saw palmetto or finasteride--will reduce
PSA significantly. I quote Dr. Julian Whitaker in his book, Prostate
Report-Prevention and Healing[11]: "When one of my patients has an
elevated PSA, I don't rush him off for a biopsy. Instead, I encourage
him to go on a low-fat diet, and I prescribe a daily course of serenoa
repens extract, 360 mg a day, along with zinc and a regimen of
antioxidant vitamins and minerals. We then recheck his PSA level
periodically, and it has been my clinical experience that, in many
cases, the PSA gradually falls." This is an example of how an underlying
condition, possibly prostate cancer, can potentially be concealed by
losing the sensitivity of the PSA diagnostic test. Although refinements
in PSA-based testing have contributed substantially to the increased
detection of early prostate cancer, the incidence of the disease is
increasing dramatically although the detection by PSA-incidence is
alling since 1992. [12] Possibly the confusion in the literature about
when to and who to treat prostate cancer has contributed to this
decline. So has the introduction of medical therapy with 5-alpha
reductase inhibitors and herbs introduced during the same time period.
The most disturbing aspects of self-treatment with such herbal remedies
are their potential effects in masking PSA, which has revolutionized our
ability to pick up prostate cancer. If one curtails the ability to
detect prostate cancer by PSA, many cancers will progress undetected
until it is too late, resulting in Stage D Disease.
As a clinical urologist, I feel that the public deserves and has the
right to know these possible consequences--further research is needed. I
am not saying that saw palmetto or finasteride should never be used, but
only that they should be used with careful medical supervision and after
obtaining a baseline PSA and digital rectal exam. Although saw palmetto
is an herb, we must treat it as a medicine. Since saw Palmetto can act
as a 5-alpha reductase inhibitor, thereby potentially interfering with
PSA levels in men and decrease prostate cancer detection, it is
imperative that men get a baseline PSA level (as is recommended by the
FDA for Finasteride, but not for the unregulated use of Saw Palmetto).
Men self -medicating themselves with this herb are not aware of this
detrimental effect. We are in a new world where patients are more
inclined to self-treat their medical conditions with alternative means.
I believe that there is some merit to this, with proper guidance by
qualified individuals. The escalating cost of medicines in the US has
provoked Americans to seek more cost-effective approaches, which is one
of the many dilemmas that our present health care system has to address
promptly. Doctors need to be better educated about nutrition and
alternative medicine. Physicians in the US are not informed about
alternative botanical medicine; we are far behind the European community
in this regard. I believe that there are many benefits to botanical
treatments for many ailments when combined with nutritional approaches.
We must discover the alternative approaches that are accessible to us,
while simultaneously using these remedies when appropriate and combining
them with conventional medical treatment. We must start to incorporate
this into our medical schools and residency programs so that we maintain
the doctor-patient relationship. To render a proper diagnostic
evaluation, doctors and patients must communicate with each other, which
means that patients should inform their doctors about their use of any
over-the-counter vitamins, minerals, or herbs. A man who treats himself
may have a fool for a patient!
Arnaldo F. Trabucco, M.D
Department of Surgery, Division of Urology
Catholic Medical Center of Brooklyn & Queens
St. Johns Hospital
Elmhurst, NY
References:
1. Weisser H., Tunn S., Behnke B., Krieg M.: Effects of the sabal
serulata extract IDS 89 and its subfractions on 5 alpha-reductase
activity in human benign prostatic hyperplasia. Prostate 1996;
28:300-306.
2. Lowe F., Ku J.: Phytotherapy in treatment of benign prostatic
hyperplasia: A critical review. Urology 1996; 48:12-20.
3. Carilla E., et al: Binding of Permixon, a new treatment for prostatic
benign hyperplasia, to the cytosolic androgen receptor in the rat
prostate. J. Steroid Biochem 1984; 20:521-523.
4. Sultan C., et al: inhibition of androgen metabolism and binding by a
liposterolic extract of serenoa repens B in human foreskin fibroblasts.
J. Steroid Biochem 1984; 20:515-519.
5. Di Silverio F., et al: Plant extracts in BPH. Minerva Urol Nefrol
1993; 45:143-149.
6. Di Silverio F., et a.: Evidence that Serenoa Repens extract displays
antiestrogenic activity in prostatic tissue of benign prostatic
hypertrophy. Eur. Urol 1992; 21:309-314.
7. Briley M., et al: Permixon, a new treatment for benign prostatic
hyperplasia, acts directly at the cytosolic androgen receptor in rat

8. Stoner E.: 5 Alpha-reductase inhibitors/finasteride. Prostate suppl.
1996; (6): 82-87.
9. Lepor H., Willford W.D., et al: The efficacy of terazosin,
finasteride, or both in benign prostatic hyperplasia. Veterans
Administration Cooperative Studies Benign Prostatic Hyperplasia Study
Group. N. Engl. J. Med. 1996; 335:533-539.
10. Dreikorn K., Schonhofer PS: Status of phytotherapeutic drugs in
treatment of benign prostatic hyperplasia. Urologe A 1995 Mar; 34(2):
119-129.
11. Whitaker J.: The Prostate Report--Prevention and Healing, chapter 7,
p 44. 1994, Phillips Publishing, Inc.
12. Stephenson R., et a.: "The fall in incidence of prostate carcinoma:
On the down side of a prostate specific antigen induced peak in
incidence"--Data from the Utah Cancer Registry. Cancer 1996; 77:
1342-1348.
13.Braeckman J.: The extract of sereona repens in the treatment of
benign prostatic hyperplasia: a multicenter open study.Current
Therapeutic Research (Vol. 55, No. 7,July, pp 776-785) 1994.

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