107_02.04cu.bandar

Hair Loss Remedies—Separating Fact From FictionIlian Bandaranayake, BA; Paradi Mirmirani, MD To understand the validity of claims for hair regrowth products 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.
is accredited by the ACCME to provide continuing approved by Michael Fisher, MD, Professor of Medicine, Albert Einstein College of Medicine.
Albert Einstein College of Medicine designates this educational activity for a maximum of 1 This activity has been planned and implemented category 1 credit toward the AMA Physician’s in accordance with the Essential Areas and Policies Recognition Award. Each physician should claim of the Accreditation Council for Continuing Medical only that hour of credit that he/she actually spent Education through the joint sponsorship of Albert Einstein College of Medicine and Quadrant This activity has been planned and produced in HealthCom, Inc. Albert Einstein College of Medicine Ms. Bandaranayake and Dr. Mirmirani report no conflict of interest. The authors report discussion of off-labeluse for tretinoin, spironolactone, Yasmin, dutasteride, and laser light therapy.
Hair loss is a common complaint in the outpa- loss. This paper explores the truth behind those tient setting. Frequently, patients conduct their claims of hair regrowth. We intend for this infor- own research on hair loss diagnosis and treat- mation to serve as a “consumer repor t” for ment and are faced with a number of manufac- healthcare providers and patients and to help turers’ claims that their products will benefit hair s e p a r a t e s o m e o f t h e v a l i d c l a i m s f o r h a i rregrowth from those that are purely fiction. Accepted for publication January 12, 2004.
Ms. Bandaranayake is a medical student and Dr. Mirmirani isan Assistant Professor in the Department of Dermatology, bothat University Hospitals of Cleveland, Case Western ReserveUniversity, Ohio. Reprints: Paradi Mirmirani, MD, 11100 Euclid Ave, #LKS3516, patient complaint, affecting approximately halfof all men and women by the age of 50 years.1 Cleveland, OH 44106 (e-mail: [email protected]).
Hair loss often can have significant negative effects on self-esteem and body image.2 Clinicians may tive and safe in adolescents, which is an important be bombarded by questions from patients who finding because AGA can occur in older children have information about hair loss remedies from or teenagers and can cause significant psychologi- the Internet or testimonials from friends. How- ever, it may be difficult or time-consuming for Some Web sites are claiming that products used doctors to learn about the dozens of products in combination with minoxidil can increase the claiming to promote hair growth and to then drug’s efficacy. For example, the Hair Loss Control appropriately counsel their patients. In this arti- Clinic Web site claims that sebum on the hair cle, we have interposed information obtained follicle at the level of the scalp prevents minoxi- from the Internet with that obtained from peer- dil’s penetration into the hair follicle, causing it to reviewed journals, when available, to support or be absorbed ineffectively.12 The site also claims refute claims made by the manufacturers or mar- that the high alcohol content of over-the-counter keters of various products. We intend for this minoxidil can cause hair damage. The clinic is information to serve as a “consumer report” for promoting a product called HLCC Scalp Therapy healthcare providers and patients and help to sep- Dexpanthenol 12% to be used prior to shampooing arate some of the valid claims for hair regrowth to dissolve sebum, theoretically allowing the minoxidil solution to better penetrate the hair fol-licle.12 Another product advertised on this site is FDA-Approved Hair Loss Remedies
Carrier Enhancement Agent, which supposedly Minoxidil—In 1988, the US Food and Drug neutralizes the alcohol in minoxidil to preventAdministration (FDA) approved minoxidil scalp irritation.12 There are no peer-reviewed stud-2% topical solution for use in treating AGA in ies supporting these claims. Because it is unclear how minoxidil topical solution works, it also is became available in 1991, and a 5% solution for unclear why such additives would increase its use in men became available over-the-counter in 1997.3 Since that time, generic formulations of Patients also may see Web sites promoting the minoxidil topical solution also have become use of retinoids with minoxidil to enhance minox- available. Minoxidil is a vasodilator and a potas- idil’s effectiveness. To date, one nonblinded study sium channel opener,3 but its mechanism of tested tretinoin 0.025% combined with minoxidil action in promoting hair regrowth is unknown 0.5% topical solution in 36 patients and showed and appears to be independent of its vasodilata- that the tretinoin increased the percutaneous tion properties.3-7 The most common adverse side absorption of the minoxidil. The combination of effects of minoxidil topical solution include scalp the 2 drugs led to visible hair growth in 66% of the irritation, which occurs in about 7% of patients patients tested.13 Therefore, the application of both using the 2% solution, and hypertrichosis, which topical minoxidil solution and tretinoin may give is noted in women.3 Because there are both some patients better results than application of generic and brand-name formulations of minoxi- topical minoxidil alone. Patients may want to try dil topical solution, the cost of this therapy varies minoxidil by itself at first and then add the depending on which solution patients choose.
