Complimentary and Integrative Medicine: Navigating a confusing evidence base.
Douglas Russell, MD
PAL Consultant
How often have you said to a family, “there just isn’t enough evidence yet for me to be able to recommend this at this time”? And how often have you found out later that the family tried it anyway? As medical professionals who prioritize safety and efficacy, what are we to do when confronted with a treatment that does not necessarily meet the randomized placebo-controlled double-blinded standard to be considered “evidence-based”? Such is the case for many complementary and integrative medicine (CIM) treatment strategies.
When not consulting at PAL I spend much of my time treating ADHD, so it is easiest for me to use ADHD as an example here, though I acknowledge this experience is by no means exclusive to that space. Between 8% and 64% of patients with ADHD utilize at least one complementary treatment approach, yet only 10% disclose this to their physician. Tolerability issues related to established psychopharmacologic treatments, difficulty accessing first line psychosocial treatments and stigma around psychiatric intervention can all contribute to families’ interest in complementary and integrative approaches.
Dietary interventions, mind-body activities, neurofeedback, sleep hygiene, physical activity have long been a present but at times controversial part of the ADHD treatment landscape. The ADHD field has also seen several promising, innovative non-psychopharmacologic treatments entering the market in recent years, such as broad-spectrum micronutrient supplementation, digital game-based therapeutics, and trigeminal nerve stimulation.
While the research base for these and other complementary and integrative treatments is growing in both volume and quality, heterogeneity of study methods and risk of bias pervade much of the existing literature making interpretation confusing. When the existing evidence base is not sufficient to clarify the benefits for a proposed treatment, the “SECS vs RUDE” criteria, first outlined by L. Eugene Arnold, MD, in 2011, can be a useful framework to determine if an intervention is reasonable to recommend.
SECS stands for ‘Safe, Easy, Cheap and Sensible’, while RUDE denotes those treatments which are ‘Risky, Unrealistic, Difficult or Expensive’. A treatment that is meets the SECS criteria might reasonably lower the threshold for recommendation even if the evidence base is limited or of poor quality. However, if any single element of the RUDE criteria is met, a treatment should not be considered advisable without convincing, high-quality evidence of efficacy.
Let us apply the SECS vs RUDE criteria to a couple of common CIM interventions in ADHD, starting with restriction of artificial food coloring. Since the Feingold Diet in 1974, restriction/elimination diets have been commonly practiced despite limited evidence. Interest was renewed in 2004 after the first of three Southampton studies investigating the effects of artificial food additives on pre-school and school aged children, studies that ultimately led to mandatory food labeling in the UK. Subsequent meta-analyses have concluded a small but significant effect. While there may larger evidence base to draw conclusions compared to some other CIM interventions, methods are heterogenous and there is risk of bias. Yet this intervention also clearly passes SECS, especially when you consider the fact that foods containing artificial ingredients also tend to be of low nutrient density.
Now let us look at neurofeedback. The practice involves isolating EEG bands of interest in real time (often theta:beta ratio), translating them into sensory outputs, then training the child to optimize their EEG pattern through operant conditioning. It typically involves multiple sessions with well-trained practitioners. The rationale for the intervention is compelling, which perhaps explains why researchers continue to study it despite results varying widely from no effect to very large effect. Creating a convincing sham condition for study is quite difficult, and this might explain historically variable results. The ICAN study published in 2021 included the most sophisticated blinding protocol to date and found that the active condition did not separate from sham. So in this case we have an intervention that arguably meets RUDE criteria based on difficulty and expense.
Bateman B, Warner JO, Hutchinson E, et al. The effects of a double blind, placebo controlled, artificial food colourings and benzoate preservative challenge on hyperactivity in a general population sample of preschool children. Arch Dis Child. 2004;89(6):506-511.
Chan, E., L.A. Rappaport, and K.J. Kemper, Complementary and alternative therapies in childhood attention and hyperactivity problems. Journal of Developmental & Behavioral Pediatrics, 2003. 24(1): p. 4-8.
Cortese S, Ferrin M, Brandeis D, et al. Neurofeedback for Attention-Deficit/Hyperactivity Disorder: Meta-Analysis of Clinical and Neuropsychological Outcomes From Randomized Controlled Trials. J Am Acad Child Adolesc Psychiatry. 2016;55(6):444-455.
Hurt EA, Arnold LE, Lofthouse N. Dietary and nutritional treatments for attention-deficit/hyperactivity disorder: current research support and recommendations for practitioners. Curr Psychiatry Rep. 2011 Oct;13(5):323-32.
Neurofeedback Collaborative Group. Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13-Month Follow-up. J Am Acad Child Adolesc Psychiatry. 2021;60(7):841-855.
Nigg JT, Lewis K, Edinger T, Falk M. Meta-analysis of attention-deficit/hyperactivity disorder or attention-deficit/hyperactivity disorder symptoms, restriction diet, and synthetic food color additives. J Am Acad Child Adolesc Psychiatry. 2012;51(1):86-97 e88.
Wu, J., Li, P., Luo, H., et al., Complementary and Alternative Medicine Use by ADHD Patients: A Systematic Review. Journal of Attention Disorders, 2022: p. 1833-1845.
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News & Notes
- Registration is now open for our upcoming in-person PAL conference!
- Date & Time:
- April 22, 2023 at 8:00 am - 12:30 pm PST
- Location:
- Hotel Bellwether (Bellingham, WA)
- Featured Speakers & Topics:
- Irritability and emotional dysregulation in ADHD and other externalizing behavioral disorders | William French, MD
- Psychotropic Medications to Support Children with Autism: A Case-Based Approach | David Camenisch, MD
- Psychotropics in pregnancy and lactation | Amritha Bhat, MD
- Register here!
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 PAL Spotlight
Rebecca Barclay has been part of the PAL team since January 2012. She is originally from New Jersey, went to college at Yale, medical school at Washington University in St. Louis, completed adult psychiatry residency at Harvard Longwood, followed by child and adolescent psychiatry fellowship at Massachusetts General Hospital. She enjoys the practice of child and adolescent psychiatry because of the potential for positive change in the lives of young people. Her hobbies include running, swimming, mountain biking, and skiing.
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Upcoming CME Conferences
April 22, 2023
Location: Bellingham
Register here!
June 3, 2023
Location: virtual conference
Visit our website for the most updated information on upcoming conferences and to view slides from our previous conferences.
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First Approach Skills Training (FAST) Trainings
PAL is offering another series of free training events for primary care-based behavioral health providers across Washington. The First Approach Skills Training (FAST) team will offer live, interactive trainings for treating anxiety, depression, behavior problems, posttraumatic stress, teen behavior challenges, and early childhood concerns in integrated primary care settings. Click any of the registration links below to learn more and get registered. Again, these trainings are free within Washington State and designed for behavioral health professionals working in integrated primary care settings.
FAST-Early Childhood | March 28, 2023 | 9:00 am - 11:00 am | Register here
FAST-Depression | April 4, 2023 | 9:00 am - 11:00 am | Register here
FAST-Trauma | April 18, 2023 | 8:30 am - 11:30 am | Register here
FAST-Parenting Teens | May 9, 2023 | 9:00 am - 11:00 am | Register here
FAST-Early Childhood | May 16, 2023 | 9:00 am - 11:00 am | Register here
Visit our website for the most updated information on upcoming trainings.
For questions about resources or provider training opportunities, please contact us at FAST@SeattleChildrens.org.
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