Finasteride is a well-known remedy for tackling hair disorders fueled by androgens, such as androgenetic alopecia. This medication operates as a selective inhibitor of the enzyme 5 alpha reductase and is typically taken orally in a daily dose of 1 mg to combat androgenetic alopecia. When taken by mouth, its bioavailability ranges from 26% to 70%, averaging at 65%, and it’s not influenced by food consumption. The highest concentration of the drug in the bloodstream, known as the peak plasma concentration, typically hits 9.2 ng/ml. In terms of its duration of action, finasteride has a terminal half-life of approximately five to six hours for men aged 18 to 60, which extends to eight hours for men older than 70.
Finasteride undergoes substantial metabolic processes in the liver, primarily through the cytochrome P450 3A4 enzyme subfamily, and it’s eventually eliminated from the body through urine and feces. While various dosages of finasteride have been explored, ranging from 0.2 mg to 5 mg, the optimal daily dose for treating male pattern hair loss in men has been established as 1 mg. Importantly, there is no marked difference in effectiveness between the 1 mg and 5 mg doses. Therefore, the prevailing recommendation supports the use of long-term daily administration of 1 mg finasteride for sustained improvements in hair loss among men.
Methods:
We embarked on a comprehensive literature quest to gather insights into the utilization of finasteride for addressing male pattern baldness. We meticulously scoured the scientific landscape for relevant literature published up until March 2014, drawing from authoritative sources like MEDLINE, EMBASE, CINAHL, LILACS, and the Cochrane registers. Our search was powered by keywords that included “finasteride,” “male pattern baldness,” and “androgenetic alopecia.” To cover all bases, a parallel exploration was conducted to explore the use of finasteride in treating female pattern hair loss, employing keywords such as “female pattern baldness,” “finasteride,” and “female pattern alopecia.”
In our quest for knowledge, we cast a wide net, reviewing a spectrum of literature, including systematic reviews, meta-analyses, national guidelines, randomized controlled trials, prospective open-label studies, and retrospective case series, all culled from the English literature.
To appraise the available evidence, we adhered to the guidelines put forth by the British Association of Dermatologists [7]. The methodology of each selected study underwent scrutiny according to the National Institute of Clinical Excellence Technical Manual, where they were graded as “++,” “+,” or “−” based on the extent to which potential biases were minimized.
We looked at the research and gave it a grade to tell you how strong the evidence is. Here’s what those grades mean:
- Grade A: This is the best grade. It’s for research that’s really solid, like studies with lots of evidence, like a big review of many studies or a well-done experiment that’s directly relevant to the people we’re talking about. It all points in the same direction and gives us a lot of confidence.
- Grade B: This is also good evidence. It’s for research that’s pretty strong but maybe not as perfect as Grade A. It could be studies that are directly related to the topic and give us consistent results. Or it might be information we get by looking at other good studies.
- Grade C: This is decent evidence. It’s for research that’s not as strong as Grade A or B but still shows us something important. It might be studies that apply to the topic and give us results that mostly agree. Or it could be information we get from studies that are not perfect but still pretty good.
- Grade D: This is not-so-great evidence. It’s for research that’s not very strong, like studies that are not directly related to what we’re talking about or studies that don’t give us clear answers. It could also be when experts have to make a decision based on their opinions because there’s not enough good research.
RESULTS
We’ve analyzed a whopping 262 studies, but only a dozen met our guidelines for this review.
Does the Drug Work for Androgenetic Alopecia (Male Pattern Baldness)?
Many studies have chipped in on this question, and here’s what they’ve found:
- A systematic review of twelve studies suggests that taking oral finasteride daily can actually boost the number of hairs you have. Plus, it makes your hair look better, as judged by both patients and experts (evidence level 1+).
- Even better, using finasteride for a long time, like up to five years, can help prevent more hair loss from happening (evidence level 1+).
- There’s a study with 270 men that hints at something interesting: if you start taking finasteride when you’re younger, it seems to work better (evidence level 1+).
- Another study that went on for a full decade found that finasteride’s effectiveness doesn’t fade over time. Some people who didn’t see results at first ended up with better hair later on (evidence level 1++).
- An Indian study involving 100 patients showed that finasteride, whether used alone or with minoxidil or ketoconazole, led to significant hair improvement compared to just using minoxidil (evidence level 1+).
- In a study where they compared 3% minoxidil to a mix of 3% minoxidil and 0.1% finasteride for male pattern hair loss, the group using both had much better results (evidence level 1+).
