Saw Palmetto
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Serenoa repens (W. Bartram) Small (syn. Sabal serrulata [Michx.]
Nutt. ex Schult. & Schult. f.; Serenoa serrulata (Michx.) G. Nichols.
[Fam. Arecaceae]
Overview
Saw palmetto is a small, low-growing, dwarf-palm tree,
native to southeastern North America, particularly Florida. The berries were a
staple food and medicine of the indigenous Floridians before the Europeans’
arrival (Duke, 1985; Vogel, 1970). Indigenous Americans prepared an aqueous
infusion of the berries to treat stomachache and dysentery (Duke, 1985). They
also used the fruit as a diuretic and sexual tonic (Duke, 1985). Since the
mid-1990s, saw palmetto has been one of the ten top-selling herbs in the U.S.
(Blumenthal et al., 1998; Blumenthal,
2001). Total sales in mainstream retail stores in 2000 in the U.S. were over
$43 million, ranking saw palmetto sixth in total herb sales (Blumenthal, 2001).
In Europe saw palmetto extract is the most commonly used phytotherapeutic agent
for benign prostatic hyperplasia (BPH) (Di Silverio et al., 1993), and in Germany it is one of the most frequently
prescribed botanical preparations (Blumenthal et al., 1998). Saw palmetto berry was commonly recommended for
various prostatic conditions by healthcare professionals in the early part of
the 20th century. It was an official drug, listed in the United States Pharmacopeia (USP) from 1906 to 1916 and in the National Formulary (NF) from 1926 to
1950 (Boyle, 1991) before its use as a therapeutic option for urinary tract
disorders by the medical community declined in the U.S. (Tyler, 1994). In the
20th century, the United States
Dispensatory, 23rd edition, included saw palmetto with an indication for
treatment of enlargement of the prostate gland (Wood and Osol, 1943).
Description
Saw palmetto preparations consist of the berry (fruit) of Serenoa repens (W. Bartram) Small (syn. Sabal serrulata) [Fam. Arecaceae] or its extracts.
Primary Uses
Prostate
Benign prostatic hyperplasia (BPH) (Marks et al., 2001, 2000; Ziegler, 1998;
Redecker, 1998; Di Silverio et al.,
1998; Braeckman et al., 1997; Bach
and Ebeling, 1996; Kondás et al.,
1996; Carraro et al., 1996;
Braeckman, 1994; Casarosa et al.,
1988; Champault et al., 1984). The
German Commission E approved the use of saw palmetto for mild to moderate BPH
stages I and II (Blumenthal et al.,
1998).
Dosage
Internal
Crude Preparations
Cut fruit and other equivalent
galenical preparations: 1–2 g (Blumenthal et al., 1998).
Crude berries: 10 g
twice daily (Pizzorno and Murray, 1999).
Fluid extract: 1:1
(g/ml), 1–2 ml twice daily; 1:2 (g/ml) 2–4 ml twice daily (Blumenthal et al., 2000).
Soft native extract: 10:1–14:1
(w/w), contains approximately 85–95%
fatty acids, 160 mg twice daily (Blumenthal et
al., 2000) or 320 mg once daily (Braeckman et al., 1997).
Dry normalized extract: 4:1
(w/w) contains approximately 25%
fatty acids, 400 mg twice daily (Blumenthal et
al., 2000).
Tea: Not
effective because the lipophilic-active constituents are insoluble in water
(Bratman and Kroll, 1999).
Note:
Most clinical trials have been conducted with native extract.
Duration of Administration
Research suggests that, four to six weeks of treatment are
needed for a therapeutic effect (Braeckman, 1994; Champault et al., 1984).
Chemistry
The main constituents of saw palmetto include carbohydrates
(inert sugar, mannitol, high-molecular-weight polysaccharides with galactose,
arabinose, and uronic acid), fixed oils (free fatty acids and their
glycerides), steroids, flavonoids, resin, pigment, tannin, and volatile oil
(Newall et al., 1996). The fruits and
seeds are rich in triacylglycerol-containing oil (50% of the fatty acids
contain 14 or less carbons) (Bruneton, 1999). The liposterolic fraction is the
primary active component. A recent systematic review described the chemistry of
saw palmetto fruit and related species at different dates of maturity, dosage
forms and commercial products, and fruit samples from other species of palm in
order to help control the quality of commercial products (Peng et al., 2002).
