Dutasteride on benign prostatic hyperplasia: a meta-analysis on randomized clinical trials in 6460 patients

Urology. 2014 Mar;83(3):539-43. doi: 10.1016/j.urology.2013.10.007. Epub 2013 Nov 16.


Objective: To investigate the clinical effectiveness of dutasteride in the treatment of benign prostatic hyperplasia by meta-analysis.

Materials and methods: Several databases were searched from inception to June 2013 for prospective clinical studies comparing dutasteride vs placebo. The continuous outcomes of therapeutic efficacy included International Prostate Symptom Score/American Urological Association Symptom Index, maximum flow rate, total prostate volume, and acute urinary retention (AUR). The dichotomous outcomes included surgery risk and the rate of sexual dysfunction. The relative risk for dichotomous outcome and the weighted mean difference for continuous outcomes were estimated using fixed effects model.

Results: Four studies met the inclusion criteria and were included, in which a total of 6460 patients received dutasteride and 6475 received placebo treatment. The average symptom score was improved by 1.98 with 95% confidence interval (CI) 1.77-2.19 (P <.00001); the average maximum flow rate was increased by 1.16 mL/s with 95% CI 0.63-1.70 (P <.0001); the total prostate volume was reduced by 13.86 mL (95% CI 12.76-14.96; P <.00001); the odds ratio for AUR was 0.35 (95% CI 0.27-0.47; P <.00001). The major side effect for dutasteride was the increased rate of sexual dysfunction compared with placebo, with odds ratio of 0.41 (95% CI 0.31-0.54; P <.00001).

Conclusion: Dutasteride is highly effective in mitigating benign prostatic hyperplasia symptoms and reducing the size of enlarged prostate and the risks of AUR and surgical intervention. However, dutasteride therapy is related to an increased rate of sexual dysfunction.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Azasteroids / adverse effects
  • Azasteroids / therapeutic use*
  • Dutasteride
  • Humans
  • Male
  • Organ Size
  • Prostatic Hyperplasia / drug therapy*
  • Prostatic Hyperplasia / pathology*
  • Sexual Dysfunction, Physiological / chemically induced
  • Urodynamics / drug effects
  • Urological Agents / adverse effects
  • Urological Agents / therapeutic use*


  • Azasteroids
  • Urological Agents
  • Dutasteride