A Critical Review of: Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13-Month Follow-Up
DOI:
https://doi.org/10.15540/nr.11.1.92Keywords:
call for retraction, neurofeedback;, pharmaceutical biasingAbstract
Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral condition affecting children and adolescents impairing academic success, self-esteem, and social interactions. Since there is no cure for ADHD, the public relies on researchers to provide an honest and objective evaluation of treatment options to help those with ADHD manage the disorder. The public’s expectation was thwarted when a study was published in the Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP) titled Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder with 13-Month Follow-Up (Arnold et al., 2021). The principal investigator and lead author was L. Eugene Arnold, MD, who referred to his coauthors as a collaborative team. The National Institute of Mental Health funded the study with a $2 million grant. This critical review of Arnold et al. examines various aspects of the study to help us understand why the findings and stated conclusion of the study deviated from a substantial body of research and clinical evidence demonstrating the effectiveness of NFB for treating ADHD.
References
American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596
Arnold, L. E., Arns, M., Barterian, J., Bergman, R., Black, S., Conners, C. K., Connor, S., Dasgupta, S., deBeus, R., Higgins, T., Hirshberg, L., Hollway, J. A., Kerson, C., Lightstone, H., Lofthouse, N., Lubar, J., McBurnett, K., Monastra, V., Buchan-Page, K., ... Williams, C. E. (2021). Double-blind placebo-controlled randomized clinical trial of neurofeedback for attention-deficit/hyperactivity disorder with 13-month follow-up. Journal of the American Academy of Child & Adolescent Psychiatry, 60(7), 841–855. https://doi.org/10.1016%2Fj.jaac.2020.07.906
Bakhshayesh, A. R., Hänsch, S., Wyschkon, A., Rezai, M. J., & Esser, G. (2011). Neurofeedback in ADHD: A single-blind randomized controlled trial. European Child & Adolescent Psychiatry, 20, 481–491. https://doi.org/10.1007/s00787-011-0208-y
Barth, B., Mayer, K., Strehl, U., Fallgatter, A. J., & Ehlis, A.-C. (2017). EMG biofeedback training in adult attention-deficit/hyperactivity disorder: An active (control) training? Behavioural Brain Research, 329, 58–66. https://doi.org/10.1016/j.bbr.2017.04.021
Crowley, R., Atiq, O., Hilden, D., & Health and Public Policy Committee of the American College of Physicians (2021). Financial profit in medicine: A position paper from the American college of physicians. Annals of Internal Medicine, 174(10), 1447–1449. https://doi.org/10.7326/M21-1178
Deaton, A., & Cartwright, N. (2018). Understanding and misunderstanding randomized controlled trials. Social Science & Medicine, 210, 2–21. https://doi.org/10.1016/j.socscimed.2017.12.005
Gevensleben, H., Holl, B., Albrecht, B., Schlamp, D., Kratz, O., Studer, P., Wangler, S., Rothenberger, A., Moll, G. H., & Heinrich, H. (2009). Distinct EEG effects related to neurofeedback training in children with ADHD: A randomized controlled trial. International Journal of Psychophysiology, 74(2), 149–157. https://doi.org/10.1016/j.ijpsycho.2009.08.005
Head, M. L., Holman, L., Lanfear, R., Kahn, A. T., & Jennions, M. D. (2015). The extent and consequences of p-hacking in science. PLoS Biology, 13(3), Article e1002106. https://doi.org/10.1371/journal.pbio.1002106
Idzik, M. F. (1965). Physician ownership in pharmacies. Notre Dame Law Review. http://scholarship.law.nd.edu/ndlr/vol41/iss1/4?utm_source=scholarship.law.nd.edu%2Fndlr%2Fvol41%2Fiss1%2F4&utm_medium=PDF&utm_campaign=PDFCoverPages
Janssen, T. W., Bink, M., Weeda, W. D., Geladé, K., van Mourik, R., Maras, A., & Oosterlaan, J. (2017). Learning curves of theta/beta neurofeedback in children with ADHD. European Child & Adolescent Psychiatry, 26, 573–582. https://doi.org/10.1007/s00787-016-0920-8
Jensen, P. S., Arnold, L. E., Swanson, J. M., Vitiello, B., Abikoff, H. B., Greenhill, L. L., Hechtman, L., Hinshaw, S. P., Pelham, W. E., Wells, K. C., Conners, C. K., Elliott, G. R., Epstein, J. N., Hoza, B., March, J. S., Molina, B. S. G., Newcorn, J. H., Severe, J. B., Wigal, T., … Hur, K. (2007). 3-year follow-up of the NIMH MTA study. Journal of the American Academy of Child & Adolescent Psychiatry, 46(8), 989–1002. https://doi.org/10.1097/CHI.0b013e3180686d48
Jureidini, J. N., & McHenry L. B. (2011). Conflicted medical journals and the failure of trust. Accountability in Research, 18(1), 45–54. https://doi.org/10.1080/08989621.2011.542683
Kamiya, J. (1968). Conscious control of brain waves. Psychology Today, 1, 56–60. https://doi.org/10.1037/e400092009-006
Kamiya, J. (1969). Operant control of the EEG alpha rhythm and some of its reported effects on consciousness. In C. T. Tart (Ed.), Altered states of consciousness. Wiley.