- There are also some new studies looking at different ways to use finasteride. One study found that using a 1% finasteride gel on your scalp twice a day is almost as good as taking the oral finasteride pill (evidence level 1+). This means you might not have to keep taking pills forever to keep your hair looking good.
So, in a nutshell, taking a 1 mg finasteride pill every day seems to be a pretty effective way to deal with male pattern baldness. Starting early is key, and the results stick around even after years of use. Combining it with minoxidil is promising (grade B). But, there’s a caveat: while it looks safe (level 1+), some recent reports suggest that the side effects might hang around even after you stop taking the drug, which they call “post-finasteride syndrome”. So, it’s a good idea to be aware of that.
As for topical finasteride formulations, the available evidence is somewhat limited, with only one randomized study to date. Therefore, further systematic research is needed in this area (grade of recommendation B).
Side effects
The Big Issue with Finasteride: Sexual Side Effects.
One of the significant downsides of finasteride has been its impact on sexual function, and it’s a big deal [16]. In fact, it’s the primary reason why many patients hesitate to take the drug, and it often leads to poor adherence to treatment regimens. This particular concern has garnered substantial attention not only on the internet but also in the media, making it a matter that deserves serious consideration.
Now, when it comes to these sexual side effects, there’s a bit of a mixed bag. You see, there are conflicting reports out there—some claim they’ve experienced these side effects, while others say they haven’t. Let’s dive into the details below.
Studies which found the side effects to be not significant [Table – 1]
Studies that Downplay the Significance of Side Effects
Numerous studies have drawn a rather reassuring picture, suggesting that the feared side effects of finasteride are, in reality, not all that significant. According to their findings, the occurrence of sexual adverse effects hovers around the range of 2.1% to 3.8%, a rate comparable to what you’d find in individuals taking a placebo. Among these effects, erectile dysfunction takes the lead, followed by ejaculatory dysfunction and a decrease in libido. What’s worth noting is that these effects tend to show up early in the course of therapy but, importantly, tend to return to normal either upon discontinuation of the drug or with continued use over time.
One interesting twist in this narrative is the notion of the “nocebo” effect, where the expectation of side effects might actually contribute to their occurrence in some patients . Essentially, it’s like the power of suggestion playing a role.
Taken together, these studies have come to the consensus that, for the majority of men, finasteride’s impact on sexual functioning is minimal and should not be a significant factor influencing the decision to either prescribe or take the medication. In fact, a recent comprehensive review of the available literature echoes these sentiments (grade of recommendation B). So, in essence, it appears that the concerns about sexual side effects might be somewhat overblown for most individuals.
Studies which found the side effects to be significant
Studies Highlighting Significant Side Effects
Now, let’s shift our attention to some recent studies that tell a different story [24],[25],[26],[27]. These findings stand in contrast to the previously mentioned studies and suggest that a subset of individuals undergoing finasteride treatment may indeed experience significant and potentially irreversible sexual side effects. These findings carry weight and warrant serious consideration, especially in the context of discussions with patients.
However, it’s important to acknowledge that these studies come with their fair share of limitations. Some had small sample sizes, which could introduce bias. Additionally, there were concerns about selection bias, as well as recall bias when gathering data on sexual function before finasteride use. Furthermore, not all of these studies conducted serum hormone analysis to provide a comprehensive picture of the hormonal changes involved (grade of recommendation C).
Use of Finasteride and Prostate Cancer
In a pivotal double-blind, randomized multicenter trial focused on preventing prostate cancer, finasteride at a dose of 5 mg was pitted against a placebo to determine its impact on cancer risk. The findings were intriguing; while finasteride was indeed effective in preventing or delaying the onset of prostate cancer, it was associated with an increased risk of high-grade prostate cancer (evidence level 1+). However, when the same subjects were followed up over the long term, it was revealed that there was no significant difference in overall survival rates or survival following a prostate cancer diagnosis (evidence level 1+). This heightened incidence of high-grade prostate cancer among the finasteride group has been attributed to the improved performance of prostate-specific antigen (PSA) screening.
Notably, it’s worth mentioning that studies associating prostate cancer risk with the 1 mg dose of finasteride are lacking (grade of recommendation B). So, when it comes to prostate cancer, the 1 mg finasteride dose may not carry the same concerns as its higher-dosage counterpart.