tretinoin only if they are not satisfied with their However, most consumers pay between $10 and Finasteride—In 1997, finasteride was approved Minoxidil 2% topical solution has been proven by the FDA for treatment of male AGA at a dose to be effective both in stimulating new hair of 1 mg/d.3 This medication is a competitive growth and in helping to prevent continued hair inhibitor of type-2 5α-reductase, which inhibits loss in both sexes.3 A recent study comparing testosterone’s conversion to dihydrotestosterone minoxidil 2% and 5% topical solution in men (DHT).14-17 Finasteride is able to decrease serum showed that the men using the extra-strength DHT by about 70%.18 Due to the potential for formulation had 45% more hair regrowth after teratogenic effects in male fetuses, finasteride is48 weeks and an earlier response to the drug.9 A not FDA approved for use in women.3 The main study published in 1992 showed that a year’s treat- side effects of finasteride therapy are sexual side ment with minoxidil 5% was effective in improv- effects such as decreased libido and erectile/ejacu- ing hair density in 9 women,10 though the latory dysfunction, which occurred in fewer than company has not yet obtained FDA approval for 2% of men in one trial. In one study, these nega- the use of this concentration in women. Minoxidil tive side effects were reversed with cessation of the topical solution has even been found to be effec- medication.19 Also, there have been no clinically significant drug interactions noted between finas- patients given minoxidil had quicker initial teride and other medications.20 The cost of this improvement whereby patients given finasteride drug averages between $30 and $60 per month.8 had slightly better results as treatment progressed.26 Multiple randomized double-blind clinical trials Choice of treatment therefore may be more a factor of finasteride versus placebo in men aged 18 to of side-effect profile, expense, and preferred form41 years with both vertex and frontal hair thinning showed that patients who took finasteride 1 mg/d Some patients may ask about combining finas- for one year had significantly increased scalp teride with minoxidil. One case study described the coverage and hair counts than patients taking improvement of one man’s alopecia from Hamilton- placebo.19,21,22 With continuous treatment of finas- Norwood class V to class III after using a combina- teride daily for 2 years, approximately two thirds of tion therapy of finasteride 5 mg/d plus a topical men have improved hair regrowth, one third of solution of minoxidil 3% and tretinoin 0.01%.27 men see no change, and approximately 1% of men The combined use of finasteride and minoxidil actually have less hair than at baseline.3 This prod- topical solution has been studied in the animal uct has shown more efficacy in younger men than model of AGA; in stumptail macaques, the com- it has in men older than 60 years, most likely bined use of finasteride with minoxidil had greater because of decreased scalp type-2 5α-reductase effects on hair loss than either treatment alone.28 Because both treatments have different modes of Finasteride also has been tested for efficacy in action, it is plausible that combining them may women with AGA. A randomized double-blind study of 137 postmenopausal women with AGAwho took finasteride 1 mg/d or placebo for one Off-Label Uses for FDA-Approved
year showed no significant difference in hair Medications
count between the 2 groups. In fact, both groups Spironolactone—This medication is often pre- of patients actually showed significant loss of hair scribed for the treatment of hypertension because during the study period.23 Another randomized of its action as an aldosterone antagonist, but it open-label study tested finasteride 5 mg/d versus also is able to inhibit the biosynthesis of andro- gens and to competitively inhibit androgen hyperandrogenic alopecia and elevated serum receptor protein binding.29 The main side effects androgens (levels >2 SD above the mean in ovu- of this medication are menstrual irregularities, latory control patients). This study found that hyperkalemia, gynecomastia in men, and gas- the women using finasteride at this elevated dose trointestinal distress.29 Women using this medi- did not see any significant improvement as cation must be warned about the potential for opposed to the women receiving no treatment.24 feminization of male fetuses if pregnancy occurs Some clinicians have had more success with the during