Kamiya, J. (2011). The first communications about operant conditioning of the EEG. Journal of Neurotherapy, 15(1), 65–73. https://doi.org/10.1080/10874208.2011.545764
Kerr, N. L. (1998). HARKing: Hypothesizing after the results are known. Personality and Social Psychology Review, 2(3), 196–217. https://doi.org/10.1207/s15327957pspr0203_4
Khazan, I., Shaffer, F., Moss, D., Lyle, R., & Rosenthal, S. (Eds.) (2023). Evidence-Based practice in biofeedback & neurofeedback (4th Ed). Association for Applied Psychophysiology and Biofeedback.
Lang, T. A., & Stroup, D. F. (2020). Who knew? The misleading specificity of “double-blind” and what to do about it. Trials, 21, Article 697. https://doi.org/10.1186/s13063-020-04607-5
Lexchin, J., Bero, L. A., Djulbegovic, B., & Clark, O. (2003). Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. BMJ, 326(7400), 1167–1170. https://doi.org/10.1136/bmj.326.7400.1167
Llamas, M. (2021). Big pharma’s role in clinical trials. Drugwatch. https://www.drugwatch.com/featured/clinical-trials-and-hidden-data
Lubar, J. F., Swartwood, M. O., Swartwood, J. N., & O'Donnell, P. H. (1995). Evaluation of the effectiveness of EEG neurofeedback training for ADHD in a clinical setting as measured by changes in T.O.V.A. scores, behavioral ratings, and WISC-R performance. Biofeedback and Self-Regulation, 20, 83–99. https://doi.org/10.1007/BF01712768
McGough, J. J. (2022). Neurofeedback for ADHD: Time to call it quits? The American Journal of Psychiatry, 179(12), 888–889. https://doi.org/10.1176/appi.ajp.20220861
Monastra, V. J., Lynn, S., Linden, M., Lubar, J. F., Gruzelier, J., & La Vaque, T. J. (2005). Electroencephalographic biofeedback in the treatment of attention-deficit/hyperactivity disorder. Applied Psychophysiology and Biofeedback, 30(2), 95–114. https://doi.org/10.1007/s10484-005-4305-x
MTA Cooperative Group. (1999). A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Arch Gen Psychiatry, 56(12), 1073–1086. https://doi.org/10.1001/archpsyc.56.12.1073
Ogrim, G., & Hestad, K. A. (2013). Effects of neurofeedback versus stimulant medication in attention-deficit/hyperactivity disorder: A randomized pilot study. Journal of Child and Adolescent Psychopharmacology, 23(7), 448–457. https://doi.org/10.1089/cap.2012.0090
Páez, A., Rovers, M., Hutchison, K., Rogers, W., Vasey, B., & McCulloch, P. (2022). Beyond the RCT: When are randomized trials unnecessary for new therapeutic devices, and what should we do instead? Annals of Surgery, 275(2), 324–331. https://doi.org/10.1097/SLA.0000000000005053
Pew Research Center. (2022). Public confidence in scientists and medical scientists has declined over the last year. https://www.pewresearch.org/science/2022/02/15/americans-trust-in-scientists-other-groups-declines/ps_22-02-15_trust-declines_00-01/
Pigott, H. E. (2011). STAR*D: A tale and trail of bias. Ethical Human Psychology and Psychiatry, 13(1), 6–28. https://doi.org/10.1891/1559-4343.13.1.6
Pigott, H. E. (2015). The STAR*D trial: It is time to reexamine the clinical beliefs that guide the treatment of major depression. The Canadian Journal of Psychiatry, 60(1), 9–13. https://doi.org/10.1177/070674371506000104
