Saw Palmetto No Better Than Placebo For Enlarged Prostate

Saw Palmetto No Better Than Placebo For Enlarged Prostate
Medical and health information
14 Feb 2006

Saw palmetto, an herbal extract commonly taken to improve urinary symptoms in men with enlargement of the prostate gland, is no more effective than a placebo, according to a new study.

The year-long, double-blind study of 225 men was led by Stephen Bent, MD, a staff physician at the San Francisco VA Medical Center, and Andrew Avins, MD, MPH, of the Northern California Kaiser Permanente Division of Research.

The results are published in the February 9, 2006 issue of the New England Journal of Medicine.

In their study, the researchers randomly assigned patients with enlargement of the prostate, also known as or benign prostate hyperplasia or BPH, to take either saw palmetto or a placebo twice a day for one year. Subjects returned at regular intervals to be assessed for symptoms and side effects. Symptoms were assessed according to a standard symptom score for BPH and objective measures of urinary function.

"If you look at the change in symptoms over time between the two groups, it was almost identical," reports Bent, who is also an assistant professor of medicine at the University of California, San Francisco. "There was no statistically significant difference at any time point during the study."

The researchers also looked at subgroups of patients - those with more and less severe symptoms and those with larger and smaller prostates - and found no difference in any of the subgroups between the herbal extract and placebo.

"The results of this study clearly do not support a strong clinical benefit of saw palmetto for BPH," concludes Bent. "However, whether other doses, formulations, or patient populations might respond differently is unknown."

The researchers estimate that saw palmetto is used by over two million men in the United States for treatment of BPH, which is said by the National Institutes of Health to affect more than 50 percent of men over 60 and upwards of 90 percent of men over 70.

Bent acknowledges that the study results are surprising, since many earlier studies concluded that saw palmetto is effective against BPH. However, he points out a number of differences between the current study and earlier research.

"Prior studies were generally small in size and short in duration," he says. "Plus, the vast majority of them did not use the standard symptom score that we used for assessing the severity of BPH," which is now commonly used to judge the efficacy of pharmaceutical drugs for treatment of the condition.

Another potential problem with earlier studies has to do with the nature of saw palmetto itself, according to Bent. "This is a very pungent herb, and it took our research team a long time to create a placebo that convincingly duplicates its strong smell and taste. We suspect that prior trials didn’t adequately address that problem." As a result, he says, "it’s possible that some of the positive findings in earlier work may be due to the fact that the blinding wasn’t adequate." In other words, patients in those studies knew whether they were taking the herb or the placebo, and "someone who’s taking something that’s smelly and likely to be the plant extract is perhaps more likely to report a benefit than someone who’s taking an odorless and tasteless tablet."

At the end of the current study, 40 percent of patients in the saw palmetto group believed they were taking the herbal extract versus 46 percent in the placebo group, demonstrating that the blinding was adequate, says Bent.

Bent notes that his research team took pains to select an herbal product that matched the levels of fatty acids and sterols - commonly believed to be saw palmetto’s active ingredients - found in most commonly available commercial preparations of the herb.

Almost all prior studies of saw palmetto used exactly the same dose, says Bent - 160 milligrams twice a day - and the current study used that dose as well. He notes that such consistency of dose is not typical among studies of most other herbal medications.

The current study subjects reported no statistically significant side effects from saw palmetto.

Bent cautions that while the study is strongly indicative, it is not conclusive. "This is a surprising finding that contradicts the weight of prior evidence," he observes. "There is good reason for other researchers to conduct another study to validate these results, taking care that blinding is done carefully once again."

In addition, says Bent, "Some people believe that higher doses may be potentially effective, and that’s an area that we did not address."

A major new NIH-funded study of saw palmetto and another commonly-used herbal treatment for BPH is currently in the final planning stages, according to Avins, who is a co-author of the current study. The new study will involve several hundred patients at 11 centers nationwide, and researchers hope it will shed more definitive light on the questions of adequate doses and other potentially useful natural treatments for BPH, says Avins.

Other co-authors of the current study include Christopher Kane, MD, and Katsuto Shinohara, MD, of SFVAMC; John Neuhaus, PhD, and Esther S. Hudes, PhD, MPH, of UCSF; and Harley Goldberg, DO, of UCSF and KPNC.

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Original Article: Saw Palmetto for Benign Prostatic Hyperplasia | NEJM

It does, though, sometimes help relieve the symptoms of active prostatitis. My doc suggested it to try “for awhile.” Did, and it helped a bit… maybe. I quit it and felt better but probably because the antibiotic was doing its work by then.

