The short term effectiveness of doxazosin in treatment of benign prostatic hyperplasia (BPH) : a randomized double-blind placebo-controlled trial

Abstract

Objective : To compare the percentage of symptom improvement between Doxazosin and placebo after three-month treatment of symptomatic uncomplicated BPH in men age > 50 years old. Design : Randomized double-blind placebo-controlled trial Setting : Urological out-patient unit in a tertiary care medical school hospital. Patients : Thirty-two patients aged 50 years or older with internation prostate symptom score (IPSS) > 8, peak flow rate < 15 ml/sec and without prostate cancer or concurrent treatments for BPH were randomly allocated into 15 cases in Doxazosin group and 17 cases in placebo group. Interventions : patients received Doxazosin or placebo 1 mg at bedtime on D1 to D3, 2 mg on D4 to D10 and 4 mg on D11 to D21. At 3-week follow up visit, the global subjective assessment which was the main outcome was evaluated by one question in order to compare the voiding feeling at that time with the time before treatment. If the subjective symptom was "much improved", the dose maintained until the end of study. It not, the dose was titrated to 8 mg and maintained until the end. The duration of treatment was three months. The global subjective assessment was done in every visits at 3, 6, 9 and 12 weel. Result : By the global subjective assessment, the symptom improvement rate was 84.6% in Doxazosin group and 80.0% in placebo group when the outcome was evaluated at the last visit of each patient. When the outcome was analyzed at 6 weeks, the improvement rate was 83.3% and 66.7% in Doxazosin and placebo group respectively. The change in IPSS and peak flow rate in Doxazosin group was better than in placebo group. The adverse effect in Doxazosin group was higher. There was no statistical significance in the difference of all outcomes between both groups. Conclusion : This limited study shows that the effectiveness of Doxazosin was not clinically and statistically different from placebo in term of symptom improvement or IPSS or peak flow rate, but the combination of these outcomes may obtain more reliable result and demonstrate effectiveness of Doxazosin.