Phytotherapy to treat BPH: Selective success or futile?

The best-designed study to date of phytotherapy for BPH, which involved a standardized extract of saw palmetto (Serenoa repens) taken for 1 year, showed this treatment was no more effective than placebo was in ameliorating BPH symptoms and signs (N Engl J Med 2006; 354:557-66), said Claus G. Roehrborn, MD, professor and chairman of urology, University of Texas Southwestern Medical Center, Dallas.

However, Paul D. Maroni, MD, argued that this study fails to mention a larger, year-long BPH study that pitted a saw palmetto formulation (Permixon), 320 mg, against tamsulosin (Flomax), 0.4 mg (Eur Urol 2002; 41:497-507). That study found equivalent reductions in International Prostate Symptom Score (4.4), equivalent increases in maximum flow rate (1.8 mL/second), and equivalent safety, explained Dr. Maroni, assistant professor of surgery/urology at the University of Colorado Health Sciences Center, Denver.

"We've had enough trials with medications that are active in BPH to ask, 'Why can't the control arm be what most would consider the standard of care: treatment with a 5-alpha-reductase inhibitor or an alpha-blocker?' " Dr. Maroni said, adding that such a study would be far more valuable to patients than potentially receiving a sugar pill.

Is placebo effect valid?

Conversely, Dr. Roehrborn said that all research that appears to support the use of phytotherapy for BPH and LUTS actually fails to acknowledge the huge impact of the placebo effect.

"We all use the placebo effect, and use it rightly, but we don't have to buy phytotherapy to use it," he said. "Patients are probably better off spending their money on a movie ticket."

"Around 20% to 30% of patients are going to have a prolonged remission, whether they take anything or not," he said. "When we consider the fact that there is this batch of patients that aren't going to need any medication, and that most men with BPH symptoms have a 15- to 20-year life expectancy [Eur Urol 2007; 51:1522-33], the costs can be mind-boggling."

Conversely, a month's supply of saw palmetto or Pygeum africanum typically costs $10 to $30. Accordingly, Dr. Maroni recommends starting patients on phytotherapy when they have moderate symptoms, thereby potentially forestalling the need for costlier traditional prescriptions for 1 or 2 years.

"I believe in doing the least possible at the lowest possible cost to control symptoms. Phytotherapy is ideal for patients with BPH who have moderate symptoms and low bother scores," Dr. Maroni explained.