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Finasteride and sexual side effects

  • Venkat Charmalaya Centre For Advanced Dermatology


Finasteride, a 5-alpha reductase inhibitor, widely used in the medical management of male pattern hairloss, has been reported to cause sexual side effects. This article critically examines the evidence available and makes recommendations as to how a physician should counsel a patient while prescribing the drug.
62 Indian Dermatology Online Journal -
January-April 2012
Volume 3
Issue 1
Address for
Dr. Venkataram Mysore,
Venkat Charmalaya-
Centre for advanced
Dermatology, 3437,
1 G cross, 7th Main,
Subbanna Garden,
Vijay Nagar, Bangalore –
560040, India.
E-mail: mysorevenkat@
Dermatologist- Hair
Transplant Surgeon,
Venkat Charmalaya-
Centre for Advanced
Dermatology, Bangalore,
Drug Prole
Access this article online
DOI: 10.4103/2229-5178.93496
Quick Response Code:
Some of the commonly faced questions by a
physician while treating a patient of pattern
hairloss are about the possible sexual side effects
caused by finasteride. Reports in the press,
of alternative medicine, all have contributed
to this image of the drug, and has lead to
apprehension in the minds of patients. Often even
dermatologists seem to hesitate to prescribe the
drug on a long term basis. This article examines
this subject in the light of evidence available.
Pattern hair loss in males is androgenic in
etiology. Antiandrogens such as finasteride
are therefore useful in the management of the
condition. Androgens, especially testosterone
increases the libido. Any drug which interferes
with the action of androgens is therefore
erection needs to be fully elucidated.[1,2] Even
an individual with low testosterone levels can
under the control of parasympathetic nervous
system. Ejaculation and detumescence require
an intact sympathetic system.[2,3]
The androgens testosterone and
dihydrotestosterone (DHT) have somewhat
different actions. The enzyme, 5α-reductase
converts testosterone to DHT. It exists in two
isoenzyme forms. While type I is predominant in
vesicles, epididymes, hair follicles, and liver.[2]
outer root sheath of the hair follicles and dermal
papillae. At all these sites, the testosterone is
converted to DHT.[4] Although the type II 5AR
enzyme has a more signicant role in pattern
hairloss (and therefore mechanism of action of
nasteride), the predominantenzyme in scalp
skinis typeI,largely becauseoflocalizationto
inhibitorof Type II 5—AR,andhasthereforea
selective action on hair follicles. Scalp skin DHT
amount of DHT found in scalp skin is derived from
both local DHT production and circulating DHT.
Thus,theeffectof nasteride on scalp DHT is
likely because of its effect on both local follicular
DHT levels as well as serum DHT levels. This
may be adequate therapeutically.
Thebioavailability ofnasteride1mg following
65%.[5] The average peak plasma concentration
hasbeenfoundto be 9.2 ng/ml measured 1-2
Finasteride and sexual side effects
Venkataram Mysore
Finasteride, a 5-alpha reductase inhibitor, widely used in the medical management of male pattern hairloss, has
been reported to cause sexual side effects. This article critically examines the evidence available and makes
recommendations as to how a physician should counsel a patient while prescribing the drug.
Key words: Androgenetic alopecia, nasteride, sexual side effects
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related to food intake. Finasteride is extensively metabolized in
A number of studies have looked at the problem of side effects
causedbynasteride.[6-11] These studies which are discussed
below reveal that sexual adverse effects occur at the rates of
followed by ejaculatory dysfunction and loss of libido. These
effects occurred early in the therapy and returned to normal on
stopping or over a time on continuous use of the drug. The only
is decreased ejaculatory volume because of predominant action
of DHT on prostate.[5]
Acomprehensivereview of a total of73papers on medical
of different pharmacological agents on sexual function.[6] The
The role of nocebo effect in the causation of ED due to
nasteridehasbeeninvestigated.[7]Nocebo effect refers to an
adverse effect that results from the psychological awareness of
reportedincreased incidence ofED, when compared to the
group without information.[7]The side effects were completely
reversible in 5 days when the medicine was discontinued,
side effects andsuggesting the role of psychological factors.
