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Serenoa repens (also known as Sabal serrulata, Saw Palmet o or Dwarf palm) is native to the U. S. South Atlantic coast, as wel as Southern Europe and North Africa. This smal palm tree grows to a height of six to ten feet, and has a fan-shaped crown of leaves and dark red berries ap- proximately the size of olives.
Saw Palmetto) Indena photos Traditional indications for the use of Saw palmetto include cystitis, chronic bronchitis, asthma, diabetes, dysentery, in- digestion, and "underdeveloped breasts." The berries have also been thought to be an aphrodisiac.1 Modern usage of Saw pal- met o is overwhelmingly for the treatment native Medicine Review Monographs of benign prostatic hyperplasia (BPH).
The berries contain approximately 1.5 percent volatile oil, comprised of 63 percent free fatty acids and 37 percent ethyl esters of those fatty acids. The fatty acids include caproic, caprylic, capric, lauric, palmitic, and oleic acids, and ethyl esters of these. In addition, the berries contain beta-sitosterol and its glucoside, beta sitosterol D-glucoside, as well as ferulic acid.1 Myristoleic acid has recently been identified ch, Inc. All rights r as a cytotoxic component in Serenoa repens extract, which raises the possibility that usage of Saw palmetto may be extended to the treatment of prostatic cancer.2 Mechanisms of Action
Testosterone is converted in prostatic cells to dihydrotestosterone (DHT), catalyzed by the enzyme steroid 5-alpha-reductase (5-AR). DHT binds to androgen receptors in the nucleus of prostate cells, stimulating cellular growth and division.3-5 In benign prostatic hyperplasia (BPH) tissue, 5-AR levels are higher than in tissue not affected by BPH.4,5 The presence of Copyright 2002 Thor Page 384 Alternative Medicine Review Monographs
DHT may also stimulate 5-AR activity, causing a positive feedback loop, and more DHT.6 The standardized liposterolic Serenoa extract has been found to be a potent inhibitor of 5-AR, resulting in decreased tissue DHT. Serenoa also competitively inhibits binding of testosterone and DHT to cytosolic and nuclear androgen receptors.7-9 As a 5-alpha-reductase inhibitor, the liposterolic extract of Serenoa repens demonstrates selectivity and specificity to prostatic cel s when compared to epididymis, testes, kidney, skin, and breast cells.10 Another component of BPH is inflammation within the prostate gland. A standardized Serenoa extract has been shown to inhibit 5-lipoxygenase, and thus the downstream pro- inflammatory arachidonic acid metabolites leukotriene B4 (LTB4) and 5-hydroxyeicosatet- raenoic acid (5-HETE).11 Benign Prostatic Hyperplasia
The liposterolic extract of the fruit, standardized to contain at least 85 percent fatty acids and sterols, is currently used in the treatment of BPH. Benign prostatic hyperplasia is one of the most common medical conditions in middle-aged and elderly males, with an incidence of 50-60 percent in men ages 40-60, and greater than 90 percent in men over 80. The disease process leading to symptomatology in older males probably begins as early as the late 20s, and may have an incidence rate of 10 percent at that age. Rarely a fatal disease, BPH affects lifestyle and comfort.12 native Medicine Review Monographs A non-malignant hypertrophy of the prostate caused by hormonal processes and/or im- balances within the prostate, BPH begins in the periurethral region and includes the stromal, epithelial, and smooth muscle tissues of the gland. The fibrous capsule surrounding the gland forces most of the growth inward, compressing the urethra and causing the typical urinary symptoms characteristic of the disease. Primary symptoms include decreased force and caliber of the urine stream; urinary hesitancy, urgency, and frequency; post-void dribbling; incomplete emptying of the bladder; dysuria; and nocturia.12 In a double-blind, placebo-controlled study of 110 BPH patients, 160 mg twice per day of a standardized Serenoa extract significantly improved nocturia, dysuria, post-voiding re- ch, Inc. All rights r sidual urine, flow rate, patient self-rating, and the physician's overall assessment.13 In another double-blind clinical study, urinary symptoms and flow rates were significantly improved in 42.9 percent of patients taking a Serenoa extract, compared to 15.4 percent of patients given placebo.14 In an open trial, 67 percent of patients on Serenoa described their subjective symptom relief as "excellent," while 25 percent characterized their relief as "good."15 No side effects or toxicity were noted.
