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Wednesday, July 17, 2024

‘Hardcore science’ or ‘just a sticker’ – do anti-anxiety patches actually work?

This month, Meghan, the Duchess of Sussex, was photographed wearing a “biosignal processing disc” affixed on her left wrist. The product, sold by a company called NuCalm, promises to transmit signals to the brain that makes the wearer feel peaceful and relaxed. NuCalm has reportedly been used by sports coaches and active military members to combat the high-stress lifestyle that comes with their jobs.

The brand’s website is filled with so much jargon that it should be studied in every marketing class: allegedly, NuCalm’s “neuroacoustic technology” harnesses oscillations, frequencies and vibrations to change a person’s brain waves. The “NuCalm experience” is reportedly “fast-acting, deep, and long-lasting”.

NuCalm sent me a pack of stickers free of charge, which I used for this story. After I unwrapped the package, these discs looked just like the type of stickers you’d find at a toy store. There was no extra heft or weight. They really were just stickers, as far as I could tell.

“It does indeed just look like a sticker,” Matthew Burke, a cognitive neurologist and assistant professor at the University of Toronto, told me. “NuCalm is not actually claiming that they’re processing signals from the body such as heart rate or skin conductance and analyzing that data. They’re just saying that these stickers pick up on bio-frequencies, which somehow exist, and fixing those.”

If one is to believe the NuCalm website, and its bullish CEO, Jim Poole, this “technology” is something like a miracle cure, providing the type of anxiety-relieving effects some people take pills for. “Change your mental state with no drugs,” screams a banner on the website.

NuCalm’s primary service is a system that involves downloading an app, where users can find ambient, spa-sounding music. The idea is to listen to it with an eye mask on, while wearing the stickers, for 10 to 15 minutes. The result is supposed to give you the best nap of your life – 20 minutes of NuCalm rest is akin to about two hours of regular sleep, according to NuCalm.

The system is based on NuCalm’s original product, a $6,000 FDA-approved medical device sold to doctors, which pulsed micro-currents into the cranium to reduce stress. According to Poole, the company decided to pivot to selling its app subscription and stickers in an effort to reach more people.

Now, Poole advises using the stickers during a session with the ambient sound app. “The disc is an add-on,” he said. NuCalm used to sell anti-anxiety tablets and cream, but the company settled on stickers after years of testing.

If you don’t want to use the full system, the sticker can be worn by itself, as Meghan did. Be warned, as the sticker’s packaging told me: “Do not wear the NuCalm while driving or operating machinery.”

Can a little sticker be Xanax-grade? Most of us with an ounce of critical thinking skills might think: probably not. Guy Leschziner, professor of neurology and sleep medicine at King’s College London, told the Telegraph that the brand’s promised results “stretch the realms of credibility”.When it comes to alternative health products, I am not a hard-nosed cynic. I’ve studied my birth chart. I love talking about my pelvic floor. But when I slapped a sticker on my wrist, I felt nothing – no vibe shift, no wave of zen, just the slight annoyance that comes with feeling totally punked.

It’s easy to dismiss these stickers as merely pointless. But I am one of the 40 million adults in this country who lives with an anxiety disorder and has to navigate the hellscape that is the American mental health care system. It’s nearly impossible to find a good therapist who is accepting clients these days – and I’m lucky enough to have a pretty decent insurance plan. I don’t take kindly to brands that exploit this crisis to make a buck. Giving someone who’s just had a panic attack a stress sticker feels akin to asking them if they’ve ever tried meditating or taking a few deep breaths. We need something that works.

Christy Harrison, a journalist and author of The Wellness Trap, which critiques the self-help industry, agreed with me. “These kinds of companies are preying on people’s vulnerabilities – whether intentionally or not – because there’s a real void in our healthcare system for addressing issues of mental health,” she said.

One of NuCalm’s most enthusiastic promoters is Tony Robbins, the infamous self-help guru who became a millionaire through hawking cheesy personal development seminars that often involve guests walking barefoot over hot embers or coals.

NuCalm’s website is full of psychobabble that felt intentionally misleading, like when you ask a salesman a direct question and he instantly changes the topic. But if you can manage to follow the website’s claims, everything sounds pretty impressive. That includes the assertion that Harvard Medical School researchers found using the system for 20 minutes can “give you the benefits of over 2 hours of restorative sleep”.

I spoke with Chung-Kang Peng, who directed the lab that ran that study. He said the results had never been published. Peng did think the relaxation effect that came from using NuCalm was “quite impressive” But the study had too small of a sample size to be conclusive, so it was never published.

