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Clinical Studies
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Saw palmetto (Serenoa repens) is used for symptoms of benign prostatic hyperplasia (BPH), as a mild diuretic, an anti-inflammatory and as an antiseptic. Saw Palmetto is also used to improve sexual vigor and as an aphrodisiac, to treat chronic non-bacterial prostatitis/chronic pelvic pain syndrome and to stimulate hair growth. In combination with other herbs Saw Palmetto is used to treat prostate cancer.
Multiple clinical studies lasting up to 48 weeks have shown that saw palmetto significantly improves urinary symptoms such as frequent urination, painful urination, hesitancy, urgency and perineal heaviness. It also decreases nocturia, improves peak and mean urinary flow and lowers residual urine volume in patients with BPH. Saw Palmetto seems to be comparable in efficacy to finasteride (Proscar), but Saw Palmetto may be better tolerated. However, it does not reduce prostate size or prostate-specific antigen (PSA) levels like finasteride. Preliminary research suggests that it is similar in efficacy to tamsulosin (Flomax) after 12 months. Treatment for one to two months with Saw Palmetto is usually necessary before significant symptomatic improvement occurs.
The applicable part of Saw Palmetto is the ripe fruit. The lipid fraction contains volatile oils and fatty oils, which are active in treating benign prostatic hyperplasia (BPH). Saw Palmetto has antiandrogenic, antiproliferative and anti-inflammatory properties that seem to be responsible for improving symptoms of benign prostatic hyperplasia (BPH). Saw Palmetto appears to non-competitively inhibit 5 alpha-reductase types 1 and 2 and to prevent the conversion of testosterone to dihydrotestosterone (DHT) in vitro, which might reduce prostate growth. However, 5 alpha-reductase levels in prostatic tissue and serum testosterone, DHT and PSA are not significantly reduced by Saw Palmetto in vivo. Saw Palmetto does not seem to affect overall prostate size, but shrinks the inner prostatic epithelium. It appears to exert prostate-specific activity and might slow prostate cell proliferation by inhibiting fibroblast growth factor and epidermal growth factor and stimulating apoptosis.
Inflammatory mediators appear to contribute to the etiology of BPH. In men with BPH a liposterolic extract of Saw Palmetto berry seems to lower tumor necrosis factor (TNF)-alpha and interleukin (IL)-1beta, which are markers of inflammation in prostate tissue. Laboratory evidence suggests that Saw Palmetto inhibits lipoxygenase and cyclooxygenase (Cox), which are involved in inflammation. Increased Cox-2 expression is also associated with an increased incidence of prostate cancer. Preliminary research indicates that Saw Palmetto reduces the proliferation of experimental prostate cells, possibly by inhibiting Cox-2 expression. Saw Palmetto also seems to have antiestrogen, antispasmodic and alpha-adrenergic inhibitory properties.
Published Clinical Studiesclin
1
The role of a lipido-sterolic extract of Serenoa repens in the management of lower urinary tract symptoms associated with benign prostatic hyperplasia.
Gerber GS, Fitzpatrick JM.
Division of Urology, University of Chicago Medical School, Chicago, IL 60637, USA. ggerber@bsd.uchicago.edu
OBJECTIVE To examine the clinical profile of medication derived from a lipido-sterolic extract of Serenoa repens (saw palmetto) for managing lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). METHODS We reviewed clinical trials involving extracts of S. repens, focusing on the benefit/risk ratio in patients with BPH. RESULTS S. repens extract significantly reduces the symptoms of BPH, increases urinary flow, improves the quality of life and is well tolerated. CONCLUSION Analysis of the overall clinical database indicates that extract of S. repens may be considered a viable first-line therapy for treating LUTS.
Publication Types:
PMID: 15291864 [PubMed - indexed for MEDLINE]
Comparison of Saw Palmetto (extract and whole berry) and Cernitin on prostate growth in rats.2
Talpur N, Echard B, Bagchi D, Bagchi M, Preuss HG.
Department of Physiology, Georgetown University Medical Center, Washington, DC 20007, USA.