I agree with avocet. I was going to claim bullshit on the article, until I saw that Kaiser Permanente was involved in the study. They have one of the most solid reputations out there of going against Big Pharma and doing what is best for the patient. One of the few medical organizations left that I will listen to for at least a moment.

Very interesting. Good find Ike.

According to this many studies have used BPH symptom scores.

My flow is better when I take it. <shrug>

I just heard about the study on this radio show called Day to Day: Slate’s Medical Examiner: Doubts on Supplements : NPR

Fortunately, I’m not showing signs of BPH…yet. I’ve been taking saw palmetto to slow down male pattern baldness. Maybe it’s helping to prevent prostate enlargement and I just don’t know it.

And, there are apparently a lot of studies that support its use for BPH.

Interesting, S&G. The uro who suggested I try saw palmetto when prostatitis was raging works with Kaiser.

I don’t agree with all their drug policies. They do not, though, allow pharmaceutical reps to visit their docs in their offices feeling that the reps will unduly influence the docs in their prescription policies; they don’t take free rep samples, either. On the other hand, their drug co-pay system is highly prejudiced at least in one area. They won’t co-pay any erectile drug even if the patient requires them. Their attitude is that patients will abuse the system by having sex more often than the system would approve. None of their business, IMO.

Ike, get you one of those hand-held rubber scalp massagers with the little rubber bumps on them. Theory is, more blood flow to the scalp, less follicle death in the long run.

Yup. Got one of those. Do it everyday. Thanks for the suggestion though.

If saw palmetto fails to show effects on the enlarged prostate gland it’s hard to conclude it does anything against hair loss. Originally it was argued that, since palmetto does have an effect on the enlarged prostate gland it’s likely that palmetto has the capability to block aromatase from testosterone to DHT. Well, a friend of mine changed from finasteride to palmetto already about a year ago. I can see him losing what he kept for about three years on finasteride. His decision, but it encouraged me to stick with my finasteride (just received another 180 pills from India for about 70 US$) :D My hair looks great, BTW ;)

And regarding the rubber massage advocates: The better the blood flow to the follicles, the more free DHT docking at the follicles, go figure… There is another thing you can observe easily: People tending to get a lot of blood pressure in the head area when doing cardio work out will be the ones with little hair on their scalp. Naively I always accused the intense blood presence in the scalp skin to be connected with hair loss. Combining this observation with the fact that minoxidil is originally targeting high blood pressure systematically and is applied to the scalp for stopping hair loss, it gives kind of a big picture. I would never ever decide to massage my scalp to increase blood flow :eek:

Ike, I was doing some “research” a few weeks ago in preparation for some DHT trials for PE and I was considering the Saw Palmetto as my intended “off cycle” treatment. However, I ran across a weird link where some guy claiming to be a doctor said to stay away from substances containing Phytoestrogens as they have negative effects on natural testosterone & estrogen production and sensitivity.

I do not have MPB in my family so I was not looking for a treatment for baldness, but masculinity is something I concern myself with. Apparently, Saw Palmetto does SOMETHING it just does not treat hair loss or prostate growth. What does it do? Good question.

Isoflavones like Soy products are Phytoestrogens (estrogenic properties) and can bind to estrogen receptors. Good, Bad, or indifferent…we should know more before we casually add this (or any substance) to our daily regimen.

(My wife an I have recently gone (mostly) organic. I’m not paranoid or freaky about it, I just read a little article about bovine IGF-1 in the majority of the milk produced in the US. Since I feed this to my growing sons everyday, I became concerned about what the secondary effects might be of a bovine growth hormone that has demonstrated viability in human subjects. Trace amounts, mind you, but why? I would prefer to let the kids bodies do what they are programmed to do without the meddlesome effects of artificial exogenous hormones.)

Is it possible that many of the health problems we face today are the products of our own “progress”?

Has anyone got a link to one of those scalp massagers? I have never seen them before.

Thanks L Born, and Goon. I do have male pattern baldness in my family. It’s handy to have three older brothers aged 54, 59 and 61, so I can see how I might age over the next fifteen years.

To slow baldness, I take finasteride and saw palmetto; I shampoo with 2% Nizoral; and I massage my head in the shower everyday with a massage brush. If the massaging is bringing DHT to my scalp, then maybe the other things I do are cancelling it out. I do have a lot more hair than any of my brothers did at my age. (By the way, none of them have had any prostate problems, as far as I know.)

And Solarwind, I have a massage brush like the "Marvy" one displayed here: http://www.cach … y.com/fromm.htm They’re fairly cheap, and should be in any drugstore. Those little plastic palm brushes (scroll down that page) will do fine, but the kind with the softer bristles will do more massaging and less scratching.