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Meta-Analysis
. 2016 Feb 4;2(2):CD009996.
doi: 10.1002/14651858.CD009996.pub2.

Amphetamines for attention deficit hyperactivity disorder (ADHD) in children and adolescents

Salima Punja  1 , Larissa Shamseer, Lisa Hartling, Liana Urichuk, Ben Vandermeer, Jane Nikles, Sunita Vohra
Affiliations
Meta-Analysis

Amphetamines for attention deficit hyperactivity disorder (ADHD) in children and adolescents

Salima Punja et al. Cochrane Database Syst Rev. .

Abstract

Background: Attention deficit hyperactivity disorder (ADHD) is one of the most common psychiatric conditions affecting children and adolescents. Amphetamines are among the most commonly prescribed medications to manage ADHD. There are three main classes of amphetamines: dexamphetamine, lisdexamphetamine and mixed amphetamine salts, which can be further broken down into short- and long-acting formulations. A systematic review assessing their efficacy and safety in this population has never been conducted.

Objectives: To assess the efficacy and safety of amphetamines for ADHD in children and adolescents.

Search methods: In August 2015 we searched CENTRAL, Ovid MEDLINE, Embase, PsycINFO, ProQuest Dissertation and Theses, and the Networked Digital Library of Theses and Dissertations. We also searched ClinicalTrials.gov, and checked the reference lists of relevant studies and reviews identified by the searches. No language or date restrictions were applied.

Selection criteria: Parallel-group and cross-over randomized controlled trials (RCTs) comparing amphetamine derivatives against placebo in a pediatric population (< 18 years) with ADHD.

Data collection and analysis: Two authors independently extracted data on participants, settings, interventions, methodology, and outcomes for each included study. For continuous outcomes, we calculated the standardized mean difference (SMD) and for dichotomous outcomes we calculated the risk ratio (RR). Where possible, we conducted meta-analyses using a random-effects model. We also performed a meta-analysis of the most commonly reported adverse events in the primary studies.

Main results: We included 23 trials (8 parallel-group and 15 cross-over trials), with 2675 children aged three years to 17 years. All studies compared amphetamines to placebo. Study durations ranged from 14 days to 365 days, with the majority lasting less than six months. Most studies were conducted in the United States; three studies were conducted across Europe. We judged 11 included studies to be at a high risk of bias due to insufficient blinding methods, failing to account for dropouts and exclusions from the analysis, and failing to report on all outcomes defined a priori. We judged the remaining 12 studies to be at unclear risk of bias due to inadequate reporting.Amphetamines improved total ADHD core symptom severity according to parent ratings (SMD -0.57; 95% confidence interval (CI) -0.86 to -0.27; 7 studies; 1247 children/adolescents; very low quality evidence), teacher ratings (SMD -0.55; 95% CI -0.83 to -0.27; 5 studies; 745 children/adolescents; low quality evidence), and clinician ratings (SMD -0.84; 95% CI -1.32 to -0.36; 3 studies; 813 children/adolescents; very low quality evidence). In addition, the proportion of responders as rated by the Clinical Global Impression - Improvement (CGI-I) scale was higher when children were taking amphetamines (RR 3.36; 95% CI 2.48 to 4.55; 9 studies; 2207 children/adolescents; very low quality evidence).The most commonly reported adverse events included decreased appetite, insomnia/trouble sleeping, abdominal pain, nausea/vomiting, headaches, and anxiety. Amphetamines were associated with a higher proportion of participants experiencing decreased appetite (RR 6.31; 95% CI 2.58 to 15.46; 11 studies; 2467 children/adolescents), insomnia (RR 3.80; 95% CI 2.12 to 6.83; 10 studies; 2429 children/adolescents), and abdominal pain (RR 1.44; 95% CI 1.03 to 2.00; 10 studies; 2155 children/adolescents). In addition, the proportion of children who experienced at least one adverse event was higher in the amphetamine group (RR 1.30; 95% CI 1.18 to 1.44; 6 studies; 1742 children/adolescents; low quality evidence).We performed subgroup analyses for amphetamine preparation (dexamphetamine, lisdexamphetamine, mixed amphetamine salts), amphetamine release formulation (long acting versus short acting), and funding source (industry versus non industry). Between-group differences were observed for proportion of participants experiencing decreased appetite in both the amphetamine preparation (P < 0.00001) and amphetamine release formulation (P value = 0.008) subgroups, as well as for retention in the amphetamine release formulation subgroup (P value = 0.03).

Authors' conclusions: Most of the included studies were at high risk of bias and the overall quality of the evidence ranged from low to very low on most outcomes. Although amphetamines seem efficacious at reducing the core symptoms of ADHD in the short term, they were associated with a number of adverse events. This review found no evidence that supports any one amphetamine derivative over another, and does not reveal any differences between long-acting and short-acting amphetamine preparations. Future trials should be longer in duration (i.e. more than 12 months), include more psychosocial outcomes (e.g. quality of life and parent stress), and be transparently reported.

