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Saw Palmetto Research

February 28, 2011 Written by JP       [Font too small?]

Italy is universally known for a great many things – it’s incredible beauty, romantic atmosphere, beloved cuisine and strong family ties. Researching phytomedicines that support prostate health generally doesn’t come to mind. Interestingly enough, that’s exactly what I discovered while investigating the current state of natural medicine in that country. Select herbal remedies which are currently considered ineffective or passe in the United States and elsewhere are still under review in this enchanting land sometimes referred to as Lo Stivale or The Boot.

The prostate is an organ that is typically considered of little significance to younger men. It serves a vital purpose in the realm of male fertility, but does so without much notice. However, almost every man over the age of 50 is grudgingly aware of the role that this walnut shaped gland plays in daily and nightly existence. As men age the prostate tends to enlarge, a condition known as benign prostatic hyperplasia or BPH, and various aspects of normal urination are affected including the emergence of frequent nighttime urination and the inability to evacuate the bladder completely. In addition, there is also the prescient concern about prostate cancer (PCa) in later life. This is not without cause. The most recent statistics from the American Cancer Society report that in 2010 over 217,730 men in the US were diagnosed with this malignancy. (1)

When benign prostatic hyperplasia (BPH) is diagnosed early, it can often be managed quite well with herbal remedies such as saw palmetto (Serenoa repens). A current study appearing in the journal Urology International examined the long-term efficacy and safety of an S. repens supplement in 120 patients with lower urinary symptoms (LUTS) caused by mild-to-moderate BPH. Over the course of 24 months, the study participants were given a once-daily soft gel containing 320 mg of an ethanolic extract of S. repens. Many statistically significant benefits were noted including: an improvement in erectile function, International Prostate Symptom Scores, maximal urinary flow, quality of life and a slight reduction in prostate size as indicated by volume measurement. Two additional studies conducted at the University of Milan, Italy also found meaningful reductions in key aspects of BPH (frequent and painful urination, urinary flow rate) in trials lasting only 30 days. (2,3)

Some scientists have also been evaluating the relative merits of combining saw palmetto with other extracts and nutrients that have demonstrated potential with respect to prostatic health. In many instances, the results they’ve discovered have been very promising indeed. For instance, a blend containing 320 mg Serenoa repens, 120 mg Urtica dioica (nettle root) and 5 mg Pinus pinaster (pine) was recently shown to be an effective and safe alternative for patients with lower urinary tract symptoms such as chronic genital-pelvic pain and prostatitis. A mixture of avocado, nettle root, saw palmetto and soy likewise produced impressive benefits in a 6 month trial involving men “who were candidates for surgery for BPH-induced LUTS”. Finally, adding a tomato extract (lycopene) and the trace mineral selenium to saw palmetto resulted in better outcomes for 102 patients given this “triple therapy” vs. a saw palmetto only supplement. All of the previously mentioned formulas were found remarkably safe given the limitations of the study designs. (4,5,6)

