This transcript has been edited for clarity.
I’m Dr Gerald Chodak for Medscape. Today I would like to talk about over-the-counter prostate supplements, prompted by a recent advertisement that my son-in-law saw on TV. That product is called ProstaGenix.
Many people are aware that over-the-counter products are not bound by the same rules and regulations as prescription drugs. Both the US Food and Drug Administration and the Federal Trade Commission are responsible for overseeing regulations and advertising for these products. They are not permitted to diagnose, cure, treat, or prevent any disease in their advertising.
This particular product, ProstaGenix, stated on the bottle that it improves urinary flow, improves sleep patterns, and reduces urgency. These claims seem to violate the regulations, and one wonders whether the Federal Trade Commission should look at it.
I looked in the literature and found one prospective, randomized trial involving ProstaGenix. However, it was a small study of short duration and was not published in a peer-reviewed journal. Looking at other products on the market, I could not find randomized trials with any of them.
However, there are randomized studies for some of the ingredients that have been included in the various supplements, including saw palmetto,pygeum,beta-sitosterol, and quercetin. Interestingly, there are some data showing a clinical improvement in urinary symptoms, mainly in the IPSS urinary symptoms score. The studies, however, are of short duration and the various dosages and preparations have not been well studied.
Going forward, it is concerning that although some of the agents or ingredients in the various supplements could indeed help patients, there is no evidence at this time that any of the combinations that are being marketed (at significant prices) provide patients with a clinical benefit.
In the future, it would be great if we could see some better prospective randomized trials designed to assess whether these agents are worthwhile. In particular, it would be helpful if some of them were compared with commercially available products as a way of assessing whether the prescription drugs provide a clinical benefit beyond that obtainable with these over-the-counter products.
The bottom line is that more information is needed. Patients need to be cautioned about the potential interactions that could occur because of the various ingredients that are included in the over-the-counter prostate supplements.
I look forward to your comments. Thank you.