Pharmacological Actions
Human
Anti-estrogenic activity (Di Silverio et al., 1992); increases urinary flow rate (Redecker, 1998; Ziegler
and Holscher, 1998; Braeckman et al.,
1997); decreases residual urine (Redecker, 1998; Ziegler and Holscher, 1998;
Braeckman et al., 1997); decreases
painful urination (Champault et al.,
1984); decreases nocturia (Boyle et al.,
2000; Ziegler and Holscher, 1998; Vahlensieck et al., 1993a, 1993b); anti-inflammatory (Ziegler and Holscher,
1998); anti-exudative (Ziegler and Holscher, 1998).
Animal
Anti-androgenic in rats (Carilla et al., 1984); relaxes smooth muscle in rats (Gutierrez et al., 1996); anti-edemic (Stenger et al., 1982).
In vitro
Anti-inflammatory (Breu et
al., 1992).
Mechanism of Action
Human
Lowers DHT levels in prostate tissue (Marks et al., 2001).
Animal
Suppresses prostatic epithelium through a
nonhormonal mechanism (Epstein et al.,
1999).
Reduces dihydrotestosterone (DHT) in
prostate tissue, which has been implicated as a causative factor of BPH in vivo (Koch and Biber; 1994).
Competes with endogenous estrogen for
receptor sites (Di Silverio et al.,
1992).
Induces apoptosis and inhibits cell
proliferation in prostate epithelium and stroma (Vacherot et al., 2000).
In vitro
The following mechanisms are based on results from in vitro studies using supraphysiologic
dosages.
Inhibits action of 5a-reductase, which catalyzes the metabolism of testosterone to
DHT (Bayne et al., 2000; Chavez and
Chavez, 1998; Marks et al., 2000;
Sultan et al., 1984), due to the free
fatty acid content of the fruit’s lipophilic extracts (Niederprüm et al., 1994; Weisser et al., 1996).
Inhibits receptor binding of androgens
(Chavez and Chavez, 1998; Sultan et al.,
1984).
Inhibits noncompetitively human a1-adrenoreceptors in vitro (Goepel et al.,
1999).
Inhibits both the cyclooxygenase and
lipoxygenase pathways in vitro (Breu et al., 1992).
Inhibits growth factors in vitro (Plosker and Brogden, 1996).
Binds selectively to and increases apoptic
index for prostate cells in vitro (Bayne
et al., 2000).
Contraindications
Saw palmetto is not indicated for advanced BPH with severe urinary
retention. It should not be used without first ruling out prostate cancer
(Bratman and Kroll, 1999). For this reason, the German Commission E clarifies
that saw palmetto relieves only the symptoms associated with BPH and recommends
consulting a healthcare provider at regular intervals (Blumenthal et al., 1998).
Pregnancy and Lactation: No
known restrictions (Blumenthal et al.,
2000), although saw palmetto is seldom used by women. Due to potential hormonal
activity, saw palmetto is not recommended for pregnant or lactating women,
though this has not been confirmed by scientific studies (Blumenthal and
Riggins, 1997; Newall et al., 1996;
Elghamry and Hänsel, 1969).
Adverse Effects
Rare cases of gastrointestinal disturbance have been reported
(Blumenthal et al., 1998). Ingestion
on an empty stomach may cause nausea (Bruneton, 1999). Hypertension was
reported in 3.1% of patients taking the saw palmetto extract Permixon®
(a proprietary form of saw palmetto) (Carraro et al., 1996), although hypertension is not a generally reported
effect associated with the use of saw palmetto, either from clinical trials or
case reports. The general safety profile of saw palmetto extracts has been
shown to be better than finasteride (Wilt et
al., 1998). Sexual dysfunction was less common with saw palmetto
(p<0.001), and the herb has not been associated with erectile dysfunction,
ejaculatory disturbance, or altered libido (Wilt et al., 1998). Gastrointestinal disturbances, urinary tract
infections, ejaculation problems, and impotence were reported in 2% of patients
taking saw palmetto in a clinical trial on 315 men with BPH stage II or III
over three years (Brach and Ebeling,
1996). Other trials have noted mild GI upset in a small percentage (1.3%) of
patients (Wilt et al., 1998).
