Over the history of civilization, there have been so-called "Miracle Cures" for hair loss. Over the years, solutions professing the cure for hair loss have been sold in the form of tonic, spray, creme, and foam, and are still sold today. A "cure for baldness" has long been a profitable claim for the salesmen for these kinds of products. Claims usually made without the scientific proof required today. The traditional "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 customers gathered around the wagon of a travelling salesman to hear his pitch. While it is true that today's consumers are more knowledgeable because there are more problems and more potential solutions on the market today. It is also true that the product information usually incorporates today's advanced knowledge into the product feature and benefit claims. While the traveling salesman might have based his claims on "secret knowledge" product claims today are more likely to use words taken out of context from the sciences of genetics and biochemistry to link 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 only sure way to be sure of claims made by any product is to research the claims made and determine if they are verified by a non-biased, third party research organization. Common sense and perhaps a bit of skepticism are also good filters for all claims made for personal-use products, including products claiming effectiveness and safety in hair restoration. You can apply some "to good to be true" tests:
A product that claims to stimulate the growth of hair is a product with a potent physiologic effect. Does the product actually stimulate the growth of hair in a significant percentage of persons who use it? If so, does it do so safely with minimal side effects?
To check claims for validity, you need to know the criteria for FDA-approved clinical trials. Clinical trials are medical investigative studies in which human beings are the test subjects, and are 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. Successes 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.
Note: 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.
