Researchers Question Efficacy Of Brain Balancing
MILWAUKEE — Roxanne Carlson vividly remembers the shock she felt three years ago when a psychologist said her son Levi had issues he might never overcome. He’d need to get a job coach, the psychologist told her, and may even have to spend his life on government disability.
“We were mortified,” she said in her home in Marinette. “We were like, ‘You’ve got to be kidding. This is the answer we’re getting?'”
Roxanne and Perry Carlson had known for five years — ever since they adopted Levi, then 10, and his brother Anthony from the Philippines — that Levi had problems. He was behind many of his peers, academically and socially. He had trouble returning affection, couldn’t process language quickly and struggled just to make conversation.
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But after five years of frustration during which school administrators were unable to help and medical professionals seemed stumped, the Carlsons weren’t about to give up. “God did not create him for that,” Roxanne said. “Perry and I were both like, ‘That’s just not happening. We will find another avenue.'”
So on the advice of a friend, they looked into the Brain Balance Achievement Centers location in Mequon, part of a national franchise operation that has nearly 80 sites across the country. It claims its $5,000 three-month, medication-free program can help children like Levi by treating an imbalance in the brain, which the company contends — contrary to the opinions of multiple experts — causes a plethora of learning disabilities including attention deficit disorder, attention deficit hyperactivity disorder, Asperger’s syndrome, dyslexia and Tourette’s syndrome.
Initially, the center also claimed it could treat the full range of autism spectrum disorders but has since backed away from that.
Clinicians and researchers from leading institutions in Wisconsin and around the country dispute Brain Balance’s claims regarding both the causes of learning disabilities and its effectiveness in treating them, citing a lack of rigorous research and a fundamental mischaracterization of neuroscience.
“I always tell people, ‘If you’re going to engage in an alternative treatment — even if it’s not expensive and not risky, but even if it just takes a lot of your child’s time and energy — remember, that’s time and energy you’re not going to get back for an appropriate treatment,'” said Thomas Frazier, a psychologist and director of the Cleveland Clinic Center for Autism.
The Carlsons, though, were at wits’ end, so they dipped into their 401(k) savings to pay for their son’s treatment, which cost $10,000 because Brain Balance recommended a six-month program. Roxanne estimates the family also spent $5,000 for gas just to make all the 2 1/2-hour trips between Marinette and Mequon.
The results, she said, validated their efforts: Levi, now 18, has more therapy ahead, but he’s looking at attending college soon and is doing much better in his classes, no longer getting C’s and D’s. The leaps he has made in his ability to communicate with others have been the most remarkable part of his transformation, she said.
“For us, that was worth $10,000,” Roxanne said.
Testimonials vs. research
Robert Melillo, a chiropractor who opened the first Brain Balance center on Long Island nine years ago, points to satisfied customers like the Carlsons as evidence that the program he created is working. But the lack of a truly independent, rigorous scientific study backing up his company’s extensive claims troubles many scientists.
Several researchers told the Journal Sentinel that other factors could explain the improvement attested to by handpicked customers, and that without a well-designed study, it would be impossible to know if the program was effective.
Some wonder if the company is preying on families with children who have learning disabilities by selling them a “cure” that’s not backed up by scientific evidence. Brain Balance is a big player in an industry that thrives on the uncertainty surrounding the causes and treatments of learning disabilities, and the desire of parents to ensure their children have the best lives possible.
The company’s reliance on testimonials in its marketing is a significant red flag, said Edward Hubbard, the director of the University of Wisconsin-Madison Educational Neuroscience Lab.
“When basically their entire advertising is built on testimonials, it tells us that they don’t have a strong evidence base to back it up,” he said.
Two peer-reviewed papers have been published on the program’s effectiveness in cases of ADD and ADHD: one in 2010 in the International Journal of Adolescent Medicine and Health and the other in 2013 in Frontiers in Public Health. Neither study contained a randomized control trial, and no published research exists on the program’s efficacy in treating other learning disabilities.
Melillo is listed among the co-authors of the 2010 paper.
Both papers show statistically significant improvements in the assessment scores for 122 ADD and ADHD children participating in the program. The only difference in the results of the two studies is that the 2013 study added a “control” group of 22 children who didn’t go through the treatment.
