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Letters to the Editor |

MTA Study Has Flaws

Peter R. Breggin, MD
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Copyright 2001 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

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Arch Gen Psychiatry. 2001;58(12):1184-1184. doi:
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The Multimodal Treatment Study of Children With Attention-Deficit/Hyperactivity Disorder (MTA)1 was seriously flawed.

First, the study was not placebo controlled or double blind. The MTA not only lacked a placebo control group, but in drawing their conclusions, the investigators relied on evaluations made by teachers and parents who were not blinded to the treatment. The MTA was "open label," with all the scientific flaws associated with such studies. As Nies and Spielberg2 observed, "Placebo effects, which occur in a large percentage of patients, can confound many studies—particularly those that involve subject responses; controls must take this into account."2 (p45)

There were no ethical or scientific reasons not to use placebo control groups. There are numerous recent double-blind placebo-controlled studies of stimulants for attention-deficit/hyperactivity disorder, including 8 that I reviewed from 1990 to 1998.3 4 One lasted longer than 15 months.5 Many children in the MTA study went without medication in the community and behavioral treatment groups. In addition, there can be no ethical or scientific reason not to use double-blind procedures.

Although the lack of placebo controls and the absence of double-blind conditions are not the only flaws in the study,6 they are sufficient to invalidate any findings that favor the use of stimulants.

Second, the most objective observers (blinded classroom raters) found no difference among any of the treatment groups.1 (pp1074,1082-1083) In addition, neither the subjects themselves nor their peers rated the children as more improved when using medication than when using behavioral or community alternatives. These negative findings from the blinded classroom observers, the children themselves, and their peers are strongest in the study and indicate that stimulant drugs offer no observable advantages over nonmedication interventions. The drugs, meanwhile, carry considerable hazards.3 4

The use of stimulant drugs to treat children should gain no encouragement from this study.

REFERENCES

MTA Cooperative Group,  A 14-Month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 1999;561073- 1086
Nies  AS, Spielberg  SP,  Principles of therapeutics. Hardman  JG, Limbird  LE.eds.Goodman & Gilman's the Pharmacological Basis of Therapeutics. 9th ed. New York, NY McGraw-Hill1996;43- 62
Breggin  PR. Psychostimulants in the treatment of children diagnosed with ADHD: risks and mechanism of action. Int J Risk Saf Med. 1999;123- 35
Breggin  PR. Psychostimulants in the treatment of children diagnosed with ADHD, I: acute risks and psychological effects. Ethical Hum Sci Serv. 1999;113- 33
Gillberg  C, Melander  H, von Knorring  A-L, Janols  L-O, Thernlund  G, Hafflof  B, Eidevall-Wallin  L, Gustafsson  P, Kopp  S. Long-term stimulant treatment of children with attention-deficit hyperactivity disorder symptoms: a randomized, double-blind, placebo-controlled trial. Arch Gen Psychiatry. 1997;54857- 864
Breggin  PR. The NIMH multimodal study of treatment for attention-deficit/hyperactivity disorder: a critical analysis. Int J Risk Saf Med. 1999;1315- 22

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MTA Cooperative Group,  A 14-Month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 1999;561073- 1086
Nies  AS, Spielberg  SP,  Principles of therapeutics. Hardman  JG, Limbird  LE.eds.Goodman & Gilman's the Pharmacological Basis of Therapeutics. 9th ed. New York, NY McGraw-Hill1996;43- 62
Breggin  PR. Psychostimulants in the treatment of children diagnosed with ADHD: risks and mechanism of action. Int J Risk Saf Med. 1999;123- 35
Breggin  PR. Psychostimulants in the treatment of children diagnosed with ADHD, I: acute risks and psychological effects. Ethical Hum Sci Serv. 1999;113- 33
Gillberg  C, Melander  H, von Knorring  A-L, Janols  L-O, Thernlund  G, Hafflof  B, Eidevall-Wallin  L, Gustafsson  P, Kopp  S. Long-term stimulant treatment of children with attention-deficit hyperactivity disorder symptoms: a randomized, double-blind, placebo-controlled trial. Arch Gen Psychiatry. 1997;54857- 864
Breggin  PR. The NIMH multimodal study of treatment for attention-deficit/hyperactivity disorder: a critical analysis. Int J Risk Saf Med. 1999;1315- 22

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