Drug Interactions
There are no known interactions associated with saw palmetto
(Brinker, 2001). Most clinical trials excluded men taking diuretics, alpha
blockers, and anticoagulants; thus, the potential for drug-herb interactions
cannot be dismissed, though none have been reported by patients or healthcare
providers. A review of the literature does not reveal evidence of adverse drug
interactions between saw palmetto and conventional drugs. In vitro, saw palmetto potentially inhibits the binding of a1-adrenoceptor antagonists (e.g.,
tamsulosin and prozacin) and calcium mobilization; the clinical relevance has
not been confirmed (Brinker, 2001).
American Herbal Products Association (AHPA) Safety Rating
Class 1: Herbs
that can be safely consumed when used appropriately. The editors note that rare
cases of stomach problems have been recorded and that the German Commission E
suggests regular consultation with a healthcare provider when using saw
palmetto for treatment of enlarged prostate, based on the assumption that it
treats only the symptoms without eliminating hypertrophic concern (McGuffin et al., 1997).
Regulatory Status
Canada:
Approved active ingredient in over 45 licensed products including some
Traditional Herbal Medicines (THMs). Natural Health Products (NHPs) and
homeopathic medicines (Health Canada, 2002).
France:
Authorized as a prescription drug reimbursable by the national health insurance
(Chauvarie, 2001).
Germany:
Dried fruit and other galenical preparations or lipophilic extracts are approved
by the Commission E as non-prescription drugs (Blumenthal et al., 1998). Fresh ripe fruit for preparation of mother tincture
and liquid dilutions are official in German
Homeopathic Pharmacopoeia (GHP, 1993).
Belgium: Approved
as a prescription adjuvant in BPH treatment.
Italy:
Authorized as a registered drug only (Ris, 2001).
Sweden:
Classified as Natural Remedy for self-medication requiring premarketing authorization.
Two combination products, Curbicin® with pumpkin seed (Curcubita pepo) and Prostakan®
with nettle root (Urtica dioica), are
registered in the Medical Products Agency (MPA) “Authorised Natural Remedies”
with the approved indication: “Traditionally used in case of micturition
problems caused by benign prostatic hyperplasia, e.g. frequent need to urinate
and nocturia. Prior to treatment other serious conditions should have been
ruled out by doctor” (MPA, 2001). A product monograph for Curbicin®
and a document discussing the risk for an anticoagulation effect are included (MPA,
2000, 1999).
Switzerland: Herbal
medicine with positive classification (List D) by the Interkantonale Konstrollstelle für Heilmittel (IKS) and
corresponding sales Category D with sale limited to pharmacies and drugstores,
without prescription (Morant and Rupanner, 2001; Ruppanner and Schaefer, 2000).
Three saw palmetto monopreparation phytomedicines, six polypreparations (i.e.,
multi-ingredient products), and 12 saw palmetto homeopathic preparations are
listed in the Swiss Codex 2000/01
(Ruppanner and Schaefer, 2000).
U.K.: Herbal
Medicine on the General Sale List,
Table A (internal or external use), Schedule 1 (requires full Product License)
(MCA, 2002).
U.S.:
Dietary supplement (USC, 1994). In view of the levels of evidence in clinical
trials of “moderate scientific quality” indicating that commercial extracts of
saw palmetto are more effective than placebo to treat symptoms of BPH, the United States Pharmacopeia (USP) moved
saw palmetto preparations from National
Formulary (NF) status to inclusion into the USP. This is the first time
this has been done for an herb formerly classed only as a dietary supplement.