An impressive review of randomized trials found via MEDLINE (1966 to 1997 search) compared treatment results of six phytotherapeutic agents: Serenoa repens, Hypoxis rooperi, Secale cereale, Pygeum africanum, Urtica dioica, and Curcubita pepo. Studies were included Copyright 2002 Thor Alternative Medicine Review Monographs Page 385
if men had BPH symptoms, phytotherapeutic agents were used singularly or in combination, a control group received placebo or pharmaceutical therapy for BPH, and treatment duration was a minimum of 30 days. This comprehensive study concluded that, when compared to the other phytotherapies, Serenoa repens provided the strongest therapeutic evidence for BPH.16 Unlike other 5-alpha-reductase inhibitors, Serenoa repens creates this effect without inhibition of cellular prostate specific antigen (PSA) secretion. This allows for the continued use of PSA values for prostate cancer screening.17 The standard pharmaceutical therapy for BPH is the drug Proscar® (finasteride), a 5-AR inhibitor. A six-month, double-blind study of 1,098 BPH patients over 50 years of age com- pared Proscar (5 mg per day) with a standardized Serenoa extract (160 mg twice per day). Both treatments decreased BPH symptoms equal y and improved quality of life. Although both treatments significantly improved symptomatology, it is interesting to note Proscar reduced prostate size by 18 percent and the Serenoa extract reduced it six percent.18 Prostate Cancer
In vitro studies have also demonstrated that myristoleic acid, found in the extract of Serenoa repens, induces apoptosis and necrosis in prostatic tumor cells,2,19 posing the potential for Serenoa in the prevention and treatment of prostate cancer.
Polycystic Ovary Syndrome (PCOS)
native Medicine Review Monographs Because of its antiandrogenic effects, Serenoa has been used clinical y for polycystic ovary syndrome. Although formal studies have not been conducted to confirm the efficacy of Serenoa in PCOS, anecdotal clinical evidence points to its use in a protocol for this condition.20 Side Effects and Toxicity
There are no known cases of toxicity. Occasionally patients experience minor gastroin- testinal symptoms including nausea and/or abdominal pain.21 ch, Inc. All rights r The dose of the standardized liposterolic Serenoa extract (85-95% fat y acids and sterols) used in the majority of clinical studies on BPH is 160 mg twice per day. Clinical results may be seen in six to eight weeks, although a six-month trial is the minimum to assess clinical efficacy. A three-month, double-blind comparison study of two dosage regimens – 160 mg once daily versus 160 mg twice daily – showed no significant differences between the dos- ages. This study of 100 outpatients with BPH symptoms noted improvements in maximum and mean urinary flow rates as well as a decrease in residual urine volume. Both dosage regimens significantly reduced the International Prostate Symptom Score (I-PSS) mean total compared to patient baseline.22 Copyright 2002 Thor Page 386 Alternative Medicine Review Monographs
Duke JA. Handbook of Medicinal Herbs. Boca Raton, FL: CRC Press; 1985:443.
Iguchi K, Okumura N, Usui S, et al. Myristoleic acid, a cytotoxic component in the extract from Serenoa repens, induces apoptosis and necrosis in human prostatic LNCaP cells. Prostate 2001;47:59-65.