the course of treatment.30 The cost of this use of finasteride in their female patients with medication at a dose of 200 mg/d is approxi- AGA. In a letter published in the British Journal mately $60 per month, though it typically is cov- of Dermatology, 2 physicians describe successful treatment of AGA in a postmenopausal woman Spironolactone has shown efficacy in treating who was given finasteride 5 mg/wk. Success was women with hirsutism,31 and it also may have mild measured via patient report of improved hair efficacy in treating AGA at a dose of 200 mg/d.32 density and review of stereotactic photographs of One study examining the efficacy of spironolac- the scalp.25 Despite this anecdotal evidence of success, the larger body of evidence weighs women taking the medication had less hair loss against the use of finasteride in postmenopausal than control patients after one year, but the women taking spironolactone still did not have Because there are only 2 FDA-approved treat- more hair after treatment than at the start of the ments for AGA, patients may wonder which is study.33 Another study that examined the use of more effective. In a recent letter published in the spironolactone 200 mg/d in 2 men and 2 women Archives of Dermatology, finasteride 1 mg/d was compared with topical minoxidil 2% in 99 men increase in the number of hairs in anagen phase aged 18 to 45 years with mid frontal and/or vertex from 22% at baseline to 84.5% at the end of hair thinning.26 The researchers found that both 6 months of treatment.34 Because this medication treatments worked equally well in stopping the only has weak evidence for its use as a treatment for progression of hair loss in patients; however, hair loss, clinicians should consider this medication only in addition to other, more proven, means of Herbal/Dietary Remedies
Saw Palmetto—Saw palmetto, or Serenoa repens, is Yasmin®—This is an oral contraceptive pill an herbal remedy that is processed from fruit of composed of ethinyl estradiol and drospirenone, an the American dwarf pine tree.42 It often is used to analogue of spironolactone. Each pill contains treat benign prostatic hypertrophy because of its drospirenone 3 mg, which is equivalent to spirono- ability to inhibit 5α-reductase levels by 32% lactone 25 mg.35 According to the manufacturer of without affecting testosterone levels in men.43 Yasmin, this oral contraceptive antagonizes androgen Extracts of saw palmetto also have been shown to receptors without affecting sex-hormone–binding have a partial antagonistic affect on testosterone globulin synthesis or affecting the binding of receptors.44 It is most likely that these 2 actions testosterone to sex-hormone–binding globulin.
led to saw palmetto being used as a hair loss rem- The manufacturer also claims that the drug edy. Saw palmetto is believed to be a safe herbal inhibits ovarian androgen production.36 The most supplement, with a primary side effect of mild common side effects are similar to side effects of gastrointestinal distress.42 Also, clinical trials other oral contraceptives and include breast conducted in human patients showed that con-tenderness, nausea, headache, emotional lability, sumption of saw palmetto supplements did not dysmenorrhea, intermenstrual bleeding, and result in any clinically significant alterations in depression.35 Some insurance plans will cover the laboratory parameters.45 Saw palmetto has no cost of oral contraceptives, but for patients paying known drug interactions.42 The cost of this sup- out of pocket, Yasmin costs approximately $30 per plement varies by manufacturer, but consumers should be able to find saw palmetto supplements for as little as $3 for a month’s supply.8 scribed for AGA, some clinicians recommend One double-blind placebo-controlled study Yasmin to patients with alopecia who also are examined saw palmetto’s effect on AGA.46 In this looking for effective contraceptive methods.
study, researchers studied the efficacy of a softgel However, to our knowledge, there are no known containing β-sitosterol 50 mg and saw palmetto published studies showing that Yasmin prevents 200 mg extract (components of the HairGenesis™ hair loss or promotes hair regrowth. Because Softgels discussed later) versus placebo in treating spironolactone has shown only slight efficacy in AGA. They found that 60% of patients taking the treatment of women with AGA,3 it is unclear active softgel rated their hair growth as improved what the effect of Yasmin may be on hair loss.
