Objective: To systematically review the placebo arms of randomized trials of medical therapy for benign prostatic hyperplasia (BPH) and thus estimate rates of progression.
Methods: We searched PubMed, the Cochrane Trials Register and the USA Food and Drug Administration website. Retrieved citations were reviewed in two stages: a title and abstract screen, followed by a review of selected full-length articles. The inclusion criterion for studies were trials of BPH with >100 patients in the placebo group.
Results: From 1774 citations screened, 16 eligible studies were found with a total of 12 158 patients. The range of mean baseline age was 62.6-66.5 years, for prostate volume 33.9-61.0 mL and for maximum urinary flow 8.6-11.6 mL/s. With studies spanning 12-48 months, the rates of surgery were 1-10% and for acute urinary retention 0.4-6.6%. Most studies showed progression, based on a worsening in clinical outcomes of the change from baseline in prostate volume and maximum urinary flow. Statistical heterogeneity prevented a quantitative synthesis of the data.
Conclusion: This systematic review confirms BPH disease progression in the form of increased prostate volume, reduction in maximum urinary flow rate and an increase in the risk of acute urinary retention and surgery. To provide quantitative estimates of effect, access to data from individual participants would be required.