Saw Palmetto berry supplement, benefit, side effects, influence on prostate gland and hair, by Ray Sahelian, M.D., author of Saw Palmetto: Nature's Prostate Healer -

Benefit of Saw Palmetto herb for a healthy prostate gland
Saw Palmetto extract supplement
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Saw palmetto is an herb that has been shown in clinical studies to have an important role in maintaining a healthy prostate. Saw palmetto (Serenoa repens, sometimes referred to as sabal in Europe) grows naturally in the southeast United States, including Georgia, Mississippi, and particularly Florida. Saw palmetto is not the only herb that has an influence on the prostate gland. Several other herbs and plant compounds that are potentially useful in maintaining a healthy prostate gland including pygeum, stinging nettle, isoflavones such as genistein and daidzein, rye pollen, phytosterols such as beta sitosterol, and carotenoids such as lycopene.
   It appears that urinary symptoms resulting from mild-to-moderate prostate enlargement respond more readily to saw palmetto than symptoms due to severe enlargement. It often takes several weeks or months for the effects of saw palmetto and other herbs to be fully appreciated. Saw palmetto and herbs have fewer side effects than drugs used for prostate enlargement but they are not as potent.

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Prostate Power Rx Supplement Facts
Saw Palmetto extract (standardized to contain 45% fatty acids - serenoa repens fruit)
Stinging Nettle 4:1 extract (urtica diocia root)
Quercetin (one study shows the combination of quercetin and finasteride works very well)
Rosemary 4:1 extract (Rosemarinus officinales leaf)
Beta Sitosterol
Pygeum 4:1 bark extract (Pygeum Africanum)
Genistein (standardized to contain 40% isoflavones)
Daidzein (standardized to contain 40% isoflavones)
   (treatment with the isoflavones daidzein and genistein, the estrogen-like compounds found in soy, block prostate growth in rats)
Lycopene

Saw Palmetto Extract
Supports Healthy Prostate Function
Saw palmetto extract contains pure Saw palmetto extract guaranteed to supply 45% fatty acids and beneficial plant sterols, which are the herb's key active ingredients. Extraction is done using carbon dioxide, the finished product is free of solvent residues.

Supplement Facts
Saw-Palmetto extract (Berry) - 320 mg* Fatty Acids - 45% fatty acids
Suggested Use: As an herbal supplement, take 1 or 2 saw palmetto capsules per day.
* Saw Palmetto daily values not established.

Note: In order for a saw palmetto product to be effective, it should either supply a daily dose of 320 mg of 85 to 95% fatty acids, or 640 mg of a 45% fatty acid extract. Some saw palmetto products that do not have these high potency fatty acid extracts may not be as effective.

Saw palmetto side effects
No significant saw palmetto side effects have been reported in the medical literature. It does not seem that saw palmetto influences levels of PSA (prostate specific antigen) to any significant degree. The following study evaluated potential saw palmetto side effects in a one year study.

A detailed safety assessment of a saw palmetto extract.
Complement Ther Med. 2008 June. Avins AL, Bent S, Staccone S, Badua E, Padula A, Goldberg H, Neuhaus J, Hudes E, Shinohara K, Kane C. Division of Research, Northern California Kaiser Permanente, United States; General Internal Medicine Section, San Francisco VA Medical Center, United States; Department of Medicine, University of California, San Francisco, United States; Department of Epidemiology and Biostatistics, University of California, San Francisco, United States.
The Saw palmetto for Treatment of Enlarged Prostates (STEP) study was a randomized clinical trial performed among 225 men with moderate-to-severe symptoms of benign prostatic hyperplasia, comparing a standardized extract of the saw palmetto berry (160mg twice daily) with a placebo over a 1-year period. There were no significant differences observed between the saw palmetto and placebo-allocated participants in the risk of suffering side effects. There were few significant between-group differences in sexual functioning or for most laboratory analyses, with only small differences observed in changes over time in total bilirubin, potassium, and the incidence of glycosuria. Despite careful assessment, no evidence for serious toxicity of saw palmetto was observed in this clinical trial.

For what conditions is saw palmetto useful?
The best known use of saw palmetto is for prostate health. As to saw palmetto and hair loss, see a few paragraphs below.

Does saw palmetto improve sex?
The aphrodisiac properties of saw palmetto have not been evaluated thoroughly. Anecdotal reports indicate that saw palmetto may help with erectile function, but I cannot make this claim with a great deal of certainty. If you have low libido or have difficulty maintaining a healthy erection, there are several herbs that are quite potent and these herbs are combined in an excellent formula.

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   The potent herbal extracts in Passion Rx include Ashwagandha, Catuaba, Cnidium, Herba Cistanches, Horny goat weed, Maca, Muira puama, Passion flower, Tongkat-Ali (Eurygold and LJ100), Tribulus and Yohimbe. A version of Passion Rx without yohimbe is also available. Passion Rx does not have saw palmetto and it does not have any hormones such as testosterone.

Saw Palmetto and Hair Loss
I am often asked whether saw palmetto is useful for hair loss. I have not come across any extensive studies in humans evaluating the role of saw palmetto in hair loss or restoring hair growth.
   One of the causes of hair loss is excess DHT (a testosterone metabolite) in hair tissue. There is some speculation that saw palmetto is a weak inhibitor of the enzyme 5 alpha reductase that converts testosterone into DHT in prostate tissue. However we don't know whether a similar effect would occur in hair tissue on the scalp, and if it did, what oral dosages would be effective. For the time being, one should not rely on saw palmetto for hair growth, however further research will elucidate whether saw palmetto is involved in blocking DHT in scalp tissue.
   The following is a note written by Dr. Sahelian in his newsletter.

Saw Palmetto, PSA, and Hair
Over the years I have been asked whether saw palmetto, the herb used for prostate enlargement, has an influence on PSA test results or on hair growth. PSA is the blood test that is often recommended to monitor prostate tumor growth. Medical science has questioned the reliability of PSA testing as a screening tool for cancer detection. Although there is a lot of controversy and varied opinions, it appears PSA testing is not as accurate a tool as was previously thought.
   Saw palmetto has been marketed as an herb that could potentially influence hair growth. One of the causes of prostate enlargement is testosterone being converted into DHT (dihydrotestosterone). Excess DHT in prostate tissue is thought to lead to prostate growth, and excess DHT in hair tissue leads to hair thinning in men and women. Could we kill two birds with one stone by the use of saw palmetto? Saw palmetto may inhibit the enzyme 5-alpha-reductase in prostate tissue. This enzyme converts testosterone to DHT. Interestingly, there are two major forms of this enzyme, called types I and II. In humans, Type I 5 alpha-reductase is predominant in the sebaceous glands of most regions of skin, including scalp. The Type II 5 alpha-reductase isozyme is primarily found in prostate tissue, seminal vesicles, epididymides and less so in hair follicles. I have not come across research as to whether saw palmetto blocks the conversion of testosterone to DHT in hair tissue to a degree adequate enough to prevent or restore hair loss. My personal opinion is that I suspect, even if saw palmetto has a mild effect, it is not nearly as potent as the drug finasteride - an alpha reductase blocker - used for prostate enlargement (as Proscar) and hair regrowth (as Propecia). I do not know if there is an additive effect to finasteride if saw palmetto is taken along with it. There was a small study a few years ago that showed a potential benefit for hair growth in male pattern baldness when saw palmetto was combined with beta sitosterol. More research is certainly needed before we can come to any conclusions.
   Bottom line, the jury is still out regarding the role of herbs and nutrients in hair growth, and we have little idea, even if they work, what dosages would be appropriate for long term use.

