You have to look at all the data as a whole.
The irony after posting this several times lmao...
Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-analysis.
Belknap SM1,
Aslam I2,
Kiguradze T2,
Temps WH2,
Yarnold PR3,
Cashy J4,
Brannigan RE5,
Micali G6,
Nardone B2,
West DP2.
Author information
Abstract
IMPORTANCE:
Two meta-analyses conclude that finasteride treatment of androgenic alopecia (Androgenetic Alopecia) is safe but do not assess quality of safety reporting.
OBJECTIVE:
To assess safety reporting for clinical trial reports of finasteride for Androgenetic Alopecia.
DATA SOURCES:
MEDLINE, ClinicalTrials.gov, and a clinical data repository for an academic medical center.
STUDY SELECTION:
Published clinical trial reports for finasteride treatment of Androgenetic Alopecia.
DATA EXTRACTION AND SYNTHESIS:
For each trial, we assessed quality of adverse event reporting, extracted the number and type of adverse events in treatment and placebo groups, and assessed duration of safety evaluation and adequacy of blinding. Two observers independently extracted the data; differences were resolved by consensus. We assessed generalizability in a large cohort of men prescribed finasteride, 1.25 mg/d or less, by assessing for eligibility in the finasteride-Androgenetic Alopecia pivotal trials.
MAIN OUTCOMES AND MEASURES:
Quality was assessed as adequate, partially adequate, inadequate, or no events reported. We used funnel plots of the hazard ratio to assess bias.
RESULTS:
Of 34 clinical trials, none had adequate safety reporting, 19 were partially adequate, 12 were inadequate, and 3 reported no adverse events. Funnel plots were asymmetric with a bias toward lower odds ratio for sexual adverse effects, suggesting systematic underdetection. No reports assessed adequacy of blinding, 18 (53%) disclosed conflicts of interest, and 19 (56%) received funding from the manufacturer. Duration of drug safety evaluation was 1 year or less for 26 of 34 trials (76%). Of 5704 men in the clinical data repository who were treated for Androgenetic Alopecia with finasteride, 1.25 mg/d or less, for Androgenetic Alopecia, only 31% met inclusion criteria for the pivotal trials referenced in the manufacturer's full prescribing information and 33% took finasteride for more than 1 year.
CONCLUSIONS AND RELEVANCE:
Available toxicity information from clinical trials of finasteride in men with Androgenetic Alopecia is very limited, is of poor quality, and seems to be systematically biased. In a cohort of men prescribed finasteride for routine treatment of Androgenetic Alopecia, most would have been excluded from the pivotal studies that supported US Food and Drug Administration approval for Androgenetic Alopecia. Published reports of clinical trials provide insufficient information to establish the safety profile for finasteride in the treatment of Androgenetic Alopecia.
https://www.ncbi.nlm.nih.gov/pubmed/25830296