Two studies in 1998 and 1999 showed that the incidence
of these side effects with nasteride therapy was generally
and there was no evidence of dose dependency or increased
incidencewithlongertherapy out to 12 months. In addition,
the side effects ceased in patients even when they continued
such as decreased libido, ED, and ejaculatory disorders
occurred in <2% of men.[10] These side-effects disappeared
not only in all men who stopped the drug because of the side
effects but also in most of those who continued therapy. The
side effects were comparable to that of placebo both at one
conducted to look into the effects of nasteride and other
covariates on sexual dysfunction as part of the analysis of The
ProstateCancerPreventionTrial(PCPT).[11] Sexual dysfunction
and its impact diminished over time. The authors concluded
thattheeffectofnasteride onsexualfunctioning isminimal
for most men and should not impact the decision to prescribe
too arrived at similar conclusions.[12]
documentedcontraryndings.[13]Avery recent study by Irwig MS
et al,[13] which has beenwidely reported in lay press and internet
onset of sexual side effects associated with the temporal use of
months despite stopping the drug. The study revealed that the
ofnasteride. The mean number of sexual encounters per
month dropped and the total sexual dysfunction score increased
from the time of nasteride cessation to the interview date.
However,therewere many limitations in thestudy,such as
nasteridedata,andno serumhormoneanalysis.Thestudy
recommended that physicians treating male pattern hair loss
(MPHL)should discussthepotential risklevelswith patients
while prescribing the drug.
An important earlier study by Mella et al,[14] conducted a
systematic review of twelve randomized trials evaluated the
dysfunction (RR, 2.22 [95% CI, 1.03-4.78] and a possible
CI, 0.99-1.95]; However, the risk of discontinuing treatment
because of sexual adverse effects was similar to that of placebo
A number of isolated case reports have also been published on
Mysore and Charmalaya: Finasteride and sexual side effects
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onmotility,andsperm counts.[16] These patients were under
were discovered. Signicantly, these parameters improved
after stopping the drug.
Another small study[17] reported three cases of young men,
Infertility. Semen quality was investigated by light microscopy to
by transmission electron microscope (TEM), presence
of Y microdeletions by PCR, and meiotic segregationby
fluorescence in situ hybridization (FISH). TEM analysis
revealed altered sperm morphology consistent with necrosis
and FISH data revealed elevated diploidy and sex chromosome
disomy frequencies. One year after the men had stopped the
use of nasteride without receiving any other treatment, a
recovery of spermatogenetic process was observed. Motility
and morphology improved whereas the meiotic pattern did
not change.
Traish[18] conducted a review of different published studies
and concluded that altered sexual functions such as erectile
dysfunction and diminished libido are reported by a subset of
men receiving nasteride, raising the possibility of a causal
relationship. The review suggested discussion with patients
on the potential sexual side effects and possible alternate
treatments before administration of the drug.
of the subject, the International Society of Hair Restoration
Surgery (ISHRS) established a Task Force on Finasteride
Adverse Event Controversies to evaluate published data and
make recommendations. The taskforce posted their initial
linkbetweennasterideand persistentsexualsideeffectsin
nasteride 1 mg for hairloss. Reports of persistent sexual
side effects have come from a variety of sources with some
internet sites attracting individuals claiming to have sexual and
psychological issues related to nasteride. While continued
difcultyhaving erections after discontinuingnasteride has
this problem remains unknown.This rare side effect is included
in Public Assessment Reports of the Medicines and Health
Regulatory Agency of the United Kingdom and the Medical
Products Agency of Sweden.
The persistence of sexual side effects appears to be a rare
event,and ithasyetto bedeterminedwhether theserecent
reports represent a true causal relationship, or if they are
simply coincidental and related to other factors such as the high
ortheplaceboeffect. Also,littledataisavailable concerning
the medical and psychological work-up of these patients to
exclude other potential causative factors.
isa complicatedissue,whichoverlaps with otherdisciplines
More research is needed to assess the actual incidence of side
effects,to determine if thereisatruecausal relationship for
We hope to participate in a multidisciplinary forum to further
evaluate this topic.
Millions of patients have benetted from nasteride with no
important for the medical community to verify anecdotal reports
and if necessary, conduct further studies so that accurate
information may be given to our patients to enable them to
make informed choices regarding the use of this medication.
The ISHRS Task Force on Finasteride Adverse Event
Controversies is in the process of gathering information and
forming an interdisciplinary panel to address these issues and to
adverse events.”
(available from
Thus, the evidence available about the safety of the drug
canbe considered asquestionable, but cannot certainly be
ignored. The matter needs further systematic investigation and
the prospect of impotence while taking a drug for hairloss is
drug brochures mention the possibility of the side effect and
the patient is often unable to distinguish between the effects
opinion about the side effects, contrary to the evidence
and individual and anecdotal experiences are highlighted and
often exaggerated. Any patient who reads such reviews is
within afewweeksof starting or,inotherinstances, donot
start the treatment at all. Losing potency for gaining hair is not
1. Thedrugisprobablythebestavailabletotreatandrogenetic
Mysore and Charmalaya: Finasteride and sexual side effects
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alopecia and the only one to address the root of the problem.