Q. I have been suffering from hair loss for 3 years and i have a little receding hair line. I started to use saw palmetto for 3 months (shen min for men) and i only noticed so small changes. I wonder i should use that more or i should use a pure saw palmetto pills. I heard there is no serious research about saw palmetto and it was not proven that saw palmetto works for hair loss problem. Do you believe saw palmetto works for everyone and i should use that more to save from genetic hair loss.
   A. I am not aware of good research that supports the use of saw palmetto for hair growth.

What's in Saw Palmetto?
There are a variety of compounds within the saw palmetto berry. As a rule they are divided into four major categories:

1) Free fatty acids. Quite a number of fatty acids are present in saw palmetto. The ones in highest concentration include oleic acid, lauric acid, myristic acid and palmitic acid.
2) Phytosterols (plant sterols). These plant sterols (phyto means plant) have a chemical structure similar to cholesterol. The most commonly found phytosterols in saw palmetto are beta-sitosterol, campesterol, stigmasterol and cycloartenol.
3) Free fatty alcohols. These are usually made up of fatty acids joined to an alcohol molecule.
4) Monoglycerides, which are single fatty acids attached to a three-carbon glycerol molecule.

Q. You mention four groups of ingredients in saw palmetto are free fatty acids, phytosterols, free fatty alcohols, and monoglycerines. From what I've read, the two active ingredients are free fatty acids and phytosterols. If these four groups of ingredients are the only ones in saw palmetto herb, and they are obviously found in most plants and grains albeit in different combinations, it shouldn't have any side effects right? In other words, there are no other groups of ingredients that could be causing some to claim there are side effects from saw palmetto similar to Propecia, finasteride?
   A. Propecia, also known as finasteride, has a completely different chemistry as the substances found in saw palmetto. There have been long term studies with saw palmetto that have not shown any major side effects, but, to be cautious, it is a good idea to take breaks from use.

Q. is there nothing else in saw palmetto except for free fatty acids, free fatty alcohols, phytosterols, and monoglycerines?
   A. Every herb has dozens or hundreds of substances and the four categories you mention form the bulk of this herb. There may be minor substances also but I have not studied these in detail.

How does Saw Palmetto work?
Unfortunately, many herbal and natural medicines have had far less research money devoted to them than they deserve. Saw palmetto is no exception. Consequently, we don't know all the answers to the exact mechanisms of how the different compounds within saw palmetto work. However, there have been enough studies to give us some clues. Some of the most likely mechanisms include the reduction in the amount of dihydrotestosterone (DHT) in prostate tissue, inhibition of the binding of DHT to androgen receptors in prostate cells, and the anti-estrogenic action in prostate tissue. Another possibility is the ability of compounds within saw palmetto to reduce the action of IGF-1 on prostate tissue. Insulin-like growth factor (IGF) action is important for prostate growth and development, and changes in the IGF system have been documented in BPH tissues.
   Unlike Proscar (finasteride), which has one active ingredient, saw palmetto has a number of different compounds within it. Thus, you can see why it would be complicated to evaluate all the possible interactions that these compounds have on a variety of tissues within our bodies. Furthermore, it is possible that a single compound within saw palmetto may not have much of an influence on its own although its combination with the other compounds would have a synergistic effect.
   The more I learn about the human body, the more I realize how complicated it is. Early in my medical career I unquestioningly accepted the results of studies done in a laboratory or on animals and was quick to use this information to generalize to humans. I now know otherwise. In order to understand truly how a medicine works, it has to be studied directly on humans. Although laboratory and animal studies can give us important information, they are never a replacement for thorough human evaluations.            
   Another complicating factor is that modern medicine does not advance solely on the basis of seeking the most efficient therapy for human diseases. There are significant economic factors that influence the funding of studies, the subsequent interpretation of the results, and especially the dissemination of this information. Many of the studies done with saw palmetto were financed either by companies who market this extract, such as Pierre Fabre Medicament, or by pharmaceutical companies, such as Merck, who have developed competing drugs that treat prostate enlargement. Merck has the drug Proscar. Not surprisingly, the results of studies obtained by Merck scientists on saw palmetto are often in disagreement with the results obtained by scientists working under the auspices of saw palmetto-selling companies.

Saw Palmetto: Berry or extract?
When you purchase saw palmetto, you will find some bottles that provide crushed berries, not the extracts. Until we learn more about the effects of using the full contents of the berries, I recommend that you buy the extracts. The extracts will contain the actual substances that are effective in a much higher concentration. The berries will provide you with smaller amounts of the needed active ingredients. Whether the crushed berries have compounds that provide other benefits is not fully known at this time. If you want to take saw palmetto berries, you may need to ingest at least one or two grams a day. The ratio of the dried berry to the lipophilic extracts is usually about 10 to 1. Some users prefer to take both the saw palmetto extracts and the berries, thinking that there are substances within the full berries that could be beneficial. We certainly need more research in order to have a fuller understanding.

Does Saw Palmetto interfere with medications?
Limited research suggests that saw palmetto does not influence the ability of the liver to metabolize other drugs, for instance saw palmetto does not alter the activity of cytochrome P450.

What about combining saw palmetto with other herbs?
Research shows when taken for 3 months, a combination of natural products (rye pollen extract, saw palmetto, Beta sitosterol, and vitamin E) compared to placebo can significantly lessen nocturia and frequency and diminish overall symptoms of prostate enlargement. (See below for the full study.)

Ask your urologist about saw palmetto before he reaches for the surgical knife
Saw palmetto may also be helpful before a surgical procedure called transurethral resection of the prostate. Pretreatment with saw palmetto, before TURP procedure, improves the efficacy of the procedure itself and reduces the risk of complications, in particular perioperative bleeding and duration of postoperative catheterization.

Is saw palmetto for a Woman, too? - Does saw palmetto lead to female breast enhancement?
I have not come across any research to indicate whether saw palmetto is useful for a woman or whether saw palmetto is helpful in PCOS. I have not seen any research as to whether saw palmetto use leads to breast enhancement.

Saw palmetto dosage
The common dosage of saw palmetto is 320 mg of a 80-90% of liposterolic extract a day, or 640 mg of a 40-50% extract.

The New England Journal and Saw Palmetto - From the March 2006 newsletter
Email from a newsletter reader: Dear Dr. Sahelian, I recently read a article in the newspaper that quoted the New England Journal of Medicine that after much testing it was found that saw palmetto was not effective in treating or helping prostate enlargement. I have been taking saw palmetto for years and it seems to help me, what are your thoughts about their findings. Thanks.

Here's a recent Newspaper headline: Saw Palmetto: A popular herbal pill used by millions of men doesn't reduce the frequent urge to go to the bathroom or other annoying symptoms of an enlarged prostate.

Let's take a closer look.
This was a double-blind trial that lasted one year and involved 225 men over the age of 49 years who had moderate-to-severe symptoms (not mild symptoms) of prostate enlargement. They were given saw palmetto extract (160 mg twice a day) and compared to a group that received placebo. Results: There was no significant difference between the saw palmetto and placebo groups in maximal urinary flow rate, prostate size, residual volume after voiding, or serum prostate-specific antigen levels. The incidence of side effects was similar in the two groups. The researchers conclude: In this study, saw palmetto did not improve symptoms or objective measures of benign prostate hyperplasia.

