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 that 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 from 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 products claim that asks for your 100% gullibility should be suspect.
  
  
• What proof of 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 and effectiveness, and they may come from paid employees. What you should want to see is documented proof that the hair restoration products has been tested in clinical trials (see below) and approved by the U.S. Food and Drug Administration for use as indicated in products packaging.
  
  
• Has the products 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. In brief, clinical trials are scientific investigations to determine whether a drug is safe and effective when used at the recommended dose, to treat a specific condition (for example, a 20 milligram dose of an antibiotic effectively treats sinusitis with minimal side effects).
  
  

  This section tells you more details about 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 and 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 large number of human study subjects and more sophisticated study of effectiveness. Successful 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 trials (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 finasteride and minoxidil (see Medical Treatments for Hair Loss), some people in the control (placebo) group reported new hair growth even though careful measurements are photographs showed that no new hair had been grown. This demonstration of "wishful thinking" indicated 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. 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 in clinical trials.

  
  
  
• Does product advertising include the listing of any side effects associated with 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 product 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 skeptical.
  
  
• Is medical examination recommended before use of the product? While inherited predisposition for hair loss, called 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 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 in an advertisement? Common deceptive practices in "testimonial" advertising include (1) different lighting conditions for the "before" and "after" photos, (2) different angles on "before" and "after" photos, so that "after" is shown to greater advantage, (3) different distances from the camera for "before" and "after" photos, and (4) using a patient with a condition different than the androgenetic alopecia that the advertised product supposedly treats-for example, using a patient with a condition such as alopecia areata that often spontaneously resolves.
  
  
• Is more than one "miracle" drug being advertised-for example, buy the advertised "miracle" product and get another one "absolutely free".

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."

We hope this information helps you avoid becoming a victim of slick advertising and helps you find effective solutions.