2. Itseffectsareproven.
3. Severalstudieshaveshownitssafetyoverlongduration
ofadministration.Thedosagegiven (1 mg) is small and
unlikely to cause side effects. Even in those cases where
4. Thereareveryfeweffectivealternativestothedrugandit
is therefore important for the patient not to stop the drug
unless he experiences any side effects.
5. Thepatientshouldcontactthedoctorforanyadvice,should
he experience a side effect.
6. Mostimportantly,theintakeofthedrugistotallyvoluntary,
as male pattern hair loss is only a cosmetic condition and
it is entirely up to the patient to take or not take the drug.
7. Thetreatingphysicianshouldprovidefullinformationabout
the drug to enable the patient to make an informed decision.
8. Itisbettertoavoidthedrugforanypatientwhohasprior
married and is trying to raise a family.
In addition, the author also feels that in patients who are
administration of lower daily doses or staggered pulse doses of
there is sound rationale for such regimens. Plasma half life of
nasterideis6-8hoursandtissuebindingis4-5days.[5] Doses
mg per day achieved 69% DHT suppression. Efcacy has
beendemonstratedforallend pointsfornasterideatdoses
efcacythatwassuperiortolowerdoses.[8,9,19] The drug may
alternate days, to gain condence of the patient and the 1
mg/daydosagemaybe restoredoncepatientiscomfortable
about the drug. The value of such a regimen was shown in a
preliminary study.[20]However,furtherlarge,longtermstudies
are needed to establish the value of such regimens.
Dr.AnithaB, Dermatologist, Venkat Charmalaya, for correcting the
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4. Choudhry R, Hodgins MB, Van der Kwast TH, Brinkmann AO,
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6. Carbone DJ Jr, Hodges S. Medical therapy for benign prostatic
hyperplasia: Sexual dysfunction and impact on quality of life. Int J
Impot Res 2003;15:299-306.
7. Mondaini N, Gontero P, Giubilei G, Lombardi G, Cai T, Gavazzi A, et al.
Finasteride 5mg and sexual side effects: How many of these are related
to a nocebo phenomenon? J Sex Med 2007;4:1708-12.
8. Kaufman KD, Olsen EA, Whiting D, Savin R, DeVillez R, Bergfeld W.
Finasteride in the treatment of men with androgenetic alopecia. J Am
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9. Leyden J, Dunlap F, Miller B, Winters P, Lebwohl M, Hecker D, et al.
Finasteride in the treatment of men with frontal male pattern hair loss.
J Am Acad Dermaol 1999;40:930-7.
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nasteride 1 mg in the treatment of men with androgenetic alopecia.
Eur J Dermatol 2002;12:38-49.
11. Moinpour CM, Darke AK, Donaldson GW, Thompson IM Jr, Langley
C, Ankerst DP, et al. Longitudinal analysis of sexual function reported
by men in the Prostate Cancer Prevention Trial. J Natl Cancer Inst
12. Anitha B, Inamadar AC, Ragunatha S. Finasteride-Its Impact on Sexual
Function and Prostate Cancer. J Cutan Aesthet Surg 2009;2:12-6.
13. Irwig MS, Kolukula S. Persistent sexual side effects of nasteride for
male pattern hair loss. J Sex Med 2011;8:1747-53.
14. Mella JM, Perret MC, Manzotti M, Catalano HN, Guyatt G. Efcacy
and safety of nasteride therapy for androgenetic alopecia: A systematic
review. Arch Dermatol 2010;146:1141-50.
15. Tu HY, Zini A. Finasteride-induced secondary infertility associated with
sperm DNA damage. Fertil Steril 2011;95:2125.e13-4.
16. Chiba K, Yamaguchi K, Li F, Ando M, Fujisawa M. Finasteride-
associated male infertility. Fertil Steril 2011;95:1786.e9-11.
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Sex Med 2011;8:872-84.
19. Drake L, Hordinsky M, Fiedler V, Swinehart J, Unger WP, Cotterill PC,
et al. The effects of nasteride on scalp skin and serum androgen levels
in men with androgenetic alopecia. J Am Acad Dermatol 1999;41:550-4.
20. Rajput RJ. Cyclical Medicine for hair loss management and improved
results in hair transplantation. Hair Transpl Forum Int 2008;18:208-10.
Cite this article as: Mysore V. Finasteride and sexual side effects. Indian
Source of Support:Nil,Conict of Interest: None declared.