Pharmaceuticals such as finasteride and alpha blockers are used to treat symptoms of benign prostatic hyperplasia (BPH) and are known to cause severe adverse reactions. Accordingly, a search for safer, natural products has been undertaken. Two natural agents (nutraceuticals) have come under recent scrutiny; because natural products, in general, often have evidence of long-term safety. The present study compares the in vivo effects on androgen-induced prostatic enlargement in rats of two nutraceuticals--the widely recognized Saw Palmetto (Serenoa repens) and the less well-known Cernitin (defined pollen extract). Non-castrated rats, had a mean prostate weight of 124 mg +/- 8.8 (S.E.M.) compared to the 24.5 mg +/- 1.9 (S.E.M.) of the castrated rat followed under the same regimen (p < 0.01). When castrated rats were given testosterone, the mass increased significantly to 250.0 mg +/- 31.7 (S.E.M.) (p < 0.01). In the five remaining groups, castrated rats receiving testosterone were given finasteride, an extract of Saw Palmetto, crushed whole berry derived from Saw Palmetto fruit, a water soluble and fat soluble extract of Cernitin or a combination of the Saw Palmetto extract and Cernitin. All treatments decreased the size of the prostate to roughly the same size as in the non-castrated rats, a size that was significantly smaller than castrated rats treated with testosterone in the same manner (p < 0.01). A second study examining non-castrated rats treated with very high doses of testosterone showed similar results. In both studies, the nutraceuticals generally decreased body weight. In conclusion, these studies show the ability of Saw Palmetto (whole berry and extract) and Cernitin to influence prostatic hyperplasia via effects on androgen metabolism.
PMID: 12962139 [PubMed - indexed for MEDLINE]
Saw palmetto for prostate disorders.3
Gordon AE, Shaughnessy AF.
Harrisburg Family Practice Residency Harrisburg, Pennsylvania 17110-2098, USA. agordon@pinnacle.health.org
Saw palmetto is an herbal product used in the treatment of symptoms related to benign prostatic hyperplasia. The active component is found in the fruit of the American dwarf palm tree. Studies have demonstrated the effectiveness of saw palmetto in reducing symptoms associated with benign prostatic hyperplasia. Saw palmetto appears to have efficacy similar to that of medications like finasteride, but it is better tolerated and less expensive. There are no known drug interactions with saw palmetto, and reported side effects are minor and rare. No data on its long-term usage are available. The herbal product also has been used to treat chronic prostatitis, but currently there is no evidence of its efficacy.
Publication Types:
PMID: 12674456 [PubMed - indexed for MEDLINE]
4
Saw palmetto extract suppresses insulin-like growth factor-I signaling and induces stress-activated protein kinase/c-Jun N-terminal kinase phosphorylation in human prostate epithelial cells.
Wadsworth TL, Carroll JM, Mallinson RA, Roberts CT Jr, Roselli CE.
Department of Physiology and Pharmacology L334, Oregon Health and Science University, 3181 Sam Jackson Park Road, Portland, Oregon 97239, USA.
A common alternative therapy for benign prostatic hyperplasia (BPH) is the extract from the fruit of saw palmetto (SPE). BPH is caused by nonmalignant growth of epithelial and stromal elements of the prostate. IGF action is important for prostate growth and development, and changes in the IGF system have been documented in BPH tissues. The main signaling pathways activated by the binding of IGF-I to the IGF-I receptor (IGF-IR) are the ERK arm of the MAPK cascade and the phosphoinositol-3-kinase (PI3K)/protein kinase B (PKB/Akt) cascade. We tested the hypothesis that SPE suppresses growth and induces apoptosis in the P69 prostate epithelial cell line by inhibiting IGF-I signaling. Treatment with 150 microg/ml SPE for 24 h decreased IGF-I-induced proliferation of P69 cells and induced cleavage of the enzyme poly(ADP-ribose)polymerase (PARP), an index of apoptosis. Treatment of serum-starved P69 cells with 150 microg/ml SPE for 6 h reduced IGF-I-induced phosphorylation of Akt (assessed by Western blot) and Akt activity (assessed by an Akt kinase assay). Western blot analysis showed that SPE reduced IGF-I-induced phosphorylation of the adapter protein insulin receptor substrate-1 and decreased downstream effects of Akt activation, including increased cyclin D1 levels and phosphorylation of glycogen synthase kinase-3 and p70(s6k). There was no effect on IGF-I-induced phosphorylation of MAPK, IGF-IR, or Shc. Treatment of starved cells with SPE alone induced phosphorylation the proapoptotic protein JNK. SPE treatment may relieve symptoms of BPH, in part, by inhibiting specific components of the IGF-I signaling pathway and inducing JNK activation, thus mediating antiproliferative and proapoptotic effects on prostate epithelia.
PMID: 15033918 [PubMed - indexed for MEDLINE]
5
Long-term clinical and biologic effects of the lipidosterolic extract of Serenoa repens in patients with symptomatic benign prostatic hyperplasia.