McConnell JD, Barry MJ, Bruskewitz RC, et al. Benign Prostatic Hyperplasia: Diagnosis and Treat- ment. Clinical practice guideline #8. AHCPR Publication no. 94-0582. Rockville, MD: Agency For Health Policy and Research, Public Health Service, U.S. Department of Health and Human Services; February Metcalf BW, Levy MA, Holt DA. Inhibitors of steroid 5 alpha-reductase in benign prostatic hyperplasia, male pattern baldness and acne. Trends Pharmacol Sci 1989;10:491-495.
Tenover J. Prostates, pates, and pimples. The potential medical uses of steroid 5-alpha-reductase inhibi- tors. Endocrinol Metab Clin North Amer 1991;20:893-909.
George FW, Russell DW, Wilson JD. Feed-forward control of prostate growth: Dihydrotestosterone induces expression of its own biosynthetic enzyme, steroid 5-alpha-reductase. Proc Natl Acad Sci Sultan C, Terraza A, Devillier 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.
Carilla E, Briley M, Fauran F, et al. Binding of Permixon, a new treatment for prostatic benign hyperpla- sia, to the cytosolic receptor in the rat prostate. J Steroid Biochem 1984;20:521-523.
Magdy El-Sheikh M, Dakkak MR, Saddique A. The effect of Permixon on androgen receptors. Acta Ob- stet Gynecol Scand 1988;67:397-399.
Paubert-Braquet M, Mencia Huerta JM, Cousse H, Braquet P. Effect of the lipidosterolic extract of Serenoa repens (Permixon) on the ionophore A23187-stimulated production of leukotriene B4 (LTB4) from human polymorphonuclear neutrophils. Prostaglandins Leukot Essent Fatty Acids 1997;57:299-304.
Bayne CW, Ross M, Donnelly F, Habib FK. The selectivity and specificity of the actions of the lipido- sterolic extract of Serenoa repens (Permixon) on the prostate. J Urol 2000;164:876-881.
Miller AL. Benign prostatic hyperplasia: nutritional and botanical therapeutic options. Altern Med Rev native Medicine Review Monographs Champault G, Patel JC, Bonnard AM. A double-blind trial of an extract of the plant Serenoa repens in benign prostatic hyperplasia. Br J Pharmac 1984:461-462.
Tasca A, Brulli M, Cavazzana A, et al. Treatment of the obstructive symptomatology of prostatic adenoma using an extract of Serenoa repens: a double-blind clinical study vs. placebo. Min Urol Nefrol Carreras JO. Novel treatment with a hexane extract of Serenoa repens in the treatment of benign prostatic hypertrophy. Arch Esp de Urol 1987;40:310-313.
Wilt TJ, Ishani A, Rutks I, MacDonald R. Phytotherapy for benign prostatic hyperplasia. Public Health Bayne CW, Donnelly F, Ross M, Habib FK. Serenoa repens (Permixon): a 5alpha-reductase types I and II inhibitor – new evidence in a coculture model of BPH. Prostate 1999;40:232-241.
Carraro JC, Raynaud JP, Koch G, et al. Comparison of phytotherapy (Permixon®) with finasteride in the treatment of benign prostatic hyperplasia; a randomized international study of 1,098 patients. Prostate ch, Inc. All rights r Vacherot F, Azzouz M, Gil-Diez-De-Medina S, et al. Induction of apoptosis and inhibition of cell prolif- eration by the lipido-sterolic extract of Serenoa repens (LSESr, Permixon) in benign prostatic hyperplasia. Marshall K. Polycystic ovary syndrome: clinical considerations. Altern Med Rev 2001;6:272-292.
McGuffin M, Hobbs C, Upton R, Goldberg A, eds. American Herbal Product Association's Botanical Safety Handbook. Boca Raton, FL: CRC Press; 1997:107.
Stepanov VN, Siniakova LA, Sarrazin B, Raynaud JP. Efficacy and tolerability of the lipidosterolic extract of Serenoa repens (Permixon) in benign prostatic hyperplasia: a double-blind comparison of two dosage regimens. Adv Ther 1999;16:231-241.
Copyright 2002 Thor Alternative Medicine Review Monographs Page 387

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