Mysore and Charmalaya: Finasteride and sexual side effects
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... a-adrenergic antagonists, such as tamsulosin and terazosin, are also commonly used for bladder control improvement in BPH. Although it is suggested to properly combine these two types of treatment for BPH, many studies have reported limited long-term effects or genitourinary side effects such as erectile dysfunction [13,14]. Therefore, BPH treatments with fewer side effects are of interest. ...
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Background Benign prostatic hyperplasia (BPH) is a disease characterized by abnormal proliferation of the prostate, which occurs frequently in middle-aged men. In this study, we report the effect of red ginseng oil (KGC11o) on BPH. Methods The BPH-induced Sprague-Dawley rats were divided into seven groups: control, BPH, KGC11o 25, 50, 100, 200, and finasteride groups. KGC11o and finasteride were administered for 8 weeks. The BPH biomarkers, DHT, 5AR1, and 5AR2, androgen receptor, prostate-specific antigen (PSA), Bax, Bcl-2, and TGF-β were determined in the serum and prostate tissue. The cell viability after KGC11o treatment was determined using BPH-1 cells, and, androgen receptor, Bax, Bcl-2, and TGF-β were confirmed by western blotting. Results In the in vivo study, administration of KGC11o reduced prostate weight by 18%, suppressed DHT (up to 22%) and 5AR2 (up to 12%) levels from administration of 100 mg/kg KGC11o (P < 0.05). PSA was significantly downregulated dose-dependently from at the concentration of 50 mg/kg KGC11o (P < 0.05). BPH-1 cell viability significantly reduced through the treatment with KGC11o. In vitro and vivo, AR, Bcl-2 TGF-β levels reduced significantly but Bax was increased (P < 0.05). Conclusion These results suggest that KGC11o may inhibit the development of BPH by significantly reducing the levels of BPH biomarkers via 5ARI, anti-androgenic effect, and anti-proliferation effect, serving as a potential functional food for treating BPH.
... 5α-reductase plays an important role in converting testosterone to dihydrotestosterone (DHT), which accelerates hair loss (the mechanism of DHT in hair loss is discussed in detail elsewhere [10]). Finasteride has several side effects, including decreased libido and erectile/ejaculatory dysfunction [11], all of which continue after cessation of the drug [12]. Finasteride also artificially lowers blood prostate-specific antigen levels [13], which may decrease the sensitivity of prostate cancer detection. ...
Purpose: The purpose of this study was to evaluate if transcutaneous application of low-intensity ultrasound can locally enhance the effects of finasteride on hair growth in a murine model of androgenic alopecia (AA). Methods: AA mice (injected twice per week with testosterone enanthate, n=11), under daily oral administration of finasteride, received 1-MHz ultrasound for 1 hour at the unilateral thigh area five times per week for 5 weeks. Non-thermal and non-cavitational ultrasound was delivered in a pulsed manner (55-ms pulse duration with a repetition frequency of 4 Hz). Skin temperature was measured during sonication, and the measurements were validated with numerical simulations of sonication-induced tissue temperature changes. Hair growth was assessed both photographically and histologically. Results: We found more hair growth on the sonicated thigh area than on the unsonicated thigh, beginning from week 3 through the end of the experiment. Histological analyses showed that the number of hair follicles doubled in the skin sections that received sonication compared to the unsonicated zone, with thicker follicular diameter and skin. An over five-fold increase was also observed in the anagen/telogen ratio in the sonicated area, suggesting an enhanced anagen phase. Skin temperature was unaltered by the administered sonication. Conclusion: The findings of the present study suggest that pulsed application of ultrasound promotes hair growth, potentially by disrupting the binding of albumin to finasteride. This may suggest further applications to enhance the pharmacological effects of other relevant drugs exhibiting high plasma protein binding.
... Finasteride and minoxidil are the mainstay treatments for alopecia. However, they only have a short-term effect and discontinuation of treatment leads to rapid hair loss and has known side effects (Mysore, 2012;Suchonwanit et al., 2019;Ha et al., 2020). Autologous follicle transplantation has also been tried, but the number of donor follicles is limited, it is an invasive procedure and the graft survival rate largely depends on the surgeon. ...
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The skin is the largest organ of the human body and its main functions include providing protection from external harmful agents, regulating body temperature, and homeostatic maintenance. Skin injuries can damage this important barrier and its functions so research focuses on approaches to accelerate wound healing and treat inflammatory skin diseases. Due to their regenerative and immunomodulatory properties, mesenchymal stromal cells (MSCs) have been reported to play a significant role in skin repair and regeneration. However, it seems that the secretome of these cells and exosomes in particular may be responsible for their functions in skin regeneration and the immunomodulation field. The present review aims to gather the available information about the role of MSC-derived exosomes for both in vitro and in vivo models of different skin conditions and to highlight the need for further research in order to overcome any limitations for clinical translation.
