“Our study confirmed our suspicion” that “these pills were junk.”

According to what appears to have been a pretty forthright presentation at the ongoing annual meeting of the American Society for Radiation Oncology (ASTRO), many commonly used men’s health and prostate supplements weren’t helping prostate cancer patients.

The presentation (by Dr. Nicholas Zaorsky of the Fox Chase Cancer Center) looked at the use of supplements by more than 2,200 men who were newly diagnosed with localized prostate cancer between 2001 and 2012, all of whom underwent radiation therapy of some type as first-line treatment. The study looked, in particular, at the use of “over-the-counter’ supplements sold with messaging that they were “men’s formula” or “prostate health” products and that often carried labels stating that they were “clinically proven” or “recommended by urologists.”

According to the authors:

  • Roughly 10 percent of the >2,200 patients were taking one or more of about 50 such products (either at time of treatment or within the following 4 years).
  • None of the products evaluated had ever been studied in a clinical trial (or at least, not in a clinical trial for prostate cancer).
  • > 90 percent of the products contained saw palmetto (which is often said to prevent or treat enlargement of the prostate, despite a complete lack of any good evidence that this is the case).
  • Some products contained ingredients described as just “other” or “trade secret enzyme” (whatever that is).
  • None of the products appeared to show any sign that they could
    • Lower risk for experiencing side effects of radiation therapy
    • Lower risk of prostate cancer progression over time
    • Lower risk of prostate cancer-specific mortality

In a report on this presentation on the HealthDay web site, Dr. Zaorsky is quoted as saying, “We suspected that these pills were junk. Our study confirmed our suspicion.”

A senior scientific representative of the Council for Responsible Nutrition, a trade association for the dietary supplement industry, apparently responded to Dr. Zaorsky’s study and comments by stating that the findings were those of “someone with a conclusion in search of data.” Given Dr. Zaorsky’s above-mentioned statement, there may be some truth to that remark!

The “New” Prostate Cancer InfoLink has long advised patients that there is absolutely no good evidence whatsoever that any particular type of supplement is able to act in a way that will effectively and safely prevent or treat prostate cancer. However, …

We are also of the opinion that the use of most such supplements is generally harmless, and so if taking one or more such supplement makes a patient “feel good” about himself, there probably is no harm and no foul. The proviso is that if you do take such supplements you should always tell your doctor or at least your pharmacist that you are doing so … on the off-chance that a particular supplement may contain an ingredient that could interact in an adverse manner with a prescription drug you are getting treated with.

And of course the more costly the supplement, the wiser you would be to really consider whether it is truly beneficial. One might be better advised to use that money to spend a pleasant day by the sea or visiting a National Park or just going to see a movie!

8 Responses

  1. I disagree, saying all supplements are not helpful. Seems to be way too broad of a study. My husband takes supplements recommended for prostate cancer specifically. His responses to radiation was beyond what we were told was possible. His side effects were very minimal. He does not take saw palmetto or any secret ingredients labeled “Mens formula.” Those may be junk. There are good supplements out there. A study like this could stop a person from trying supplements that may work for many people.

  2. I wouldn’t call most of these “worthless” supplements harmless, as many of them are quite expensive and a patient’s finances could be seriously impacted … and obviously better spent.

  3. Dear Rob:

    I would gently note that it is not my responsibility to tell people how to spend their cash … although I would also note that I clearly pointed out that there might be better ways to spend it, especially if the supplement was a costly one.

  4. Sitemaster, I agree with your comment that there is often a psychological benefit. When we are feeling so out-of-control, taking a pill can sometimes help us feel that we are doing at least something for ourselves. The placebo effect is real.

    Most supplements are harmless, but some are not, as was proved by the SELECT trial. Vitamin E, especially when coupled with high levels of selenium, was harmful. We recently saw that those who took a placebo fared better than those who took pomegranate extract, perhaps suggesting the supplement may be interfering with our natural cancer-fighting. I hope we all know to avoid anti-oxidants especially during radiation therapy.

    To my knowledge, sulforaphane/broccoli sprout extract is the only supplement that has made it as far as succeeding in a double-blind randomized clinical trial without equivocal evidence. (It is an ingredient in Pomi-T.) It seems to be safe in doses used. Of course, we would like to have larger confirming studies to validate this. And it may be that, owing to increased bioavailability of sulforaphane by eating broccoli, we may be better off with the food than the pill.

  5. This is case of the pot calling the kettle black. Radiologists and the radiotherapy industry have deployed a wide range of putative treatments for prostate cancer which has generated enormous revenues, but have evaded systematic trials. In a recent review of benefits and harms of treatments for localized prostate cancer in Annals of Internal Medicine (2008:148, 435-448), Wilt and colleagues concluded that, “No randomized trial evaluated brachytherapy, cryotherapy, radical prostectomy, or photon-beam or intensity modulated radiation therapy. … Only 3 randomized trials compared effectiveness between primary treatments. No trial enrolled patients with prostate cancer primarily detected with prostate screening.” So, who’s irresponsible in this dialogue — the radiologist who bills thousands of dollars for treatments associated with severe iatrogenic harms and no established benefit, or the herbal company selling a “prostate health” supplement for 20 bucks?

    At least there are randomized controlled trials of saw palmetto, which has been used as a potential treatment for benign prostatic hypertrophy. I looked at the NIH PubMed database this evening and found (to my surprise) that there were several recent trials supporting efficacy for this purpose either as a monotherapy or in conjunction with prescription meds. I don’t know of any credible source that has suggested that saw palmetto or other natural products used for BPH (e.g., pygeum, nettle root) are therapeutic for prostate cancer.