This saw palmetto study was also published in the New England Journal of Medicine (the journal that published the glucosamine and chondroitin study that I reviewed in the last issue).  However, the menopause study that showed the black cohosh and St. John's wort to be effective, was NOT published in the NEJM. Why would it? The supplements worked. I know I'm being hard on the NEJM, and perhaps they are very honest, but I can't help but suspect that they have a strong anti-supplement bias.

Stephen Bent, MD, Assistant Professor of Medicine, UCSF, said he and his colleagues picked saw palmetto to study because of its widespread use and positive findings from previous studies. Here's an interesting tidbit: some of Dr. Bent's research colleagues have received fees or support from drug companies. Hmmm....

Problems with the study:
There have been dozens of studies done in the past with saw palmetto, and the majority were done on men who had mild to moderate prostate symptoms. In a vast majority of the previous studies, saw palmetto was effective in improving their symptoms. I interviewed Dr. Bent:

Sahelian: Why weren't patients with mild BPH also included in the saw palmetto study?
Bent: Good question. There are several reasons for not including patients with mild symptoms in this saw palmetto study: 1) patients with mild symptoms have less "room" to improve - so it is harder to detect a benefit and requires more patients and a larger study, 2) most prior studies included patients with moderate to severe symptoms - so we chose to use a similar patient population, 3) most patients do not present to doctors or complain of symptoms until they are at least moderate, so therapy of any kind is usually not used for mild symptoms.
   My comments: I'm going to disagree with Dr. Bent: 1. If patients with mild symptoms have less room to improve, why was the glucosamine study I reviewed last time done mostly on patients with mild symptoms and why did the media and the editorial board of the NEJM declare that glucosamine and chondroitin were not effective for mild arthritis pain when it appears that it is difficult to detect a benefit in cases of mild symptoms? 2. Most saw palmetto studies in the past actually were done in patients with mild symptoms to moderate. 3. Many patient with mild BPH do try to use saw palmetto or other herbs, so it does not appear to be correct when the doctor says "therapy of any kind is usually not used for mild symptoms."

Sahelian: Were the saw palmetto capsules taken with or without food?
Bent: Participants were instructed to take the capsules twice a day with meals.
   My comments: We don't know if the results would have been different if both saw palmetto capsules had been taken at the same time to allow for higher blood levels, or if the capsules were taken on an empty stomach the results would be different. I find that sometimes when herbs or nutrients are taken with a meal, the herbs get diluted and "lost" with the rest of the meal and perhaps absorbed so slowly over several hours that they practically become ineffective. I know that when I take herbs for libido with a full stomach I don't feel the effects as well as if I take them on an empty stomach. Therefore, this is something to consider as a possible factor in the outcome.

Sahelian: What was the saw palmetto extract potency? You mentioned saw palmetto 160 mg twice daily but I cannot find the % of liposterolic extract.
Bent: The saw palmetto extract contained 92 percent total fatty acids before the study and 90 percent total fatty acids with 0.33 percent sterols at the midpoint of the study.
   My comments:  I wonder if using a higher saw palmetto dose, perhaps twice the amount, would have made a difference since the patients being treated had moderate to severe prostate enlargement. Actually Dr Bent agrees, he says: "Now that this study is negative, I think it's reasonable to try a higher saw palmetto dose."

My Overall Opinion
Over the past several decades, dozens of studies have indicated that saw palmetto herb is helpful in mild to moderate symptoms of BPH. A comprehensive analysis of 21 trials involving over 3,000 men found saw palmetto provided "mild to moderate improvement" in symptoms with fewer adverse events than finasteride (Proscar). The multistudy analysis was performed by the Cochrane Collaboration, a nonprofit group that specializes in reviewing medical literature. (By the way, did the researchers purposely choose men with moderate and severe symptoms in order for the saw palmetto results to fail?)
   For the time being I am still confident that saw palmetto herb has a role to play in prostate health. Maybe saw palmetto does not work well in severe cases of prostate enlargement. But, we have to look at the totality of experiments and not rely on the results of the latest study, otherwise we would feel like ping pong balls shifting from one side to the other based solely on the latest results. Also, it is quite possible that a blend of several herbs that have an influence on prostate health would potentially work significantly better than saw palmetto alone.
    Prescription drugs that treat BPH have many side effects, for instance finasteride causes sexual problems and terazosin causes dizziness.

Saw Palmetto Research Update
Serenoa repens ( Permixon ) inhibits the 5alpha-reductase activity of human prostate cancer cell lines without interfering with PSA expression.
Int J Cancer. 2005 Mar 20;114(2):190-4.
Saw palmetto is an effective dual of 5alpha-reductase isoenzyme activity in the prostate. Unlike other 5alpha-reductase inhibitors, saw palmetto induces its effects without interfering with the cellular capacity to secrete PSA. Saw palmetto, unlike other 5alpha-reductase inhibitors, does not inhibit binding between activated AR and the steroid receptor-binding consensus in the promoter region of the PSA gene. Therefore, we confirm the therapeutic advantage of saw palmetto over other 5alpha-reductase inhibitors as treatment with the phytotherapeutic agent will permit the continuous use of PSA measurements as a useful biomarker for prostate cancer screening and for evaluating tumour progression.

Prostate cancer is a significant cause of death in Western countries and is under the strong influence of androgens. The steroid 5alpha-reductase 2 catalyzes the metabolism of testosterone into the more potent androgen dihydrotestosterone in the prostate gland. Finasteride is a competitive and specific inhibitor of Type II 5 alpha-reductase, an intracellular enzyme that converts the androgen testosterone into dihydrotestosterone (DHT). Two distinct isozymes of 5 alpha-reductase are found in mice, rats, monkeys, and humans: Type I and II. Each of these isozymes is differentially expressed in tissues and developmental stages. In humans, Type I 5 alpha-reductase is predominant in the sebaceous glands of most regions of skin, including scalp and liver. Type I 5 alpha-reductase is responsible for approximately one-third of circulating DHT. The Type II 5 alpha-reductase isozyme is primarily found in prostate, seminal vesicles, epididymides and hair follicles as well as liver, and is responsible for two-thirds of circulating DHT.

A randomized, double-blind, placebo-controlled trial to determine the effectiveness of botanically derived inhibitors of 5-alpha-reductase in the treatment of androgenetic alopecia.
J Altern Complement Med. 2002 Apr;8(2):143-52. Prager N, Bickett K, French N, Marcovici G.
Clinical Research and Development Network, Aurora, CO, USA.
One contributing factor to androgenic alopecia is the conversion of testosterone (T) to dihydrotestosterone (DHT) via the enzyme 5-alpha reductase (5AR). This metabolism is also key to the onset and progression of benign prostatic hyperplasia (BPH). Here, we report the first example of a placebo-controlled, double-blind study undertaken in order to examine the benefit of these botanical substances in the treatment of AGA. The goal of this study was to test botanically derived 5AR inhibitors, specifically the liposterolic extract of saw palmetto and beta-sitosterol, in the treatment of androgenic alopecia. Subjects: Included in this study were males between the ages of 23 and 64 years of age, in good health, with mild to moderate AGA. The results of this pilot study showed a highly positive response to treatment. The blinded investigative staff assessment report showed that 60% of (6/10) study subjects dosed with the active study formulation were rated as improved at the final visit.