... In long-term oral administration, it decreases the thinning of the hair and increases the coverage of the scalp by growing hair. However, the oral intake of finasteride offers unwanted side effects, such as impotence, erectile dysfunction, and impaired reproductive function [8]. At the same time, it also alters the normal DHT level of the body and hence may alter the normal male characteristics [9]. ...
PurposeThis investigation was aimed to develop and evaluate lipid nanoemulsion-based gel of finasteride for topical administration, to increase drug availability into the skin for a long duration and to improve the in vivo potential of finasteride against alopecia.Methods Nanoemulsion was prepared by a high-speed homogenization method using Vit E oil, cholesterol, and soya lecithin, characterized, and thickened using guar gum (nanoemulgel). Nanoemulgel was evaluated for pH, viscosity, drug release, skin permeability, and in vivo efficacy against alopecia.Results and DiscussionSize of the drug-loaded nanoemulsion droplets was observed to be 195.20 ± 9.43 nm with uniform size distribution (PDI; 0.25 ± 0.08) and negative zeta potential (− 7.61 ± 1.35 mV). The pH 5.37 ± 0.74 of the developed gel was found to be near to the skin pH. Gel showed slow release (94.77% in 24 h) and restricted permeation through the skin, i.e., 30.7% in 24 h. Macroscopic examination showed improved hair growth in the case of nanoemulgel. Hair diameter and length were observed to be increased significantly in the case of gel as compared with the testosterone treated group. The histological investigation supports the result of macroscopic examination where nanoemulgel restored the conditions (short length hair, necrotic cell appearance with miniaturized follicles) created by testosterone on the skin. Moreover, the developed formulation was observed to be safe and stable for at least 90 days.Conclusion The results prove the clinical pertinence of this stable gel as it ensured longer stay over the skin, slower permeation and higher efficacy against alopecia.
Male and female pattern hair loss (PHL) is an innocuous condition, but it has a major psychological impact on the sufferer. This paper aims to provide a simple algorithmic approach toward diagnosis, staging, and treatment of PHL in males and females. It also aims at simplifying the decision-making process for the surgeon with regard to timing and extent of procedure for hair transplant surgeries. Various treatment options, their merits and demerits, along with scientific evidence supporting or not supporting the treatment options are discussed in detail.
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Hair loss and predominantly female hair loss is a common dermatologic condition with serious psychosocial consequences. Effective treatments remain scarce mainly due to the multifactorial elements involved in the onset of this chronic condition. The approved drugs available are based on molecules designed towards a single pharmacological target and do not interact with the various biochemical mechanisms involved in alopecia. Phytochemical compounds and their derivatives represent a plethora of biologically active agents, which act in synergism and simultaneously activate different biochemical pathways. Here we present an herbal formulation composed of herbs, vitamins, and minerals acting on hair regrowth and hair micro vascularization. This study aimed at evaluating the potential of PhyllotexTM to treat multifactorial androgenetic alopecia (AGA) in males and females, as well as delving into its molecular mechanisms of action. In vitro studies showed that the herbal formula stimulates cell proliferation of both dermal papilla and HaCaT cells and increases the phosphorylated form of the extracellular signal-regulated kinase 1 and 2 (ERK1/2), a well-known marker for cell proliferation. Surprisingly, expression of TGF-β1 was significantly suppressed without blocking DHT production. Additionally, the formula was able to rescue cells from the oxidative stress conditions generated by 2,2'-Azobis (2-amidinopropane) dihydrochloride (AAPH), a high oxidative agent. This data supports the potential use of this formulation as a hair growth-promoting agent for the treatment of both male and female AGA due to its multifactorial composition, which grants it the ability to cope with the different mechanisms involved in alopecia.
Background and objectives: Finasteride 1 mg/day is indicated for androgen-dependent conditions such as male androgenetic alopecia (AGA). Methods: The literature is comprehensively summarized on the pharmacodynamics, pharmacokinetics, mechanism of action, and metabolism of finasteride. Pairwise and network meta-analyses were performed to assess the efficacy of finasteride reported in clinical trials. The adverse events profile is described along with the post-marketing reports. Results and conclusion: Finasteride 1 mg/day significantly increased total hair count compared to placebo after 24 weeks (mean difference =12.4 hairs/cm2, p < 0.05), and 48 weeks (mean difference =16.4 hairs/cm2, p < 0.05). The efficacy of the two doses of finasteride (5 mg/day and 1 mg/day) and topical finasteride (1% solution) were not significantly different. The most commonly reported sexual events include erectile dysfunction and decreased libido. Increasing patient complaints and analysis of the FAERS database led to the inclusion of depression in the FDA label in 2011, as men were found to be at a risk of suicide due to the persistent sexual side effects, commonly termed as post-finasteride syndrome. Finasteride is shown to be reasonably tolerated in both men and women; however, patients need to be educated about the possible short- and long-term side-effects.