The Results of a Safety Assessment Involving a Saw Palmetto Extract

Saw Palmetto Placebo
Test Baseline 12 Months Baseline 12 Months
Albumin (gm/dl) 4.17 ± 0.02 4.08 ± 0.03 4.11 ± 0.02 4.04 ± 0.03
Bilirubin: total (mg/dl) 0.93 ± 0.03 0.88 ± 0.03 0.90 ± 0.03 0.96 ± 0.03
Calcium (mg/dl) 9.64 ± 0.03 9.60 ± 0.03 9.60 ± 0.03 9.59 ± 0.03
Carbon dioxide (mmol/dl) 29.59 ± 0.22 28.65 ± 0.22 29.17 ± 0.22 28.73 ± 0.22
Chloride (mmol/dl) 101.85 ± 0.27 102.94 ± 0.28 102.22 ± 0.27 103.03 ± 0.28
Cholesterol, Total (mg/dl) 206.22 ± 3.47 205.97 ± 3.53 204.70 ± 3.45 204.02 ± 3.48
Creatine Kinase (CPK) (U/l)§ 157.06 ± 9.82 154.01 ± 9.97 156.98 ± 9.80 143.19 ± 9.90
Creatinine (mg/dl) 1.03 ± 0.02 1.03 ± 0.02 1.03 ± 0.02 1.04 ± 0.02
Glucose (mg/dl) 96.04 ± 2.89 96.08 ± 2.93 97.87 ± 2.87 102.12 ± 2.89
Hematocrit (%) 44.34 ± 0.29 43.99 ± 0.29 43.77 ± 0.29 43.91 ± 0.29
International Normalized Ratio (INR) (no units) 0.93 ± 0.01 0.94 ± 0.01 0.92 ± 0.01 0.93 ± 0.01
Platelet Count (109/L) 241.88 ± 4.85 238.14 ± 4.89 246.83 ± 4.82 237.56 ± 4.85
Potassium (mmol/dl) 4.32 ± 0.03 4.35 ± 0.04 4.38 ± 0.03 4.33 ± 0.04
Prostate Specific Antigen (PSA) (ng/ml) 1.78 ± 0.14 1.85 ± 0.14 1.62 ± 0.14 1.77 ± 0.14
SGOT (AST) (U/L) 26.34 ± 1.23 25.22 ± 1.25 27.80 ± 1.23 28.69 ± 1.24
SGPT (ALT) (U/L) 27.28 ± 1.75 25.91 ± 1.77 30.25 ± 1.74 30.82 ± 1.75
Sodium (mmol/dl) 138.42 ± 0.21 138.15 ± 0.22 138.43 ± 0.22 138.09 ± 0.22
Testosterone (ng/dl) 372.97 ± 12.01 356.15 ± 12.10 376.48 ± 11.98 375.07 ± 11.99
Triglycerides (mg/dl) 152.97 ± 9.21 143.13 ± 9.32 168.90 ± 9.11 143.62 ± 9.17
Urea nitrogen (BUN) (mg/dl) 13.92 ± 0.42 14.82 ± 0.43 14.78 ± 0.42 14.75 ± 0.43
White Blood Cells (WBC) (109/L) 6.30 ± 0.15 6.08 ± 0.15 5.95 ± 0.15 6.00 ± 0.15

Source: Complement Ther Med. 2008 June; 16(3): 147–154. (link)

The most impressive S. repens study of late comes courtesy of the First Urologic Clinic at the University of Milan, Italy. Researchers enrolled 144 patients with BPH “who were candidates for transurethral resection of the prostate (TURP) and open prostatectomy (OP)”. Half of the group was given a placebo and the remainder a 320 mg/day dosage of a saw palmetto extract known as Permixon two months prior to undergoing surgery. The findings were quite remarkable: those receiving the saw palmetto supplement had a shortened duration of surgery (59.8 min. vs. 77.6 min), no intraoperative complications (0% vs. 15%), need for transfusion (0% vs. 38.3%), hastened postoperative course (64.95 hours vs. 91.7 hours) and a shortened hospitalization stay (5.92 days vs. 7.92 days). (7)

The life expectancy of men is rising and will most likely continue upward in the coming years. This reality dictates that the occurrence of prostate-related conditions will likewise become a more prevalent health care concern. Saw palmetto may very well play an important role in postponing the symptoms and trajectory of prostate ills associated with hormonal changes that occur with age. What’s more, the berries of this unassuming palm tree probably have much more to reveal in terms of complimenting conventional care. Only further investigations will reveal the potential and shortcomings of this and other phytomedicines. Bravo to the Italian researchers who are spearheading the quest for more clarification. Tante grazie!

Note: Please check out the “Comments & Updates” section of this blog – at the bottom of the page. You can find the latest research about this topic there!

Be well!

