Hair Foundation
"Miracle Cures" for Hair Loss

Miracle cures for hair loss were sold by snake-oil salesmen in the Old West and they are sold on the World Wide Web today. A "cure for baldness" has long been a profitable claim for nostrums. The Old West snake-oil salesman might sell his product as a cure for baldness when his audience was made up mostly of men, and a cure for "women's complaints" when his audience was mostly women. In the next town, he might sell it as a cure for rheumatism. The common thread in all of his claims is they are unverified by any scientifically acceptable evidence.

We might believe that we are more sophisticated and knowledgeable than the citizens of a small town in the Old West who gathered around the wagon of the snake-oil salesman to hear his pitch. While it is true that we are probably more knowledgeable because there is more information to know about, it is also true that the purveyors of nostrums incorporate today's advanced knowledge into their claims. The Nineteenth Century snake-oil salesman might base his claims on "secret knowledge" passed along to him by an ancient medicine man. The purveyor of nostrums today is more likely to use words taken out of context from the sciences of genetics and biochemistry to link his claims to scientific research.

Skepticism and the Unverified Claim

How can you check out the claims of products to determine if their effectiveness and safety has been verified in well-designed scientific and clinical studies? The rules of healthy skepticism apply for all claims made for personal-use products, including products claiming effectiveness and safety in hair restoration.

You can apply some "truth-of-claims" tests:

  • Do claims use words such as "amazing", "scientific breakthrough", "developed by doctors"? These are classic snake-oil claims and your skepticism should be thoroughly aroused. Any product claim that asks for your 100% gullibility should be suspect.

  • What proof of product effectiveness and safety is offered? If the only "proof" is anecdotal "testimonials from satisfied users", be skeptical. So-called testimonials are not scientifically valid evidence of safety or effectiveness. What you should want to see is documented proof that the hair restoration product has been tested in clinical trials (see below) and approved by the U.S. Food and Drug Administration for use as indicated in product packaging.

  • Has the product been approved by the U.S. Food and Drug Administration (or the equivalent of the FDA in other countries)? A product that stimulates the growth of hair is a product with a potent physiologic effect. What you should want to know is (1) does the product actually stimulate the growth of hair in a significant percentage of persons who use it, and (2) if so, does it do so safely with minimal side effects? FDA approval assures you that both product effectiveness and product safety have been rigorously investigated in clinical trials.

  • To check claims for validity, you need to know the criteria for FDA-approved clinical trials. Clinical trials are (1) medical investigative studies in which human beings are the test subjects, and (2) required by the FDA for the approval of a new drug or new uses of an existing drug. Before clinical trials are undertaken, a product has usually been studied in laboratory tests and in animals to determine mechanism of action and safety. If these initial studies provide encouraging results, trials in humans may be undertaken, beginning with Phase I studies of safety. Encouraging results in Phase I trials may lead to Phase II and III trials with an increasingly larger number of human study subjects and more sophisticated study of effectiveness. Success in Phase III clinical trials are the studies that may lead to FDA approval. There are several types of Phase III clinical trials but the "gold standard" for unbiased study results is the randomized, double-blind, placebo-controlled trial (RCT) with a statistically significant number of study subjects. In the RCT, study subjects are randomly assigned to a study group or a control group, and neither the investigators nor the study subjects know who is receiving the study drug and who is receiving placebo (a non-drug with no physiologic effect-a "sugar pill"). Thus, RCTs are "double-blind"-both investigators and study subjects are "blinded" regarding who is receiving the investigative drug and who is receiving placebo. [Interestingly, in the clinical trials of FDA-approved hair restoration drugs minoxidil and finasteride (see Non-Surgical Hair Loss Treatment) some people in the control (placebo) group reported new hair growth even though careful measurements and photographs showed that no new hair had been grown. This demonstration of "wishful thinking" indicates the value of blinded studies that eliminate bias-a tendency to see what you want to see. It is important to keep this in mind when evaluating glowing anecdotal reports of effectiveness from people who used non-FDA approved hair restoration remedies.] RCTs are also designed to assure that the number of people being studied will yield a statistically meaningful result. Product effectiveness and safety are two parameters always investigated in clinical trials. Pharmaceutical firms sponsor RCTs to gather the data necessary to win FDA approval for a new drug or new uses for an existing drug. FDA rules specify conditions under which clinical trials are conducted. The studies are conducted by recognized medical investigators in hospitals and medical research centers. If a product wins FDA approval, it must be marketed within FDA guidelines, and claims cannot exceed the findings of clinical trials.

  • Does product advertising include the listing of any side effects associated with the use of the product? FDA-approved clinical trials include study of product safety and side effects. It would be unusual to find that a product with a potent physiologic effect-such as stimulating hair growth-has no side effects. While side effects may be minimal and may be experienced by relatively small numbers of products users, potential users of the product must be made aware of the potential for side effects. If product advertising fails to mention side effects, or claims no side effects, be very skeptical.

  • Is medical examination recommended before use of the product? While inherited predisposition for hair loss (androgenetic alopecia) (see Hair Loss and Its Causes) is the most common cause of baldness, there are other causes that may require medical investigation prior to hair restoration. This is especially true for women, whose hair loss may be due to a number of causes that mimic androgenetic alopecia.

  • Is the product really a "hair thickener" rather than a hair restoration product? Read the product marketing information carefully to be sure you understand the claims. Some products are capable of making temporary chemical changes in hair that "thicken" each hair fiber and create the effect of greater fullness in overall cosmetic effect. Hair thickeners do not stimulate hair growth but they may produce a temporary cosmetic improvement.

  • Are there deceptive before and after pictures? These may come in several forms: 1) different lighting conditions, most commonly the "after" picture being the darkest 2) different angles- this is particularly common with the top view of the scalp used as the "before" because the hair looks thicker as the patient lifts his head, showing more of the face and less of the top of the scalp 3) different distances from the camera, the "after" picture often being at a greater distance 4) the picture being of a condition or disease different from that being promoted- alopecia areata and telogen effluvium (usually postpartum) are 2 commonly used diseases because of their tendency to spontaneously resolve.

  • Is more than one "miracle" drug being advertised? A single miracle is hard to come by, much less two.
  • The best way to judge hair restoration product claims is on the basis of objective criteria such as the results of FDA-approved clinical trials. In assessing product claims, remember two famous quotations:

  • From showman P.T. Barnum-"There's a sucker born every minute".

  • From philosopher George Santayana-"Skepticism is the chastity of the intellect".