Saw Palmetto Warning : Problems with Detecting Prostate Cancer?

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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.