Since I’m Terrified About What I Read Online, I’m Going to Take 0.25mg Propecia Twice a Week
I am a 22 year old male who has had thinning hair for almost 5 years and have got to a point where my quality of life has deteriorated, due to this I decided to take the plunge with propecia.I took my first dose of propecia yesterday at 0.25 mg and plan to take this twice a week, every Tuesday and Saturday, having read about success with this regime.
I know propecia only has a half life of 8-12 hours but it takes the body around a week to start creating the enzyme that creates DHT in the body and studies show that 0.25-0.5 mg has up to 80% success of 1.0 – 5.0mg. This is because I’m terrified of sides on propecia and also I would not be comfortable taking any medication every day of my life. I just wondered what you think of this regime?
When the Propecia (finasteride) studies were performed that eventually led to the medication’s FDA approval, various doses were tried. The 1mg dose gave the most consistent results for treating hair loss. Above the 1mg daily dose, the results were no better than the 1mg daily dose; however, below the 1mg dose, it was found to be less effective. In your case with taking a 1/4 dose only twice a week, the medication will be out of your system for days at a time, so the benefits might be fairly limited.
The side effects you are concerned about may happen, but statistically it is a small risk; however, I have found that the risk of sexual side effects increases in those young men who obsess over the possibility of having side effects, somewhat talking themselves into it. It is your call, of course.
Why don’t you take the actual recommended dose and see if you even experience any side effects? Despite the horror stories only a small minority of men experience any negatives. If you try it at this reduced, unsubstantiated dose you risk getting no benefit for your hair at all.
If you try it and subsequently have problems you can reduce the dose in a consistent manner until the side effects stop. That’s much more sensible than starting on 1/14th of the proven dose and hoping for the best.
The reason why your suggestion is not sensible is the side effects do not always ‘stop’. The FDA didn’t find 1mg to be the most effective dose, in fact the dosage was quite arbitrary. Studies have shown that 0.05mg of Propecia are almost as effective as a full mg which shows you how potent this medication is.
The regulatory package and studies that formed the basis of Propecia approval in the US for baldness are publicly available at http://www.fda.gov (go to drugs@FDA, then Propecia, then Approval History, then Review, then Medical Review).
It is obviously not the case that the study of 1 mg dosing was “arbitraryâ€. Dosing is based on numerous considerations, including nonclinical animal safety and toxicology data, in vitro studies, human pharmacology and pharmacokinetic studies, and initial uncontrolled studies – all summarized in the regulatory application (and scientific literature, also publicly available, at http://www.ncbi.nlm.nih.gov/pubmed). Companies usually don’t put several hundred million dollars into programs and then just randomly come up with a dose to be studied.
It is also not the case that 0.05 mg is equally effective. In fact, the effectiveness of 0.05 mg wasn’t even studied in any of the clinical studies that supported approval (and included 3217 patients). One of the 13 studies (number 065) that supported approval was a 6-week study of 249 patients equally divided into groups to receive doses of 0.01, 0.05, 0.2, 1, and 5 mg (or placebo) to evaluate the effect of drug on scalp DHT and sebum (a clinical pharmacology study), not to study of efficacy or safety. This study found that men treated for 6 weeks with daily doses ranging from 0.01 to 5 mg had a dose-related decrease in scalp skin and serum DHT levels (lower the dose, lower the levels). But, the effect on DHT in the 1 mg dose group was not that much different from the 5 mg group. This led to the choice of only 1 mg in the phase 3 studies.
It is naive to think that playing around with different doses without evidence of efficacy based on blog postings is equivalent to data collected on 3217 patients. In the absence of large amounts of data, it’s also incorrect to assume that a lower dose equals lower risk of side effects. Sometimes it does, sometimes it doesn’t. Only 1 mg was assessed in the three phase 3 studies that supported approval.
The issue of reversibility of side effects is a separate one (and an additional issue that the initial poster has to think about). While there is little clinical trial evidence of irreversibility of sexual side effects with finasteride, many patients anecdotally report this and it is currently being evaluated
Just for clarity, I recognize that the initial poster was talking about 0.5 finasteride and the answer of another blogger discussed 0.05 (the latter blogger probably meant 0.5). My lengthy response above is the same, whether 0.05 or 0.5 mg. The efficacy of finasteride 0.5 mg was not studied in any of the 13 trials that comprised the Propecia approval. I am also not aware of published controlled safety and efficay studies evaluating this dose for baldness post-approval.
Well I would respond but looks like biotechMD pretty much answered any questions. Please provide some genuine studies where taking a tiny portion of an effective dose actually does anything.
Hi Biotech MD,
I appreciate your thorough response. I actually meant 0.05mg rather than the 0.5mg you suggested. You seem incredibly knowledgeable about Propecia and very experienced in the pharmaceutical industry. I was referring to a peer-reviewed article that was published by Dr. Frankel in the Journal of Dermatology shortly after Propecia was approved.
https://www.fda.gov/ohrms/dockets/dailys/00/jun00/060700/cp00001.rtf
Will you provide your interpretation of his study? I’m looking at figure 1 (which I believe is the study number 065 you mentioned). The data presented shows there is no statistically significant additional reduction of DHT measured in the scalp beyond the 0.05mg level up to 5.0mg. While this isn’t measuring hair count, Propecia preserves hair by reducing DHT so this would directly relate to efficacy.
There is a second study he references (in table 8.1.2.4.2 which I cannot find) that does show there was a larger mean improvement for 1.0 mg dose of Propecia over the 0.2 mg but the result is not statistically significant since the values overlapped at the 95% confidence interval.
I would love to hear your explanation of these studies. Since you seem to know so many about Propecia, do you work at Merck or did you in the past or is this an independent interest of yours?