Position of Other Professional Societies:
Given the conflicting data and the paramount importance of the subject, the International Society of Hair Restoration Surgery took a proactive step by forming a task force specifically focused on the controversies surrounding adverse events associated with finasteride [28]. This task force was charged with the mission of thoroughly assessing the published data and providing recommendations based on their findings. Importantly, their investigation did not uncover substantial evidence of sexual dysfunction linked to the once-daily use of 1 mg finasteride for hair loss. Furthermore, they called upon the medical community to critically evaluate anecdotal reports and emphasized the need for additional research in this area.
Food and Drug Administration (FDA) Stance on the Matter:
The Food and Drug Administration (FDA) recently conducted a comprehensive review of 421 post-marketing reports related to sexual dysfunction associated with the use of 1 mg finasteride. These reports were submitted to the agency’s adverse events reporting system database over the span of 1998 to 2011. Their analysis revealed a reassuring trend: most of the reported side effects tended to normalize within three months after discontinuation of the drug. Additionally, when analyzing controlled clinical trials, the FDA found that out of 945 men, 36 (3.8%) reported experiencing one or more adverse sexual events during their treatment with 1 mg finasteride. In comparison, 20 (2.1%) of the 934 men who received a placebo reported similar experiences.
In another important facet of their review, the FDA scrutinized 251 cases involving altered semen quality associated with the use of 1 mg finasteride, drawing these cases from the sponsor’s safety database. Among these cases, they identified 13 instances that merited further evaluation. This comprehensive analysis provides a valuable perspective on the safety profile of finasteride.
Food and Drug Administration’s Recommendations on Labeling Changes:
On April 11, 2012, the U.S. Food and Drug Administration (FDA) made a noteworthy announcement concerning revisions to the professional labels for Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) [28]. These updates involved the inclusion of information regarding libido disorders, ejaculation disorders, and orgasm disorders that persisted even after discontinuation of the drug. Additionally, they introduced a description of reports linking male infertility and/or poor semen quality to finasteride, with the reassurance that these issues typically normalized or improved after discontinuing the drug. While these relationships are not definitively established, the FDA deemed it essential to include them in the drug labels to ensure that both patients and healthcare professionals are informed about the possible side effect profile.
Notification to Healthcare Professionals:
In their notification to healthcare professionals, the FDA emphasized that there isn’t a clear cause-and-effect relationship between finasteride and the sexual adverse events that continue after stopping the medication. It’s a crucial point for healthcare providers to consider this new label information when determining the most appropriate treatment options for their patients. The FDA underlined that, for its approved indications, finasteride remains a safe and effective medication.
Notification to Patients:
The FDA directed its message to patients, advising them to engage in a discussion with their healthcare provider to thoroughly weigh the risks and benefits associated with finasteride use. Importantly, they urged patients not to discontinue the medication without first consulting their healthcare provider. This guidance underscores the importance of informed decision-making when it comes to this medication.
Position of IADVL Therapeutic Guidelines Committee:
Considering the complexity of the issue, the IADVL Therapeutic Guidelines Committee has formulated a set of recommendations to guide its members in their clinical practice and usage of finasteride:
- Effectiveness: Finasteride is indeed effective in the management of androgenetic alopecia.
- Mechanism and Efficacy: The mechanism of action and efficacy of finasteride have been well-established and confirmed.
- Safety: Numerous studies have demonstrated the drug’s safety over prolonged use, and there’s no conclusive evidence establishing a causal link between the drug and sexual side effects.
- Lack of Alternatives: At present, safer and proven alternatives to finasteride have yet to be identified by researchers.
- Patient Counseling: Patients must receive comprehensive counseling about the drug’s efficacy and potential side effects, preferably through patient information brochures.
- Reporting Side Effects: Patients should promptly contact their doctor if they experience any side effects.
- Voluntary Use: It’s crucial to recognize that the decision to take the drug is entirely voluntary since patterned hair loss is primarily a cosmetic concern. Patients who choose not to take the drug should understand that their hair loss may continue to progress.
- Informed Decision-Making: Treating physicians must provide patients with all necessary information about the drug to enable them to make an informed decision.
- Considerations: It is advisable to avoid prescribing finasteride to patients with a history of oligospermia or infertility, particularly if they are newly married and planning to start a family. Additionally, patients who express apprehensions about the drug should be considered for alternative options. There is no requirement for semen analysis before prescribing the drug.
- No Coercion: Physicians should refrain from exerting any pressure or coercion on patients to take finasteride.
