American Academy of Pediatrics on ASD Alternative Therapies

[Guest guest]

As this clinical report shows, the majority of parents who have children with ASDs have tried some form of alternative therapy on them, but as the report shows, ALL the forms of alternative therapies have been shown to be useless,with some being medically dangerous or fatal.

As this has been reported repeatedly in the media, no parent can claim to be ignorant of the facts, yet they persist in subjecting their children to these sorts of treatments.

Administrator

http://aappolicy.aappublications.org/cgi/content/full/pediatrics;120/5/1162

CLINICAL REPORT Published online November 1, 2007PEDIATRICS Vol. 120 No. 5 November 2007, pp. 1162-1182 (doi:10.1542/peds.2007-2362)

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Complementary and Alternative Medicine

Complementary and alternative medicine (CAM) is defined by the National Center for Complementary and Alternative Medicine as "a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine."200 The definition of CAM adopted by the Cochrane Collaboration is "a broad domain of healing resources that encompasses all health systems, modalities, and practices and their accompanying theories and beliefs, other than those intrinsic to the politically dominant health systems of a particular society or culture in a given historical period."201 Detailed reviews of CAM as related to developmental disabilities and ASD-specific CAM have been published recently.202–204

Use of CAM is common in children with ASDs.152,205–207 Levy et al206 reported that by the time their clinical population received a formal diagnostic evaluation for a suspected ASD, almost one third of the children already had received a complementary or alternative therapy, and a survey conducted in a predominantly white, middle-to-upper socioeconomic-status private-practice population found that 92% of parents who responded had used CAM therapies for their children with ASDs.205 Another recent parent survey found that 52% of the children with an ASD had been treated with at least 1 CAM therapy, compared with 28% of a group of control children without disabilities.207 Surveys indicate that only 36% to 62% of caregivers who used CAM therapies for their children with ASDs had informed the child's primary care physician,207,208 although more information on CAM is something that families indicate that they want from their child's primary health care professionals.209

It is important that health care professionals understand how to evaluate the evidence used to support all treatments, including CAM, psychopharmacologic, and other interventions. Ideally, the evidence supporting or refuting a treatment should include peer-reviewed studies with appropriately diagnosed, well-defined homogeneous study populations; a randomized, double-blind, placebo-controlled design; an adequate sample size to support the statistical analysis presented; control for confounding factors; and use of appropriate, validated outcome measures. When evaluating the efficacy of studies, it is particularly important to keep in mind confounding factors, such as the placebo effect, and the natural history of the disorder. Participation in a study may alter the way a parent interacts with a child and confound the perceived outcome,210 and improvements are expected with maturation and educational interventions. Only appropriately controlled studies are helpful in proving that an effect is attributable to the intervention being studied.

The practitioner should encourage families to seek additional information when they encounter the following claims or situations211:

treatments that are based on overly simplified scientific theories;

therapies that are claimed to be effective for multiple different, unrelated conditions or symptoms;

claims that children will respond dramatically and some will be cured;

use of case reports or anecdotal data rather than carefully designed studies to support claims for treatment;

lack of peer-reviewed references or denial of the need for controlled studies; or

treatments that are said to have no potential or reported adverse effects.

To help to describe their proposed rationales and mechanisms, CAM therapies used to treat ASDs have been categorized as "nonbiological" or "biological."204 Examples of nonbiological interventions include treatments such as auditory integration training, behavioral optometry, craniosacral manipulation, dolphin-assisted therapy, music therapy, and facilitated communication. Examples of biological therapies include immunoregulatory interventions (eg, dietary restriction of food allergens or administration of immunoglobulin or antiviral agents), detoxification therapies (eg, chelation), gastrointestinal treatments (eg, digestive enzymes, antifungal agents, probiotics, "yeast-free diet," gluten/casein-free diet, and vancomycin), and dietary supplement regimens that are purported to act by modulating neurotransmission or through immune factors or epigenetic mechanisms (eg, vitamin A, vitamin C, vitamin B6 and magnesium, folic acid, folinic acid, vitamin B12, dimethylglycine and trimethylglycine, carnosine, omega-3 fatty acids, inositol, various minerals, and others).203,204

For most of the aforementioned CAM interventions, there is not enough scientific evidence yet to support or refute their use as treatment for ASDs. However, evaluation of treatments is possible, and a few CAM treatments have been appropriately studied. For example, more than a dozen randomized, double-blind, placebo-controlled trials involving more than 700 patients have demonstrated that secretin (a biological treatment) is not an effective treatment for ASDs.212,213 Evaluation of nonbiological treatments also is feasible. This has been demonstrated in the case of facilitated communication, a technique that uses a trained facilitator to provide physical support to a nonverbal person's hand or arm while that person uses a computer keyboard or other device to spell. Evidence suggests that the communications produced actually originate from the facilitator214,215 and that facilitated communication is not a valid treatment for ASDs.216–218

