CONTINUING MEDICAL EDUCATION

Hair Loss Remedies—Separating
Fact From Fiction
Ilian Bandaranayake, BA; Paradi Mirmirani, MD

GOAL
To understand the validity of claims for hair regrowth products
OBJECTIVES
Upon completion of this activity, dermatologists and general practitioners should be able to:
1. Explain the efficacy of various hair regrowth products.
2. Describe the side effects of various hair regrowth products.
3. Advise patients of the hair regrowth products most appropriate for them.
CME Test on page 123.
This article has been peer reviewed andapproved by Michael Fisher, MD, Professor of
Medicine, Albert Einstein College of Medicine.
Review date: January 2004.
This activity has been planned and implemented
in accordance with the Essential Areas and Policiesof the Accreditation Council for Continuing Medical
Education through the joint sponsorship of Albert
Einstein College of Medicine and Quadrant
HealthCom, Inc. Albert Einstein College of Medicine

is accredited by the ACCME to provide continuing
medical education for physicians.
Albert Einstein College of Medicine designates
this educational activity for a maximum of 1
category 1 credit toward the AMA Physician’s
Recognition Award. Each physician should claim
only that hour of credit that he/she actually spentin the activity.
This activity has been planned and produced inaccordance with ACCME Essentials.

Ms. Bandaranayake and Dr. Mirmirani report no conflict of interest. The authors report discussion of off-label
use for tretinoin, spironolactone, Yasmin, dutasteride, and laser light therapy.

Hair loss is a common complaint in the outpatient setting. Frequently, patients conduct theirown research on hair loss diagnosis and treatment and are faced with a number of manufacturers’ claims that their products will benefit hairAccepted for publication January 12, 2004.
Ms. Bandaranayake is a medical student and Dr. Mirmirani is
an Assistant Professor in the Department of Dermatology, bothat University Hospitals of Cleveland, Case Western Reserve
University, Ohio.
Reprints: Paradi Mirmirani, MD, 11100 Euclid Ave, #LKS3516,
Cleveland, OH 44106 (e-mail: paradi.mirmirani@uhhs.com).

loss. This paper explores the truth behind thoseclaims of hair regrowth. We intend for this information to serve as a “consumer repor t” forhealthcare providers and patients and to help
separate some of the valid claims for hairregrowth from those that are purely fiction.
Cutis. 2004;73:107-114.

A

ndrogenetic alopecia (AGA) is a common
patient complaint, affecting approximately halfof all men and women by the age of 50 years.1
Hair loss often can have significant negative effects
VOLUME 73, FEBRUARY 2004 107

Hair Loss Remedies

on self-esteem and body image.2 Clinicians may
be bombarded by questions from patients who
have information about hair loss remedies fromthe Internet or testimonials from friends. However, it may be difficult or time-consuming for
doctors to learn about the dozens of products
claiming to promote hair growth and to thenappropriately counsel their patients. In this article, we have interposed information obtained
from the Internet with that obtained from peerreviewed journals, when available, to support orrefute claims made by the manufacturers or marketers of various products. We intend for thisinformation to serve as a “consumer report” forhealthcare providers and patients and help to separate some of the valid claims for hair regrowthfrom those that are purely fiction.

FDA-Approved Hair Loss Remedies
Minoxidil—In 1988, the US Food and Drug
Administration (FDA) approved minoxidil
2% topical solution for use in treating AGA inmen. A 2% solution marketed toward womenbecame available in 1991, and a 5% solution foruse in men became available over-the-counter in
1997. 3 Since that time, generic formulations ofminoxidil topical solution also have become
available. Minoxidil is a vasodilator and a potassium channel opener, 3 but its mechanism ofaction in promoting hair regrowth is unknown
and appears to be independent of its vasodilatation properties.3-7 The most common adverse side
effects of minoxidil topical solution include scalp
irritation, which occurs in about 7% of patientsusing the 2% solution, and hypertrichosis, which
is noted in women. 3 Because there are bothgeneric and brand-name formulations of minoxidil topical solution, the cost of this therapy varies
depending on which solution patients choose.
However, most consumers pay between $10 and$20 for a 1-month supply. 8
Minoxidil 2% topical solution has been provento be effective both in stimulating new hair
growth and in helping to prevent continued hairloss in both sexes.3 A recent study comparing
minoxidil 2% and 5% topical solution in men
showed that the men using the extra-strength
formulation had 45% more hair regrowth after
48 weeks and an earlier response to the drug. 9 A
study published in 1992 showed that a year’s treatment with minoxidil 5% was effective in improving hair density in 9 women, 10 though thecompany has not yet obtained FDA approval forthe use of this concentration in women. Minoxidil
topical solution has even been found to be effec108 CUTIS®