    There are tantalizing findings in animal models indicating that a variety of natural agents, including grape seed extract, curcumin and resveratrol can inhibit prostate cancer. Unfortunately, these compounds have no commercial potential and will not be developed by industry. NIH is generally uninterested in these approaches. Without human trials, there’s no way of knowing whether such findings extrapolate to human disease. However, simply dismissing the potential of therapies from complex organic compounds out of hand is unfortunate. There is a long history in medicine of discovery hinging on understanding the effects of natural compounds on disease (e.g. lime for scurvy, quinine from cinchona bark for malaria).

  6. Dear Brian:

    (1) “Tantalizing findings” exist with respect to the use of almost everything under the sun in hundreds of different diseases … That doesn’t mean that they are either clinically effective or safe. The use of things like citrus fruits to prevent scurvy and quinine to prevent malaria went on tp be proven. (It didn’t take randomized double-blind trials to prove their effectiveness either, which was a good thing because no one had thought that type of trial up at the time!) Most of the effective drug therapies in the world can be traced back, historically, to a precursor with an origin in some type of “natural product” (inclusive of all of the new “biological” agents that are now commonplace.

    (2) Many of the treatments we use today predate the development of the randomized double-blind clinical trial … and the good Dr. Wilt is actually wrong when he says that “No randomized trial … evaluated radical prostatectomy …” There was actually a large Scandinavian trial that did exactly that. It clearly proved a survival benefit for radicasl surgery compared to simple monitoring in a set of patients diagnosed on the basis of their clinical symptoms (prior to the use of the PSA test) in the Scandinavian countries. There is no evidence that radical prostatectomy improves survival in men with low-risk disease. Indeed there is a lot of evidence that careful monitoring is just as effective as any form of treatment in men with low-risk disease. There was also a randomized trial of cryotherapy (in Canada). However, he is correct that there were never any randomized trials of some other forms of therapy, and the randomized trial of proton beam radiation therapy is ongoing as I write.

    (3) The possible value of saw palmetto in the prevention of BPH is very different to the complete lack of value of saw palmetto in the treatment of prostate cancer.

    (4) Actually, with respect to resveratrol, a company spent many millions of dollars attempting to prove that it was effective and safe in the treatment of selected types of cancer. They failed. It wasn’t.

    Having said all of that … I agree with you that there is a clear “pot calling the kettle black” aspect to the above report … which was just one of the reasons that I drew attention to the report here. The other one being to make the point that if one is going to use these alternative products it is important to let your doctor and pharmacist know about it so that they can watch for possible drug-drug interactions and their side effects. These are not uncommon.

  7. Brian,

    You may be interested in the CAMUS randomized clinical trial of saw palmetto. The authors concluded, “Saw palmetto extract does not affect serum prostate specific antigen more than placebo, even at relatively high doses.”

    Resveratrol (and curcumin) never made it to the randomized clinical trial phase based on their pharmacokinetics. It was found that the bioavailability was so low that they could not duplicate the concentrations found to be effective in in vivo or in vitro lab results. There are chemistry laboratories working on methods for enhancing bioavailability.

    There are many randomized clinical trials (RCTs) of therapies that have been reported upon on this site. Treatments are often compared to standard-of-care rather than placebo for ethical reasons, and to prove the benefit is worth the added cost or toxicity. So, for example, the M. D. Anderson external beam radiation dose escalation trial proved that clinical progression was reduced with higher doses. But I agree that there is regrettably a dearth of RCTs comparing, say, robotic RP to open RP, IMRT to 3D-CRT, LDRBT to HDRBT, etc. Some of them are in ongoing RCTs like the ProtecT trial in the UK. Some, I doubt we will ever see.

  8. Allen and Sitemaster,

    Thanks for your informed commentary and critique. When I quoted Wilt, I left out “robotic” from “robotic radical prostectomy,” apologies to the good Dr. Wilt for the major typo. I am aware of the Scandinavian trial (and so was his group.)

    I’m not recommending that anyone take nutritional supplements for cancer and would be astonished if any off the shelf nutraceutical would have a meaningful effect on prevention or course of the disease. Interesting about bioavailability issues with resveratrol, similar to issues with curcumin. I had read the CAMUS trial failed to show efficacy of saw palmetto for BPH, and thus my surprise to see recent refereed studies with positive findings.

    I disagree that there are an abundance of preclinical agents in the refereed medical literature that have been replicated across labs. My impression is that there are surprisingly few university/med school labs doing this work, at least in terms of publications in mainstream journals. Reassuring to know work is going on at private companies on testing and development of different derivatives of novel agents, but very little of this information is readily accessed in the public domain.

    It’s disheartening that with 200,000+ men diagnosed annually with prostate cancer, even coarse decisions about (for example) relative efficacy of different types of radiation therapy are a matter of debate rather than large scale trials. Unfortunately, as Allen wrote, it’s hard to imagine circumstances in the USA which would allow a RCT among treatments. I’m not criticizing Dr. Zarkosky’s conclusion that supplements taken by patients have no demonstrated benefit, only that he’s not applying similar standards of evidence to evaluate therapies employed by his own profession.

    In any event, I’m grateful to have this well monitored forum to discuss issues, challenge assumptions, and disseminate evidence-based findings relevant to understanding and treating prostate cancer.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.

%d bloggers like this: