Depression risk of 5-alpha reductase inhibitors: impact of active-comparator versus non-drug user control groups on risk measurement

The risk of depression with 5-ARI use is likely minimal. Observational data utilizing active comparators suggests a 10% reduction in risk, while randomized data from a cancer prevention trial suggests a potential risk increase of approximately 10%. Previous reports of up to 200% increased risk likely stem from inappropriate control group selection that failed to account for disease burden.