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Beware of Non-Evidence-Based Treatments
All parents want their children to lead healthy and fulfilling lives. Unfortunately, as parents of children with autism strive to help their children they can fall victim to duplicitous claims that encourage them to try unsafe, expensive and ineffective non-evidence-based treatments. Before beginning any treatment, parents should question whether there is a coherent scientific rationale behind it, and think critically about its associated risks and benefits. They should also ask their healthcare practitioner whether the treatment has been proven effective and safe in objective scientific studies, and whether those studies have been published in well-established, highly reputable, peer-reviewed medical journals.
It is important to remember that anyone can start a journal or post a study on the Internet to tout the efficacy of dangerous or useless interventions. Healthcare fraud is a huge business in the US, and parents of children with autism are often targeted. Fringe treatment providers prey on desperation and fear, and deceive parents with numerous unfounded claims.
To be considered evidence-based, a treatment must be thoroughly investigated in multiple well-designed scientific studies and show measurable, sustained improvements in targeted areas. A study’s design largely depends on its focus and purpose, but there are some characteristics that well-designed studies tend to have. These include but are not limited to:
-Use of well-matched comparison groups – participants receiving the new intervention should be compared to a group of participants receiving a standard community intervention, and/or a group receiving no intervention. The comparison groups should match the ‘new treatment group’ in average age, gender distribution, diagnosis, level of functioning, and any other potentially confounding variables.
-Random assignment of participants to treatment/comparison groups.
-Pre- and post-test design – performance on a given test is measured before and after the intervention to measure change.
-Use of representative samples – study participants should be representative of the target population. That is, a study testing an intervention for toddlers with ASD and average IQs should not use a sample of autistic school-aged children with an uncharacteristically high rate of mental retardation.
-‘Blinding’ of individuals involved in the experiment – where appropriate, investigators and participants should not know group assignments (e.g., placebo v. medication) in order to prevent biases during data collection.
-Use of adequately large samples based on past research and statistical analysis.
Below is an overview of commonly discussed treatments that currently are not scientifically validated:
Biomedical Non-Evidence-Based Treatments
Chelation: Chelation therapy involves administering chemicals designed to bind to heavy metals and eliminate them from the body. Chelating agents have a legitimate use in the treatment of poisoning from lead, mercury and other metals. There is no evidence that supports chelation as a safe treatment alternative because autism is not caused by metal poisoning. In 2005, a child with autism died from chelation therapy, when the chelating agent bonded with calcium in his body and caused his heart to stop. No paper published in the peer-reviewed literature has reported abnormal levels of mercury in individuals with autism spectrum disorder. Moreover, symptoms of mercury poisoning are unlike symptoms of autism, making chelation an impractical way to improve symptoms.
Lupron Therapy: Lupron is a testosterone-inhibiting drug used in the treatment of precocious puberty (which is rare) and prostate cancer, as well as for the “chemical castration” of sex offenders. Its use for autism is based on the hypothesis that testosterone magnifies the toxic effects of mercury (see above). There is no evidence that Lupron is safe or effective for the treatment of autism. In addition, it can have harmful side effects including hives, difficulty breathing/ swallowing, numbness, tingling, weakness, painful or difficult urination, blood in the urine, bone pain, testicular pain and osteoporosis.
Hyperbaric Oxygen Therapy (HBOT): HBOT has been proven effective for treatment of gangrene, carbon monoxide poisoning, “the bends” and various other conditions related to oxygen in blood. There is no evidence to support ASD as an insufficiency of oxygen in the blood. Evidence also fails to support HBOT as safe or effective for the treatment of autism. Furthermore, the benefits of hyperbaric oxygen delivered in a soft-shelled chamber are no different than with a less expensive oxygen tent, or nasal cannula.
Gluten Free-Casein Free (GFCF) Diet: Those who promote gluten (protein found in wheat, rye, and barley products) and casein (protein found in dairy products) free diets claim that children with autism have “leaky guts” that allow opioids to escape into the bloodstream and then travel to the brain and cause autistic behaviors. There is no evidence for this claim, and studies have found that compared to typically developing children, children with autism have no more opioids in their blood. Furthermore, children on the GFCF diet have been found to have lower bone density than controls, which could lead to osteoporosis. A large-scale study of the safety and efficacy of the GFCF diet indicated that children on the diet had similar outcomes to those who were not on the diet.
Stem Cell Therapy: Stem cell therapy for autism is illegal in the United States, but that hasn’t stopped some from offering this as a treatment for autism in Costa Rica, China, and other countries. There is no evidence that the treatment is safe or effective for autism, and no guarantee that the stem cells used in these countries are even human.
Secretin Injections: Secretin is a hormone that controls digestion. It is currently prepared from pigs as a synthetic human form is not available. The FDA has approved use of single doses of secretin in diagnosing gastrointestinal problems such as ulcers or impaired pancreatic function in adults, but it has not formally approved the hormone for autism treatment. No data exists on the safety or efficacy of repeated doses of secretin or its use in children. In a report, the National Institutes of Child Health and Human Development states that the efficacy of secretin in ASD treatment is currently unknown.
