Bioforce Responds to JAMA Saw Palmetto Study

ROGGWIL, SwitzerlandAndy Suter, head of the medical research department at Bioforce AG, commented on the recent JAMA study that questioned saw palmettos ability to reduce urinary problems for men with enlarged prostate glands.

The study looks well designed and statistically sound, but it has one significant flawthe patient selection," Suter said. The authors write in the discussion of the publication, ... a greater percentage of men in our study ... may have had LUTS (lower urinary tract symptoms, i.e., urinary problems) due to causes other than BPH.

This is highly important and relevant to understanding the trials negative outcomes. At the outset of the trial, the mens diagnosis for BPH (benign prostatic hyperplasia, the treatment of symptoms of which are the primary acknowledged indication for saw palmetto extracts) was based solely on observed symptoms. More specifically, and this is particularly significant in a study of this importance, neither ultrasound imaging of the prostate to determine its size nor rectal palpation (i.e., digital rectal exam) was carried out to confirm the diagnosis.

Patients included in the trial had a low average PSA (prostate specific antigen) value with a large standard deviation of 2.07±1.78. PSA level is strongly correlated to the prostate size and this low value indicates the majority of the patients might not be affected by BPH at all (Urology. 1999;53(3):581-9 and Urology. 1994;44(6):825-31). A further inclusion criterion confirms this finding: the initial maximum urinary peak flow rates were rather high with 14.9 ml/s, a value which corresponds to a normal population with only minor BPH symptoms (Eur Urol. 2001;39(1):36-41). A value of 10ml/s usually better represents patients affected by BPH.

The negative outcome of this trial is in contrast to the beneficial results the majority of BPH patients experience with a saw palmetto berry preparation of good quality. In our own clinical trials with our saw palmetto extract, Prostasan®, the BPH symptoms decreased after a treatment duration of eight weeks between 35 to 51 percent (Ars Medici. 2005;2:1-3).We at Bioforce are thus still convinced that standardized saw palmetto berry products are a beneficial and safe treatment for the urinary symptoms of mild to moderate BPH, which has been reflected by everyday use and clinical experiences for more than 40 years."