Because of methodologic flaws, insufficient numbers of patients, or lack of replication, many CAM therapies have been inadequately evaluated; therefore, evidence-based recommendations for their use are not possible. The most recent and most appropriately designed trials have demonstrated no significant benefit of dimethylglycine,219,220 vitamin B6 and magnesium,221,222 or auditory integration training.223–225 Both positive226 and negative227,228 results have been described for small, methodologically flawed studies of intravenous immunoglobulin. A recent double-blind, placebo-controlled trial revealed no statistically significant differences on Aberrant Behavior Checklist subscale scores between small groups of children with ASDs who were given omega-3 fatty acids and those who were given placebo.229 However, the investigators noted a trend toward superiority of omega-3 fatty acids over placebo for hyperactivity, which suggests that further investigation may be warranted.229 The gluten/casein-free diet is based on a hypothesis of abnormal gut permeability and exogenous opiate excess. Although use of the gluten/casein-free diet for children with ASDs is popular, there is little evidence to support or refute this intervention, and reviewers have determined that meaningful conclusions cannot be drawn from the existing literature.230,231 Subsequent to these reviews, a randomized, double-blind pilot study demonstrated no significant benefit.232 Double-blind, placebo-controlled elimination and challenge studies are in progress, and it is anticipated that these studies will provide substantially more useful information regarding the efficacy of the gluten/casein-free diet.204,230 Measurement of urinary peptides has not been proven to be clinically useful as a marker for ASDs or as a tool to determine if dietary restriction is warranted or would be effective.

Many popular interventions, such as chelation of heavy metals, antifungal agents to decrease presumed yeast overgrowth, and antiviral agents to modulate the immune system, have not yet been studied in people with ASDs; their popularity is based on unproven theories and anecdotes or case reports. None of these interventions can be endorsed as treatment for ASDs outside of well-designed and appropriately monitored clinical trials. Some treatments, such as intravenous chelation, may be particularly dangerous and should be discouraged. One child with autism died as a result of chelation with edetate disodium (Na2EDTA) despite the facts that a causal association between mercury and ASDs has not been demonstrated, there is no scientific evidence that chelation is an effective treatment for ASDs, and the effectiveness of chelation therapy to improve nervous system symptoms of chronic mercury toxicity has not been established.233 Unless there is clear evidence of current heavy metal toxicity, chelation by any method is not indicated outside of monitored clinical trials.

In some cases, interesting findings await replication or further investigation. For example, in a double-blind, placebo-controlled trial of vitamin C, improvement was found in total and sensory motor scores on the Ritvo-Freeman Real Life Rating Scale,234 and several small studies have suggested that music therapy had some short-term benefit on communication skills but not on behavior problems of children with ASDs.235 Recently, a group of 20 children with ASDs were compared with children without ASDs and found to have an imbalance of methionine and homocysteine metabolism, which was interpreted to represent impaired capacity for methylation and increased oxidative stress.236 Treatment with trimethylglycine, folinic acid, and methylcobalamin resulted in normalization of laboratory findings. The study did not measure clinical response to the intervention, but anecdotal improvements were noted. Interpretation of these preliminary findings awaits further investigation.

Health care practitioners who diagnose and treat children with ASDs should recognize that many of their patients will use nonstandard therapies. The importance of becoming knowledgeable about CAM therapies, inquiring about current and past CAM use, providing balanced information and advice about treatment options, identifying risks or potential harmful effects, avoiding becoming defensive or dismissing CAM in ways that convey a lack of sensitivity or concern, maintaining open communication, and continuing to work with families even if there is disagreement about treatment choices has been emphasized.237 It also is essential to critically evaluate the scientific merits of specific therapies and share this information with families, educate families about how to evaluate information and recognize pseudoscience, and insist that studies that examine CAM be held to the same scientific and ethical standards as all clinical research.202,238

Parents of children with ASDs will understandably pursue interventions that they believe may present some hope of helping their child, particularly if the therapies are viewed as being unlikely to have any adverse effects. Unfortunately, families are often exposed to unsubstantiated, pseudoscientific theories and related clinical practices that are, at best, ineffective and, at worst, compete with validated treatments or lead to physical, emotional, or financial harm. Time, effort, and financial resources expended on ineffective therapies can create an additional burden on families. Health care professionals can help parents and other caregivers to distinguish empirically validated treatment approaches from treatments that have been proven to be ineffective and those that are unproven and potentially ineffective and/or harmful.