tive and safe in adolescents, which is an important
finding because AGA can occur in older children
or teenagers and can cause significant psychological distress.11
Some Web sites are claiming that products usedin combination with minoxidil can increase thedrug’s efficacy. For example, the Hair Loss Control
Clinic Web site claims that sebum on the hairfollicle at the level of the scalp prevents minoxidil’s penetration into the hair follicle, causing it to
be absorbed ineffectively.12 The site also claims
that the high alcohol content of over-the-counterminoxidil can cause hair damage. The clinic is
promoting a product called HLCC Scalp Therapy
Dexpanthenol 12% to be used prior to shampooing
to dissolve sebum, theoretically allowing theminoxidil solution to better penetrate the hair follicle.12 Another product advertised on this site is
Carrier Enhancement Agent, which supposedly
neutralizes the alcohol in minoxidil to prevent
scalp irritation.12 There are no peer-reviewed studies supporting these claims. Because it is unclear
how minoxidil topical solution works, it also is
unclear why such additives would increase its
effectiveness.
Patients also may see Web sites promoting theuse of retinoids with minoxidil to enhance minoxidil’s effectiveness. To date, one nonblinded study
tested tretinoin 0.025% combined with minoxidil
0.5% topical solution in 36 patients and showedthat the tretinoin increased the percutaneousabsorption of the minoxidil. The combination of
the 2 drugs led to visible hair growth in 66% of thepatients tested.13 Therefore, the application of both
topical minoxidil solution and tretinoin may givesome patients better results than application of
topical minoxidil alone. Patients may want to try
minoxidil by itself at first and then add thetretinoin only if they are not satisfied with theirinitial results.
Finasteride—In 1997, finasteride was approvedby the FDA for treatment of male AGA at a doseof 1 mg/d.3 This medication is a competitive
inhibitor of type-2 5α-reductase, which inhibits
testosterone’s conversion to dihydrotestosterone(DHT).14-17 Finasteride is able to decrease serum
DHT by about 70%.18 Due to the potential for
teratogenic effects in male fetuses, finasteride is
not FDA approved for use in women.3 The mainside effects of finasteride therapy are sexual side
effects such as decreased libido and erectile/ejaculatory dysfunction, which occurred in fewer than
2% of men in one trial. In one study, these negative side effects were reversed with cessation of the
medication.19 Also, there have been no clinicallyHair Loss Remedies

significant drug interactions noted between finasteride and other medications.20 The cost of thisdrug averages between $30 and $60 per month.8
Multiple randomized double-blind clinical trialsof finasteride versus placebo in men aged 18 to
41 years with both vertex and frontal hair thinningshowed that patients who took finasteride 1 mg/d
for one year had significantly increased scalp
coverage and hair counts than patients taking
placebo.19,21,22 With continuous treatment of finasteride daily for 2 years, approximately two thirds ofmen have improved hair regrowth, one third ofmen see no change, and approximately 1% of men
actually have less hair than at baseline.3 This product has shown more efficacy in younger men thanit has in men older than 60 years, most likely
because of decreased scalp type-2 5α-reductase
activity in older men.3
Finasteride also has been tested for efficacy inwomen with AGA. A randomized double-blind
study of 137 postmenopausal women with AGA
who took finasteride 1 mg/d or placebo for one
year showed no significant difference in haircount between the 2 groups. In fact, both groupsof patients actually showed significant loss of hairduring the study period. 23 Another randomized
open-label study tested finasteride 5 mg/d versus
no treatment in premenopausal women withhyperandrogenic alopecia and elevated serum
androgens (levels >2 SD above the mean in ovulatory control patients). This study found thatthe women using finasteride at this elevated dose
did not see any significant improvement as
opposed to the women receiving no treatment. 24
Some clinicians have had more success with theuse of finasteride in their female patients with
AGA. In a letter published in the British Journalof Dermatology, 2 physicians describe successfultreatment of AGA in a postmenopausal woman
who was given finasteride 5 mg/wk. Success wasmeasured via patient report of improved hairdensity and review of stereotactic photographs ofthe scalp. 25 Despite this anecdotal evidence of
success, the larger body of evidence weighsagainst the use of finasteride in postmenopausal
women with AGA.
Because there are only 2 FDA-approved treatments for AGA, patients may wonder which ismore effective. In a recent letter published in theArchives of Dermatology, finasteride 1 mg/d wascompared with topical minoxidil 2% in 99 men
aged 18 to 45 years with mid frontal and/or vertex
hair thinning.26 The researchers found that both
treatments worked equally well in stopping the
progression of hair loss in patients; however,patients given minoxidil had quicker initial
improvement whereby patients given finasteride
had slightly better results as treatment progressed.26
Choice of treatment therefore may be more a factorof side-effect profile, expense, and preferred formof medication (oral vs topical).
Some patients may ask about combining finasteride with minoxidil. One case study described theimprovement of one man’s alopecia from HamiltonNorwood class V to class III after using a combination therapy of finasteride 5 mg/d plus a topicalsolution of minoxidil 3% and tretinoin 0.01%.27
The combined use of finasteride and minoxidil
topical solution has been studied in the animalmodel of AGA; in stumptail macaques, the combined use of finasteride with minoxidil had greater
effects on hair loss than either treatment alone.28
Because both treatments have different modes ofaction, it is plausible that combining them mayyield better results.