JP

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6 Comments & Updates to “Saw Palmetto Research”

  1. JP Says:

    Update 05/06/15:

    http://www.pagepressjournals.org/index.php/aiua/article/view/aiua.2015.1.25/4568

    Arch Ital Urol Androl. 2015 Mar 31;87(1):25-7.

    Effectiveness on urinary symptoms and erectile function of Prostamev Plus® vs only extract Serenoa repens.

    Prostatic inflammation is widespread in the male population. Two groups of 50 patients each with symptoms of prostatic inflammation and ecocolorDoppler indicative of prostatitis were identified. Both groups were further subdivided into two subgroups (respectively A1, A2, B1, and B2). Group A1 underwent therapy with oral levofloxacin 500 mg daily for 10 days plus co-treatment with oral Serenoa repens (320 mg) plus Bromeline plus Nettle (Prostamev Plus®) daily for two months; Group A2 with oral levofloxacin 500 mg daily for 10 days plus oral Serenoa repens extract 320 mg/day for two months; Group B1 specific antibiotic treatment for 10 days (included levofloxacin if sensitive) plus co-treatment with oral Serenoa repens (320 mg) plus Bromeline plus Nettle (Prostamev Plus®) daily for two months; Group B2 with specific antibiotic treatment for 10 days plus Serenoa repens 320 mg/day for two months. The groups treated with Prostamev Plus® in comparison to the groups treated with Serenoa repens extract (saw palmetto) achieved better improvements of both IPSS score, urinary flow and sexual life.

    Be well!

    JP

  2. JP Says:

    Update 05/06/15:

    http://www.karger.com/Article/Abstract/366521

    Urol Int. 2015;94(2):187-93.

    Comparison of tamsulosin plus serenoa repens with tamsulosin in the treatment of benign prostatic hyperplasia in Korean men: 1-year randomized open label study.

    INTRODUCTION: In Korea, increasing attention has recently been given to the use of phytotherapeutic agents to alleviate the symptoms of BPH. Serenoa repens has been shown to have an equivalent efficacy to Finasteride or Tamsulosin in the treatment of BPH in previous studies. The present study was designed to compare the efficacy and safety of Serenoa repens plus tamsulosin with tamsulosin only over 12 months in men with LUTS secondary to BPH.

    MATERIALS AND METHODS: One hundred forty men with symptomatic BPH (IPSS≥10) were recruited in our hospital for a 12-month, open-label, randomized trial. Patients were randomly assigned to either tamsulosin 0.2 mg/day plus Serenoa repens 320 mg/day (n=60) or tamsulosin 0.2 mg/day only (n=60). Prostate volume and PSA were measured at baseline and at end-point, whereas total IPSS, and its storage and voiding subscores, LUTS-related QoL, Qmax, and PVR were evaluated at baseline and later every 6 months.

    RESULTS: Total 103 patients were finally available: 50 in the TAM+SR group and 53 in the TAM group. At 12 months, total IPSS decreased by 5.8 with TAM+SR and 5.5 with TAM (p=0.693); the storage symptoms improved significantly more with TAM+SR (-1.7 vs. -0.8 with TAM, p=0.024). This benefit with regard to storage symptom in the TAM+SR group lasts at 12 months (-1.9 vs. -0.9, p=0.024). The changes of voiding subscore, LUTS-related QoL, Qmax, PVR, PSA, and prostate volume showed no significant differences between the TAM+SR and TAM groups. During the treatment period, 8 patients (16.9%) with TAM and 10 (20%) with TAM+SR had drug-related adverse reactions, which included ejaculatory disorders, postural hypotension, dizziness, headache, gastro-intestinal disorders, rhinitis, fatigue and asthenia.

    CONCLUSIONS: The combination treatment of Serenoa repens and tamsulosin was shown to be more effective than tamsulosin monotherapy in reducing storage symptoms in BPH patients after 6 months and up to 12 months of treatment.