How small? About 12 people, Emma Cui, who ran the study as a postdoc student, told me. She can’t remember the exact number, though, because this study took place 10 years ago.

Peng’s team was also studying the older version of NuCalm, which included cranial electrical stimulation – not the subscription as it’s sold now, or the stickers. Anyone who doesn’t read NuCalm’s website too closely might miss this fact, and think that the Harvard study relates to the brand’s current offerings.

The brand also says that its product produces “clinical-grade results”. But what does that mean, exactly? Next to nothing, says Rina Raphael, author of The Gospel of Wellness: Gyms, Gurus, Goop and the False Promise of Self-Care, because “clinically proven” is not a regulated term. “Anyone can use that term for basically anything,” she said. “It does not mean that their product has been proven to be effective.”

Raphael refers to NuCalm’s barrage of official-sounding data as “science washing”, which is when companies attempt to validate their products with impressive-sounding but meaningless claims.

“The average reader sees that and thinks, ‘Wow, look at all this evidence,’ but that doesn’t necessarily mean that their exact product is effective,” she added.

I called Poole, the brand’s CEO, and asked him to put in simple terms how frequency stickers work.

“I can tell you with great confidence: 99%of the human population still doesn’t understand this,” Poole explained.

Poole is not a neuroscientist. He does have a BA in psychology and says he worked in mental health facilities for five years before getting an MBA. He then worked on Wall Street doing mergers and acquisitions of medical device companies. Poole took NuCalm over from Dr Blake Holloway, a naturopath, 14 years ago. (Holloway died in 2020.)

Explaining the product, he said: “We’re gonna go hardcore, high-level science.” Inside the sticker, Poole said, is a Tesla coil. That’s a device invented by Nikola Tesla in 1891 that produces high voltage. The sticker also has a “metallic design” that Poole describes as a “six-layer multi-wave oscillator”. This holds the sticker’s “energy source”.

According to Poole, said energy taps into the “pericardium meridian”, a pathway that, according to traditional Chinese medicine (TCM), flows to the heart. The disc, he says, presents the brain with Gaba, a neurotransmitter known to produce a calming effect on the body. (People seeking an alternative to pharmaceuticals sometimes buy Gaba supplements to reduce stress, though there’s limited evidence this works.)

In the middle of this rundown, Poole interrupts himself, scoffing: “I can’t imagine any of this is print-worthy for the consumer, but I’m trying to help you understand what we do, OK?”

I agree with him: this all sounds like gibberish. Poole may think that he’s testing my intelligence with his product description, but it feels more insulting to me. Before shelling out $80 for a pack of stickers, customers deserve a coherent explanation of how something works.

Also: I cut the sticker in half, and saw no visible coil.

Poole insisted that NuCalm has been “working with the Department of Defense for 13 years”, though did not provide corroboration of this claim to me. He also said that he lectures at the Pentagon and trains FBI recruits at Quantico. Representatives for the FBI and DoD declined my request for comment, although the Guardian has learned that NuCalm is not covered as a health benefit under the DoD’s plan.

A representative for the military operational medicine research program (MOMRP) said its department “is aware of NuCalm” but was unable to comment. “This most likely [means] MOMRP is not involved with the product,” the representative added.

It’s unclear how these agencies might use NuCalm – whether they are working with the original FDA-approved medical device, or the current system of stickers, ambient music and an eye mask.

Poole also said that FedEx pilots used NuCalm to improve pilot safety and reduce fatigue. A representative from the Air Line Pilots Association, a pilots’ union, said that FedEx had worked with NuCalm to offer the app system to their pilots. This rep added that the union does not officially endorse NuCalm.

NuCalm claims that it has been used in “2,000,000 surgical procedures as a replacement for general anesthesia without a single reported adverse event”, which, again, I could not confirm.

One small study from 2019 compared the use of NuCalm as an alternative to anesthesia in rhinologic procedures, saying it “may enhance pain control and anxiety management”. There are dentist offices around the country that use NuCalm and cranial electrical stimulation to help reduce pre-appointment jitters.

Burke, the neuroscientist, believes that a wellness sticker could potentially help someone chill out – though not for the reason advertised.

“If these products work, it’s almost certainly because of the placebo effect,” he said. “The likely explanation is that these stickers help people through the psychological intervention of making them feel like they are being treated.”

When people are put in a state where they expect to get better, it changes the brain biologically. The placebo effect kicks off a reaction that releases endorphins and dopamine, two neurotransmitters known for making people feel good. Those effects won’t cure anyone – a patient with cancer will still have cancer – but they might feel a little less depressed, more hopeful, in less pain.