Saw palmetto extract treatment modifies bax/bcl-2 index expression and caspase-3 activity in prostatic tissue from patients with benign prostatic hyperplasia.
 J Urol. 2005 Feb;173(2):507-10.
Permixon is a lipidosterolic extract of widely used Saw palmetto extract to treat men with benign prostatic hyperplasia (BPH). We tested the effect of this Saw palmetto extract on molecular mechanisms associated with apoptosis in prostatic tissue from men with symptomatic BPH treated for 3 months before surgery.  Saw palmetto extract increased molecular markers involved in the apoptotic process. This could have clinical relevance due to the improvement in symptoms produced by treatment with Saw palmetto extract.

Saw palmetto and benign prostatic hyperplasia.
Am J Chin Med. 2004;32(3):331-8.
Benign prostatic hyperplasia (BPH) is a common health issue that affects 8% of all men at the age of 40, 60% of men in their 70s, and 90% of those greater than 80 years of age. One-fourth of these men will develop moderate to severe lower urinary tract symptoms that greatly affect their quality of life. Recent evidence suggests that the use of saw palmetto leads to improvements in urinary function for those suffering from BPH. The favorable comparison of saw palmetto with tamsulosin, a well-known first line agent in the treatment of urinary tract symptoms, demonstrates promise towards a beneficial effect of this herbal agent, with very few, if any, adverse effects. However, what degree of this beneficial activity is due to placebo effects is yet to be determined. In addition, the precise mechanism of action of saw palmetto in men with BPH remains unclear.

Serenoa repens ( Permixon - saw palmetto ) inhibits the 5alpha-reductase activity of human prostate cancer cell lines without interfering with PSA expression.
Int J Cancer. 2004 Nov 12;
The phytotherapeutic agent saw palmetto is an effective dual inhibitor of 5alpha-reductase isoenzyme activity in the prostate. Unlike other 5alpha-reductase inhibitors, saw palmetto induces its effects without interfering with the cellular capacity to secrete PSA. Here, we focussed on the possible pathways that might differentiate the action of saw palmetto from that of synthetic 5alpha-reductase inhibitors. We demonstrate that saw palmetto, unlike other 5alpha-reductase inhibitors, does not inhibit binding between activated AR and the steroid receptor-binding consensus in the promoter region of the PSA gene. This was shown by a combination of techniques: assessment of the effect of saw palmetto on androgen action in the LNCaP prostate cancer cell line revealed no suppression of AR and maintenance of PSA protein expression at control levels. This was consistent with reporter gene experiments showing that saw palmetto failed to interfere with AR-mediated transcriptional activation of PSA and that both testosterone and DHT were equally effective at maintaining this activity. Our results demonstrate that despite saw palmetto effective inhibition of 5alpha-reductase activity in the prostate, it did not suppress PSA secretion. Therefore, we confirm the therapeutic advantage of saw palmetto over other 5alpha-reductase inhibitors as treatment with the phytotherapeutic agent will permit the continuous use of PSA measurements as a useful biomarker for prostate cancer screening and for evaluating tumour progression.

Effect of permixon (saw palmetto extract) on human prostate cell growth: Lack of apoptotic action.
Hill B, Kyprianou N. Division of Urology, University of Maryland School of Medicine, Baltimore, Maryland.
Prostate. 2004 Sep 15;61(1):73-80.
Permixon, a phytotherapeutic agent derived from the saw palmetto extract or Serenoa repens plant, is a lipid/sterol extract that is believed to interfere with 5alpha-reductase activity, thus inhibiting prostate growth. In this study, we investigated the magnitude and specificity of the effect of saw palmetto extract on cell proliferation and apoptosis in human prostate cancer cells. The effect of saw palmetto extract was examined in androgen-independent PC-3 prostate cancer cells, androgen-sensitive LNCaP prostate cancer cells, and MCF-7 breast cancer cells in vitro. Cell growth, apoptosis induction, and cell proliferation was studied after exposure to saw palmetto extract at two concentrations (10 and 100 microg/ml). Exposure of prostate and breast cancer cells to a high dose of saw palmetto extract resulted in a significant decrease in the rate of cell growth; an effect that was not time-dependent and was not associated with cell cycle arrest. Saw palmetto extract treatment (at either high or low dose) had no effect on apoptosis induction in prostate cancer cell lines. Furthermore, in vitro saw palmetto extract was a weak inhibitor of 5alpha-reductase activity type 2 in prostatic homogenates. The results indicate the ability of saw palmetto extract to affect prostate cancer cell growth without inducing apoptosis or cell cycle arrest. This effect was not prostate-specific and was only manifested at high concentrations of saw palmetto extract. Furthermore our findings indicate that saw palmetto extract is weak inhibitor of 5alpha-reductase compared to finasteride. This study challenges previous evidence on the anti-growth effect of saw palmetto extract in the prostate and its ability to inhibit 5alpha-reductase activity, while questioning apoptosis as a mechanism of action of this phytotherapeutic against prostate growth, a concept that may have therapeutic significance.

The role of a lipido-sterolic extract of Serenoa repens (saw palmetto) in the management of lower urinary tract symptoms associated with benign prostatic hyperplasia.
BJU Int. 2004 Aug;94(3):338-44.
To examine the clinical profile of medication derived from a lipido-sterolic extract of saw palmetto for managing lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). We reviewed clinical trials involving extracts of saw palmetto, focusing on the benefit/risk ratio in patients with BPH. Saw palmetto extract significantly reduces the symptoms of BPH, increases urinary flow, improves the quality of life and is well tolerated. Analysis of the overall clinical database indicates that extract of saw palmetto may be considered a viable first-line therapy for treating LUTS.

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.
Oregon Health and Science University, 3181 Sam Jackson Park Road, Portland,
Endocrinology. 2004 Jul;145(7):3205-14. Epub 2004 Mar 19.
A common alternative therapy for benign prostatic hyperplasia (BPH) is the extract from the fruit of saw palmetto. 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.  We tested the hypothesis that saw palmetto suppresses growth and induces apoptosis in the P69 prostate epithelial cell line by inhibiting IGF-I signaling. Treatment with 150 microg/ml saw palmetto extract for 24 h decreased IGF-I-induced proliferation of P69 cells. Conclusions: saw palmetto 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 (cell-destroying) effects on prostate epithelia.

Efficacy of pretreatment with Serenoa repens ( saw palmetto ) on bleeding associated with transurethral resection of prostate
Minerva Urol Nefrol. 2004 Mar;56(1):73-8.
Aim of the study is to evaluate the efficacy of a pretreatment with lipidic-sterolic extract of saw palmetto (Permixon ) to reduce bleeding during transurethral resection of prostate (TURP) in patients with benign prostatic hyperplasia. We enrolled 108 patients, randomised either in the saw palmetto group or in the control one. Patients in the saw palmetto group received a pretreatment with saw palmetto  (320 mg/die of Permixon ) for at least 8 weeks before the TURP procedure. In the control group patients did not receive any medical treatment before the intervention. In the saw palmetto group the perioperative bleeding was significantly lower than in the control one (respectively 124 vs 287 ml) and the need of transfusion decreased remarkably. Moreover, in the saw palmetto group, the duration of postoperative catheterization (respectively 3 vs 5 days) and the evaluated hematological parameters (red cells 4.5 vs 4 million, hemoglobin 13 vs 11.9 g, hematocrit 40% vs 35%) were significantly lower than in the control group. The pretreatment with saw palmetto, before TURP procedure, improves the efficacy of the procedure itself and reduces the risk of complications, in particular perioperative bleeding and duration of postoperative catheterization.