Off-Label Uses for FDA-Approved
Medications
Spironolactone—This medication is often prescribed for the treatment of hypertension becauseof its action as an aldosterone antagonist, but it
also is able to inhibit the biosynthesis of androgens and to competitively inhibit androgen
receptor protein binding. 29 The main side effectsof this medication are menstrual irregularities,
hyperkalemia, gynecomastia in men, and gastrointestinal distress. 29 Women using this medication must be warned about the potential for
feminization of male fetuses if pregnancy occurs
during the course of treatment. 30 The cost of thismedication at a dose of 200 mg/d is approximately $60 per month, though it typically is covered by insurance policies. 8
Spironolactone has shown efficacy in treating
women with hirsutism,31 and it also may have mild
efficacy in treating AGA at a dose of 200 mg/d.32
One study examining the efficacy of spironolactone in women with AGA showed that the
women taking the medication had less hair loss
than control patients after one year, but the
women taking spironolactone still did not havemore hair after treatment than at the start of thestudy.33 Another study that examined the use of
spironolactone 200 mg/d in 2 men and 2 womenwith AGA showed that the patients had anincrease in the number of hairs in anagen phasefrom 22% at baseline to 84.5% at the end of
6 months of treatment.34 Because this medication
only has weak evidence for its use as a treatment forhair loss, clinicians should consider this medication
VOLUME 73, FEBRUARY 2004 109

Hair Loss Remedies

only in addition to other, more proven, means oftherapy.
Yasmin®—This is an oral contraceptive pillcomposed of ethinyl estradiol and drospirenone, ananalogue of spironolactone. Each pill contains
drospirenone 3 mg, which is equivalent to spironolactone 25 mg.35 According to the manufacturer ofYasmin, this oral contraceptive antagonizes androgen
receptors without affecting sex-hormone–binding
globulin synthesis or affecting the binding of
testosterone to sex-hormone–binding globulin.
The manufacturer also claims that the drug
inhibits ovarian androgen production.36 The mostcommon side effects are similar to side effects ofother oral contraceptives and include breast
tenderness, nausea, headache, emotional lability,
dysmenorrhea, intermenstrual bleeding, anddepression.35 Some insurance plans will cover thecost of oral contraceptives, but for patients payingout of pocket, Yasmin costs approximately $30 per
month.8
Because spironolactone is sometimes prescribed for AGA, some clinicians recommend
Yasmin to patients with alopecia who also arelooking for effective contraceptive methods.
However, to our knowledge, there are no known
published studies showing that Yasmin prevents
hair loss or promotes hair regrowth. Because
spironolactone has shown only slight efficacy intreatment of women with AGA,3 it is unclear
what the effect of Yasmin may be on hair loss.
However, this may be a reasonable choice of contraceptive in a woman with AGA.
Dutasteride—This new 5α-reductase inhibitor
blocks both type-1 and type-2 isoenzymes.37 By
inhibiting both types of 5α-reductase, dutasteride isable to achieve a greater than 90% suppression of
DHT.37 This medication was developed for the treatment of benign prostatic hyperplasia, with side
effects similar to those of finasteride.38 As with finasteride, women are advised not to take this productbecause of the potential risk of birth defects in male
fetuses. 37 In November 2002, dutasteride wasapproved by the FDA for use in patients with benign
prostatic hyperplasia. 39 This medication costs
approximately $75 for a 1-month supply.8
Although dutasteride is not yet FDA approved
for alopecia, the manufacturers have completed
phase 2 clinical trials of the medication for thetreatment of hair loss and are hopeful it will beapproved by the FDA in 2006.40 There are no studies published regarding this medication’s effect on
AGA, but preliminary results from the manufacturer
showed that dutasteride reduced scalp DHT in men
to a greater extent than finasteride.41
110 CUTIS®