“I don’t know why you would have a control group in one paper and not the other,” said Amy Van Hecke, a researcher and developmental neuroscientist who founded and directs the Marquette University Autism Clinic.
The 2013 study’s claims of independence also raised questions. The study didn’t list Melillo as a co-author and claimed that it was completely independent of Brain Balance despite its reliance on data from the 2010 study.
The issues with the 2013 paper extend beyond the replication of data and questions about its independence. Differences between the control and experimental groups make it difficult to draw significant conclusions from the studies, said Benedetto Vitiello, an ADHD expert and psychiatrist at the National Institute of Mental Health who helps test treatments for their efficacy.
“They did an expensive amount of work in terms of generating data, and it’s probably the best you can do in clinical settings where you need to take what you have, but it is not really an experiment, just because there are so many different variables that are not controlled,” he said.
Citing a lack of evidence, the Wisconsin Department of Health Services Treatment Intervention Advisory Council, which recommends treatments for coverage under the state’s Medicaid plans based on their efficacy, gave Brain Balance its second-lowest rating out of its five-tier system.
None of this proves that the program doesn’t work. But because other evidence-based treatments exist, all of the scientists interviewed by the Journal Sentinel said they wouldn’t recommend this treatment.
Melillo and Jeremy Fritz, the owner of the Mequon center, say their program is backed by plenty of evidence in the form of research papers and internal data, even if it hasn’t reached mainstream acceptance yet. The costs of the program are still less than some parents have to pay for mainstream treatments, they said.
Asked why the company — which started franchising in 2008 — has been expanding rather than seeking independent verification of its methods, Melillo said he had trouble securing funding for research and wanted to be sure the treatment was available as broadly as possible without being hampered by scientific bureaucracy.
“We know that it’s making a difference, and to not expand and to help as many families as possible, that to me is unethical,” said Melillo, who specialized in chiropractic neurology and has a master’s degree in clinical rehabilitation neuropsychology.
Frazier, who oversees clinical trials at the Cleveland Clinic’s autism center, said he has “never run into a situation where I had a really, really promising treatment and couldn’t find some source of funding to do a fairly rigorous trial for it.”
Even Gerry Leisman, an Israel-based neuroscientist and longtime research partner of Melillo’s, said he wished the company had done more clinical trials before expanding, although he had no issue with the way the company has developed and marketed itself.
“Should there have been clinical trials before they opened their doors? The answer is yes,” Leisman said.
The number of Brain Balance Achievement Centers built or in development is set to reach about 100 by the end of the year.
An imbalance in the brain
Erik Aulenbacher, 36, a plumber from Hartford, and his wife, Julianne, 33, a nurse, tell a story that’s very similar to the Carlsons.
Although their daughter, whose name they requested be kept out of this article, was never medically diagnosed with a learning disability, they and some of her teachers could tell that the 4-year-old just wasn’t connecting as well as she should. Traditional treatments like speech and occupational therapy weren’t accomplishing enough, the couple said.
“The real eye-opener I guess was when you have a teacher say, ‘Did you ever think your child has autism?'” Erik said.
When they visited the Mequon Brain Balance center, Fritz, who like Melillo is a chiropractor, told them in great detail about a brain imbalance in which one side of the brain dominates the other, causing the specific behaviors attributed to learning disabilities like autism.
Melillo says it can be addressed through exercises designed to stimulate the weak half. His program combines physical and cognitive activities to activate under-performing parts of the brain. Activities such as hopscotch, balancing, reacting to different stimuli and calling out colors, numbers and shapes are all employed during half of the session.
“Utilizing the balance and spin and coordination, what it does is it requires more coordination between their brain and body, so you’re building each of those systems in a sensory-motor way,” Fritz said.
The second half of the individual sessions incorporates many of these hemisphere-specific simulation techniques in conjunction with academic instruction of subjects like math and reading. Assessment tests are taken at the beginning and throughout the session to measure progress.
Fritz emphasized that the program’s focus is as much on what happens at home as in the center. The program requires children to do some of the exercises at home, make changes to their diets and engage in more physical activities to help stimulate the brain. It also asks parents to interact more with their children.
Brain Balance’s pitch is especially appealing to families like the Carlsons and Aulenbachers whose children have autism-like issues without the diagnosis. They received much more support from Brain Balance employees than traditional medical professionals, they said. Fritz followed up with them often, displayed exceptional enthusiasm about children and, most importantly, had answers they believed.
