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Fox story fails to dent dubious hair-growth helmet claims

Rating

4 Star

Categories

New helmet technology helping patients tackle baldness

Our Review Summary

theradomeThis story describes a fairly new laser device that is said to promote hair growth. Although other laser products for this purpose exist, this is the first of its kind to be wearable. This may make it more likely that those with hair loss will continue using the device.

While the story does a fair job of addressing our criteria and includes reasonable comments from an independent expert, it falls short in several important areas and is only marginally satisfactory in others. For example, it fails to provide any critical analysis of the claim that 97% of study participants benefited from use of the product. The story also oversells the novelty of the device, and doesn’t mention several more established approaches that may be helpful for treating hair loss.

 

Why This Matters

Millions of people experience hair loss, according to the American Academy of Dermatology. The causes of hair loss are numerous, and not all treatments work for all people. Some people, especially women, experience low self-esteem with hair loss. Thus, a hair loss treatment that is safe, easy-to-use, and relatively cheap could prove to be a valuable option.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story states that Theradome costs $895. That’s accurate, and the helmet can be purchased online.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The only sentence in the Fox News story quantifying benefits is this line: “According to the Theradome website, 97 percent of subjects saw positive results after 26 weeks of treatment and they reported a 20 percent increase in hair growth.”

But what do they mean by “positive results” and “20% increase in hair growth”? How was hair growth defined and how was it measured? And how many people were in this Theradome trial?

We couldn’t find any discussion of these specific claims on the Theradome website, but the manufacturer does state the following in its FAQs: “In our clinical studies ALL participants benefited from the Theradome™ and experienced one or more of the following: 1. Slows down and minimizes hair loss. 2. Doubles the follicle size of existing hair. 3. Grows new, healthy hair.” And in its “What to Expect?” section, Theradome says: “*Results may vary from person to person.”

We couldn’t find any published studies supporting these claims. If the helmet does indeed help more than 97 percent of subjects, why are there so many bad reviews of the product on Amazon?

It is clear that a more critical approach in evaluating Theradome’s claims and clinical trials was necessary.

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

Dermatologist Dr. Schweiger mentions he is confident that Theradome is safe “since the lights are low energy and are not UV.” This statement could have been explored more thoroughly, but it does appear that the low-energy lasers used in this product are widely considered safe. A review of similar low-energy lasers used for pain relief had this to say: “With the exception of prolonged, direct exposure of the eyes to the laser beam, the safety of these low-energy devices does not seem to be a major issue.” We’ll give the story a pass here. Higher-energy lasers used for surgical procedures have much greater potential to cause harm.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story does not address any limitations of the referenced studies, which were conducted by the helmet manufacturer Theradome, as stated on its website. Since these studies are not made public, it’s difficult to point out what these limitations actually are. What was the sample size? Was Theradome being compared to any other treatment or a placebo? We also couldn’t find any other studies on the Internet supporting Theradome’s claims.

Regarding laser devices in general, the American Academy of Dermatology states: “Because the FDA classifies these products as medical devices, the products do not undergo the rigorous testing that medicines undergo. The long-term effectiveness and safety for these devices are not known.”

Does the story commit disease-mongering?

Satisfactory

The story does not engage in disease mongering.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story quoted two expert sources: the CEO and inventor of Theradome, Dr. Tamim Hamid, and an independent dermatologist, Dr. Eric Schweiger, who is also a celebrity doctor, with appearances on major network news shows.

Schweiger’s comments in the story are reasonable, but it was a lost opportunity for Fox News to analyze Theradome’s bold claims. Schweiger could have provided a more critical perspective on helmet hair-growth technology and helped walk readers through the evidence that purportedly supports its effectiveness.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story quotes a patient who implies the existence of alternatives when she says, “I was using creams that were developed for the coats of animals when they had problems with their coat. I was using oils developed for animals that were dangerous to use and smelled really bad.” She also mentions steroid injections, and the story references “conventional baldness remedies” in passing without identifying what those remedies are. While this is hardly a complete accounting of the legitimate alternatives to Theradome or laser devices, we’ll give the benefit of the doubt to the story for at least nodding in the direction of alternatives. According to the American Academy of Dermatology, treatments for hair loss include medications like minoxidil, finasteride, and corticosteroids, as well as procedures such as hair transplantation, scalp reduction, scalp expansion, and scalp flaps.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story states that Theradome is cleared by the FDA and lists a price of $895. This conveys the (accurate) impression that the product is available, although it doesn’t specify where consumers could obtain this laser helmet. In addition, stating that the device is “cleared” by the FDA will likely mislead many readers into thinking that the agency has vetted the company’s claims of efficacy. FDA “clearance” means only that the device is deemed “substantially equivalent” to a device that is already legally marketed for the same use. It doesn’t provide any assurance that the product works.

Does the story establish the true novelty of the approach?

Not Satisfactory

The story quotes Dr. Hamid suggesting that he was part of a group that “discovered” the fact that lasers can regrow hair around 2009. He says his discovery was based on animal research that had been lying dormant since the 1960s. But Dr. Hamid’s timeline seems to be off. A competing laser comb that treats hair loss was cleared for sale by the FDA in 2007, and there are references to lasers promoting hair growth in the literature at least as far back as 2005. This suggests that any “discovery” about this application for lasers occurred well before 2009 and wasn’t unique to Hamid. The story does note that there are other laser products that consumers could use, like brushes, combs and other hand-held devices. And it notes that Theradome is the first of its kind to be wearable, since consumers don’t have to hold it up to their scalps, according to Schweiger. But the impression the story gives — that Hamid (and, by extension, Theradome) was the first to harness this technology for the treatment of human hair loss — is not accurate.

Does the story appear to rely solely or largely on a news release?

Satisfactory

Since the story features an independent perspective from an interview, we can be sure it didn’t rely excessively on any news releases.

Total Score: 7 of 10 Satisfactory

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