Herbal/Dietary Remedies
Saw Palmetto—Saw palmetto, or Serenoa repens, isan herbal remedy that is processed from fruit of
the American dwarf pine tree.42 It often is used totreat benign prostatic hypertrophy because of its
ability to inhibit 5α-reductase levels by 32%
without affecting testosterone levels in men.43
Extracts of saw palmetto also have been shown tohave a partial antagonistic affect on testosterone
receptors.44 It is most likely that these 2 actions
led to saw palmetto being used as a hair loss remedy. Saw palmetto is believed to be a safe herbal
supplement, with a primary side effect of mild
gastrointestinal distress. 42 Also, clinical trials
conducted in human patients showed that consumption of saw palmetto supplements did not
result in any clinically significant alterations inlaboratory parameters. 45 Saw palmetto has no
known drug interactions.42 The cost of this supplement varies by manufacturer, but consumers
should be able to find saw palmetto supplements
for as little as $3 for a month’s supply.8
One double-blind placebo-controlled study
examined saw palmetto’s effect on AGA.46 In thisstudy, researchers studied the efficacy of a softgel
containing β-sitosterol 50 mg and saw palmetto
200 mg extract (components of the HairGenesis™
Softgels discussed later) versus placebo in treating
AGA. They found that 60% of patients taking theactive softgel rated their hair growth as improved
from baseline as opposed to only 10% of thepatients taking placebo. However, this study had alimited patient population and also concurrently
tested β-sitosterol, so any improvement cannot be
attributed to saw palmetto alone.
Biotin—This is a water-soluble B complex
vitamin that is used in the body as a cofactor forbiochemical carboxylations. Patients that are
deficient in this vitamin often have alopecia,
brittle nails, and a scaly erythematous dermatitis. 47,48 Biotin is water-soluble, and there are no
known side effects of supplementation and no
documented cases of biotin overdose. 49 As withother supplements, cost of treatment will dependon the manufacturer, but consumers should be
able to find biotin for as little as $2 for a month’s
supply. 8
Dietary supplementation with biotin has beenshown to improve the clinical condition of brittle nails, 48 but no studies have been conducted
looking at biotin’s effect on AGA. Although it istrue that biotin deficiency can lead to alopecia,
such a deficiency has not been demonstrated inhealthy humans eating a mixed diet. 47 The only
2 situations in which human biotin deficiency has

Hair Loss Remedies

been demonstrated are in patients with extended
consumption of raw egg whites50-52 and in patientswith malabsorption syndromes receiving parenteralnutrition without biotin supplementation. 50,53
Supplementing the diet with biotin is unlikely toharm a patient, but there is no data to suggest any
improvement in hair regrowth.

Other Hair Regrowth Products
Avacor ™—Sold through the Internet and directlyfrom the manufacturer, Avacor is a hair regrowth
product marketed toward both sexes for treatment
of AGA.54 The product line consists of a scalp
detoxifying shampoo, an herbal supplement, and a
topical solution. The purpose of the shampoo as
stated by the manufacturer is to deep clean thescalp to improve the absorbency of the topicaltreatment. The herbal supplements are to betaken twice daily to “maintain a healthy hair follicle” and consist of bilberry, ginkgo biloba, saw
palmetto, and horsetail. The topical solution,
which is marketed to men only, claims to dilate
blood vessels in the scalp, allowing increased
nutrient and oxygen delivery to the scalp. The
Web site claims that these products must be used
together and that they have no known side
effects. 54 The cost of this product is $239.95 for a
3-month supply.55
The official Avacor Web site has a summary of aclinical study performed by The New York Hair
Clinic and the Hair and Skin Treatment Center inwhich 200 men aged 18 to 65 years used the 3-partsystem for 24 weeks.55 The Web site claims that 91%
of the men had a decrease in hair loss and anincrease in strength and thickness of preexistinghair within 3 months.55 However, this study does notappear to be published in any journal and consumers
can only receive a copy of the study if they purchasethe product.
A Wellness Letter highlighting dietary supplements, published by the University of California at
Berkeley, showed that Avacor contains minoxidil
in its topical solution despite its claims to be madefrom only natural ingredients.56 In April 2003, the
FDA sent the makers of Avacor a letter informing
them that their products are considered drugs
under section 201(g) of the Federal Food, Drug,and Cosmetic Act and should have had anapproved New Drug Application prior to being
marketed in the United States. The FDA also
points out that the 3 individual components are
mislabeled because the active ingredients are notlisted on their labels.57
Given the lack of peer-reviewed evidence of hair
growth and with all of the controversy surrounding

