Effects of Bowman-Birk inhibitor concentrate (BBIC) in patients with benign prostatic hyperplasia

BACKGROUND. The Bowman-Birk inhibitor is a soybean-derived protease inhibit or that has anti-inflammatory and anticarcinogenic activities. METHODS. A Phase I trial of Bowman-Birk inhibitor concentrate (BBIC) in 19 male subjects with benign prostatic hyperplasia (BPH) and lower urinary tra ct symptoms (LUTS) has been performed. RESULTS. The results of the trial indicated that there M as no dose-limitin g toxicity of BBIC. There was a statistically significant decrease in serum PSA levels in ail BBlC-treated patients. Some BBIC-treated patients exhibi ted a relatively large reduction in serum PSA levels, ranging up to a 43% r eduction. There was also a statistically significant decrease in serum trig lyceride levels and a decrease in prostate volume in the treated patients. The scores recorded in response to a urinary symptom questionnaire indicate d improved urinary activities in the BBIC-treated patients; however, the co ntrol subjects exhibited similar improvements in urinary activities during the course of the trial. CONCLUSIONS. The data obtained in this trial, particularly the data suggest ing that BBIC treatment may lead to reduced serum PSA levels and reduced pr ostate volumes, suggest that a Phase Il clinical trial of BBIC for the ther apy of BPH is warranted. Prostate 48:16-28, 2001. (C) 2001 Wiley-Liss, Inc.