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Impact of placebo assignment in clinical trials of tic disorders

Authors


  • Funding agencies: The study was supported by a grant from the Junta de Castilla y León 2008.

  • Relevant conflicts of interest/financial disclosures: Nothing to report.

  • Full financial disclosures and author roles may be found in the online version of this article.

  • This article first published online ahead of print on 13 February 2013. It has since been updated. Dr. Mahone's name had been misspelled.

Correspondence to: Dr. Esther Cubo, Neurology Department, Hospital Universitario Burgos, Avda Islas Baleares 3, Burgos, 09006, Spain; esthercubo@gmail.com

ABSTRACT

Background

Understanding the impact of placebo treatment is pivotal to the correct interpretation of clinical trials. The aim of present study was to examine the placebo effect in tic disorders.

Methods

Raw data were obtained for 6 placebo-controlledparallel and cross-over trials that involved medical interventions for tic disorders. Tic severity was measured using the Yale Global Tic Severity Scale. Placebo effect was defined as an improvement of at least 30% over baseline scores in the total tic score and was considered clinically relevant when at least 10% of patients in the placebo-arm met that benchmark.

Results

In total, 91 placebo-treated patients (80% males; mean age, 16.5 years; standard deviation, 10.5 years) were included. Although there was a trend toward improvement in the total tic scores after placebo administration (P=0.057), the magnitude of the placebo effect was small (Cohen's d=0.16) but relevant (19% of the sample). Females were more likely than males to have a placebo effect.

Conclusions

The magnitude of the placebo effect in tic disorders appeared to be small. Further longitudinal studies using objective assessments for tic disorders are warranted to confirm the current results. © 2013 Movement Disorder Society

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