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Conflict of interest statement

Salima Punja ‐ none known. Larissa Shamseer ‐ none known. Lisa Hartling ‐ none known. Liana Urichuk ‐ received salary support from the Addiction & Mental Health Program of Alberta Health Services ‐ Edmonton Zone during the course of this review. Dr Urichuk also received a grant for a research project entitled "Neurofeedback for children with Attention Deficit Hyperactivity Disorder" from the Sick Kids Hospital Foundation and John and Lotte Hecht Memorial Foundation. Ben Vandermeer ‐ none known. Catherine Jane Nikles ‐ published a paper in the area of amphetamines for ADHD (Nikles 2006). The study was excluded due to the nature of the design. Dr Nikles was not involved in assessing the eligibility of this study, which was performed by two independent authors. Sunita Vohra ‐ is the recipient of an Alberta Innovates ‐ Health Scholar salary award. Dr Vohra's institution receives funds from Alberta Innovates ‐ Health Solutions and protects 75% of her time for research. Other funders include Health Canada, Canadian Institutes of Health Research, Women & Children’s Health Research Institute and National Health, Medical Research Council (Australia) and SERIN‐ETD Acupuncture Research Fund. SERIN is a commercial entity who provided acupuncture needles for a trial. The population is not pediatric ADHD. None of these companies pose a conflict of interest as regards this review.