Antifungal Agent Therapy: Some people believe that bacteria in the gut cause autism, and since antifungal medications can eliminate bacteria they believe they can simultaneously cure autism. There is no evidence to support any antifungal agent as an autism cure. Importantly, treating children with antifungal agents is potentially harmful; possible side effects include itching, irritation, burning, diarrhea, stomach pain, and skin rashes. Some antifungal treatments, including Diflucan, Sporanox, Lamisil, and Nizoral, are absorbed in the body and can impede liver functioning over time.
Vitamin Supplements: It is important to maintain a healthy and balanced diet. To achieve this goal, healthcare providers may recommend nutritional supplements to people with and without autism. Use of supplements can be problematic however, when they are misused in an attempt to cure an individual of autism. There is no scientific evidence suggesting that vitamin supplements can cure autism. Using supplements without consulting a healthcare provider can be dangerous. Some supplements (e.g., vitamin A) can be toxic when taken in high doses for sustained periods; others may not contain what they claim.
Raw Camel Milk: Raw camel milk has been alleged to cure autism-related ills with benefits ranging from improved eye contact and motor skills to decreased inflammation. Although it may be nutritious, there is no scientific research that upholds claims that raw camel milk is an autism “cure-all.”
Marijuana Therapy: Marijuana is an illicit drug whose use in ASD treatment is neither medically nor scientifically supported for the core symptoms of autism. Reported short-term side effects of marijuana use include distorted perception; impaired coordination; and impaired thinking, problem solving, learning and memory. Long-term marijuana use has been associated with decreased learning abilities, increased risk of respiratory diseases associated with smoking, and decreased motivation. There are studies ongoing on specific chemical components called cannabinoids for treatment of epilepsy.
Nicotine Patch Therapy: Research studies have uncovered abnormalities in nicotinic acetylcholine receptors in the brains of people with autism, and some scientists have posited that core symptoms of ASD could be attributed to these alterations. Some findings specifically indicate a shortage of these receptors, leading some to believe that stimulating or increasing these receptors could eliminate ASD symptoms. Proponents of nicotine patch use in individuals with ASD believe that the nicotine released into the body from the patch activates and upregulates receptors, and thereby reduces ASD symptoms. Despite having a rationale that is based on scientific findings, use of this treatment is not supported by scientific evidence. No clinical trials have demonstrated that nicotine patches are safe or effective in the treatment of ASD. Common side effects reported in clinical studies evaluating safety and efficacy of the patches include skin irritation; sleep problems, including insomnia and nightmares; headaches, indigestion, and nervousness.
Bleach Therapy: In bleach therapy, an individual with ASD is given a diluted form of bleach orally or through an enema in an attempt to cure their symptoms. Bleach doses are given repeatedly; supporters of this treatment have recommended that children drink the bleach mixture up to eight times per day or receive an enema up to three times per week. The rationale for the treatment is that bleach can eliminate bacteria, parasites, yeast, and heavy metals and consequently eliminate ASD symptoms. This treatment has been widely denounced for the harm it can cause as well as its complete lack of scientific basis. Ingesting bleach can lead to severe fever, diarrhea, vomiting, and other complications.
Transcranial Magnetic Stimulation: TMS is a procedure in which magnetic fields are used to stimulate nerve cells in the brain to enhance or reduce certain functions. TMS is currently used to treat mental illnesses, including depression and schizophrenia. The most commonly reported short-term side effects include headaches and scalp discomfort. Therapeutic TMS is relatively new so long-term side effects, if any, are unknown. Investigations into the efficacy of TMS in ASD treatment are currently underway, but presently there is no evidence to support its use.
Psychological and Behavioral Non-Evidence-Based Treatments
Therapeutic Horseback Riding: Horseback-riding therapy for individuals with ASD aims to foster motor, communication, and social skills, while improving responses to external stimuli. Although a few studies touting the benefits of therapeutic riding have been published in peer-reviewed journals, they are either mainly descriptive, involve small samples or rely on poor outcome measures, and thus cannot support the therapy as a useful, evidence-based intervention.
Dolphin-Assisted Therapy: When undergoing dolphin-assisted therapy (DAT), an individual with autism swims, touches, and interacts with dolphins. Alleged benefits of dolphin therapy include improved emotional control and communication skills, as well as increased attention. Some proponents also claim that the emotional experience created by DAT helps individuals become more receptive to more conventional treatments. There is no scientific evidence suggesting that DAT is efficacious in the long-term improvement of ASD symptoms. Moreover, DAT involves significant safety risks given that dolphins are powerful animals that are capable of harming humans despite extensive training.
Prism Glasses: Prism glasses alter the visual perception of individuals with ASD and are thought to improve behavior and challenging vision-related symptoms as a result. Supporters believe that some individuals with ASD suffer from distorted perception and compensate using abnormal movements and postures such as head tilting. Prism glasses aim to ameliorate perceptual distortions and aid visual development. Their purported benefits extend to other areas, including spatial localization, visual awareness, decrease in sensory seeking behaviors, organization, gait, eye contact, mood, facial expressions, and fine and gross motor skills. Unfortunately these benefits have no scientific backing; no studies with strong experimental designs have supported the use of this expensive therapy in individuals with autism.
Holding Therapy: Holding therapy is based on the erroneous notion that autism is a disorder of attachment caused by a parent’s failure to bond with their child. In a holding therapy session, a caregiver physically restrains a child with autism in order to force eye contact and repair attachment. This treatment has been deemed ineffective and dangerous. There is no scientific evidence suggesting that holding therapy works and fatalities have resulted from its use.