from baseline as opposed to only 10% of the However, this may be a reasonable choice of con- patients taking placebo. However, this study had a limited patient population and also concurrently Dutasteride—This new 5α-reductase inhibitor tested β-sitosterol, so any improvement cannot be blocks both type-1 and type-2 isoenzymes.37 By inhibiting both types of 5α-reductase, dutasteride is Biotin—This is a water-soluble B complex able to achieve a greater than 90% suppression of vitamin that is used in the body as a cofactor for DHT.37 This medication was developed for the treat- biochemical carboxylations. Patients that are ment of benign prostatic hyperplasia, with side deficient in this vitamin often have alopecia, effects similar to those of finasteride.38 As with finas- brittle nails, and a scaly erythematous dermati- teride, women are advised not to take this product tis.47,48 Biotin is water-soluble, and there are no because of the potential risk of birth defects in male known side effects of supplementation and no fetuses.37 In November 2002, dutasteride was documented cases of biotin overdose.49 As with approved by the FDA for use in patients with benign other supplements, cost of treatment will depend prostatic hyperplasia.39 This medication costs on the manufacturer, but consumers should be able to find biotin for as little as $2 for a month’s Although dutasteride is not yet FDA approved for alopecia, the manufacturers have completed Dietary supplementation with biotin has been phase 2 clinical trials of the medication for the shown to improve the clinical condition of brit- treatment of hair loss and are hopeful it will be tle nails,48 but no studies have been conducted approved by the FDA in 2006.40 There are no stud- looking at biotin’s effect on AGA. Although it is ies published regarding this medication’s effect on true that biotin deficiency can lead to alopecia, AGA, but preliminary results from the manufacturer such a deficiency has not been demonstrated in showed that dutasteride reduced scalp DHT in men healthy humans eating a mixed diet.47 The only 2 situations in which human biotin deficiency has been demonstrated are in patients with extended this product, it would not be wise for clinicians to consumption of raw egg whites50-52 and in patients recommend this therapy to any patient.
with malabsorption syndromes receiving parenteral HairGenesis™—This product line consists of nutrition without biotin supplementation.50,53 4 items: Revitalizing Oral Softgel™ supplements Supplementing the diet with biotin is unlikely to (β-sitosterol 50 mg and saw palmetto 200 mg harm a patient, but there is no data to suggest any extract) that claim to strengthen and protect hair; Topical Activator Serum that consists of various 5α-reductase inhibitors; Hair Revitalizing Formulation, Other Hair Regrowth Products
a shampoo that has similar components to the Avacor™—Sold through the Internet and directly Topical Activator Serum; and Hair and Scalp from the manufacturer, Avacor is a hair regrowth Conditioner that also is meant to strengthen and product marketed toward both sexes for treatment protect hair. Although the company states that of AGA.54 The product line consists of a scalp the products may be used individually, it recom- detoxifying shampoo, an herbal supplement, and a mends using them all synergistically, at a cost of topical solution. The purpose of the shampoo as $200 for a 3-month supply.58 The efficacy of the stated by the manufacturer is to deep clean the oral softgel containing saw palmetto is discussed scalp to improve the absorbency of the topical above; there are no known research studies treatment. The herbal supplements are to be published about the other 3 components of the taken twice daily to “maintain a healthy hair fol- licle” and consist of bilberry, ginkgo biloba, saw Nioxin®—This product line is sold only palmetto, and horsetail. The topical solution, through hair salons and does not aim to regrow which is marketed to men only, claims to dilate hair; rather, it claims to “create an optimum scalp blood vessels in the scalp, allowing increased environment” for regrowth and maintenance of nutrient and oxygen delivery to the scalp. The the current hair count. The manufacturer claims Web site claims that these products must be used to accomplish this by clearing the scalp of excess together and that they have no known side sebum that may contain high levels of DHT.
