Open‐label use of placebos in the treatment of ADHD: a pilot study
- 12 December 2007
- journal article
- research article
- Published by Wiley in Child: Care, Health and Development
- Vol. 34 (1), 104-110
- https://doi.org/10.1111/j.1365-2214.2007.00797.x
Abstract
Background This study examined short‐term efficacy, side effects and acceptability of a placebo treatment procedure designed to maintain children with attention deficit hyperactivity disorder (ADHD) on 50% of their usual stimulant dose. Methods An open‐label prospective crossover trial was conducted in 26 children with ADHD, ages 7–15 years, stable on stimulant therapy, followed at a community‐based developmental paediatrics ADHD clinic. Subjects were randomly assigned to one of two orders of experimental conditions: (1) baseline (100%) dose (1 week), then 50% dose (1 week), then 50% dose + placebo (1 week), or (2) baseline (100%), then 50% dose + placebo, then 50% dose. The inert nature of the placebo was fully disclosed to parent and child. Treatment was open‐label for child, parents and physician, but single blind for teachers. Main outcome measures included weekly IOWA Conners parent and teacher rating scales, the Pittsburgh side effects rating scale (PSERS) and the Clinical Global Impressions (CGI) scale. Results Parent IOWA showed ADHD behaviour tended to remain the same when the dose of stimulant medication was reduced with placebo but to deteriorate when the dose was reduced without placebo. There were no significant differences between conditions on the Teacher IOWA. PSERS scores were higher at baseline than on 50% dose. On the CGI, there was a significant difference (P = 0.004) between the 50% dose and the 50% + placebo conditions. Individual subject analysis showed that eight subjects met criteria for responder. Conclusions Results indicate that the open‐label placebo treatment was acceptable and efficacious in the short term for some children.This publication has 20 references indexed in Scilit:
- Conditioned Placebo Dose ReductionJournal of Developmental & Behavioral Pediatrics, 2005
- Placebo effects in developmental disabilities: Implications for research and practiceMental Retardation and Developmental Disabilities Research Reviews, 2005
- The Ethical Use of Placebo in Clinical Trials Involving ChildrenJournal of Child and Adolescent Psychopharmacology, 2004
- The Functional Neuroanatomy of the Placebo EffectAmerican Journal of Psychiatry, 2002
- Effects of methyphenidate and expectancy on children with ADHD: Behavior, academic performance, and attributions in a summer treatment program and regular classroom settings.Journal of Consulting and Clinical Psychology, 2002
- Hyperbaric oxygen for children with cerebral palsy: a randomised multicentre trialThe Lancet, 2001
- Placebo Effects in AutismJournal of Developmental & Behavioral Pediatrics, 2000
- Lack of Benefit of a Single Dose of Synthetic Human Secretin in the Treatment of Autism and Pervasive Developmental DisorderThe New England Journal of Medicine, 1999
- Conditioned suppression of humoral immunity in the rat.Journal of Comparative and Physiological Psychology, 1982
- THE MECHANISM OF PLACEBO ANALGESIAThe Lancet, 1978