Bilal Chughtai, MD

When it comes to supplements and how to talk to patients about them, it's a very complex discussion. Now, there are some patients who give you a very unique opportunity to build a very strong relationship through discussions on supplements. You can go ahead and shut that door and say, “Hey, look, the AUA (American Urological Association) doesn't recommend them, they don't work, and that's it. I don't recommend them.” A lot of times, you then close that opportunity to build a relationship with that patient. A condition like enlarged prostate with LUTS is known to progress in patients over time. When it comes to supplements, it's a unique opportunity for us, as urologists, to start talking about recommendations. Suggesting high-quality supplements that have been independently tested by the USP (United States Pharmacopeial Convention) is important.

When it comes to supplements, there's also a unique opportunity to allow patients to use the supplements in a way that you can monitor any adverse effects and progression of the patient’s condition. When it comes to supplements, as physicians, it's important for us to have some understanding of them. We should be able to guide our patients, to some degree, on what supplements have the most promising data or have the highest chance of working. At the same time, we must ensure that we're following the standard of care for our patients and providing high-quality care for them.

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Closing out his discussion on saw palmetto extracts in benign prostatic hyperplasia and lower urinary tract symptoms, Bilal Chughtai, MD, shares practical advice for physicians.

Saw Palmetto Extracts in BPH and LUTS: Practical Advice on Patient Education

When it comes to Permixon itself, there are no contraindications for its use. I would be careful when utilizing Permixon to ensure that patients are screened and fall under the correct category. These patients should have more mild symptoms and an IPSS (International Prostatism Symptom Score) of 8 or maybe as high as 13, a Qmax (maximal flow rate) of around 15 or maybe even a little bit lower, but not a very high PVR (postvoid residual urinary volume). These are patients who are very carefully selected and can do very well with a compound like Permixon.

When we take a look at Permixon and saw palmetto, we see that there is almost no real drug-to-drug interaction. In addition, although Permixon's mechanism of action is proposed through androgen receptor signaling, it doesn't affect PSA (prostate-specific antigen) or prostate cancer screening, because it doesn't affect the PSA number. Further, when you look at adverse effect profiles, this drug has shown a very high safety profile, where the most common complaint is something like gastrointestinal upset (nausea in probably 1% of people who take it). In addition, high blood pressure is rarely reported and, even more rarely, erectile dysfunction is noted. Ultimately, when it comes to a compound that's able to preserve sexual function, minimize changes for the patient, but improve lower urinary tract symptoms (LUTS), Permixon has shown exquisite safety.

A brief review of the safety profile associated with use of saw palmetto extracts in benign prostatic hyperplasia and lower urinary tract symptoms.

Adverse Event Profile of Saw Palmetto Extracts in BPH and LUTS

When it comes to the clinical data with saw palmetto, there have been extensive meta-analyses and Cochran reviews trying to understand exactly where the role is for saw palmetto. Unfortunately, when it comes to a lot of the studies for saw palmetto, including CAMUS and STEP, one problem is that there wasn’t a complete standardization of what compound was used. The question also becomes, in CAMUS and STEP, would the saw palmetto that was used meet the USP [US Pharmacopeia] criteria today? Sometimes, you have to look at the data with a grain of salt

The second thing about these supplement studies is the absence of clear-cut entry criteria and exactly how patients fell off. A lot of times you were having patients with sometimes moderate to severe lower urinary tract symptoms combined with those with mild to moderate symptoms. Ultimately, when you take a very heterogeneous group, a lot of times you lose signals, making it hard to determine exactly how this compound would be helpful. When it comes to the clinical trial data as a whole, unfortunately, the data have been mixed. It’s partially because you have a supplement that isn’t well regulated or standardized. Additionally, some of the studies were quite heterogeneous as well.

When it comes to Permixon and the European data that goes with it, the ability to help lower urinary tract symptoms secondary to BPH [benign prostatic hyperplasia] looks very promising. Some of the data, especially for Permixon, does rival that of alpha blockers and PDE5 [phosphodiesterase-5] inhibitors. Now, some of these trials have very carefully selected populations. Therefore, there may be a very clear-cut role in clinical benefit for Permixon in the properly selected patient.

When you look at the data for Permixon, we can see that it’s got a very gradual onset of action. I think in a carefully selected population, what I would define as the mild BPH group, patients will do quite well with a compound like Permixon. These are usually patients that aren’t looking for active medical treatment. They still require them to be monitored and ensure that there isn’t significant progression of their condition, but ultimately that group can do fairly well with Permixon for a long time. What’s even more notable about saw palmetto as a whole is that in the CAMUS trial, part of that was a dose-finding study, and even a 3XD [3 times appropriate dose] for saw palmetto showed exquisite safety, even at very high doses.

Expert insight on clinical trial data informing the use of saw palmetto extracts in benign prostatic hyperplasia and lower urinary tract symptoms.

BPH and LUTS: Interpreting Clinical Data on Saw Palmetto Extracts

The US Pharmacopeia [USP] is an independent not-for-profit company that has been present to help standardize and enrich the supplement market. This is done by standardizing labeling, what’s in the bottle, and ensuring that the compound that you have is what it is, and there are no harmful additives or other components.

Right now, there’s only 1 USP-verified saw palmetto with the brand name of Flomentum. It’s the only one that’s listed on their website.

The European Pharmacopeia is very similar to the USP, where they help standardize the compounds as well as the additives that are put in to ensure that the patients receive a standardized compound. Unlike the United States, Europe sometimes considers these compounds almost first-line agents. For those with mild lower urinary tract symptoms secondary to BPH [benign prostatic hyperplasia], it’s common to use these compounds.

The American Neurological Association guidelines don’t recommend the use of supplements for lower urinary tract symptoms secondary to BPH. Their stance is that it’s a relatively unregulated market. If you look at the studies that have been done with most of the supplements, there isn’t a clear-cut standardization. The data have been mixed at best, especially when you look at trials such as CAMUS or STEP.

A brief overview of regulation in nutraceuticals/food supplement use for patients with benign prostatic hyperplasia and lower urinary tract symptoms.

Bilal Chughtai, MD

Articles

Saw Palmetto Extracts in BPH and LUTS: Practical Advice on Patient Education

Adverse Event Profile of Saw Palmetto Extracts in BPH and LUTS

BPH and LUTS: Interpreting Clinical Data on Saw Palmetto Extracts

Regulation of Nutraceuticals/Food Supplements in BPH and LUTS