this product, it would not be wise for clinicians torecommend this therapy to any patient.
HairGenesis™—This product line consists of
4 items: Revitalizing Oral Softgel™ supplements(β-sitosterol 50 mg and saw palmetto 200 mg
extract) that claim to strengthen and protect hair;
Topical Activator Serum that consists of various 5αreductase inhibitors; Hair Revitalizing Formulation,a shampoo that has similar components to the
Topical Activator Serum; and Hair and Scalp
Conditioner that also is meant to strengthen andprotect hair. Although the company states thatthe products may be used individually, it recommends using them all synergistically, at a cost of$200 for a 3-month supply.58 The efficacy of theoral softgel containing saw palmetto is discussed
above; there are no known research studies
published about the other 3 components of the
HairGenesis system.
Nioxin ® —This product line is sold only
through hair salons and does not aim to regrow
hair; rather, it claims to “create an optimum scalp
environment” for regrowth and maintenance ofthe current hair count. The manufacturer claims
to accomplish this by clearing the scalp of excess
sebum that may contain high levels of DHT.
Ingredients include various vitamin-B coenzymes, biotin, saw palmetto, aloe, ginseng, andamino acids. The manufacturer claims that the
Nioxin system has no known side effects. 59 As
this product is sold only in salons, the cost for amonth’s supply will vary depending on the placeof purchase. One salon that we contacted offered
a one-month starter kit for $30. The manufacturer does not disclose its clinical studies but
claims that its studies are conducted by “worldrenowned” researchers who are experts in hairthinning. 59 However, there is no known published scientific evidence that any of the ingredients in Nioxin are effective in treating hair loss
or maintaining hair count, or that excess sebum
leads to hair thinning.
Laser Light Therapy—Low-intensity laser lighttherapy has been shown to be effective in promoting wound healing 60 and in improving circulation. 61,62 For these reasons, some hair loss
treatment centers are offering the use of lasers fortreating alopecia in both men and women. To
date, there are no known studies looking at theefficacy of these lasers for treating hair loss. The
use of low-intensity laser light for treating alopecia is FDA approved for safety only, not for
efficacy. 29 This therapy is expensive, costing as
much as $3500 for the recommended 6 months oftreatment. 63
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Although various Web sites claim efficacy
based on double-blind placebo-controlled studiesof laser light treatment versus placebo laser treatment,64,65 such studies are not available for viewing
anywhere on the Web sites. To the best of ourknowledge, there are no peer-reviewed articles
supporting efficacy of this type of treatment for
AGA. Until reliable evidence of the effectivenessof laser light therapy for alopecia is published, thistreatment remains experimental, at best.

Conclusion
Any consumer looking on the Internet for a treatment for hair loss is exposed to a multitude of
remedies. However, only the FDA-approved treatments for AGA, finasteride and minoxidil, have
any well-studied factual evidence of efficacy.
Smaller studies have shown possible benefit ofcombining topical tretinoin with minoxidil, as
well as combining finasteride and minoxidil.
Spironolactone in high doses (100–200 mg),dutasteride, and saw palmetto, also may provide
benefit; however, larger studies are needed to consider these agents as first-line treatments for
AGA. In addition to efficacy, clinicians need toconsider patient preferences, safety profile, andcost when counseling patients about treatment
options for AGA.
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DISCLAIMER
The opinions expressed herein are those of the authors and do not necessarily represent the views of the sponsor or its publisher. Please review complete prescribing
information of specific drugs or combination of drugs, including indications, contraindications, warnings, and adverse effects before administering pharmacologic
therapy to patients.

FACULTY DISCLOSURE
The Faculty Disclosure Policy of the Albert Einstein College of Medicine requires that faculty participating in a CME activity disclose to the audience any relationship witha pharmaceutical or equipment company that might pose a potential, apparent, or real conflict of interest with regard to their contribution to the activity. Any discussionsof unlabeled or investigational use of any commercial product or device not yet approved by the US Food and Drug Administration must be disclosed.

114 CUTIS®