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This is a critical review of the current literature data about sexual dysfunction as a potential side effect related to drugs commonly used for the treatment of Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms. In this narrative review, we analyzed data from the literature related to the development of sexual dysfunctions during the treatment of BPH or LUTS. Both α-blockers and 5-alpha reductase inhibitors (5-ARIs) can induce erectile dysfunction, ejaculatory disorders and a reduction in sexual desire. The sexual side effect profile of these drugs is different. Among the α-blockers, silodosin appears to have the highest incidence of ejaculatory disorders. Persistent sexual side effects after the discontinuation of finasteride have been recently reported; however, further studies are needed to clarify the true incidence and the significance of this finding. However, most of the published studies are affected by a weak methodology and other important limitations, with only a few RCTs available. Therefore, it is desirable that future studies will include validated tools to assess and diagnose the sexual dysfunction induced by these medications, especially for ejaculation and sexual desire disorders.
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Essentials of psychiatry in dermatology and aesthetic practice will indeed add value to the everyday practice. The entire book is conceptualized in manner that professionals should find it easy to use the information in enhancing comprehensive services. More than two dozen well know professionals across India have joined hands to make this book useful.
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Androgens have an intense consequence on the human scalp and body hair. Scalp hair sprouts fundamentally in awol of androgens whereas the body hair hike is vulnerable to the activity of androgens. Androgenetic alopecia (AGA) invoked as males emulate Alopecia due to the cause of the dynamic reduction of scalp hair. Androgens are medium of terminus growth of hair although the body. Local and system androgens convert the extensive terminal follicles into lesser vellus like structure. The out start of this type of alopecia is intensely irregular and the reason behind this existence of enough circulating steroidal hormones androgens and due to genetic predisposition. Effective treatments are available in the market as well as under clinical and preclinical testing. Many herbal formulations are also available but not FDA approved. Different conventional and NDDS formulations are already available in the market. To avoid various systemic side effects of both Finasteride and Minoxidil, topical formulations and natural products (nutrients, minerals, vitamins) now a days are being widely used to treat Androgenic alopecia. CAM (complementary and alternative medicine) provides the option to elect favorable, low-risk, adjuvant and alternative therapies. Herein, we offer a widespread review of topical marketed formulations, natural products, and CAM treatment options for AGA. Graphic Abstract
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Abstract: Finasteride 0.2 mg per day is nearly as effective as 1 mg per day. Long term side effects of finasteride may result from cumulative effect of long term, regular, daily dose. In this study we have compared the results of finasteride 1mg once in three days with daily use of finasteride 1mg with a two year follow up. The low dose finasteride group also received low dose once in three days supplements of different nutrients in synergistic combinations on different days of the week, following a once in a three day cycle. The female groups received minoxidil and compared with minoxidil plus low dose supplements. Faster and better improvement was recorded with Folliscopic counts of hair density and caliber in men and women beginning as early as two months. Average DHT (dihydrotestosterone) suppression and clinical benefit with finasteride once in three days was as good as using it every day. Each dose of finasteride was completely washed out of the system in three days before administering the next dose, thus each dose behaved as a single dose preventing the possibility of long term side effects. The use of low dose nutritional supplements provided earlier and better results when followed before and after hair transplant procedures as well. Patients reported improvement with a self assessment questionnaire.
Background. Finasteride 1 mg (Propecia®) is indicated for the treatment of men with androgenetic alopecia (male pattern hair loss, MPHL). However, the long-term (> 2 years) efficacy and safety of finasteride in this population has not been previously reported. Objectives. To assess the efficacy and safety of finasteride in men with MPHL compared to treatment with placebo over five years. Methods. In two 1-year, Phase III trials, 1,553 men with MPHL were randomized to receive finasteride 1 mg/day or placebo, and 1,215 men continued in up to four 1-year, placebo-controlled extension studies. Efficacy was evaluated by hair counts, patient and investigator assessments, and panel review of clinical photographs. Results. Treatment with finasteride led to durable improvements in scalp hair over five years (p ≤ 0.001 versus placebo, all endpoints), while treatment with placebo led to progressive hair loss. Finasteride was generally well tolerated and no new safety concerns were identified during long-term use. Conclusions. In men with MPHL, long-term treatment with finasteride 1 mg/day over five years was well tolerated, led to durable improvements in scalp hair growth, and slowed the further progression of hair loss that occurred without treatment.
