The Efficacy and Safety of Combined Therapy with α-Blockers and Anticholinergics for Men with Benign Prostatic Hyperplasia: A Meta-Analysis

Abstract

We performed a meta-analysis to compare treatment with α-blockers and anticholinergics (ie combination therapy) to α-blocker monotherapy to clarify the efficacy and safety of this treatment approach among men with storage urinary symptoms related to benign prostatic hyperplasia. We searched for trials of men with benign prostatic hyperplasia/lower urinary tract symptoms that were randomized to combination treatment or α-blockers alone. We pooled data from 7 placebo controlled trials meeting inclusion criteria. Primary outcomes of interest included changes in International Prostate Symptom Score (storage subscores) and urinary frequency. We also assessed post-void residual volume, maximal flow rate and the incidence of urinary retention. Data were pooled using random effects models for continuous outcomes and the Peto method to generate odds ratios for acute urinary retention. Combination therapy had a significantly greater reduction in International Prostate Symptom Score storage subscores (Δ -0.73, 95% CI -1.09 - -0.37) and voiding frequency (Δ -0.69 voids, 95% CI -0.97 - -0.41). There was also a greater reduction in maximal urinary flow rate (Δ -0.59 ml per second, 95% CI-1.04 - -0.14) and increase in post-void residual urine volume (Δ 11.60 ml, 95%CI 8.50-14.70) with combination therapy. The number needed to treat withcombination therapy to cause 1 acute urinary retention episode was 101 (95% CI 60-267). Combination treatment with α-blockers and anticholinergics significantly improved storage voiding parameters compared to men treated with α-blocker therapy alone. This treatment approach is safe with a minimal risk of increased post-void residual urine volume, decreased maximal urinary flow rate or acute urinary retention.