Updated meta-analysis of clinical trials of Serenoa repens (saw palmetto) extract in the treatment of symptomatic benign prostatic hyperplasia.
BJU Int. 2004 Apr;93(6):751-6.
To determine, by analysing all available clinical trial data, the clinical efficacy against placebo of an extract from the fruit of the American dwarf palm tree, saw palmetto (Permixon, Pierre Fabre Medicament, Castres, France), as there is controversy about the use of phytotherapeutic agents in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH). All clinical trial data published on Permixon (saw palmetto), comprising 14 randomized clinical trials and three open-label trials, involving 4280 patients, were analysed. This meta-analysis of all available published trials of saw palmetto for treating men with BPH showed a significant improvement in peak flow rate and reduction in nocturia above placebo.

Multiple doses of saw palmetto (Serenoa repens) did not alter cytochrome P450 2D6 and 3A4 activity in normal volunteers.
Clin Pharmacol Ther. 2003 Dec;74(6):536-42.
Saw palmetto is the most commonly used herbal preparation in the treatment of benign prostatic hyperplasia. Our results indicate that extracts of saw palmetto at generally recommended doses are unlikely to alter the disposition of coadministered medications primarily dependent on the CYP2D6 or CYP3A4 pathways for elimination.

Comparison of Saw Palmetto (extract and whole berry) and Cernitin on prostate growth in rats.
Mol Cell Biochem. 2003 Aug;250(1-2):21-6.
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. The present study compares the in vivo effects on androgen-induced prostatic enlargement in rats of two nutraceuticals--the widely recognized Saw Palmetto and the less well-known Cernitin (defined rye pollen extract). Non-castrated rats, had a mean prostate weight of 124 mg compared to the 24.5 mg of the castrated rat followed under the same regimen. When castrated rats were given testosterone, the mass increased significantly to 250.0 mg. 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. 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.

Long-term clinical and biologic effects of the lipidosterolic extract of Saw palmetto in patients with symptomatic benign prostatic hyperplasia.
Adv Ther. 2002 Nov-Dec;19(6):297-306.
Permixon, the lipidosterolic extract of Serenoa repens (saw palmetto), is widely used for the treatment of symptoms associated with benign prostatic hyperplasia (BPH). This open study assessed the efficacy and tolerability of saw palmetto160 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 for those on saw palmetto 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 saw palmetto treatment and significantly improved 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 with saw palmetto. 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 saw palmetto and support its use as a first-line medical therapy for uncomplicated symptomatic BPH.

The lipidosterolic extract of Serenoa repens (saw palmetto) in the treatment of benign prostatic hyperplasia: a comparison of two dosage regimens.
Adv Ther. 2002 Nov-Dec;19(6):285-96.
This 6-month double-blind, randomized, parallel-group study compared two dose regimens of Libeprosta, the lipidosterolic extract of saw palmetto in 100 male outpatients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH). The patients received two 80-mg tablets twice daily or two 80-mg tablets three times daily. Baseline evaluations included maximum and mean urinary flow rates, postvoid residual urine volume, and International Prostate Symptom Score (I-PSS) total and quality-of-life scores. Both regimens significantly reduced the I-PSS mean total score from baseline values; improvements achieved statistical significance after month 3 and were maintained for the duration of the study. Significant improvements from baseline also occurred in quality-of-life scores, maximum and mean urinary flow rates, and residual urine volume. The decrease in residual urine with both regimens was highly significant. No significant differences in efficacy were noted between the two dose groups, and no treatment-related complications or clinical adverse events occurred. In this clinical study, the lipidosterolic extract of saw palmetto was a well-tolerated agent that may significantly improve lower urinary tract symptoms and flow measurements in men with BPH.

Randomized trial of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) on symptoms of benign prostatic hyperplasia.
Preuss HG. Int Urol Nephrol 2001;33(2):217-25. Georgetown University Medical Center, Washington, DC 20007, USA.
Because benign prostatic hyperplasia (BPH) is relatively common, it is important to discover safe and effective means to treat this often debilitating perturbation. Accordingly, we examined the effectiveness of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) in treating symptoms of BPH. We undertook a randomized, placebo-controlled, double-blind study. Patients received either placebo or the combined natural products for 3 months. Nocturia showed a markedly significant decrease in severity in patients receiving the combined natural products compared to those taking placebo. Daytime frequency was also lessened significantly. PSA measurements, maximal and average urinary flow rates, and residual volumes showed no statistically significant differences. When taken for 3 months, a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) compared to placebo can significantly lessen nocturia and frequency and diminish overall symptomatology of BPH as indicated by an improvement in the total AUA Symptom Index score. The combination of natural products caused no significant adverse side effects.

Saw Palmetto May Help Battle Prostate Cancer
Extract from the Saw Palmetto berry, a commonly used herbal supplement taken by men with enlarged prostates, may also have anti-cancer properties, researchers announced at a meeting of The American Society for Cell Biology. "Since we knew that saw palmetto berry extract had some effect on the prostate, we decided to take this a step further. We wanted to know if the saw palmetto had any effect on prostate cancer cells," said researchers at Children's Hospital in Boston, Massachusetts. The research team analyzed the effects of saw palmetto berry extract on cancer cells. To accomplish this, they exposed prostate cancer cells and a generic cancer cell line to various concentrations of saw palmetto berry extract. The cancer cell growth in laboratory cell cultures was then monitored. About one-fifth the amount of berry extract was needed to decrease the cell growth of the prostate cancer cells compared to the amount needed to slow down the growth of the generic cancer cells.
   Dr. Sahelian says: Men who take saw palmetto for enlarged prostates now can perhaps benefit even more by having a possibly lower risk in developing prostate cancer.

Saw Palmetto supplement natural treatment emails
Q. I have significant erectile dysfunction, have been taking saw palmetto to counteract prostate enlargement, and I am wondering if the saw palmetto works (in part?) by "suppressing the effects of testosterone" or by actually possibly suppressing the levels of testosterone in the body? My total testosterone is less than 1/2 of the normal "low" value, while free testosterone is about 10% below the normal "low value". I am 58 and have been using Saw Palmetto for about 4 years, the same length of time I have been experiencing ED. I have recently started testosterone injections.
   A. My latest understanding with saw palmetto in regards to testosterone is that it may inhibit its conversion into DHT in prostate tissue. Whether saw palmetto influences levels of testosterone in the body or is a factor in causing erectile dysfunction is not clear to me at this time.

Q. In your research, have you come across any studies that shows the benefits and effects of saw palmetto for women especially for those suffering with Polycystic ovarian syndrome PCOS? Are there any benefits with those suffering from incontinence, such as my mother who's 81?
   A. We have not come across any research indicating that saw palmetto would be beneficial in the 2 conditions you mention.