Background: Androgenetic alopecia (male pattern hair loss) is caused by androgen-dependent miniaturization of scalp hair follicles, with scalp dihydrotestosterone (DHT) implicated as a contributing cause. Finasteride, an inhibitor of type II 5α-reductase, decreases serum and scalp DHT by inhibiting conversion of testosterone to DHT. Objective: Our purpose was to determine whether finasteride treatment leads to clinical improvement in men with male pattern hair loss. Methods: In two 1-year trials, 1553 men (18 to 41 years of age) with male pattern hair loss received oral finasteride 1 mg/d or placebo, and 1215 men continued in blinded extension studies for a second year. Efficacy was evaluated by scalp hair counts, patient and investigator assessments, and review of photographs by an expert panel. Results: Finasteride treatment improved scalp hair by all evaluation techniques at 1 and 2 years (P < .001 vs placebo, all comparisons). Clinically significant increases in hair count (baseline = 876 hairs), measured in a 1-inch diameter circular area (5.1 cm2 ) of balding vertex scalp, were observed with finasteride treatment (107 and 138 hairs vs placebo at 1 and 2 years, respectively; P < .001). Treatment with placebo resulted in progressive hair loss. Patients’ self-assessment demonstrated that finasteride treatment slowed hair loss, increased hair growth, and improved appearance of hair. These improvements were corroborated by investigator assessments and assessments of photographs. Adverse effects were minimal. Conclusion: In men with male pattern hair loss, finasteride 1 mg/d slowed the progression of hair loss and increased hair growth in clinical trials over 2 years. (J Am Acad Dermatol 1998;39:578-89.)
Finasteride has been associated with reversible adverse sexual side effects in multiple randomized, controlled trials for the treatment of male pattern hair loss (MPHL). The Medicines and Healthcare Products Regulatory Agency of the United Kingdom and the Swedish Medical Products Agency have both updated their patient information leaflets to include a statement that "persistence of erectile dysfunction after discontinuation of treatment with Propecia has been reported in post-marketing use." We sought to characterize the types and duration of persistent sexual side effects in otherwise healthy men who took finasteride for MPHL. We conducted standardized interviews with 71 otherwise healthy men aged 21-46 years who reported the new onset of sexual side effects associated with the temporal use of finasteride, in which the symptoms persisted for at least 3 months despite the discontinuation of finasteride. The types and duration of sexual dysfunction and the changes in perceived sexual frequency and sexual dysfunction score between pre- and post-finasteride use. Subjects reported new-onset persistent sexual dysfunction associated with the use of finasteride: 94% developed low libido, 92% developed erectile dysfunction, 92% developed decreased arousal, and 69% developed problems with orgasm. The mean number of sexual episodes per month dropped and the total sexual dysfunction score increased for before and after finasteride use according to the Arizona Sexual Experience Scale (P<0.0001 for both). The mean duration of finasteride use was 28 months and the mean duration of persistent sexual side effects was 40 months from the time of finasteride cessation to the interview date. Study limitations include a post hoc approach, selection bias, recall bias for before finasteride data, and no serum hormone levels. Physicians treating MPHL should discuss the potential risk of persistent sexual side effects associated with finasteride.
To report a case of low-dose finasteride-induced secondary infertility with associated elevated sperm DNA fragmentation index (DFI) and otherwise normal semen parameters. Case report. University hospital. A 48-year-old man on low-dose finasteride and his 37-year-old wife with normal menses and normal gynecologic exam. Determination of sperm DFI and discontinuation of low-dose finasteride. Sperm DFI. The sperm DFI done a year earlier was 30%. This value was unchanged when repeated 2 months later. The patient was advised to stop finasteride. Three months after discontinuing the finasteride, the DFI decreased to 21% and subsequent DFI after another 3 months improved to 16.5%. To date, there is still no documented full-term pregnancy or live birth. The significant reduction in DFI within 3 months of finasteride cessation and continued improvement suggests a causal link between finasteride and sperm DNA damage. We hypothesize that low-dose finasteride may exert a negative influence on sperm DNA integrity, resulting in increased pregnancy losses. We suggest that in infertile men using finasteride, sperm DFI should be measured in addition to semen parameters, and a trial of discontinuation of finasteride may be warranted.
