Efficacy and safety of botulinum toxin injection for benign prostatic hyperplasia: a systematic review and meta-analysis

Purpose: The aim of this study was to overcome the limitation of overlooking the placebo effect in previous studies and to demonstrate the overall treatment efficacy and safety of botulinum toxin type A (BTX-A) compared with placebo. Methods: We conducted a systematic review and meta-analysis of the published literature in PubMed, Cochrane Library, and Embase reporting on BTX use in lower urinary tract symptoms (LUTS)/benign prostate hyperplasia (BPH). Single-group analysis for the placebo effect and meta-regression analysis for the moderator effect were performed with high-quality RCTs compared with placebo. Results: A total of three studies were included, with a total sample size of 522 subjects (260 subjects in the experimental group and 262 subjects in the control group). Study duration ranged from 8 to 24 weeks. The pooled overall SMD in the mean change in IPSS for the BTX-A group versus the placebo group was −1.02 (95 % CI −1.97, −0.07). The other outcomes (Q_max, prostate volume, and post-voided residual volume) were not statistically different between the two groups. The placebo effect in single-group analysis ranged from 0 to 27.9 % for IPSS, and from −1.1 to 28.7 % for Q_max (lowest to highest, respectively). Conclusions: This evidence-based systematic review and meta-analysis of the BTX-A injection for LUTS/BPH showed no differences in efficacy compared with placebo and also showed no difference in procedure-related adverse events occurred. Thus, the results of this study do not provide evidence of clinical benefits of using the BTX-A injection for LUTS/BPH in real clinical practice.