Is that such a bad thing? Burke warned that when people feel good because of a placebo, they’re less likely to seek out treatment that might work more permanently.

“If someone believes that their bio-frequencies are out of whack, they might not address some of the actual underlying factors that might be driving their depression, insomnia, or pain,” Burke said.

Dr Tara Swart, a neuroscientist and senior lecturer at MIT Sloan School of Management, told me it was a “red flag” that NuCalm doesn’t list the ingredients in its sticker. (On the site, it says the patch is made of “a proprietary blend of inhibitory neurotransmitters”.)

“I just can’t trust anything that isn’t open about its ingredients,” Swart said. “The website is confusing, because it says the patch is using frequencies, but it also says it’s releasing a substance through your skin. I’d like to know what that substance is. Why the secrecy?”

Kristofer Rau, an assistant professor of neuroscience at Virginia Tech Carilion School of Medicine, was similarly skeptical. He found it difficult to make sense of NuCalm’s meandering explanation of how the stickers work.

“NuCalm’s site has a lot of descriptions of biological mechanisms and various neurotransmitters, and there’s a lot of accuracy in those descriptions, but they tie in a lot of wild assumptions about what their product does,” he said. “That’s what a lot of biotech companies do when they’re trying to sell their stuff. Without any specifics or better research, it comes off as quackery.”

I wanted to speak to a true NuCalm believer, so I found Kacie Corbelle, a 37-year-old hair and makeup artist who lives in Boston, on TikTok. She spent $2,000 on her NuCalm subscription back in 2020, when she was stressed out and unemployed due to Covid lockdowns.

Corbelle’s friends describe her as an “al dente hippie” – not entirely a crunchy, granola type, but certainly willing to venture outside the mainstream. She’s a proponent of “biohacking”, a Silicon Valley buzzword for “optimizing” your body in hopes of living better and longer.

“My family literally doesn’t understand,” she said. “I know it sounds crazy, but when I use it, dude, I feel like I go to a different planet, a different universe.” Corbelle lost 110lb in a year, which she credits in part to NuCalm.

Part of what drew her to the system was the suggestion that “high-powered people” rely on it to get things done. “I think a lot of CEOs will use it during lunchtime, and I’m just this makeup artist from Boston,” she said

NuCalm’s marketing touts testimonials from Jim Kwik, a “brain coach” who sells speedreading workshops. Terry Tallen, a 1970s college football star and current CEO of his eponymous investment group, is also a fan. He helped train the Golden State Warriors in how to use NuCalm during the 2018 season.

In a statement sent to Page Six, Poole added that “hundreds” of celebrities rely on his company, but he would not share any names to respect their privacy. “If an athlete or celebrity wants to share, that is their prerogative,” he added.

Even before Goop, pseudoscientific products have long relied on the super-rich to legitimize their products. Robert MacDougall, a professor at Ontario’s Western University who studies pseudoscience, said that the discovery of electricity in the late 19th century coincided with the dawn of the electrical medicine fad, when it was en vogue to carry around belts that pulsed mild currents through the body. Some men wore these devices near their groin, in an attempt to increase their sexual potency. Patients were usually part of the Gilded Age’s aristocracy: it was believed that members of the upper class had finely tuned nervous systems and were more susceptible to mood disorders.

“In a weird way, these were almost fashionable disorders, which could be a status symbol: it was a sign that you were highly civilized and evolved,” MacDougall said.

In the 1930s, a San Diego optics engineer named Royal R Rife claimed that a machine he invented used electromagnetic waves to destroy bacteria. He went so far as to say his device cured 15 “hopeless” cancer patients in 30 days. The American Medical Association banned the use of his beam ray, which his supporters said was part of a vast conspiracy to cover up his supposedly brilliant work. To this day, there are contraband clinic operators who offer Rife machine treatment.

In 1996, a Washington state couple were convicted of medical fraud and spent time in prison after posing as doctors and fraudulently claiming their Rife machine could cure cancer. At least one patient died in their care after opting for the Rife treatment over a surgery that could have saved his life.

Richard Eaton still believes in Rife’s machine. He is the president of AlphaBio Centrix, another stress patch company he says his father founded after working on a contract to produce space suits with Nasa. (The contract, he says, fell through, and the agency never actually used the product.) Eaton counts Rife as a pioneer in the bio-frequency industry who was unfairly targeted.

“His machine worked, but big pharma could not make money off of it, so they went back to pills,” he said. I told him that sounded conspiratorial. “A little bit,” he said. “But I don’t think so.”

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