- Staggered Dosing: For patients concerned about side effects, the committee suggests considering lower or staggered doses of the drug to enhance patient compliance. It’s worth noting that finasteride has a plasma half-life of six to eight hours and a tissue binding duration of four to five days . A dose of 0.2 mg is sufficient to suppress dihydrotestosterone levels, with 0.5 mg daily as an initial option to build patient confidence before transitioning to the standard 1 mg daily dose. However, it’s important to highlight that this recommendation is based on expert opinion (grade of recommendation D).
These guidelines aim to facilitate a balanced and informed approach to the use of finasteride for androgenetic alopecia, recognizing both its benefits and potential risks. Ultimately, patient autonomy and informed decision-making should guide the course of treatment
Unlocking the Mystery: Finasteride in Managing Female Pattern Hair Loss
Ah, the enigmatic realm of female pattern hair loss—it’s a puzzle that has left both patients and doctors scratching their heads. The exact causes remain shrouded in mystery. But, in the quest for solutions, finasteride has emerged as a potential player, although its effectiveness is a subject of debate. Let’s delve into this follicular mystery and dissect the limited data available.
First, how does finasteride work its magic in female pattern hair loss? Well, that’s the million-dollar question. The mechanism remains elusive. But here’s the deal: a daily dose of 1 mg orally, similar to what’s prescribed for male pattern hair loss, may be recommended for those who either don’t respond well to or can’t tolerate minoxidil therapy. But—and it’s a big but—don’t expect overnight miracles. You’ll need to give it a year to see if your hair loss stabilizes, and regrowth, if it happens, can take a leisurely two years or even longer.
Now, here’s where it gets a tad complicated: despite the sparse data, factors like menopausal status, circulating androgen levels, and pesky symptoms of hyperandrogenism don’t seem to be predictors of how well finasteride will work for you. On the plus side, it’s generally well-tolerated. But, and this is a crucial “but,” if you’re a woman of childbearing age, you absolutely must be on reliable contraception while taking finasteride. No exceptions. And yes, a pregnancy test before starting the drug is a non-negotiable checkpoint.
Now, let’s talk evidence. There’s a study, rated at level 2+, that went the extra mile: it was double-blind and placebo-controlled. They recruited 137 postmenopausal women with androgenetic alopecia, gave some of them finasteride, and kept a close watch for a year. Guess what they found? No significant difference in hair count between the finasteride group and the placebo group after a year. Both groups experienced a decrease in hair count over the frontal and parietal scalp during the study. Not exactly the news we were hoping for. Even assessments from patients, investigators, photographic analysis, and scalp biopsies failed to show any signs of slowing hair thinning, increased hair growth, or overall hair improvement in those taking finasteride compared to the placebo bunch.
Now, before you give up all hope, there’s a glimmer of optimism on the horizon. Some daring souls have ventured into the realm of higher doses—specifically, 2.5 to 5 mg daily. And guess what? These studies hinted at something intriguing: oral finasteride in doses of 2.5 mg per day or more might just do the trick for postmenopausal women dealing with patterned hair loss, as long as there are no signs of hyperandrogenism on the clinical or lab front (grade of recommendation C).
Guidelines Committee Speaks: Navigating Finasteride Use for Female Pattern Hair Loss
Here’s the scoop from the therapeutic guidelines committee, the navigators of the treatment ship when it comes to finasteride and female pattern hair loss:
- Limited Evidence at Higher Dosages: Brace yourself, because the evidence for using higher doses of finasteride to tackle female pattern hair loss in postmenopausal women is somewhat limited (level C). It’s like exploring uncharted waters; we’re not entirely sure what to expect. However, it’s an option worth considering, especially for those who’ve hit a roadblock in their hair loss battle.
- No Childbearing Age: If you’re in the childbearing age zone, sorry, but finasteride isn’t your go-to solution. The possible risk of teratogenicity—the potential to harm a developing fetus—rules it out as a viable option in this phase of life. But hey, that doesn’t mean it’s off the table forever.
- Proper Counseling is Key: For those who do embark on the finasteride journey, it should come with a side of proper counseling to keep things safe and sound. Pregnancy is a strict no-go, so contraception is an absolute must. Doctors should ensure that patients fully understand the risks and responsibilities that come with the territory.
In Summary: Finasteride is indeed a well-known player in the world of dermatology, especially for the treatment of androgenetic alopecia. But, here’s the catch—while current evidence suggests it’s generally safe, there’s a growing shadow of concern cast by its potential sexual side effects. This means one thing: patients deserve to be armed with the right information before embarking on this treatment journey.
So, there you have it—a glimpse into the world of finasteride and its role in managing female pattern hair loss. It’s a journey filled with question marks, but also one where informed choices and careful considerations can make all the difference.
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