Dr. Devon MacEachron\'s Blog

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What is it? In 2006 Dr. Robert Melillo – a chiropractor – entered into a partnership with his nephew to launch the Brain Balance franchise model. Since then, over 130 franchises have been purchased across the country. The concept is based on Dr. Melillo’s book: Disconnected Kids: The Groundbreaking Brain Balance Program for Children with Autism, ADHD, Dyslexia, and Other Neurological Disorders. He describes his program as a “non-medical and drug-free approach” based on “cutting edge brain science” for achieving “optimum body and brain balance.” He argues that kids who have learning or behavioral issues have “inadequately developed sensory and motor systems” and because “the brain is built from the bottom up,” sensory and motor work must be done “before any higher learning, behavioral or academic changes can truly happen.”

He addresses this presumed deficit with “motor” exercises (e.g. rhythm and timing, primitive and postural reflexes, eye-muscle balance) and “sensory” exercises (e.g. hearing, vision, smell, taste, touch). Academic skills are also (briefly) addressed. The sensory, motor, and academic work is all condensed into 3 one-hour sessions per week at a center. Your child is taught by a “coach” – an unlicensed person who need have no background in education, health, occupational therapy, chiropractic, or any related field. A blogger who got details from a former center employee insider’s perspective reports that “most staff are very young (21/22 on average), with no real relevant qualifications, and there’s a high turnover; most don’t stay longer than a few months. That could be partly because of the wages; $10 an hour.”

In addition to the 3 hours per week your child gets at a center, the program includes nutritional recommendations and exercises to be done at home.

Most families are advised that their child requires two 3-month sessions at a cost of $6,000 per session, plus several hundred dollars for the assessment and proprietary nutritional supplements (including KidGenius vitamins “that help promote brain growth!”). Total cost is approximately $13-14,000. Cost per session works out to about $182/hour, of which the coach gets approximately $10. None of the cost is covered by health insurance.

Can it help? Let’s break the question down into what part (s) of it work, and for who?

Let’s start with “who.” I’m skeptical that children with all the different issues they claim to treat can be helped with the same basic treatment. A blog titled Total and Utter Neurobollocks states: “They claim to effectively treat pretty much any developmental disorder under the sun, including autism, ADHD, Asperger’s, Tourette’s and dyslexia, without the use of any drugs. This is because all these disorders are (apparently) caused by an “underlying functional imbalance or under-connectivity of electrical (brain) activity within and between the right and left sides of the brain.” Any alarm bells ringing yet? They should be. Whenever someone comes along with a miracle-cure for a range of unrelated conditions, and has come up with the equivalent of a Unified Field Theory of neurodevelopmental disorders, something must be a bit fishy.”

There are also multiple parts of “it” to consider – sensory motor exercises, academic skills tutoring, and dietary changes each would be expected to have different effects (if any). Some aspects of the program’s interventions might prove helpful to individual children. I’m all for good nutrition, academic skills tutoring, and parents spending quality time exercising with their children, for example. But there is no indication that the core theoretical basis of the program – that sensory-motor exercises will “balance” the brain and improve “functional connectivity” – has any basis in fact. That aspect of the program is based on speculation, not on credible evidence.

One parent, Natalie Hanson, chronicled her family’s experience in a blog. She wrote: “We went into it very hopeful.” “So…he’s a chiropractor. Whatever. If the program works, who cares?” Two years later she wrote: “many of you have reached out via the blog and via email for guidance about whether to pursue Brain Balance for your children. It’s so hard to hear your stories and your desperation, which (in many cases) mirrors our own.” But, “knowing what we know now, I don’t think we would do it again… The most valuable thing we’ve done is remove gluten and dairy from our kids’ diet, and get their genome mapped so that we can address underlying issues with their biochemistry through food, supplements, and ultimately medications.” Later that year she wrote: “I continue to get so many questions about Brain Balance from hopeful parents. I would just like to reiterate again that I WOULD NOT recommend investing in this program for your kids. It is extremely expensive, and the results are fleeting at best. You’re better off changing their food habits and finding other ways to address the behaviors. I know this may be unpopular for those of you looking for answers, but these programs are not what you’re looking for – what they are promising is, sadly, too good to be true.”