“They spent so much more time with us — one-on-one, over the phone, in the office, everything,” Julianne Aulenbacher said.
Fritz estimated that half the children who go through the Mequon Brain Balance center are like Levi Carlson and the Aulenbachers’ daughter: children who have academic, behavioral or social issues but aren’t diagnosed. Parents are looking for results and don’t want to medicate their kids to get them, he said.
“When we get change and we have those testimonials, that to me has more value than research,” Fritz said.
Scientists, though, emphasized that learning disability treatments need to be tested carefully because of a range of variables that could make a treatment appear more effective than it actually is, especially with autism.
“Autism has one of the highest, if not the highest, placebo effect of any neuropsychiatric disorder I’ve ever been engaged with,” Frazier said.
Between 50 and 100 children go through the Mequon center per year, and although Fritz declined to provide exact revenue figures, the center takes in at least $250,000 per year based on those numbers.
Chip Miller, Brain Balance’s CEO, said the company’s centers are on track to see between 4,500 and 5,000 children nationally this year. At $5,000 per student, total revenue would be at least $22.5 million, with the main company taking at least $1.8 million in royalties.
Left vs. right?
Melillo’s claims about the underlying causes of learning disabilities also were challenged by researchers, who said they didn’t match up with the current understanding of how the brain works.
Melillo cited a study he, Leisman and others published in a 2013 edition of a leading autism journal, the Journal of Autism and Developmental Disorders. The study showed that lower brain activity was recorded in the right hemispheres of brains of children with autism, although when Van Hecke read the article, she said that while it presented interesting ideas, it was far from conclusive evidence supporting the Brain Balance program or the mechanisms it attributes to learning disabilities.
The general understanding in the mainstream scientific community is that autism has complex genetic and environmental causes that affect brain development, Frazier and Van Hecke said.
“There is no evidence that I’ve seen that’s compelling and replicated to suggest that there’s a dominance of one hemisphere over another,” Frazier said.
There is evidence to suggest that the brains of children with autism have connectivity issues, but they are typically over long distances or short distances in the brain rather than only between hemispheres. Connectivity issues have come up in ADHD research, but the research is far from conclusive and doesn’t point to hemispheric issues, Vitiello said.
Leisman conceded that Brain Balance oversimplifies the connectivity issues in the brain and added that the idea of hemisphere-specific issues in the brain isn’t supported by research.
“I wish their corporate folks would be a little bit more careful with using sound bites,” he said.
Still, while mainstream treatments for autism and ADHD have come a long way in recent years, the options are limited.
For children with autism, applied behavioral analysis, a time-intensive (30 to 40 hours per week) behavioral therapy, is the only evidence-based treatment option. The therapy focuses on conditioning children to do certain behaviors and avoid others. Derivatives like the Early Start Denver Model have also been proven to be effective.
“We know that the more intensively (the therapy is) delivered, particularly in young children, the more effective it’s going to be for improving functional skills, adaptive daily living skills, communication, decreasing interfering behaviors and decreasing challenging behaviors,” Frazier said.
There are no evidence-based treatments for autism that rely on medications, although certain drugs may be prescribed to treat specific symptoms.
Evidence-based, medication-free behavioral therapies are available for children with ADD or ADHD, Vitiello said. Certain medications like Ritalin can be used to treat symptoms of ADHD but aren’t meant as cures.
Educators are working on addressing some of the gaps in services that the Aulenbachers and Carlsons experienced, said Hubbard, the educational neuroscientist. Schools have classically applied a “wait to fail” model where struggling children weren’t given treatments until they dipped below a certain level. The model is shifting to a “response to intervention” model where those children are given broad-based interventions and placed appropriately based on how they respond to the intervention.
Hubbard said some school districts haven’t adopted the newer approach because of financial constraints.
In the meantime, Brain Balance — despite all the questions about its effectiveness — has centers popping up all over the country. Miller, the company’s CEO, said that is proof enough of the program’s effectiveness, pointing to the 40 percent of franchisees who are former Brain Balance customers.
The Carlsons and Aulenbachers have no problem with the expansion.
“We’re living, breathing proof that it works,” Julianne Aulenbacher said. “Our child is amazing.”
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