Post Finasteride Syndrome

What is Post Finasteride Syndrome and is it real? 

The Post Finasteride Syndrome (PFS) Foundation is a non-profit organisation dedicated to helping fund research on the characterization, underlying biological mechanisms, and treatments of PFS while improving public awareness of the condition. 

They define this condition as: 

• Enduring sexual dysfunction persists after stopping treatment with a 5 alpha-reductase inhibitor (Finasteride, Dutasteride). This can include loss of libido, Erectile Dysfunction, and loss of genital sensation and orgasmic function. 

Other symptoms include: 

• Physical: Gynaecomastia (breast enlargement), fatigue, muscle pain, cramps and spasms, dry skin, tinnitus.
• Psychological and Neurological: Depression, insomnia, anxiety, and suicidal ideation. Reduced concentration and decreased memory and mental performance. 

Finasteride works by acting on the enzyme 5alpha reductase, to stop the conversion of testosterone into its active metabolite Dihydrotestosterone or DHT. DHT acts on hair follicles to cause miniaturisation, causing them to become shorter and finer. It also shortens the growth cycle of hair from years to months. 

Side effects are commonly reported with many medications. Finasteride can cause reduced libido, erectile dysfunction, and mood changes. Post finasteride syndrome refers to the persistence of these and other symptoms such as depression, suicidal ideation, and cognitive problems after the drug has been stopped.   

Post finasteride syndrome has caused much controversy. 

Essentially there is not enough high-quality clinical data about this condition, which has led to many medical professionals denying its existence. However, it has been listed in the National Institutes of Health’s Genetic and Rare Diseases Information Centre in the USA, and the FDA and MHRA have cited longstanding sexual dysfunction as a possible consequence of treatment. 

What do clinical trials say?

Again, the jury is still out. 

A long-term study that followed men over a five-year period showed that side effects with Finasteride such as reduced libido and ED only occurred in 2% of patients. The incidence of side effects was similar to placebo at one and 5 years and they disappeared in all men who stopped the drug because of side effects but also in most who continued the treatment.(2)

In addition, a meta-analysis which looks at the results of many clinical trials concluded that there was a low incidence of sexual side effects and that there was also no significant difference between the incidence of side effects when comparing the drug with the placebo.(3) 

However, the quality of adverse event reporting in the majority of finasteride clinical trials has been brought into question by another meta-analysis which looked at the evidence from 34 different studies. 

They concluded that of 34 trials, none had adequate safety reporting, and there was a bias towards under-detection of side effects, with 18 studies reporting conflicts of interest and 19 receiving funding from the manufacturer.  As a result of all these factors, they could not accurately establish the rate of adverse effects with the data from these 34 trials. 
 
An example of bias in the clinical trial setting is that many of these trials have used questionnaires to report side effects, which may not be completely objective and subject to bias (for example, if the subject is reluctant or embarrassed to talk about issues such as sexual dysfunction). In addition, until recently, many clinical trials on finasteride did not use an objective, validated quantitative scale to assess side effects. In the case of erectile dysfunction (ED), they did not utilise the  International Index of Erectile Dysfunction (IIED), which provides a quantitative scale of assessment. All these factors would affect reporting of adverse effects. 

The Nocebo Effect

It’s important to understand the role that psychological factors can play in the way a drug and its side effects are perceived. Nocebo refers to an adverse effect that is not caused by the pharmacological effect of the drug. In one study, a group of 120 men, all of who were receiving treatment for Finasteride were split into two equal groups. The first group received counselling about the potential side effects of the drug, the second group did not. The group that received information about the side effects reported a significantly higher proportion of sexual side effects. All the side effects were reversible on discontinuation of the medication.(4) 

Is it possible to recover fully from post finasteride syndrome? 

Some men have made a partial recovery but there are no reports of PFS patients returning to full health. But a handful of PFS patients have reported that they've felt 80%, 90% or even 99% better over a period of one to five years.

Can we cure post finasteride syndrome?

Unfortunately, there is currently no evidence based effective treatment for post finasteride syndrome. 

Are there alternatives to Finasteride treatment?

We know that Finasteride is a very effective treatment for Male Androgenetic Alopecia (MAA) or male pattern hair loss. However, there are some other options. 

Minoxidil - topical solution 2% or 5% 

It is thought to work by increasing the anagen(growth) phase of hair. 

It may need to be applied twice daily for at least 3-4 m months before the effects are realised. Continued application is needed to maintain the hair growth, otherwise, the newly grown hair may be shed within a few months. A recent study found that the 5% Minoxidil solution was superior at improving hair growth than the 2% in men with MAA.(5) 

Minoxidil 2.5mg oral tablets

These are taken as a one-a-day dose and act on the prostaglandin synthesis pathways in the hair scalp and follicles. Although used as an “off-label” therapy it has been shown to be effective in male pattern baldness.(6)

Alpecin C1 Caffeine shampoo 

Caffeine shampoos, such as Alpecin C1 Caffeine Shampoo, have shown to be a promising treatment with reported increases in hair thickness and strength.

So, should I take Finasteride medication? 

It’s important to remember that post finasteride syndrome is rare, with an estimated 1000 men believed to be suffering from the condition worldwide. This is compared to the millions of men who have had successful treatment of their hair loss with this drug. 

If you need further advice, speak to one of our pharmacists today. 

References

1. Post-finasteride syndrome: An emerging clinical problem. NeuroBiol Stress 2020 May; 12: 100209. Silvia Diviccaro, Roberto Cosimo Melcangi, ∗ and Silvia Giatti
2. Kaufman KD. Long-term (5-year) multinational experience with finasteride 1 mg in the treatment of men with androgenetic alopecia. Eur J Dermatol. 2002;12:38–49.
3. The efficacy and safety of 5α-reductase inhibitors in androgenetic alopecia: a network meta-analysis and benefit-risk assessment of finasteride and dutasteride, Aditya K Gupta 1, Andrew Charrette. J Dermatolog Treat. 2014 Apr;25(2):156-61. doi: 10.3109/09546634.2013.813011. Epub 2013 Jul 5.
4. Finasteride 5mg and Sexual Side Effects: How Many of these are Related to a Nocebo Phenomenon? Nicola Mondaini MD,Paolo Gontero MD,Gianluca Giubilei MD,Giuseppe Lombardi MD,Tommaso Cai MD,Andrea Gavazzi MD,Riccardo Bartoletti MDFirst published: 26 July 2007 https://doi.org/10.1111/j.1743-6109.2007.00563.xCitations: 34
5. Clinical Trial J Am Acad Dermatol, 2002 Sep;47(3):377-85. doi: 10.1067/mjd.2002.124088. A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men, Elise A Olsen 1, Frank E Dunlap, Toni Funicella, Judith A Koperski, James M Swinehart, Eduardo H Tschen, Ronald J Trancik
6. Jimenez-Cauhe J, Saceda-Corralo D, Rodrigues-Barata R, Hermosa-Gelbard A, Moreno-Arrones OM, Fernandez-Nieto D, et al. Effectiveness and safety of low-dose oral minoxidil in male androgenetic alopecia. J Am Acad Dermatol. 2019;81: 648–649. doi:10.1016/j.jaad.2019.04.054