To describe a male patient with finasteride-associated infertility. Case report. Tertiary-care clinic for male infertility. A patient with azoospermia who had been taking finasteride (1-mg dose) for 1 year for androgenic alopecia. He had been diagnosed with oligospermia 5 years before. Discontinuation of finasteride. Improvement of semen parameters. After cessation of finasteride, the patient's semen volume increased immediately, and sperm concentration was up to more than 10 × 10(6)/mL 16 weeks after stopping finasteride. He is now trying to achieve pregnancy by intrauterine insemination. Cessation of finasteride improved spermatogenesis and allowed the couple to attempt less-invasive fertility therapy. In this case, the patient had impaired spermatogenesis before he started the drug. In such patients, the drug may further decrease spermatogenesis. We suggest that drug cessation could be taken into consideration for infertile male patients with impaired semen parameters who are taking finasteride at a 1-mg dose.
5α-reductase inhibitors (5α-RIs), finasteride and dutasteride, have been approved for treatment of lower urinary tract symptoms, due to benign prostatic hyperplasia, with marked clinical efficacy. Finasteride is also approved for treatment of hair loss (androgenetic alopecia). Although the adverse side effects of these agents are thought to be minimal, the magnitude of adverse effects on sexual function, gynecomastia, depression, and quality of life remains ill-defined. The goal of this review is to discuss 5α-RIs therapy, the potential persistent side effects, and the possible mechanisms responsible for these undesirable effects. We examined data reported in various clinical studies from the available literature concerning the side effects of finasteride and dutasteride. Data reported in the literature were reviewed and discussed. Results.  Prolonged adverse effects on sexual function such as erectile dysfunction and diminished libido are reported by a subset of men, raising the possibility of a causal relationship. We suggest discussion with patients on the potential sexual side effects of 5α-RIs before commencing therapy. Alternative therapies may be considered in the discussion, especially when treating androgenetic alopecia.
Androgenetic alopecia is the most common form of alopecia in men. To determine the efficacy and safety of finasteride therapy for patients with androgenetic alopecia. MEDLINE, EMBASE, CINAHL, Cochrane Registers, and LILACS were searched for randomized controlled trials reported in any language that evaluated the efficacy and safety of finasteride therapy in comparison to treatment with placebo in adults with androgenetic alopecia. Two reviewers independently evaluated eligibility and collected the data, including assessment of methodological quality (Jadad score). Outcome measures included patient self-assessment, hair count, investigator clinical assessment, global photographic assessment, and adverse effects at short term (≤12 months) and long term (≥24 months). Heterogeneity was explored by testing a priori hypotheses. Twelve studies fulfilled the eligibility criteria (3927 male patients), 10 of which demonstrated a Jadad score of 3 or more. The proportion of patients reporting an improvement in scalp hair was greater with finasteride therapy than with placebo treatment in the short term (relative risk [RR], 1.81 [95% confidence interval (CI), 1.42-2.32]; I², 64%) and in the long term (RR, 1.71 [95% CI, 1.15-2.53]; I², 16%); both results were considered to have moderate-quality evidence. The number needed to treat for 1 patient to perceive himself as improved was 5.6 (95% CI, 4.6-7.0) in the short term and 3.4 (95% CI, 2.6-5.1) in the long term. Moderate-quality evidence suggested that finasteride therapy increased the mean hair count from baseline in comparison to placebo treatment, expressed as a percentage of the initial count in each individual, at short term (mean difference [MD], 9.42% [95% CI, 7.95%-10.90%]; I², 50%) and at long term (MD, 24.3% [95% CI, 17.92%-30.60%]; I², 0%). Also, the proportion of patients reported as improved by investigator assessment was greater in the short term (RR, 1.80 [95% CI, 1.43-2.26]; number needed to treat, 3.7 [95% CI, 3.2-4.3]; I², 82%) (moderate-quality evidence). Moderate-quality evidence suggested an increase in erectile dysfunction (RR, 2.22 [95% CI, 1.03-4.78]; I², 1%; number needed to harm, 82.1 [95% CI, 56-231]) and a possible increase in the risk of any sexual disturbances (RR, 1.39 [95% CI, 0.99-1.95]; I², 0%). The risk of discontinuing treatment because of sexual adverse effects was similar to that of placebo (RR, 0.88 [95% CI, 0.51-1.49]; I², 5%) (moderate-quality evidence). Moderate-quality evidence suggests that daily use of oral finasteride increases hair count and improves patient and investigator assessment of hair appearance, while increasing the risk of sexual dysfunction.