As the percentage of women who suffer hair loss grows, so too will the number of products sold to women for their hair loss. These products, hawked by late night pitches via infomercials, prey on those who may be concerned about recent or dramatic hair loss. We at ISHRS prescribe to the “if it sounds too good to be true, it probably is” theory and urge caution when considering these products.
Advances in surgical and microsurgical technique over the past 50 years make surgical treatment of hair loss a possibility for many of the millions of Americans. Advances in understanding of the biochemistry and physiology of hair growth and hair loss make medical treatment of hair loss a scientifically documented reality for the first time in history. Efficacy of surgical and FDA-approved medical treatment is confirmed in clinical trials (See Medical Hair Restoration Treatments and Nonsurgical hair loss treatment options for more information). Scientifically confirmed success of surgical and medical hair restoration is a phenomenon of recent decades. Undocumented claims of "miracle cure" for hair loss have been with us for much longer—at least since the days of the patent medicine salesmen of the 19th Century.
How can you sort out the undocumented claims of "miracle hair loss cures" from the scientifically documented facts about hair restoration? We hope the following explanation can help you make informed decisions about treatment for hair loss. Read on about "Miracle Cures" for Hair Loss: You Can Put Them to the Test Even Without Using Them.
One of the burgeoning "miracle cure" fields is hair restoration, advertised in print, on television and over the Internet.
How can you check out these products to determine if they will do what is claimed for them?
One way is to accept the claims at face value, purchase the products, and try them.
The other way is to approach the claims with a healthy skepticism and apply some "truth-of-claims tests" to determine if a product appears to be what the seller promises:
Do claims use words such as "miraculous", "amazing", "sensational", "scientific breakthrough", "developed by doctors"?
These are classic Snake Oil claims and your skepticism should go into high gear. Any product claim that asks for your 100% gullibility should be suspect.
What proof of product effectiveness is offered?
If the only "proof" is anecdotal—e.g., a testimonial that "I used Product X and had a full head of hair in 30 days"—be skeptical. So-called testimonials are not scientifically valid proof of effectiveness. What you want to see is documented proof that the product has been tested in clinical trials (see below) and approved by the U.S. Food and Drug Administration (FDA) for use as indicated in product packaging.
Has the product been approved by the FDA?
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 hair growth in a majority 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.
Has the product been tested in 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, efficacy and safety. There are several types of clinical trials but the "gold standard" for unbiased study results is the randomized, double-blind controlled trial (RCT).
In the RCT, study subjects are randomly assigned to a study group or control group, and neither the investigators nor the study subjects and controls know who is receiving the treatment under investigation 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 finasteride and minoxidil a significant percentage of people receiving placebo 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 remedies.] RCTs are also designed to assure that the number of people being studied will yield a statistically meaningful result. Product effectiveness and product 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 the clinical trials are conducted. The studies are conducted by recognized medical investigators in hospitals and medical centers, or by physicians in private offices independent of any involvement by the firm paying for the trials. If a product wins FDA approval, it must be marketed within FDA guidelines and claims cannot exceed the findings of clinical trials. As of June 2001, two hair-restoration agents have been approved by the FDA—finasteride (Propeciaâ ) and minoxidil (Rogaineâ ). See Nonsurgical hair loss treatment options for information about these treatments.
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 of hair growth--had no side effects. While side effects may be minimal and may be experienced by relatively small numbers of people, potential users of the product should be aware of the potential for side effects. If product advertising fails to mention side effects or claims no side effects, be skeptical.
Is a medical examination recommended before use of the product?
While inherited tendency for hair loss is the most common cause of baldness in the U.S., there are other causes that may require medical treatment prior to hair restoration (See About hair loss for more information). Surgical or non-surgical hair restoration should not be undertaken prior to examination by a physician specializing in hair loss and restoration. Be skeptical of a product claim that (1) omits recommendation for use under medical supervision, or (2) says you can use the product without medical supervision.
"Miracle cures" for hair loss typically have little or no scientific basis for their claims and no controlled trials of safety and efficacy. On the other hand are science-based medical treatments for male and female pattern baldness that have shown promise in limited studies, but to date have not been proven safe and/or effective in large controlled trials acceptable for FDA approval. Some of these over-the-counter treatments are potential candidates for future approval by the FDA. Claims of effectiveness for these treatments usually cannot be documented by reference to clinical trials; claims are more likely to be anecdotal.
Is the product a "hair thickener" rather than a hair restorer?
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 strand and create an effect of "a fuller head of hair". Hair thickeners do not stimulate hair growth but they may produce a temporary cosmetic improvement in thinning hair. A ISHRS physician can counsel you regarding the use of a hair thickener to complement hair restoration.
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 and subsequent FDA approval. Consultation with hair restoration doctor is the best first step when you are considering hair restoration.