Q. Hello doctor, I had taken saw palmetto to try to inhibit hair loss about 5 months ago. Most studies show that it is useful in treating BPH but also inhibits DHT in the prostate. Have you had any experience with anyone that experienced serious side effects using this? I am currently suffering serious erectile dysfunction issues. And from your website I read that saw palmetto reduces IGF action and DHT in the prostate. My question is that is this permanent? Will the prostate continue to grow once this IGF is reduced and DHT upon stoppage of this drug?
   A. First, it is difficult to say what kind of effect saw palmetto has on hair follicles and hair growth. My suspicion is that it has little influence (as opposed to finasteride, Proscar, Propecia) although we just don't know for certain since the role of saw palmetto and hair growth has not been studied to any great extent. Thus far I have not come across any serious side effects from the use of saw palmetto. I suspect any influence that saw palmetto has over prostate tissue is reversible once the saw palmetto is stopped.

Q. Is there info available re taking saw palmetto along with prescription meds such as high blood pressure meds?
   A. As far as we know, saw palmetto does not interfere to any clinical degree with other medicines.

Q. Have you, by perusing research, or through clinical experience found anything to suggest that saw palmetto may reduce erectile efficiency ?
   A. I have not come across any research regarding the influence of saw palmetto on erectile dysfunction. However, people report that the use of Prostate Power Rx enhances their sexuality. This product has saw palmetto and several other other herbs for prostate health.

Q. Does saw palmetto really enhance the glands in the breast tissue, does saw palmetto lead to breast enhancement?
   A. I haven't seen human clinical research regarding the effect of saw palmetto on breast tissue. One test tube study that showed saw palmetto may slow the growth of breast cancer cells. We have had one report of a male who noticed breast enlargement after several months of taking saw palmetto.

Q. I found an inquiry on your web site about possible male breast enlargement from the use of saw palmetto interesting due to my personal experience. About six months into the use of saw palmetto I developed painful gynecomastia (breast pain) on one side. After extensive diagnostic efforts including a mammogram and a full endocrine blood work-up (both negative except that testosterone was on the low side of the normal range), surgical removal was suggested by one surgeon. A second surgeon asked about saw palmetto use and suggested discontinuing it. I did so and the problem resolved in about 30 days. The endocrinologist asked about supplements and specifically ruled out saw palmetto as a cause of breast enhancement in response to my question. Since I am not biologically trained, and this happened about six years ago, I cannot recall the exact explanation, but the endocrinologist explained his understanding of saw palmetto’s biological mechanisms. When I researched the described mechanisms, it became clear to me that there was a serious academic controversy about the mechanisms. Without fully understanding the debate, I understood enough at the time to understand that depending on who was right, saw palmetto could effect male breast enlargement. In the course of my research I found a re-print of a non-technical publication by an herbalist in the 1950’s who noted that saw palmetto could be used for female breast enlargement and generally for female hormonal imbalances.
   A. Your personal experience with saw palmetto leading to male breast enlargement is interesting. We will keep an eye out for any research on this topic.

Q. I have read somewhere that saw palmetto might be used to treat adult acne. I have the type that form in cysts...they're painful, and I'm 24. What do you know about this?
   A. It is unlikely that saw palmetto helps acne. You may try eating more cold water fish such as halibut and salmon, and more vegetables, while cutting back on nuts, dairy and refined carbohydrates. Omega-3 oils in fish are likely to benefit your skin.

Q. I'm a 52 yrs old very healthy male. I wake up at nite about 3-4 times, my PSA level has not changed since last year which is 5.1 , then I was examined by my urologist, no lump was found during my rectal examination, he prescribed a drug. I read your article and I want to take this saw palmetto you described. My question is will this saw  interfere with my medication or i can take it any time?, will this extract help to reduce my PSA level ? will this extract work in very short time and stop or do I have to take it for life?
   A. Saw palmetto should not interfere with drugs used for prostate enlargement. I doubt if it will reduce PSA levels. Saw palmetto should be taken for many years as long as there is prostate enlargement.

Q. I take Propecia to combat male pattern hair loss and was wondering whether it would be just as effective to take saw palmetto instead. I recall that at the time your book was written, it was inconclusive as to whether saw palmetto could prevent or reverse such hair loss. Are any such studies in the works? And, would supplementation with standardized Saw Palmetto extract be as effective as Propecia?
     A. It is unlikely that saw palmetto would work as well. At best saw palmetto is a very weak 5-alpha-reductase inhibitor. Whether the benefits of a combination Propecia and saw palmetto are additive is still not known.
 

The Science of Saw Palmetto
(excerpt from Dr. Sahelian's book on saw palmetto)

The Proof is In the Flow
One of the earliest studies evaluating the role of saw palmetto in the therapy of BPH was done in 1984 by Dr. Champault and colleagues at the Hospital Jean Verdier in Bondy, France. These researchers used a trademarked version of saw palmetto extract named Permixon, which is owned by a French company called Pierre Fabré Medicaments. (Other trademarks include Capistan, Strogen, Libeprosta and Sereprostat.) Permixon's main components are free (90%) and esterified (7%) fatty acids, sterols, flavonoids and other substances (Carraro, 1996).

Fifty-five patients with BPH who had symptoms of frequent urination, nocturia, and poor urinary flow were given 160 mg of saw palmetto twice a day for 30 days. The results were compared to another group that received placebo pills. At the end of this period, both objective measurements of urinary flow and subjective reporting from patients had improved on average by 50 percent compared to placebo. Saw palmetto  was well tolerated with only minor side effects reported, one being headaches. Standard blood chemistry measurements showed no changes. The researchers conclude, "As predicted from pharmacological and biochemical studies, saw palmetto appears to be a useful therapeutic tool in the treatment of benign prostatic hyperplasia." (A note worth mentioning at this point is that many of the studies evaluating the effects of saw palmetto were conducted or funded by the pharmaceutical company that sells Permixon, the trademarked version of saw palmetto extract.)

Champault and colleagues published a follow up study that involved administering saw palmetto to 47 patients with prostatic adenoma. An adenoma is a benign growth or cancer that has a very low risk of spreading or expanding. The study period this time went for 14 months, and in some cases up to two and a half years. They found saw palmetto  to be efficacious and perfectly tolerated (Champault, Bonnard, 1984).

Two years later, a British group headed by Dr. Reece Smith, from the Department of Urology and Radiology at Southampton General Hospital, repeated a similar study. Thirty-three patients were given saw palmetto at 160 mg twice daily and compared to a group of 37 individuals who did not receive any therapy. Interestingly, both the medication treated group and the placebo group had a significant improvement in flow rate and symptoms. No side effects were noted on saw palmetto except for two patients who had nausea, and one who reported an increase in sexual drive. The researchers did not seem to be completely convinced of saw palmetto's benefits. They say, "In conclusion, whilst the regime of saw palmetto used in this trial was safe, well tolerated and associated with considerable, symptomatic improvement, we have no evidence that this improvement was due to anything more than the psychosocial value of being involved in the trial and meeting a number of sufferers from a similar condition."

With these conflicting reports on the effectiveness of saw palmetto, an extensive study was sorely needed. Fortunately, such a study was published in 1996. Not only did it evaluate the effectiveness of saw palmetto in the therapy of BPH, but it also compared saw palmetto  to Proscar, the medical gold standard in the therapy of BPH.

Herb vs Drug --The Match of the Decade
The big contest had come with billions of future dollars riding on the outcome. Could extracts from a common, dwarf palm tree berry compete with the so-called "gold standard" of traditional BPH therapy? Merck and Company, one of the largest pharmaceutical corporations in the world, had invested hundreds of millions of dollars in the past decade in creating, studying, and marketing finasteride (Proscar). This medicine has become one of the most frequently used drugs in the therapy of BPH. But, could there be a cheaper, as effective, and more natural alternative, such as saw palmetto?

