One more nail in the coffin for saw palmetto

Extracts of the berries of the saw palmetto plant (Serenoa repens) have long been used as an alternative form of therapy by men with symptoms suggesting lower urinary tract disorders (e.g., difficulty with urination; frequent urination; etc.). However, there is good evidence that such treatment is ineffective.

While no one has ever suggested that saw palmetto could be used to actually treat prostate cancer, many men take saw palmetto because they believe that this will lower their PSA level and thus “must” be helping to lower their risk for benign prostatic hyperplasia and perhaps for prostate cancer. Frankly, it doesn’t.

The Complementary and Alternative Medicine for Urologic Symptoms or CAMUS trial was carried out between June 5, 2008 and October 10, 2012. This multi-center, randomized trial enrolled 369 men, all > 45 years of age, who had AUA symptom scores of between 8 and 24. The 369 patients were then randomly assigned to treatment with a placebo or with escalating doses of saw palmetto (320 mg once daily for the first 24 weeks; 320 mg twice a day for the next 24 weeks; and 960 mg three times a day for the last 24 weeks of the 72-week-long trial).

In an earlier report, the trial coordinators published data showing that treatment with escalating doses of saw palmetto was no more effective in reducing urinary tract symptoms that treatment with the placebo (see Barry et al.).

In the most recent report using data from this study, Andriole et al. have now shown that treatment with escalating doses of saw palmetto (as compared to treatment with a placebo) also has no significant impact on patient’s PSA levels. Here are the data they report:

  • Serum PSA levels were obtained from all patients in the trial at baseline and at weeks 24, 48, and 72.
  • Serum PSA levels were similar at baseline for men randomized to the saw palmetto group and men randomized to the placebo group.
    • The average (mean) PSA level at baseline for men in the saw palmetto group was 2.20 ± 1.95 ng/ml.
    • The mean PSA level at baseline for men in the placebo group was 1.93 ± 1.59 ng/ml.
    • This difference was not statistically significant.
  • Changes in PSA level over the course of the trial were similar for men randomized to the saw palmetto group and men randomized to the placebo group.
    • The mean decrease in PSA level for men in the saw palmetto group at 72 weks was 0.23 ± 0.83 ng/ml.
    • The mean PSA level at baseline for men in the placebo group was 0.16 ± 1.08 ng/ml.
    • Again, this difference was not statistically significant.

Andriole and his colleagues conclude that, “Saw palmetto extract does not affect serum [PSA levels] more than placebo, even at relatively high doses.”

The “New” Prostate Cancer InfoLink recognizes that there are few known significant risks associated with the use of saw palmetto berry extracts as a “herbal” therapy. However, it is now also clear that there are also few (if any) clinical benefits associated with the use of this form of alternative care (except to the pockets of those manufacturing and selling this product).

9 Responses

  1. In my paper regarding Diet and Supplements found on my website I refer readers to this URL, which explains that purchasing saw palmetto as a 5-AR inhibitor or for any ailment associated with prostate cancer is a waste of money. Take particular note of the second paragraph.

  2. I’m interested in reading a double blind study on Beta Prostate, the product.

  3. Here are links to reports of the results of two randomized, double-blind trials of beta-sitosterol (the primary active ingredient in Beta Prostate) in the treatment of BPH. Both trials were conducted nearly 20 years ago in Germany. Clinical trials like these conducted 20 years ago may well have had methodological flaws that would not be acceptable today.

    In both trials — the first reported by Klippel et al. and the second reported by Berges et al. — beta-sitesterol appears to have shown some degree of activity.

    I would note, however, that I have not checked whether the daily dose of beta-sitosterol administered in these two trials is similar to that recommended for the commercially available Beta Prostate product. Your should also be aware of the potential side effects associated with use of beta-sitosterol products, which can include erectile dysfunction, decreased sex drive, and a reduction in the ability to absorb certain vitamins, including vitamin E and beta-carotene.

  4. Thanks, but herein lies the issues I have with supplements as well as with Roger Mason’s website, “young again”. . .and his insistence of his herbal remedies that he supports but not others.

    How is any novice supposed to meander through the bullshit and misinformation? Mason is all over beta-sitosterol, brags about selling his company, investing in silver to support his peceived philanthropy. Yet Joe Public has absolutely no understanding of exactly what they are taking, has no recent comparative data to other interventions, and these companies are thriving on the fears of patients desperately trying to find a solution to their political issue.

    At what point in time does the medical community call out the herbal community publicly instead of colllectively sitting back and shaking their heads?

  5. Q: “At what point in time does the medical community call out the herbal community publicly instead of colllectively sitting back and shaking their heads?”

    A: When we make appropriate adjustments to the First Amendment to the Constitution, which will happen at about the same time as we make appropriate adjustments to the Second Amendment! At present Mr. Mason and others have the legal right to say pretty much whatever they like about the products they market … and there is nothing that the medical community can do about it, which is why they just shake their heads.

  6. If the comparative reference is the Second Amendment, then the herbal community is at risk. Right now the NRA is about to get a nice dose of well deserved humility (read “ass kicking”) as they again, attempt to bully anyone who disagrees with them and refuse to capitulate on anything.

    Two-thirds of US women are not amused right now by the NRA stance … and we all saw their focused power last month during the election.

  7. At what point are we going to call out the medical community for placing nearly blind faith in corrupted studies funded by big pharma?

  8. Dear Glenn:

    Respectfully, … if you believe that the average physician has “blind faith” in the studies funded to prove particular points by commercial interest groups of any type, you are clearly not reading the right medical publications.

  9. I use saw palmetto and from 8 times a night going to the toilet for a pee I now go once and sometimes none bat all. Don’t take any notice of these professors and know-it-alls about enlarged prostate. It’s worked for me and I’m just an average bloke in my mid 60s.

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