Pytel YA, Vinarov A, Lopatkin N, Sivkov A, Gorilovsky L, Raynaud JP.
Scientific Research Institute of Urology, Moscow, Russia.
Permixon, the lipidosterolic extract of Serenoa repens, is widely used for the treatment of symptoms associated with benign prostatic hyperplasia (BPH). This open study assessed the efficacy and tolerability of Permixon 160 mg twice daily administered for 2 years. One hundred fifty-five men with clinically diagnosed BPH and complaints of prostatic symptoms were enrolled in the study. At 6, 12, 18, and 24 months, the International Prostate Symptom Score (I-PSS), quality of life, and sexual function score were recorded, and urodynamics and biologic values were measured. Adverse events were recorded every 3 months. I-PSS and quality of life improved significantly from baseline at each evaluation time point. At the end of the study and at each evaluation, maximum urinary flow also improved significantly. Prostate size decreased. Sexual function remained stable during the first year of treatment and significantly improved (P = .001) during the second year. Prostate-specific antigen was not affected, and no changes in plasma hormone levels were observed. Nine patients reported 10 adverse events, none related to treatment. Improvements in efficacy parameters began at 6 months and were maintained up to 24 months. These data demonstrate the long-term efficacy and tolerability of Permixon and support its use as a first-line medical therapy for uncomplicated symptomatic BPH.
Publication Types:
PMID: 12665050 [PubMed - indexed for MEDLINE]
Serenoa repens for benign prostatic hyperplasia.6
Wilt T, Ishani A, Mac Donald R.
General Internal Medicine (111-0), Minneapolis VA/VISN 13 Center for Chronic Disease Outcomes Research, One Veterans Drive, Minneapolis, Minnesota 55417, USA. Tim.Wilt@med.va.gov
BACKGROUND: Benign prostatic hyperplasia (BPH), nonmalignant enlargement of the prostate, can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH has been growing steadily. The extract of the American saw palmetto or dwarf palm plant, Serenoa repens (also known by its botanical name of Sabal serrulatum), is one of the several phytotherapeutic agents available for the treatment of BPH. OBJECTIVES: This systematic review aimed to assess the effects of Serenoa repens in the treatment of LUTS consistent with BPH. SEARCH STRATEGY: Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, Cochrane Library, Phytodok), by checking bibliographies, and by contacting manufacturers and researchers. SELECTION CRITERIA: Trials were eligible if they (1) randomized men with BPH to receive preparations of Serenoa repens (alone or in combination) in comparison with placebo or other BPH medications, and (2) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements. Eligibility was assessed by at least two independent observers. DATA COLLECTION AND ANALYSIS: Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of Serenoa repens with placebo or other BPH medications was the change in urologic symptom scale scores. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for side effects was the number of men reporting side effects. MAIN RESULTS: In this update, 3 new trials involving 230 additional men (7.8%) have been included. 3139 men from 21 randomized trials lasting 4 to 48 weeks were assessed. 18 trials were double-blinded and treatment allocation concealment was adequate in 11 studies. Compared with placebo, Serenoa repens improved urinary symptom scores, symptoms, and flow measures. The weighted mean difference (WMD) for the urinary symptom score was -1.41 points (scale range 0-19), (95%CI = -2.52, -0.30, n = 1 study) and the risk ratio (RR) for self rated improvement was 1.76 (95%CI = 1.21, 2.54, n = 6 studies). The WMD for nocturia was -0.76 times per evening (95%CI = -1.22, -0.32; n = 10 studies). The WMD for peak urine flow was 1.86 ml/sec (95%CI = 0.60, 3.12, n = 9 studies). Compared with finasteride, Serenoa repens produced similar improvements in urinary symptom scores (WMD = 0.37 IPSS points (scale range 0-35), 95%CI = -0.45, 1.19, n = 2 studies) and peak urine flow (WMD = -0.74 ml/sec, 95%CI = -1.66, 0.18, n = 2 studies). Adverse effects due to Serenoa repens were mild and infrequent. Withdrawal rates in men assigned to placebo, Serenoa repens or finasteride were 7%, 9%, and 11%, respectively. REVIEWER'S CONCLUSIONS: The evidence suggests that Serenoa repens provides mild to moderate improvement in urinary symptoms and flow measures. Serenoa repens produced similar improvement in urinary symptoms and flow compared to finasteride and is associated with fewer adverse treatment events. The long term effectiveness, safety and ability to prevent BPH complications are not known. The results of this update are in agreement with our initial review.
Publication Types:
PMID: 12137626 [PubMed - indexed for MEDLINE]
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