Pigott, H. E., Leventhal, A. M., Alter, G. S., & Boren, J. J. (2010). Efficacy and effectiveness of antidepressants: Current status of research. Psychotherapy and Psychosomatics, 79(5), 267–279. https://doi.org/10.1159/000318293
Plana-Ripoll, O., Pedersen, C. B., Holtz, Y., Benros, M. E., Dalsgaard, S., de Jonge, P., Fan, C. C., Degenhardt, L., Ganna, A., Greve, A. N., Gunn, J., Iburg, K. M., Kessing, L. V., Lee, B. K., Lim, C. C. W., Mors, O., Nordentoft, M., Prior, A., Roest, A. M., … McGrath, J. J. (2019). Exploring comorbidity within mental disorders among a Danish national population. JAMA Psychiatry, 76(3), 259–270. https://doi.org/10.1001/jamapsychiatry.2018.3658
Schwarz, A. (2017). ADHD nation: Children, doctors, big pharma, and the making of an American epidemic. Scribner/Simon & Schuster.
Shean, G. (2014). Limitations of randomized control designs in psychotherapy research. Advances in Psychiatry, 2014, Article 561452. https://doi.org/10.1155/2014/561452
Sterman, M. B. (2000). Basic concepts and clinical findings in the treatment of seizure disorders with EEG operant conditioning. Clinical EEG and Neuroscience, 31(1), 45–55. https://doi.org/10.1177/155005940003100111
Sterman, M. B., & Friar, L. (1972). Suppression of seizures in an epileptic following sensorimotor EEG feedback training. Electroencephalography and Clinical Neurophysiology, 33(1), 89–95. https://doi.org/10.1016/0013-4694(72)90028-4
Sterman, M. B., MacDonald, L. R., & Stone, R. K. (1974). Biofeedback training of the sensorimotor EEG rhythm in man: Effects on epilepsy. Epilepsia 15(3), 395–416. https://doi.org/10.1111/j.1528-1157.1974.tb04016.x
Sterman, M. B., Wyrwicka, W., & Roth, S. R. (1969). Electrophysiological correlates and neural substrates of alimentary behavior in the cat. Annals of the New York Academy of Sciences, 157(2), 723–739. https://doi.org/10.1111/j.1749-6632.1969.tb12916.x
Trullinger, M., Novian, A., Russell-Chapin, L., & Pradhan, D. (2019). Perspectives on type III statistical errors: Exaggerating the effects of placebo in neurofeedback. NeuroRegulation, 6(1), 38–38. https://doi.org/10.15540/nr.6.1.38
Watson, G. L., Arcona, A. P., Antonuccio, D. O., & Healy, D. (2014). Shooting the messenger: The case of ADHD. Journal of Contemporary Psychotherapy, 44(1), 43–52. https://doi.org/10.1007/s10879-013-9244-x
West, S. G., Duan, N., Pequegnat, W., Gaist, P., Des Jarlais, D. C., Holtgrave, D., Szapocznik, J., Fishbein, M., Rapkin, B., Clatts, M., & Mullen, M. (2008). Alternatives to the randomized controlled trial. American Journal of Public Health, 98(8), 1359–1366. https://doi.org/10.2105/AJPH.2007.124446
Zuberer, A., Brandeis, D., & Drechsler, R. (2015). Are treatment effects of neurofeedback training in children with ADHD related to the successful regulation of brain activity? A review on the learning of regulation of brain activity and a contribution to the discussion on specificity. Frontiers in Human Neuroscience, 9, Article 135. https://doi.org/10.3389/fnhum.2015.00135
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