This USP status is designated only for articles that are either approved by the
Food and Drug Administration and/or have a USP-accepted use (USP, 2002). The
mother tincture 1:10 (w/v), 65%
alcohol (v/v), of ripe fruit, is an
OTC Class C drug official in Homeopathic
Pharmacopoeia of the United States (HPUS, 1992).
Clinical Review
Nineteen studies are outlined in the
following table, “Clinical Studies on Saw Palmetto,” including 7,210
participants. All but two (Gerber et al.,
1998; Champault et al., 1984),
demonstrated positive effects for BPH. Numerous studies concluded that saw
palmetto improves symptoms of BPH including one randomized, single-blind,
placebo controlled, parallel group multi-center study (R, SB, PC, PG, MC)
(Braeckman et al., 1997), two
open-label (OL), MC studies, (Braeckman, 1994; Ziegler and Holscher, 1998), an
R, DB, controlled study (Carraro et al.,
1996), a R, comparative study (Di Silverio et
al., 1998), a prospective MC study (Bach and Ebeling, 1996), a R, PC study
(Champault et al., 1984), and two
observational studies (Vahlensieck et al.,
1993a and 1993b). Two OL studies found positive results (Kondás et al., 1996; Redecker, 1998), but
another OL study failed to find significant improvement in objective measures
of bladder outlet obstruction (Gerber et
al., 1998). Similarly, one DB, C study found no difference between saw palmetto
and placebo (Reece et al., 1986).
Several clinical trials (Carraro et al.,
1996; Rhodes et al, 1993; Strauch et al., 1994) have shown that serum
levels of testosterone, dihydrotestosterone, and prostate-specific-antigen
(PSA) are not changed significantly. One PC study looked at hormone levels, finding
no changes in testosterone, luteinizing hormone (LH), or follicle stimulating
hormone (FSH) levels (Casarosa et al.,
1988).
It is well-accepted that at least 30–50% of BPH patients
report an improvement in their symptoms after treatment with placebo (Bruneton,
1999). This percentage is about the same after simple monitoring (Chapple,
1993). Two meta-analyses of 18 R, PC trials concluded that saw palmetto
treatment for at least 30 days improves urologic symptoms and flow measures
(Wilt et al., 1998, 2000). Adverse effects were mild and
infrequent. The authors concluded that further research is needed using
standardized preparations to determine saw palmetto’s long-term effectiveness
and ability to prevent BPH complications. Another meta-analysis (Boyle et al., 2000) focused on 11 R clinical
trials and two OL trials using saw palmetto extract on men with BPH. The
analysis concluded that saw palmetto compared to placebo provided significant
improvement in the peak urinary flow rate and a reduction in nocturia.
Some anecdotal reports state that saw palmetto can mask
prostate cancer by lowering PSA levels. However, several large studies
including a total of 1,256 patients did not show this effect (Carraro et al., 1996; Braeckman, 1994).
Originally, it was thought that saw palmetto relieves the symptoms associated
with an enlarged prostate without reducing the enlargement (Blumenthal et al., 1998). However, a recent study
has detected shrinkage of the epithelial tissue in the transition zone of the
gland (Marks et al., 2000; Marks and
Tyler, 1999). Further studies are needed to confirm the finding.
A meta-analysis of recent PC trials included seven clinical
studies (Boyle et al., 2000). All
trials lasted three months, and indicated a decrease in nocturia frequency (0.5
times per night) and an increase in the peak rate of urinary flow rate by 1.5
ml/second over placebo. A six-month, R, DB, PC study (Carraro et al., 1996) comparing Permixon®
and finasteride (Proscar®) included 951 patients with BPH, and showed
an equally improved symptom score in both groups (37% with Permixon®
vs. 39% with finasteride), and equally improved peak urinary flow rates. One of
the first U.S. trials (Gerber et al.,
1998) reported symptomatic, but not urodynamic, improvement in 46 men treated
for six months with a saw palmetto berry extract.
