APPENDICES. A systematic review and economic model of the ...

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338 Appendix 12 Study Intervention Participants Outcomes Age (For both trials: 89 ATX n = 129, placebo n = 124) ATX: 9.7 years (mean), 1.6 years (SD) Placebo: 10.0 years (mean), 1.5 years (SD) IQ (For both trials: 89 ATX n = 129, placebo n = 124) ATX: 103 (mean) Placebo: 106.9 (mean) Co-morbid disorders (For both trials: 89 ATX n = 129, placebo n = 124) ODD: ATX: n = 53 (41.1%); placebo: n = 45 (36.3%) Elimination disorders: ATX: n = 10 (7.8%); placebo: n = 15 (12.1%) Phobias: ATX: n = 16 (12.4%); placebo: n = 13(10.5%) Dysthymia: ATX: n = 7 (5.4%); placebo: n = 5 (4.0%) Generalised anxiety disorder: ATX: n = 4 (3.1%); placebo: n = 3 (2.4%) Major depressive disorder: ATX: n = 4(3.1%); placebo: n = 4 (3.2%) Diagnostic subtypes (For both trials: 89 ATX n = 129, placebo n = 124) Inattentive: ATX: n = 24 (18.6%); placebo: n = 24 (19.4%) Hyperactive/impulsive: ATX: n = 1 (0.8%); placebo: n = 2 (1.6%) Combined: ATX: n = 104 (80.6%); placebo: n = 98 (79%) Additional information Previous/concurrent medication: To be admitted into the trial, individuals were required not to be in receipt of psychotropic medication
Core symptoms Educational performance Quality of life Adverse events NB: combined results Adverse events occurring in >10% of any treatment group [% of ATX (n = 129)/placebo group (n = 124)] Headache 30.2/28.2% Abdominal pain 31/21.8% Rhinitis 25.6/32.3% Decreased appetite *21.7/7.3% Pharyngitis 16.3/15.3% Vomiting 14.7/12.1% Cough increased 13.2/11.3% Nervousness 13.2/6.5% Somnolence 9.3/8.1% Nausea 10.1/10.5% *p < 0.05 vs placebo Not reported CGI–ADHD, Severity ATX baseline (n = 64), mean (SD) 4.9 (0.8), change mean (SD) –1.2 (1.4) Placebo baseline (n = 61) mean (SD) 4.8 (0.8), change mean (SD) –0.5 (1.0) F = 9.5, p = 0.003 ADHD Rating Scale, total ATX baseline (n = 64), mean (SD) 41.2 (8.9), change mean (SD) –15.6 (13.7) Placebo baseline (n = 61), mean (SD) 41.4 (7.9), change mean (SD) –5.5 (11.6) F = 19.0, p < 0.001 CPRS–ADHD Index ATX baseline (n = 59), mean (SD) 27.4 (6.2), change mean (SD) –5.7 (10.4) Placebo baseline (n = 54), mean (SD) 28.7 (5.8), change mean (SD) –2.6 (8.4) F = 5.3, p = 0.023 Weight (kg): mean (SD) ATX (n = 127): baseline 37.0 (12.1); change –0.5 (1.4) Placebo: (n = 122): baseline 37.8 (10.7); change 1.4 (1.4) Placebo > ATX, p < 0.001 ADHD Rating Scale, inattentive subscales ATX baseline (n = 64), mean (SD) 22.0 (3.9), change mean (SD) –7.5 (7.2) Placebo baseline (n = 61), mean (SD) 22.2 (4.0), change mean (SD) –3.0 (6.6) F = 15.2, p < 0.001 © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 ADHD Rating Scale, hyperactive/impulsive subscale ATX baseline (n = 64), mean (SD) 19.3 (6.1), change mean (SD) –8.0 (7.4) Placebo baseline (n = 61), mean (SD) 19.2 (5.5), change mean (SD) –2.5 (5.9) F = 20.0, p < 0.001 Conclusions Authors’ conclusions: ATX significantly reduced ADHD Rating Scale total scores compared with placebo (p < 0.001). Changes in the CGI–ADHD-S (p = 0.003) and CPRS–ADHD Index (p = 0.023) also showed ATX to be statistically superior to placebo in reducing ADHD symptoms. ATX was effective for the treatment of children with ADHD. In addition, ATX was found to be well tolerated Reviewer’s comments: No comments noted 339
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Appendices A systematic review and
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