    Be well!

    JP

  3. JP Says:

    Update 05/06/15:

    http://onlinelibrary.wiley.com/doi/10.1002/pros.22866/abstract

    Prostate. 2014 Nov;74(15):1471-80.

    Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial).

    BACKGROUND: Phytotherapy has been used to treat patients with lower urinary tract symptoms (LUTS). We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens (SeR), Lycopene (Ly), and Selenium (Se) + tamsulosin versus single therapies.

    METHODS: PROCOMB trial (ISRCTN78639965) was a randomized double-blinded, double-dummy multicenter study of 225 patients between 55 and 80 years old, PSA ≤ 4 ng/ml, IPSS ≥12, prostate volume ≤60 cc, Qmax ≤15 ml/sec, postvoid residual urine (PVR) <150 ml. Participants were randomized group A (SeR-Se-Ly), group B (tamsulosin 0.4 mg), group C (SeR-Se-Ly + tamsulosin 0.4 mg). The primary endpoints of the study were the reduction of IPSS, PVR, and increase of Qmax in group C versus monotherapy groups.

    RESULTS: The decrease for combination therapy was significantly greater versus group A (P < 0.05) and group B (P < 0.01) for IPSS and versus group A (P < 0.01) for PVR from baseline to 6 months. A greater decrease in IPSS was observed for Group C versus group A (P < 0.01) and increase in Qmax versus group B (P < 0.01), from 6 months to 12 months. At one year, the changes of IPSS and Qmax were greater for Group C versus monotherapies (each comparison <0.05). The proportions of men with a decrease of at least three points (each comparison P < 0.05) and decrease of 25% for IPSS (each comparison P < 0.01) were greater for Group C.

    CONCLUSION: SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS.

    Be well!

    JP

  4. JP Says:

    Updated 08/28/15:

    http://onlinelibrary.wiley.com/doi/10.1002/pros.23059/abstract

    Prostate. 2015 Aug 26.

    Effects of hexanic extract of serenoa repens (permixon® 160 mg) on inflammation biomarkers in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia.

    BACKGROUND: Chronic prostatic inflammation (CPI) could be a cause of symptomatic or complicated benign prostatic hyperplasia (BPH). In previous in vitro and in vivo studies, Hexanic Extract of Serenoa repens (HESr) namely Permixon® has demonstrated potent anti-inflammatory properties. With the aim to provide new insight onto HESr anti-inflammatory properties in human we explore its effect on CPI biomarkers in men with lower urinary tract symptoms (LUTS) related to BPH using a non-invasive method and investigate links between biomarkers and clinical symptoms.

    METHODS: An international, randomized, double-blind, parallel-group, tamsulosin-controlled study was carried out in 206 men with BPH-related LUTS. Patients received oral daily HESr 320mg or tamsulosin 0.4 mg during 3 months. The first urine stream after digital rectal examination (DRE) was collected at Day 1 and Day 90 and mRNA was extracted from prostatic epithelial cells desquaming in the lumen of the glands and seminal plasma fluid after DRE. mRNA quantification of the 29 most significant published inflammation markers in BPH and protein detection in urine was performed.

    RESULTS: At D90, a decrease in mean gene expression was observed for 65.4% of the markers detected in the HESr group versus 46.2% in the tamsulosin group. In the 15 most frequently expressed genes, this difference was higher (80% vs. 33% respectively). Three proteins (MCP-1/CCL2, IP-10/CXCL10, and MIF) were detected. At D90, a decrease in the number of patients who expressed MCP-1/CCL2 and IP-10/CXCL10 was observed only in the HESr group. Moreover, MIF expression was significantly reduced by HESr compared with tamsulosin (P = 0.007). Finally, in contrast to tamsulosin, the subgroup of patients treated by HESr and who over expressed MIF at baseline, had a higher response to the International Prostate Symptom Score (I-PSS) than those who did not over express this protein (mean I-PSS change: -6.4 vs. -4.5 respectively). As the study is exploratory, results should be confirmed in a powered clinical study.

