Limitations of Using Outcomes in the Placebo Arm of a Clinical Trial of Benign Prostatic Hyperplasia to Quantify Those in the Community

Compared with community-dwelling men, men in the placebo arm of this clinical trial of BPH treatments had a substantially lower risk of BPH-related outcomes. Extrapolation of findings from the placebo arm of clinical trials to describe the natural history of disease in community-dwelling men should be done with caution and appropriate recognition of limitations.