Figures

1
1
Study flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Forest plot of comparison: 1 Amphetamines versus placebo, outcome: 1.1 Total ADHD symptom score ‐ parent ratings.
4
4
Forest plot of comparison: 1 Amphetamines versus placebo, outcome: 1.3 Total ADHD symptom score ‐ teacher ratings.
5
5
Forest plot of comparison: 1 Amphetamines versus placebo, outcome: 1.23 Proportion of participants who experienced at least one adverse event.
6
6
Forest plot of comparison: 2 Subgroup analysis 1: Type of amphetamine, outcome: 2.6 Proportion of participants experiencing decreased appetite.
1.1
1.1. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 1 Total ADHD symptom score ‐ parent ratings.
1.2
1.2. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 2 Hyperactivity/impulsivity ‐ parent ratings.
1.3
1.3. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 3 Total ADHD symptom score ‐ teacher ratings.
1.4
1.4. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 4 Hyperactivity/impulsivity ‐ teacher ratings.
1.5
1.5. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 5 Inattention ‐ teacher ratings.
1.6
1.6. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 6 Total ADHD symptom score ‐ clinician ratings.
1.7
1.7. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 7 Hyperactivity/impulsivity ‐ clinician ratings.
1.8
1.8. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 8 Inattention ‐ clinician ratings.
1.9
1.9. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 9 Total ADHD symptom score ‐ investigator/research personnel ratings.
1.10
1.10. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 10 Hyperactivity/impulsivity ‐ investigator/research personnel ratings.
1.11
1.11. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 11 Inattention ‐ investigator/research personnel ratings.
1.12
1.12. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 12 Proportion of responders (Clinical Global Impression ‐ Improvement; CGI ‐ I).
1.13
1.13. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 13 Clinical Global Impression ‐ Severity (CGI ‐ S) score.
1.14
1.14. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 14 Academic performance.
1.15
1.15. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 15 Quality of life.
1.16
1.16. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 16 Retention: proportion of participants who completed the trial.
1.17
1.17. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 17 Proportion of participants experiencing decreased appetite.
1.18
1.18. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 18 Proportion of participants experiencing insomnia/trouble sleeping.
1.19
1.19. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 19 Proportion of participants experiencing abdominal pain.
1.20
1.20. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 20 Proportion of participants experiencing nausea/vomiting.
1.21
1.21. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 21 Proportion of participants experiencing headaches.
1.22
1.22. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 22 Proportion of participants experiencing anxiety/nervousness.
1.23
1.23. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 23 Proportion of participants who experienced at least one adverse event.
1.24
1.24. Analysis
Comparison 1 Amphetamines versus placebo, Outcome 24 Proportion of participants who dropped out/withdrew due to an adverse event.
2.1
2.1. Analysis
Comparison 2 Subgroup analysis 1: Type of amphetamine, Outcome 1 Total ADHD symptom score ‐ parent ratings.
2.2
2.2. Analysis
Comparison 2 Subgroup analysis 1: Type of amphetamine, Outcome 2 Proportion of responders (CGI ‐ I).
2.3
2.3. Analysis
Comparison 2 Subgroup analysis 1: Type of amphetamine, Outcome 3 Academic performance.
2.4
2.4. Analysis
Comparison 2 Subgroup analysis 1: Type of amphetamine, Outcome 4 Retention: proportion of participants who completed the trial.
2.5
2.5. Analysis
Comparison 2 Subgroup analysis 1: Type of amphetamine, Outcome 5 Proportion of participants who dropped out/withdrew due to an adverse event.
2.6
2.6. Analysis
Comparison 2 Subgroup analysis 1: Type of amphetamine, Outcome 6 Proportion of participants experiencing decreased appetite.
2.7
2.7. Analysis
Comparison 2 Subgroup analysis 1: Type of amphetamine, Outcome 7 Proportion of participants experiencing insomnia/trouble sleeping.
2.8
2.8. Analysis
Comparison 2 Subgroup analysis 1: Type of amphetamine, Outcome 8 Proportion of participants experiencing abdominal pain.
2.9
2.9. Analysis
Comparison 2 Subgroup analysis 1: Type of amphetamine, Outcome 9 Proportion of participants experiencing headaches.
2.10
2.10. Analysis
Comparison 2 Subgroup analysis 1: Type of amphetamine, Outcome 10 Proportion of participants experiencing nausea/vomiting.
3.1
3.1. Analysis
Comparison 3 Subgroup analysis 2: Type of amphetamine release formulation, Outcome 1 Total ADHD symptom score ‐ parent ratings.
3.2
3.2. Analysis
Comparison 3 Subgroup analysis 2: Type of amphetamine release formulation, Outcome 2 Proportion of responders (CGI ‐ I).
3.3
3.3. Analysis
Comparison 3 Subgroup analysis 2: Type of amphetamine release formulation, Outcome 3 Academic performance.
3.4
3.4. Analysis
Comparison 3 Subgroup analysis 2: Type of amphetamine release formulation, Outcome 4 Retention: proportion of participants who completed the trial.
3.5
3.5. Analysis
Comparison 3 Subgroup analysis 2: Type of amphetamine release formulation, Outcome 5 Proportion of participants experiencing decreased appetite.
3.6
3.6. Analysis
Comparison 3 Subgroup analysis 2: Type of amphetamine release formulation, Outcome 6 Proportion of participants experiencing abdominal pain.
4.1
4.1. Analysis
Comparison 4 Subgroup analysis 3: Funding source, Outcome 1 Total ADHD symptom score ‐ parent ratings.
4.2
4.2. Analysis
Comparison 4 Subgroup analysis 3: Funding source, Outcome 2 Proportion of responders (CGI ‐ I).
4.3
4.3. Analysis
Comparison 4 Subgroup analysis 3: Funding source, Outcome 3 Academic performance.
5.1
5.1. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 1 Total ADHD symptom score ‐ parent ratings.
5.2
5.2. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 2 Hyperactivity/impulsivity ‐ parent ratings.
5.3
5.3. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 3 Total ADHD symptom score ‐ teacher ratings.
5.4
5.4. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 4 Hyperactivity/impulsivity ‐ teacher ratings.
5.5
5.5. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 5 Inattention ‐ teacher ratings.
5.6
5.6. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 6 Total ADHD symptom score ‐ clinician ratings.
5.7
5.7. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 7 Hyperactivity/impulsivity ‐ clinician ratings.
5.8
5.8. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 8 Inattention ‐ clinician ratings.
5.9
5.9. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 9 Total ADHD symptom score ‐ investigator/research personnel ratings.
5.10
5.10. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 10 Hyperactivity/impulsivity ‐ Investigator/research personnel ratings.
5.11
5.11. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 11 Inattention ‐ investigator/research personnel ratings.
5.12
5.12. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 12 Proportion of responders (CGI ‐ I).
5.13
5.13. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 13 CGI ‐ S score.
5.14
5.14. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 14 Quality of life.
5.15
5.15. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 15 Academic performance.
5.16
5.16. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 16 Retention: proportion of participants who completed the trial.
5.17
5.17. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 17 Proportion of participants who experienced at least one adverse event.
5.18
5.18. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 18 Proportion of participants who dropped out/withdrew due to an adverse event.
5.19
5.19. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 19 Proportion of participants experiencing decreased appetite.
5.20
5.20. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 20 Proportion of participants experiencing insomnia/trouble sleeping.
5.21
5.21. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 21 Proportion of participants experiencing abdominal pain.
5.22
5.22. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 22 Proportion of participants experiencing headaches.
5.23
5.23. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 23 Proportion of participants experiencing anxiety/nervousness.
5.24
5.24. Analysis
Comparison 5 Sensitivity analysis 1: Fixed‐effect model, Outcome 24 Proportion of participants experiencing nausea/vomiting.
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Spencer 2006b {published data only}
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References to studies awaiting assessment

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References to other published versions of this review

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