The largest study ever done comparing Proscar with saw palmetto was a six month double-blind, randomized trial and included 1,098 men (Carraro, 1996). (Double blind means that neither the researchers, nor the patients, know whether they are taking the real medicine or a dummy pill until the code is broken at the end of the study.) It was done in 87 urology centers in nine European countries. All the men had BPH, were over the age of 50 years, and had symptoms associated with bladder flow obstruction.

Saw palmetto extract, in the form of the trademarked version Permixon, was administered at a dose of 160 mg twice a day, in the morning and evening, for a period of 26 weeks. This was compared to Proscar at a 5 mg dosage in the morning. Each patient was evaluated prior to the start of the medicines, at 6 weeks, 13 weeks, and after 26 weeks. At each of these visits, urinary flow rates were measured, an International Prostate Symptom Score (IPSS) was determined, and each patient was requested to complete a form evaluating their quality of life, including their sexual function. (The IPSS has seven questions relating to urgency, daytime and nighttime urinary frequency, hesitancy, sensation of incomplete voiding, and force of urine stream.) Furthermore, ultrasound examinations of the bladder were done at 13 and 26 weeks to evaluate the amount of urine left in the bladder as well as to assess the size of the prostate gland. Several blood studies were also done, including measuring PSA (prostate specific antigen) levels. (High PSA levels are often indicative of prostate cancer.)

Who Won?
It was a close tie with both medicines showing advantages and disadvantages. Both saw palmetto and Proscar similarly decreased the total IPSS score. There was improvement noted in both groups within 6 weeks, and the improvement continued as the study went on. Other findings included:

The researchers conclude, "The results of this double-blind randomized study demonstrate that 320 mg daily of saw palmetto and 5 mg of finasteride are equally effective in the management of BPH. Unpublished observations suggest that saw palmetto is as active as finasteride on medium-sized and small prostates, but is less inhibitory on very large prostates. This difference might be at the origin of the higher incidence of urinary retention we noted with saw palmetto in this study. "In the treatment of men with mild or moderate symptoms of BPH, saw palmetto and finasteride are clinically equivalent. The long-term efficacy of finasteride has been established in placebo-controlled studies; that of saw palmetto needs to be confirmed."

We should keep in mind, though, that the addition of saw palmetto to other herbs and natural nutrients could lead to better therapeutic outcomes. I'll discuss these options in a later chapter.

The Longest Saw Palmetto Study
Although doctors have used saw palmetto with patients for over a decade, an actual study evaluating the long-term use of this herb was not published until 1996 (Bach). This was a trial conducted in Germany, where doctors have been using saw palmetto and other herbs for the therapy of BPH on a regular basis for many years. A total of 89 urologists and 435 patients entered the 3-year prospective study and 315 patients completed it. The patients' age ranged between 41 and 89 years. They were treated with saw palmetto at 160 mg twice a day for 3 years.

The results showed nocturia to be improved in 73 percent of the patients. At the start of the study, only 13 patients did not have nocturia, whereas, at the conclusion of the 3-year trial, 114 patients were symptom-free. Daytime frequency improved in 54 percent of the patients. Residual volume diminished by 50 percent. With respect to digital rectal examination, after three years of therapy with saw palmetto, no changes in the size of the prostate could be determined.

Overall, 80 percent of the patients and doctors felt the improvements on saw palmetto were either good or very good. The researchers conclude, "If one compares the results of the present three-year study of IDS 89 (saw palmetto extract) with published data on the long-term treatment of BPH using synthetic active ingredients--i.e. a three-year finasteride study (Stone, 1994), and an 18-months study on the selective alpha-1-blocker, terazosin (Wilde, 1993)--one can, despite methodological reservations, conclude somewhat unexpectedly that better clinical efficacy [effectiveness] has been documented in respect to the saw palmetto preparation. Withdrawal from therapy because of adverse events was 1.8 percent with saw palmetto , as opposed to 11 percent with finasteride and 10 percent with terazosin."

This study is very important because it has been known that patients with BPH have a significant response to placebo that can go on for many months, and even up to two years. This finding was reported by Dr. J. Curtis Nickel, professor or urology at Queen's University Faculty of Medicine in Kingston, Ontario, at the 1997 annual meeting of the American Urological Association (Family Practice News, August 1, 1997, p30). Therefore, the 3-year study reported above lends additional credence to the effectiveness of saw palmetto. Unfortunately, this 3-year study was not placebo-controlled. Hence, more long-term, placebo-controlled studies are required to satisfy the skepticism of critics.

Saw Palmetto Summary
The results of numerous studies published over the past few decades indicate that saw palmetto improves symptoms in a reasonable number of patients suffering from BPH. The benefits often occur without a dramatic decrease in the size of the prostate gland. The response to saw palmetto extract is similar in many ways to that of finasteride, even though they probably work in different ways.

On the legal front with Saw Palmetto Berries Co-Op
In April 2006, Saw Palmetto Berries Co-Op of Florida Inc. retained an attorney, Rakesh Amin, who sent Physician Formulas a letter. In the letter, Rakesh Amin alleges that Physician Formulas, by promoting a product called "Prostate Power Rx" which I formulated using saw palmetto and other prostate herbs, has violated the trademark "Prostate Rx" held by Saw Palmetto Berries Co-Op of Florida. Apparently, this company promotes a product called Prostate Rx which has saw palmetto herb.
   However, there is no valid case here. Saw Palmetto Berries Co-Op does not own a trademark on the word prostate, they do not own a trademark on the word Rx. Their trademark only applies to the use of "Prostate Rx" ... but no other variations. To make this clear, the United States Trademark and Patent office has already granted the use of a another similar trademark "Prostate Health Rx" to a different company called Eniva. Having done so, the USPTO has already made it quite clear that they do not see any variations of the trademarked word combination "Prostate Rx" -- such as "Prostate Health Rx" or "Prostate Power Rx"  to be an infringement on the "Prostate Rx" trademark. Therefore, if they granted Prostate Health Rx a trademark, then Prostate Power Rx should be perfectly fine.
     This is a clear case of a company, in this case  Saw Palmetto Berries Co-Op of Florida Inc., wasting their hard earned dollars on legal fees and trying to intimidate other companies just because they can. It's a shame that Saw Palmetto Berries Co-Op is wasting their time, and the valuable time of others, on this frivolous issue. You would think Rakesh Amin, the lawyer they hired, would be straightforward with the Saw Palmetto Berries Co-Op company CEO, Gregory P. Zaino, and Rakesh Amin would advise Gregory P. Zaino that Saw Palmetto Berries Co-Op has no valid case. If Saw Palmetto Berries Co-Op decides to pursue this case, it is likely PF will ask the court to have PF be reimbursed all legal costs due to this frivolous lawsuit.
    