Dr. Harriet Hall, a retired family physician who writes about pseudoscience and questionable medical practices on the website Science-Based Medicine, wrote a critical review, saying she was initially skeptical because “miraculous results are reported (“He spoke for the first time!”),” but says the biggest red flag is that they claim their program is “clinically proven,” yet they provide mostly testimonials as evidence. Anecdotal reports do not provide evidence of the efficacy of a treatment. Dr. Hall examines the one research study then mentioned on the website in which “They speculate that ADHD is related to a “functional dysconnectivity,” hemispheric imbalance, subcortical dysfunction, a lack of temporal coherence, and a difference in arousal level between the hemispheres. They provide no evidence that these are characteristic of ADHD or were present in their subjects, or that their treatments specifically changed any of them. They assumed an underactive right hemisphere (it was not clear why) and they provided interventions that they assumed (without any supporting evidence) ought to remedy the alleged imbalance.”

When I checked the Brain Balance website for listings of research I found that several articles and a few studies are now listed. Some sound astonishingly compelling. A 2013 randomized control study (that part sounded good!) reports the “elimination of ADHD symptoms in 81% of participating children after completing a 12 week program.” As if that weren’t enough, 60% also achieved a two-grade level academic increase and 35% achieved a four grade level increase in academic skills! Sounds too good to be true, doesn’t it?

The lead author was Dr. Gary Leisman. I googled his name, and the fifth hit that shows up is a Finding of Scientific Misconduct published by the NIH in 1994. Apparently, this “authority” falsely claimed to have earned an M.D. degree he never earned, to have been a professor of neurology at Harvard Medical School (he had no such affiliation), and to have been awarded 13 U.S. Patents (he never was). Since that time, he has been working in Cuba and Israel.

Other articles include tenuous links to Brain Balance methodologies from some solid research findings. For example, the finding that children with autism have higher than normal connectivity between certain areas of the brain was extrapolated to “lend further support to the Brain Balance theory of Functional Disconnection…The Brain Balance Program combines customized sensory-motor and cognitive activities to repair the miscommunication.”

Why isn’t their more research? Well, first of all, neuroscience has moved far beyond the simple left brain/right brain dichotomy. Furthermore, the idea that diverse conditions are caused by a disconnection syndrome between the two hemispheres is preposterous enough to fail to get research funding.

Why don’t the people making money from Brain Balance programs fund some research? Melillo has argued that Brain Balance is too busy treating patients to do rigorous scientific studies. How convenient.

Can it hurt? Yes – your pocketbook.

What should parents do? Spend their time and money on treatments that are efficacious. Dietary changes, academic skills tutoring, exercise, and maybe even some sensory-motor therapy – depending on the child’s needs – provided by someone trained and licensed to provide it (a good occupational or physical therapist, for example).

(This topic has been moved ahead of the queue by popular demand)

What is an essential oil? Let’s start with what an essential oil is. An essential oil is an extract taken from the leaves, roots, stems or blossoms of a plant that is distilled into a concentrated form and sold in health food stores and by homeopaths, chiropractors, aromatherapists, wellness advocates, and others. The word “essential” refers to the extract being highly condensed. They are meant to be inhaled through a diffuser or applied to the skin. Often they are mixed into blends, such as doTerra’s product InTune Focus, which is marketed for “difficulty paying attention and staying on task.”

The two largest companies selling essential oils are Young Living and doTerra, and together they have over a billion dollars a year in annual sales. It’s big business. The essential oils market has boomed in the last 20 years as “wellness” and “natural” living have trended simultaneously with self-care through online sources and reduced trust in “traditional” medicine and governmental institutions. Young Living introduces a new product each year, with last year’s blend of pepper, spruce, and frankincense called: Fulfill Your Destiny. According to the company, it “encompasses the complex and beautiful journey that leads to achieving your goals and highest potential.” There’s a fascinating article in The New Yorker (October 9, 2017) called “Something in the Air”  about the big business of essential oils if you’re interested.

Surveys suggest that more than 50% of families of children with ADHD try some form of alternative medicine. Part of the appeal to parents of essential oils is that the products are supposedly “natural,” “safe,” and have been used for centuries.

Essential oils recommended for ADHD include: vetevier (an Indian grass), lavender oil, cedarwood, coconut oil, Roman chamomile, mandarin, ylang-ylang, rhodiola, helichrysum, rosemary, valerian, peppermint, and frankincense. It’s a long list, and the matching of any individual oil to a specific symptom it’s supposed to treat varies quite a bit by source.

Do they help? It’s hard to say, as there is very little research into whether, or how much, they may help. Many of the theories on mechanisms of action involve vague statements that would be extremely difficult if not impossible to test such as “balances the nervous system” and “stabilizes the energy field.” In some cases this is deliberate as the companies marketing the products try to avoid claims that could get them into trouble with the FDA.