effects.54 The cost of this product is $239.95 for a Ingredients include various vitamin-B coen- zymes, biotin, saw palmetto, aloe, ginseng, and The official Avacor Web site has a summary of a amino acids. The manufacturer claims that the clinical study performed by The New York Hair Nioxin system has no known side effects.59 As Clinic and the Hair and Skin Treatment Center in this product is sold only in salons, the cost for a which 200 men aged 18 to 65 years used the 3-part month’s supply will vary depending on the place system for 24 weeks.55 The Web site claims that 91% of purchase. One salon that we contacted offered of the men had a decrease in hair loss and an a one-month starter kit for $30. The manufac- increase in strength and thickness of preexisting turer does not disclose its clinical studies but hair within 3 months.55 However, this study does not claims that its studies are conducted by “world- appear to be published in any journal and consumers renowned” researchers who are experts in hair can only receive a copy of the study if they purchase thinning.59 However, there is no known pub- lished scientific evidence that any of the ingredi- A Wellness Letter highlighting dietary supple- ents in Nioxin are effective in treating hair loss ments, published by the University of California at or maintaining hair count, or that excess sebum Berkeley, showed that Avacor contains minoxidil in its topical solution despite its claims to be made Laser Light Therapy—Low-intensity laser light from only natural ingredients.56 In April 2003, the therapy has been shown to be effective in pro- FDA sent the makers of Avacor a letter informing moting wound healing60 and in improving circu- them that their products are considered drugs lation.61,62 For these reasons, some hair loss under section 201(g) of the Federal Food, Drug, treatment centers are offering the use of lasers for treating alopecia in both men and women. To approved New Drug Application prior to being date, there are no known studies looking at the marketed in the United States. The FDA also efficacy of these lasers for treating hair loss. The points out that the 3 individual components are use of low-intensity laser light for treating alope- mislabeled because the active ingredients are not cia is FDA approved for safety only, not for efficacy.29 This therapy is expensive, costing as Given the lack of peer-reviewed evidence of hair much as $3500 for the recommended 6 months of growth and with all of the controversy surrounding Although various Web sites claim efficacy 10. Rushton DH, Fenton DA. Quantitative evaluation of topi- based on double-blind placebo-controlled studies cal 5% minoxidil in the treatment of diffuse androgen- of laser light treatment versus placebo laser treat- dependent alopecia in females [abstract]. Br J Dermatol.
ment,64,65 such studies are not available for viewing anywhere on the Web sites. To the best of our 11. Price VH. Androgenetic alopecia in adolescents. Cutis.
knowledge, there are no peer-reviewed articles supporting efficacy of this type of treatment for 12. Hair Loss Control Clinic Center for Hair Restoration.
AGA. Until reliable evidence of the effectiveness of laser light therapy for alopecia is published, this www.hlcconline.com/howwemademinoxidilbetter.htm.
treatment remains experimental, at best.
13. Bazzano GS, Terezakis N, Galen W. Topical tretinoin for Conclusion
hair growth promotion. J Am Acad Dermatol. 1986;15: Any consumer looking on the Internet for a treat- ment for hair loss is exposed to a multitude of 14. Rittmaster RS. Finasteride. N Engl J Med. 1994;330: remedies. However, only the FDA-approved treat- ments for AGA, finasteride and minoxidil, have 15. Liang T, Heiss CE, Cheung AH, et al. 4-Azasteroidal any well-studied factual evidence of efficacy.
5α-reductase inhibitors without affinity for the androgen Smaller studies have shown possible benefit of receptor. J Biol Chem. 1984;259:734-739.
combining topical tretinoin with minoxidil, as 16. Stoner E. The clinical development of a 5α-reductase well as combining finasteride and minoxidil.
inhibitor, finasteride. J Steroid Biochem. 1990;37: Spironolactone in high doses (100–200 mg), dutasteride, and saw palmetto, also may provide 17. Gormley GJ, Stoner E, Bruskewitz RC, et al, for the benefit; however, larger studies are needed to con- Finasteride Study Group. The effect of finasteride in men sider these agents as first-line treatments for with benign prostatic hyperplasia. the Finasteride Study AGA. In addition to efficacy, clinicians need to Group. N Engl J Med. 1992;327:1185-1191.
consider patient preferences, safety profile, and 18. Bartsch G, Rittmaster RS, Klocker H. Dihydrotestosterone cost when counseling patients about treatment and the concept of 5α-reductase inhibition in human benign prostatic hyperplasia. Eur Urol. 2000;37:367-380.
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information of specific drugs or combination of drugs, including indications, contraindications, warnings, and adverse effects before administering pharmacologic
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