An observational retrospective evaluation of 79 young men with long‐term adverse effects after use of finasteride against androgenetic alopecia
Giorgio Chiriacò, Sabina Cauci, Giorgio Mazzon, Carlo Simone Trombetta
Andrology2016
In plain terms
Researchers in Italy asked 79 young men who still had problems after stopping the hair-loss drug finasteride to fill in detailed questionnaires, on average almost four years after they had stopped. Nearly 9 in 10 reported less feeling in the penis, and about 8 in 10 reported weaker ejaculation and a penis that felt colder. About 3 in 4 said they felt less pleasure or emotion in life, about 7 in 10 had trouble concentrating, and about half reported losing muscle. About 6 in 10 said their symptoms had got worse after they stopped the drug.
What it doesn’t show: It can't show how common these problems are among men who take finasteride, or prove the drug caused them: every man in it already had lasting symptoms, most were found through an online forum for affected men, there was no comparison group, and how they were before the drug was based on memory.
Summary (paraphrased)
Seventy-nine men (mean age ~33) reporting long-term adverse effects after finasteride for hair loss were surveyed with a 100-item questionnaire plus validated sexual and aging-male symptom scales. Mean time since discontinuation was about 44 months, documenting multi-year persistence. The most common sexual complaints were loss of penile sensitivity (87%), reduced ejaculatory force (82%), and low penile temperature (79%) — genital sensory loss outranked severe erectile dysfunction in frequency. Non-sexual symptoms were dominated by anhedonia (76%), impaired concentration (72%), and loss of muscle tone or mass (52%), supporting a multisystem syndrome rather than isolated sexual dysfunction.
Evidence
Extracted from the full text; page numbers refer to the paper. The library’s own notes are labelled as such.
- Design
- Case seriesRetrospective observational study (authors' term); one-time questionnaire survey of men with persistent symptoms after finasteride, with recalled pre-treatment sexual function and no comparison group
- Setting
- Urology Unit, Trieste University Hospital (Italy); participants from several countries (Italy 34.2%, Canada and USA 20.2% each, UK 12.7%); study dates not stated
- Population
- Men over 18 and under 50 who took finasteride for hair loss and had side effects lasting at least 6 months after stopping, and who had seen a doctor at least once, including a blood test. Required ASEX scores in the dysfunction range or an AMS score of 27 or more. Excluded: documented sexual dysfunction or mental illness before finasteride, BMI over 30, chronic disease, earlier hormone-altering drugs, and anyone involved in finasteride litigation.
- Size
- 79 · 79 men, 17 from the clinic and 62 from Propeciahelp.com (an internet forum for PFS); 66 had been in the group's earlier studies; AMS data for 78
- Exposure
- Finasteride for hair loss at 1 mg/day (57, 72.2%), 1.25 mg/day (18, 22.8%) or 0.5 mg/day (4, 5.1%); mean use 27.3 months (range 1–120)
- Compared with
- None; current ASEX compared with the same men's recalled pre-finasteride ASEX
- Outcome
- Symptom type and frequency from an ad hoc 100-item questionnaire; sexual function on the Arizona Sexual Experience Scale (ASEX, 5–30, higher is worse; dysfunction defined as 19 or more, any item 5 or more, or any three items 4 or more); androgen-deficiency symptoms on the Aging Male Symptom scale (AMS, 17–85; severe 50 or more).
- Follow-up
- None; single assessment a mean 44.1 months (180–5,057 days) after stopping finasteride
Key results
- Symptoms began during finasteride use in 71 of 79 (89.9%) and after stopping in 8 (10.1%); since stopping, symptoms had worsened in 49 (62.0%), were unchanged in 19 (24.1%) and improved in 11 (13.9%) · p. 247, Table 1
- Sexual symptoms on the ad hoc questionnaire: loss of penile sensitivity 69 (87.3%), decreased ejaculatory force 65 (82.3%), decreased penile temperature 62 (78.5%), reduced ejaculate volume 58 (73.4%), loss of scrotal sensitivity 49 (62.0%) · p. 247, Table 1
- Non-sexual symptoms: reduced pleasure or emotions (anhedonia) 60 (75.9%), lack of concentration 57 (72.2%), loss of muscle tone or mass 41 (51.9%), anxiety 20 (25.3%), gynecomastia 8 (10.1%) · p. 247, Table 1
- ASEX total 21.0 ± 2.67 now vs 7.7 ± 2.52 recalled before finasteride (p < 0.001); 78.5% scored 19 or more. Scores of 5–6 (severe): sex drive 55 of 79 (69.6%), getting or keeping an erection 35 (44.3%), reaching orgasm 15 (19.0%), orgasm satisfaction 16 (20.3%) · pp. 247–248, Table 2
- Sexual arousal: the paper reports 13.9% with scores of 5–6 and a mean of 4.4 ± 0.87, but Table 2's post-finasteride arousal row does not add up. Its counts (1, 11, 30, 31, 5, 6) sum to 84 (106.3%), not 79, and give a mean of about 3.5 (SD about 1.1). Every other row in Table 2 matches its stated mean and SD, and the total of 21.0 is consistent with 4.4, so the 13.9% figure (repeated in the text and conclusion) cannot be confirmed · pp. 247–249, Table 2
- AMS (78 men): mean 52.3 ± 10.47; severe (50 or more) 47 (60.3%), moderate 27 (34.6%), slight 4 (5.1%) · p. 247
Limitations the authors note
- Retrospective design, with no baseline information from before finasteride use
- Participants were recalled by phone after taking part via a dedicated website, so several biases cannot be excluded; incomplete clinical assessment from the records provided; missing or non-spontaneous information
- No objective testing of penile sensitivity
- Relatively small number of men, partly because of strict selection
Also worth weighing (library’s note)
- All men already had persistent symptoms and were selected partly on dysfunction scores, so the percentages describe this group, not how often symptoms occur in finasteride users
- 62 of 79 were recruited from a PFS internet forum, and 66 of 79 had taken part in the group's earlier studies
- Pre-finasteride function was rated from memory, years later
- The headline comparison (87.3% loss of penile sensitivity vs 44.3% severe erection difficulty) sets a yes/no item from the ad hoc questionnaire against severe scores on a different scale
- The ad hoc 100-item questionnaire is not a validated instrument, and the paper says medical visits took place "when done", without saying how many men were examined
- Inclusion says under 50 years old, while results give an age range of 22–50
Funding: University of Udine and University of Trieste grants, 2012–2014 Interests: None declared
What it can support (library’s note): A description of the symptoms reported by a selected group of men with lasting problems after finasteride for hair loss, notably genital sensory changes and non-sexual symptoms. It cannot give frequencies for finasteride users in general or establish causation.
Why it’s in the corpus
A foundational PFS phenotyping case series: a one-time questionnaire survey of 79 selected men with persistent symptoms, describing their sexual, neuropsychiatric and physical symptoms a mean of 44 months after discontinuation; its percentages apply to this group, not to PFS in general. The clinical counterpart to the corpus's mechanistic entries.