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Meta-Analysis: Risk of Tics Associated With Psychostimulant Use in Randomized, Placebo-Controlled Trials
Stephanie C Cohen1, Jilian M Mulqueen2, Eduardo Ferracioli-Oda3
1Yale School of Medicine.
Insights
Psychostimulant medications do not increase the risk of new or worsening tics in children with attention-deficit/hyperactivity disorder (ADHD). This meta-analysis found similar tic rates in children treated with psychostimulants versus placebo.
Area of Science:
- Pediatric Neurology
- Child Psychiatry
- Clinical Pharmacology
Background:
- Clinical practice often restricts psychostimulant use in children with tics or family history due to concerns about worsening tic symptoms.
- This fear is not supported by evidence from randomized controlled trials.
Purpose of the Study:
- To conduct a meta-analysis examining the risk of new onset or worsening of tics as an adverse event of psychostimulant medications.
- To evaluate the association between psychostimulant treatment and tic exacerbation in children with ADHD.
Main Methods:
- Systematic literature search for double-blind, randomized, placebo-controlled trials of psychostimulants in children with ADHD.
- Fixed effects meta-analysis calculating the risk ratio of tics in psychostimulant versus placebo groups.
- Stratified subgroup analysis and meta-regression to explore influencing factors like stimulant type, dose, and trial design.
Main Results:
- 22 studies with 2,385 children with ADHD were included.
- Event rates for new/worsening tics were similar: 5.7% (psychostimulant) vs. 6.5% (placebo).
- No significant difference in tic risk between psychostimulant and placebo groups (RR=0.99, p=.962); no factors significantly modified risk, except crossover trials.
Conclusions:
- Meta-analysis of controlled trials does not support an association between psychostimulant use and new or worsening tics.
- Clinicians should consider rechallenging children with tics, as symptoms are likely coincidental, not treatment-induced.
- Evidence suggests psychostimulants can be safely used in children with ADHD, even those with tics or family history.
Objective:
Clinical practice currently restricts the use of psychostimulant medications in children with tics or a family history of tics for fear that tics will develop or worsen as a side effect of treatment. Our goal was to conduct a meta-analysis to examine the risk of new onset or worsening of tics as an adverse event of psychostimulants in randomized, placebo-controlled trials.
Method:
We conducted a PubMed search to identify all double-blind, randomized, placebo-controlled trials examining the efficacy of psychostimulant medications in the treatment of children with attention-deficit/hyperactivity disorder (ADHD). We used a fixed effects meta-analysis with risk ratio of new onset or worsening tics in children treated with psychostimulants compared to placebo. We used stratified subgroup analysis and meta-regression to examine the effects of stimulant type, dose, duration of treatment, recorder of side effect data, trial design, and mean age of participants on the measured risk of tics.
Results:
We identified 22 studies involving 2,385 children with ADHD for inclusion in our meta-analysis. New onset tics or worsening of tic symptoms were commonly reported in the psychostimulant (event rate = 5.7%, 95% CI = 3.7%-8.6%) and placebo groups (event rate = 6.5%, 95% CI = 4.4%-9.5%). The risk of new onset or worsening of tics associated with psychostimulant treatment was similar to that observed with placebo (risk ratio = 0.99, 95% CI = 0.78-1.27, z = -0.05, p = .962). Type of psychostimulant, dose, duration of treatment, recorder, and participant age did not affect risk of new onset or worsening of tics. Crossover studies were associated with a significantly greater measured risk of tics with psychostimulant use compared to parallel group trials.
Conclusion:
Meta-analysis of controlled trials does not support an association between new onset or worsening of tics and psychostimulant use. Clinicians may want to consider rechallenging children who report new onset or worsening of tics with psychostimulant use, as these symptoms are much more likely to be coincidental rather than caused by psychostimulants.
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