Effects of Isoflavone in Patients With Watchful Waiting Benign Prostate Hyperplasia
Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
Participant gender:
Summary
Benign prostatic hyperplasia (BPH) is a common problem among aging Caucasian men that
produces significant morbidity and hea1th care costs. It is likely that BPH is just as common
among Chinese men. Debate exists as to whether currently available surgical and
pharmacological options for BPH are appropriate for men in the watchful-waiting stage of this
condition. Evidence suggests that the consumption of soy isoflavones is related to lower
rates of BPH among Asian men. The advantages of soy isoflavones over conventional therapies
may include better patient compliance, improved safety and lower cost. Despite the fact that
soy isoflavones are safe and contain a health-conferring ingredient with a defined mechanism
of action, no randomised control trial has been performed using isoflavones to treat BPH.
Therefore, a randomised control trial is proposed to test the tolerability and effectiveness
of soy isoflavones (Soylife) verses placebo in 182 men with defined watchful waiting BPH over
a period of 12 months. In this trial, patients who fulfill the inclusion criteria, will
either be given 40mg of soy isoflavones capsule (once daily) or a placebo capsule. They will
be reviewed every three months with maximal urine flow rate, international prostate symptoms
score and quality of life measured. Baseline tests include RFT, LFT, FBC, MSU, PSA and
testosterone and to be repeated at 6th month and 12th month. The investigators hypothesize
that this intervention will reduce lower urinary tract symptoms and slow the progression of
the disease.