Five studies focused on a saw palmetto
and nettle combination for BPH symptoms. One R, DB, PC study on the Nutralite®
product examined use of a saw palmetto, nettles, lemon bioflavonoid extract,
and vitamin A combination, and found significant improvement in prostate
epithelial contraction without adverse effects (Marks et al., 2000). The same combination produced a 32% reduction in
dihydrotestosterone levels compared to baseline in six months in prostate
tissue extracted via needle biopsy (Marks et
al., 2001). Four well-designed studies on the fixed combination, PRO
160/120®, ranging from 12 weeks to one year, found good efficacy and
tolerance (Sökeland, 2000; Sökeland and Albrecht, 1997; Metzher et al., 1996; Schneider et al., 1995).
Branded Products*
IDS 89: Strathmann AG & Co. / Sellhpsweg 1 / 22459 /
Hamburg / Germany / Tel: +49-401-55-9050 / Fax: +49-40-55-9051-00 /
www.strathmann.de / Email: info@strathmann.de.
LG 166/S: Laboratori Guidotti S.p.A, Via Trieste 40 56126
Pisa, Italy / Tel: +39-05-05-0521-1 / Fax: +39-05-04-0250 / Email:
a.viti@giofil.it / www.giofil.it. 160 mg liposterolic extract.
Nutrilite® Saw Palmetto with Nettle Root:
Nutrilite® / 5600 Beach Blvd. / Buena Park, CA 90622 / U.S.A. / Tel:
(714) 562-6200 / www.nutrilite.com. One tablet contains 106 mg saw palmetto
lipoidal extract and 80 mg nettle root extract.
Permixon®: Pierre Fabre Médicament / 45, Place
Abel-Gance / 92654 Boulogne / France / Tel: +33-01-49-10-8000 / Fax: +33-01-49-10-9712
/ www.dermaweb.com. Liposterolic hexane extract of saw palmetto berries,
comprised of free (90%) and esterified (7%) fatty acids, sterols, polyprenic
compounds, and flavonoids. This extract was the template for current
liposterolic extracts manufactured using either ethanol or carbon dioxide
extraction.
PRO 160/120®: Dr. Willmar Schwabe Pharmaceuticals
/ International Division / Willmar Schwabe Str. 4 / D-76227, Karlsruhe /
Germany / Tel: +49-721-4005 ext. 294 / www.schwabepharma.com / Email:
melville-eaves@schwabe.de. Fixed combination of 160 mg of saw palmetto extract
(WS 1473), 10–14.3:1, and 120 mg of stinging nettle root (Urtica dioica) dry extract (WS 1031), 8.3–12.5:1.
Prostagutt® (a.k.a. WS 1473): Dr. Wilmar Schwabe
Pharmaceuticals. Liposterolic extract made from alcohol extraction.
Prostagutt® forte: Dr. Willmar Schwabe
Pharmaceuticals. Fixed combination of 160 mg of saw palmetto extract (WS 1473),
10–14.3:1, and 120 mg of stinging nettle root (Urtica dioica) dry extract (WS 1031), 8.3–12.5:1.
Prostaserene®: Therabel Research / Egide Van
Ophemstraat 110 / 1180 / Bruxelles / Belgium / Tel: +32-02-370-4611 / Fax: +32-02-370-4690. Liposterolic
extract of saw palmetto berries.
Solaray® Saw Palmetto: Nutraceutical Corporation
/ 1400 Kearns Blvd / Park City, Utah 84060 / U.S.A. / Tel: 800-669-8877 /
www.nutraceutical.com. Each 160-mg gelcap contains 85%-95% (approximately 136
mg) essential fatty acids and steroids.
Strogen forte®: Strathmann AG & Co. The liposterolic extract is produced through
carbon dioxide extraction. Sabal extract IDS 89 is a constituent of Strogen®
forte.
Strogen® S: Strathmann AG & Co. Sabal extract IDS 89 is a constituent of
Strogen® S.
Talso®: Sanofi Synthelabo GmbH / 174 avenue de
France / 75013 Paris / France / Tel: +331 53 77 4000 / www.sanofi-synthelabo.fr.
*American equivalents, if any, are found in the Product
Table beginning on page 398.
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