Evidence from randomized clinical trials examining the efficacy of such oils in treating ADHD is sparse, to say the least. The few studies that do exist, whether yielding positive or negative results, tend to suffer from inadequate trial design (e.g. small sample size, short duration), incomplete reporting, and/or lack of an appropriate control group.(1) This doesn’t mean the oils don’t work – it just means we don’t have much scientific evidence either way.

Most of the “evidence” in support of essential oils for ADHD is anecdotal and comes from testimonials. “Testimonials” are personal accounts of someone’s experience. They are generally subjective: “My child was less hyperactive,” “He was calmer,” and so on. Testimonials are inherently selective. People are more likely to talk about an “amazing cure” than about something that didn’t work. Companies selling products are certainly more likely to quote positive testimonials. And for many people stories are more powerful and convincing than statistics published in hard-to-read and hard-to-find scientific journals.

Are the stories true? In all honesty, I don’t know. Maybe your child’s symptoms really were improved by inhaling vetevier. Or maybe you or your child thought they were.

The placebo effect is a phenomenon in both traditional and alternative medicine. A person’s expectations when they ingest a medicine can have an influence on its real effectiveness. A study published in the Journal of Essential Oil Therapy in 2007 with Spanish sage oil separated participants for a memory task into a group told that the oil would impair their memory and a group told it would have a positive influence. The positive expectancy group did better and the negative expectancy group did worse than a control group who ingested the oil but were told nothing of its potential impact. We want things to work, so sometimes they do. As long as they work, though, that’s great – right? I’d say yes – if they’re not harmful in any way.

Are they safe? Maybe. Maybe not. Similar to prescription drugs, essential oils and blends contain biologically active compounds that can elicit pharmokinetic and pharmodynamic responses. There’s real medicine in there! Once consumed such substances are absorbed, distributed, metabolized, and eliminated by the body, often inhibiting or inducing metabolic enzymes or transporters. While composed of natural substances like leaves or roots, “natural” does not equate to “safe.” Approximately 50% of the drugs used in mainstream medicine were originally developed from “natural” substances. Remember the discovery of penicillin from mold?

Because essential oils are not regulated for quality control, the chemistry, potency, purity, and safety of any given oil is largely unknown and can vary from one product to the next. Differences in plant chemistry caused by weather or pesticides, as well as harvesting, storage, manufacturing and formulation processes introduce variability. Variability can influence responses and health.

From the government’s perspective, if a product is intended for a therapeutic use, such as treating or preventing disease, it’s considered a drug. The fact that an essential oil comes from a plant doesn’t keep it from being regulated as a drug. Under the law, drugs must meet requirements such as FDA approval for safety and effectiveness before they go on the market. The FDA determines a product’s intended use based on factors such as claims made in the labeling, on websites, and in advertising, as well as what consumers expect it to do. So, when the marketing of an essential oil for ADHD steps over a line and makes drug-like claims, the FDA may step in. In 2014 they warned an online company selling valerian for ADHD that it was in violation of interstate commerce laws for selling products that “in light of their toxicity or other potentiality for harmful effect, the method of their use, or the collateral measures necessary to their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them.”(2) The same year they scolded doTerra and Young Living for their claims about treating ADHD. So the companies changed their marketing literature to downplay promises made.

Why aren’t there more studies? Most plants and raw botanicals can’t be patented, so why should a company spend money proving they’re effective? Any negative results could harm future sales. The big companies involved in this booming market are making a lot of money as things stand. Why rock the boat?

What about scientists doing research in the academic realm? Research with essential oils is hard to do because patients can’t be blinded to the odors. But probably the main reason there hasn’t been more scientific research is that obtaining funding for research from governmental agencies for “alternative medicines” is a challenge. I wish this were different.

What should a parent do? Proceed cautiously. There’s very little scientific support for positive effects of essential oils in the treatment of ADHD. Evidence of the safety of essential oils with children is also scarce. Essential oils contain potentially powerful substances that may help, but they may hurt. We just don’t have enough information to know.

(1) Complementary and Alternative Medicine use in Pediatric Attention-Deficit Hyperactivity Disorder (ADHD): Reviewing the Safety and efficacy of Herbal Medicines by Hajrah Mazhar, Emrson Harkin, Brian Foster, Cory Harris in Curr Dev Disorders Rep (2016) 3:15-24.

(2) https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm418714.htm.