title: Efficacy and safety of botulinum toxin injection for benign prostatic hyperplasia: a systematic review and meta-analysis.
abstract: OBJECTIVE
  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.
authors.affiliation: Institute for Clinical Molecular Biology Research, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, Republic of Korea.
authors.forename: Sung Ryul
authors.initials: SR
authors.lastname: Shim
authors.affiliation: Department of Epidemiology and Medical Informatics, Korea University, Seoul, Republic of Korea.
authors.forename: Young Joo
authors.initials: YJ
authors.lastname: Cho
authors.affiliation: Department of Education, College of Education, Jeonju University, Jeonju, Republic of Korea.
authors.forename: In-Soo
authors.initials: IS
authors.lastname: Shin
authors.affiliation: Department of Urology, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, 140-743, Republic of Korea. piacekjh@hanmail.net.
authors.forename: Jae Heon
authors.initials: JH
authors.lastname: Kim
mesh_terms: D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007267:Injections; D008297:Male; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
keywords: Benign prostatic hyperplasia; Botulinum toxin; Meta-analysis; Placebo