    CONCLUSIONS: These results showed for the first time at clinical level the anti-inflammatory properties of HESr, already indicated in BPH-related LUTS. Thus, HESr could be of interest to prevent unfavourable evolution in patients with CPI.

    Be well!

    JP

  5. JP Says:

    Updated 04/22/16:

    http://www.tandfonline.com/doi/abs/10.3109/13685538.2016.1169400?journalCode=itam20

    Aging Male. 2016 Apr 5:1-5.

    The therapeutic potential of royal jelly in benign prostatic hyperplasia. Comparison with contemporary literature.

    The aim of this study is to establish the scientific benefit of royal jelly (RJ) on prostatic-specific antigen (PSA), post-void residual (PVR) volume and International Prostate Symptom Score (IPSS) in benign prostatic hyperplasia. For the study, a group of 40 men were administered 38 mg of RJ over a period of three months, their PSA values, prostate volumes and the volumes of their transitory prostate zones, PVR and IPPS values were measured at the end of the first month, and at the end of the third month. The results of this study confirm the potential of RJ in reducing PSA scores and improving IPSS values. Since the use of RJ did not lead to any significant reduction in PVR, prostate volume, or to any involution of the transitory zone, it appears that it may only affect the blood marker of prostatic hyperplasia and to improve quality-of-life (QoL) in those patients. Overall, in comparison to phytotherapy and conventional therapy, RJ had similar positive effects on QoL in patients with BPH, however it exhibited markedly better effects on reducing PSA levels in blood. The therapeutical use of RJ exhibited no side effects.

    Be well!

    JP

  6. JP Says:

    Updated 09/02/16:

    http://www.ncbi.nlm.nih.gov/pubmed/27583656

    Minerva Urol Nefrol. 2016 Sep 1.

    Efficacy of IDIProst® Gold, a formulation containing Serenoa repens, Crocus sativus and PMBE, in men with concomitant LUTS and ED.

    BACKGROUND: The relationship between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) has received increased attention recently. This study aims to evaluate the efficacy of IDIProst® Gold, a product containing Serenoa repens, Crocus sativus and PMBE (Pinus massoniana bark extract), in improving sexual function, urinary symptoms and quality of life in patients with concomitant LUTS and ED.

    METHODS: 140 men (mean age 48 years) were enrolled and treated in this study. All patients were administered IDIProst® Gold (Crocus sativus, PMBE, Serenoa repens) once daily for three months. At visit (T0) and after ninety days of treatment (T90), the patients were evaluated and asked to complete three self-administered questionnaires: IPSS (International Prostate Symptoms Score), IIEF-5 (International Index of Erectile Function) and SF-36 (Short Form Health Survey). The main outcomes were the improved IIEF-5 and IPSS scores in the 40‒60 age group. The secondary outcome was the improved quality of life score among treated patients.

    RESULTS: The baseline mean scores at T0 were 17.29 and 15.12 for the IPSS and IIEF-5 respectively. After three months of treatment (T90), the questionnaire results were as follows: 10.21 and 20.53 for IPSS and IIEF-5 respectively. Statistically significant differences (p<0.001) were reported between the two visits in terms of IPSS and IIEF-5 for all the groups treated, but particularly the 40‒60 age group. There was also a statistically significant improvement (p<0.001) in quality of life between T0 and T90 (3.82 vs. 1.45). Compliance with the study protocol was 100%. 140 patients were enrolled out of a population of 164. No adverse events were reported.

    CONCLUSIONS: Treatment once daily with IDIProst® Gold (Serenoa repens, Crocus sativus and PMBE) for three months significantly improved sexual function, urinary symptoms and quality of life in patients with concomitant LUTS and ED, especially in the 40‒60 age group.

    Be well!

    JP

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