Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-analysis
Belknap et al., 2015
“toxicity information from clinical trials of finasteride in men with AGA is very limited, is of poor quality, and seems to be systematically biased.”
”Of 34 clinical trials, none had adequate safety reporting.”
Meta-analysis of 34 clinical trials of Finasteride for use in androgenic alopecia discovered serious flaws, poor quality reporting and systematic bias.
None of the 34 articles considered had adequate safety reporting. Of 25 clinical trial reports with a control arm, none reported on blinding adequacy. 18 publications (53%) disclosed authors with conflicts of interest, while 19 articles (56%) received funding from a pharmaceutical manufacturer of finasteride. 12 articles (35%) did not disclose their funding.
Nonsexual adverse drug events were not reported in 28 articles. The only study to use a validated measure to assess depression found a clinically and statistically significant increase in Beck Depression Inventory Scores after exposure to finasteride, but did not adequately assess adverse effects other than depression.
The authors note that the opportunity to identify and characterize drug toxicity may be lost when investigators do not use validated, effective methods for detecting adverse events, grading their severity, and evaluating causality.
They conclude “one might reasonably expect that 34 studies and 2 meta-analyses would be adequate to establish the rate of finasteride adverse effects in AGA, yet this does not seem to be the case.”