More saw palmetto emails
Q. If DHT is the business end of testosterone, then will supplements that diminish DHT or (5 alpha reductase) also decrease masculine strength and stamina and also is it true that DHT keeps estrogen in check and therefore reducing DHT will increase estrogen in a man? Though your saw palmetto product is targeted toward prostate health, wouldn't it also be effective for androgenic alopecia caused by sensitivity to DHT at the follicle site?
   A. Research with saw palmetto and other herbs is so limited that it is difficult to be exact in our answers. Perhaps, but it is possible that certain compounds may act locally in prostate tissue but have a different effect in other tissues. The enzymes that convert testosterone to DHT in hair tissue are different that in prostate tissue, and perhaps different in muscle tissue. The extent of estrogen rise in men from saw palmetto, if any, would theoretically seem to be minimal. As mentioned above, hair tissue acts differently than prostate tissue, but it is possible that saw palmetto may have some effect in hair although we have not seen much research on this topic.

Q. Thanks to Dr. Ray Sahelian, M.D. For about nine months I had mixed results using another product that contained Beta-Sitosterol, 600 mg plus a number of minerals such as, Zinc, Copper, Manganese, etc. etc.. I replaced the aforementioned supplement with Prostate Power Rx and within two to three weeks I experienced a truly significant improvement in my condition. Now after about six weeks of use I am a very happy camper. I now only get up during the night ,one or two times as opposed to three, four and sometimes five times. Also, during the day I have very much more control over my need to find a men's room. I highly recommend Prostate Power RX. JB, Hollister, California

Q. I read your article on serenoa repens saw palmetto and hair loss. What is your opinion ( I know research is lacking ) on combining Finasteride with serenoa repens ( saw palmetto ) --- given the former is a type 2 inhibitor whereas the saw palmetto is a dual inhibitor would you speculate there may be a beneficial effect or an adverse one involving hormonal feedback loops ?
   A. You ask a good question. I don't see any obvious harm adding saw palmetto to finasteride, but I honestly don't know whether there would be a synergistic effect. I still am not convinced daily use of finasteride in doses greater than 1 mg is safe in the long run. Finasteride may blunt sexuality, but more research is needed.

Q. Dear Dr. Sahelian: I recently read a article in the newspaper that quoted the New England Journal of Medicine that after much testing it was found that saw palmetto was not effective in treating or helping bph. I have been taking saw palmetto for years and it seems to help me.

Q. My husband is 45, in good health and is taking no medications. He has been taking a saw palmetto complex (2 capsules a day for the past year and a half consisting of Vitamin B6 5mg, zinc 15mg, Saw Palmetto Extract 160 mg for one capsule, pumpkin seed oil extract 40 mg, pygeum extract10 mg, and uva-ursi extract 5 mg. His father had prostate cancer about 13 years ago but survived it and is alive today at 80 yrs. old. My husband's uncle also had prostate cancer and died from it within a year after he was diagnosed. His brother died from brain cancer at 52 yrs. of age. My husband is taking the saw palmetto complex to help prevent getting prostate cancer not because of any physical problems that he has such as an enlarged prostate. My question is do you think it is beneficial for him to continue taking this supplement (preventive maintenance) and if so, does it need to be taken everyday or ever other day or how often? He takes a multivitamin everyday and COq10 30 mg. every other day. Also, can the ingredients in the saw palmetto complex he takes cause him to have impotence or a lower sex drive?
   A. We can't provide individual advice as to whether a person should or should not take saw palmetto or any other herb or supplement. In my opinion, saw palmetto may actually be beneficial for sexual function, although I am still waiting for more research on this topic.

Q. Does saw palmetto decrease libido or erection? Since it prevents testosterone to be converted to DHT, which is an important hormone for maintaining good libido and erection, it would make sense that saw palmetto could cause decrease libido or erection.
   A. Actually we have not seen any studies regarding the influence of saw palmetto on libido. Our limited clinical anecdotal experience indicates that saw palmetto may, in some people, help with erectile function.

Q. What do you think of this statement about saw palmetto I found on a web site: “Three recent studies investigating the effectiveness and effect of saw palmetto on prostate tissue came up with the same conclusion: Saw palmetto has an effect similar to chemotherapy on prostate cells—it kills both unhealthy and healthy cells!”
   A. Some in vitro studies have shown this effect. I have not seen any good human studies regarding the use of saw palmetto supplement and evaluation of prostate tissue by biopsy to determine if the effects seen in the lab when prostate cells are directly exposed to high concentrations of saw palmetto herb would be similar to a human being taking a saw palmetto supplement that goes through the digestive process, blood stream, and ends us in the prostate gland in much smaller concentrations.

Q. I found the number of inquiries on Dr. Sahelian’s web site about possible male breast enlargement from the use of saw palmetto interesting due to my personal experience. About six months into the use of saw palmetto I developed painful gynecomastia on one side. After extensive diagnostic efforts including a mammogram and a full endocrine blood work-up (both negative except that testosterone was on the low side of the normal range), surgical removal was suggested by one surgeon. A second surgeon asked about saw palmetto use and suggested discontinuing it. I did so and the problem resolved in about 30 days. The endocrinologist asked about supplements and specifically ruled out saw palmetto as a cause in response to my question. Since I am not biologically trained, and this happened about six years ago, I cannot recall the exact explanation, but the endocrinologist explained his understanding of saw palmetto’s biological mechanisms. When I researched the described mechanisms, it became clear to me that there was a serious academic controversy (albeit with one view in a distinct minority) about the mechanisms. Without fully understanding the debate, I understood enough at the time to understand that depending on who was right, saw palmetto could effect male breast enlargement. In the course of my research I found a re-print of a non-technical publication by an herbalist in the 1950’s who noted that saw palmetto could be used for female breast enlargement and generally for female hormonal imbalances. In light of the number of inquiries, my personal experience, the academic dispute, and the older herbalist publication indicating some folk wisdom on the subject, a warning about possible side effects should be considered.

Q. My hair loss mitigation program included 600 traditional 1/4 inch plugs, when they fell out, two scalp reductions, a Frishee device reduction, and brandy flap (?) which removed 45 square inches of scalp in total. I then had 3500 micro plugs, one to five hairs each, placed in the 17 square inches of remaining bald area, which gave me a full head of hair.
Which of course, began to fall out about a year after implantation, 100-125 hairs per day, which is alot when you only have 50% left to start. Rogaine and Propecia didn't help. I am flat out of donor plug material unless they use body hair, which by the way, is being done. I digress. On the internet in 2005 I came across anecdotal stories about the efficacy of saw palmetto for hair loss. I purchased from a Saw Palmetto product and began a regimen of a couple pills in the morning and couple in the evening. The saw palmetto product had Zinc 15 mg - 100%, Selenium 55 mcg - 79%, Saw Palmetto extract 320 mg standardized to 85% fatty acids. No help. I went for six pills morning and six evening.
In three days, my hair stopped falling out. Nothing in the comb. Nothing in the shower. If I wait a week to shampoo, THEN I might get 25 to 50 hairs tops. I went from 125 hairs per day, to 125 hairs lost, per month. I didn't grow any new hair, but since 20% of your hair is "at rest" at any one time, that hair began to surface over the next 18 months and the remaining hair, avoiding dormancy, stuck around for company. 18 months is not a quick process. But it made a startling demonstrative difference. I wish I'd have started those pills twenty years ago.
   A. This is interesting, I wonder if very high dosages of saw palmetto are required to stop hair loss. However, the long term side effects of high dose saw palmetto herb use are not clearly understood.

If I am taking warfarin, can I take saw palmetto herbal extract?
    This herb is not known to cause bleeding problems, but it is difficult to predict interactions with medications.

Saw palmetto is sometimes misspelled as saw palmeto or pametto or palmetta
This page was last updated 2009.