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

BACKGROUND: The Bowman-Birk inhibitor is a soybean-derived protease inhibitor 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 tract symptoms (LUTS) has been performed. RESULTS: The results of the trial indicated that there was no dose-limiting toxicity of BBIC. There was a statistically significant decrease in serum PSA levels in all BBIC-treated patients. Some BBIC-treated patients exhibited a relatively large reduction in serum PSA levels, ranging up to a 43% reduction. There was also a statistically significant decrease in serum triglyceride levels and a decrease in prostate volume in the treated patients. The scores recorded in response to a urinary symptom questionnaire indicated improved urinary activities in the BBIC-treated patients; however, the control subjects exhibited similar improvements in urinary activities during the course of the trial. CONCLUSIONS: The data obtained in this trial, particularly the data suggesting that BBIC treatment may lead to reduced serum PSA levels and reduced prostate volumes, suggest that a Phase II clinical trial of BBIC for the therapy of BPH is warranted

Symptom persistence in a community cohort of women with interstitial cystitis/bladder pain syndrome (IC/BPS): 3-, 6-, 9-, and 12-month follow-up from the RICE cohort

INTRODUCTION AND HYPOTHESIS: The persistence of interstitial cystitis/bladder pain syndrome (IC/BPS) symptoms has been described in women seeking medical care. The purpose of this study was to determine whether symptoms persist among a population-based sample of women. METHODS: A probability sample of U.S. women was identified through a two-stage telephone screening process using the RICE high-sensitivity case definition. A randomly-selected subgroup (n=508) was enrolled in a longitudinal study and interviewed about their symptoms at baseline, 3, 6, 9, and 12 months. Bivariate and multivariate linear regression analyses determined predictors of persistence of symptoms over the four waves. RESULTS: A total of 436 women with a mean age of 47.5 years responding to all waves were included in the analysis. Forty-one percent met the RICE high sensitivity case definition at baseline and in all four waves; an additional 21% met the definition at baseline and in three waves. Women with a college degree (+12% vs. no college, p=0.02) and who were younger (−5% per decade of age, p<0.01) had higher chances of symptom persistence at each wave. Scoring one standard deviation higher on the continuity of symptoms and the O’Leary Sant Interstitial Cystitis Symptom index increased the chances of symptom persistence by 4% and 2 %, respectively (both p’s<0.01). CONCLUSIONS: The majority of women demonstrated symptom persistence across at least three of four waves over 12 months. These women tended to be younger, college-educated, and to have reported a history of greater continuity of symptoms and higher severity of symptoms at baseline